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Introduction Le psoriasis est une manifestation extra-articulaire frequente dans la spondyloarthrite axiale (axSpA), avec une prevalence d’environ 9 % dans les axSpA etablies [1] . Quelques donnees suggerent que le psoriasis peut avoir un retentissement sur l’evolution de l’axSpA [2] . Cependant, les consequences du psoriasis associe aux axSpA ne sont pas clairement connues. Les objectifs etaient de determiner la prevalence et les consequences du psoriasis sur les axSpA recentes sur 6 ans de suivi. Materiels et methodes La cohorte prospective multicentrique DESIR ayant inclus des patients adultes avec douleurs dorsales inflammatoires recentes evoquant une axSpA a ete analysee sur 6 ans. Le psoriasis a ete evalue a chaque visite et la prevalence et l’incidence cumulees ont ete calcules. Les patients avec et sans psoriasis a n’importe quel moment ont ete compares. L’activite de la maladie (ASDAS-CRP, compte articulaires et d’entheses, CRP), la capacite fonctionnelle (HAQ-AS), la qualite de vie et l’utilisation des traitements au cours des 6 ans ont ete evaluees. Ces criteres de jugements ont ete compares par analyse univariee puis par analyses multivariees et par des modeles lineaires a effet mixte. Resultats 589 patients etaient presents a 6 ans (moyenne d’âge 40,5 ± 8,7 ans, 45,8 % d’hommes, duree moyenne des symptomes a l’inclusion de 1,5 ± 0,9 ans). La prevalence cumulee du psoriasis est passee de 16,8 % (99/589) a l’inclusion a 26,8 % (158/589) apres 6 ans, soit une incidence de 2,1/100 patients-annees (Figure). Sur 6 ans de suivi, les patients atteints de psoriasis ont developpe davantage de synovite (p = 0,008). Il n’y avait pas de consequences significatives du psoriasis sur la capacite fonctionnelle (HAQ-AS) et l’activite de la maladie (ASDAS-CRP). Les patients atteints de psoriasis ont recu davantage de methotrexate (25,5 % contre 11,8 %, p Conclusion Le psoriasis est frequent dans les axSpA recentes et apparait regulierement au cours du temps, motivant un suivi regulier et une prise en charge multidisciplinaire en collaboration avec les dermatologues. Les patients atteints d’axSpA et souffrant de psoriasis avaient plus de synovites au fil du temps et recevaient plus de biotherapies ; en revanche leur maladie n’etait pas plus active ni plus severe. Les consequences du psoriasis chez les patients atteints d’axSpA ont pu etre masquees par une plus grande utilisation des traitements chez ces patients, ainsi des etudes supplementaires sont necessaires.

Introduction Dans le rhumatisme psoriasique (RP), l’obtention d’un controle de la maladie est associee a une amelioration du pronostic, bien qu’il n’existe pas de mesure unique universellement acceptee de faible activite de la maladie ou de remission. Les resultats rapportes par le patient (PRO) constituent des indicateurs majeurs d’amelioration clinique durant le traitement. A ce jour, la correlation entre PRO et controle de la maladie n’est pas pleinement decrite dans le RP. Nous avons etudie cette correlation chez des patients atteints de RP inclus dans l’etude de phase III SELECT-PsA 1. Patients et methodes Des patients atteints de RP actif et ayant une reponse inadequate a ≥ 1 DMARD biologique ont ete randomises pour recevoir upadacitinib (UPA) 15 mg une fois par jour (1×/j), UPA 30 mg 1×/j, adalimumab (ADA) 40 mg toutes les 2 semaines ou un placebo (PBO) pendant 24 semaines. Les questionnaires de PRO etaient les suivants : Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-Item Short-Form Health Survey (SF-36), et Work Productivity and Activity Impairment (WPAI). Les mesures de controle strict de la maladie comprenaient l’observation d’une activite minimale de la maladie (MDA), la reponse ACR70 et la remission basee le score DAPSA [Disease Activity Index in PsA] ou PASDAS [PsA Disease Activity Score]. La proportion de patients ayant atteint un controle strict de la maladie a ete determine chez les patients ayant vs n’ayant pas decrit d’ameliorations des PRO ≥ a des differences minimales cliniquement importantes (MCID) dans la population traitement actif et PBO a la semaine 24. Resultats Au total, 1 704 patients ont ete inclus dans l’etude SELECT PsA 1, dont respectivement 59,2 %, 72,4 %, 51,3 %, 62,3 %, 64,6 % et 63,9 % ont decrit des ameliorations ≥ MCID (repondeurs MCID) dans les questionnaires FACIT-F, SF-36-PCS, SF-36-MCS, WPAI Limitation des activites, WPAI Limitation globale de l’activite professionnelle et WPAI Presenteisme, a la semaine 24. La proportion de patients ayant atteint la MDA, une reponse ACR70 ou la remission DAPSA a la semaine 24 etait significativement plus elevee (p nominal ≤ 0,01) chez les patients ayant decrit des ameliorations ≥ MCID pour tous les PRO ( Figure 1 , Figure 2 ). Des resultats comparables ont ete observes chez les patients en remission PASDAS, sauf pour le score SF-36-MCS ( Fig. 2 ). Les patients ayant decrit des ameliorations ≥ MCID pour tous les PRO ont ete plus nombreux a atteindre une reponse ACR70 et la MDA (29 %–49 %) que la remission DAPSA ou PASDAS (14 %-19 %). Conclusion Les patients atteints de RP ayant decrit des ameliorations cliniquement significatives des principaux PRO (fatigue, qualite de vie, productivite au travail) etaient plus susceptibles de repondre a des criteres stricts de controle de la maladie. Ces resultats suggerent une etroite correlation entre l’amelioration significative des criteres orientes sur le patient et l’obtention d’un controle strict de la maladie.

ObjectivesTo investigate patient characteristics predictive of response to secukinumab in patients with psoriatic arthritis (PsA) with axial manifestations.MethodsIn a post-hoc analysis from the MAXIMISE trial (NCT02721966) in patients with PsA and axial manifestations, we tested the hypothesis that the OR of the effect of treatment on the primary endpoint of the trial (Assessment of SpondyloArthritis international Society (ASAS) 20 responder status at week 12) would be different depending on 12 prespecified predictor variables. We applied a two-model logistic regression approach, a main effects and an interaction model.ResultsThe OR (95% CI) for ASAS20 response for the presence of nail dystrophy was 3.2 (95% CI 0.93 to 10.99) in the secukinumab 150 mg group and 5.0 (95% CI 1.47 to 17.19) in the secukinumab 300 mg group compared with the placebo group (p=0.029). Odds of being a responder were similar in men and women in the secukinumab groups, though men fared worse than women in the placebo group (p=0.039). Current smokers were less likely to be ASAS20 responders compared with never smokers regardless of the treatment group (p=0.589).ConclusionNail dystrophy was identified as a predictor of response to secukinumab in patients with PsA with axial manifestations in the MAXIMISE trial. These findings may be explained by the nail-entheseal concept as part of the axial phenotype in PsA .

BackgroundThere is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs.ObjectivesTo describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA).MethodsWe described patient characteristics, flares and adverse events (AEs) in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology COVAX registry.ResultsA total of 110 cases were reported to the registry. Thirty-six adolescent cases were reported from four countries, most with JIA (42%). Over half (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection postvaccination.Seventy-four adult JIA cases were reported from 11 countries. Almost two-thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three female patients aged 20–30 years were diagnosed with SARS-CoV-2 postvaccination; all fully recovered.ConclusionsThis is an important contribution to research on SARS-CoV-2 vaccine safety in adolescents with RMDs and adults with JIA. It is important to note the low frequency of disease flares, serious AEs and SARS-CoV-2 reinfection seen in both populations, although the dataset is limited by its size.

BackgroundBarriers and facilitators to physical activity in inflammatory arthritis can be assessed through the Inflammatory arthritis Facilitators and barriers questionnaire (IFAB) questionnaire. The objective was to measure the correlation between IFAB and self-reported physical activity levels.MethodsThis was an international, multicentric, cross-sectional study in 2019-20 (NCT04426747). Consecutive spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) patients completed the 10-item IFAB, ranging − 70 to 70 with lower scores indicating more barriers. Physical activity was measured by the IPAQ-S questionnaire, steps per day collected by smartphone, and psychological readiness to change by stages of behavior change. Spearman correlations and multivariable linear regression were calculated.ResultsOf 245 patients included, 150 were analysed: 69 (46%) axSpA, 63 (42%) RA, 18 (12%) PsA. Mean age was 48.6 years (standard deviation, SD 17.1), mean disease duration 11.7 (10.1) years and 60% were women. Barriers to physical activity were moderate: mean IFAB, 6 (SD 19.2); 39 (26%) patients scored less than − 5, corresponding to significant barriers. The mean physical activity was 2837 (SD 2668, median 1784) MET-minutes per week. Physical activity was correlated with the IFAB (rho 0.28, p

© 2021 Elsevier Ltd. All rights reserved, Background: The COVID-19 pandemic has raised numerous questions among patients with immune-mediated inflammatory diseases regarding potential reciprocal effects of COVID-19 and their underlying disease, and potential effects of immunomodulatory therapy on outcomes related to COVID-19. The seroprevalence of SARS-CoV-2 and factors associated with symptomatic COVID-19 in patients with immune-mediated inflammatory diseases are still unclear. The Euro-COVIMID study aimed to determine the serological and clinical prevalence of COVID-19 among patients with immune-mediated inflammatory diseases, as well as factors associated with COVID-19 occurrence and the impact of the pandemic in its management. Methods: In this multicentre cross-sectional study, patients aged 18 years or older with a clinical diagnosis of rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Sjögren's syndrome, or giant cell arteritis were recruited from six tertiary referral centres in France, Germany, Italy, Portugal, Spain, and the UK. Demographics, comorbidities, treatments, and recent disease flares, as well as information on COVID-19 symptoms, were collected through a questionnaire completed by participants. SARS-CoV-2 serology was systematically tested. The main outcome was the serological and clinical prevalence of COVID-19. Factors associated with symptomatic COVID-19 were assessed by multivariable logistic regression, and incidence of recent disease flares, changes in treatments for underlying disease, and the reasons for treatment changes were also assessed. This study is registered with ClinicalTrials.gov, NCT04397237. Findings: Between June 7 and Dec 8, 2020, 3136 patients with an immune-mediated inflammatory disease answered the questionnaire. 3028 patients (median age 58 years [IQR 46-67]; 2239 [73·9%] women and 789 [26·1%] men) with symptomatic COVID-19, serological data, or both were included in analyses. SARS-CoV-2 antibodies were detected in 166 (5·5% [95% CI 4·7-6·4]) of 3018 patients who had serology tests. Symptomatic COVID-19 occurred in 122 (4·0% [95% CI 3·4-4·8]) of 3028 patients, of whom 24 (19·7%) were admitted to hospital and four (3·3%) died. Factors associated with symptomatic COVID-19 were higher concentrations of C-reactive protein (odds ratio 1·18, 95% CI 1·05-1·33; p=0·0063), and higher numbers of recent disease flares (1·27, 1·02-1·58; p=0·030), whereas use of biological therapy was associated with reduced risk (0·51, 0·32-0·82; p=0·0057). At least one disease flare occurred in 654 (21·6%) of 3028 patients. Over the study period, 519 (20·6%) of 2514 patients had treatment changes, of which 125 (24·1%) were due to the pandemic. Interpretation: This study provides key insights into the epidemiology and risk factors of COVID-19 among patients with immune-mediated inflammatory diseases. Overall, immunosuppressants do not seem to be deleterious in this scenario, and the control of inflammatory activity seems to be key when facing the pandemic., Pfizer, Sanofi, Amgen, Galapagos, and Lilly funded this study through unrestricted grants.

ObjectiveTo investigate baseline use of biologic or targeted synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) and COVID-19 outcomes in rheumatoid arthritis (RA).MethodsWe analysed the COVID-19 Global Rheumatology Alliance physician registry (from 24 March 2020 to 12 April 2021). We investigated b/tsDMARD use for RA at the clinical onset of COVID-19 (baseline): abatacept (ABA), rituximab (RTX), Janus kinase inhibitors (JAKi), interleukin 6 inhibitors (IL-6i) or tumour necrosis factor inhibitors (TNFi, reference group). The ordinal COVID-19 severity outcome was (1) no hospitalisation, (2) hospitalisation without oxygen, (3) hospitalisation with oxygen/ventilation or (4) death. We used ordinal logistic regression to estimate the OR (odds of being one level higher on the ordinal outcome) for each drug class compared with TNFi, adjusting for potential baseline confounders.ResultsOf 2869 people with RA (mean age 56.7 years, 80.8% female) on b/tsDMARD at the onset of COVID-19, there were 237 on ABA, 364 on RTX, 317 on IL-6i, 563 on JAKi and 1388 on TNFi. Overall, 613 (21%) were hospitalised and 157 (5.5%) died. RTX (OR 4.15, 95% CI 3.16 to 5.44) and JAKi (OR 2.06, 95% CI 1.60 to 2.65) were each associated with worse COVID-19 severity compared with TNFi. There were no associations between ABA or IL6i and COVID-19 severity.ConclusionsPeople with RA treated with RTX or JAKi had worse COVID-19 severity than those on TNFi. The strong association of RTX and JAKi use with poor COVID-19 outcomes highlights prioritisation of risk mitigation strategies for these people.

Objectif: La qualité du sommeil est diminuée chez les patients atteints de rhumatisme psoriasique (RPso) et près de 40 % des patients souffrant de RPso considèrent les troubles du sommeil comme un problème prioritaire. Ce travail analyse les déterminants des troubles du sommeil chez les patients souffrant de RPso. Méthodes: Il s'agissait d'une analyse transversale d'une étude observationnelle (ReFlap, NCT03119805) menée dans 14 pays sur des patients adultes ayant un RPso diagnostiqué depuis ≥ 2 ans. Le sommeil a fait l'objet d'une auto-évaluation au moyen de l’échelle numérique (0–10) « sommeil » du questionnaire Psoriatic Arthritis Impact of Disease (PSAID-12). Les troubles du sommeil ont été définis par une EN ≥ 4. Les variables démographiques et cliniques associées aux troubles du sommeil ont été évaluées par analyse univariée et par régression de Poisson afin d'estimer le rapport de prévalence (RP) [intervalle de confiance à 95 %]. Résultats: Au total, 396 patients ont été analysés: âge moyen 51,9 ± 12,6 ans, 51 % de femmes, 59,7 % sous biothérapie, 53,3 % ayant un psoriasis couvrant 1–5 % de la surface corporelle; 23,7 % en rémission et 36,9 % avec un faible niveau d'activité selon le score Disease Activity in Psoriatic Arthritis (DAPSA). Le score médian (25 e/75 e centiles) de la qualité du sommeil auto-rapportée était de 2 (0–6), 157 patients (39,6 %) présentaient des troubles du sommeil. Dans le modèle de régression de Poisson, l'anxiété (RP: 1,05 [1,02–1,08], p < 0,01) et la douleur (RP: 1,06 [1,04–1,09], p < 0,001) rapportées par le patient ont été associées de manière indépendante aux troubles du sommeil. Conclusions: Dans cette étude multicentrique, les troubles du sommeil étaient présents chez 40 % des patients atteints de RPso; contrairement à l'inflammation, la douleur et l'anxiété ont été associées aux difficultés de sommeil. L'impact sur le sommeil semble multifactoriel dans le RPso.

Background Barriers and facilitators to physical activity in inflammatory arthritis can be assessed through the Inflammatory arthritis FAcilitators and Barriers (IFAB) questionnaire. The objective was to measure the correlation between IFAB and self-reported physical activity levels. Methods This was an international, multicentric, cross-sectional study in 2019–20. Consecutive spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) patients completed the 10-item IFAB, which ranges from − 70 to 70 with lower scores indicating more barriers. Physical activity was measured by the IPAQ-S questionnaire, steps per day collected by smartphone, and psychological readiness to change by stages of behaviour change. Spearman correlations and multivariable linear regression were calculated. Results Of 245 patients included, 150 were analysed: 69 (46%) axSpA, 63 (42%) RA, 18 (12%) PsA. Mean age was 48.6 years (standard deviation, SD 17.1), mean disease duration 11.7 (10.1) years and 60% were women. Barriers to physical activity were moderate: mean IFAB, 6 (SD 19.2); 39 (26%) patients scored less than − 5, corresponding to significant barriers. The mean physical activity was 2837 (SD 2668, median 1784) MET-minutes per week. The IPAQ-S questionnaire was correlated with the IFAB (rho 0.28, p p Conclusion Perceived barriers and facilitators to physical activity were correlated with physical activity, indicating that targeting patients with high barriers and low facilitators to physical activity could be an effective option to improve physical activity levels. Trial registration ClinicalTrial NCT04426747. Registered 11 June 2020 - Retrospectively registered.

Introduction Psoriatic arthritis (PsA) is a multidimensional inflammatory disease for which multiple outcome measures can be used to assess disease activity. In 2006, the OMERACT has proposed the first core domain set in PsA. Since 2006, much work has been performed on outcome measures in PsA. Objectives The purpose of this study was to assess outcome measures collected in recent PsA registries or longitudinal cohorts. Methods A systematic literature review was performed in Pubmed Medline (PROSPERO CRD42020175745) to identify all articles reporting on either registries or longitudinal cohorts in PsA, published between 2010 and March 2020. Registries centered on drugs or not PsA-specific, trials and long-term extension studies were excluded. The data collection comprised patient characteristics and the clinical outcome measures reported, including composite scores and patient reported outcomes (PROs). Statistics were descriptive. Results Of 673 articles, 73 were analysed, reporting on 27 registries/cohorts. Overall, 16,183 patients were included, with a mean of 599 per study; 51% were men, weighted mean age was 49.7 ± 9.3 years and weighted mean disease duration was 6.8 ± 0.2 years. Overall, 58 different outcome measures were collected. Disease activity composite scores were used in 20/27 (74%) registries through 8 different scores (most frequently Minimal Disease Activity: 41%, DAS28: 33% and DAPSA: 30%). Among the domains of PsA, joint involvement was reported in 26/27 (96%) registries (through the 66/68 joint count: 85%) and skin psoriasis in 93% (through PASI: 72%), whereas enthesitis, dactylitis and axial involvement were less often reported (respectively, 77%, 74% and 52%). Furthermore, 22/27 (82%) studies reported HAQ; the other frequently reported PROs were patient global assessment (70%) and pain (63%). Conclusions Data collection in PsA is very heterogeneous, reflecting the need for international consensus on outcome measures.

Background/Aims MAXIMISE, the first randomised controlled trial evaluating efficacy of a biologic for psoriatic arthritis (PsA) axial manifestations, showed that secukinumab 300 and 150 mg provided rapid and significant improvement in ASAS20 responses through Week 12. We report the effect of secukinumab on clinical and imaging outcomes through 52 weeks. Methods This Phase 3, double-blind, multicentre trial included 498 patients (≥18 years) with PsA who fulfilled CASPAR criteria presenting with spinal pain VAS ≥40/100, BASDAI ≥4 and inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs. Patients were randomised to secukinumab 300 mg (N = 167), 150 mg (N = 165) or placebo (N = 166) weekly for 4 weeks and every 4 weeks thereafter. At Week 12, placebo patients were re-randomised to secukinumab 300/150 mg. The primary endpoint was ASAS20 with secukinumab 300 mg at Week 12. Exploratory assessments at Week 52 included ASAS20/40, BASDAI50, spinal pain (VAS) and improvement in Berlin magnetic resonance imaging (MRI) score for spine and sacroiliac joints. Results The primary endpoint was met. ASAS20/40 responses at Week 12 were 62.9%/43.6% (secukinumab 300 mg) and 66.3%/39.5% (secukinumab 150 mg) versus 31.2%/12.2% (placebo), respectively (P < 0.0001). ASAS20/40 responses improved further with secukinumab 300/150 mg from baseline through 52 weeks. 74.1%/74.7% and 63.0%/50.6% of placebo patients, re-randomised at Week 12 to secukinumab 300/150 mg, achieved ASAS20/40 at Week 52. At baseline, 59.5% (secukinumab 300 mg), 54.2% (secukinumab 150 mg) and 64.2% (placebo) of patients had positive MRI scores for the sacroiliac joints and/or the spine. Reductions in Berlin MRI scores for the entire spine and sacroiliac joints were sustained with secukinumab 300/150 mg from baseline through 52 weeks (Table 1). 64.6%, 69.1% and 33.6% of patients with inflammatory back pain at baseline, confirmed by ASAS, Calin et al. and Berlin criteria in the secukinumab 300 mg, 150 mg and placebo groups, respectively, achieved ASAS20 at Week 12. P184 Table 1:Endpoints at Week 52CriteriaSecukinumab 300 mg SC (N = 164)Secukinumab 150 mg SC (N = 157)Placebo to secukinumab 300 mg SC (N = 81)Placebo to secukinumab 150 mg SC (N = 80)Clinical endpointsASAS20, % responders (n/M)a75.5 (123/163)77.3 (119/154)74.1 (60/81)74.7 (59/79)ASAS40, % responders (n/M)a62.6 (102/163)60.4 (93/154)63.0 (51/81)50.6 (40/79)BASDAI50, % responders (n/M)b68.3 (95/139)58.5 (83/142)55.6 (40/72)54.1 (40/74)Spinal pain VAS, mean change from BL (SD), nb-42.4 (27.0), 140-43.8 (26.2), 142-43.1 (25.0), 72-36.4 (25.2), 74Imaging endpointBerlin MRI score for entire spine, mean change from BL (SD), nb-0.6 (2.3), 121-0.3 (1.3), 124-0.8 (2.7), 63-0.4 (1.3), 60Berlin MRI score for SIJ, mean change from BL (SD), nb-0.7 (2.2), 122-0.5 (1.7), 122-0.9 (2.4), 63-1.0 (2.7), 59N=total number of patients in the group; n=number of patients with response; M=number of evaluable patients. aIntermediate missing data as well as any data missing in the case of study discontinuation is imputed using LOCF; bObserved data. Patients with initial placebo treatment were re-randomised to secukinumab 300 or 150 mg at Week 12. ASAS, Assessment of SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BL, baseline; LOCF, last observation carried forward; MRI, magnetic resonance imaging; SC, subcutaneous; SD, standard deviation; SIJ, sacroiliac joints; VAS, visual analogue scale. Conclusion Secukinumab improved signs and symptoms of axial disease (ASAS20/40) through 52 weeks with reduced inflammatory MRI lesions in the spine and sacroiliac joints in PsA patients with axial manifestations. Efficacy at Week 52 was comparable in patients who switched at Week 12 from placebo to secukinumab 300/150 mg. Disclosure X. Baraliakos: Consultancies; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen. Member of speakers’ bureau; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Novartis. L. Gossec: Consultancies; AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB. Grants/research support; Lilly, Mylan, Pfizer, Sandoz. E. Pournara: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. S. Jeka: Grants/research support; AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Lilly, Egis, UCB, Celgene. R. Blanco: Consultancies; AbbVie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma, MSD. Grants/research support; AbbVie, MSD, Roche. S. D'Angelo: Consultancies; AbbVie, Biogen, BMS, Celgene, Lilly, MSD, Novartis, UCB. Member of speakers’ bureau; AbbVie, BMS, Celgene, Lilly, Novartis, Pfizer, Sanofi. G. Schett: Honoraria; AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Roche, UCB. B. Schulz: Corporate appointments; Employee of Novartis. M. Rissler: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. D. Whyms: Corporate appointments; Employee of Novartis. C. Perella: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. L.C. Coates: Consultancies; : AbbVie, Amgen, Biogen, Celgene, Pfizer, UCB, Boehringer Ingelheim, Novartis, Lilly, Janssen, Sun Pharma, Prothena, Gilead. Grants/research support; AbbVie, Janssen, Lilly, Novartis, Pfizer, Amgen.

Future disease outbreaks of epidemic proportion are inevitable. Advance planning and preparation is essential to mitigate future public health risks; the WHO emphasises the importance of in-depth evaluation of response to and lessons learnt from a national/international pandemic.1 Research is critical to an informed, evidence-based response, therefore establishing pandemic research study protocols, systems to manage and report data, and rapid response teams are considered key to well-prepared, accelerated research in public health emergencies.2 Establishing international data collection registries poses many challenges, which are only amplified in the urgent nature of a global pandemic. The aim of this manuscript is to reflect on the successes and challenges of the European Alliance of Associations for Rheumatology (EULAR) COVID-19 registry3 to better understand how the rheumatology community (and other disease-specific communities) can be better prepared for rapid response research in the future. In particular, we consider the successes and challenges of the registry, what can be learnt from this experience, and what procedures and resources should be established and strengthened now in preparation for future pandemics. In the early stages of the SARS-CoV-2 pandemic, a need was identified for data to address the lack of information on the relationship between COVID-19 outcomes and rheumatic and musculoskeletal diseases (RMDs) and their associated treatments. Generally, immunomodulatory/immunosuppressive treatments and comorbidities are associated with an increased risk of serious infection in people with rheumatic diseases,4 which indicated that these patients may be at a higher risk of more severe COVID-19 infection. Conversely, some rheumatic disease treatments are being studied for the prevention or treatment of COVID-19 and its associated complications.5 To rapidly collect data on and learn about COVID-19 outcomes in this population, the COVID-19 Global Rheumatology Alliance (GRA)6 set up a global provider-entered registry, 13 days after initial Twitter discussions …

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Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA).These post hoc analyses determined whether additional benefits related to various PsA domains are observed in patients simultaneously achieving 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100), the primary endpoint of the SPIRIT-H2H study.Patients with active PsA and psoriasis in SPIRIT-H2H (N = 566) were categorised into two sets of four response groups irrespective of treatment allocation (approved dosages of ixekizumab or adalimumab): patients who simultaneously achieved ACR50 and PASI100 response, achieved ACR50 response only, achieved PASI100 response only, or did not achieve ACR50 or PASI100 response after 24 and 52 weeks of treatment. Patients achieving simultaneous ACR50 and PASI100 response were compared with the other patient response groups at the corresponding time point for efficacy and health-related quality of life (HRQoL) outcomes.Patients simultaneously achieving ACR50 and PASI100 responses at week 24 or 52 showed higher rates of ACR70 response, minimal disease activity, Disease Activity in Psoriatic Arthritis ≤ 4, resolution of enthesitis and dactylitis, and HRQoL improvement at weeks 24 and 52, respectively, than the other corresponding response groups at both time points.High levels of disease control, such as those obtained with simultaneous achievement of ACR50 and PASI100 response, were linked to better outcomes across a wide range of endpoints that are important for patients with PsA. Patients meeting this combined endpoint showed more comprehensive and thus greater control of disease activity. Trial registration NCT03151551 Key Points • Treatment goals for patients with psoriatic arthritis emphasise the importance of improving both musculoskeletal and non-musculoskeletal manifestations of the disease. • A combined endpoint considering both these manifestations, achievement of at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index, was linked with achievement of a number of other endpoints relevant to psoriatic arthritis, including health-related quality of life that are important to patients with psoriatic arthritis. • Patients meeting the combined endpoint were more likely to achieve a disease state of remission, which is the stated aim of treatment for psoriasis.

Introduction Les patients atteints de maladies musculosquelettiques inflammatoires/auto-immunes (I-RMD) n’ont pas ete inclus dans les etudes de tolerance des vaccins contre le SARS-CoV-2 et sont souvent inquiets quant a la tolerance de la vaccination. Notre objectif est d’etudier la tolerance des vaccins contre le SARS-CoV-2 chez les patients atteints de maladies musculosquelettiques inflammatoires/auto-immunes (I-RMD). Patients et methodes Pour cela, nous avons cree avec l’EULAR un registre international de cas rapportes par les medecins rhumatologues et internistes de patients atteints d’I-RMD et de RMD non inflammatoire (NI-RMD) vaccines contre le SARS-CoV-2. Du 5 fevrier 2021 au 27 juillet 2021, nous avons recueilli des donnees sur la demographie, la vaccination, le diagnostic de RMD, l’activite de la maladie, les traitements immunomodulateurs/immunosuppresseurs, les poussees, les evenements indesirables (EI) et les infections COVID-19 chez les patients vaccines. Les donnees ont ete analysees de maniere descriptive. Resultats L’etude a inclus 5121 participants de 30 pays, la majorite de France (40 %), Italie (16 %) et Portugal (14 %), 90 % avec des I-RMD (n = 4604, 68 % de femmes, âge moyen 60,5 ans) et 10 % avec des NI-RMD (n = 517), 77 % de femmes, âge moyen 71,4 ans. La polyarthrite rhumatoide (33 %), les connectivites (18 %), les spondyloarthrites (11 %), le rhumatisme psoriaqique (10 %) et les vascularites (12 %) etaient les diagnostics les plus frequents ; 54 % des patients ont recu des traitements de fond synthetiques conventionnels (csDMARD), 42 % des DMARD biologiques ou cibles et 35 % des immunosuppresseurs. La plupart des patients ont recu le vaccin Pfizer/BioNTech (70 %), 17 % AstraZeneca/Oxford et 8 % Moderna. Une infection COVID post-vaccination a ete signalee dans 0,7 a 1,1 % des cas, selon le statut vaccinal (entierement/partiellement vaccine) et le groupe RMD. Des poussees d’I-RMD ont ete signalees dans 4,4 % des cas (0,6 % de poussees severes), dont 1,5 % ont entraine des changements de medicaments. Des EI ont ete signales dans 37 % des cas (37 % I-RMD, 40 % NI-RMD), des EI severes dans 0,4 % des cas, tres divers et avec une frequence comparable et meme inferieure a celle observee chez les patients atteints de NI-RMD (1,1 %). Discussion La tolerance au vaccin n’etait pas differente entre les groupes I-RMD et NI-RMD. Dans les essais cliniques de vaccins a ARN contre le SRAS-CoV-2 dans la population generale, les taux d’EI graves etaient tres semblables a ceux de notre etude, allant de 0,4 % a 0,6 % dans le groupe vaccine et de 0,5 % a 0,6 % dans le groupe temoin, ce qui suggere que ces EI graves ne sont pas necessairement lies au vaccin. Conclusion Il s’agit de la plus grande etude de la tolerance des vaccins anti-SRAS-CoV-2 chez pres de 5000 patients atteints de maladies inflammatoires/auto-immunes rhumatologiques. Le profil de securite des vaccins contre le SRAS-CoV-2 chez les patients atteints d’I-RMD etait rassurant, et comparable a celui des patients atteints de NI-RMD. La majorite des patients ont bien tolere leur vaccination, avec de rares poussee d’I-RMD et de tres rares EI severes probablement non lies a la vaccination. Ces resultats devraient rassurer les rhumatologues et les personnes vaccinees, et favoriser la confiance dans la securite du vaccin COVID-19 chez les patients atteints de I-RMD.

We thank Arnaud and Devilliers1 for their correspondence on our article.2 They raise the important topic of risk prediction models for estimating the risk of COVID-19-related death, and the potential development of a risk prediction tool using data from our article. We agree with the authors that patients using immunosuppressive/immunomodulatory agents have different risks, depending on factors such as their age, chronic conditions and specific drug therapies. However, we also recognise that there are significant limitations in using the estimates published in our manuscript to develop a COVID-19-related death risk prediction model to guide vaccination strategies. These limitations include: 1. While robust models that predict the prognosis of COVID-19 are desirable to support decisions about shielding, hospital admission, treatment and population level interventions such as COVID-19 vaccination, this was not the primary aim of the published study. Importantly, it should be noted that owing to the voluntary nature of the registry there is an inherent selection bias, with an over-representation of severe cases, as discussed in our manuscript. Any model developed in a specific dataset will only reflect the risk for a particular patient under similar circumstances and receiving similar care. Therefore, in the same way that the hospitalisation and death rates reported in our article cannot be extrapolated to the entire population of patients with rheumatic diseases, a risk model developed using the …

Comorbidities in patients with rheumatoid arthritis (RA) are often associated with poor health outcomes and increased mortality. Treatment decisions should take into account these comor-bidities due to known or suspected associations with certain drug classes. In clinical practice, it is critical to balance potential treatment benefit against the possible risks for comorbidities as well as the articular manifestations of RA. This review summarises the current literature relating to prevalence and risk factors for the important comorbidities of cardiovascular disease, infections, lymphomas and nonmelanoma skin cancers in patients with RA. The impact on patient outcomes and the interplay between these comorbidities and the therapeutic options currently available, including tumour necrosis factor inhibitors and newer biological therapies, are also explored. As newer RA therapies are developed, and patients gain wider and earlier access to advanced therapies, in part due to the emergence of biosimilars, it is important to consider the prevention or treatment of comorbidities as part of the overall management of RA., Medical writing support and the APC was funded by Fresenius Kabi SwissBioSim GmbH

International audience

ObjectiveTo evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi).MethodsAdults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi due to IR (lack of efficacy or intolerance) were randomised (2:1) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44. Patients receiving placebo crossed over to guselkumab at week 24. The primary (ACR20) and key secondary (change in HAQ-DI, ACR50, change in SF-36 PCS and PASI100) endpoints, at week 24, underwent fixed-sequence testing (two-sided α=0.05). Adverse events (AEs) were assessed through week 56.ResultsAmong 285 participants (female (52%), one (88%) or two (12%) prior TNFi), 88% of 189 guselkumab and 86% of 96 placebo→guselkumab patients completed study agent through week 44. A statistically significantly higher proportion of patients receiving guselkumab (44.4%) than placebo (19.8%) achieved ACR20 (%difference (95% CI): 24.6 (14.1 to 35.2); multiplicity-adjusted p80% of week 24 responders maintained response at week 48. Through week 24, serious AEs/serious infections occurred in 3.7%/0.5% of 189 guselkumab-randomised and 3.1%/0% of 96 placebo-randomised patients; the guselkumab safety profile was similar through week 56, with no deaths or opportunistic infections.ConclusionGuselkumab significantly improved joint and skin manifestations and physical function in patients with TNFi-IR PsA. A favourable benefit–risk profile was demonstrated through 1 year.Trial registration numberNCT03796858.

International audience; Objective: Update the French Society for Rheumatology (SFR) recommendations on the everyday management of patients with spondyloarthritis, including psoriatic arthritis.Methods: Following standardized procedures, a systematic literature review was done by four supervised rheumatology residents based on questions defined by a task force of 16 attending rheumatologists. The findings were reviewed during three working meetings that culminated in each recommendation receiving a grade and the level of agreement among experts being determined.Results: Five general principles and 15 recommendations were developed. They take into account pharmacological and non-pharmacological measures along with treatment methods based on the dominant phenotype present (axial, articular, enthesitis/dactylitis) and the extra-articular manifestations (psoriasis, inflammatory bowel disease, uveitis). NSAIDs are the first-line pharmacological treatment in the various presentations. Conventional synthetic disease modifying antirheumatic drugs (csDMARDs) are not indicated in the axial and isolated entheseal forms. If the response to conventional treatment is not adequate, targeted therapies (biologics, synthetics) should be considered; the indications depend on the clinical phenotype and presence of extra-articular manifestations.Conclusion: This update incorporates recent data (published since the prior update in 2018) and the predominant clinical phenotype concept. It aims to help physicians with the everyday management of patients affected by spondyloarthritis, including psoriatic arthritis.

We thank Rosenbaum et al 1 for their correspondence on our article.2 In their reply, they largely report updated results of COVID-19 occurrence and subjective patient-reported COVID-19 severity from their patient survey of adult patients with spondyloarthritis and specifically comment that in their analysis, sulfasalazine did not ‘increase the risk to develop COVID-19’, nor did it increase the severity of those who were infected. Unfortunately, no details of the statistical methods, including any additional statistical adjustments (eg, age, sex, comorbidities and disease activity) or details of missing data, were included, and only a point estimate of risk was provided for each therapy without CIs, only p values, which therefore limits interpretation. While it is important to share reports of outcomes of COVID-19 among our populations of patients with rheumatic and musculoskeletal diseases (RMDs), it must be pointed out that the survey presented, as well as the subsequent analysis, is fundamentally different from our report on COVID-19-related mortality set within the Global Rheumatology Alliance (GRA) provider database and therefore the two outputs should not be compared , either directly or indirectly. First, the GRA database is based on physician reports of COVID-19 among patients with known rheumatic disease and therefore can only be used to look at the associations between demographic and clinical features and COVID-19 outcomes among those known to have COVID-19. The data cannot be used to look at factors associated with acquisition of SARS-CoV-2 infection or development of COVID-19 disease, which is the focus of the report presented in the correspondence. These factors should not be compared since restricting the analysis to patients with an existing COVID-19 diagnosis may cause relationships between any variables that relate to COVID-19 acquisition to be distorted compared with a more general population, due to collider bias.3 Indeed, factors associated with …

The emergence of COVID-19 in early 2020 led to unprecedented changes to rheumatology clinical practice worldwide, including the closure of research laboratories, the restructuring of hospitals and the rapid transition to virtual care. As governments sought to slow and contain the spread of the disease, rheumatologists were presented with the difficult task of managing risks, to their patients as well as to themselves, while learning and implementing new systems for remote health care. Consequently, the COVID-19 pandemic led to a transformation in health infrastructures and telemedicine that could become powerful tools for rheumatologists, despite having some limitations. In this Viewpoint, five experts from different regions discuss their experiences of the pandemic, including the most challenging aspects of this unexpected transition, the advantages and limitations of virtual visits, and potential opportunities going forward., The COVID-19 pandemic led to unprecedented changes in rheumatology clinical practice. In this Viewpoint article, we asked five experts to describe their experiences of the COVID-19 pandemic, how their clinical practice has changed, and the opportunities and challenges that lie ahead., The contributors Eloisa Bonfá is a full professor of rheumatology and the clinical director of the largest tertiary public hospital of Latin America. Her main clinical and research interests are systemic lupus erythematosus and autoimmunity, with relevant contributions in the fields of autoantibodies, vaccines and drug monitoring in autoimmune diseases. She graduated at the University of São Paulo Medical School, Brazil, and undertook specialist training in rheumatology in the same university followed by a 4-year rheumatology research fellowship at the Hospital for Special Surgery, New York. Laure Gossec is a professor of rheumatology at Sorbonne Université and Pitié-Salpêtrière Hospital, Paris, France. She has a half-time clinical position where she mainly sees patients with inflammatory arthritis, and a half-time teaching and research position. Her main research interests are patient-reported outcomes and quality of life, as well as e-health and big data in psoriatic arthritis, spondyloarthritis and rheumatoid arthritis and she has authored more than 350 papers. She is a past-chair of the epidemiology standing committee of EULAR. David Isenberg is the Academic Director of Rheumatology at University College London, UK. He has run both general and autoimmune rheumatic disease clinics for over 30 years. His major research interests are in the structure, function and origin of autoantibodies and improving the assessment of patients with autoimmune rheumatic diseases. Zhanguo Li is a professor and head of the department of rheumatology and immunology at the Peking University People’s Hospital, China. He is the past president of APLAR, and the president of the Clinical Immunology Committee at the Chinese Society for Immunology. He is Editor-in-Chief of the Chinese Journal of Rheumatology. His research interests are the mechanisms and immune therapy of rheumatic diseases, including rheumatoid arthritis and systemic lupus erythematosus. Soumya Raychaudhuri is a Professor at Harvard Medical School, and a practicing rheumatologist at the Brigham and Women’s Hospital Arthritis Center. He is also appointed at the Broad Institute, and the University of Manchester. He spends most of his time running a lab that is focused on defining mechanisms of disease in rheumatoid arthritis, and other immune-mediated diseases, using computational biology, genetics and functional genomics.

International audience; Objective: Sex differences may modify symptoms, disease expression, and treatment effects. The objective of this study was to evaluate the link between life impact and sex in psoriatic arthritis (PsA).Methods: Remission and Flare in Psoriatic Arthritis (ReFlaP; ClinicalTrials.gov identifier: NCT03119805) was a study in 14 countries of consecutive adult patients with definite PsA. Participants underwent comprehensive PsA assessment using the following measures: Disease Activity in Psoriatic Arthritis (DAPSA), Minimal Disease Activity (MDA), and Psoriatic Arthritis Impact of Disease (PsAID). Disease activity was compared by sex using t-tests or Wilcoxon tests. The association of PsAID with sex was analyzed using hierarchical generalized linear models.Results: Of 458 participants, 50.2% were male and the mean ± SD age was 53.1 ± 12.6 years. The mean ± SD PsA duration was 11 ± 8.2 years, and 51.5% of participants were being treated with biologic disease-modifying antirheumatic drugs. Women, compared to men, had worse mean ± SD Leeds Enthesitis Index scores (0.8 ± 1.7 versus 0.3 ± 0.9), pain on a numerical rating scale (NRS; range 0-10) (4.7 ± 2.7 versus 3.5 ± 2.7), HAQ DI scores (0.9 ± 0.7 versus 0.5 ± 0.6), fatigue on an NRS (5.2 ± 3 versus 3.3 ± 2.8), and PsAID scores (4.1 ± 2.4 versus 2.8 ± 2.3) (P < 0.001 for all). Women were also less frequently at treatment target compared to men according to DAPSA (cutoffs of ≤4 for remission and >4 and ≤14 for low disease activity; mean ± SD score 16.9 ± 14.9 in women versus 12.6 ± 16.6 in men) and MDA (25.7% versus 50.0%; P < 0.001 for all) scores. High life impact (PsAID score ≥4) was associated with female sex (odds ratio [OR] 2.3), enthesitis (OR 1.34), tender joints (OR 1.10)(P < 0.001 for all), and comorbidities (OR 1.22, P = 0.002).Conclusion: High life impact was independently associated with female sex, enthesitis, comorbidities, and tender joints. At treatment target, women had higher life impact compared to men. It is necessary for life impact to become a part of PsA treat-to-target strategies.

ObjectivesPatient care can vary substantially by country. The objective was to explore differences in psoriatic arthritis (PsA) across countries for disease activity, impact and treatments.MethodsA cross-sectional analysis of 13 countries from the Remission/Flare in PsA study (NCT03119805) of consecutive adult patients with definite PsA was performed. Countries were classified into tertiles by gross domestic product (GDP)/capita. Disease activity (Disease Activity in PsA, DAPSA and Minimal Disease Activity, MDA) and their components, disease impact (patient-reported outcomes) and biological disease-modifying antirheumatic drugs (bDMARDs) were analysed per country and compared between the three tertiles of GDP/capita by parametric and non-parametric tests. We also explored the percentage of patients with significant disease activity (DAPSA >14) and no ongoing bDMARD prescription.ResultsIn 439 patients (50.6% male, mean age 52.3 years, mean disease duration 10.1 years), disease activity and disease impact were higher in the lowest GDP/capita countries. DAPSA remission and MDA were attained in the lowest tertile in 7.0% and 18.4% patients, vs 29.1% and 49.5% in the middle tertile and 16.8% and 41.3% in the high tertile, respectively (all p14 and no bDMARDs was 18.5%, and was higher in lower GDP/capita countries (p=0.004).ConclusionPsA patients from countries with the lowest GDP/capita, despite similar use of bDMARDs, were more likely to have high disease activity and worse disease impact. There is a need for more equity in healthcare.

International audience

ObjectiveWhile COVID-19 vaccination prevents severe infections, poor immunogenicity in immunocompromised people threatens vaccine effectiveness. We analysed the clinical characteristics of patients with rheumatic disease who developed breakthrough COVID-19 after vaccination against SARS-CoV-2.MethodsWe included people partially or fully vaccinated against SARS-CoV-2 who developed COVID-19 between 5 January and 30 September 2021 and were reported to the Global Rheumatology Alliance registry. Breakthrough infections were defined as occurring ≥14 days after completion of the vaccination series, specifically 14 days after the second dose in a two-dose series or 14 days after a single-dose vaccine. We analysed patients’ demographic and clinical characteristics and COVID-19 symptoms and outcomes.ResultsSARS-CoV-2 infection was reported in 197 partially or fully vaccinated people with rheumatic disease (mean age 54 years, 77% female, 56% white). The majority (n=140/197, 71%) received messenger RNA vaccines. Among the fully vaccinated (n=87), infection occurred a mean of 112 (±60) days after the second vaccine dose. Among those fully vaccinated and hospitalised (n=22, age range 36–83 years), nine had used B cell-depleting therapy (BCDT), with six as monotherapy, at the time of vaccination. Three were on mycophenolate. The majority (n=14/22, 64%) were not taking systemic glucocorticoids. Eight patients had pre-existing lung disease and five patients died.ConclusionMore than half of fully vaccinated individuals with breakthrough infections requiring hospitalisation were on BCDT or mycophenolate. Further risk mitigation strategies are likely needed to protect this selected high-risk population.

ObjectiveTo evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs).MethodsThis is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0–100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate.Results129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65 min at baseline and 44 min at 3 months). The primary outcome was met: the BioSecure score was 81.2±13.1 and 75.6±13.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference.ConclusionsEducating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues.Trial registration numberNCT02855320.

IntroductionAlthough patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries.MethodsA multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still’s disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18–35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups.ResultsFifty-three patients (21 with RA/JIA/Still’s, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons.ConclusionsDespite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease.

ObjectiveTo analyse how non-adherence to prescribed treatments might be prevented, screened, assessed and managed in people with rheumatic and musculoskeletal diseases (RMDs).MethodsAn overview of systematic reviews (SR) was performed in four bibliographic databases. Research questions focused on: (1) effective interventions or strategies, (2) associated factors, (3) impact of shared decision making and effective communication, (4) practical things to prevent non-adherence, (5) effect of non-adherence on outcome, (6) screening and assessment tools and (7) responsible healthcare providers. The methodological quality of the reviews was assessed using AMSTAR-2. The qualitative synthesis focused on results and on the level of evidence attained from the studies included in the reviews.ResultsAfter reviewing 9908 titles, the overview included 38 SR on medication, 29 on non-pharmacological interventions and 28 on assessment. Content and quality of the included SR was very heterogeneous. The number of factors that may influence adherence exceed 700. Among 53 intervention studies, 54.7% showed a small statistically significant effect on adherence, and all three multicomponent interventions, including different modes of patient education and delivered by a variety of healthcare providers, showed a positive result in adherence to medication. No single assessment provided a comprehensive measure of adherence to either medication or exercise.ConclusionsThe results underscore the complexity of non-adherence, its changing pattern and dependence on multi-level factors, the need to involve all stakeholders in all steps, the absence of a gold standard for screening and the requirement of multi-component interventions to manage it.

Objective To propose a list of variables to be collected right after the diagnosis has been made and during the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice. Methods The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of ax-SpA by means of a systematic literature research; (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of each variable in a 4 grade scale from “not very useful/useless” to “mandatory”; (3) a consensus on the minimum interval of time for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”. Results The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Data to be collected at the initial systematic review comprised 5 patient's self-administered questionnaires, 3 variables of the physician's interview, 2 variables of the physical examination, 2 variables of the specific ax-SpA imaging and 2 other investigations. Two variables were recommended to be systematically collected at each visit, 1 variable twice a year, 6 variables yearly and 1 variable every 2 years. Conclusions Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported right after the diagnosis and during follow-up of patients with ax-SpA in daily practice.

Resume L’activite du rhumatisme psoriasique doit etre quantifiee pour permettre une prise de decision therapeutique. L’evaluation de l’activite repose sur une evaluation des articulations, de la peau, des symptomes du patient et de l’inflammation biologique. Plusieurs outils ont ete valides, et nous proposons le DAPSA (Disease Activity in Psoriatic Arthritis) en routine et le MDA (Minimal Disease Activity criteria) pour la recherche. Il est important en pratique de tenir compte egalement de la consommation eventuelle d’AINS et/ou de corticoides, de l’existence et de l’activite des manifestations extra-articulaires et de l’evolution radiographique. L’imagerie echographique et IRM peuvent etre utiles lorsque l’evaluation clinique est difficile. Les Patient Reported Outcome (PROs) en dehors de la douleur et de l’appreciation globale permettent d’evaluer le retentissement de la maladie sur le patient.

Resume Dans le rhumatisme psoriasique (RPso), de nombreux agents therapeutiques sont maintenant disponibles, mais les decisions de traitement ne sont pas toujours simples. Les recommandations recentes pour la prise en charge du RPso incluent les recommandations francaises et les recommandations de la Ligue europeenne contre le rhumatisme (EULAR). Ces deux recommandations discutent la place de differents medicaments, notamment les traitements de fond synthetiques conventionnels comme le methotrexate, les biotherapies comme les inhibiteurs du TNF, les inhibiteurs de l’IL-17 et les inhibiteurs de l’IL-12/23, et d’autres medicaments comme les inhibiteurs de JAK et l’apremilast. Les recommandations seront examinees ici.

International audience; Objectives MAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA). Methods This phase 3b, double-blind, placebocontrolled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two nonsteroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12. Results Patients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p

Objectives Remission (REM) or low disease activity (LDA) states were compared in a clinical trial setting of the FUTURE 2 study (NCT01752634) using Disease Activity Index for Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) composite indices in secukinumab treated PsA patients. Methods The proportion of patients reaching DAPSA-REM (cut-off ≤4) or REM+LDA (≤14), and very low disease activity (VLDA; achieving 7/7 criteria) or MDA (≥5/7), were compared in the overall population, by prior use of anti–TNF therapy, and by time since diagnosis using as observed data. The proportion of patients who met individual core component and other variables of interest were also computed to assess residual disease activity in DAPSA-REM/REM+LDA states and VLDA/MDA responses. The relationship between DAPSA/MDA and patient reported outcomes (PROs), including health-related quality of life, physical function, and fatigue were assessed using mixed model for repeated measures. Results More patients could achieve DAPSA-REM or DAPSA-REM+LDA status than VLDA or MDA responses, respectively, at all the time points in the overall population, irrespective of anti‒TNF status and time since diagnosis. Higher proportion of patients reaching DAPSA-REM or VLDA achieved more thresholds of core components (joints, pain, patient and physician global assessments, and function) than DAPSA-REM+LDA or MDA over Week 104. There were differences with numerically higher proportion of patients achieving patient global assessment ≤10 mm and ≤20 mm, and physician global assessment ≤10 mm with MDA than with DAPSA-REM+LDA, and patient pain VAS ≤15 mm, PASI ≤1, HAQ ≤0.5 with VLDA or MDA than with DAPSA-REM or DAPSA-REM+LDA, respectively, through 104 weeks. Improvements in PROs were significantly better for patients in DAPSA-REM+LDA versus DAPSA-moderate+high disease activity status, and for MDA responders versus non-responders. Conclusion These analysis add to the evidence that both DAPSA and MDA composite index measures can be used for evaluation of the status and treatment response utilizing a treat to target approach in PsA patients in a clinical trial setting and improve patient health related outcomes. Funding The study and analysis was funded by Novartis Pharma AG, Basel, Switzerland.

International audience; The provisional EULAR recommendations address several aspects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus, and the disease caused by SARS-CoV-2, COVID-19 and are meant for patients with rheumatic and musculoskeletal diseases (RMD) and their caregivers. A task force of 20 members was convened by EULAR that met several times by videoconferencing in April 2020. The task force finally agreed on five overarching principles and 13 recommendations covering four generic themes: (1) General measures and prevention of SARS-CoV-2 infection. (2) The management of RMD when local measures of social distancing are in effect. (3) The management of COVID-19 in the context of RMD. (4) The prevention of infections other than SARS-CoV-2. EULAR considers this set of recommendations as a ‘living document’ and a starting point, which will be updated as soon as promising new developments with potential impact on the care of patients with RMD become available.

Objectives: The objective was to develop and validate a self-administered questionnaire to identify in people with Inflammatory arthritis (IA) Facilitators And Barriers to Physical activity (PA): the IFAB questionnaire. Methods: The development of the questionnaire included a systematic review of barriers and facilitators to PA to identify key themes, face validity assessment by 11 experts and cognitive debriefing with 14 patients. The psychometric properties of the questionnaire were assessed by convergent validity (Spearman correlation) against the modified Health Assessment Questionnaire (mHAQ), the Fear-Avoidance Beliefs Questionnaire subscale for PA and the Tampa Scale for Kinesiophobia, internal consistency (Cronbach α) in 63 IA patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA). Reliability and feasibility were assessed in 32 IA patients. Results: The questionnaire comprises 10 items: 4 assessing either barriers or facilitators, 3 assessing barriers and 3 assessing facilitators. The items are related to: psychological status (N=6), social support (N=2), disease (N=1), environmental factors (N=1). In the validation study of 63 patients: 26 RA, 24 axSpA, 13 PsA; mean age 52.8 (standard deviation 16.5) years, mean disease duration 12.5 (12.3) years, 53% women. The questionnaire was correlated (r=0.24) with mHAQ. Internal consistency (Cronbach α 0.69) and reliability (interclass coefficient 0.79 [95% confidence interval 0.59; 0.88]) were satisfactory, as was feasibility (missing data 12%, mean completion time Conclusion: The questionnaire allows the assessment of barriers and facilitators to PA in patients with IA. This questionnaire may guide targeted interventions to increase levels of PA in these patients.

ObjectiveTo perform an update of a review of the efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) in psoriatic arthritis (PsA).MethodsThis is a systematic literature research of 2015–2018 publications on all DMARDs in patients with PsA, searching Medline, Embase and the Cochrane Library. Efficacy was assessed in randomised controlled trials. For safety, cohort studies, case–control studies and long-term extensions (LTEs) were analysed.Results56 publications (efficacy: n=33; safety n=23) were analysed. The articles were on tumour necrosis factor (TNF) inhibitors (n=6; golimumab, etanercept and biosimilars), interleukin (IL)-17A inhibitors (n=10; ixekizumab, secukinumab), IL-23-p19 inhibitors (n=2; guselkumab, risankizumab), clazakizumab (IL-6 inhibitor), abatacept (CD80/86 inhibitor) and ABT-122 (anti-TNF/IL-17A), respectively. One study compared ustekinumab (IL-12/23i) with TNF inhibitor therapy in patients with entheseal disease. Three articles investigated DMARD tapering. Trials on targeted synthetic DMARDs investigated apremilast (phosphodiesterase-4 inhibitor) and Janus kinase inhibitors (JAKi; tofacitinib, filgotinib). Biosimilar comparison with bio-originator showed non-inferiority. Safety was evaluated in 13 LTEs, 9 cohort studies and 1 case–control study investigating malignancies, infections, infusion reactions, multiple sclerosis and major cardiovascular events, as well as efficacy and safety of vaccination. No new safety signals were identified; however, warnings on the risk of venous thromboembolic events including pulmonary embolism when using JAKi were issued by regulators based on other studies.ConclusionMany drugs in PsA are available and have demonstrated efficacy against placebo. Efficacy varies across PsA manifestations. Safety must also be taken into account. This review informed the development of the European League Against Rheumatism 2019 updated PsA management recommendations.

ObjectiveTo update the European League Against Rheumatism (EULAR) recommendations for the pharmacological treatment of psoriatic arthritis (PsA).MethodsAccording to the EULAR standardised operating procedures, a systematic literature review was followed by a consensus meeting to develop this update involving 28 international taskforce members in May 2019. Levels of evidence and strengths of recommendations were determined.ResultsThe updated recommendations comprise 6 overarching principles and 12 recommendations. The overarching principles address the nature of PsA and diversity of both musculoskeletal and non-musculoskeletal manifestations; the need for collaborative management and shared decision-making is highlighted. The recommendations provide a treatment strategy for pharmacological therapies. Non-steroidal anti-inflammatory drugs and local glucocorticoid injections are proposed as initial therapy; for patients with arthritis and poor prognostic factors, such as polyarthritis or monoarthritis/oligoarthritis accompanied by factors such as dactylitis or joint damage, rapid initiation of conventional synthetic disease-modifying antirheumatic drugs is recommended. If the treatment target is not achieved with this strategy, a biological disease-modifying antirheumatic drugs (bDMARDs) targeting tumour necrosis factor (TNF), interleukin (IL)-17A or IL-12/23 should be initiated, taking into account skin involvement if relevant. If axial disease predominates, a TNF inhibitor or IL-17A inhibitor should be started as first-line disease-modifying antirheumatic drug. Use of Janus kinase inhibitors is addressed primarily after bDMARD failure. Phosphodiesterase-4 inhibition is proposed for patients in whom these other drugs are inappropriate, generally in the context of mild disease. Drug switches and tapering in sustained remission are addressed.ConclusionThese recommendations provide stakeholders with an updated consensus on the pharmacological management of PsA, based on a combination of evidence and expert opinion.

Resume Contexte L’information et l’education (ETP) du patient sont recommandees pour les patients atteints de rhumatisme inflammatoire chronique (RIC) : polyarthrite rhumatoide (PR) et spondyloarthrite (SpA). Cependant, il n’y a pas de consensus sur les connaissances essentielles destinees a ameliorer l’autogestion par les patients de leur maladie. Le but de cette etude etait de determiner ces connaissances. Methodes A partir des questionnaires de connaissances patients (QC) publies et selectionnes par une revue de la litterature, une liste d’elements de connaissances a ete etablie, classes par domaines et sous-domaines. Un processus Delphi conduit aupres de rhumatologues, professionnels de sante et des patients en 2014-2015, a selectionne les elements juges utiles. Resultats Trois QC publies ont ete analyses : 2 pour la PR, 1 pour la SpA ; 5 QC non publies ont egalement ete recueillis. Dans les QC, 90 items de connaissances etaient mentionnes pour la PR et 67 pour la SpA. Le processus Delphi a implique de 18 a 32 participants a chaque tour. Le premier tour Delphi a elargi la liste a 322 items pour PR et 265 items pour SpA. Le deuxieme tour a selectionne 69 et 59 items pour la PR et la SpA respectivement, dont 36 (52 %) et 34 (57 %) n’etaient pas presents ou ont ete modifies par rapport aux QC publies. Les domaines cles concernaient les traitements pharmacologiques, la gestion de la fatigue, les competences d’adaptation tels que les aspects socioprofessionnels, la communication patient-soignant et la prise de decision partagee. Conclusion Cette etude a permis d’obtenir un corpus de connaissances considerees comme essentielles pour les patients pour faciliter la gestion de leur rhumatisme inflammatoire. Le choix de nombreux elements reflete l’accent mis recemment sur les recommandations professionnelles et le point de vue des patients. Cette etude permettra de developper de nouveaux QC actualises pour les patients.

ObjectivesCOVID-19 outcomes in people with rheumatic diseases remain poorly understood. The aim was to examine demographic and clinical factors associated with COVID-19 hospitalisation status in people with rheumatic disease.MethodsCase series of individuals with rheumatic disease and COVID-19 from the COVID-19 Global Rheumatology Alliance registry: 24 March 2020 to 20 April 2020. Multivariable logistic regression was used to estimate ORs and 95% CIs of hospitalisation. Age, sex, smoking status, rheumatic disease diagnosis, comorbidities and rheumatic disease medications taken immediately prior to infection were analysed.ResultsA total of 600 cases from 40 countries were included. Nearly half of the cases were hospitalised (277, 46%) and 55 (9%) died. In multivariable-adjusted models, prednisone dose ≥10 mg/day was associated with higher odds of hospitalisation (OR 2.05, 95% CI 1.06 to 3.96). Use of conventional disease-modifying antirheumatic drug (DMARD) alone or in combination with biologics/Janus Kinase inhibitors was not associated with hospitalisation (OR 1.23, 95% CI 0.70 to 2.17 and OR 0.74, 95% CI 0.37 to 1.46, respectively). Non-steroidal anti-inflammatory drug (NSAID) use was not associated with hospitalisation status (OR 0.64, 95% CI 0.39 to 1.06). Tumour necrosis factor inhibitor (anti-TNF) use was associated with a reduced odds of hospitalisation (OR 0.40, 95% CI 0.19 to 0.81), while no association with antimalarial use (OR 0.94, 95% CI 0.57 to 1.57) was observed.ConclusionsWe found that glucocorticoid exposure of ≥10 mg/day is associated with a higher odds of hospitalisation and anti-TNF with a decreased odds of hospitalisation in patients with rheumatic disease. Neither exposure to DMARDs nor NSAIDs were associated with increased odds of hospitalisation.

Author(s): Gianfrancesco, Milena A; Hyrich, Kimme L; Gossec, Laure; Strangfeld, Anja; Carmona, Loreto; Mateus, Elsa F; Sufka, Paul; Grainger, Rebecca; Wallace, Zachary; Bhana, Suleman; Sirotich, Emily; Liew, Jean; Hausmann, Jonathan S; Costello, Wendy; Robinson, Philip; Machado, Pedro M; Yazdany, Jinoos; COVID-19 Global Rheumatology Alliance Steering Committee

Background The additional benefit of methotrexate (MTX) as a concomitant treatment in PsA has not been fully elucidated for TNF inhibitors (TNFi) and no real-world data on this currently exist for ustekinumab (UST). We investigated the additive effect of MTX on the ability to reach composite treatment targets beyond monotherapy with UST or TNFi, and the ability to improve patient-reported outcomes in a real-world clinical setting in 8 European countries. Methods The PsABio study (NCT02627768) evaluates persistence, effectiveness and tolerability of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (LDA) or remission, as well as the patient acceptable symptom state (PASS; score ≤4) of the 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) were evaluated. Here we present 6-month follow-up data using intention to treat (ITT) analysis; patients who stopped/switched initial treatment were imputed as non-responders. The effect of MTX co-therapy was investigated within UST and TNFi cohorts, as well as between the cohorts, using multivariate logistic regression including interaction terms, and propensity score (PS) analysis to adjust for imbalanced, potentially prognostic, baseline covariates. Results Of 930 patients, data was available for 868 ITT patients, including patients who switched/stopped before 6 months (UST: n = 28/426 [6.6%], TNFi: n = 44/442 [10.0%]). At baseline there were no relevant differences in demographics and disease activity, however there were significant differences in skin involvement as well as csDMARD and NSAID exposure. Co-therapy with MTX did not increase the likelihood of achieving any of the outcomes in either the UST or TNFi cohorts (Table 1). After PS adjustment, co-treatment with MTX did not influence treatment effects differently when added to UST compared with TNFi. concomitant use of csDMARDs other than MTX yielded very similar results. Conclusion In a real-world setting, concomitant treatment with MTX in addition to UST or TNFi was not associated with enhanced effects across a broad variety of disease outcomes, including disease activity, disease impact, and skin involvement within or between treatment cohorts, after PS adjustment for baseline confounders. Disclosures S. Siebert: Consultancies; AbbVie, UCB, Pfizer, Janssen, Boehringer Ingelheim, Celgene, Novartis. Grants/research support; Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim. E. Gremese: Consultancies; AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, Pfizer. P. Bergmans: Shareholder/stock ownership; Johnson & Johnson. Other; Employee of Janssen. K. de Vlam: Consultancies; Johnson & Johnson. B. Joven-Ibáñez: Member of speakers’ bureau; Celgene, Novartis, MSD, Pfizer, AbbVie, Janssen. G. Katsifis: None. T.V. Korotaeva: Consultancies; Pfizer, MSD, Novartis, AbbVie, Celgene, Biocad, Janssen, UCB, Lilly, Novartis-Sandoz. W. Noël: Other; Employee of Janssen. C. Selmi: None. P.P. Sfikakis: None. P. Smirnov: Other; Employee of Janssen. E. Theander: Other; Employee of Janssen. M.T. Nurmohamed: Grants/research support; Pfizer, AbbVie, Roche, BMS, MSD, Mundipharma, UCB, Janssen, Menarini, Lilly, Sanofi, Celgene. L. Gossec: Honoraria; AbbVie, Celgene, Janssen, Lilly, Novartis-Sandoz, Pfizer, Sanofi, UCB. Grants/research support; Pfizer. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO Pharma, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB. Grants/research support; AbbVie, Janssen, Lilly, MSD, Pfizer, Roche.