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Objective To investigate the effect of pharmacological treatment of SpA on depressive symptoms and explore whether this effect differs between drug classes. Methods Data from the observational Assessment of SpondyloArthritis international Society Health Index Validation Study were used. Patients were assessed at baseline and after initiation of NSAIDs/conventional synthetic DMARDs (csDMARDs)/TNF inhibitors (TNFis). Depressive symptoms were assessed with the Hospital Anxiety and Depression Scale depression subscale [HADS-D; 0–21 (best–worst)]. Covariables included demographics and disease characteristics, including disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)/BASDAI]. The change in HADS-D from baseline was compared between treatments (NSAIDs/csDMARDs/TNFis) with analysis of variance and multivariable regression analysis. Results A total of 304 patients were included; 102/45/157 initiated NSAIDs/csDMARDs/TNFis and 260 (85%) / 44 (15%) had axial/peripheral SpA. At baseline, the mean HADS-D was 6.9 (s.d. 4.2); 126 (42%) were possibly depressed (HADS-D ≥8) and 66 (22%) were probably depressed (HADS-D ≥11). At follow-up, depressive symptoms significantly improved in all treatment groups. In multivariable regression without disease activity measures, initiating TNFis compared with NSAIDs was associated with greater improvement in depressive symptoms [β = −1.27 (95% CI −2.23, −0.32)] and lower odds of possible depression at follow-up [odds ratio 0.47 (95% CI 0.23, 0.94)]. This association was attenuated after additional adjustment for disease activity (ASDAS/BASDAI) but not CRP. csDMARDs did not differ from NSAIDs regarding their effect on HADS-D. Between-drug class results were confirmed in axial SpA (axSpA), although less clear in peripheral SpA. Conclusion Treatment of active SpA also improves depressive symptoms. Especially in axSpA, TNFis have a greater effect than NSAIDs, which is mainly explained by a stronger effect on disease activity. We found no evidence for a direct link between CRP-mediated inflammation and depressive symptoms in SpA.

Objectives To compare the influence of age on inflammatory (bone marrow oedema [BME]) and structural (fat lesions [FL], erosions and ankylosis) MRI lesions in the sacroiliac joints (SIJ) of patients with and without axial spondyloarthritis (axSpA). Methods In a retrospective study, SIJ MRI (STIR/T1 sequences) of consecutive patients with chronic back pain diagnosed with axSpA or non-SpA were evaluated based on SIJ quadrants (SIJ-Q). Two blinded readers evaluated BME and structural lesions. Reader agreement was evaluated for prevalence of MRI lesions related to age. Results MRIs of 309 (175 axSpA, 134 non-SpA) patients were evaluated. Their mean age was 38.5 (11.4) and 43.4 (13.8) years, 67% and 36% were male, CRP was 1.6 (2.4) and 1.1 (2.1) mg/dl and median symptom duration was 48 and 60 months for axSpA and non-SpA, respectively. SIJ-Q with BME and erosions were significantly more frequent in axSpA vs non-SpA patients independent of age, while this difference was seen for FL only in patients ≥50 years. The proportion of patients with ≥1 or ≥3 BME or chronic lesions except for FL increased with age in both groups, and was constantly higher in axSpA vs non-SpA. In univariate analyses, only female sex was significantly associated with more FL. Conclusions The proportion of patients with MRI lesions was high in both axSpA and non-SpA patients. However, the prevalence of BME and erosions was significantly more frequent in patients with axSpA, was independent of age and also allowed for discrimination. FL occurred more frequently only in older age groups and were less reliable for discrimination vs non-SpA patients.

Purpose Refusal to receive SARS-CoV-2 vaccination poses a threat to fighting the COVID-19 pandemic. Little is known about German cancer patients’ attitude towards and experience with SARS-CoV-2 vaccination. Methods Patients were enrolled between 04–11/2021. They completed a baseline questionnaire (BLQ) containing multiple choice questions and Likert items ranging from 1 (“totally disagree”) to 11 (“totally agree”) regarding their attitude towards vaccination and COVID-19. A follow-up questionnaire (FUQ) was completed after vaccination. Results 218 patients (43% female) completed BLQ (110 FUQ; 48% female). Most patients agreed to “definitely get vaccinated” (82%) and disagreed with “SARS-CoV-2 vaccination is dispensable due to COVID-19 being no serious threat” (82%; more dissent among men, p = 0.05). Self-assessment as a member of a risk group (p = 0.03) and fear of COVID-19 (p = 0.002) were more common among women. Fear of side effects was more common among women (p = 0.002) and patients with solid or GI tumors (p = 0.03; p p = 0.001). High tolerability correlated with confidence in the vaccine being safe (r = 0.305, p = 0.003). Most patients would agree to get it yearly (78%). After vaccination, patients felt safe meeting friends/family (91%) or shopping (62%). Vacation (32%) or work (22%) were among others considered less safe (less frequent among men, p Conclusion Acceptance of SARS-CoV-2 vaccination is high and it is well tolerated in this sensitive cohort. However, concerns about vaccine safety remain. Those and gender differences need to be addressed. Our results help identify patients that benefit from pre-vaccination consultation.

ObjectivesTo define the instruments for the Assessment of SpondyloArthritis international Society–Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).MethodsAn international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments’ psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS.ResultsThe updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments.ConclusionsThe selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials.

Introduction: Sustained improvement of high degree in clinical outcomes have been demonstrated in phase 3 trials with secukinumab in both psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The objective of the SERENA study was to evaluate the effectiveness, retention rates, and safety of secukinumab in patients with PsA and AS. Methods: SERENA is an ongoing, longitudinal, real-world observational study involving patients with moderate-to-severe psoriasis, PsA, or AS. Patients had received at least 16 weeks of secukinumab treatment before recruitment to the study. Retention rate was defined as percentage of patients who continued secukinumab treatment over the course of study. Effectiveness of secukinumab in AS and PsA cohorts was assessed using descriptive statistics. Results: The current interim analysis included 1004 patients with PsA or AS. Overall secukinumab retention rates at 2 years after enrolment were 74.9 and 78.9% in patients with PsA and AS, respectively. At baseline and at 2 years, swollen joint count [3.3 (5.8) vs. 2.9 (5.8)], tender joint count [6.3 (9.4) vs. 5.6 (7.2)] in patients with PsA and BASDAI scores [3.2 (2.3) vs. 2.9 (2.3)] in patients with AS, suggest sustained effectiveness for patients remaining on secukinumab for at least 2 years after enrolment. A total of 73 patients had treatment interruption; 78% of these patients reinitiated secukinumab without a loading dose. No new or unexpected safety signals were reported. Conclusions: After more than 2 years since initiation, secukinumab demonstrated high retention rates and favorable safety profile as well as sustained effectiveness in patients who continued secukinumab treatment.

Background/Aims Psoriatic arthritis (PsA) is a multi-system disease with a range of management options. Treatment may vary by geographic location. We compared disease characteristics and prescribing practices in the UK and Europe in the post-Covid era. Methods The ASSIST study was a cross-sectional observational study of PsA patients aged 18 years and older selected from 24 centres across 5 countries (UK, France, Germany, Italy and Spain) between July 2021 and March 2022 (IRAS: 287039). Patients attending a face-to-face appointment with a diagnosis of PsA made by a rheumatologist were selected by systematic sampling at each centre and treated in routine clinical practice. Patient and disease characteristics, current treatment and treatment decisions (medications unchanged, switched, added or reduced) were recorded. The analysis was descriptive, with no imputation of missing data. Results 503 patients were included, with arthritis subtype, patient age, disease activity and duration shown (Table 1). Physician- and patient-reported disease severity was highest in the UK, where median patient age was lowest. Conventional synthetic (cs) DMARDS constituted a higher percentage of current PsA treatment in UK than continental Europe (66.4% vs 44.9%), whereas biologic use was more frequent in Europe (68.1% vs 36.4%). Adalimumab was the most commonly used biologic in the UK and Spain. Adalimumab and secukinumab were equally used in Germany, and ixekizumab and adalimumab were joint-first in Italy. Implementing change to the current PsA treatment was most common in the UK, predominantly being a treatment increase. This may reflect the higher level of disease activity or younger patient age in the UK than other countries, as treatment escalation is more likely earlier in the disease course. In the UK, treatment escalation was more commonly achieved by medication addition (26.2%) than medication switch (14%) or dose increase (7.5%). In Europe, medication addition and switch were of more similar frequency (10.9% vs 9.85%). Conclusion Disease characteristics and treatment strategies varied between countries, but particularly between UK and the rest of Europe. In contrast to mainland Europe, csDMARDs predominated in the UK, perhaps reflecting current NICE guidelines. Treatment escalation was most common in the UK, in keeping with higher disease activity. Disclosure L. Watson: None. C. Coyle: None. M. Brooke: None. U. Kiltz: None. E. Lubrano: None. R. Queiro: None. D. Trigos: None. J. Brandt-Juergens: None. S. D'Angelo: None. A. Delle Sedie : None. E. Dernis: None. P. Helliwell: None. P. Ho: None. A. Hueber: None. B. Joven: None. M. Koehm: None. C. Montilla: None. J. Packham: None. J.P. Tasende: None. F.J.R. Garcia: None. A. Ruyssen-Witrand: None. R. Scrivo: None. S. Twigg: None. M. Welcker: None. M. Soubrier: None. T. Wirth: None. L. Gossec: Consultancies; AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB. Grants/research support; Amgen, Galapagos, Lilly, Pfizer, Sandoz, UCB. L.C. Coates: None.

Background/Aims A personalised approach is required to optimise management of psoriatic arthritis (PsA). Shared decision-making between physician and patient is key, resulting in greater patient satisfaction and outcomes. We assessed the degree of perceived collaboration following clinic visits in the UK and Europe and whether this was associated with treatment escalation. Methods The ASSIST study was a cross-sectional observational study of PsA patients aged 18 years and older selected from 24 centres across 5 countries (UK, France, Germany, Italy and Spain) between July 2021 and March 2022 (IRAS: 287039). Patients attending a face-to-face appointment with a diagnosis of PsA made by a rheumatologist were selected by systematic sampling at each centre and treated in routine clinical practice. Patients completed the collaboRATE questionnaire (scored 0-9), where high scores indicate greater perceived collaboration. The perceived efficacy in patient-physician interactions (PEPPI) tool (scored 5-25) assessed the patients’ view on their confidence in the consultation. Patient, physician, and disease characteristics were recorded, alongside treatment decisions (medications unchanged, switched, added or reduced). The analysis was descriptive, with no imputation of missing data. Results 503 patients were included, with key characteristics shown (Table 1). Generally, the level of disease severity was low (mean total PsAID score 3.6/10) and PEPPI scores were high, indicating patient confidence in the consultation. A subgroup (n = 10) perceived difficulty in sharing their concerns (PEPPI 5) had treatment escalation. However, in patients with high collaboRATE scores, even patients with low PsAID scores had treatment escalation. Conclusion Patients report high levels of shared decision-making in face-to-face PsA consultations, unrelated to treatment escalation. In patients with low PsAID scores, those with higher perceived collaboration are more likely to have treatment escalation than those without, perhaps reflecting the identification of otherwise undetected symptoms/concerns. Disclosure L.L. Watson: None. C. Coyle: None. M. Brooke: None. U. Kiltz: None. E. Lubrano: None. R. Queiro: None. D. Trigos: None. J. Brandt-Juergens: None. S. D'Angelo: None. A. Delle Sedie : None. E. Dernis: None. P. Helliwell: None. P. Ho: None. A. Hueber: None. B. Joven: None. M. Koehm: None. C. Montilla: None. J. Packham: None. J.P. Tasende: None. F.J.R. Garcia: None. A. Ruyssen-Witrand: None. R. Scrivo: None. S. Twigg: None. M. Welcker: None. M. Soubrier: None. T. Wirth: None. L. Gossec: Consultancies; AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB. Grants/research support; Amgen, Galapagos, Lilly, Pfizer, Sandoz, UCB. L.C. Coates: None.

Background/Aims Psoriatic arthritis (PsA) is a heterogeneous, multi-dimensional disease. Treatment pathways are not well defined and have to be tailored to the individual; however, little is known about the factors underpinning a decision to intensify treatment. By comparing treatment data between countries, we can understand more about factors influencing patient outcomes and establish international benchmarks in practice. Methods ASSIST was a cross sectional study of patients (18 years and older) diagnosed with PsA. Participants were selected from 24 centres across 5 countries (UK, France, Germany, Italy and Spain). Patients were selected from face to face (F2F) appointments using systematic sampling with random starting numbers generated for each site. Participants were treated as usual in their routine clinical practice. The Health Assessment Questionnaire (HAQ) and the EQ-5D-5L QoL survey were provided to all participants as patient-reported outcome tools. The perceived confidence on patient-physician interaction score (PEPPI) and the CollaboRATE measure were used to assess patient satisfaction with a consultation. Results 503 patients from 24 centres across five countries in Europe (49.1% F, 50.9% M) (mean age 53) participated in the survey between 12/07/2021-22/03/2022. Despite similar rates of treatment escalation and similar satisfaction with consultations, QoL was poorer in the UK. Comparing EQ-5D-5L scores, participants in the UK (107) reported worse outcomes across all domains except pain/discomfort versus participants in mainland Europe (396). 52.3% in the UK reported some problems with self-care versus 33.9% in mainland Europe. 72.9% of patients in the UK reported issues with mobility (mainland Europe: 61.6%). The UK had the highest percentage of participants reporting issues with anxiety (66.4%). The UK had the most severe HAQ scores, (mean= 0.936) compared to means of 0.62 or below in other countries. Physician-reported severity of disease was higher in the UK; however, patients in the UK reported the second highest PEPPI scores, the second highest collaboRATE scores and comparable methods of treatment escalation (dose adjustment or addition of another medication) to mainland Europe. Moreover, data on co-morbidities (including FCI categorical breakdown) does not demonstrate obvious variation between the UK and Europe. Conclusion Overall, patients with PsA in the UK reported lower quality of life (QoL) compared to patients in mainland Europe. It is not clear from our data why the UK performs less well on the majority of EQ-5D-5L domains and HAQ scoring compared to Europe. This may relate to variation in disease activity; however, there is potential selection bias in the higher disease activity reported by physicians in the UK as patients with more severe disease could have been selected for F2F appointments compared to mainland Europe. There may also be additional factors outside of the consultation impacting these scores, which could be identified with future research. Disclosure C. Coyle: None. L. Watson: None. M. Brooke: None. U. Kiltz: None. E. Lubrano: None. R. Queiro: None. D. Trigos: None. J. Brandt-Jürgens: None. S. D'Angelo: None. A. Delle Sedie: None. E. Dernis: None. P. Helliwell: None. P. Ho: None. A. Hueber: None. B. Joven Ibáñez: None. M. Köhm: None. C. Montilla Morales: None. J. Packham: None. J. Antonio Pinto Tasende: None. F. Ramíez García: None. A. Ruyssen-witrand: None. R. Scrivo: None. S. Twigg: None. M. Welcker: None. M. Soubrier: None. T. Wirth: None. L. Gossec: None. L. Coates: None.

Objective To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI). Method First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated. Results The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21–0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries. Conclusions An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health.

Zusammenfassung Hintergrund Regelmäßige Bewegung und spezifisches Training sind wichtige Bausteine in der Therapie rheumatischer Erkrankungen, weil ein gesundheitlicher Nutzen für die Patient*innen nachgewiesen ist. Basierend auf den internationalen Empfehlungen der WHO für Gesunde, geben die „2018 EULAR Empfehlungen zu körperlicher Aktivität von Menschen mit entzündlich-rheumatischen und degenerativen Erkrankungen“ erstmals evidenzbasierte Empfehlungen zu Gestaltung, Durchführung und Implementierung von Bewegungsübungen bei diesen Patient*innen. Ziel Übersetzung ins Deutsche und sprachliche Validierung in Deutschland, Österreich und der Schweiz. Methoden Eine professionelle Übersetzung der EULAR Bewegungsempfehlungen ins Deutsche wurde durch deutschsprachige Experten*innen aus allen 3 Ländern überarbeitet. Die Validierung erfolgte in einem Feldtest mit Rheumatolog*innen, Ergo- und Physiotherapeut*innen, Pflegefachpersonen und medizinischen Fachangestellten aus der Rheumatologie. In den 3 Ländern wurden jeweils 8 strukturierte Interviews zu Verständlichkeit, Wortwahl, Vollständigkeit und Umsetzbarkeit durchgeführt. Die Experten*innen diskutierten die Änderungsvorschläge, bis jeweils ein Konsens erreicht wurde. Zuletzt gaben sie den Grad ihrer Zustimmung zu der finalen Übersetzungsversion an. Ergebnisse Die professionelle Übersetzung wurde substanziell überarbeitet. Aufgrund der Ergebnisse der Feldtests wurden verschiedene Änderungen einzelner Worte sowie Umformulierungen zur besseren Verständlichkeit vorgenommen. Der Grad der Zustimmung lag mit durchschnittlichen Bewertungen zwischen 10 (SD 0,0) und 8,9 (SD 1,5) insgesamt sehr hoch. Diskussion Die vorliegende sprachlich validierte deutschsprachige Version der 2018 EULAR Bewegungsempfehlungen kann und soll dazu beitragen, Fachpersonal darin zu unterstützen, körperliche Aktivität bei Menschen mit entzündlich-rheumatischen und degenerativen Erkrankungen zu fördern.

BACKGROUND: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary.OBJECTIVE: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).METHODS: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies.RESULTS: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials.CONCLUSION: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Zusammenfassung Hintergrund Die App Stores von Apple und Google bieten eine Vielzahl von Gesundheits-Apps an. Das Auffinden qualitativ hochwertiger Apps ist immer noch eine Herausforderung. Fragestellung Lassen sich unter Anwendung der SARASA(„semiautomated retrospective App Store analysis“)-Methode für das Fachgebiet Rheumatologie deutschsprachige Apps identifizieren? Material und Methode SARASA ist eine Methode zur teilautomatisierten Auswahl und Charakterisierung von App Store-gelisteten Apps nach formalen Kriterien. Nach der ersten Anwendung in 02/2018 wurde SARASA 02/2020 erneut auf den Apple App Store angewendet. Ergebnisse In 02/2018 konnten für Apps in den Store-Kategorien „Medizin“ oder „Gesundheit und Fitness“ Metadaten zu 103.046 Apps und bei einer erneuten Erhebung in 02/2020 Daten zu 94.735 Apps über das deutsche Frontend des Apple App Stores ausgelesen werden. Im Jahr 2018 wurden nach Anwendung der Suchbegriffe 59 Apps mit einer deutschsprachigen Beschreibung für das Fachgebiet Rheumatologie identifiziert, 2020 waren dies 53 Apps, die jeweils manuell weiter überprüft wurden; 2018 waren noch mehr der gefundenen Apps für Patienten als für Ärzte vorgesehen, dies war 2020 ausgeglichener. Zudem zeigte sich, dass bei bestimmten Krankheitsbildern von den App-Entwicklern keine Bearbeitungen erfolgten. Die prozentuale Verteilung von Treffern nach Suchbegriffen zeigte im Vergleich von 2018 zu 2020 große Schwankungen. Diskussion Die SARASA-Methode stellt ein hilfreiches Werkzeug dar, um Gesundheits-Apps teilautomatisiert zu identifizieren, die vordefinierten, formalen Kriterien entsprechen. Die inhaltliche Qualität muss anschließend manuell überprüft werden. Weiterentwicklungen der SARASA-Methode und die weitere Konsentierung und Standardisierung von Qualitätskriterien sind sinnvoll. Qualitätskriterien sollten beim Angebot von Gesundheits-Apps in den App-Stores berücksichtigt werden.

Despite aqualitatively and structurally good care of patients with rheumatoid arthritis (RA) in Germany, there are still potentially amendable deficits in the quality of care. For this reason, the German Society for Rheumatology (DGRh) has therefore decided to ask agroup of experts including various stakeholders to develop quality standards (QS) for the care of patients with RA in order to improve the quality of care. The QS are used to determine and quantitatively measure the quality of care, subject to relevance and feasibility. The recently published NICE and ASAS standards and asystematic literature search were used as the basis for development. Atotal of 8QS, now published for the first time, were approved with the intention to measure and further optimize the quality of care for patients with RA in Germany. © 2021. The Author(s)., Zusammenfassung Trotz einer qualitativ und strukturell guten Versorgung von Patient*innen mit rheumatoider Arthritis (RA) in Deutschland bestehen weiterhin potenziell behebbare Defizite in der Qualität der Versorgung. Aus diesem Grund hat die Deutsche Gesellschaft für Rheumatologie (DGRh) eine Expert*innengruppe, in der verschiedene Interessengruppen vertreten waren, beauftragt, nationale Qualitätsstandards (QS) mit dem Ziel zu entwickeln, die rheumatologische Versorgung von Patient*innen mit RA in Deutschland qualitativ zu verbessern. QS dienen der Festlegung und quantitativen Messung guter Versorgungsqualität unter dem Vorbehalt von Relevanz und Realisierbarkeit. Als Grundlage für die Entwicklung dienten die kürzlich publizierten Standards von NICE und ASAS und eine systematische Literatursuche. Insgesamt wurden 8 hiermit erstmals veröffentlichte QS konsentiert, die als Grundlage dienen können, die Versorgungsqualität von Patient*innen mit RA in Deutschland zu messen und weiter zu optimieren.

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.

\(\bf Hintergrund\) Die aktuell grassierende SARS-CoV-2-Pandemie und begrenzte Kapazitäten in der ambulanten rheumatologischen Versorgung werfen, auch angesichts der digitalen Revolution, Fragen nach möglichen Alternativen zu klinischen Visiten auf. Ob und inwieweit Patienten mit entzündlich rheumatischen Erkrankungen bereit und in der Lage sind, mit den neuen Medien wie etwa Videosprechstunden (VSS) umzugehen, ist unklar. \(\bf Methoden\) Mitten in der Pandemie wurden im Mai 2020 ambulante Patienten mit einem standardisierten Fragebogen systematisch befragt, um ihre Möglichkeiten und die Bereitschaft für die Teilnahme an VSS zu ermitteln. Der behandelnde Arzt gab an, ob er die Durchführung einer VSS für möglich und auch für sinnvoll hielt. \(\bf Ergebnisse\) Insgesamt wurden 232 Patienten mit entzündlich rheumatischen Erkrankungen befragt (64,7 % weiblich, mittleres Alter 54,0 \(\pm\) 15,2 Jahre), seropositive (\(\it n\) = 58) und seronegative (\(\it n\) = 51) rheumatoide Arthritis (RA), Spondyloarthritis (SpA) (\(\it n\) = 77) inklusive der axialen SpA (axSpA) und der Psoriasisarthritis (PsA) sowie Kollagenosen und Vaskulitiden (KoV) (\(\it n\) = 46). Die mittlere Krankheitsdauer betrug 5,5 \(\pm\) 8,2 Jahre, bei 75 Patienten (32,3 %) handelte es sich um eine Erstdiagnose. Die mittlere Krankheitsaktivität (0–10, subjektive Patienteneinschätzung) lag bei 4,7 \(\pm\) 2,5. Insgesamt wussten 176 Patienten grundsätzlich über die Möglichkeit der Durchführung von VSS Bescheid (75,9 %), und 166 sahen sich technisch in der Lage, daran teilzunehmen (71,6 %), aber nur 131 waren grundsätzlich auch bereit dazu (56,5 %). Die logistische Regressionsanalyse zeigte, dass die Bereitschaft zur Teilnahme an VSS mit zunehmendem Alter abnahm (\(\beta\) = 0,28, \(\it p\) = 0,01). Nach ärztlicher Einschätzung wurden VSS bei 161 Patienten aus technischen (69,4 %) und bei 127 aus medizinischen Gründen (54,7 %) prinzipiell für möglich gehalten. Die Durchführung von VSS im Rahmen der Versorgung wurde vom Arzt aber nur bei 76 Patienten (32,8 %) für sinnvoll gehalten. \(\bf Zusammenfassung\) Nicht alle Patienten können oder wollen an VSS teilnehmen, mit zunehmendem Alter nimmt die Bereitschaft dazu ab. Auch die ärztliche Einschätzung der Sinnhaftigkeit von VSS beschränkte sich auf etwa ein Drittel der befragten Patienten. Dies ist für zukünftige Planungen von VSS zu berücksichtigen. \(\bf Background\) The currently disseminating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and limited capacities in outpatient rheumatological care, pose questions about possible alternatives to clinical visits, also in view of the digital revolution. It is unclear whether and to what extent patients with inflammatory rheumatic diseases are willing and in a position to deal with the new media, such as video consultation. \(\bf Methods\) In the middle of the pandemic in May 2020 outpatients were surveyed using a standardized questionnaire in order to document their possibilities and willingness to participate in a video consultation. The treating physicians were asked whether carrying out a video consultation was considered to be a possible and meaningful option. \(\bf Results\) Overall, 232 patients with inflammatory rheumatic diseases were surveyed (64.7% female, average age 54.0 \(\pm\) 15.2 years), seropositive (\(\it n\) = 58) and seronegative (\(\it n\) = 51) rheumatoid arthritis (RA), spondyloarthritis (SpA, \(\it n\) = 77) including axial SpA (axSpA) and psoriatic arthropathy (PsA) as well as collagenosis and vasculitis (CoV, \(\it n\) = 46). The mean duration of disease was 5.5 \(\pm\)8.2 years, whereby in 75 patients (32.3%) it was the first diagnosis. The mean disease activity (0–10, subjective patient self-estimation) was 4.7 \(\pm\) 2.5. Overall, 176 patients were basically aware of the possibility to carry out video consultations (75.9%) and 166 considered that they were technically capable to participate (71.6%) but only 131 were principally willing to participate (56.5%). Logistic regression analyses showed that the willingness to participate in video consultations decreased with increasing age (\(\beta \) = 0.28, \(\it p\) = 0.01). According to the medical estimation video consultations were thought to be principally possible for 161 patients for technical reasons (69.4%) and for 127 for medical reasons (54.7%); however, a video consultation within the framework of treatment was only considered to be meaningful by the physician for 76 patients (32.8%). \(\bf Conclusion\) Not all patients can or want to participate in video consultations and the willingness declines with increasing age. The estimation of the meaningfulness of video consultations by physicians was also limited to approximately one third of the patients surveyed. This must be taken into consideration for the future planning of video consultations.

ObjectivesEvidence on the current status of gender equity in academic rheumatology in Europe and potential for its improvement is limited. The EULAR convened a task force to obtain empirical evidence on the potential unmet need for support of female rheumatologists, health professionals and non-clinical scientists in academic rheumatology.MethodsThis cross-sectional study comprised three web-based surveys conducted in 2020 among: (1) EULAR scientific member society leaders, (2) EULAR and Emerging EULAR Network (EMEUNET) members and (3) EULAR Council members. Statistics were descriptive with significance testing for male/female responses assessed by χ2 test and t-test.ResultsData from EULAR scientific member societies in 13 countries indicated that there were disproportionately fewer women in academic rheumatology than in clinical rheumatology, and they tended to be under-represented in senior academic roles. From 324 responses of EULAR and EMEUNET members (24 countries), we detected no gender differences in leadership aspirations, self-efficacy in career advancement and work–life integration as well as the share of time spent on research, but there were gender differences in working hours and the levels of perceived gender discrimination and sexual harassment. There were gender differences in the ranking of 7 of 26 factors impacting career advancement and of 8 of 24 potential interventions to aid career advancement.ConclusionsThere are gender differences in career advancement in academic rheumatology. The study informs a EULAR task force developing a framework of potential interventions to accelerate gender-equitable career advancement in academic rheumatology.

Although the pathogenesis of spondyloarthritis (SpA) has still not been elucidated our options to treat SpA have definitely improved in the last decades. There are two main types of SpA: (i) axial spondyloarthritis (axSpA), also covering the classical ankylosing spondylitis (AS) which is largely equivalent to radiographic (r)-axSpA but different from non-radiographic (nr)-axSpA, and (ii) peripheral SpA (pSpA) also covering psoriatic arthritis (PsA) as the main subtype. The subtype nr-axSpA has historically developed because the approval of drugs for AS did not cover forms without structural changes in the sacroiliac joints which is mandatory in the 1984 New York criteria. The definitions for axSpA are based on the 2009 Assessments in AxSpA International Society (ASAS) classification criteria. Several biologic disease modifying anti-rheumatic drugs (bDMARDs) such as the tumor necrosis factor alpha inhibitors (TNFi) and the interleukin-17-inhibitors (IL-17i) are approved mostly for the whole spectrum of SpA including axSpA and PsA but L-17i does not work in inflammatory bowel disease (IBD). Targeted synthetic (ts) DMARDs cover mainly the janus kinase (JAK)-inhibitors which have recently been developed to inhibit inflammation in several rheumatic and other immune mediated diseases such as IBD. Indeed, the physiologic mechanism of JAK-mediated signal transduction has been recognized as an important target because the inhibition of its actions was shown to successfully work as a therapeutic mechanism. There are now 4 small molecule JAK inhibitors (JAKi) that currently play a role in rheumatology with variable selectivity for the four different JAK isoforms: tofacitinib, baricitinib, upadacitinib and filgotinib. In this review, we summarize current clinical trial data and evaluate the use of the JAK1 selective inhibitor upadacitinib in the treatment of axSpA, including nr-axSpA and r-axSpA. Even though the efficacy and safety of upadacitinib over shorter periods of time has been convincing to date, long-term trials are needed to fully establish its performance and also evaluate the safety at higher doses, and its use in PsA.

ZusammenfassungDie Gicht gehört neben der rheumatoiden Arthritis zu den häufigsten Ursachen von Gelenkentzündungen. Als metabolisch bedingte Erkrankung geht sie meist mit Hyperurikämie und der Ablagerung von Uratkristallen in Gelenken, Sehnen und Weichteilgeweben einher, wodurch Entzündungszustände ausgelöst werden können. Die Gichtarthritis tritt weltweit insbesondere in den Industrieländern mit steigender Prävalenz auf (weltweit 0,6%), wobei die größte Häufigkeit bei den Maoris in Ozeanien (bis zu 10%) gemessen wurde. In Deutschland tritt die Gicht altersabhängig mit einer Prävalenz von 1,63% auf, wobei Männer ungefähr dreimal so häufig wie Frauen betroffen sind. Kardiovaskuläre und vor allem renale Komorbiditäten können zu vermehrten Komplikationen und einer erhöhten Sterblichkeit von Patienten mit Gicht führen. Grundsätzlich haben Gichtpatienten eine erhöhte Mortalität im Vergleich zur Gesamtbevölkerung. Die zunehmende Inzidenz führt zu steigenden Gesundheitskosten, besonders durch vermehrte Hospitalisierungen. Darüber hinaus wurden bei Gichtpatienten mehr Arbeitsunfähigkeitstage sowie reduzierte Erwerbsfähigkeit mit entsprechenden volkswirtschaftlichen Konsequenzen nachgewiesen.

Background/Aims SERENA is an ongoing, prospective, non-interventional study evaluating retention, effectiveness, safety/tolerability and quality of life in > 2,900 patients with moderate to severe plaque psoriasis, active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) treated with secukinumab at 438 sites across Europe for up to 5 years. We present interim results reporting secukinumab treatment retention and safety data through two years in PsA and AS patients. Methods This interim analysis presents data from 534 PsA and 470 AS patients enrolled (target population fulfilling eligibility criteria) and followed for at least two years. Patients (≥18 years) with active PsA or AS should have received at least 16 weeks secukinumab treatment before enrolment in the study. Retention rate was defined as percentage of patients who did not discontinue secukinumab treatment. Treatment break was defined as interruption of therapy for at least three months after last injection. Results The mean treatment duration prior to enrolment in the study was 1.0 year and 0.91 year for PsA and AS, respectively. The retention rates for secukinumab after one year since enrolment and since initiation of treatment were: PsA, 85.2% (n = 519, CI: 82.01-88.32) and 96.8% (n = 528, CI: 95.18-98.38); AS, 85.8% (n = 452, CI: 82.52-89.17) and 94.2% (n = 464, CI: 91.94-96.42), respectively. After two years since enrolment and since initiation of treatment, the retention rates were: PsA, 74.9% (n = 498, CI: 70.99-78.81) and 87.0% (n = 515, CI: 83.99-89.99); AS, 78.9% (n = 437, CI: 75.01-82.88) and 84.8% (n = 454, CI: 81.39-88.21), respectively. At baseline, the majority of PsA (79.5%; n/N=423/532) patients were receiving secukinumab 300 mg, while 97.0% (n/N=456/470) of AS patients were receiving secukinumab 150 mg. The majority of patients continued their initial secukinumab dose; “no dose change” in secukinumab treatment was reported after one and two years in the study (year one: PsA, 93.4% [n = 499] and AS, 92.6% [n = 435]; year two: PsA, 89.7% [n = 479] and AS, 87.9% [n = 413]). Secukinumab treatment break was recorded for 31 PsA patients (median [min, max] treatment break duration in days: 125.0 [61-461]) and for 42 AS patients (118.0 [61-813]), mainly due to adverse events reported in 58.1% (n = 18) and 45.2% (n = 19) of patients, respectively. The retreatment started with monthly dosing in most of the cases: PsA, 80.6% (n/N=25/31) and AS, 76.2% (n/N=32/42). No new or unexpected safety signals were reported. Conclusion Secukinumab retention rates in a real-world setting after more than two years since initiation of treatment and after two years since study enrolment indicate high persistence rates. Safety data collected prospectively for up to two years confirm the favorable safety profile of secukinumab. Disclosure K. Gaffney: Consultancies; AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis, UCB. Member of speakers’ bureau; AbbVie, Celgene, Lilly, Gilead, MSD, Novartis, UCB, Pfizer. Grants/research support; AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis, UCB. U. Kiltz: Consultancies; AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB. P. Sfikakis: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer. Grants/research support; AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer. N. Gullick: Consultancies; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. Member of speakers’ bureau; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. Grants/research support; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. A. Theodoridou: Consultancies; UCB, Amgen, Novartis. J. Brandt-Juergens: Consultancies; AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, Medac. Member of speakers’ bureau; AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, Medac. E. Lespessailles: Consultancies; Amgen, Expanscience, Lilly, MSD. Member of speakers’ bureau; Amgen, Expanscience, Lilly, MSD. Grants/research support; Abbvie, Amgen, Lilly, MSD, UCB,. J. Fang: Other; Employee of Novartis. E. Pournara: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. B. Schulz: Other; Employee of Novartis. P. Jagiello: Other; Employee of Novartis.

Background/Aims Secukinumab has demonstrated long-lasting efficacy and a favorable safety profile in patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS). SERENA is an ongoing, longitudinal, observational study in > 2900 patients with moderate to severe psoriasis, active PsA, and AS. We report interim data on impact of intermediate treatment interruption on secukinumab effectiveness in patients with active PsA or AS. Methods This analysis included data for 534 PsA and 470 AS patients enrolled in SERENA between Oct 2016 and Oct 2018 and followed-up for at least 2 years. Patients (≥18 years) with active PsA or AS were required to have received ≥16 weeks of secukinumab treatment before enrolment. Treatment interruption was defined as interruption of secukinumab therapy for at least 3 months between the last injection and re-initiation. Effectiveness assessments included swollen and tender joint count in PsA patients, and Patient Global Assessment (PtGA) and BASDAI score in AS patients before and during treatment interruption and post secukinumab re-initiation. Patients with assessments in ≥ 2 of the time periods were included. Last assessment prior to intermediate treatment interruption was used as baseline. The assessment closest to 6 months after re-initiation was considered the post-secukinumab re-initiation assessment. Results A total of 31 (5.8%) PsA patients and 42 (8.9%) AS patients had an intermediate treatment interruption since initiation of secukinumab treatment. The mean (SD) duration of treatment interruption was 24.8 (16.4) and 26.4 (22.9) weeks for PsA and AS patients, respectively. The mean (SD) duration of secukinumab treatment before the treatment interruption was 86.8 (50.3) and 90.2 (46.9) weeks, and after the treatment interruption was 73.6 (44.4) and 63.2 (46.8) weeks. The most commonly reported reasons included adverse events (AEs; 18 [58.1%] PsA, 19 [45.2%] AS), patient decision (3 [9.7%] PsA, 3 [7.1%] AS), and COVID-19 outbreak-related reasons (1 [3.2%] PsA, 6 [14.3%] AS patients). More than 80% of PsA patients and 76% of AS patients reinitiated secukinumab without a loading phase after the treatment interruption. The swollen and tender joint count increased in PsA patients from the last assessment prior to the treatment interruption (1.3 [1.0] and 7.2 [11.4]; n = 6) to the first assessment during the treatment interruption (4.0 [1.4] and 16.5 [19.1]; n = 2), and gradually decreased post secukinumab re-initiation (0.4 [0.5] and 2.0 [0.7]; n = 5). PtGA and BASDAI remained stable in AS patients from the last assessment prior to the treatment interruption to the first assessment during the treatment interruption and after secukinumab re-initiation. Conclusion Secukinumab intermediate treatment interruption occurred due to a variety of reasons in the real-world setting, mainly AEs and patient decision. Most patients re-initiated secukinumab treatment without a loading phase. No notable impact of the intermediate treatment interruption was observed on the effectiveness of secukinumab. Disclosure K. Gaffney: Consultancies; AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis, UCB. Member of speakers’ bureau; AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis, UCB. Grants/research support; AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis, UCB. U. Kiltz: Consultancies; AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB. P. Sfikakis: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer. Grants/research support; AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer. N. Gullick: Consultancies; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. Member of speakers’ bureau; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. Grants/research support; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. G. Katsifis: Consultancies; Abbvie, Amgen, Genesis Pharma, Janssen, MSD, Novartis, Pfizer, Roche, Sobi, UCB. Honoraria; AbbVie, Aenorasis, Amgen, Genesis Pharma, Janssen, MSD, Novartis, Pfizer, Roche, UCB. A. Kandili: None. J. Brandt-Juergens: Consultancies; AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, Janssen. Member of speakers’ bureau; AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, Medac. P. Goupille: Consultancies; AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, UCB. Honoraria; AbbVie, Amgen, Biogen, BMS, Chugai, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi, UCB. N. Maiden: Member of speakers’ bureau; Eli-Lilly, UCB. M. Aassi: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. B. Schulz: Other; Employee of Novartis. E. Pournara: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. P. Jagiello: Other; Employee of Novartis.

To compare the influence of age on inflammatory (bone marrow oedema. BME) and structural (fat lesions (FL), erosions and ankylosis) MRI lesions in the SIJ of patients with and without axial spondyloarthritis (axSpA).In a retrospective study, SIJ MRI (STIR/T1 sequences) of consecutive patients with chronic back pain diagnosed with axSpA or non-SpA were evaluated based on SIJ quadrants (SIJ-Q). Two blinded readers evaluated BME and structural lesions. Reader agreement was evaluated for prevalence of MRI lesions related to age.MRIs of 309 (175 axSpA, 134 non-SpA) patients were evaluated. Their mean age was 38.5 ± 11.4 vs 43.4 ± 13.8 years (y), 67% and 36% were male, CRP 1.6 ± 2.4 vs 1.1 ± 2.1 mg/dl, median symptom duration 48 and 60 months, respectively. SIJ-Q with BME and erosions were significantly more frequent in axSpA vs non-SpA patients independent of age, while this difference was seen for FL only in patients ≥50 y. The proportion of patients with ≥1 or ≥ 3 BME or chronic lesions except for FL increased with age in both groups, and was constantly higher in axSpA vs non-SpA. In univariate analyses, only female sex was significantly associated with more FL.The proportion of patients with MRI lesions was high in both, axSpA and non-SpA patients. However, the prevalence of BME and erosions was significantly more frequent in patients with axSpA, was independent of age and also allowed for discrimination. FL occurred more frequently only in older age groups and were less reliable for discrimination vs. non-SpA patients.

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic condition, historically considered a predominantly male disease. However, increasing evidence suggests a more equal prevalence between men and women. Of the limited research conducted to date, it is apparent that gender differences exist in terms of time to diagnosis, treatment outcomes and health-related quality of life (HRQoL). Despite this, women are underrepresented in clinical trials and most studies do not stratify by gender to identify potential differences in terms of disease manifestations and treatment response. In this perspectives article, we reflect on the potential biological and social factors contributing to these differences and propose three key areas of education and research that should be prioritised in order to address the unmet needs of female patients with axSpA, namely: (1) to identify ways to increase awareness of disease occurrence in female patients among healthcare professionals (HCPs), (2) to improve understanding of gender differences in disease manifestation and outcomes, and (3) to conduct gender-stratified clinical trials with a representative sample of female patients.