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ZusammenfassungQualitätsstandards (QS) sind messbare Konstrukte, die helfen sollen, Versorgungslücken quantitativ zu erfassen, um langfristig die Versorgungsqualität zu verbessern. Die Assessment of SpondyloArthritis International Society (ASAS) hat kürzlich erstmals internationale QS für das Management von Patient*innen mit axialer Spondyloarthritis (axSpA) konsentiert und veröffentlicht. Die Deutsche Gesellschaft für Rheumatologie (DGRh) hat daraufhin beschlossen, diese Standards durch eine Gruppe von Expert*innen aus unterschiedlichen Versorgungsbereichen zu übersetzen, zu prüfen und ggf. zu übernehmen. Vor diesem Hintergrund wurden erstmals nationale QS für das Management von Patient*innen mit axSpA für Deutschland entwickelt. Hierbei wurde v. a. auf Machbarkeit und Praxisrelevanz geachtet. Letztlich wurden 9 QS definiert, mit denen die Qualität der Versorgung in Deutschland gemessen und verbessert werden kann bzw. soll.

Zusammenfassung Hintergrund Der oft langsame Beginn einer axialen Spondyloarthritis (axSpA), die initial zum Teil wenig spezifischen Symptome (Rückenschmerzen), aber auch begrenzte Ressourcen und die damit verbundenen Verzögerungen in der rheumatologischen Versorgung sind Faktoren, die zu verspäteter Diagnose und Therapie dieser meist jungen Patienten mit beitragen. Rheumatologische Fachassistenten (RFA) können zur Verbesserung der Versorgung beitragen, indem sie vom Rheumatologen delegierte ärztliche Leistungen übernehmen. Ziel der Arbeit Ziel ist, zu untersuchen, ob geschulte RFA bei Patienten mit chronischem Rückenschmerz und noch unklarer Diagnose mithilfe eines strukturierten Fragebogens anamnestische und klinische Befunde wie Rheumatologen erheben können. Material und Methoden In der multizentrisch durchgeführten PredAS-Studie wurden bei Patienten mit dem Leitsymptom chronischer Rückenschmerz demografische Basisdaten, Anamnese und patientenberichtete Endpunkte mittels strukturierter Fragebögen von RFA und Rheumatologen unabhängig voneinander erfasst. Zudem wurden Funktion (BASFI) und Wirbelsäulenbeweglichkeit (BASMI) standardisiert gemessen. Um die mögliche Erleichterung durch Nutzung digitaler Medien zu testen, wurden 2 Patientengruppen getrennt untersucht: Die Ergebnisse der einen Kohorte wurden mittels papierbasierter Case Report Forms (CRF) und die Ergebnisse der anderen elektronisch mittels iPad dokumentiert. Die Konkordanz der Dokumentationen zwischen RFA und Rheumatologen wurde als Kappa-Koeffizient, als prozentuale Übereinstimmung und auf individueller Patientenebene berechnet. Ergebnisse Bei fast drei Viertel der 141 Patienten mit chronischen Rückenschmerzen wurden Charakteristika des entzündlichen Rückenschmerzes identifiziert. Die Konkordanz bei Dokumentation durch RFA und Arzt war bei den anamnestischen Angaben zum Rückenschmerz höher als bei der Angabe zur Lokalisation des Rückenschmerzes. Bei der Erhebung des BASMI zeigte sich kein Unterschied zwischen RFA und Arzt (ICC 0,925) (95 %-CI 0,879–0,953). Der Zeitaufwand für die strukturierte Dokumentation betrug beim Arzt 20 ± 6,7 min und bei der RFA 28,5 ± 13 min. Diskussion Die Ergebnisse sprechen dafür, dass geschulte RFA die Rheumatologen bei der anamnestischen Aufarbeitung und ersten körperlichen Untersuchung im Rahmen der Diagnosestellung erheblich und qualifiziert unterstützen können.

BackgroundUpadacitinib (UPA) was shown to be safe and effective through 2 years in patients (pts) with active ankylosing spondylitis (AS) naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) in the pivotal phase 2/3 SELECT-AXIS 1 trial.1,2ObjectivesTo assess the efficacy and safety of UPA in pts with active AS with an inadequate response (IR) to bDMARDs.MethodsSELECT-AXIS 2 (NCT04169373) was conducted under a master protocol and includes two separate studies (one for AS bDMARD-IR and one for non-radiographic axial spondyloarthritis [nr-axSpA]). The AS bDMARD-IR study is a randomized, double-blind, placebo (PBO)-controlled, phase 3 trial that enrolled adults ≥18 years with AS who met modified New York criteria, had BASDAI and pt’s assessment of total back pain scores ≥4 (numeric rating scale 0–10) at study entry, and had an IR to one or two bDMARDs (TNF inhibitor or IL-17 inhibitor). Pts were randomized 1:1 to receive oral UPA 15 mg once daily (QD) or PBO during the 14-week (wk) double-blind treatment period. The primary endpoint was ASAS40 response at wk 14. Multiplicity-controlled secondary endpoints evaluated at wk 14 were improvements from baseline in disease activity (ASDAS [CRP], ASDAS ID [ResultsAll 420 randomized pts with active AS received assigned treatment (UPA 15 mg, n=211; PBO, n=209); 409 (97%) received study drug through wk 14. Baseline demographic and disease characteristics were generally similar between treatment groups and reflective of an active AS bDMARD-IR population (74% male; mean age 42.4 years; mean disease duration 7.7 years; 83% HLA-B27 positive; mean BASDAI 6.8). Significantly more pts achieved the primary endpoint of ASAS40 response at wk 14 with UPA vs PBO (45% vs 18%; PP≤0.05). All multiplicity-controlled secondary endpoints met statistical significance for UPA vs PBO at wk 14 across multiple clinical domains of AS (PConclusionUPA 15 mg QD was significantly more effective than PBO over 14 wks of treatment in pts with active AS and IR to bDMARDs. No new safety risks were identified with UPA compared with its known safety profile.3,4 These findings are consistent with and complementary to those of SELECT-AXIS 1 (bDMARD-naïve AS population),1,2 and support the use of UPA in pts with active AS, including those who had a previous IR to bDMARD therapy.References[1]van der Heijde D, et al. Arthritis Rheumatol. 2021;73(suppl 10).[2]van der Heijde D, et al. Lancet. 2019;394(10214):2108–2117.[3]Cohen SB, et al. ARD. 2021;80:304–311.[4]Burmester G, et al. Rheumatol Ther. 2021;1–19.AcknowledgementsAbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsDésirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB, Employee of: Director of Imaging Rheumatology BV, Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, and Werfen, Grant/research support from: AbbVie, Novartis, Joachim Sieper Speakers bureau: AbbVie, Janssen, Merck, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Merck, and Pfizer, Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB., Grant/research support from: AbbVie, GSK, Lilly, Novartis, Pfizer, and UCB, Robert Inman Consultant of: AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, and Sandoz, Grant/research support from: AbbVie, Amgen, and Janssen, Hideto Kameda Speakers bureau: AbbVie, Asahi-Kasei, BMS, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis, and Pfizer, Consultant of: AbbVie, Janssen, Lilly, Novartis, Sanofi, and UCB, Grant/research support from: AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai, and Mitsubishi-Tanabe, Xiaofeng Zeng: None declared, Yunxia Sui Shareholder of: May own AbbVie stock or options, Employee of: AbbVie, Xianwei Bu Shareholder of: May own AbbVie stock or options, Employee of: AbbVie, Aileen Pangan Shareholder of: May own AbbVie stock or options, Employee of: AbbVie, Peter Wung Shareholder of: May own AbbVie stock or options, Employee of: AbbVie, In-Ho Song Shareholder of: May own AbbVie stock or options, Employee of: AbbVie

BackgroundThere are conflicting data regarding effect of nonsteroidal anti-inflammatory drugs (NSAID) on radiographic spinal progression in axial spondyloarthritis (axSpA). The analysis of the first 2-year of the GErman SPondyloarthritis Inception Cohort (GESPIC) showed that higher NSAID intake may retard new bone formation in r-axSpA. It remained, however, unclear, whether cyclooxygenase-2 selective inhibitors (COX2i) might have a stronger effect than non-selective (NS) ones and if the effect could be observed also in nr-axSpA.ObjectivesTo investigate the effect of NSAIDs (COX2i and NS) intake on radiographic spinal progression in patients with r-axSpA and nr-axSpA.MethodsBased on availability of at least two sets of spinal radiographs during 10-year follow-up, 243 patients with early axSpA (130 and 113 nr- and r-axSpA, respectively) from GESPIC were included in this analysis. The patients contributed a total of 540 2-year radiographic intervals. Radiographs were scored by 3 trained and calibrated readers according to modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Final mSASSS was calculated as a mean of 3 readers, and progression was defined as absolute mSASSS change score over 2 years. NSAID type, daily dose, and frequency of intake were recorded at visits. The ASAS index of NSAID intake (0-100) counting both dose and duration of intake was calculated for intervals. The association between NSAID intake (NSAID type and NSAID score) and radiographic spinal progression over 2 years was analysed using longitudinal generalized estimated equations (GEE).ResultsAt baseline, 161 (66.3%) patients were treated with NSAIDs. While 289 (53.5%) and 128 (23.7%) 2-year radiographic intervals were covered by NS and COX-2i respectively, 123 (22.8%) intervals were not covered by NSAID. The significant association between higher NSAID intake and retardation of radiographic spinal progression was found in adjusted multivariable longitudinal GEE analysis. This effect was mostly attributable to patients with r-axSpA (Table 1). mSASSS progression was numerically lower in patients taking COX2i (irrespectively of dose) as compared to patients treated with NS-NSAIDs; in stratified analysis, however, there was no clear dose-dependency (as reflected by NSAID index) in both groups (Figure 1, Table 1).Table 1.The association between radiographic spinal progression (mSASSS change score) and NSAID intake in patients with axSpA in multivariable longitudinal GEEAll axSpA β (95% CI)* (n=461)nr-axSpA β (95% CI)*(n=244)r-axSpA β (95% CI)* (n=217)NSAID intake score, per 10 points-0.04 (-0.09, 0.00)-0.02 (-0.06, 0.02)-0.07 (-0.13, 0.00)NSAID type§ NS inhibitors vs No NSAID0.30(-0.07, 0.66)0.25(-0.07, 0.57)0.26(-0.40, 0.92) COX2i vs No NSAID0.17(-0.19, 0.54)0.15(-0.15, 0.46)0.18(-0.49, 0.85) COX2i vs NS inhibitors-0.12(-0.37, 0.12)-0.10(-0.28, 0.09)-0.08(-0.57, 0.40)Analysis stratified according to NSAID typeNon-selective NSAID intake score, per 10 points-0.06(-0.12, 0.00)-0.04(-0.09, 0.01)-0.07(-0.17, 0.03)COX2 selective NSAID intake score, per 10 points-0.06(-0.13, 0.02)-0.03(-0.07, 0.02)-0.09(-0.18, 0.01)axSpA: axial spondyloarthritis; COX2i, cyclooxygenase-2 selective inhibitors; n, number of current 2-year radiographic intervals in multivariable analyses; NS, non-selective COXi; NSAID, non-steroidal anti-inflammatory drugs.*All multivariable models were adjusted for sex, symptom duration at the beginning of the interval, time-averaged ASDAS the interval, classification as radiographic axSpA, smoking in the interval, mSASSS at the beginning of theinterval, and TNFi use in the interval.§NSAID intake score was added in this model.ConclusionHigher NSAID intake is associated with lower radiographic spinal progression, particularly in r-axSpA patients. COX2i might possess a stronger inhibitory effect on radiographic progression as compared to NS-NSAIDs.Disclosure of InterestsMurat Torgutalp: None declared, Valeria Rios Rodriguez Consultant of: AbbVie, Grant/research support from: Falk e.V, Ani Dilbaryan: None declared, Fabian Proft Speakers bureau: Novartis, Lilly, UCB AbbVie, AMGEN, BMS, Hexal, MSD, Pfizer, Roche and Janssen, Grant/research support from: Novartis, Lilly and UCB, Mikhail Protopopov Consultant of: Novartis and UCB, Maryna Verba: None declared, Judith Rademacher Consultant of: Novartis and UCB, Hildrun Haibel Consultant of: Boehringer, Janssen, MSD, Novartis, Sobi, Roche, Pfizer, AbbVie, and Sobi, Joachim Sieper Speakers bureau: Abbvie, Janssen, Lilly, Merck, Novartis, UCB, Consultant of: AbbVie, Lilly, Merck, Novartis, UCB, Martin Rudwaleit Speakers bureau: AbbVie, Boehringer Ingelheim, Celgen, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB., Consultant of: AbbVie, Boehringer Ingelheim, Celgen, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB., Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, Pfizer.

Obwohl die Pathogenese der Spondyloarthritiden (SpA) in den letzten Jahren intensiv beforscht worden ist, sind die Konsequenzen fur die Therapie eher als gering anzusehen. Fur die Zytokine Tumor-Nekrose-Faktor(TNF)-α und Interleukin(IL)-17 gab es zwar Hinweise auf ihre mogliche Rolle fur die Pathogenese der SpA, ihre herausragende Rolle konnte aber dann erst durch ihre Inhibition in klinischen Studien gezeigt werden, wahrend andere Erfolg versprechende Targets wie IL‑23 oder auch IL‑6 in klinischen Studien nicht als relevant (zumindest bei der axialen Beteiligung) gezeigt werden konnten. Die Mikrobiota des Darms spielt vermutlich eine wichtige Rolle in der Pathogenese, aber noch nicht fur die Therapie der SpA. Schlieslich ist die fruhzeitige, effektive und langfristige Suppression der Entzundung zurzeit die beste Pravention, um langerfristig Ankylose zu verhindern.

Tumor-Nekrose-Faktor-α Inhibitoren (TNFi) sind eine effektive, aber kostenintensive Behandlungsmoglichkeit bei Patienten mit axialer Spondyloarthritis (axSpA), die unter konventioneller Behandlung keine Krankheitskontrolle erreichen. Ziel dieser Studie war es, die Krankheitskosten bei axSpA zu ermitteln fur Patienten mit und ohne TNFi-Behandlung. Basierend auf Routinedaten, wurden Patienten mit axSpA, die zwischen 2011 und 2015 erstmalig TNFi erhielten, identifiziert und verglichen mit einer nach Alter und Geschlecht gematchten Referenzgruppe von axSpA-Patienten ohne TNFi-Behandlung. Die Kosten fur ambulant-arztliche und stationare Versorgung, Arznei‑, Heil- und Hilfsmittelversorgung sowie Arbeitsunfahigkeit wurden uber einen Zeitraum von 2 Jahren analysiert. Bei Patienten mit TNFi-Behandlung umfasste der 2‑Jahres-Zeitraum 1 Jahr vor und 1 Jahr nach dem Beginn der TNFi-Behandlung. Daten von 1455 axSpA-Patienten mit TNFi-Behandlung wurden in die Analysen einbezogen. Die Kosten fur ambulant-arztliche und stationare Versorgung, Arzneimittel (ohne TNFi) und Arbeitsunfahigkeit sind nach Beginn der TNFi-Behandlung signifikant gesunken. Die durchschnittlichen Gesamtkosten stiegen von 6075 € im Jahr vor Beginn der TNFi-Behandlung auf 27.871 € im Jahr nach Beginn der TNFi-Behandlung. Ohne Berucksichtigung der Kosten fur TNFi sanken die Gesamtkosten um 22 % auf 4761 €. Die durchschnittlichen Gesamtkosten der Referenzgruppe von 1455 alters- und geschlechtsgematchten axSpA-Patienten ohne TNFi-Behandlung blieben uber 2 Jahre hinweg stabil: Im ersten Jahr betrugen diese 3939 € und im zweiten Jahr 3832 €. Die TNFi-Behandlung fuhrte zu einem starken Anstieg der Gesamtkosten bei axSpA-Patienten. Ein Teil dieses Kostenanstiegs wurde durch eine Senkung der Kosten fur ambulant-arztliche und stationare Versorgung, Arzneimittel (ohne TNFi) und Arbeitsunfahigkeit kompensiert. Bei axSpA-Patienten ohne TNFi-Behandlung blieben die Krankheitskosten uber 2 Jahre hinweg stabil.

Quality standards (QS) are measurable constructs designed to quantify gaps in care and subsequently to improve quality of care. The Assessment of SpondyloArthritis International Society (ASAS) recently generated and published international QS for the management of patients with axial spondyloarthritis (axSpA) for the first time. The German Society of Rheumatology (DGRh) then decided to translate, review and possibly adopt these standards by a group of experts from different care settings. Against this background, national QS for the management of patients with axSpA for Germany were developed for the first time. The main focus was on feasibility and practical relevance. Ultimately, nine QS were defined with which the quality of care in Germany can and should be measured and improved.Qualitätsstandards (QS) sind messbare Konstrukte, die helfen sollen, Versorgungslücken quantitativ zu erfassen, um langfristig die Versorgungsqualität zu verbessern. Die Assessment of SpondyloArthritis International Society (ASAS) hat kürzlich erstmals internationale QS für das Management von Patient*innen mit axialer Spondyloarthritis (axSpA) konsentiert und veröffentlicht. Die Deutsche Gesellschaft für Rheumatologie (DGRh) hat daraufhin beschlossen, diese Standards durch eine Gruppe von Expert*innen aus unterschiedlichen Versorgungsbereichen zu übersetzen, zu prüfen und ggf. zu übernehmen. Vor diesem Hintergrund wurden erstmals nationale QS für das Management von Patient*innen mit axSpA für Deutschland entwickelt. Hierbei wurde v. a. auf Machbarkeit und Praxisrelevanz geachtet. Letztlich wurden 9 QS definiert, mit denen die Qualität der Versorgung in Deutschland gemessen und verbessert werden kann bzw. soll.

BackgroundRheumatology education today can be very diverse, and you can find everything from structured textbooks to YouTube channels to social media accounts. Peer-reviewed content is still recognized as a very high-quality source of information. App-based content has the advantage of bundling information in one place, always available on the go. However, the majority of offerings are only available in English.ObjectivesAn app was to be created to learn about imaging in rheumatology in a very easy to understand way in different languages, with experts being able to create translated content very easily.MethodsUsing mySQL, Java, Objective C and JavaScript, a case database with specific structure and numerous interactive elements was created for academic teaching. Special functions for the annotation of images were provided. The development was initially for devices with the iOS operating system, and later for Android. Rheumatologists and radiologists worldwide were invited to participate via the social media channels LinkedIn, Instagram, Facebook, Twitter, and TikTok.ResultsThe app, called BerlinCaseViewer, was developed for smartphones, tablets and Mac computers. All information is entered and processed in a web-based database. Using XML files and ZIP archives, the relevant data is then transferred to the mobile apps. Case of the month and learning modules on rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis are available, many in English, Spanish, French, Italian, Portuguese, German, and other languages (Figure 1). In addition to the medical image data, the patient’s medical history is also presented in an exciting way with the help of multiple-choice questions. Only when all questions are answered, the diagnosis becomes visible. Timeline functions can be used to visualize medical courses as well. Colored overlays are used to annotate images and can be placed with pixel precision. The user can decide whether these should be displayed as aids. Content is peer-reviewed before publication.Figure 1.Multi-lingual presentation of medical training cases.ConclusionBerlinCaseViewer is a new approach not only to train medical professionals, but also to connect colleagues and overcome language barriers. As a platform, BerlinCaseViewer is open to all medical professionals to collaborate, whether to contribute their own cases or translate existing cases for use in the local language.References[1]BerlinCaseViewer home page: https://www.berlincaseviewer.de/Disclosure of Interests:Kay-Geert Hermann Shareholder of: Co-founder of BerlinFlame GmbH, Mikhail Protopopov: None declared, Aline Serfaty: None declared, Ihsane Hmamouchi: None declared, Fernando Sommerfleck: None declared, Fabio Macori: None declared, Katharina Ziegeler: None declared, Torsten Diekhoff: None declared, Denis Poddubnyy Shareholder of: Co-founder of BerlinFlame GmbH, Joachim Sieper Shareholder of: Co-founder of BerlinFlame GmbH

BackgroundVitamin D deficiency has been shown to be associated with higher disease activity and severity of several inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease and spondyloarthritis (SpA). It is, however, unknown if vitamin D level might affect the response to treatment with biologic disease-modifying anti-rheumatic drugs (bDMARDs) in patients with SpA.ObjectivesTo investigate the association between vitamin D serum levels and the response to a bDMARD therapy in patients with axial SpA.MethodsPatients with a radiographic axial SpA (r-axSpA), fulfilling the modified New York criteria and starting a bDMARD therapy were recruited between 2015 and 2019 in an extension of the prospective German Spondyloarthritis Inception Cohort (GESPIC-AS). All patients were required to have at inclusion high disease activity (BASDAI >=4 and/or ASDAS >=2.1) despite previous treatment with nonsteroidal anti-inflammatory drugs. Demographics, patient clinical characteristics and vitamin D serum levels were collected at baseline. Disease activity measures (BASDAI, CRP, ASDAS) were assessed at baseline and after 6 months of bDMARD treatment. Vitamin D deficiency was defined as serum level of 25-hydroxyvitamin D < 20 ng/mL. A multivariable regression analysis was performed to determine the association between vitamin D serum level at baseline and the treatment response as defined by BASDAI and ASDAS change scores at month 6 as compared to baseline.ResultsA total of 129 patients with r-axSpA were included in the study. No patient took supplements of vitamin D at baseline. Patients had an average age (mean±SD) of 36.5±10.5 years, 64.3% were males and 86.6% were HLA-B27 positive. The prevalence of vitamin D deficiency in our cohort was 54.3%. Patient characteristics and disease activity were comparable with regard to the presence of vitamin D at baseline (Table 1); with the exception of body mass index (BMI), which was higher in patients with vitamin D deficiency. In the multivariable linear regression analysis, baseline serum level of vitamin D was independently and significantly associated with higher change in BASDAI and ASDAS (Figure 1).Table 1.Baseline characteristics of patients with radiographic axial SpA (n=129) according to vitamin D levels at baseline.Patients with vitamin D deficiency (Patients with normal levels of vitamin Dn=59Age, years36.6±11.036.3±10.0Male sex46 (65.7)37 (62.7)BMI, kg/m226.0±4.5*24.0±3.8Smoking, ever41 (58.6)29 (49.2)Winter and Spring, n (%)33 (47.1)23 (39.0)Symptom duration, years11.5±11.310.3±7.1HLA-B27 positive62 (88.6)50 (84.7)Uveitis ever17 (24.3)12 (20.3)Psoriasis ever11 (15.7)7 (11.9)IBD ever, n (%)2 (2.9)7 (11.9)CRP, mg/L12.9±19.313.9±15.3BASDAI5.7±1.45.4±1.4ASDAS3.4±0.83.5±0.8BASFI4.6±2.24.4±1.9BASMI3.1±1.52.7±1.3NSAID intake, current50 (71.4)45 (76.3)DMARDs intake, ever9 (12.9)6 (10.2)TNFi naive55 (78.6)47 (79.7)Corticoids intake, current5 (7.1)2 (3.4)*p value All numerical variables were presented as mean±SD, all categorical variables were presented as n (%).BMI, body mass index; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; IBD, inflammatory bowel disease; NSAID, nonsteroidal anti-inflammatory drug; TNFi, tumor necrosis factor inhibitor.Figure 1.Association between the response to bDMARDs (change in BASDAI and ASDAS after 6 months) and level of vitamin D at baseline in patients with radiographic axial SpA in the multivariable regression analysis.ConclusionHigher vitamin D levels at baseline may predict a better treatment response to bDMARDs in patients with r-axSpA. It has to be shown, however, if vitamin D supplementation might result in a better treatment response in axial SpA.Disclosure of InterestsNone declared

BackgroundThere is some evidence that NSAIDs, in particular celecoxib (CEL), might possess not only symptomatic efficacy but also disease-modifying properties in radiographic axial spondyloarthritis (r-axSpA) formerly known as ankylosing spondylitis, retarding progression of structural damage in the spine if taken continuously. For biological disease-modifying antirheumatic drugs (bDMARDs), retardation of structural damage progression has also been demonstrated, but at least 4 years of treatment seem to be necessary (at least for tumour necrosis factor inhibitors – TNFi) to see such an effect. Therefore, a combination of an NSAID with a TNFi might bring additional benefits in terms of retardation of structural damage progression especially in high-risk patients.ObjectivesThe aim of this RCT was to evaluate the impact of treatment with the COX-II-selective NSAID (CEL) when added to a TNFi (golimumab - GOL) compared with TNFi (GOL) alone on progression of structural damage in the spine over 2 years in patients with r-axSpA.MethodsEligible patients had r-axSpA and high disease activity (BASDAI ≥4), NSAID failure and risk factors for radiographic spinal progression: C-reactive protein >5 mg/l and/or ≥1 syndesmophyte(s). The trial consisted of two phases: a 12-week run-in phase, in which all included patients received treatment with GOL 50 mg every 4 weeks sc, followed by a 96-week controlled treatment period, in which patients who achieved a BASDAI improvement of ≥2 points were randomly assigned to GOL + CEL 200 mg bid or GOL alone arms. The primary endpoint was radiographic spinal progression as assessed by the change in the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) after 108 weeks in the intent-to-treat population, read by 3 independent readers blinded for the treatment arm and the time-point.ResultsOf the 157 screened patients, 81.5% (n=128) were enrolled into the run-in phase. 109 patients fulfilled the BASDAI response criterion at w12 and were randomized 1:1 (54 vs. 55) to GOL+CEL or GOL alone; 97 (45 vs. 52) patients completed the study at w108. Clinical characteristics of the randomized patients are shown in Tab. 1. The mSASSS change after w108 was 1.1 (95%CI 0.2; 2.0) vs. 1.7 (95%CI 0.8; 2.6) in the GOL+CEL vs. GOL alone groups, respectively, p=0.79. Figure 1 shows the cumulative probability of the mSASSS change in both treatment arms. New syndesmophytes in the opinion of three readers occurred in 11% vs. 25% of the patients in the GOL+CEL vs. GOL alone groups, respectively, p=0.12. During the study, a total of 14 serious adverse events (SAE) were reported (7 in the GOL+CEL group, 5 in the GOL alone group and 2 during the run-in phase).Figure 1.Cumulative probability plot of mSASSS progression over 108 weeks of treatment.ConclusionIn this study, a combined therapy with GOL+CEL did not show significant superiority over GOL monotherapy in retarding radiographic spinal progression over two years in r-axSpA patients.However, the observed numerical reduction in radiographic spinal progression associated with the combined treatment might be, however, clinically relevant for patients at high risk for progression.Table 1.Baseline characteristics of randomized patientsParametersGOL+CEL N=54GOL alone N=55All patients N=109validnvaluevalidnvaluevalidnvalueSex, malen (%)5440 (74.1)5541 (74.5)10981 (74.3)Age, yearsMean (SD)5439.9 (9.9)5537.5 (10.8)10938.7 (10.4)Smokern (%)5319 (35.8)5522 (40)10841 (38)HLA-B27 positivityn (%)5445 (83.3)5147 (92.2)10592 (87.6)BASDAIMean (SD)546.2 (1)556.1 (1.1)1096.1 (1.1)BASMIMean (SD)542.6 (1.9)542.9 (1.4)1082.8 (1.6)CRP > 5 mg/Ln (%)5438 (70.4)5538 (69.1)10976 (69.7)ASDAS-CRPMean (SD)543.6 (0.6)553.7 (0.9)1093.7 (0.8)Prior bDMARDsn (%)5417 (31.5)559 (16.4)10926 (23.9)Presence of ≥ 1 syndesmophyte(s)n (%)5427 (50)5528 (50.9)10955 (50.5)mSASSSMean (SD)5413.5 (16.9)5510.3 (13.2)10911.9 (15.2)AcknowledgementsThe CONSUL study has been supported by a grant from the German Ministry of Education and Research (BMBF), grant number FKZ 01KG1603 and study medication (golimumab) was provided free of charge by MSD Sharp & Dohme GmbH, Munich, Germany.Furthermore we would like to thank Anne Weber, Bianca Mandt, Claudia Lorenz, Hildrun Haibel, Judith Rademacher, Laura Spiller, Petra Tietz as well as all participating rheumatologist and included patients.Disclosure of InterestsFabian Proft Speakers bureau: AMGEN, AbbVie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: Novartis, Grant/research support from: Novartis, UCB, Lilly, Burkhard Muche Speakers bureau: UCB Pharma, AMGEN, Consultant of: UCB Pharma, AMGEN, Valeria Rios Rodriguez Speakers bureau: AbbVie, Falk e.V., Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Joachim Listing: None declared, Maryna Verba: None declared, Uta Kiltz: None declared, Jan Brandt-Juergens: None declared, Maren Sieburg: None declared, Swen Holger Jacki: None declared, Joachim Sieper Speakers bureau: AbbVie, Janssen, Merck, Novartis, Consultant of: Abbvie, Janssen, Lilly, Merck, Novartis, UCB, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer.

BackgroundPatients with chronic inflammatory arthritis (e.g. rheumatoid arthritis; RA) or inflammatory exacerbations of chronic degenerative joint diseases (e.g. osteoarthritis; OA) suffer from recurrent pain, restricted function and reduction of daily activities. The current standard of intraarticular (i.a.) therapy is the injection of steroids, which can increase risk of infection, cartilage degenerations, and other well-known systemic side effects. A novel approach without such complications could be the activation of peripheral opioid receptors, e.g. by i.a. application of small, systemically inactive doses of morphine.ObjectivesThe aim of this randomized placebo-and active drug controlled double blind trial was to investigate reduction of pain in chronic knee arthritis patients following i.a. injections of morphine, a standard steroid (triamcinolone), or placebo. The primary hypothesis was that i.a. morphine results in significantly lower pain scores than placebo. The primary outcome parameter was reduction of the Visual Analogue Scale (VAS) pain at day 7.MethodsAdult patients with chronic knee arthritis because of osteoarthritis (OA) or inflammatory arthritis (IA, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, oligoarthritis or monarthritis) and a high level of pain (VAS pain ≥ 4 out of 10) at baseline received a single dose of either morphine 3 mg i.a., or triamcinolone 40 mg i.a., or placebo (NaCl 0.9%) i.a., Patients were monitored closely throughout the entire study period with a total of 4 visits over weeks and documented pain in the morning and evening in a patient´s diary. Safety data was collected during the whole study period. P-values were calculated using two-sided T-tests.Results114 patients were screened, 93 were treated and 89 (96%) completed day 7. Of these n= 61 (66%) were diagnosed with OA and n= 32 (34%) with IA 48 (52%) patients were female, mean age was 58.5 (SD 14 years) and mean disease duration 6.7 years (median 2 years, range Figure 1.Mean VAS pain over one week in patients with chronic knee arthritis treated with morphine, triamcinolone or placebo as a single intraarticular injection.ConclusionIn this randomized, placebo and active controlled double blind trial a single dose of 3 mg i.a. administered morphine did not lead to significant improvements in comparison to placebo and was inferior to triamcinolone at day 7. The same was true during the first 7 days as shown in the pain documentation in patient diaries. These data does not support the use of i.a. morphine for pain reduction in patients with chronic arthritis.Disclosure of InterestsHildrun Haibel Speakers bureau: AbbVie, MSD, Janssen, Roche and Pfizer, Consultant of: Roche, Boehringer, Janssen, MSD, Novartis, and Sobi, Grant/research support from: BMBF Neuroimpa 01EC1403F, Joachim Sieper Speakers bureau: Abbvie, Janssen, Lilly, Merck,Novartis, UCB, Consultant of: Abbvie, Lilly, Merck, Novartis, UCB, Denis Poddubnyy Speakers bureau: AbbVie, Bristol Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer, Valeria Rios Rodriguez: None declared, Fabian Proft Speakers bureau: Abbvie, BMS, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, BMS, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: Novartis, Judith Rademacher: None declared, Sabrina Igel: None declared, Peter Martus: None declared, Christoph Stein Grant/research support from: BMBF Neuroimpa 01EC1403F.

BackgroundMagnetic resonance imaging (MRI) of the spine and sacroiliac joints (SIJ) are important tools for the diagnosis of axial SpA. However, there is very little data investigating how clinical symptoms and response to treatment relate to the degree of MRI inflammation and to its change over time.ObjectivesTo evaluate the relationship between clinical response in axial SpA patients and inflammation in MRI of spine and SIJ after 6 months of treatment.MethodsIn the ESTHER study1, a total of 76 patients with early axial SpA with a symptom duration less than 5 years, and with active inflammation on MRI in the spine and/or SIJ at baseline were randomized to be treated with etanercept (n=40) or sulfasalazine (n=36) for one year.Clinical and laboratory outcome assessments included C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI) and ankylosing spondylitis disease activity score (ASDAS). The following efficacy parameters were calculated: change in CRP, BASDAI, BASFI and ASDAS between baseline and Week 24; response of the ASAS response criteria for 20 and 40% improvement in disease activity (ASAS20 and ASAS40); and ASAS criteria for partial remission at Week 24.MRI of spine and SIJ were performed at weeks 0, 24, and 48; and were scored by two radiologists, who were blinded for all clinical data, treatment arm and time point, according to the Berlin scoring system. The final osteitis score for the SIJ and for the spine was calculated as the mean score of both readers. Residual inflammation in MRI at Week 24 was defined as an osteitis score of ≥5 for SIJ and >0 for the spine (median values at Week 24).To understand the relationship between MRI and clinical outcomes, two types of models were performed: 1) a model with status scores at baseline and Week 24 for MRI and clinical outcome parameters; and 2) a model with change scores between baseline and Week 24 for MRI and clinical outcome parameters.ResultsA total of 67 patients with axial SpA were included in this analysis due to availability of MRIs at baseline and Week 24. The characteristics of patients included for this analysis were similar to the whole group of the ESTHER study. SIJ and spine osteitis score on MRI at baseline (mean±SD) was 6.9±6.1 and 1.5±2.5, respectively.The status scores showed no association at baseline, neither at Week 24, with the only exception of ASAS20 at Week 24 (Figure 1). However, changes in osteitis score of SIJ and spine were associated to clinical response outcomes between baseline and Week 24 (Figure 1). Further, we compared patients with and without residual inflammation on MRI of the spine and SIJ as defined above. There were no differences between the groups regarding clinical response and disease activity at week 24.Figure 1.Association between disease activity parameters and MRI osteitis score in spine and SIJ in patients with axial spondyloarthritis over 6 months of treatment. Each line in the figure refers to an outcome (dependent variable) in the multivariable regression analysis, which were adjusted for age, sex, symptom duration and HLA-B27 positivity. MRI, magnetic resonance imaging; SIJ, sacroiliac joints.ConclusionChange of score for osteitis in MRI of spine and SIJ was associated to disease activity in patients with axial SpA during 6 months of treatment. Presence of residual inflammation on MRI after 6 months of treatment seems to be irrelevant regarding clinical response and clinical disease activity.References[1]Song IH, et al. Ann Rheum Dis. 2011;70(4):590-596.AcknowledgementsThe ESTHER study was supported by an unrestricted research grant from Pfizer. We would like to thank to Anja Weiß and Christian Althoff who participated in the analysis of the study.Disclosure of InterestsValeria Rios Rodriguez Speakers bureau: Falk e.V., Consultant of: AbbVie, Murat Torgutalp: None declared, Hildrun Haibel Speakers bureau: MSD, Janssen, Roche, Pfizer, Novartis, AbbVie, and Sobi, Consultant of: Boehringer, Janssen, MSD, Novartis, Sobi, Kay-Geert A Hermann: None declared, Fabian Proft Speakers bureau: AbbVie, AMGEN, BMS, Hexal, MSD, Pfizer, Roche and Janssen, Grant/research support from: Novartis, Lilly and UCB, Mikhail Protopopov: None declared, Judith Rademacher: None declared, Joachim Sieper Speakers bureau: Abbvie, Janssen, Lilly, Merck,Novartis, UCB, Consultant of: AbbVie, Lilly, Merck, Novartis, UCB, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB., Consultant of:: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, Pfizer

The often slow onset of ankylosing spondylitis (AS), the initially partially unspecific symptoms (back pain) and the scarcity of resources in rheumatological care are important factors leading to delayed diagnosis and treatment of these mostly young patients in Germany. Qualified nurses specialized in rheumatology might improve quality of care by providing medical services delegated by the rheumatologists.The aim was to investigate whether qualified nurses specialized in rheumatology can interpret anamnestic and clinical findings such as rheumatologists in patients with chronic low back pain and still unclear diagnosis using a structured questionnaire.In the multicenter PredAS study a structured anamnestic questionnaire was applied independently by qualified nurses specialized in rheumatology and rheumatologists to patients referred to rheumatology practices with the leading symptom of low back pain. The questionnaire covered basic demographic data, medical history and patient reported outcomes. Additionally, measurements of physical function using the Bath ankylosing spondylitis functional index (BASFI) and spinal mobility using the Bath ankylosing spondylitis metrology index (BASMI) were standardized. In order to test the possible facilitation by using digital media, the results of two patient groups were separately documented on paper-based report forms and on an i‑pad. Concordance between documentation by qualified nurses specialized in rheumatology and rheumatologists was studied by calculating Cohen's kappa, intraclass correlation coefficients (ICC) and percentage agreement on an individual patient level.Nearly 75% of the 141 patients with chronic low back pain were identified as having the characteristics of inflammatory back pain. The concordance of the documentation for the anamnesis of back pain by qualified nurses specialized in rheumatology and physicians was higher than for the localization of the back pain. The results for the BASMI showed no differences between qualified nurses specialized in rheumatology and physicians (ICC 0.925, 95 % confidence interval, CI 0.879-0.953). The time taken for the structured documentation was 20 ± 6.7 min for physicians and 28.5 ± 13 min for qualified nurses specialized in rheumatology.The results indicate that well-trained qualified nurses specialized in rheumatology have a high potential to take over some of the workload from rheumatologists during documentation of the anamnesis and the initial physical examination in the diagnosis of ankylosing spondylitis.HINTERGRUND: Der oft langsame Beginn einer axialen Spondyloarthritis (axSpA), die initial zum Teil wenig spezifischen Symptome (Rückenschmerzen), aber auch begrenzte Ressourcen und die damit verbundenen Verzögerungen in der rheumatologischen Versorgung sind Faktoren, die zu verspäteter Diagnose und Therapie dieser meist jungen Patienten mit beitragen. Rheumatologische Fachassistenten (RFA) können zur Verbesserung der Versorgung beitragen, indem sie vom Rheumatologen delegierte ärztliche Leistungen übernehmen.Ziel ist, zu untersuchen, ob geschulte RFA bei Patienten mit chronischem Rückenschmerz und noch unklarer Diagnose mithilfe eines strukturierten Fragebogens anamnestische und klinische Befunde wie Rheumatologen erheben können.In der multizentrisch durchgeführten PredAS-Studie wurden bei Patienten mit dem Leitsymptom chronischer Rückenschmerz demografische Basisdaten, Anamnese und patientenberichtete Endpunkte mittels strukturierter Fragebögen von RFA und Rheumatologen unabhängig voneinander erfasst. Zudem wurden Funktion (BASFI) und Wirbelsäulenbeweglichkeit (BASMI) standardisiert gemessen. Um die mögliche Erleichterung durch Nutzung digitaler Medien zu testen, wurden 2 Patientengruppen getrennt untersucht: Die Ergebnisse der einen Kohorte wurden mittels papierbasierter Case Report Forms (CRF) und die Ergebnisse der anderen elektronisch mittels iPad dokumentiert. Die Konkordanz der Dokumentationen zwischen RFA und Rheumatologen wurde als Kappa-Koeffizient, als prozentuale Übereinstimmung und auf individueller Patientenebene berechnet.Bei fast drei Viertel der 141 Patienten mit chronischen Rückenschmerzen wurden Charakteristika des entzündlichen Rückenschmerzes identifiziert. Die Konkordanz bei Dokumentation durch RFA und Arzt war bei den anamnestischen Angaben zum Rückenschmerz höher als bei der Angabe zur Lokalisation des Rückenschmerzes. Bei der Erhebung des BASMI zeigte sich kein Unterschied zwischen RFA und Arzt (ICC 0,925) (95 %-CI 0,879–0,953). Der Zeitaufwand für die strukturierte Dokumentation betrug beim Arzt 20 ± 6,7 min und bei der RFA 28,5 ± 13 min.Die Ergebnisse sprechen dafür, dass geschulte RFA die Rheumatologen bei der anamnestischen Aufarbeitung und ersten körperlichen Untersuchung im Rahmen der Diagnosestellung erheblich und qualifiziert unterstützen können.

Background:There are inconclusive data on the effect of tumor necrosis factor inhibitors (TNFi) on radiographic spinal progression in axial spondyloarthritis (axSpA). Although inflammation and new bone formation are linked in axSpA, TNFi failed to show inhibition of radiographic spinal progression over two years compared to historical cohorts in pivotal studies in radiographic axSpA. Subsequent observational studies suggested that a longer treatment duration, earlier treatment initiation and effective inflammation suppression might be required to achieve inhibition of radiographic progression.Objectives:The aim of the current study was to evaluate the effect of TNFi on radiographic spinal progression in patients with early axSpA in a long-term inception cohort.Methods:A total of 266 patients with early axSpA (with r-axSpA with symptom duration ≤10 years and nr-axSpA with symptom duration ≤5 years) from the German Spondyloarthritis Inception Cohort (GESPIC) with at least two sets of spinal radiographs obtained at least 2 years apart during a 10-year follow-up were included. These patients contributed with a total of 542 2-year radiographic intervals. Spinal radiographs were evaluated by three trained and calibrated readers according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The final mSASSS was calculated as a mean of three reader scores. The association between the current TNFi, previous TNFi and radiographic spinal progression defined as the absolute mSASSS change score over 2 years was analyzed using longitudinal generalized estimating equations (GEE) analysis.Results:Only 9 patients were treated with a tumor necrosis factor inhibitor (TNFi) at baseline, and a total of 77 patients received TNFi during the entire follow-up period that gave 103 2-year intervals covered by TNFi of any duration, and 78 intervals covered by TNFi with treatment duration of at least 12 months. Radiographic spinal progression in axSpA patients receiving TNFi in the current 2-year interval was not different from progression in patients not treated with TNFi, while TNFi in the previous 2-year interval was associated with lower progression compared to patients without TNFi in this interval (Figure 1). The latter was also evident for patients who received TNFi in both previous and current 2-year intervals, i.e. patients treated with TNFi over 4 years. The longitudinal GEE analysis confirmed no significant association between current TNFi treatment and radiographic spinal progression but a significant association between TNFi in the previous 2-year interval (especially if this was continued also in the current interval giving 4 years in total) and the progression in the current one (Table 1).Table 1.The association between the change of the mSASSS over two years and current and/or previous treatment with TNFi in the longitudinal generalized estimation equation analysis.TNFi treatment definitionReferenceβ*(95% CI)TNFi for ≥12 months in the previous 2-year intervalTNFi for ≥12 months in the current 2-year intervalYesNo TNFi for ≥12 months in the current 2-year interval-0.19(-0.56 to 0.18)YesNo TNFi for ≥12 months in the previous 2-year interval-0.56(-0.95 to -0.17)YesYesNo TNFi for ≥12 months in the current and previous 2-year intervals-0.59(-1.03 to -0.15)*Parameter estimates from the multivariable models adjusted for sex, symptom duration at the beginning of the current 2-year interval, time-averaged ASDAS in the current 2-year interval, smoking in the current 2-year interval, classification as non-radiographic or radiographic axSpA, and mSASSS at the beginning of the current 2-year interval.Conclusion:TNFi treatment exhibits a time-shifted inhibitory effect on radiographic spinal progression in axSpA that becomes evident only in the second 2-year interval after treatment initiation.Acknowledgements:GESPIC was initially supported by the BMBF. As consequence of the funding reduction by BMBF according to schedule in 2005 and stopped in 2007, complementary financial support has been obtained also from Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. Starting from 2010, the core GESPIC cohort was supported by AbbVie.Disclosure of Interests:Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Valeria Rios Rodriguez: None declared, Murat Torgutalp: None declared, Ani Dilbaryan: None declared, Maryna Verba: None declared, Fabian Proft: None declared, Mikhail Protopopov: None declared, Judith Rademacher: None declared, Hildrun Haibel: None declared, Joachim Sieper: None declared, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

Background:Upadacitinib (UPA) was efficacious and well tolerated vs placebo (PBO) during the first 14 weeks (wks) of the phase 2/3 SELECT-AXIS 1 study in patients (pts) with active ankylosing spondylitis (AS) who had an inadequate response to NSAIDs.1Objectives:To report efficacy and safety of UPA through 1 year in the SELECT-AXIS 1 study.Methods:In SELECT-AXIS 1 (NCT03178487) pts were randomized 1:1 to UPA 15 mg once daily (QD) or PBO; at wk 14, pts continued in the 90-wk open-label extension and received UPA 15 mg QD; reported here are data up to wk 64. The study enrolled pts (≥18 y) with active AS (defined as BASDAI ≥4 and pt assessment of back pain ≥4 [numeric rating scale, 0–10] at screening and baseline [BL]) who had inadequate response to ≥2 NSAIDs or intolerance to or contraindication for NSAIDs and were biologic DMARD naive. Efficacy assessments included percentage of pts with Assessment of SpondyloArthritis international Society (ASAS) 20/40 response, ASAS partial remission, BASDAI50, AS Disease Activity Score (ASDAS) and change from BL in ASDAS and BASFI. Data are reported as observed and by using non-responder imputation (NRI). Treatment-emergent adverse events (TEAEs) were reported as events per 100 patient-years (PY) up to January 31, 2020.Results:Of 187 pts, 178 pts (each n=89 for UPA and PBO arms) completed wk 14 on study drug and entered the open-label extension; 160 pts completed wk 64. Efficacy was maintained or continued to improve throughout the study in the continuous UPA group: 85% (95% CI, 77%–93%) of pts achieved ASAS40 at wk 64 in the as-observed analysis and 72% (63%–81%) in the NRI analysis (Figure). Pts who switched from PBO to UPA at wk 14 showed similar speed of onset and magnitude of response vs pts initially randomized to UPA: 81% (95% CI, 72%–89%) in the as-observed analysis and 70% (61%–80%) in the NRI analysis achieved ASAS40 at wk 64 (Figure). Similar results were observed for other efficacy endpoints (Figure). Among all 182 pts receiving UPA, 618 AEs were reported. AEs leading to discontinuation and serious AEs were low (Table). No serious infections, active tuberculosis, venous thromboembolic events, gastrointestinal perforation, major adverse cardiovascular events, renal dysfunction, or deaths were reported.Table 1.TEAEs per 100 PYsEvents/(E/100 PY)UPA 15 mg QDN=182 (237.6 PY)Any AE618 (260.1)Serious AE14 (5.9)AE leading to discontinuation15 (6.3)Infections205 (86.3) Opportunistic infection*2 (0.8) Herpes zoster†5 (2.1)Creatine phosphokinase elevation‡28 (11.8)Hepatic disorder§24 (10.1)Neutropenia||7 (2.9)Anemia||3 (1.3)Lymphopenia||2 (0.8)Malignancy¶1 (0.4)Death0AE, adverse event; PY, patient-year; QD, once daily; TEAE, treatment-emergent AE; UPA, upadacitinib.*Two non-serious events of esophageal candidiasis in the same patient.†Five events in 4 patients; all non-serious and limited to 1 dermatome.‡All events were non-serious and none led to study drug discontinuation; majority were asymptomatic.§Majority based on asymptomatic alanine aminotransferase/aspartate aminotransferase elevations; all were non-serious and none led to study drug discontinuation.||All events were non-serious and none led to study drug discontinuation.¶Squamous cell carcinoma of tongue in 61-year-old male former smoker; no reasonable possibility to be study drug related per investigator.Conclusion:UPA 15 mg QD showed sustained and consistent efficacy over 1 year. Pts who switched from placebo to UPA at wk 14 showed a similar efficacy response compared with pts who received continuous UPA. No new safety findings were observed compared with safety data from the UPA clinical development program in other indications.2References:[1]van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.[2]Cohen, et al. Arthritis Rheumatol. 2019;71(suppl 10).Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by M Hovenden and J Matsuura of ICON plc (North Wales, PA) and was funded by AbbVie.Disclosure of Interests:Atul Deodhar Speakers bureau: Novartis, Pfizer, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB, Désirée van der Heijde Consultant of: AbbVie, BMS, Cyxone, Eisai, Galapagos, Gilead, GlaxoSmithKline, Lilly, Novartis, Pfizer, and UCB Pharma, Joachim Sieper Speakers bureau: AbbVie, Janssen, Lilly, Merck, and Novartis, Consultant of: AbbVie, Janssen, Lilly, Merck, and Novartis, Filip van den Bosch Speakers bureau: AbbVie, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Walter P Maksymowych Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Novartis and Pfizer, Tae-Hwan Kim Speakers bureau: AbbVie, Celltrion, Kirin, Lilly, and Novartis, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Lilly, Novartis, Pfizer, UCB, Gilead, and Paradigm, Bernard Combe Speakers bureau: AbbVie, Lilly, Merck, Consultant of: AbbVie, Lilly, Gilead, Janssen, Novartis, Roche-Chugai, and Sanofi, Grant/research support from: AbbVie and Lilly, Yunxia Sui Shareholder of: AbbVie, Employee of: AbbVie, xin wang Shareholder of: AbbVie, Employee of: AbbVie, Alvina Chu Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie

Background:The diagnostic approach in axial spondyloarthritis (SpA) relies on a estimation of the post-test disease probability that is based on evaluation of positive and negative results of diagnostic tests in the context of the pre-test disease probability.Objectives:To evaluate the diagnostic value of SpA parameters and their combination for the diagnosis of axial SpA in patients with an a priori different probability of the diagnosis.Methods:A total of 361 patients with chronic back pain and suspicion of axial SpA (181 referred by primary care physicians or orthopaedists, 180 recruited via an online screening tool) received a structured rheumatologic examination as a part of the OptiRef study [1], which resulted into a diagnosis or exclusion of axial SpA. The prevalence of axial SpA indicating the pre-test probability was 40% in the physician-referred subgroup and 20% in the online screening subgroup. Sensitivities, specificities, and likelihood ratios (LRs) for SpA features were determined in both subgroups and the respective post-test probabilities of axial SpA were calculated.Results:The relative diagnostic value of single SpA features varied substantially between the groups with different referral pathways – see the online disease probability calculator http://www.axspa.de/calculator.html. It can be seen that the diagnostic values of the SpA parameters vary substantially between the groups. For instance, HLA-B27 positivity increased the probability of the presence of axial SpA by 35% to 55% in online-screened patients and by 22% to 62% in physician-referred patients. Furthermore, the absence of HLA-B27 resulted in a sharp decrease in the probability of the presence of axial SpA in physician-referred patients (from 40% to 6%). This decrease was less sharp in the online screening group (from 20% to 10%). Furthermore, combinations of parameters performed differently in the studied subgroups. Figure 1 illustrates that the observed differences in the diagnostic values of the SpA parameters in different subgroups were only clinically relevant in the presence of a low number of positive test results. For instance, combining IBP with anterior uveitis increased the post-test probability for axial SpA to 78% in the online screening group and to 87% in the physician-referred group, whereas using HLA-B27 positivity and active sacroiliitis on MRI in combination with IBP resulted in a surge in the post-test probability of the presence of axial SpA to around 95% in both groups.Conclusion:The diagnostic value of a single diagnostic test in the clinical practice is not fixed and a number of factors including the referral pathway can affect it. Fluctuation of the diagnostic values is especially relevant when the number of positive parameters is low (1-2).References:[1]Proft F, et al. Semin Arthritis Rheum. 2020;50:1015-1021.Acknowledgements:The OptiRef study was supported by a research grant from Novartis.Disclosure of Interests:None declared

Background:Diet has been previously described as an impact factor on the course of rheumatic diseases, such as rheumatoid arthritis and systemic lupus erythematosus (SLE). It has been previously reported that dietary sugar intake may contribute to subclinical inflammation and disease activity in SLE. However, there is very little investigation on the possible association between nutritional parameters and their influence on spondyloarthritis (SpA).Objectives:To investigate the possible impact of nutritional parameters on the disease activity in patients with SpA.Methods:Patients with radiographic axial SpA and starting a biological therapy were recruited between 2015 and 2019 in an extension of the prospective German Spondyloarthritis Inception Cohort (GESPIC). Dietary habits were collected at baseline using the country-specific validated food frequency questionnaire (FFQ) developed for the use in the German Health examination Survey for Adults 2008-2011. The FFQ includes questions about the frequency and amount of 53 food items, consumed during the past 4 weeks, and enabled to compute individual mean consumptions of foods in grams per day. Total energy intake (in Kcal per day) and nutritional parameters: carbohydrates, free sugars, total fats, saturated fats, mono and poly-unsaturated fats, proteins and dietary fiber, were calculated for each patient using a nutrition organization software and the database of Federal Food Code (Bundeslebensmittelschlüssel), version 3.02. Disease activity measures (BASDAI, CRP and ASDAS), as well as height, weight and body mass index (BMI) were assessed at baseline before starting the biological treatment.Results:A total of 104 patients from 129 patients with axial SpA enrolled in the cohort were included in this nutritional analysis. The mean age (mean±SD) was 37.0±11.0 years old with symptoms duration of 11.3±9.9 years, 68.3% were males, and 86.5% were HLA-B27 positive. Patients presented BMI of 25.1±4.3 kg/m2, BASDAI 5.6±1.4, CRP 14.0±18.2 mg/l, and ASDAS 3.5±1.0.In the univariable and multivariable regression analysis, a higher energy intake and carbohydrates were associated with higher disease activity, measured by ASDAS, BASDAI and CRP. This association was attributable to the full intake of carbohydrates and specifically to the total of free sugars (monosaccharides and disaccharides) and the decrease of dietary fiber as shown in the multivariable analyses (Figure 1). This effect was independent of age, sex, smoker status and BMI.Conclusion:A higher intake of carbohydrates and a higher consumption of free sugars are associated with higher disease activity in patients with AS.Figure 1.Multivariable linear regression analysis of the association between CRP and nutritional parameters in patients with radiographic axial SpA (n=104), adjusted for age, sex, body mass index and smoker status. Model 1 included variable of total energy intake, model 2 included variable of total intake of carbohydrates (CH) and model 3 included variable of free-sugar (monosaccharides and disaccharides).B, linear regression coefficient; CH, carbohydrates; CI, confidence interval; MS-FA, monosaturated fatty acids; PuS-FA, polyunsaturated fatty acids, S-FA, saturated fatty acids.Disclosure of Interests:None declared.

Introduction Ixekizumab, un anticorps monoclonal ayant une forte affinite pour l’IL-17A, a deja demontre son efficacite dans la spondyloarthrite axiale radiographique [1] , [2] . COAST-X (NCT02757352) est une etude de phase 3 qui a permis d’evaluer l’efficacite et le profil de tolerance d’ixekizumab chez des patients souffrant de spondyloarthrite axiale non-radiographique active avec des signes objectifs d’inflammation. Patients et methodes COAST-X etait une etude controlee versus placebo, randomisee, menee en double aveugle pendant une duree de 52 semaines, ayant inclus des patients atteints de spondyloarthrite axiale non-radiographique repondant aux criteres de classification ASAS (mais pas aux criteres de New York modifies), avec un BASDAI ≥ 4, des douleurs rachidiennes ≥ 4, des signes objectifs d’inflammation (sacroiliite a l’IRM et/ou une CRP > 5 mg/L), et une reponse inadequate ou une intolerance aux anti-inflammatoires non steroidiens. La lecture de l’imagerie etait centralisee. La randomisation etait stratifiee sur le pays et la presence de signes d’inflammation (IRM/CRP), et la repartition entre les groupes faite selon un ratio 1 :1 :1 pour recevoir ixekizumab 80 mg toutes les 4 semaines, ixekizumab 80 mg toutes les 2 semaines, ou un placebo. Des modifications des traitements conventionnels concomitants ainsi que le recours a un traitement de secours par ixekizumab 80 mg toutes les 2 semaines administre en ouvert, etaient autorises apres la semaine 16, a la discretion de l’investigateur. Le critere de jugement principal etait le taux d’ASAS40 evalue aux semaines 16 et 52. Les patients avec des donnees manquantes et ceux qui ont eu recours au traitement de secours par ixekizumab toutes les 2 semaines ont ete consideres comme non repondeurs. Resultats Au total, 303 patients ont ete randomises pour recevoir du placebo (n = 105), ixekizumab 80 mg toutes les 4 semaines (n = 96), ixekizumab 80 mg toutes les 2 semaines (n = 102). Significativement plus de patients ont atteint la reponse ASAS40 a la semaine 16 dans les groupes ixekizumab 80 mg toutes les 2 semaines (40 %) et ixekizumab 80 mg toutes les 4 semaines (35 %) par rapport au placebo (19 %, p Conclusion Cette etude a demontre l’efficacite symptomatique de l’ixekizumab a la dose de 80 mg, administre toutes les 2 ou de 4 semaines, chez les patients souffrant de spondyloarthrite axiale non-radiographique avec des signes objectifs d’inflammation et ce, sans signal inattendu de securite.

Introduction Les patients avec un diagnostic clinique de spondyloarthrite (SpA) (en incluant le rhumatisme psoriasique – Rhpso) peuvent avoir des symptomes principalement peripheriques ou principalement axiaux. Cependant, des chevauchements entre ces symptomes sont frequents et ils n’existent pas de sous-groupes clairement definis. L’objectif de cette etude a ete d’identifier des groupes des manifestations musculosquelettiques peripheriques selon leur localisation anatomique dans le spectre des SpA (en incluant le Rhpso). Patients et methodes Etude transversale et internationale avec 24 pays participants. Des patients consecutifs avec un diagnostic de SpA axiale (axSpA), SpA peripherique (pSpA), rhumatisme psoriasique (Rhpso), SpA associe a maladie inflammatoire de l’intestin (SpA-MICI), arthrite reactive (ReA) et SpA juvenile ont ete eligibles. Une analyse de cluster pour chaque manifestation peripherique musculosquelettique (affection articulaire peripherique, enthesite et dactylite) a ete realisee en utilisant des donnees sur la localisation anatomique de ces symptomes observes a n’importe quel moment de la maladie. La distribution de ces manifestations peripheriques et les caracteristiques cliniques ont ete comparees entre les differents clusters. Resultats Un total de 4465 patients ont ete inclus. Trois clusters ont ete trouves selon la localisation de l’affection articulaire, nommes « arthrite rare (a) », « principalement membres inferieurs (b) » et « principalement mains (c) ». Les patients du groupe « a » avaient, en comparaison avec les groupes « b » et « c », une prevalence plus importante d’hommes (63,9 % vs 51,3 % vs 41,5 %), de HLA-B27 (79,8 % vs 48,2 % vs 34,8 %) et de diagnostic de axSpA (67,2 % vs 20,9 % vs 23,7 %), mais une prevalence plus basse de psoriasis (23,2 % vs 67,8 % vs 59,6 %) et de diagnostic de Rhpso (17,2 % vs 61,7 % vs 58,5 %). Entre les clusters « b » et « c », l’uveite etait plus frequente chez le premier (15,7 % vs 8,7 %), tandis que la maladie inflammatoire de l’intestin etait plus frequente chez le deuxieme (3,5 % vs 6,7 %). Concernant la localisation de l’enthesite, nous avons trouve aussi 3 clusters, nommes « enthesite du talon (d) », « enthesite axiale (e) » et « polyenthesite (f) ». Les patients du cluster « f » avaient une frequence plus eleve de fibromyalgie concomitante (41,3 % vs 17,4 % vs 31,3 %), de psoriasis (48,3 % vs 28,4 % vs 23,4 %) et de Rhpso (40,8 % vs 22,7 % vs 21,5 %) en comparaison avec les groupes « d » et « e », mais une prevalence moindre d’hommes (40 % vs 61,9 % vs 56,2 %) et de diagnostic d’axSpA (37,5 % vs 61,4 % vs 64,1 %). Finalement, nous avons trouve 3 clusters selon la localisation des dactylites : « absence de dactylite (g) », « principalement orteils (h) » et « principalement doigts (i) ». Le groupe « g » a montre, en comparaison avec les groupes « h » et « i », la plus grande prevalence d’hommes (61,4 % vs 51,4 % vs 52,9 %), de HLA-B27 (66,6 % vs 52,5 % vs 50,0 %) et de diagnostic d’axSpA (62,6 % vs 20 % vs 11,8 %), mais la plus basse frequence de psoriasis (26,9 % vs 68,6 % vs 79,4 %) et de diagnostic de Rhpso (21,5 % vs 65,7 % vs 52,9 %). Conclusion Cette etude suggere la presence de groupes heterogenes d’affection peripherique chez des patients atteints de SpA (et Rhpso) sans groupes clairement definis, ce qui confirme un clair chevauchement entre les differents sous-types de SpA.

Introduction L’efficacite et la tolerance d’UPA, un inhibiteur de JAK, a ete demontree vs PBO au cours des 14 premieres semaines (S) de l’etude de phase 2/3 SELECT-AXIS1 chez des pts atteints de spondylarthrite ankylosante (SA) active ayant eu une reponse inadequate aux AINS [1] . L’objectif de cette analyse intermediaire est de rapporter l’efficacite et la tolerance d’UPA a 1 an dans l’etude SELECT-AXIS 1. Patients et methodes SELECT-AXIS1 ( NCT03178487 ) comprend une periode randomisee, controlee vs PBO, de 14S, suivie d’une extension en ouvert (OLE) de 90S. Nous rapportons ici les donnees jusqu’a S64. L’etude a inclus des pts (≥ 18 ans) atteints de SA active (definie par BASDAI ≥ 4 et evaluation de la douleur rachidienne par le pt ≥ 4 [EVA, 0–10] lors de la selection et a l’inclusion) ayant eu une reponse inadequate a ≥ 2 AINS ou une intolerance ou une contre-indication aux AINS et qui etaient naifs de bDMARD. A l’inclusion, les pts etaient randomises selon un ratio 1 :1 pour recevoir UPA 15 mg 1x/j ou un PBO. A partir de S14, les pts ont continue dans l’OLE et ont recu UPA 15 mg 1x/j. L’evaluation de l’efficacite incluait le % de repondeurs ASAS20/40, ASAS-PR, BASDAI50 et ASDAS et la variation des scores ASDAS et BASFI par rapport a l’inclusion. Les donnees sont rapportees a la fois telles qu’observees (AO) et en utilisant, pour les donnees manquantes, la methode d’imputation des non-repondeurs (NRI) pour les variables binaires ou un modele a effets mixtes pour mesures repetees pour les variables continues. Les evenements indesirables (EI) ont ete evalues tout au long de l’etude et sont rapportes en nombre d’evenements pour 100 patients-annee (PA) jusqu’au 31 janvier 2020. Resultats Sur 187 pts, 178 pts (n = 89 dans chacun des bras UPA et PBO) ont termine la S14 et sont entres dans l’OLE ; 160 pts ont termine la S64. L’efficacite a ete maintenue ou s’est amelioree pendant toute l’etude dans le groupe UPA en continu : reponse ASAS40 a S64 : 85 %(IC95 %, 77 %–93 %) (AO) et 72 %(CI95 %, 63 %–81 %) (NRI) ( Fig. 1 ). Les pts du bras PBO traites par UPA a partir de S14 ont montre une reponse de rapidite et d’ampleur similaires a celle observee chez les pts randomises a l’inclusion pour recevoir UPA : 81 %(IC95 %, 72 %–89 %)–(AO) et 70 %(61 %–80 %)-(NR)I des pts etaient repondeurs ASAS40 a S64 ( Fig. 1 ). Des resultats similaires etaient observes pour d’autres criteres d’evaluation de l’efficacite. Parmi les 182 pts traites par UPA (237,6 PA), 618 EI (260,1/100 PA) ont ete rapportes. Les EI ayant entraine l’arret du traitement (15 evts [6,3/100 PA]) et les EI graves (14 evts [5,9/100 PA]) ont ete peu nombreux. Aucun cas d’infection grave, de tuberculose active, d’evt thromboembolique veineux, de perforation gastro-intestinale, d’EI CV majeur, d’insuffisance renale ou de deces n’a ete rapporte. Conclusion UPA 15 mg 1x/j a montre une efficacite constante et maintenue sur 1 annee. Une efficacite similaire a ete observee pour les pts du bras PBO traites par UPA a partir de S14 par rapport aux pts traites par UPA depuis l’inclusion. Aucun nouveau signal de tolerance n’a ete observe par rapport aux donnees du programme clinique d’UPA dans d’autres indications [2] .

Background: In 2010 the latest ASAS-EULAR recommendations for ankylosing spondylitis and the ASAS recommendations for the use of TNF-inhibitors (TNFi) have been published. Since then new treatments for axial Spondyloarthritis (axSpA) have become available. Aim: To update and integrate the two sets[for full text, please go to the a.m. URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Background:Upadacitinib (UPA) has been shown to be effective in patients with active ankylosing spondylitis (AS) [1]. However, improvements in global functioning and health-related quality of life (HRQoL) in these patients, and their relationship with established clinical response measures have not been fully characterized.Objectives:To evaluate the effect of UPA on the Assessment of SpondyloArthritis international Society Health Index (ASAS HI) and Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire and quantify incremental improvements in ASAS HI and ASQoL response in patients achieving established AS disease activity and physical function improvements at Week (Wk) 14.Methods:This was a post-hoc analysis of the SELECT-AXIS 1 trial [1]. Patients received either UPA 15 mg once daily or placebo (PBO) for 14 wks. Mean change in ASAS HI and ASQoL from baseline (BL) to Wks 4, 8 and 14 for UPA and PBO were calculated and UPA vs PBO responses were compared. Changes in ASAS HI and ASQoL above the minimum clinically important difference (MCID ≥3-point improvement for both measures) and ASAS HI ‘good health state’ (ASAS HI score ≤5) at Wk 14 were determined. Changes from BL in ASAS HI and ASQoL were assessed within the combined UPA and PBO group reaching established improvement thresholds across AS clinical response measures (ASAS response criteria, ASDAS improvement criteria, and BASFI MCID) at Wk 14. Mean ASAS HI and ASQoL changes across groups within each measure and magnitude of ASAS HI and ASQoL change between responders and non-responders were compared.Results:UPA treatment resulted in significant improvement from BL in ASAS HI and ASQoL at Wk 14 with more patients achieving a MCID and ASAS HI good health state vs PBO (Table). Significant improvements were observed earlier for ASAS HI than for ASQoL, starting at Wk 4. At Wk 14, achievement of clinical improvement thresholds was associated with increasing improvements in both ASAS HI and ASQoL scores (Figures 1 and 2). The magnitude of improvement between the best and worst response categories was greater for ASAS HI than ASQoL: 43-fold vs 7-fold for ASAS response, 5-fold vs 3.8-fold for ASDAS improvement, and 34-fold vs 10.4-fold for BASFI MCID achievement.Table.ASAS HI and ASQoL Outcomes at Week 14ASAS HIASQoLOutcomeUPA(n=93)PBO(n=94)UPA(n=93)PBO(n=94)LSM change from baseline-2.8a-1.4-4.2a-2.7Achievement of MCID (≥3-point improvement)c, n/N (%)38/85 (44.7)b24/89 (27.0)51/83 (61.4)b37/86 (43.0)ASAS HI good health state (ASAS HI score ≤5)d, n/N (%)33/74 (44.6)b15/71 (21.1)NANAapbpcIn patients with ASAS HI/ASQoL score ≥3 at baselinedIn patients with ASAS HI >5 at baselineLSM, least squares mean; NA, not applicableConclusion:UPA treatment in patients with active AS resulted in clinically meaningful improvements vs PBO in global functioning and HRQoL as measured by ASAS HI and ASQoL, with both measures showing discriminatory ability. Earlier UPA vs PBO response and greater magnitude of change across known clinical response groups suggests that ASAS HI may demonstrate greater responsiveness and ability to capture improvements in AS disease activity and physical function achieved with treatment.References:[1]van der Heijde D, et al.Lancet2019;394:2108–17.Acknowledgments:Financial support for the study was provided by AbbVie. AbbVie participated in interpretation of data, review, and approval of the abstract. All authors contributed to development of the abstract and maintained control over final content. Medical writing services, provided by Joann Hettasch of JK Associates Inc., were funded by AbbVie.Disclosure of Interests:Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Patrick Zueger Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Naijun Chen Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

Background:Disease flares in axial spondyloarthritis (axSpA) might occur even in patients with otherwise stable disease receiving highly effective anti-inflammatory therapy such as TNF inhibitors. The frequency of disease flares, especially in patients with axSpA receiving long-term stable therapy, and factors associated with flares are not sufficiently investigated.Objectives:The objective was to assess the frequency of disease flares and to identify factors associated with flares in patients with early axSpA receiving continuous long-tem (up to 10 years) treatment with a TNF inhibitor etanercept.Methods:In the ESTHER (etanercept versus sulfasalazine in early axial spondyloarthritis trial), patients with early axSpA (symptom duration ≤5 years) were treated with ETN (n=40) versus sulfasalazine (n=36) for 48 weeks [2]. After one year all patients were treated continuously with etanercept (n=17 patients temporarily interrupted treatment in the 2nd year to assess time to flare and were then (re-)treated with etanercept, except 4 patients who completed the study in sustained remission) for up to 10 years in total. Only patients who were continuously treated with etanercept for at least 6 months were included in the current analysis. The disease flare was defined as a worsening of the ASDAS by ≥0.9 as compared to the value obtained at the previous visit. Univariate and multivariable cox-regression analyses were performed to analyze the predictors of flares.Results:Out of 76 patients who entered the study at baseline, 62 patients (n=32 with radiographic (r-) axSpA and n=30 with non-radiographic (nr-) axSpA) fulfilled the criterion of the continuous etanercept treatment. A total of 22 patients (35%) experienced at least one flare over the entire treatment period 10 patients (31.3%) in the r-axSpA and 12 patients (40%) in the nr-axSpA subgroup) - figure. A total of 81 flares occurred (33 and 48 in the r- and nr-axSpA subgroups, respectively) in the 10 years of follow-up. None of the documented disease flares resulted in a direct study withdrawal. The majority of flares occurred within first 4 years of treatment (figure). There were also no statistically significant differences between nr- and r-axSpA in the time until the first flare (p=0.4, Log-rank test). In the multivariable Cox regression analysis normal CRP values (≤5mg/l), HLA-B27 negativity, higher physician global assessment, a longer symptom duration at study entry, higher spinal ankylosis and higher fatty degeneration in the sacroiliac joints but lower spinal osteitis scores and lower ankylosis scores in the sacroiliac joints at baseline MRI were associated with a higher risk for flares.Conclusion:Disease flares according to the ASAS definition of clinically important worsening in axSpA based on ASDAS occurred ~1/3 of patients with early axSpA who received a treatment with etanercept for up to 10 years without major differences between r- and nr- forms of axSpA. HLA-B27 negativity, normal CRP, higher spinal ankylosis scores, higher fatty degeneration scores but lower ankylosis scores in the SIJ´s at baseline MRI were associated with a higher risk for flares.Figure 1.Baseline characteristics of all patients with with continous ETC treatment.all≥1 flareno flarepatientsn (%)62 (100)22 (35.5)40 (64.5)malen (%)38 (61.3)16 (72.7)22 (55)agemean (SD)34.1 (8.3)32.6 (7.8)35 (8.6)BASDAImean (SD)2.7 (2)1.8 (1.8)3.2 (1.9)ASDASmean (SD)1.6 (0.8)1.3 (0.7)1.7 (0.8)Figure 2.Kaplan-Meier curves indicating time to first flare and flare free survival propability.Acknowledgments:The ESTHER study was supported by an unrestricted research grant from Pfizer. Murat Torgutalp’s (MT) work at Charité - Universitätsmedizin was supported by an award from the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Murat Torgutalp: None declared, Anja Weiß: None declared, Mikhail Protopopov Consultant of: Novartis, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Kay Hermann: None declared, Christian Althoff: None declared, Olaf Behmer Employee of: Pfizer Pharma GmbH, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB

Background:There is lack of international consensus as to what defines a structural lesion on MRI of the sacroiliac joints (SIJ) typical of axial spondyloarthritis (axSpA). The ASAS MRI group has generated updated consensus lesion definitions that describe each of the MRI lesions in the SIJ1. These definitions have been evaluated by 7 readers from the ASAS-MRI group on MRI images from the ASAS Classification Cohort.Objectives:We aimed to identify quantitative cut-offs based on numbers of slices and SIJ quadrants that define a positive MRI for structural lesions typical of axSpA, the gold standard being majority central reader decision as to the presence of a structural lesion typical of axSpA with high confidence.Methods:MRI structural lesions meeting ASAS definitions were recorded in an eCRF that comprises global assessment (structural lesion typical of axSpA present/absent and degree of confidence (-4 (absent) to +4 (present)), and detailed scoring of lesions per SIJ quadrant. Detailed scoring was based only on assessment of DICOM images (n =148). We calculated sensitivity and specificity for numbers of SIJ quadrants and consecutive slices with erosion, sclerosis, and fat lesions where a majority of readers (≥4/7) agreed as to the presence of a structural lesion typical of axSpA with high confidence (≥ +3). We tested candidate lesion definitions for predictive diagnostic utility in cases assessed after 4.4 years of follow up by the local rheumatologist.Results:Structural lesions typical of axSpA were observed by majority read in 33 (32.4%) of 102 cases diagnosed with axSpA, and 3 (6.8%) of 44 cases without axSpA and 29 cases were assigned a high degree of confidence (≥ +3) by a majority of readers. Cut-offs achieving specificity of 95% were erosion in ≥2 consecutive slices (sensitivity 83%), erosion ≥3 SIJ quadrants (sensitivity 90%), and fat lesion (≥1cm horizontal depth) in ≥1 SIJ quadrant (sensitivity 59%) (Table). These had very high positive predictive values (>95%) for diagnosis of axSpA in cases diagnosed by the rheumatologist after 4.4 years follow up.Conclusion:ASAS-defined erosion in ≥2 consecutive slices or in ≥3 SIJ quadrants and ASAS-defined fat lesion with depth >1cm in ≥1 SIJ quadrant are high priority candidates for defining an MRI structural lesion typical of axSpA. This will require similar assessment in additional axSpA cohorts.References:[1]Maksymowych et al. Ann Rheum Dis 2019; 78:1550-8.Table 1.Majority readers agree structural lesion indicative of axSpA is present with confidence ≥3/4 is the gold-standard external referenceSensitivitySpecificityErosion Score ≥1 SIJ qdr93.1 (77.2-99.2)80.6 (72.4-87.3)Erosion Score ≥2 SIJ qdr93.1 (77.2-99.2)90.8 (84.1-95.3)Erosion Score ≥3 SIJ qdr89.7 (72.6-97.8)95.8 (90.5-98.6)Erosion in 2 consecutive slices82.8 (64.2-94.2)95.0 (89.3-98.1)Fat lesion ≥1 SIJ qdr82.8 (64.2-94.2)81.5 (73.4-88.0)Fat lesion ≥2 SIJ qdr69.0 (49.2-84.7)86.6 (79.1-92.1)Fat lesion ≥3 SIJ qdr62.1 (42.3-79.3)91.6 (85.1-95.9)Fat lesion in 2 consecutive slices55.2 (35.7-73.6)93.3 (87.2-97.1)Fat lesion (>1cm depth) ≥158.6 (38.9-76.5)95.0 (89.3-98.1)Fat lesion (>1cm depth) ≥255.2 (35.7-73.6)95.8 (90.5-98.6)Fat lesion (>1cm depth) ≥351.7 (32.5-70.6)97.5 (92.8-99.5)Fat lesion (>1cm depth) in 2 consecutive slices48.3 (29.4-67.5)97.5 (92.8-99.5)Table. SIJ qdr: sacroiliac joint quadrantDisclosure of Interests:Walter P. Maksymowych Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, and UCB, Xenofon Baraliakos: None declared, Ulrich Weber: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Susanne Juhl Pedersen Grant/research support from: Novartis, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Stephanie Wichuk: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Joel Paschke: None declared, Robert G Lambert: None declared, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB

Background:Inflammatory bowel disease (IBD) and specifically Crohn’s disease (CD) is known to be associated with spondyloarthritis (SpA). However, only little is known about factors associated with the development of spondyloarthritis in CD.Objectives:To identify factors associated with the presence of SpA in a cohort of patients with CD.Methods:Patients with a definite diagnosis of CD naïve to or not being treated with biological agents for at least 3 months were included in a CD-arm of the German Spondyloarthritis Inception Cohort (GESPIC-Crohn). Gastroenterologists were encouraged to include consecutively recently diagnosed CD patients. Patients were classified according to the Montreal classification including location and behavior of CD. Patients received a structured assessment of SpA manifestations (including magnetic resonance imaging of sacroiliac joints and spine) by a rheumatologist who was responsible for the final diagnosis of SpA / no SpA. Clinical activity of CD was assessed by the Harvey-Bradshaw Index (HBI). In addition, colonoscopy was performed, Simple endoscopic Score for Crohn’s Disease (SES-CD) was determined and fecal calprotectin was measured.Results:A total of 108 patients with CD were enrolled. The mean (mean ± SD) age was 36.6 ± 12.7 years, and CD symptom duration was 5.3 ± 7.4 years. At baseline, 44 (40.7%) patients were treated with non-biologic immunomodulating drugs: 16 (14.8%) patients received mesalazine, 27 (25.0%) azathioprine, and 1 (0.9%) methotrexate. Oral steroids were given to 38 (35.2%) patients. A total of 103 (96.3%) patients were biologics naïve. SpA was diagnosed in 23 (21.3%) patients: 12 had axial SpA and 11 peripheral SpA. Patients with SpA had higher prevalence of HLA-B27, of clinical SpA features (back pain, inflammatory back pain, peripheral arthritis, enthesitis), higher level of CRP and higher activity of CD as measured by the HBI. There were not substantial differences between SpA vs. non-SpA patients in terms of CD duration, endoscopic activity, disease location or behavior, or treatment, except for mesalazine, which was more frequently administered in patients with SpA than non-SpA (39.1% vs. 8.2%, p=0.001, respectively).Conclusion:SpA was present in 21% of patients with CD in this early cohort with almost equal proportions of axial and peripheral forms. Presence of HLA-B27 and higher clinical activity of CD were associated with the presence of SpA.TABLE.Baseline demographic and clinical characteristics of the included patients with Crohn’s disease with or without spondyloarthritis.VARIABLETOTALn=108SpAn=23No SpAn=85PAge, years, mean ± SD36.6 ± 12.737.5 ± 11.336.3 ± 13.10.44Male sex, n (%)50 (46.3)10 (43.5)40 (47.1)0.82CD symptom duration, years, mean ± SD5.3 ± 7.45.4 ± 7.25.1 ± 7.50.63HLA-B27 positive, n (%)13 (12.0)6 (26.1)7 (8.2)0.03Montreal classification Location: L1 - ileal68 (63.0)13 (56.5)55 (64.7)0.48 L2 - colonic000 L3 - ileocolonic39 (36.1)7 (30.4)32 (37.6)0.63 L4 – isolated upper disease10 (9.3)3 (13.0)7 (8.2)0.44Behavior:B1 – non-stricturing, non-penetrating69 (63.9)15 (65.2)54 (63.5)1.00 B2 - stricturing19 (17.6)4 (17.4)15 (17.6)1.00 B3 - penetrating6 (5.6)06 (7.1)0.34 Peri-anal disease7 (6.5)2 (8.7)5 (5.9)0.64 C-reactive protein, mg/l, mean ± SD10.7 ± 24.813.6 ± 23.210.0 ± 25.30.02 Harvey-Bradshaw Index, mean ± SD3.6 ± 4.05.5 ± 4.73.1 ± 3.60.01 Fecal calprotectin, mcg/d, mean ± SD185.9 ± 213.7211.7 ± 243.8179.5 ± 207.90.43Treatment of CD Mesalazine, n (%)16 (14.8)9 (39.1)7 (8.2)0.001 Methotrexate, n (%)27 (25.0)3 (13.0)24 (28.2)0.18 Azathioprine, n (%)1 (0.9)01 (1.2)1.00 Biologics naive, n (%)103 (96.3)22 (95.7)81 (96.4)1.00Disclosure of Interests:Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Susanne Lüders: None declared, Judith Rademacher: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Maryna Verba: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Elena Sonnenberg: None declared, Michael Schumann: None declared, Lea Isabell Kredel: None declared, Britta Siegmund Consultant of: Abbvie, Boehringer, Celgene, Falk, Janssen, Lilly, Pfizer, Prometheus, Takeda, Speakers bureau: Abbvie, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Takeda (BS served as representative of the Charité), Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB

Einleitung: Patienten mit axialer Spondyloarthritis (axSpA) werden im Deutschland durch Rheumatologen und Ärzte anderer Fachrichtungen (Orthopäden, Allgemeinmediziner) betreut. Das Ziel der Studie war, die Versorgungssituation von Patienten mit axialer SpA abhängig von der Betreuung[zum vollständigen Text gelangen Sie über die oben angegebene URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Although the pathogenesis of spondylarthritis (SpA) has been the subject of intensive research in recent years, the consequences for treatment are relatively minor. Basic research studies indicated a potentially important role of the cytokines tumor necrosis factor (TNF) alpha and interleukin (IL)-17 for the pathogenesis of SpA but their outstanding role could then only be demonstrated by their inhibition in clinical studies, while other promising targets, such as IL‑23 and IL‑6 could not be shown to be relevant (at least against axial manifestations) in clinical studies. The intestinal microbiota probably plays an important role in the pathogenesis but not yet for the treatment of SpA. Ultimately, early effective and long-term suppression of inflammation is currently the best method to prevent ankylosis in the long run.

Tumour necrosis factor-alpha inhibitors (TNFi) are an effective but expensive treatment option in axial spondylarthritis (axSpA) patients who fail to achieve disease control under conventional treatment.The aim of this study was to assess the cost of illness in axSpA patients treated with and without TNFi.Using German health insurance data, patients with axSpA who newly received TNFi between 2011 and 2015 were identified and matched by age and sex to a reference group of patients with axSpA without TNFi treatment. Costs for services performed in an outpatient setting, inpatient care, pharmacotherapy and for productivity loss due to absence from paid work were analyzed over a 2-year period. In patients treated with TNFi , the 2‑year period included 1 year before and 1 year after the initiation of TNFi.Data from 1455 axSpA patients who received TNFi treatment were included in the analyses. Costs for services performed in an outpatient setting, inpatient care, pharmacotherapy (excluding TNFi) as well as productivity loss significantly decreased after initiation of TNFi. Mean total costs increased from € 6075 in the year prior to TNFi initiation to € 27,871 in the year after TNFi initiation. Excluding costs for TNFi, total costs decreased by 22% to € 4761. Mean total costs among the reference group of 1455 age and sex-matched axSpA patients who did not receive TNFi remained stable over 2 years: € 3939 in the first year vs. € 3832 in the second year.Initiation of TNFi treatment led to a sharp increase in the total costs of axSpA patients. Part of this increase was offset by a decrease of costs for services performed in an outpatient setting, inpatient care, pharmacotherapy (excluding TNFi) as well as productivity loss. In patients who did not receive TNFi, the costs remained stable over 2 years.

Objective The aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS). Methods Baseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31–743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640–819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs. Results A total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant. Conclusion Secukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs. Electronic supplementary material The online version of this article (10.1186/s13075-019-1911-1) contains supplementary material, which is available to authorized users.

Tables S1. List of ethical approval reference numbers for each participating center in MEASURE 1. (DOCX 21 kb)

Background:Axial spondyloarthritis (axSpA) is characterized by development of structural damage in the spine, assessed by conventional radiographs (CR). The modified Stokes Ankylosing Spondylitis Scoring System (mSASSS) includes all the SpA-relevant CR findings and is the most frequently used scoring system for quantification of spinal structural damage in patients (pts) with axSpA. Radiographic progression over 2 years using mean mSASSS progression, scored by a blinded ‘paired’ (sets of CRs of the same patient) approach, is considered as a key treatment outcome reflecting structural progression in clinical trials. However, this approach has been accompanied by questions about the influence of pts showing mSASSS ‘improvement’, indicating possible disappearance of syndesmophytes over time, something ‘naturally unexpected’.Objectives:To investigate the performance of mSASSS in assessing spinal radiographic damage and progression in axSpA pts using different approaches of CR evaluations.Methods:Complete sets (cervical and lumbar CRs) from the German SpA Inception Cohort (GESPIC) at baseline and after 2 years were blinded to all clinical and demographic characteristics and then scored using the mSASSS by 5 different experienced readers, 2 blinded and 3 unblinded to the timepoint of CR performance. The final mSASSS score was calculated as a mean of 2 (blinded) or 3 (unblinded) readers. Descriptive statistics, cumulative probability plots and shift analyses (agreement of 2/2 readers in the blinded and 2/3 readers in the unblinded group) were performed for each reader group.Results:A total of 210 pts (mean age 37.3y, 51% male, 79% HLA-B27+) with non-radiographic (n=115) and radiographic (n=95) axSpA at baseline were included. The mean mSASSS at baseline was 4.3±8.3 vs. 3.4±7.9, while the mean progression was 0.7±2.3 vs.1.0±1.9 mSASSS units for the blinded vs. the unblinded group, respectively (Figure). On the patient level, progression of ≥2 mSASSS units was found in 30 (14.3%) vs. 37 (17.6%) pts in the blinded vs. the unblinded group, while agreement between groups was seen in 179 (85.2%) pts, 18 (8.9%) pts for progression and 161 (76.7%) for no progression.Figure 1.Cumulative probability plot for mean mSASSS scores (all scores) in blinded (A) and unblinded (B) and ‘definite’ scores in blinded (C) and unblinded (D) scoring approachIn the analysis of ‘definite’ CR findings (only scores of 2=syndesmophytes or 3=ankylosis), the mean mSASSS score at baseline was 3.3±8.0 vs. 2.6±7.2 and the mean radiographic progression was 0.6±2.4 vs. 0.8±2.1 mSASSS units for the blinded vs. the unblinded group, respectively (Figure). On the patient level, progression was found in 37 (17.6%) vs. 33 (15.7%) pts in the blinded vs. the unblinded group, while agreement between groups was seen in 188 (89.5%) pts, 24 (11.3%) for progression and in 164 (78.1%) pts for no progression.In the shift analysis, mSASSS worsening was found in 35 (0.8%) and mSASSS ‘improvement’ in only 4 (0.1%) out of a total of 4.373 vertebral edges (VE) analyzed in the blinded and in 109 (2.2%) and 2 (0.04%), respectively, out of a total of 4.914 VE analyzed in the unblinded group (Table). The majority of progression was found for the development of ‘definite’ signs of progression in both the blinded (25/35, 71.4%) and the unblinded (61/109, 56%) group, while more VE showing ‘minor’ (only scores of 1=sclerosis, squaring, erosion) signs of progression were found in the unblinded (48/109, 44%) vs. to the blinded (10/25, 28.6%) group.Conclusion:Despite lower mean baseline mSASSS, higher mean mSASSS progression was found using the unblinded approach, while in the shift analysis the unblinded approach was also more specific, confirming the absence of ‘improvement’ of radiographic damage over time. These results were similar in the analysis on the patient’s level. The scoring approach and the influence of ‘minor’ radiographic changes should be taken into account for avoiding the so-called ‘background noise’ in the evaluation of mSASSS.Acknowledgements:GESPIC was initially supported by the BMBF. As a consequence of the funding reduction by BMBF according to schedule in 2005 and stopped in 2007, complementary financial support has been obtained also from Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. Starting from 2010, the core GESPIC cohort was supported by AbbVie.Table 1.Shift analysis of the blinded and unblinded reading approach on the basis of VE.Disclosure of Interests:None declared

Background:The treatment of patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) has been revolutionised by the introduction of biologic DMARDs targeting TNF, IL17, and IL23 inhibitors (i). In Germany, about 30-50% of axSpA and PsA patients receive treatment with bDMARDs. Although many patients benefit from these drugs, in some patients effectiveness of the standard dose may be insufficient and higher doses are used.Objectives:To describe dosing of TNFi and non-TNFi bDMARDs over a 2 year period in a real world cohort of patients with axSpA and PsA managed by rheumatologists.Methods:RABBIT-SpA is a prospective longitudinal cohort study including axSpA and PsA patients enrolled at the start of a new conventional treatment (including NSAID) or b/tsDMARD treatment. Description of dosing of TNFi (adalimumab bio-original (bo), adalimumab bio-similar (bs), etanercept bo, etanercept bs, golimumab, certolizumab) in comparison to nonTNFi-bDMARDs (secukinumab, ustekinumab, ixekizumab, guselkumab) in axSpA and PsA. Standard dosing was defined according to the current labels for axSpA and PsA.Results:1628 patients (axSpA: n=903, PsA: n=725) were included in this analysis. At inclusion mean age was 44 years in axSpA and 51 years in PsA. 44% of patients with axSpA and 58% of those with PsA were female. The mean disease duration of axSpA was 7.6 years, of PsA 6.4 years.Standard doses of TNFi were used during a 2 year period in > 90% of patients with axSpA and PsA (Figure 1). In contrast, standard doses of non-TNFi-bDMARDs were only used in 70-80% of patients. The percentage of documented higher doses in patients with axSpA ranged from 20-30% at different time points. In PsA, this percentage increased from 27% at baseline to 44% at 2 years. On the other hand, TNFi were used in lower doses than the label in up to 9% and 7 % of patients with axSpA and PsA, respectively, after 2 years.Figure 1.Percentages of patients with axSpA or PsA who received less than, equal to, or more than the approved doses of bDMARDs at baseline and at 5 follow-up visits.Conclusion:While TNFi are used in licensed doses in most patients, non-TNFi-bDMARDs were often used in higher doses, which corresponds to higher doses approved in other indications like psoriasis. The effectiveness of this treatment strategy in axSpA and PsA needs to be analysed further.Acknowledgements:RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris.We thank all participating patients and rheumatologists.Disclosure of Interests:Anne Regierer Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Anja Weiß Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Denis Poddubnyy: None declared, Herbert Kellner: None declared, Frank Behrens: None declared, Georg Schett: None declared, Juergen Braun: None declared, Joachim Sieper: None declared, Anja Strangfeld Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris

Background:Patients with a diagnosis of Spondyloarthritis (SpA) and Psoriatic Arthritis (PsA) may have predominant axial or peripheral symptoms, and the frequency and distribution of these symptoms may determine the clinical diagnosis by the rheumatologist (“clinical clusters”). Clustering analysis represents an unsupervised exploratory analysis which tries to identify homogeneous groups of cases (“statistical clusters”) without prior information about the membership for any of the cases.Objectives:To identify “statistical clusters” of peripheral involvement according to the specific location of these symptoms in the whole spectrum of SpA and PsA (without prior information about the diagnosis of the patients), and to evaluate whether these “statistical clusters” are in agreement with the “clinical clusters”.Methods:Cross-sectional and multicentre study with 24 participating countries. Consecutive patients considered by their treating rheumatologist as suffering from either PsA, axial SpA (axSpA) or peripheral SpA (pSpA) were enrolled. Four different cluster analyses were conducted: the first one using information about the specific location from all the peripheral musculoskeletal manifestations (i.e., peripheral arthritis, enthesitis and dactylitis), and thereafter a cluster analysis for each peripheral manifestation individually. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters.Results:4465 patients were included in the analysis. Two clusters were found with regard to the location of all the peripheral manifestations (Fig. 1). Cluster 1 showed a low prevalence of peripheral manifestations in comparison with cluster 2; however, when peripheral involvement appeared in cluster 1, this was mostly represented by arthritis of hip, knee and ankle, as well as enthesitis of the heel. Patients from cluster 1 showed a higher prevalence of males (63% vs 44%), HLA-B27 positivity (69% vs 38%) and axial involvement (80% vs 52%), as well as more frequent diagnosis of axSpA (66% vs 21%) and more frequently fulfilling the ASAS axSpA criteria (69% vs. 41%). Patients from cluster 2 showed a higher prevalence of psoriasis (63% vs 25%), a more frequent diagnosis of PsA (61% vs 19%), and they fulfilled more frequently the peripheral ASAS (26% vs 11%) and the CASPAR criteria (57% vs 19%).Figure 1.Distribution of the peripheral involvement across clustersThree clusters were found with regard to the location of the peripheral arthritis. Clusters 2 and 3 showed a high prevalence of peripheral joint disease, although this was located more predominantly in the lower limbs in cluster 2, and in the upper limbs in cluster 3. Cluster 1 showed a higher prevalence of males, HLA-B27 positivity, axial involvement, a lower presence of psoriasis, a more frequent diagnosis of axSpA and fulfilling the ASAS axSpA criteria in comparison with clusters 2 and 3, respectively. Clusters 2 and 3 showed a higher prevalence of enthesitis and dactylitis in comparison with cluster 1, a more frequent diagnosis of PsA and fulfillment of the CASPAR criteria.Information about the location of enthesitis exhibited three groups: cluster 1 showed a very low prevalence of enthesitis, while cluster 2 and 3 showed a high prevalence of enthesitis, with a predominant involvement of axial enthesis in cluster 2 and peripheral enthesitis in cluster 3.Finally, the analysis of dactylitis also exhibited three clusters that showed a very low prevalence of dactylitis, predominantly toes and predominantly fingers involvement, respectively.Conclusion:These results suggest the presence of heterogeneous patterns of peripheral involvement in SpA and PsA patients without clearly defined groups, confirming the clear overlap of these peripheral manifestations across the different underlying diagnoses.Acknowledgements:This study was conducted under the umbrella of ASAS with unrestricted grant of Abbvie, Pfizer, Lilly, Novartis, UCB, Janssen and Merck.Disclosure of Interests:None declared

Background:The ASAS definition of a positive MRI for inflammation in the spine (ASAS-MRIspine+) is intended for classification of patients as having axSpA but is often misused for diagnostic purposes. This is problematic because bone marrow edema (BME) in the spine may occur in 20-40% of those with mechanical back disorders. The ASAS MRI group has generated updated consensus lesion definitions which have been validated on MRI spine images from the ASAS Classification Cohort.Objectives:We aimed to identify quantitative cut-offs based on numbers of vertebral corners that define ASAS-MRIspine+, there being two gold standards: A. majority central reader decision as to the presence of spine MRI findings consistent with axSpA B. rheumatologist expert opinion diagnosis of axSpA.Methods:Eight ASAS-MRI readers recorded MRI lesions in the spine according to recently updated ASAS definitions from 62 cases in an eCRF that comprises global assessment (MRI consistent with axSpA? (yes/no)), and detailed scoring of lesions for all sites in the spine. We calculated sensitivity and specificity for numbers of vertebral corners with BME where a majority of readers (≥5/8) agreed as to the presence of MRI findings consistent with axSpA. We selected cut-offs with ≥95% specificity. These cut-offs were analyzed for their predictive utility for rheumatologist diagnosis of axSpA by calculating positive and negative predictive values (PPV, NPV) and selecting cut-offs with PPV ≥95%. Both criteria were considered requirements for designation of MRI cut-offs defining ASAS-MRIspine+.Results:MRI findings consistent with axSpA were observed by majority read in 8 (20%) of 40 cases diagnosed with axSpA, and 0 (0%) of 19 cases without axSpA. Cut-offs achieving specificity of ≥95% for MRI findings consistent with axSpA were 4 vertebral corners (sensitivity 75%) for all cases, 3 vertebral corners (sensitivity 37.5%) for cases with ≥1 additional location with inflammation, 1 vertebral corner (sensitivity 62.5%) in cases with ≥2 vertebral corner fat lesions (Table 1). All of the above cut-offs also had very high PPV (≥95%) for diagnosis of axSpA in cases diagnosed by the rheumatologist (Table 2).Table 1.Majority readers agree MRI findings consistent with axSpA are present is the gold-standard external referenceMRI cut-offsSensitivity (95%CI)Specificity (95%CI)BME in ≥2 vertebral corners87.5 (47.3 - 99.7)87.0 (75.1 - 94.6)BME in ≥ 3 vertebral corners87.5 (47.3 - 99.7)94.4 (84.6 - 98.8)BME in ≥4 vertebral corners75.0 (34.9 - 96.8)98.2 (90.1 - 100.0)Cases with ≥1 additional non-corner site inflammatory lesionBME in ≥2 vertebral corners37.5 (8.5 - 75.5)94.4 (84.6 - 98.8)BME in ≥3 vertebral corners37.5 (8.5 - 75.5)98.2 (90.1-100.0)Cases with ≥2 vertebral corner fat lesionsBME in ≥1 vertebral corner62.5 (24.5 - 91.5)100.0 (93.4-100.0)BME in ≥2 vertebral corners62.5 (24.5 - 91.5)100.0 (93.4-100.0)Table 2.Predictive values of cut-offs for number of vertebral corners with BME according to the diagnostic ascertainment of the rheumatologistMRI cut-offsSensitivity (95%CI)Specificity (95%CI)PPVNPVMRI findings consistent with axSpA ≥any 2 readers52.5 (36.1 - 68.5)94.7 (74.0 - 99.9)95.5 (75.3 - 99.3)48.6 (40.2 - 57.2)MRI findings consistent with axSpA ≥majority read20.0 (9.1 - 35.6)100.0 (82.4 - 100.0)100.037.3 (33.7 - 40.9)BME in ≥ 4 vertebral corners17.5 (7.3 - 32.8100.0 (82.4 - 100.0)100.036.5 (33.3 - 39.9)Cases with ≥1 additional inflammatory lesionBME in ≥ 3 vertebral corners10.00 (2.8 - 23.7)100.00 (82.4 - 100.0)100.034.5 (32.2 - 36.9)Cases with ≥2 vertebral corner fat lesionsBME in ≥1 vertebral corner12.50 (4.2 - 26.8)100.00 (82.4 - 100.0)100.035.2 (32.6 - 37.9)Conclusion:A cut-off of BME in ≥4 vertebral corners, or ≥3 corners in the setting of additional inflammatory lesions at other locations or corner fat, are primary candidates for defining ASAS-MRIspine+. These cut-offs apply to typical patients referred to a rheumatologist with a high index of suspicion of axSpA and may not be appropriate in other populations.Disclosure of Interests:None declared

Background:The timeframe for maximum treatment response varies across patients with radiographic axial spondyloarthritis (r-axSpA). Understanding which patients may benefit from additional time on treatment could influence treatment decisions.Objectives:This post-hoc analysis aims to determine the percentage of patients, previously exposed to TNFi, who progressed from ASAS20 at week 16 to ASAS40 response at week 52 with ixekizumab (IXE) treatment and to explore factors that may associate with additional improvement after 16 weeks.Methods:Patients who achieved Assessment of SpondyloArthritis International Society (ASAS)20 at week 16 from COAST-W (NCT02696798), a Phase 3, randomized, double-blind, placebo-controlled trial, in tumour necrosis factor inhibitor (TNFi)-experienced patients who fulfilled the ASAS criteria for r-axSpA, were analysed. Patients treated with IXE 80 mg Q4W were categorized according to their ASAS response at week 52: sustaining ASAS20 but not reaching an ASAS40 response or achieving ASAS40. Patient demographics and disease characteristics at baseline were analysed by descriptive statistics, and the individual components determining ASAS response at baseline and at week 52 are provided.Results:At week 16, 22.8% (n=26/114) of patients achieved ASAS20 but not ASAS40; of these, 2 patients discontinued the study before week 52. Amongst the patients who continued through week 52, 50% (12/24) of patients achieved ASAS40; the other 50% sustained their ASAS20 response. Patients who achieved ASAS40 at week 52 were older, had longer disease duration, were less likely to be HLA-B27 positive, and had worse BASDAI and BASFI scores at baseline (Table 1, part a). Achieving ASAS40 appeared to depend most on the Patient Global Assessment of Disease Activity and spinal pain score over time (Table 1, part b).Table 1.a) Demographics and Characteristics at Baseline (week 0) and b) Descriptive observed data for the individual components of the ASAS response criteria at week 52, mean (SD)a)IXEQ4WPatients sustaining an ASAS20 but not reaching an ASAS40 response at week 52 (n=12)Patients achieving an ASAS40 response at week 52 (n=12)Age, years47.3 (13.3)49.6 (12.3)Duration of symptoms since axSpA onset, years16.4 (9.2)18.6 (12.6)HLA B27 positive, n (%)12 (100)9 (75)Current tobacco use, n (%)4 (33.3)1 (8.3)ASDAS Score4.0 (1.0)4.2 (1.1)BASDAI Score7.4 (1.2)7.8 (1.7)Serum CRP concentration (mg/L)23.0 (47.1)28.0 (66.0)Spinal Pain due to Ankylosing Spondylitis (NRS)8.2 (0.8)8.5 (1.6)Patient Global Assessment of Disease Activity (NRS)7.8 (1.3)8.6 (1.2)BASFI7.1 (1.4)7.4 (2.3)BASDAI stiffness score7.1 (1.5)7.6 (2.2)b)IXEQ4WPatient Global Assessment of Disease Activity (NRS)5.5 (1)3.2 (1.3)Spinal Pain due to Ankylosing Spondylitis (NRS)5.6 (1)3 (1.9)BASFI5.0 (1.5)3.7 (2.1)BASDAI stiffness score4.1 (1.4)3.4 (2.3)Values are mean (SD) unless stated otherwiseASAS= Assessment of SpondyloArthritis International Society; ASDAS= Ankylosing Spondylitis Disease Activity Score; axSpa = axial spondyloarthritis; BASDAI= Bath Ankylosing Spondylitis Disease Activity Index; BASFI= Bath Ankylosing Spondylitis Functional Index; CRP= C-reactive protein; HLA= human leucocyte antigen; NRS = numeric rating scale; SD= standard deviationConclusion:For patients with r-axSpA previously exposed to TNFis and showing modest response to IXE over 16 weeks, longer exposure to IXE may be required to achieve ASAS40.Acknowledgements:The authors would like to acknowledge Philana Fernandes, an employee of Eli Lilly, for her editorial and writing support.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: Abbvie, BMS, Chugai, Celgene, Eli Lilly, Pfizer, Galapagos, UCB, MSD, Consultant of: Abbvie, BMS, Chugai, Celgene, Eli Lilly, Pfizer, Galapagos, UCB, MSD, Grant/research support from: Abbvie, Celgene, MSD, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Giliad, GlaxoSmith & Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly, GlaxoSmith & Kline, Novartis, Pfizer, UCB, Soyi Liu Leage Employee of: Eli Lilly, Yves Schymura Employee of: Eli Lilly, Rebecca Bolce Shareholder of: Eli Lilly, Employee of: Eli Lilly, David Sandoval Shareholder of: Eli Lilly, Employee of: Eli Lilly, Jessica A. Walsh Consultant of: AbbVie, Novartis, Eli Lilly, UCB, Amgen & Pfizer, Grant/research support from: AbbVie, Pfizer, Merck, Joachim Sieper Speakers bureau: Abbvie, Janssen, Eli Lilly and Novartis, Consultant of: Abbvie, Janssen, Eli Lilly and Novartis.

Background:There is no international consensus on the optimal number of slices for evaluation of MRI structural lesions in the SIJ. An “all slice” method evaluates lesions from the most anterior slice, defined as the first slice with vertical height of ≥1cm of the SIJ joint cavity, up to the most posterior slice, defined as the most posterior slice where ≥1cm vertical height of the cartilaginous portion is still visible. The SPARCC method scores the transitional slice between cartilaginous and ligamentous compartments as the first slice and then an additional 4 slices anterior to the transitional slice.Objectives:We aimed to investigate inter-reader reliability, the extent of detection of lesions, and frequency of cases with a positive MRI for structural lesions when using an “all slice” approach versus the SPARCC scoring of 5 central slices.Methods:MRI T1W images with DICOM series were available from 148 cases who had MRI performed in the ASAS-Classification Cohort. Seven central readers recorded MRI lesions in an eCRF that recorded global assessments of presence/absence of changes suggestive of axSpA and structural lesions typical of axSpA. Structural lesions per the ASAS definitions were also recorded in consecutive semicoronal slices using the “all slice” approach, but also recording the transitional slice, according to their presence/absence in SIJ quadrants (erosion, fat lesion, sclerosis) or halves (backfill, ankylosis). Structural lesion frequencies were assessed descriptively according to majority agreement (≥4/7) of central readers and also any 2 central readers. Reliability for detection of MRI lesions was compared between central and local readers using the ICC.Results:The mean (SD) (range) number of anterior and posterior slices peripheral to the 5 central slices was 1.0 (1.0) (0-4) and 2.2 (1.8) (0-6) per case, respectively. There were 2 cases (1.4%) where ≥2 readers scored structural lesions in peripheral slices but not in the 5 central slices. The mean percentage of the total structural lesion score that was captured by the 5 central slices was >75% for all types of lesions except ankylosis (59%) (Table 1). Inter-reader reliability was greater for all lesions when assessing the 5 central slices and especially for erosion and backfill (Table 1).Conclusion:The major component of structural lesion data is captured by assessment of 5 slices, which includes the transitional slice and the subsequent 4 anterior slices. Moreover, reliability for detection of structural lesions is substantially worse in peripheral slices.MRI Lesion“All slice”Central 5 slicesPeripheral slicesP value central vs peripheral slicesP value“all slice” vs central slicesMean (SD) Lesion Score Per CaseErosion2.4 (4.5) (0-22.9)1.8(3.4) (0-17.1)0.6 (1.4) (0-10.1)< 0.001Fat lesion2.5 (5.9) (0-34.0)1.8 (4.5) (0-25.1)0.7 (1.8) (0-9.9)< 0.001Sclerosis2.0 (4.9) (0-39.0)1.5 (3.6) (0-26.1)0.5 (1.5) (0-12.9)< 0.001Backfill0.5 (1.5) (0-12)0.4 (1.2) (0.0-9.3)0.1 (0.4) (0-2.7)< 0.0010.84Ankylosis0.5 (3.4) (0-30.7)0.3 (2.3) (0-20.0)0.2 (1.2) (0-11.3)0.100.18Mean (SD) (Range) % of Total Lesion Score in Central vs Peripheral slicesErosion100%76.4% (28.9%) (0-100%)23.6% (28.9%) (0-100%)NAFat lesion100%75.4% (26.5%) (0-100%)24.6% (26.5%) (0-100%)NASclerosis100%79.5% (22.9%) (0-100%)20.5% (22.9%) (0-100%)NABackfill100%86.0% (20.2%) (0-100%)14.0% (20.2%)(0-100%)NAAnkylosis100%59.0% (36.4%) (0-100%)41.0% (36.4%) (0-100%)0.56NAICC of 7 readers (Mean (SD) (Range))MRI lesionAll slicesCentral 5 slicesPeripheral slicesErosion0.54 (0.15) (0.28-0.84)0.58 (0.13) (0.34-0.85)0.40 (0.17) (0.10-0.66)Fat lesion0.61 (0.18) (0.30-0.89)0.63 (0.16) (0.35-0.88)0.52 (0.20) (0.19-0.82)Sclerosis0.73 (0.18) (0.36-0.94)0.73 (0.16) (0.36-0.91)0.67 (0.19) (0.27-0.94)Backfill0.37 (0.21) (0.10-0.85)0.39 (0.19) (0.14-0.83)0.18 (0.23) (0.0-0.80)Ankylosis0.97 (0.02) (0.91-0.99)0.99 (0.01) (0.97-1.0)0.85 (0.10) (0.62-0.98)Disclosure of Interests:None declared.

Background:Observational cohort studies have shown that there is low, but still detectable progression level in radiographic sacroiliitis, which might also have an impact on the function in patients with axial spondyloarthritis (axSpA). Recent data showed that tumor necrosis factor inhibitors (TNFi) might retard spinal progression when initiated earlier and taken longer in patients with axSpA. However, the question of whether they also have such an effect on radiographic progression in sacroiliac joints (SIJs) is still unclear.Objectives:To investigate the longitudinal association between radiographic sacroiliitis progression and treatment with TNFi in patients with early axial SpA in a long-term inception cohort.Methods:Based on the availability of at least two sets of SIJ radiographs, 301 patients (166 with nr-axSpA, symptom duration ≤5 years and 135 with r-axSpA, symptom duration ≤10 years) from the German Spondyloarthritis Inception Cohort (GESPIC) were included in this analysis. These patients contributed with a total of 737 2-year radiographic intervals. Two trained and calibrated central readers scored the radiographs according to the modified New York criteria. If both scored an image as definite radiographic sacroiliitis, the patient was classified as having r-axSpA. The sacroiliac sum score was calculated as a mean of both readers. The association between previous as well as current TNFi use and radiographic sacroiliitis progression, which was defined as the change in the sacroiliitis sum score over 2 years, was analysed using longitudinal generalized estimating equations (GEE) analysis.Results:At baseline, 9 (3.0%) patients were treated with a TNFi, and 87 (28.9%) patients received at least one TNFi during the entire follow-up period. A total of 141 of the radiographic intervals were covered with TNFi of any duration, while 109 of them were covered with a TNFi of at least 12 months. While receiving ≥12 months TNFi in the previous interval was associated with a lower progression of the sacroiliitis sum score compared to not receiving TNFi in the previous interval, this was not the case in patients who received TNFi ≥12 months in the current 2-year interval (Figure 1). The significant association between TNF ≥12 months in the previous interval and progression in the sacroiliitis sum score were confirmed in the adjusted multivariable longitudinal GEE analysis. In addition, a similar trend for the beneficial effects was observed in different models, which included other treatment definitions with TNFi in the previous 2-year interval (Table).Table 1.The longitudinal GEE analysis of the association between progression in the sacroiliitis sum score and TNFi use.TNFi treatment definitionReferenceβ* (95% CI)TNFi for ≥ 12 months in the previous 2-year intervalNo TNFi for ≥ 12 months in the previous 2-year interval-0.09 (-0.18, -0.003)Any TNFi use in the previous 2-year intervalNo TNFi use in the previous 2-year interval-0.09 (-0.17, 0.002)TNFi for ≥ 12 months in the current 2-year intervalNo TNFi for ≥ 12 months in the current 2-year interval-0.03 (-0.11, 0.06)Any TNFi use in the current 2-year intervalNo TNFi use in the current 2-year interval0.05 (-0.05, 0.14)TNFi for ≥ 12 months in the previous and ≥ 12 months in the current 2-year intervalNo TNFi for ≥ 12 months in the previous and ≥ 12 months in the current 2-year interval-0.08 (-0.17, 0.004)* Parameter estimates from the multivariable models adjusted for sex, age at the beginning of the current 2-year interval, HLA-B27 positivity, symptom duration at the beginning of the current 2-year interval, time-averaged elevated CRP, time-averaged BASDAI, and time-averaged NSAID intake score in the current 2-year interval.Conclusion:Treatment with TNFi was associated with retardation of radiographic sacroiliitis progression in patients with axSpA. This effect becomes evident between 2 and 4 years after treatment initiation.References:Acknowledgements:GESPIC was initially supported by the BMBF. As a consequence of the funding reduction by BMBF according to schedule in 2005 and stopped in 2007, complementary financial support has been obtained also from Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. Starting from 2010, the core GESPIC cohort was supported by AbbVie.Disclosure of Interests:Murat Torgutalp: None declared, Valeria Rios Rodriguez: None declared, Maryna Verba: None declared, Mikhail Protopopov: None declared, Fabian Proft: None declared, Judith Rademacher: None declared, Hildrun Haibel: None declared, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Joachim Sieper: None declared, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, MSD, Novartis, and Pfizer

Introduction La distribution des manifestations peripheriques musculosquelettiques chez tous les sous-types de spondyloarthrite (SpA) et leurs caracteristiques ont ete peu etudiees. De plus, tres peu d’etudes ont evalue la distribution des manifestations peripheriques selon la region geographique. L’objectif de cette etude a ete de comparer la prevalence, les caracteristiques et les traitements des manifestations musculosquelettiques peripheriques chez les patients atteints de tous sous-types possibles de SpA ainsi que leur distribution selon la region geographique. Patients et methodes Etude transversale avec 24 pays participants. Des patients consecutifs avec un diagnostic de SpA axiale (axSpA), SpA peripherique (pSpA), rhumatisme psoriasique (Rhpso), SpA associe a maladie inflammatoire de l’intestin (SpA-MICI), arthrite reactive (ReA) et SpA juvenile etaient eligibles pour l’etude. La prevalence des manifestations peripheriques (affection articulaire peripherique, enthesite, dactylite, tarsite et affection des articulations racines) leur localisation et leur traitement ont ete evalues, ainsi que leur distribution dans les differentes regions du monde. Resultats Un total de 4465 patients (61 % hommes, âge moyenne 45 ans) ont ete inclus appartenant a quatre regions : Amerique Latine (n = 538), Europe et Amerique du Nord (n = 1677), Asie (n = 975), Moyen-Orient et Afrique du Nord (n = 1275). La prevalence des diagnostics etait axSpA (60,9 %), Rhpso (23,1 %), pSpA (9,7 %), SpA-MICI (2,5 %), ReA (1,3 %), et Juv-SpA (1,3 %). Parmi la totalite des patients, 78,3 % avaient eu au moins une manifestation peripherique ; 56,9 % au moins une affection articulaire peripherique, 44,3 % une enthesite, 33,7 % une affection des articulations racines, 15,3 % une dactylite et 7,7 % une tarsite. Les patients d’Amerique Latine avaient la prevalence la plus haute d’affection articulaire peripherique (79,9 %), d’enthesite (68,8 %), de dactylite (25,5 %) et de tarsite (23,6 %), tandis que la prevalence d’affection des articulations des racines des membres etait plus elevee chez les patients d’Asie (57,4 %). L’affection articulaire peripherique etait plus frequente chez les patients avec pSpA (94,7 %) et moins souvent chez les patients avec axSpA (36,0 %). Les patients atteints de Rhpso avaient plus souvent une atteinte polyarticulaire (58,9 %) tandis que les axSpA avaient une atteinte surtout mono-articulaire (20,1 %). L’atteinte des petites articulations des membres superieurs etait plus souvent observee chez les patients avec Rhpso (52,0 %) tandis que l’atteinte des grosses articulations des membres inferieurs etait plus souvent chez les MICI-SpA (55,9 %) et pSpA (51,2 %). Parmi les patients avec atteinte des articulations proximales, la hanche etait surtout observee dans les axSpA (86 %) tandis que l’epaule etait plus frequente au cours du Rhpso (60,9 %). Les patients atteints de axSpA avaient la prevalence la plus basse d’enthesite (40,9 %) et de dactylite (6,0 %) ; cependant, les dactylites etaient plus souvent localises aux pieds au cours de la axSpA et aux mains au cours des ReA et SpA-MICI. Conclusion Cette etude suggere que toutes ces manifestations musculosquelettiques peripheriques peuvent etre trouvees dans tous les sous-types de SpA (en incluant le Rhpso), avec seulement des differences quantitatives. Ces resultats confirment le chevauchement entre les differentes entites et suggerent que la probabilite de trouver ces manifestations depend de la maladie sous-jacente. En plus, ces resultats confirment la grande variabilite dans l’expression de la maladie entre pays.

Introduction Les resultats a la semaine (S) 16 de l’etude COAST-W (NCT02696798) ont montre que l’ixekizumab (IXE) etait superieur au placebo (PBO) sur l’amelioration des signes et symptomes de spondyloarthrite axiale radiographique (r-axSpA) active chez des patients (pts) ayant presente une reponse inadequate (IR) ou une intolerance aux anti-TNF [1] . L’objectif de la presente etude d’extension etait d’evaluer l’efficacite et la tolerance de l’IXE en traitement continu a S52. Patients et methodes Des pts adultes atteints de r-axSpA active (repondant aux criteres ASAS) et ayant presente une reponse inadequate ou une intolerance a 1 ou 2 anti-TNF ont ete randomises (1 :1 :1) pour recevoir un PBO ou 80 mg d’IXE toutes les 2 (IXEQ2 W) ou 4 semaines (IXEQ4 W). A S16 les pts qui recevaient de l’IXE continuaient a recevoir de l’IXE, et les pts recevant un PBO etaient randomises (1 :1) pour recevoir l’IXEQ2 W ou l’IXEQ4 W jusqu’a S52. Resultats Des 212 pts initialement randomises pour recevoir l’IXE, 169 (80 %) ont termine l’etude a S52. Les 2 posologies d’IXE ont conduit au maintien de l’amelioration de l’activite de la maladie jusqu’a S52 (ASAS40 a S16 : IXEQ4 W [n = 98] = 28,6 %, IXEQ2 W [n = 90] = 33,3 % ; ASAS40 a S52 : IXEQ4W = 39,8 %, IXEQ2W = 33,3 % ; ASDAS [1] sur la fonction, les signes objectifs d’inflammation, la qualite de vie, l’etat de sante et la fonction globale ont ete maintenues voire ameliorees jusqu’a S52. Les pts initialement randomises pour recevoir un PBO et qui ont switche sous IXE ont rapidement atteint des niveaux d’amelioration de leurs signes et symptomes similaires a ceux observes chez les pts initialement randomises pour recevoir l’IXE (PBO puis IXEQ4 W ou IXEQ2 W [n = 93] : ASAS40 a S16 = 14,0 % ; ASAS40 a S52 = 38,7 % ; ASDAS [1] . Conclusion Ces resultats sont les premieres donnees a long terme d’efficacite et de tolerance de l’IXE dans la r-axSpA chez des pts ayant presente une reponse inadequate ou une intolerance aux anti-TNF. Les 2 posologies d’IXE ont montre une amelioration similaire des signes et symptomes et maintenue jusqu’a S52, sans nouveau signal de tolerance. Ces resultats montrent que chez les patients atteints de r-axSpA et ayant presente une reponse inadequate ou une intolerance a 1 ou 2 anti-TNF, l’IXE, un anti-IL17A, constitue une alternative therapeutique.

The clinical course of axial spondyloarthritis (SpA) is variable and characterized by chronic back pain and extraspinal manifestations, such as asymmetrical arthritis, dactylitis and enthesitis. Extra-articular manifestations in the eyes (anterior uveitis), skin (psoriasis) and intestines (chronic inflammatory bowel disease) are also frequent manifestations in patients with SpA. Due to the heterogeneity of disease manifestations and the partial concentration on structural alterations in the sacroiliac joints visible in X‑ray images, the diagnosis is often delayed for many years. An important step in the direction of improved early recognition of axial SpA was establishment of the Assessment of SpondyloArthritis International Society (ASAS) classification criteria published in 2009, which focused on the initally deep-seated back pain and chronicity in relatively young patients as well as the importance of magnetic resonance imaging and HLA B 27 determination in the early stages of the disease. In order to achieve the foundations for an effective and timely therapy of affected patients, in 2014 on the initiative of the German Society of Rheumatology, S3 guidelines on axial SpA including Bechterew's disease and early forms were formulated in cooperation with other specialist societies. This article gives an overview of the contents of the S3 guidelines on axial SpA.

The management of patients with spondyloarthritis (SpA) has experienced a paradigm shift in recent years. This is true for the treatment of axial as well as peripheral manifestations. International treat to target (T2T) recommendations for SpA based on the T2T strategy have now also been published, which contain 5 higher level principles (A-E) in addition to the 15 recommendations. In order to make the recommendations known and to promote national distribution, German experts have now issued a translation of the T2T recommendations for SpA into German.

ZusammenfassungDer klinische Verlauf der axialen Spondyloarthritis (SpA) ist ziemlich variabel. Im Vordergrund stehen entzündliche chronische Rückenschmerzen, aber auch extraspinale Manifestationen wie asymmetrische Oligoarthritis, Enthesitis und Daktylitis. Nicht wenige Patienten haben auch extraartikuläre Manifestationen an Augen (anteriore Uveitis), Haut (Psoriasis) oder Darm (chronisch entzündliche Darmerkrankungen). Durch die Heterogenität des klinischen Bildes, der teilweise schwierigen Bewertung klinischer Symptome und der Konzentration auf konventionell röntgenologisch festgestellte strukturelle Veränderungen in den Sakroiliakalgelenken (New-York-Kriterien 1984 für ankylosierende Spondylitis) ist es zu einer mehrere Jahre betragenden Verzögerung bei der Diagnosestellung gekommen. Ein wichtiger Schritt in Richtung Früherkennung waren die 2009 publizierten ASAS-Klassifikationskriterien für axSpA, die sowohl die Bedeutung der Magnet -resonanztomografie als auch die Bestimmung von HLA-B27 in frühen Phasen der Erkrankung betonen. Um die Grundlagen für eine effektive und frühzeitige Therapie der betroffenen Patienten zu gewährleisten, ist dann im Jahr 2014 auf Initiative der Deutschen Gesellschaft für Rheumatologie (DGRh) eine S3-Leitlinie “Axiale Spondylo arthritis inklusive Morbus Bechterew und Frühformen” unter Mitwirkungen vieler anderer Fachgesellschaften erstellt worden. Dieser Artikel gibt einen Überblick über den Inhalt der S3-Leitlinie zur axialen SpA.

Background:Previous studies showed that patients with non-radiographic and radiographic axial spondyloarthritis (nr- and r-axSpA) have similar disease burden and similar response to anti-inflammatory therapy given similar level of inflammatory activity. Only little is known, however, about long-term disease course in patients with early axSpA.Objectives:To investigate the long-term (up to 10 years) clinical course of patients with early axSpA.Methods:In total, 525 patients with early axSpA (r-axSpA with symptom duration ≤10 years and nr-axSpA with symptom duration ≤5 years) from the German Spondyloarthritis Inception Cohort (GESPIC) were included. The final patient classification was based on central reading results in 458 patients with available pelvic X-rays, and on local rheumatologist judgement in 67 patients. A total of 251 patients were finally classified as r-axSpA and 274 as nr-axSpA. Clinical evaluation, which included disease activity (BASDAI, C-reactive protein – CRP, ASDAS) as well as therapy recording, was performed at baseline and every 6 months thereafter until year 2 and annually thereafter till year 10. Treatment was conducted at the discretion of the local rheumatologist.Results:Since the cohort has started prior to introduction of TNF inhibitors (TNFi), only 2% patients received TNFi at baseline that increased to 23% at year 10 (15% in nr-axSpA and 31% in r-axSpA) – Figure 1. The use of NSAIDs and csDMARDs decreased in both groups (Figure 1), while use of systemic steroids did not change substantially (9% at baseline, 8% at year 10). The proportion of patients with low disease activity according to BASDAI (Conclusion:Patients with nr-axSpA and r-axSpA showed a similar disease course in terms of disease activity on the group level. The drop-out rate in this observational cohort was overall high, but comparable between groups. The lower proportion of patients with nr-axSpA being treated with TNFi might reflect a later introduction of TNFi for this indication.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research as well as by Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. From 2010 till 2019 GESPIC has been supported by Abbvie.Disclosure of Interests:Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Murat Torgutalp: None declared, Maryna Verba: None declared, Johanna Callhoff: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Judith Rademacher: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

Background:Peripheral symptoms (PS), such as arthritis, enthesitis, and dactylitis, are common in axial spondyloarthritis (axSpA); data showing the association of PS and spinal radiographic progression in axSpA are controversial.Objectives:To analyze the association of PS and spinal radiographic progression in patients with axSpA.Methods:A total of 210 patients with axSpA (115 with radiographic and 95 with non-radiographic axSpA) were selected for analysis. Spinal radiographs were scored by two readers in a random order according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Pelvic radiographs were scored according to the grading system of the modified New York criteria; a sacroiliitis sum score was calculated as a sum of the grades for both sacroiliac joints. Mann-Whitney and Fisher exact tests were performed for group comparisons. A multivariable regression analysis was performed to analyze the influence of PS on radiographic progression.Results:Of the 101 (48.1%) patients with PS, 78 had peripheral arthritis, 48 - enthesitis, 12 - dactylitis. 32 patients had ≤1 PS. Patients with PS were older, less frequently HLA-B27 positive, compared with patients with no PS (73 (73.0%) vs. 93 (85.3%), p=0.028), had higher disease activity (time-averaged ASDAS over 2 years 2.6 ± 0.9 vs. 2.3 ± 0.9; p=0.032), worse physical function (BASFI 3.5 ± 2.3 vs. 2.3 ± 2.2, pTable 1.Association of peripheral symptoms with radiographic progression in axial spondyloarthritis after 2 years of follow-up.Multivariable linear regression analysisOutcomeβ (95 %CI)mSASSS change score−0.98 (-1.68 to -0.28)*Change of the sacroiliitis sum score−0.06 (-0.32 to 0.20)**Multivariable logistic regression analysisOutcomeOdds ratio (95 %CI)Progression of mSASSS by ≥2 points0.33 (0.12 to 0.91)*Progression of sacroiliitis by at least 1 grade in opinion of both readers0.84 (0.33 to 2.09)**mSASSS - modified Stoke Ankylosing Spondylitis Spine Score.*Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, baseline syndesmophytes, and time-averaged ASDAS.**Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, sacroiliitis sum score at baseline, and time-averaged ASDAS.Conclusion:Presence of PS is associated with distinct characteristics of SpA including slower radiographic spinal progression which might be explained partly by the numerically lower mSASSS score at baseline.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research (BMBF). As funding by BMBF was reduced in 2005 and stopped in 2007, financial support has been obtained from Abbott / Abbvie, Amgen, Centocor, Schering-Plough, and Wyeth. Since 2010 GESPIC is supported by Abbvie.Dr. Murat Torgutalp was supported by the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB

Background:Long-term data on anti-TNF treatment in patients with early axial spondyloarthritis (SpA) is scarce.Objectives:The objective of this analysis was to assess the long-term clinical efficacy (up to 10 years of treatment) of a tumor necrosis factor (TNF) inhibitor etanercept (ETN) in patients with early axial spondyloarthritis, who participated in the long-term (until year 10) extension of the ESTHER (Etanercept vs. Sulfasalazine in Early Axial Spondyloarthritis Trial) trial.Methods:In the previously reported ESTHER trial, patients with early active axial SpA [including both non-radiographic axial SpA (nr-axSpA) and radiographic axial SpA (r-axSpA)/ankylosing spondylitis (AS)] with a symptom duration of Results:Out of 76 initial patients, 25% (n=19, 12 with r-axSpA and 7 with nr-axSpA) completed year 10 of the study. At baseline, completers were significantly more often male and showed lower values of patient (PGA) and physician global assessments of disease activity (PhGA), ASDAS (Ankylosing Spondylitis Disease Activity Score), BASMI (Bath Ankylosing Spondylitis Metrology Index), and AS-QoL (Ankylosing Spondylitis Quality of Life Questionnaire) as compared to non-completers (Table 1). When analyzing clinical data of the completers, mean BASDAI, BASFI and ASDAS values were constantly Conclusion:A sustained clinical response was shown over the 10 years of the study for the completers with comparable rates between r-axSpA and nr-axSpA. ETN was well tolerated across the entire treatment period and showed a good safety profile with no new safety signals.Table 1.Baseline characteristics of patients with axial spondyloarthritis who completed the study as compared to patients who dropped out.Completer(n=19)Non-Completer(n=57)p valueAge, years32.5 (7.4)32.8 (8.9)0.91Male patients, n (%)15 (78.9)29 (50.9)0.034Symptomduration, years1.1 (1.2)1 (1.7)0.81HLA-B27 positivity, n (%)18 (94.7)44 (77.2)0.091Elevated CRP (CRP>5mg/l), n (%)7 (38.9)33 (62.3)0.088Fulfilled New York criteria, n (%)12 (63.2)27 (47.4)0.24Patient global (0-10)6.1 (1.9)7.2 (1.7)0.025Physician global (0-10)5.5 (1.5)6.5 (1.2)0.007ASDAS3 (0.7)3.5 (0.8)0.042BASDAI (0-10)5.4 (1.1)5.8 (1.3)0.27BASFI (0-10)4 (2.1)4.4 (2)0.41BASMI (0-10)1.2 (1.3)2 (1.6)0.039AS-QoL (0-18)7.6 (3.9)10.1 (3.9)0.019Acknowledgments:The ESTHER study was supported by an unrestricted research grant from Pfizer.Murat Torgutalp’s work at Charité was supported by an award from the Scientific and Technological Research Council of Turkey.Disclosure of Interests:Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Murat Torgutalp: None declared, Anja Weiß: None declared, Mikhail Protopopov Consultant of: Novartis, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Olaf Behmer Employee of: Pfizer Pharma GmbH, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB