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Elevated inflammatory markers are associated with severe coronavirus disease 2019 (COVID-19), and some patients benefit from Interleukin (IL)-6 pathway inhibitors. Different chest computed tomography (CT) scoring systems have shown a prognostic value in COVID-19, but not specifically in anti-IL-6-treated patients at high risk of respiratory failure. We aimed to explore the relationship between baseline CT findings and inflammatory conditions and to evaluate the prognostic value of chest CT scores and laboratory findings in COVID-19 patients specifically treated with anti-IL-6. Baseline CT lung involvement was assessed in 51 hospitalized COVID-19 patients naive to glucocorticoids and other immunosuppressants using four CT scoring systems. CT data were correlated with systemic inflammation and 30-day prognosis after anti-IL-6 treatment. All the considered CT scores showed a negative correlation with pulmonary function and a positive one with C-reactive protein (CRP), IL-6, IL-8, and Tumor Necrosis Factor α (TNF-α) serum levels. All the performed scores were prognostic factors, but the disease extension assessed by the six-lung-zone CT score (S24) was the only independently associated with intensive care unit (ICU) admission (p = 0.04). In conclusion, CT involvement correlates with laboratory inflammation markers and is an independent prognostic factor in COVID-19 patients representing a further tool to implement prognostic stratification in hospitalized patients.

Pain is the main symptom of entheseal diseases (enthesopathies) despite a paucity of nerve endings in the enthesis itself. Eicosanoids, cytokines, and neuropeptides released during inflammatory and repeated non-physiological mechanical challenge not only stimulate or sensitize primary afferent neurons present in structures adjacent to the enthesis or but also trigger a "neuro-vascular invasion" that allows spreading of nerves and blood vessels into the enthesis. Nociceptive pseudo-unipolar neurons support this process by releasing neurotransmitters from peripheral endings that induce neovascularization and peripheral pain sensitization. This process may explain the frequently observed dissociation between subjective symptoms, i.e. pain and the structural findings in imaging in entheseal disease.

Background/Aims The combined use of Power Doppler and B-mode ultrasound (PDUS) allows visualisation of morphological and pathophysiological changes of the synovium. ULTIMATE (NCT02662985) was the first large, randomised, double-blind, placebo-controlled PDUS phase IIIb study in psoriatic arthritis (PsA) to demonstrate that the validated Global OMERACT EULAR Synovitis Score (GLOESS), an ultrasound score at patient level, could detect the early and continuous decrease in synovitis in a multicentre setting using different ultrasound devices and examiners. Since the ultrasound assessment for GLOESS is time-consuming owing to the number of joints assessed, we investigated the ability of various reduced joint sets to predict GLOESS. Methods ULTIMATE was a 52-week study of secukinumab with a 12-week, double-blind, placebo-controlled period followed by a 12-week, open-label treatment period and 6-month open-label extension period. GLOESS for 24 paired joints was calculated, with a resultant potential score ranging from 0 to 144. Based on their composite PDUS scores, highly correlated joint clusters were identified with a Spearman’s rank correlation matrix and a Clustered Image Map. Representative joints were then selected from each group by various approaches (best correlation, model optimisation, etc.) yielding several joint combinations. For these reduced joint sets, GLOESS was predicted with linear models based on data from 60% of randomly selected patients from ULTIMATE. The remaining 40% of patient data were used for model validation and diagnostics. Results Five models were established with reduced pairs of joint sets (9-13 pairs) for PDUS-detected synovitis. The joints included in each linear model are summarised in the Table. All five reduced joint set models demonstrated scores very close to full 48 joint GLOESS (R2 ∼0.95); models 1-3 (based on 9 joint pairs) were less accurate at predicting GLOESS than models 4 and 5 (based on 13 and 12 joint pairs, respectively) for the secukinumab cohort in the open-label part (data to be shown in poster). Conclusion All models of reduced joint sets for PDUS-detected synovitis predicted GLOESS well. The next steps will be to document responsiveness and ability to discriminate between active and placebo treatment. Disclosure P.G. Conaghan: Consultancies; P.G.C. has received consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Janssen, Merck, Novartis and Pfizer, Stryker and UCB. Member of speakers’ bureau; P.G.C. has received speakers bureau fees from AbbVie, Novartis and Pfizer. M. D'agostino: Consultancies; M.A.D'A. has received consultancy fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi, and UCB. Member of speakers’ bureau; M.A.D'A. has received speakers bureau fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Roche, Sanofi and UCB. M. Boers: Consultancies; M.B. has received consultancy fees from Novartis. E. Naredo: Honoraria; E.N. has received honoraria for clinical trials from AbbVie, BMS and Novartis. Member of speakers’ bureau; E.N. has received speakers bureau fees from AbbVie, BMS, Celgene GmbH, Janssen, Lilly, Novartis, Pfizer, Roche and UCB. Grants/research support; E.N. has received research grants from Eli Lilly. P. Mandl: Member of speakers’ bureau; P.M. has received speakers bureau fees from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. Grants/research support; P.M. has received grant/research support from AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche and UCB. P. Carron: Consultancies; P.C. has received consultancy fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Member of speakers’ bureau; P.C. has received speakers bureau fees from AbbVie, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Gilead, Merck Sharp Dohme, Novartis, Pfizer and UCB. Grants/research support; P.C. has received grant/research support from Merck Sharp Dohme, Pfizer and UCB. M. Backhaus: Consultancies; M.B. has received consultancy fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Member of speakers’ bureau; M.B. has received speakers bureau fees from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. Grants/research support; M.B. has received grant/research support from BMS, Galapagos, Jonsson, MSD, Novartis, Pfizer, Roche and UCB. A. López-Rodríguez: Consultancies; A.L.R. has received consultancy fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. Member of speakers’ bureau; A.L.R. has received speakers bureau fees from Eli Lilly, GSK, Janssen, Novartis, Roche and UCB. P. Hanova: Consultancies; P.H. has received consultancy fees from Novartis. P. Goyanka: Other; P.G. is an employee of Novartis. B.G. Sahoo: Other; B.G.S. is an employee of Novartis. C. Gaillez: Shareholder/stock ownership; C.G. is a shareholder of Novartis and BMS. Other; C.G. is an employee of Novartis. W. Bao: Shareholder/stock ownership; W.B. is a shareholder of Novartis. Other; W.B. is an employee of Novartis.

Objectives To assess whether two cluster analysis-based axial SpA (axSpA) endotypes (A for purely axial; B for both axial and peripheral) are stable over time and are associated with different long-term disease outcomes. Methods K-means cluster analysis was performed at each visit (until 5 years) on 584 patients from the DESIR cohort, who completed all planned visits, and validated in 232 consecutive axSpA patients from the BeGiant cohort. Cluster stability overtime was assessed by kappa statistics. A generalized linear mixed-effect analysis was applied to compare outcomes between clusters. Classification and regression tree (CART) analysis was performed to determine a decision rule able to assign a given patient to a definite cluster at onset. Results Both endotypes remained remarkably stable over time. In the DESIR cohort, patients in cluster B showed higher disease activity, worse functional outcome and higher need for anti-rheumatic drugs than patients in cluster A. CART analysis yielded three main clinical features (arthritis, enthesitis and dactylitis) that accurately determined cluster assignment. These results could be replicated in the Be-GIANT cohort. Conclusion Cluster-based axSpA endotypes were reproducible in two different cohorts, stable over time and associated with different long-term outcome. The axSpA endotype with additional peripheral disease manifestations is associated with more severe disease and requires more intensive drug therapy Clinical trial registration clinicaltrials.gov, https://clinicaltrials.gov, NCT01648907.

INTRODUCTION: OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials.METHODS: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes.RESULTS: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property.CONCLUSIONS: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

Resume Objectif Evaluer comment les patients presentant un rhumatisme inflammatoire chronique ont fait face a l’epidemie de COVID-19 concernant leur maladie et identifier des facteurs de risque d’infection a SARS-CoV-2 chez ces patients. Methodes Les patients suivis dans un service de rhumatologie francais ou inscrits sur la plateforme securisee d’e-medecine Spondy+ ont ete invites a remplir un questionnaire portant sur la presence de symptomes du COVID-19, sur les resultats des tests diagnostiques et les modifications de traitement durant la periode de confinement. Les reponses au questionnaire ont ete rapportees a l’aide de statistiques descriptives. Les facteurs associes au risque de COVID-19 et a un arret de traitement a visee rhumatologique ont ete evalues a l’aide d’une regression logistique. Resultats Sur les 2081 questionnaires envoyes, nous avons obtenu 655 reponses provenant de 474 patients atteints de spondyloarthrite (SpA), 129 de polyarthrite rhumatoide (PR) et 52 de rhumatisme psoriasique (RP). La moyenne d’âge etait de 51 ans ± 13,4 ans avec une predominance feminine (61,8 %). L’incidence de COVID-19 etait de 6,9 % (IC 95 % : 5,1–9,2 %), avec 12 cas confirmes par PCR et 33 fortes suspicions. Cinq patients ont necessite une hospitalisation dont un en unite de soins intensifs et aucun deces n’a ete constate. Les facteurs independamment associes a un risque d’infection etaient une notion de contage au SARS-CoV-2, un jeune âge, et l’absence d’intoxication tabagique. Plus de 30 % des patients rapportaient avoir suspendu ou arrete au moins un traitement de leur rhumatisme inflammatoire durant la periode de confinement, la plupart par peur d’une contamination (79,3 %). Parmi ceux-ci, 63,4 % ont rapporte une majoration de l’activite de leur maladie. Conclusion Notre etude ne montre pas d’augmentation de l’incidence ou de la severite de COVID-19 chez les patients presentant un rhumatisme inflammatoire chronique. Elle apporte des arguments en faveur de la securite des traitements anti-rhumatismaux en periode epidemique.

Objectives To delineate the impact of peripheral musculoskeletal manifestations on stratification of disease phenotype and outcome in new-onset spondyloarthritis (SpA), using a prospective observational nationwide inception cohort, the BelGian Inflammatory Arthritis and spoNdylitis cohorT (Be-Giant). Methods Newly diagnosed adult SpA patients, fulfilling the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial or peripheral SpA, were included in Be-Giant and prospectively followed every six months. Peripheral involvement (defined as arthritis, enthesitis and/or dactylitis) was determined in relation to clinically similar patient subsets at baseline and disease activity patterns during two-year follow-up, identified through K-means cluster analysis and latent class growth analysis. Results From November 2010 to March 2020, 367 patients were enrolled in Be-Giant, of whom 162 (44%) had peripheral manifestations. Two patient clusters [A, axial predominant (n = 248) and B, peripheral predominant (n = 119)] were identified at diagnosis. Longitudinal analysis (n = 115) revealed two trajectories of disease activity in each cluster: one with persistently high disease activity over time (‘High’), the other rapidly evolving to low disease activity (‘Low’). In cluster A patients, peripheral manifestations predisposed to the ‘High’ trajectory [odds ratio (OR) = 2.0, 95% CI: 1.3, 3.1, P = 0.001], despite more rapid initiation of biologics compared with patients without peripheral manifestations (hazard ratio (HR) = 2.1, 95% CI: 1.0, 4.4, P = 0.04 – Cox proportional-hazards model). Conclusion Peripheral musculoskeletal manifestations are major determinants of phenotypical diversity in new-onset SpA. Intriguingly, stratification of axial SpA according to concomitant peripheral involvement identified an endotype with an unfavorable outcome despite more prompt therapeutic intensification with biologics. These observations justify an endotype-tailored approach beyond current ASAS/EULAR management recommendations.

To assess patient perspective and professional practice of intraarticular therapies (IATs) across Europe, an expert international multidisciplinary panel designed two open web-based surveys: one targeting people who had experienced at least two IATs (44 items); and one targeting health care providers (HCPs) (160 items). Surveys were disseminated via patient and professional associations and social media. A descriptive analysis was performed. The surveys were answered by 200 patients and 186 HCPs from 26 countries, showing that IAT is routinely performed by rheumatologists (97%) and orthopaedic surgeons (89%), with specific training being compulsory in a few countries. The most frequent indications for IAT are arthritis (76%), osteoarthritis (74%), crystal arthritis (71%) and bursitis (70%); the most frequently injected joints are knee (78%) and shoulder (70%); and the most used compounds are glucocorticoids. The majority of HCPs report informing patients about side-effects (73%), benefits (72%), and the nature of the procedure (72%), which coincides with 27% of patients reporting that they had not been informed about benefits or potential complications of IATs; 73% of patients had not been asked whether they wanted an anaesthetic. Few HCPs (10%) obtain written consent (56% get oral consent, being mandatory for 32%), a procedure deemed necessary by 41% of the patients. 50% of patients reported a clear benefit of IAT and 20% experienced complications including pain, impaired mobility, rashes, or swelling. In summary, the practice of IAT is variable across Europe, and although patients perceive it as relatively safe and usually effective procedure, some gaps were identified.

Objectives Imaging is one of the most rapidly evolving fields in medicine. Unfortunately, many imaging technologies have been applied as measurement instruments without rigorous evaluation of the evidence supporting their truth, discriminatory capability and feasibility for that context of use. The Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Instrument Selection Algorithm (OFISA) is used to evaluate such evidence for use of an instrument in a research setting. The objectives of this work are to: [1] define and describe the key conceptual aspects that are essential for the evaluation of imaging as an outcome measurement instrument and [2] describe how these aspects can be assessed through OFISA. Methods Experts in imaging and/or methodology met to formalize concepts and define key steps. These concepts were discussed with a team of patient research partners with interest in imaging to refine technical and methodological aspects into comprehensible information. A workshop was held at OMERACT2020 and feedback was incorporated into existing OMERACT process for domain and instrument selection. Results Three key lessons were identified: (1) a clear definition of the domain we want to measure is a necessary prerequisite to the selection of a good instrument, (2) the sources of variability that can directly influence the instrument should be clearly identified, (3) incorporating these first two lessons into OFISA improves the quality of every instrument selection process. Conclusions The incorporation of these lessons in the updated OMERACT Filter (now 2.2) will improve the quality of the selection process for all types of outcome measurement instruments.

Resume Objectif Proposer des recommandations pour une utilisation pertinente de l’echographie dans la polyarthrite rhumatoide (PR) en pratique quotidienne, fondees sur les donnees de la litterature et l’opinion d’experts en echographie osteo-articulaire. Methodes A partir d’une analyse systematique de la litterature, un comite scientifique a selectionne des thematiques et questions pertinentes pour elaborer une premiere version des recommandations. Celles-ci ont ete soumises a un groupe d’experts en echographie osteo-articulaire selon une procedure Delphi, permettant l’elaboration d’une version preliminaire des recommandations qui ont ensuite ete reformulees et validees par un groupe d’experts elargi en evaluant leur pertinence, leur comprehensibilite et leur exhaustivite, au cours d’une reunion presentielle. Le degre d’accord des experts et la faisabilite de ces recommandations en pratique ont ete precises. Resultats A l’issue de 2 tours de Delphi, un consensus a ete obtenu sur 3 principes generaux, incluant les definitions des sites articulaires, tendineux et osseux a evaluer, et 10 recommandations. Elles soulignent l’interet de l’echographie pour aider au diagnostic de PR devant des arthralgies inflammatoires ou une oligoarthrite inclassee et pour evaluer l’etendue de l’atteinte inflammatoire et structurale initialement. Elles positionnent cet examen au cours du suivi et une fois la remission clinique obtenue avant d’envisager la decroissance therapeutique. Elles precisent son interet pour aider a la realisation des gestes techniques. Conclusion Ces 10 recommandations consensuelles devraient permettre une homogeneisation ainsi qu’une optimisation des pratiques cliniques, conduisant a ameliorer la prise en charge des patients presentant une PR.

ObjectivesTo establish evidence-based recommendations to guide health professionals using intra-articular therapies (IAT) in adult patients with peripheral arthropathies.MethodsA multidisciplinary international task force established the objectives, users and scope and the need for background information, including systematic literature reviews) and two surveys addressed to healthcare providers and patients throughout Europe. The evidence was discussed in a face-to-face meeting, recommendations were formulated and subsequently voted for anonymously in a three-round Delphi process to obtain the final agreement. The level of evidence was assigned to each recommendation with the Oxford levels of evidence.ResultsRecommendations focus on practical aspects to guide health professionals before, during and after IAT in adult patients with peripheral arthropathies. Five overarching principles and 11 recommendations were established, addressing issues related to patient information, procedure and setting, accuracy, routine and special aseptic care, safety issues and precautions to be addressed in special populations, efficacy and safety of repeated joint injections, use of local anaesthetics and aftercare.ConclusionWe have developed the first evidence and expert opinion-based recommendations to guide health professionals using IAT. We hope that these recommendations will be included in different educational programmes, used by patient associations and put into practice via scientific societies to help improve uniformity and quality of care when performing IAT in peripheral adult joints.

In most rheumatic and musculoskeletal diseases (RMDs), global assessments of disease activity by physicians and patients are 'anchor outcomes' in therapeutic trials evaluating whether a treatment is effective.To compare physicians' vs patients' global assessments of disease activity in RMD trials and explore reasons for discrepancies between them.Eligible trials were sampled from systematic reviews of treatments for RMDs by using the Cochrane database of systematic reviews (i.e., reviews from the Cochrane Musculoskeletal Group, [CMSG]). Randomized controlled trials (RCTs) of interventions for RMDs were eligible if they reported quantitative analyses of both physicians´ and patients´ global assessments at the same time point for the comparison of the same experimental intervention against the same comparator (i.e., placebo, no treatment, or other treatment). We accepted data from trial comparisons for each type of outcome, regardless of the type of intervention and type of RMD within the CMSG. Using mixed-effects meta-regression models, we assigned the dependent variable as the ratio of odds ratios (ROR) of global change with the experimental intervention, versus the control comparator. An ROR1 would indicate that physicians rated the experimental intervention more favorable than their patients did.We were able to estimate the ROR (data from both physicians' and patients' global assessments) across 70 trials (116 randomized comparisons) in 7 diseases (ankylosing spondylitis, fibromyalgia, psoriatic arthritis, osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus, and gout). The combined ROR across all effectiveness comparisons were rated significantly in favor of the intervention by physicians: ROR=1.15 CI 95% (1.07 to 1.23). This combined ROR was based on a substantial heterogeneity across comparisons (IIn comparative effectiveness research on rheumatology, physicians' global assessments of disease activity, surprisingly, are more in favor of the experimental interventions than are those of the patients.

BackgroundDespite the worldwide increasing request of education on paediatric musculoskeletal ultrasound (PedMSUS), content, conduct and format of PedMSUS courses have never been internationally agreed.ObjectivesTo produce educational procedures for the conduct, content and format of EULAR/PReS PedMSUS courses.MethodsAfter a systemic literature review and expert opinion collection, a panel of items for the development of procedures on PedMSUS courses was identified. Agreement on the items was assessed through Delphi surveys among a taskforce of 24 members, which included 18 experts in PedMSUS (8 rheumatologists, 1 radiologist, 9 paediatric rheumatologists), 1 methodologist and rheumatologist expert in MSUS, 2 patient research partners, 1 health professional in rheumatology and 2 EMEUNET/EMERGE members, from 8 different European countries. Each item was assessed through a 5-point Likert scale (0, full disagreement; 5, full agreement); agreement was reached for >75% of answers rating 4–5. All items with agreement were included in the preliminary core set of educational procedures, which underwent external assessment by a broader Consensus group (Faculty and Tutors of previous EULAR PedMSUS courses and PReS Imaging Working Party members), through Delphi survey.ResultsTwo Delphi surveys produced the preliminary core set of procedures for basic, intermediate, advanced and teach-the-teachers (TTT) PedMSUS courses. A Delphi survey within the Consensus group produced agreement on the proposed procedures.ConclusionsShared EULAR/PReS procedures for the conduct, content and format of basic, intermediate, advanced and TTT PedMSUS courses were identified on international basis.

Resume Objectif Les resultats mesures d’activite de la maladie telles que le score d’activite clinique (DAS 28) ou les scores echographiques sont souvent divergents. Les objectifs de cette etude etaient de determiner la proportion de desaccords entre ces deux methodes d’evaluation chez des patients atteints de polyarthrite rhumatoide (PR) et de decrire les facteurs associes a ces divergences. Methodes Tous les patients atteints de PR inscrits dans le registre suisse des arthrites inflammatoires (SCQM) pour lesquels au moins un score DAS 28 et un score echographique concomitant etaient disponibles ont ete inclus. L’activite de la maladie a ete classee dans plusieurs categories (remission, faible a moderee et forte) selon des seuils etablis pour les deux scores etudies. Une analyse longitudinale a ete realisee pour les patients ayant beneficie d’au moins deux evaluations. Resultats Sur les 2369 evaluations incluses (1091 patients), 1196 (50,4 %) etaient divergentes. Par rapport au score DAS 28, le score echographique surestimait et sous-estimait l’activite de la maladie (23,5 % et 26,8 %, respectivement). Les facteurs cliniques et demographiques significativement associes aux resultats divergents etaient les composantes individuelles du score DAS 28 lorsque l’echographie etait utilisee comme reference et l’âge, la duree de la maladie et le nombre d’articulations gonflees lorsque la reference etait le score DAS 28. Le principal facteur lie a l’echographie ayant ete associe a une divergence etait la presence d’une tenosynovite echographique. Dans l’analyse longitudinale de 1081 patients, la proportion de desaccords est restee essentiellement la meme. Conclusion Les taux de desaccord entre les evaluations cliniques et echographiques de l’activite de la maladie dans la PR etaient eleves et le sont restes au cours du suivi, meme lorsque les evaluateurs echographiques avaient connaissance des resultats de l’examen clinique. Des facteurs lies a l’examen clinique et a l’echographie ont ete associes aux divergences.

Background Many patients with psoriatic arthritis do not reach minimal disease activity (MDA) on methotrexate alone. This phase 4 open-label study aimed to compare attainment of MDA following introduction of adalimumab with methotrexate escalation in patients with psoriatic arthritis who do not reach MDA after an initial methotrexate course (≤15 mg every week). Methods CONTROL was a phase 4, randomised, two-part, open-label study conducted in 14 countries and 46 sites. We recruited patients with confirmed active psoriatic arthritis, naive to biologic disease-modifying antirheumatic drugs, with an inadequate response to 15 mg or less of methotrexate. In part 1, patients were randomly assigned (1:1) to receive either methotrexate 15 mg (oral or subcutaneous) every week with the addition of adalimumab 40 mg (subcutaneously) every other week (adalimumab plus methotrexate group) or methotrexate (oral or subcutaneous) escalation up to 25 mg every week (escalated methotrexate group). Randomisation was done using Interactive Response Technology and stratified by the duration of methotrexate treatment (≤3 months and >3 months). In this open-label study there was no masking; participants, people giving the interventions, those assessing outcomes, and those analysing the data were aware of group assignment. The primary endpoint was the proportion of patients who reached MDA at 16 weeks. After 16 weeks (part 2), patients who reached MDA (responders) had their current therapy maintained or modified, wheras patients who did not reach MDA (non-responders) had their therapy escalated until 32 weeks. The primary endpoint in part 2 was the proportion of patients who reached MDA at 32 weeks, analysed in all patients who received one or more doses of study drug. The study is registered with ClinicalTrials.gov, NCT02814175. Findings Between Aug 5, 2016, and March 19, 2020, 245 of 287 patients initially assessed were enrolled in the study (50% men and 50% women; 92% of patients were White). 123 patients were randomly assigned to receive adalimumab plus methotrexate and 122 patients to receive escalated methotrexate. All 245 patients were included in the primary analysis, and 227 completed part 1 and entered part 2. A significantly higher proportion of patients reached MDA at 16 weeks in the adalimumab plus methotrexate group (51 [41%] patients) compared with the escalated methotrexate group (16 [13%] patients; p

Spondyloarthritis (SpA) contemplates the inflammatory involvement of the musculoskeletal system, gut, skin, and eyes, delineating heterogeneous diseases with a common pathogenetic background. In the framework of innate and adaptive immune disruption in SpA, neutrophils are arising, across different clinical domains, as pivotal cells crucial in orchestrating the pro-inflammatory response, both at systemic and tissue levels. It has been suggested they act as key players along multiple stages of disease trajectory fueling type 3 immunity, with a significant impact in the initiation and amplification of inflammation as well as in structural damage occurrence, typical of long-standing disease. The aim of our review is to focus on neutrophils’ role within the spectrum of SpA, dissecting their functions and abnormalities in each of the relevant disease domains to understand their rising appeal as potential biomarkers and therapeutic targets.

Intravenous iloprost is currently recommended in the treatment of Raynaud's phenomenon (RP) refractory to oral therapy and of digital ulcers (DUs) related to systemic sclerosis (SSc). In real-life practice there is a huge heterogeneity about the Iloprost regimens used.A survey was carried out on SSc patients that interrupted Iloprost infusion to compare acral vascular symptoms just before Iloprost withdrawal and just after the missed infusion. Severity, and frequency of RP, new DUs onset or aggravation of those pre-existing were reported. Last available capillaroscopic images were also evaluated.The analysis includes 50 patients. After iloprost withdrawal, 11 patients reported a RP worsening because of enhanced intensity (p = 0.007). Only 8 patients of them also complained of an increased frequency (p = 0.07). None of the patients experienced digital ulcers for the first-time during quarantine. Among the 27 patients with a history of digital ulcers, 9 reported worsening and 7 recurrence of DUs. Overall, 17 patients (34.0 %) complained of a worsening of SSc vascular acral manifestations, namely RP or DUs. Reduced capillary density was associated with RP worsening, in particular, each unit increase of capillary density corresponds to an average 44 % decrease in the odds of RP worsening (OR 0.56, CI 95 % 0.36-0.97, p = 0.037). As for RP worsening, the aggravation of DU was associated with a lower capillary density.Low capillary density can predict a worsening of both RP and DUs in controlled quarantine conditions within a month after iloprost discontinuation in SSc patients.

ObjectivesTo develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.MethodsThe OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima–media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.ResultsAgreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72–0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from −1.19 to −2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corrcoeff0.37–0.48).ConclusionWe developed a provisional OGUS for potential use in clinical trials.

ObjectivesThis study aimed to determine the prevalence of ultrasound-detected tendon abnormalities in healthy subjects (HS) across the age range.MethodsAdult HS (age 18–80 years) were recruited in 23 international Outcome Measures in Rheumatology ultrasound centres and were clinically assessed to exclude inflammatory diseases or overt osteoarthritis before undergoing a bilateral ultrasound examination of digit flexors (DFs) 1–5 and extensor carpi ulnaris (ECU) tendons to detect the presence of tenosynovial hypertrophy (TSH), tenosynovial power Doppler (TPD) and tenosynovial effusion (TEF), usually considered ultrasound signs of inflammatory diseases. A comparison cohort of patients with rheumatoid arthritis (RA) was taken from the Birmingham Early Arthritis early arthritis inception cohort.Results939 HS and 144 patients with RA were included. The majority of HS (85%) had grade 0 for TSH, TPD and TEF in all DF and ECU tendons examined. There was a statistically significant difference in the proportion of TSH and TPD involvement between HS and subjects with RA (HS vs RA pConclusionsUltrasound-detected TSH and TPD abnormalities are rare in HS and can be regarded as markers of active inflammatory disease, especially in newly presenting RA.

Background Rheumatoid arthritis (RA) is characterized by increased cardiovascular (CV) mortality. CV events are particularly high in patients with RA-specific autoimmunity, including rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA), raising the question whether RA-specific autoimmunity itself is associated with CV events. Methods New CV events (myocardial infarction, stroke or death by CV cause) were recorded in 20,625 subjects of the Electricité de France – Gaz de France (GAZEL) cohort. Self-reported RA cases in the GAZEL cohort were validated by phone interview on the basis of a specific questionnaire. In 1618 subjects, in whom plasma was available, RF and ACPA were measured. A piecewise exponential Poisson regression was used to analyze the association of CV events with presence of RA as well as RA-specific autoimmunity (without RA). Results CV events in GAZEL were associated with age, male sex, smoking, hypertension, hyperlipidemia, and diabetes mellitus (HR from 1.06 to 1.87, p p = 0.03) independently of conventional CV risk factors. One hundred seventy-eight subjects showed RF or ACPA positivity without presence of RA. CV events were not associated with ACPA positivity (HR: 1.52, 95% CI: 0.47–4.84, p = 0.48) or RF positivity (HR: 1.15, 95% CI: 0.55–2.40, p = 0.70) in the absence of RA. Conclusions RA, as a clinical chronic inflammatory disease, but not mere positivity for RF or ACPA in the absence of clinical disease is associated with increased CV risk.

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ., Background: Synovial tissue research has become widely developed in several rheumatology centres, however, large discrepancies exist in the way synovial tissue is handled and, more specifically, how data pertaining to biopsy procedure, quality check and experimental results are reported in the literature. This heterogeneity hampers the progress of research in this rapidly expanding field. In that context, under the umbrella of European Alliance of Associations for Rheumatology, we aimed at proposing points to consider (PtC) for minimal reporting requirements in synovial tissue research. Methods: Twenty-five members from 10 countries across Europe and USA met virtually to define the key areas needing evaluation and formulating the research questions to inform a systematic literature review (SLR). The results were presented during a second virtual meeting where PtC were formulated and agreed. Results: Study design, biopsy procedures, tissue handling, tissue quality control and tissue outcomes (imaging, DNA/RNA analysis and disaggregation) were identified as important aspects for the quality of synovial tissue research. The SLR interrogated four databases, retrieved 7654 abstracts and included 26 manuscripts. Three OPs and nine PtC were formulated covering the following areas: description of biopsy procedure, overarching clinical design, patient characteristics, tissue handling and processing, quality control, histopathology, transcriptomic analyses and single-cell technologies. Conclusions: These PtC provide guidance on how research involving synovial tissue should be reported to ensure a better evaluation of results by readers, reviewers and the broader scientific community. We anticipate that these PtC will enable the field to progress in a robust and transparent manner over the coming years., This work was funded by EULAR (SCI020)

The first part of the guidelines and recommendations for musculoskeletal ultrasound, produced under the auspices of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB), provides information about the use of musculoskeletal ultrasound for assessing extraarticular structures (muscles, tendons, entheses, ligaments, bones, bursae, fasciae, nerves, skin, subcutaneous tissues, and nails) and their pathologies. Clinical applications, practical points, limitations, and artifacts are described and discussed for every structure. After an extensive literature review, the recommendations have been developed according to the Oxford Centre for Evidence-based Medicine and GRADE criteria and the consensus level was established through a Delphi process. The document is intended to guide clinical users in their daily practice.Der erste Teil der Leitlinien und Empfehlungen für den muskuloskelettalen Ultraschall, die unter der Schirmherrschaft der European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) erstellt wurden, enthält Informationen über den Einsatz des muskuloskelettalen Ultraschalls zur Beurteilung von extraartikulären Strukturen (Muskeln, Sehnen, Gelenke, Bänder, Knochen, Schleimbeutel, Faszien, Nerven, Haut, subkutanes Gewebe und Nägel) und deren Pathologien. Für jede Struktur werden die klinische Anwendung, praktische Punkte, Einschränkungen und Artefakte beschrieben und diskutiert. Nach einer ausführlichen Literaturrecherche wurden die Empfehlungen gemäß den Kriterien des Oxford Centre for Evidence-based Medicine und den GRADE-Kriterien entwickelt, und der Konsensgrad wurde durch die Delphi-Methode ermittelt. Das Dokument ist als Leitfaden für klinische Anwender in der täglichen Praxis gedacht.

Background & Aims: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. Methods: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. Results: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21–0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). Conclusions: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. ClinicalTrials.gov

A 42-year-old woman with a 15-year history of psoriatic disease with skin, nail and joint involvement presented for routine follow-up visit. The patient did not complain of relevant articular symptoms, physical examination was unremarkable excepted for feet nail onychodystrophy and routine laboratory tests were unaltered.

ObjectiveTo produce European League Against Rheumatism (EULAR) recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs).MethodsBased on the literature reviews and expert opinion (through Delphi surveys), a taskforce of 23 members (12 experts in ultrasound in RMDs, 9 in methodology and biostatistics together with a patient research partner and a health professional in rheumatology) developed a checklist of items to be reported in every RMD study using ultrasound. This checklist was further refined by involving a panel of 79 external experts (musculoskeletal imaging experts, methodologists, journal editors), who evaluated its comprehensibility, feasibility and comprehensiveness. Agreement on each proposed item was assessed with an 11-point Likert scale, grading from 0 (total disagreement) to 10 (full agreement).ResultsTwo face-to-face meetings, as well as two Delphi rounds of voting, resulted in a final checklist of 23 items, including a glossary of terminology. Twenty-one of these were considered ‘mandatory’ items to be reported in every study (such as blinding, development of scoring systems, definition of target pathologies) and 2 ‘optional’ to be reported only if applicable, such as possible confounding factors (ie, ambient conditions) or experience of the sonographers.ConclusionAn EULAR taskforce developed a checklist to ensure transparent and comprehensive reporting of aspects concerning research and procedures that need to be presented in studies using ultrasound in RMDs. This checklist, if widely adopted by authors and editors, will greatly improve the interpretability of study development and results, including the assessment of validity, generalisability and applicability.

ObjectiveTo summarise the evidence on intra-articular therapies (IAT) to inform the 2020 EULAR recommendations.MethodsAn overview of systematic reviews (SR) including randomised-controlled trials (RCTs) of IAT in adults with arthropathies was performed up to July 2020. Pain, function, and frequency of adverse events were the main efficacy and safety outcomes, respectively. Quality was assessed with the A MeaSurement Tool to Assess Systematic Reviews (AMSTAR)-2 tool.ResultsOf 184 references identified, 16 met the inclusion criteria, and a search of their reference lists identified 16 additional SRs. After quality assessment, 29 were finally included. Of these, 18 focused on knee osteoarthritis (KOA), 6 on hip osteoarthritis (HOA), 3 on shoulder capsulitis (SC), and 3 on rheumatoid arthritis. Overall, hyaluronic acid showed a small effect on pain and function in KOA but not in HOA or shoulder capsulitis. Intra-articular glucocorticoids showed a small effect in pain and function in KOA and function in HOA and SC. Platelet-rich plasma showed benefit in pain and function in KOA but not in HOA. Mesenchymal stem cells behaved similarly. Most SR results were of moderate quality and RCTs included often presented a high risk of bias, mainly due to inadequate blinding and heterogeneous results. All interventions were well tolerated with no clear safety differences.ConclusionsThis overview underlines that most IAT currently used in KOA, HOA, and SC exert small effects and are well tolerated. However, no firm conclusions can be drawn for inflammatory arthritis due to the limited data found.

International audience; Aims: To analyze whether there is sufficient data from published literature to demonstrate that ultrasound, including elastography, present good metric properties (truth, discrimination and feasibility) in autoimmune myositis (AIM). Methods: A population, intervention, comparator and outcome-structured (PICO) search was performed in Medline, Cochrane Library and Embase database from 01/01/1973 to 08/05/2019. The inclusion criteria required original research involving adult humans, reported in English, assessing ultrasound and elastography in patients with an AIM. Conference abstracts and computer-assisted diagnostics that focused on technique and not ultrasound domains were excluded. Results: Approximately 2670 articles were identified. Forty-one full-text articles were included in the final analysis. There were 551 AIM patients studied. Eighteen studies (43.9%) had a control group, of which 15 (63.3%) were healthy controls. The age of participants (including controls) varied from 18 to 86 years, and most were females (59%). Diagnosis of AIM was largely biopsy-proven, although some were derived through clinical presentation, positive clinical imaging (ultrasound or otherwise) and/or electromyography and steroid responsiveness. The features examined with ultrasound in the 41 included articles consisted of: muscle echogenicity, bulk, atrophy, architecture, power Doppler, perfusion characteristics, shear wave modulus, shear wave velocity, elasticity index and fasciculations. Twelve studies (29.2%) used quantitative methods to assess these characteristics, whilst others used semi-quantitative, dichotomous/binary and descriptive scoring systems. Criterion validity was met in 14 studies (12/14, 85.7%) and construct validity in 22 studies (22/25, 88.0%). Most published articles reported Level 3b to Level 5 evidence with varying degrees of bias. There was only one longitudinal study examining discrimination. Reliability and feasibility were under-reported. Conclusion: This is the first systematic review studying the utility of ultrasound, including elastography, in AIM. There is some evidence for criterion and construct validity, suggesting that ultrasound may be a promising outcome measurement instrument in AIM. Agreement on the standardization of acquisition, and the definitions of target domains, is required. Additionally, further validation studies are required to determine discrimination, reliability and feasibility.

Background/Aims Power Doppler (PD) ultrasonography (PDUS) is a sensitive, non-invasive imaging technology used to assess joint synovitis and enthesitis in psoriatic arthritis (PsA). The European Alliance of Associations for Rheumatology (EULAR) and the Outcome Measures in Rheumatology (EULAR-OMERACT) developed a standardised ultrasonography composite scoring system that is sensitive to change (the global EULAR-OMERACT synovitis score [GLOESS]) to detect and score joint synovitis. We report primary (12-week) efficacy and safety data from ULTIMATE (NCT02662985), the first large, randomised, double-blind, placebo-controlled Phase 3 study to assess the time course of response to subcutaneous secukinumab on joint synovitis with PDUS in PsA. Methods This 52-week study has a 12-week double-blind treatment period followed by 12week open-label and 6-month open-label extensions. The study recruited biologic-naive patients with active PsA and inadequate response to conventional disease-modifying antirheumatic drug(s), with joint synovitis on PDUS (≥1 joint [of 48] with both total synovitis PDUS score and PD signal ≥2; or ≥ 2 joints with PDUS score ≥2 and PD signal ≥1) at screening and baseline and ≥1 clinical enthesitis site at baseline. Patients received secukinumab (300 or 150 mg) or placebo weekly followed by 4-weekly dosing (from Week 4). The primary endpoint was the difference in mean change in GLOESS from baseline to Week 12 between secukinumab and placebo, determined by mixed-effects model repeated measures analysis. Safety analyses included all patients who received ≥1 dose of study treatment. Results Of 166 patients enrolled, 96% (160/166) completed 12 weeks of treatment (secukinumab: 99% [82/83]; placebo: 94% [78/83]). Baseline demographics, clinical and ultrasound characteristics were similar across treatment groups. The primary endpoint was met; adjusted mean change in GLOESS was significantly higher with secukinumab than placebo (-9.0 vs -5.8; P = 0.004) at Week 12 (Table 1), with statistical significance seen as early as Week 1. All key secondary endpoints were met. No new or unexpected safety signals were reported. P187 Table 1:Efficacy of secukinumab at Week 12EndpointsSecukinumab (300 mg + 150 mg)a (N = 83)Placebo (N = 83)Difference/OR (95% CI)P valuePrimaryPDUS GLOESS, LS mean change (SE)b,c-9.0 (0.9)-5.8 (0.9)Difference: -3.2d (-5.5; -0.8)0.004SecondaryACR20, % responders6834OR: 4.1e (2.1; 8.0)10% of body surface area received 300 mg; remainder received 150 mg;bGLOESS using PDUS composite score of 24 paired joints; the range for the GLOESS is 0-144;cAdjusted means and mean change values are from MMRM including treatment, centre and analysis visit as factors, baseline score and weight as continuous covariates and treatment by analysis visit as an interaction term;dDifference in adjusted mean change;eOR. ACR, American College of Rheumatology; CI, confidence interval; EULAR-OMERACT, European League Against Rheumatism and the Outcome Measures in Rheumatology; GLOESS, global EULAR-OMERACT synovitis score; LS, least squares; MMRM, mixed-effects model repeated measures; N, total number of randomised patients; OR, odds ratio; PDUS, Power Doppler ultrasonography; SE, standard error; SPARCC, Spondyloarthritis Research Consortium of Canada Enthesitis Index. Conclusion Secukinumab demonstrated a rapid and significant decrease in synovitis over 12 weeks (per GLOESS), and superior efficacy on ACR20/50 responses and SPARCC enthesitis vs placebo at Week 12 in biologic-naive patients with PsA. The safety profile of secukinumab was consistent with previous reports. Disclosure M. D'Agostino: Honoraria; M-A.D has received speaker/consultancy fees from Sanofi, Novartis, BMS, Celgene, Roche, AbbVie, UCB and Eli Lilly. G. Schett: Honoraria; G.S. has received honoraria from AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Roche and UCB. A. López Rodríguez: Corporate appointments; A.L.R. is a clinical trial researcher, speaker and consultant for Roche, Eli Lilly, Novartis, BMS and Neovacs. L. Šenolt: Honoraria; L.S. has received speaker's honoraria from AbbVie, Amgen, BMS, Celgene, Eli Lilly, MSD, Novartis, Pfizer, Roche and UCB., L.S. has received expenses for attendance at advisory board meetings from AbbVie, BMS, Celgene, MSD, Novartis, Pfizer, Roche and UCB., L.S. has received honoraria for clinical trials from AbbVie, Amgen, BMS, Celgene, Novartis, Pfizer, Takeda and UCB. Grants/research support; L.S. has received research grants from AbbVie. J. Maldonado-Cocco: Consultancies; J.M-C. is a speaker/consultant for Pfizer, Merck Sharp & Dohme, Sanofi-Aventis, Novartis, BMS, Roche, Boehringer Ingelheim, Schering-Plough, Abbott, UCB, Eli Lilly and Gilead. Other; J.M-C. is a clinical researcher as PI in clinical trials for Pfizer, Merck Sharp & Dohme, Sanofi-Aventis, Novartis, BMS, Roche, Boehringer Ingelheim, Schering-Plough, Abbott, UCB, Eli Lilly and Gilead. R. Burgos-Vargas: None. E. Naredo: Honoraria; E.N. has received speaker fees from AbbVie, Roche, BMS, Pfizer, UCB, Lilly, Novartis, Janssen and Celgene GmbH, and honoraria for clinical trials from AbbVie, Novartis and BMS. Grants/research support; E.N. has received research grants from Lilly. P. Carron: Consultancies; P.C. is a speaker/consultant for Pfizer, Merck Sharp & Dohme, Novartis, BMS, AbbVie, UCB, Eli Lilly, Gilead and Celgene Corporation. Grants/research support; P.C. has received research grants from UCB, Merck Sharp & Dohme and Pfizer. M. Boers: Consultancies; M.B. is a consultant for BMS, Novartis, Pfizer, GSK and Mylan. A. Duggan: Other; A-M.D. is an employee of Novartis. P. Goyanka: Other; P.G. is an employee of Novartis. C. Gaillez: Shareholder/stock ownership; C.G. is a shareholder of NVS and BMS. Other; C.G. is an employee of Novartis.

The aim of this study was to evaluate the accuracy of synovial fluid analysis in the identification of calcium pyrophosphate dihydrate crystals compared to microscopic analysis of joint tissues as the reference standard. This is an ancillary study of an international, multicentre cross-sectional study performed by the calcium pyrophosphate deposition disease (CPPD) subgroup of the OMERACT Ultrasound working group. Consecutive patients with knee osteoarthritis (OA) waiting for total knee replacement surgery were enrolled in the study from 2 participating centres in Mexico and Romania. During the surgical procedures, synovial fluid, menisci and hyaline cartilage were collected and analysed within 48 hours from surgery under transmitted light microscopy and compensated polarised light microscopy for the presence/absence of calcium pyrophosphate crystals. All slides were analysed by expert examiners on site, blinded to other findings. A dichotomic score (absence/ presence) was used for scoring both synovial fluid and tissues. Microscopic analysis of knee tissues was considered the gold standard. Sensitivity, specificity, accuracy, positive and negative predictive values of synovial fluid analysis in the identification of calcium pyrophosphate crystals were calculated. 15 patients (53% female, mean age 68 yo ± 8.4) with OA of grade 3 or 4 according to Kellgren-Lawrence scoring were enrolled. 12 patients (80%) were positive for calcium pyrophosphate crystals at the synovial fluid analysis and 14 (93%) at the tissue microscopic analysis. The overall diagnostic accuracy of synovial fluid analysis compared with histology for CPPD was 87%, with a sensitivity of 86% and a specificity of 100%, the positive predictive value was 100% and the negative predictive value was 33%. In conclusion synovial fluid analysis proved to be an accurate test for the identification of calcium pyrophosphate dihydrate crystals in patients with advanced OA.

Highlights • Incidence of COVID 19 was not increased in patients with inflammatory rheumatisms. • Continuation of anti-rheumatic drugs was not associated with an increased risk of COVID-19. • In inflammatory rheumatisms treatment adherence was reduced because of fear of contagion., Objective: to explore how patients with chronic inflammatory rheumatic diseases (CIRDs) coped with their disease during the COVID-19 pandemic and to identify possible predictive factors of SARS-CoV-2 infection in this population. Methods: Patients followed in a single rheumatology department in France or registered on the Spondy+ platform, a secure e-health platform for spondyloarthritis patients, were invited to complete a questionnaire focused on their experiences around COVID19 symptoms, testing and medications access during the lockdown period. Descriptive statistics were used to report questionnaire’s results. Factors associated with COVID-19 or with treatment discontinuation were assessed by logistic regression. Results: We obtained 655 answers from the 2,081 contacted patients: 474 with spondyloarthritis, 129 with rheumatoid arthritis and 52 with psoriatic arthritis. The population was predominantly female (61.8%) with a mean age of 51.0 ± 13.4 years. Incidence of COVID-19 was 6.9% (95%CI: 5.1-9.2%)), including 12 confirmed and 33 highly-suspicious cases. No death was observed and five patients needed to be hospitalized. Factors independently associated with an increased risk of infection were SARS-CoV-2 exposure, younger age and non-smoking. More than 30% of the patients suspended or decreased the dosage of one of their drugs during the lockdown period. This was followed in 63.4% of them by increased disease activity. Modifications were mostly motivated by fear of contagion (79.3%). Conclusion: We did not observe any increase of incidence or severity of COVID-19 in patients suffering of the 3 most common CIRDs. This survey also adds evidence of the safety of anti-rheumatic drugs use regarding COVID-19.

ObjectiveTo evaluate the discriminatory ability of ultrasound in calcium pyrophosphate deposition disease (CPPD), using microscopic analysis of menisci and knee hyaline cartilage (HC) as reference standard.MethodsConsecutive patients scheduled for knee replacement surgery, due to osteoarthritis (OA), were enrolled. Each patient underwent ultrasound examination of the menisci and HC of the knee, scoring each site for presence/absence of CPPD. Ultrasound signs of inflammation (effusion, synovial proliferation and power Doppler) were assessed semiquantitatively (0–3). The menisci and condyles, retrieved during surgery, were examined microscopically by optical light microscopy and by compensated polarised microscopy. CPPs were scored as present/absent in six different samples from the surface and from the internal part of menisci and cartilage. Ultrasound and microscopic analysis were performed by different operators, blinded to each other’s findings.Results11 researchers from seven countries participated in the study. Of 101 enrolled patients, 68 were included in the analysis. In 38 patients, the surgical specimens were insufficient. The overall diagnostic accuracy of ultrasound for CPPD was of 75%—sensitivity of 91% (range 71%–87% in single sites) and specificity of 59% (range 68%–92%). The best sensitivity and specificity were obtained by assessing in combination by ultrasound the medial meniscus and the medial condyle HC (88% and 76%, respectively). No differences were found between patients with and without CPPD regarding ultrasound signs of inflammation.ConclusionUltrasound demonstrated to be an accurate tool for discriminating CPPD. No differences were found between patents with OA alone and CPPD plus OA regarding inflammation.

Objectives To identify and synthesize the evidence for the use and measurement properties of musculoskeletal ultrasound in assessing structural joint damage in patients with rheumatoid arthritis (RA). Methods A systematic literature search (SLR) of the PubMed, Embase and Cochrane Library was performed. Original articles were included published in English reporting on ultrasound of bone erosion, cartilage damage and the measurement properties of ultrasound according to the OMERACT filter 2.1. Results Of the 1.495 identified articles 149 were included in the final review, most of which reported on cross-sectional studies and used the OMERACT definitions for ultrasonographic pathology. Among these, bone erosions were assessed in 139 (93.3%), cartilage damage in 24 (16.1%), enthesophytes in 8 (5.4%), osteophytes in 15 (10.1%) and malalignment and ankylosis in a single (0.9%) study, respectively. Most studies (126/149, 84.6%) assessed the joints of the hands. The overwhelming majority of studies (127/149, 85.2%) assessed structural joint damage bilaterally. Validity, reliability and responsiveness were assessed in 21 (14.1%), 34 (22.8%) and 17 (11.4%) studies, respectively. Conclusion While the results of this SLR suggest that ultrasound is a sensitive, reliable and feasible tool to detect damage in RA, they also highlight the need for further research and validation. Findings of this SLR will inform the next steps of the OMERACT Ultrasound Working Group in developing an ultrasound score for assessing structural joint damage in patients with RA.

Background Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug. Objectives To conduct a systematic review (SR) to identify studies addressing the measurement properties of radiographic outcome instruments for structural damage in PsA and appraise the evidence through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Framework Instrument Selection Algorithm (OFISA). Methods A SR was conducted using search strategies in EMBASE and MEDLINE to identify full-text English studies which aimed to develop or assess the measurement properties of radiographic outcome instruments in PsA. Determination of eligibility and data extraction was performed independently by two reviewers with input from a third to achieve consensus. Two reviewers assessed the methodology and results of eligible studies and synthesized the evidence using OMERACT methodology. Results Twelve articles evaluating radiographic instruments were included. The articles assessed nine peripheral (hands, wrists and/or feet) and six axial (spinal and/or sacroiliac joints) radiographic instruments. The peripheral radiographic instruments with some evidence for reliability, cross-sectional construct validity and longitudinal construct validity were the Ratingen and modified Sharp van der Heijde scores. No instruments had evidence for clinical trial discrimination or thresholds of meaning. There was limited evidence for the measurement properties of all identified axial instruments. Conclusion There are significant knowledge gaps in the responsiveness of peripheral radiographic instruments. Axial radiographic instruments require further validation, and the need to generate novel instruments and utilise other imaging modalities should be considered.

Ultrasound in increasingly used in rheumatology practice in the assessment of inflammatory patient, including facilitating early diagnosis of rheumatoid arthritis (RA), predicting its outcome, measuring structural damage, and monitoring its progression. This imaging modality can visualize both inflammatory and structural changes in patients with unclassified arthritis and RA, as well as other inflammatory arthritides such as psoriatic arthritis (PsA), spondyloarthropathy (SpA), and crystal arthritis. This chapter aims to provide an overview of the recent advances of this technique for in the assessment of RA. Firstly, the principles which underpin the physics of ultrasound are summarized, followed by the musculoskeletal pathologies which are amenable to ultrasound examination. In addition, it also highlights the role of ultrasound in procedures (e.g. ultrasound-guided biopsy and ultrasound-guided injection).

Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.

Objective.To describe the Outcome Measures in Rheumatology (OMERACT) stepwise approach to select and develop an imaging instrument with musculoskeletal ultrasound (US) as an example.Methods.The OMERACT US Working Group (WG) developed a 4-step process to select instruments based on imaging. Step 1 applies the OMERACT Framework Instrument Selection Algorithm (OFISA) to existing US outcome measurement instruments for a specific indication. This step requires a literature review focused on the truth, discrimination, and feasibility aspects of the instrument for the target pathology. When the evidence is completely unsatisfactory, Step 2 is a consensus process to define the US characteristics of the target pathology including one or more so-called “elementary lesions”. Step 3 applies the agreed definitions to the image, evaluates their reliability, develops a severity grading of the lesion(s) at a given anatomical site, and evaluates the effect of the acquisition technique on feasibility and lesion(s) detection. Step 4 applies and assesses the definition(s) and scoring system(s) in cross-sectional studies and multicenter trials. The imaging instrument is now ready to pass a final OFISA check.Results.With this process in place, the US WG now has 18 subgroups developing US instruments in 10 different diseases. Half of them have passed Step 3, and the groups for enthesitis (spondyloarthritis, psoriatic arthritis), synovitis, and tenosynovitis (rheumatoid arthritis) have finished Step 4.Conclusion.The US WG approach to select and develop outcome measurement instruments based on imaging has been repeatedly and successfully applied in US, but is generic for imaging and fits with OMERACT Filter 2.1.