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ObjectiveWe evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).MethodsPsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed.ResultsAt 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups.ConclusionIn the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA.

International audience

International audience; No abstract available

ObjectivesTo evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years.MethodsPsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months. Safety data were collected over 3 years. Analyses to compare the modes of action were adjusted on baseline differences by propensity scores (PS).ResultsIn 895 patients (mean age 49.8 years, 44.7% males), at 3 years, the proportion of patients still on their initial treatments was similar with ustekinumab (49.9%) and TNFi (47.8%). No difference was seen in the risk of stopping/switching; PS-adjusted hazard ratio (95% CI) for stopping/switching ustekinumab versus TNFi was 0.87 (0.68 to 1.11). In the overall population, cDAPSA LDA/remission was achieved in 58.6%/31.4% ustekinumab-treated and 69.8%/45.0% TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63 to 1.26) for cDAPSA LDA; 0.72 (0.50 to 1.05) for remission. MDA/VLDA was achieved in 41.4%/19.2% of ustekinumab-treated and 54.2%/26.9% of TNFi-treated patients with overlapping PS-adjusted ORs. A greater percentage of TNFi-treated patients achieved effectiveness outcomes. Both treatments exhibited good long-term safety profiles, although ustekinumab-treated patients had a lower rate of adverse events (AEs) versus TNFi.ConclusionAt 3 years, there was generally comparable persistence after ustekinumab or TNFi treatment, but AE rates were lower with ustekinumab.

ObjectivesTo describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD).MethodsPhysician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively.ResultsThe study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD).ConclusionThe safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.

Background: There is evidence that patients and physicians are frequently misaligned in their perspectives on psoriatic arthritis (PsA) treatment priorities, which may be associated with increased disease activity, greater disability, and poorer health-related quality of life of PsA patients. Objective: To identify factors associated with patient–physician misalignment in satisfaction with PsA disease control. Methods: In a cross-sectional survey of physicians and their patients with PsA from the United States and Europe, satisfaction with disease control was examined and classified as satisfied, neutral, or dissatisfied. Bivariate and multivariate regression analyses explored alignment in satisfaction between physicians and patients. Results: There were 656 PsA patient–physician pairs included in the analysis. Misalignment occurred in 20.6% of cases. Greater disease impact, worse physician-reported disease severity, and lower patient-reported involvement in treatment decisions were associated with misalignment. Conclusion: Greater patient–physician engagement may improve satisfaction, alignment, and outcomes in PsA disease control.

Resume Le rhumatisme psoriasique (RPso) est une maladie inflammatoire chronique heterogene qui a un impact physique et psychologique sur les patients. Les personnes atteintes de RPso ont une qualite de vie reduite par rapport a la population generale ou aux patients atteints de psoriasis, et l’impact est similaire a celui des patients atteints de polyarthrite rhumatoide. L’impact du RPso semble etre tres large, couvrant tous les aspects de la vie, c’est-a-dire les activites et la participation, les aspects physiques et emotionnels, mais aussi des domaines tels que la fatigue, le « faire face » a la maladie ou le sommeil. Plusieurs questionnaires generiques et specifiques a la maladie sont disponibles pour mieux evaluer ces aspects du RPso. Une meilleure comprehension des problemes de qualite de vie auxquels sont confrontes les patients atteints de RPso pourrait ameliorer la communication medecin-malade et, a terme, la qualite des soins.

To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities.Prospective, randomized, controlled, open, 12-month trial (NCT02374749).consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group).change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management).502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p0.01).This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.

International audience; Background: Individuals with chronic low back pain (cLBP) may benefit from multimodal functional restoration programs (FRPs).Objective: The aim of this study was to analyze characteristics of individuals with cLBP who were referred or not to an FRP. Because cLBP is a bio-psycho-social disorder, medical and social parameters were analysed.Methods: This was an observational cross-sectional study performed in 2017 in 6 tertiary centres in France. Consecutive individuals with cLBP visiting a rheumatologist or physical medicine and rehabilitation physician were included. Individuals referred or not to an FRP were compared by demographic characteristics, duration of sick leave over the past year, self-reported physical activity>1h/week, pain (numeric rating scale 0-10), anxiety/depression (Hospital Anxiety and Depression Scale), disability (Oswestry Disability Index) and kinesiophobia (Tampa Kinesiophobia Scale). Univariate and multivariate logistic regression analyses were performed, estimating odds ratios (ORs) and 95% confidence intervals (CIs).Results: We included 147 individuals with cLBP. The mean (SD) age was 49 (12) years and 88 (60%) were women; 58 (38%) were referred to an FRP. On multivariate analysis, referral to an FRP was associated with reduced pain level (OR: 0.95, 95% CI: 0.91-0.99, for each 1-point increase in pain score), self-reported lack of physical activity (OR: 0.84, 95% CI: 0.72-0.98) and longer sick leave (OR: 1.03, 95% CI: 1.01-1.05, for 30 more days of sick leave).Conclusion: In this multicentric observational study, referral to an FRP was linked to pain, self-reported physical activity and sick leave but not medical characteristics assessed. These findings confirm the bio-psycho-social approach of FRPs for cLBP.

ObjectivesTo provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field.MethodsAn international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items.ResultsThe task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.ConclusionsThese updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost.

© 2018, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology. Objective: The implementation of value-based health care in inflammatory arthritis requires a standardized set of modifiable outcomes and risk-adjustment variables that is feasible to implement worldwide. Methods: The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary working group that consisted of 24 experts from 6 continents, including 6 patient representatives, to develop a standard set of outcomes for inflammatory arthritis. The process followed a structured approach, using a modified Delphi process to reach consensus on the following decision areas: conditions covered by the set, outcome domains, outcome measures, and risk-adjustment variables. Consensus in areas 2 to 4 were supported by systematic literature reviews and consultation of experts. Results: The ICHOM Inflammatory Arthritis Standard Set covers patients with rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis (JIA). We recommend that outcomes regarding pain, fatigue, activity limitations, overall physical and mental health impact, work/school/housework ability and productivity, disease activity, and serious adverse events be collected at least annually. Validated measures for patient-reported outcomes were endorsed and linked to common reporting metrics. Age, sex at birth, education level, smoking status, comorbidities, time since diagnosis, and rheumatoid factor and anti-citrullinated protein antibody lab testing for RA and JIA should be collected as risk-adjustment variables. Conclusion: We present the ICHOM inflammatory arthritis Standard Set of outcomes, which enables health care providers to implement the value-based health care framework and compare outcomes that are important to patients with inflammatory arthritis.

Resume Objectifs Analyser les facteurs associes a la fatigue en se focalisant sur les comorbidites dans une importante cohorte de patients atteints de polyarthrite rhumatoide (PR). Methodes Des analyses transversales ont ete realisees sur les patients atteints de PR de l’etude longitudinale francaise COMEDRA, un programme realise par des infirmiers sur la prise en charge des comorbidites. La fatigue a ete evaluee par la question no 3 du score RAID (Rheumatoid Arthritis Impact of Disease) sur une echelle numerique de 0 a 10 (NRS). Trois niveaux de fatigue ont ete definis : acceptable (≤ 2 sur 10), moderee (3 ou 4 sur 10) et severe (≥ 5 sur 10). Des modeles univaries et multivaries ont ete appliques pour explorer les relations entre fatigue et caracteristiques demographiques, sociales et de la maladie, comorbidites (cardiovasculaires, infections, cancer, pulmonaires, osteoporose et psychiatriques), activite physique, qualite de vie et traitements. Resultats Les analyses ont ete realisees pour 962 patients. Le score moyen de fatigue etait de 3,8 ± 2,7 et 40 % des patients ont indique souffrir d’une fatigue severe. Les patients presentaient en moyenne 1,8 comorbidites, l’anxiete/depression etant la plus frequente (52 %). Dans l’analyse univariee, la fatigue severe etait plus frequente chez les femmes, les patients sans activites professionnelles et ceux pratiquant peu d’activite physique. Elle a ete associee a la duree et a l’activite de la maladie, au score de handicap mHAQ, a la douleur et aux problemes de sommeil et emotionnels. La fatigue severe a ete correlee avec l’indice de multimorbidite qui evalue le nombre de morbidites, et associee a l’obesite, l’hypertension, la BPCO et l’anxiete/depression. Les analyses multivariees ont associe le risque de fatigue severe au sexe feminin, a l’activite de la maladie, au score de handicap mHAQ, aux traitements en cours par AINS et agents biologiques, au score de multimorbidite, a l’obesite et a l’anxiete/depression. Conclusions les comorbidites, la sante mentale et l’activite physique devraient etre evaluees dans la prise en charge du probleme courant qu’est la fatigue severe dans la PR.

Objective.To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.Methods.Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2–5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient’s global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.Results.Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.Conclusion.This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.

Resume La fatigue est un probleme notable dans le rhumatisme psoriasique. L’objectif de cette revue systematique de la litterature avec meta-analyse etait d’evaluer l’effet des traitements de fond antirhumatismaux biologiques et de l’apremilast sur la fatigue dans des essais comparatifs randomises sur le rhumatisme psoriasique et de comparer cet effet a celui constate sur la douleur dans ces memes essais. Une revue systematique de la litterature a ete realisee dans les bases de donnees PubMed, Embase et Cochrane jusqu’en janvier 2017. Tous les essais comparatifs randomises portant sur les traitements de fond biologiques et l’apremilast dans le rhumatisme psoriasique et evaluant la fatigue (quel que soit le score utilise) ont ete inclus. Deux evaluateurs ont collecte les donnees relatives aux niveaux de fatigue et de douleur, a l’inclusion et au point d’evaluation le plus proche de 24 semaines apres le debut du traitement. Les differences moyennes standardisees compilees ont ete calculees par le logiciel RevMan. Apres selection de 295 publications, sept essais comparatifs randomises ont ete analyses, comparant l’adalimumab (n = 2), le certolizumab pegol (n = 1), le secukinumab (n = 2), l’ustekinumab (n = 1) et l’apremilast (n = 1) a un placebo. Les etudes incluaient 2341 patients avec les caracteristiques (moyenne ponderee ± ecart-type) suivantes : âge 48,6 ± 1,3 ans, duree de la maladie 7,7 ± 1,6 ans, 51,6 % de femmes. La fatigue etait importante a l’inclusion (score d’evaluation fonctionnelle des traitements de maladie chronique (FACIT) : 28,7 ± 2,4). La difference moyenne standardisee compilee etait pour la fatigue − 0,44 (intervalle de confiance a 95 % : − 0,54, − 0,35) et pour la douleur − 0,62 (− 0,73, − 0,52). A 24 semaines, les traitements de fond biologiques et l’apremilast ont eu un effet leger sur la fatigue et plus marque sur la douleur dans les essais comparatifs randomises sur le rhumatisme psoriasique. Il est important de tenir compte de ces resultats dans la prise de decision therapeutique conjointe.

The first EULAR provisional recommendations on the management of rheumatic and musculoskeletal diseases (RMDs) in the context of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), largely based on expert opinion, were published in June 2020. Since then, an unprecedented number of clinical studies have accrued in the literature. Several SARS-CoV-2 vaccines have been approved for population-wide vaccination programmes in EULAR-affiliated countries. Studies regarding vaccination of patients with (inflammatory) RMDs have released their first results or are underway.EULAR found it opportune to carefully review to what extent the initially consensus expert recommendations stood the test of time, by challenging them with the recently accumulated body of scientific evidence, and by incorporating evidence-based advice on SARS-CoV-2 vaccination. EULAR started a formal (first) update in January 2021, performed a systematic literature review according to EULAR’s standard operating procedures and completed a set of updated overarching principles and recommendations in July 2021. Two points to consider were added in November 2021, because of recent developments pertaining to additional vaccination doses.

Although the management of rheumatoid arthritis (RA) has improved in major way over the last decades, this disease still leads to an important burden for patients and society, and there is a need to develop more personalized approaches. Machine learning (ML) methods are more and more used in health-related studies and can be applied to different sorts of data (clinical, radiological, or 'omics' data). Such approaches may improve the management of patients with RA.In this paper, we propose a review regarding ML approaches applied to RA. A scoping literature search was performed in PubMed, in September 2021 using the following MeSH terms: 'arthritis, rheumatoid' and 'machine learning'. Based on this search, the usefulness of ML methods for RA diagnosis, monitoring, and prediction of response to treatment and RA outcomes, is discussed.ML methods have the potential to revolutionize RA-related research and improve disease management and patient care. Nevertheless, these models are not yet ready to contribute fully to rheumatologists' daily practice. Indeed, these methods raise technical, methodological, and ethical issues, which should be addressed properly to allow their implementation. Collaboration between data scientists, clinical researchers, and physicians is therefore required to move this field forward.

Summary Background Patients with primary systemic vasculitis or polymyalgia rheumatica might be at a high risk for poor COVID-19 outcomes due to the treatments used, the potential organ damage cause by primary systemic vasculitis, and the demographic factors associated with these conditions. We therefore aimed to investigate factors associated with COVID-19 outcomes in patients with primary systemic vasculitis or polymyalgia rheumatica. Methods In this retrospective cohort study, adult patients (aged ≥18 years) diagnosed with COVID-19 between March 12, 2020, and April 12, 2021, who had a history of primary systemic vasculitis (antineutrophil cytoplasmic antibody [ANCA]-associated vasculitis, giant cell arteritis, Behcet's syndrome, or other vasculitis) or polymyalgia rheumatica, and were reported to the COVID-19 Global Rheumatology Alliance registry were included. To assess COVID-19 outcomes in patients, we used an ordinal COVID-19 severity scale, defined as: (1) no hospitalisation; (2) hospitalisation without supplemental oxygen; (3) hospitalisation with any supplemental oxygen or ventilation; or (4) death. Multivariable ordinal logistic regression analyses were used to estimate odds ratios (ORs), adjusting for age, sex, time period, number of comorbidities, smoking status, obesity, glucocorticoid use, disease activity, region, and medication category. Analyses were also stratified by type of rheumatic disease. Findings Of 1202 eligible patients identified in the registry, 733 (61·0%) were women and 469 (39·0%) were men, and their mean age was 63·8 years (SD 17·1). A total of 374 (31·1%) patients had polymyalgia rheumatica, 353 (29·4%) had ANCA-associated vasculitis, 183 (15·2%) had giant cell arteritis, 112 (9·3%) had Behcet's syndrome, and 180 (15·0%) had other vasculitis. Of 1020 (84·9%) patients with outcome data, 512 (50·2%) were not hospitalised, 114 (11·2%) were hospitalised and did not receive supplemental oxygen, 239 (23·4%) were hospitalised and received ventilation or supplemental oxygen, and 155 (15·2%) died. A higher odds of poor COVID-19 outcomes were observed in patients who were older (per each additional decade of life OR 1·44 [95% CI 1·31–1·57]), were male compared with female (1·38 [1·05–1·80]), had more comorbidities (per each additional comorbidity 1·39 [1·23–1·58]), were taking 10 mg/day or more of prednisolone compared with none (2·14 [1·50–3·04]), or had moderate, or high or severe disease activity compared with those who had disease remission or low disease activity (2·12 [1·49–3·02]). Risk factors varied among different disease subtypes. Interpretation Among patients with primary systemic vasculitis and polymyalgia rheumatica, severe COVID-19 outcomes were associated with variable and largely unmodifiable risk factors, such as age, sex, and number of comorbidities, as well as treatments, including high-dose glucocorticoids. Our results could be used to inform mitigation strategies for patients with these diseases. Funding American College of Rheumatology and the European Alliance of Associations for Rheumatology.

ObjectivesTo evaluate 6-month effectiveness of ustekinumab versus tumour necrosis factor inhibitor (TNFi), analysing predictors of low disease activity (LDA)/remission.MethodsPsABio is a prospective, observational cohort study of patients with psoriatic arthritis (PsA) at 92 sites in eight European countries, who received first-line to third-line ustekinumab or a TNFi. Comparative achievement at 6 months of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) LDA/remission, and minimal disease activity (MDA)/very LDA using propensity score (PS)-adjusted multivariate logistic regression was assessed.ResultsIn the final analysis set of 868 participants with 6-month follow-up data (ustekinumab, n=426; TNFi, n=442), with long-standing disease and a high mean cDAPSA score (31.0 vs 29.8, respectively), proportions of patients in ustekinumab/TNFi treatment groups achieving cDAPSA LDA at 6 months were 45.7%/50.7%. cDAPSA remission was achieved in 14.9%/19.2%, and MDA in 26.4%/30.8% of patients. PS-adjusted odds ratios (OR; 95% confidence interval (CI)) of reaching cDAPSA LDA and MDA were 0.73 (0.46 to 1.15) and 0.87 (0.61 to 1.25) with ustekinumab versus TNFi, indicating no significant difference. High baseline body mass index or high cDAPSA were associated with a lower chance (OR (95% CI)) of reaching cDAPSA LDA with TNFi (0.94 (0.89 to 0.99) and 0.64 (0.52 to 0.79), respectively). Predictive factors were similar to previously published evidence, with cDAPSA and 12-item Psoriatic Arthritis Impact of Disease scores and chronic widespread pain at baseline appearing as new risk factors for unfavourable outcome. Safety data were similar between groups.ConclusionTreatment targets were reached similarly after 6 months of treatment with ustekinumab and TNFi.

Introduction Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA). Objective 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. Methods 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. Results 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. Conclusion 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.

Objective To assess the efficacy and safety of upadacitinib (UPA), an oral Janus kinase inhibitor, as monotherapy or in combination with non-biologic DMARDs (nbDMARDs) in patients with PsA. Methods Pooled data were analysed from patients with prior inadequate response or intolerance to one or more nbDMARD (SELECT-PsA 1) or one or more biologic DMARD (SELECT-PsA 2) who received placebo, UPA 15 mg once daily (QD) or UPA 30 mg QD as monotherapy or in combination with two or fewer nbDMARDs for 24 weeks. Efficacy outcomes included achievement of ACR responses, Psoriasis Area and Severity Index responses, minimal disease activity and change from baseline and clinically meaningful improvement in the HAQ Disability Index. Adverse events (AEs) were summarized. Results A total of 1916 patients were included; 574 (30%) received monotherapy and 1342 (70%) received combination therapy. Placebo-subtracted treatment effects for a 20% improvement in ACR criteria at week 12 were 33.7% (95% CI 24.4, 43.1) and 34.0% (95% CI 27.9, 40.1) for UPA 15 mg QD monotherapy and combination therapy, respectively, and 45.7% (95% CI 36.9, 54.5) and 39.6% (95% CI 33.7, 45.5) for UPA 30 mg QD monotherapy and combination therapy, respectively. Treatment effects for other outcomes were consistent between monotherapy and combination therapy. AE frequency was generally similar for UPA monotherapy and combination therapy, although hepatic disorders and creatine phosphokinase elevation were more common with combination therapy vs monotherapy. Conclusion The efficacy and safety of UPA were generally consistent when administered as monotherapy or in combination with nbDMARDs through 24 weeks, supporting the use of UPA with or without nbDMARDs in PsA. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov): SELECT-PsA 1 (NCT03104400), SELECT-PsA 2 (NCT03104374)

ObjectiveTo describe coronavirus disease 2019 (COVID-19) and pregnancy outcomes in patients with rheumatic disease who were pregnant at the time of infection.MethodsSince March 2020, the COVID-19 Global Rheumatology Alliance has collected cases of patients with rheumatic disease with COVID-19. We report details of pregnant women at the time of COVID-19 infection, including obstetric details separately ascertained from providers.ResultsWe report on 39 patients, including 22 with obstetric detail available. The mean and median age was 33 years, range 24–45 years. Rheumatic disease diagnoses included rheumatoid arthritis (n = 9), systemic lupus erythematosus (n = 9), psoriatic arthritis/other inflammatory arthritides (n = 8), and antiphospholipid syndrome (n = 6). Most had a term birth (16/22), with 3 preterm births, 1 termination, and 1 miscarriage; 1 woman had yet to deliver at the time of report. One-quarter (n = 10/39) of pregnant women were hospitalized following COVID-19 diagnosis. Two of 39 (5%) required supplemental oxygen (both hospitalized); no patients died. The majority did not receive specific medication treatment for their COVID-19 (n = 32/39, 82%), and 7 patients received some combination of antimalarials, colchicine, anti–interleukin 1β, azithromycin, glucocorticoids, and lopinavir/ritonavir.ConclusionWomen with rheumatic diseases who were pregnant at the time of COVID-19 had favorable outcomes. These data have limitations due to the small size and methodology; however, they provide cautious optimism for pregnancy outcomes for women with rheumatic disease particularly in comparison to the increased risk of poor outcomes that have been reported in other series of pregnant women with COVID-19.

Introduction/objectives To evaluate the journey to diagnosis, disease characteristics and burden of disease in male and female patients with axial spondyloarthritis (axSpA) across Europe. Method Data from 2846 unselected patients participating in the European Map of Axial Spondyloarthritis (EMAS) study through an online survey (2017–2018) across 13 countries were analysed. Sociodemographic characteristics, lifestyle, diagnosis, disease characteristics and patient-reported outcomes (PROs) [disease activity –BASDAI (0–10), spinal stiffness (3–12), functional limitations (0–54) and psychological distress (GHQ-12)] were compared between males and females using chi-square (for categorical variables) and student t (for continuous variables) tests. Results In total, 1100 (38.7%) males and 1746 (61.3%) females participated in the EMAS. Compared with males, females reported considerable longer diagnostic delay (6.1 ± 7.4 vs 8.2 ± 8.9 years; p p p p p Conclusion The patient journey to diagnosis of axSpA is much longer and arduous in females, which may be related to physician bias and lower frequency of HLA-B27 carriership. Regarding PROs, females experience higher disease activity and poorer psychological health compared with males. These results reflect specific unmet needs in females with axSpA needing particular attention. Key Points• Healthcare professionals’ perception of axSpA as a predominantly male disease may introduce some bias during the diagnosis and management of the disease. However, evidence about male-female differences in axSpA is scarce.• EMAS results highlight how female axSpA patients report longer diagnostic delay and higher burden of the disease in a large sample of 2846 participants of 13 European countries.• Results reflect unmet needs of European female patients. Healthcare professionals should pay close attention in order to accurately diagnose and efficiently manage axSpA cases while further research should be developed on the cause of reported gender differences.

Wearable activity trackers are playing an increasingly important role in healthcare. In the field of rheumatic and musculoskeletal diseases (RMDs), various applications are currently possible. This review will present the use of activity trackers to promote physical activity levels in rheumatology, as well as the use of trackers to measure health parameters and detect flares using artificial intelligence. Challenges and limitations of the use of artificial intelligence will be discussed, as well as technical issues when using activity trackers in clinical practice.Tragbare Aktivitätstracker spielen eine immer wichtigere Rolle im Gesundheitswesen. Im Bereich der rheumatischen und muskuloskeletalen Erkrankungen („rheumatic and musculoskeletal diseases“, RMD) sind derzeit verschiedene Anwendungen möglich. In der vorliegenden Übersichtsarbeit werden sowohl der Einsatz von Aktivitätstrackern zur Förderung des körperlichen Aktivitätsniveaus in der Rheumatologie vorgestellt als auch der Einsatz von Trackern zur Messung von Gesundheitsparametern und zur Erkennung von Krankheitsschüben mittels künstlicher Intelligenz. Herausforderungen und Grenzen des Einsatzes von künstlicher Intelligenz werden ebenso diskutiert wie technische Fragen beim Einsatz von Aktivitätstrackern in der klinischen Praxis.

BackgroundThe interleukin-23p19-subunit inhibitor guselkumab effectively treats signs and symptoms of psoriatic arthritis (PsA). We evaluated the effect of guselkumab on fatigue.MethodsAcross two phase 3 trials of guselkumab (DISCOVER-1, DISCOVER-2), patients with active PsA despite standard therapy were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W,N= 373); guselkumab 100 mg at week 0, week 4, and then Q8W (N= 375); or placebo (N= 372) through week 24, after which patients in the placebo group crossed over to guselkumab Q4W. Fatigue was measured as a secondary endpoint using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument (range 0–52, higher scores indicate less fatigue). Least-squares mean changes in FACIT-Fatigue scores were compared between treatments using a mixed-effect model for repeated measures. Mediation analysis was used to adjust for indirect effects on fatigue deriving from improvement in other outcomes, including ≥20% improvement in American College of Rheumatology criteria (ACR20; prespecified), minimal disease activity (MDA; post hoc), or C-reactive protein (CRP; post hoc).ResultsBaseline mean (SD) FACIT-Fatigue scores in DISCOVER-1 (N= 381) and DISCOVER-2 (N= 739), ranging from 29.1 (9.5) to 31.4 (10.1), indicated substantial levels of fatigue relative to the United States general population (43.6 [9.4]). Across studies, mean improvements, and proportions of patients with ≥4-point improvements, in FACIT-Fatigue scores at week 24 with guselkumab Q4W and Q8W (5.6–7.6 and 54–63%, respectively) were larger vs placebo (2.2–3.6 and 35–46%). Improvement in FACIT-Fatigue scores with guselkumab was sustained from week 24 to week 52, with moderate-to-large effect sizes (Cohen’sd= 0.52–0.81 at week 24; 0.66–0.91 at week 52). Mediation analyses demonstrated that substantial proportions of the effects of guselkumab vs placebo on fatigue were direct effect, after adjusting for achievement of ACR20 (Q4W 69–70%, Q8W 12–36% direct effect) or MDA (72–92% across dosing regimens) response or for change in serum CRP concentrations (82–88% across dosing regimens).ConclusionsIn patients with active PsA, guselkumab 100 mg Q4W or Q8W led to clinically meaningful and sustained improvements in fatigue through 1 year. A substantial portion of the improvement in FACIT-Fatigue scores induced by guselkumab was independent of effects on the achievement of other select outcomes.Trial registrationName of the registry: ClinicalTrials.govTrial registrations: DISCOVER-1, NCT03162796; DISCOVER-2, NCT03158285Date of registration: DISCOVER-1, May 22, 2017; DISCOVER-2, May 18, 2017URLs of the trial registry record:DISCOVER-1,https://clinicaltrials.gov/ct2/show/NCT03162796?term=NCT03162796&draw=1&rank=1DISCOVER-2,https://clinicaltrials.gov/ct2/show/NCT03158285?term=NCT03158285&draw=2&rank=1

Background: The impact and consequences of the COVID-19 pandemic on people with rheumatic disease are unclear. We developed the COVID-19 Global Rheumatology Alliance Patient Experience Survey to assess the effects of the COVID-19 pandemic on people with rheumatic disease worldwide. Methods: Survey questions were developed by key stakeholder groups and disseminated worldwide through social media, websites, and patient support organisations. Questions included demographics, rheumatic disease diagnosis, COVID-19 diagnosis, adoption of protective behaviours to mitigate COVID-19 exposure, medication access and changes, health-care access and communication with rheumatologists, and changes in employment or schooling. Adults age 18 years and older with inflammatory or autoimmune rheumatic diseases were eligible for inclusion. We included participants with and without a COVID-19 diagnosis. We excluded participants reporting only non-inflammatory rheumatic diseases such as fibromyalgia or osteoarthritis. Findings: 12 117 responses to the survey were received between April 3 and May 8, 2020, and of these, 10 407 respondents had included appropriate age data. We included complete responses from 9300 adults with rheumatic disease (mean age 46·1 years; 8375 [90·1%] women, 893 [9·6%] men, and 32 [0·3%] participants who identified as non-binary). 6273 (67·5%) of respondents identified as White, 1565 (16·8%) as Latin American, 198 (2·1%) as Black, 190 (2·0%) as Asian, and 42 (0·5%) as Native American or Aboriginal or First Nation. The most common rheumatic disease diagnoses included rheumatoid arthritis (3636 [39·1%] of 9300), systemic lupus erythematosus (2882 [31·0%]), and Sjogren's syndrome (1290 [13·9%]). Most respondents (6921 [82·0%] of 8441) continued their antirheumatic medications as prescribed. Almost all (9266 [99·7%] of 9297) respondents adopted protective behaviours to limit SARS-CoV-2 exposure. A change in employment status occurred in 2524 (27·1%) of 9300) of respondents, with a 13·6% decrease in the number in full-time employment (from 4066 to 3514). Interpretation: People with rheumatic disease maintained therapy and followed public health advice to mitigate the risks of COVID-19. Substantial employment status changes occurred, with potential implications for health-care access, medication affordability, mental health, and rheumatic disease activity. Funding: American College of Rheumatology.

Objectives The optimal treatment target in axial spondyloarthritis (axSpA) is remission; however, a consensual definition of remission is lacking. Our objective was to explore rheumatologists’ perception of remission using vignette cases and a priority exercise. Methods A cross-sectional survey of rheumatologists’ perceptions of remission in axSpA was performed in 2020 using (i) 36 vignette cases, with a single clinical picture and three varying parameters [axial pain (ranging from 2 to 5 on a 0–10 scale)], fatigue (2–8), and morning stiffness ( Results Overall, 200 French rheumatologists participated in 2400 vignette evaluations. Of these, 463 (19%) were classified as remission. The six vignette cases representing 56% of all remission cases had Conclusions When conceptualizing remission in axSpA, rheumatologists took into account morning stiffness and axial pain as expected; the link between remission and fatigue was much weaker. Furthermore, rheumatologists also included EAMs and NSAID use in the concept of remission. Consensus is needed for definition of remission in axSpA.

ObjectivesTo investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM).MethodsDemographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 Global Rheumatology Alliance physician-reported registry. A 3-point ordinal COVID-19 severity scale was defined: (1) no hospitalisation, (2) hospitalisation (and no death) and (3) death. ORs were estimated using multivariable ordinal logistic regression. Sensitivity analyses were performed using a 4-point ordinal scale: (1) no hospitalisation, (2) hospitalisation with no oxygen (and no death), (3) hospitalisation with oxygen/ventilation (and no death) and 4) death.ResultsOf 348 patients, 48% were not hospitalised, 39% were hospitalised (and did not die) and 13% died. Older age (OR=1.59/decade, 95% CI 1.31 to 1.91), high disease activity (OR=3.50, 95% CI 1.25 to 9.83; vs remission), ≥2 comorbidities (OR=2.63, 95% CI 1.39 to 4.98; vs none), prednisolone-equivalent dose >7.5 mg/day (OR=2.40, 95% CI 1.09 to 5.28; vs no intake) and exposure to rituximab (OR=2.71, 95% CI 1.28 to 5.72; vs conventional synthetic disease-modifying antirheumatic drugs only) were independently associated with severe COVID-19. In addition to these variables, in the sensitivity analyses, male sex (OR range: 1.65–1.83; vs female) was also significantly associated with severe outcomes, while COVID-19 diagnosis after 1 October 2020 (OR range: 0.51–0.59; vs on/before 15 June 2020) was significantly associated with less severe outcomes, but these associations were not significant in the main model (OR=1.57, 95% CI 0.95 to 2.59; and OR=0.61, 95% CI 0.37 to 1.00; respectively).ConclusionsThis is the first large registry data on outcomes of COVID-19 in people with IIM. Older age, male sex, higher comorbidity burden, high disease activity, prednisolone-equivalent dose >7.5 mg/day and rituximab exposure were associated with severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with IIM.

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.

International audience; Background: Functional restoration programs (FRPs) are integrative programs to improve function in chronic low back pain (cLBP). They are costly and time-consuming. The aim was to assess the effectiveness of a condensed FRP (CFRP) for patients with cLBP in professional activity. Methods: Longitudinal 3 months study of patients with cLBP in one tertiary care hospital, participating in a CFRP over 4 separate days. The primary outcome was the Oswestry Disability Index (ODI). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom state, presenteeism, absenteeism and psychological distress. Outcomes were compared using paired sample Student's t-test or Chi2 between baseline and last follow-up. Logistic regression was used to identify factors associated with better response (improvement of ODI higher than 12.8). Results: In all, 193 patients were analysed, mean age 44.6 (standard deviation (SD) 10.4) years, mean cLBP duration 9.0 (SD 8.8) years. A small improvement was observed for ODI (mean difference-5.9, 95% confidence interval:-7.6,-4.1), as well as most other outcomes. Multivariate analysis showed an association between ODI improvement and higher duration of low back pain (odds ratio for 5 years: 1.41 (1.06,1.88)) and lower baseline back strength (Sorensen, odds ratio for 1 minute: 0.54 (0.29,0.99)). Conclusion: this CFRP showed small effect to improve function, pain and other quality of life, in cLBP. Four-day programs may be an interesting option in cLBP patients still in professional activity for whom a long 1-month FRP is difficultly manageable. Further studies with randomized controlled designs are needed to confirm the benefits.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ., Objectives: To determine factors associated with COVID-19-related death in people with rheumatic diseases. Methods: Physician-reported registry of adults with rheumatic disease and confirmed or presumptive COVID-19 (from 24 March to 1 July 2020). The primary outcome was COVID-19-related death. Age, sex, smoking status, comorbidities, rheumatic disease diagnosis, disease activity and medications were included as covariates in multivariable logistic regression models. Analyses were further stratified according to rheumatic disease category. Results: Of 3729 patients (mean age 57 years, 68% female), 390 (10.5%) died. Independent factors associated with COVID-19-related death were age (66-75 years: OR 3.00, 95% CI 2.13 to 4.22; >75 years: 6.18, 4.47 to 8.53; both vs ≤65 years), male sex (1.46, 1.11 to 1.91), hypertension combined with cardiovascular disease (1.89, 1.31 to 2.73), chronic lung disease (1.68, 1.26 to 2.25) and prednisolone-equivalent dosage >10 mg/day (1.69, 1.18 to 2.41; vs no glucocorticoid intake). Moderate/high disease activity (vs remission/low disease activity) was associated with higher odds of death (1.87, 1.27 to 2.77). Rituximab (4.04, 2.32 to 7.03), sulfasalazine (3.60, 1.66 to 7.78), immunosuppressants (azathioprine, cyclophosphamide, ciclosporin, mycophenolate or tacrolimus: 2.22, 1.43 to 3.46) and not receiving any disease-modifying anti-rheumatic drug (DMARD) (2.11, 1.48 to 3.01) were associated with higher odds of death, compared with methotrexate monotherapy. Other synthetic/biological DMARDs were not associated with COVID-19-related death. Conclusion: Among people with rheumatic disease, COVID-19-related death was associated with known general factors (older age, male sex and specific comorbidities) and disease-specific factors (disease activity and specific medications). The association with moderate/high disease activity highlights the importance of adequate disease control with DMARDs, preferably without increasing glucocorticoid dosages. Caution may be required with rituximab, sulfasalazine and some immunosuppressants.

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.