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Background: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis., Methods: This proof-of-concept, randomised, double-blind, placebo-controlled, phase 2, Bayesian (NAMASTE) trial was done at nine hospitals in the UK. Participants aged 18-75 years with axial spondyloarthritis, meeting the Assessment in SpondyloArthritis international Society (ASAS) criteria and the ASAS-defined MRI criteria, with active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), were eligible. Those who had inadequately responded or had intolerance to previous treatment with an anti-TNF agent were included. Participants were randomly assigned (6:1) to receive subcutaneous namilumab 150 mg or placebo at weeks 0, 2, 6, and 10. Participants, site staff (except pharmacy staff), and central study staff were masked to treatment assignment. The primary endpoint was the proportion of participants who had an ASAS ≥20% improvement (ASAS20) clinical response at week 12 in the full analysis set (all randomly assigned participants). This trial is registered with ClinicalTrials.gov (NCT03622658)., Findings: From Sept 6, 2018, to July 25, 2019, 60 patients with moderate-to-severe active axial spondyloarthritis were assessed for eligibility and 42 were randomly assigned to receive namilumab (n=36) or placebo (n=six). The mean age of participants was 39·5 years (SD 13·3), 17 were women, 25 were men, 39 were White, and seven had previously received anti-TNF therapy. The primary endpoint was not met. At week 12, the proportion of patients who had an ASAS20 clinical response was lower in the namilumab group (14 of 36) than in the placebo group (three of six; estimated between-group difference 6·8%). The Bayesian posterior probability η was 0·72 (>0·927 suggests high clinical significance). The rates of any treatment-emergent adverse events in the namilumab group were similar to those in the placebo group (31 vs five)., Interpretation: Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated., Funding: Izana Bioscience, NIHR Oxford Biomedical Research Centre (BRC), NIHR Birmingham BRC, and Clinical Research Facility., Competing Interests: Declaration of interests CW received funding from the Arthritis Therapy Acceleration Program (grant KENN161704) and Izana Bioscience. MHA-M holds stocks in GSK, UCB, and AstraZeneca; is an employee of AstraZeneca; and was an employee of UCB. BAF has received research funding from Janssen, Galapagos, and Celgene; and consultation fees from Novartis, Galapagos, Servier, Janssen, Roche, Sanofi, Bristol Myers Squibb, and UCB. AC has received payment or honoraria from Novartis, UCB, Amgen, AbbVie, and Janssen; and support for attending meetings or travel (or both) from Eli Lilly, UCB, and Novartis. RS has received research funding from Celgene and Novartis; payment or honoraria from AbbVie, Biogen, Eli Lilly, MSD, Novartis, Roche, and UCB; support for attending meetings or travel (or both) from AbbVie, Novartis, Eli Lilly, and UCB; participated on a data safety monitoring board or advisory board for AbbVie, Novartis, Eli Lilly, and UCB; is part of a chairmanship of trustees for the British Society for Spondyloarthritis and a trustee of the Bath Institute for Rheumatic Diseases. JP is a member of the executive committee of the British Society for Spondyloarthritis. KG has received research funding from Biogen, AbbVie, Pfizer, Novartis, Eli Lilly, Celltrion, Janssen, and Gilead; consulting fees from AbbVie, Novartis, UCB, and Eli Lilly; honoraria from AbbVie, Novartis, UCB, and Eli Lilly; and support for attending meetings or travel (or both) from Novartis, UCB, and Eli Lilly. NG has received research funding from Izana Bioscience, AbbVie, AstraZeneca, Eli Lilly, and Novartis; consulting fees from AbbVie, Novartis, and UCB; and payment or honoraria from AbbVie, Eli Lilly, Janssen, Novartis, and UCB; support for attending meetings or travel (or both) from AbbVie, Eli Lilly, UCB, and Novartis; receipt of equipment, materials, drugs, medical writing gifts, or other services from Eli Lilly and Novartis. THC was a chief medical officer at Izana Bioscience, received salary and stock options from Izana Bioscience, and participated in data safety monitoring board meetings. PMM has received consulting or speakers fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, and UCB; and is supported by the National Institute for Health Research (NIHR), University College London Hospitals, and Biomedical Research Centre (BRC). PCT has received research funding from Galapagos and Izana Bioscience; consulting fees from AbbVie, Biogen, Galapagos, Gilead, GSK, Janssen, Eli Lilly, Pfizer, Sanofi, Nordic Pharma, Fresenius, UCB, and Izana Bioscience; payment or honoraria from AbbVie; support for attending meetings or travel (or both) from Eli Lilly; and participated on data safety monitoring boards for Kymab and Immunovant. PB has received research funding from Regeneron, BenevolentAI, GSK, and Novartis. JM, JAC, and JT declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Idiopathic inflammatory myopathies are a group of autoimmune diseases with a broad spectrum of clinical presentations, primarily characterised by immune-mediated muscle injury. Until recently, there was little insight into the pathogenesis of idiopathic inflammatory myopathies, which challenged the recognition of the breadth of heterogeneity of this group of diseases as well as the development of new therapeutics. However, the landscape of idiopathic inflammatory myopathies is evolving. In the past decade, advances in diagnostic tools have facilitated an enhanced understanding of the underlying disease mechanisms in idiopathic inflammatory myopathies, enabling the expansion of therapeutic trials. The fields of transcriptomics, prot§eomics, and machine learning offer the potential to gain greater insights into the underlying pathophysiology of idiopathic inflammatory myopathies. Harnessing insights gained from these sophisticated tools could contribute to the identification of differences at a molecular level among patients, accelerating the development of targeted, tailored therapies. Bolstered by the validation and standardisation of robust outcome measures, many promising therapies are in clinical trial development. Although challenges remain, there is great optimism in the field due to the progress in innovative diagnostics, outcome measures, and therapeutic approaches. In this Review, we discuss the expanding landscape of idiopathic inflammatory myopathies as the frontier of precision medicine becomes imminent., Competing Interests: Declaration of interests MF has received consulting or speaker fees from Sanofi, AbbVie, Eli Lilly, Taiho Pharmaceutical, Maruho, Janssen, Novartis, Sun Pharma, UCB, and Japan Blood Products Organization. PMM has received consulting or speaker fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, and UCB. JJP has received consulting fees from Alexion, Roivant, argenx, EMD Serono, Pfizer, Kezar Life Sciences, and Guidepoint; and clinical trial research support from Alexion, Pfizer, and Kezar Life Sciences. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Differences in the distribution of individual-level clinical risk factors across regions do not fully explain the observed global disparities in COVID-19 outcomes. We aimed to investigate the associations between environmental and societal factors and country-level variations in mortality attributed to COVID-19 among people with rheumatic disease globally., Methods: In this observational study, we derived individual-level data on adults (aged 18-99 years) with rheumatic disease and a confirmed status of their highest COVID-19 severity level from the COVID-19 Global Rheumatology Alliance (GRA) registry, collected between March 12, 2020, and Aug 27, 2021. Environmental and societal factors were obtained from publicly available sources. The primary endpoint was mortality attributed to COVID-19. We used a multivariable logistic regression to evaluate independent associations between environmental and societal factors and death, after controlling for individual-level risk factors. We used a series of nested mixed-effects models to establish whether environmental and societal factors sufficiently explained country-level variations in death., Findings: 14 044 patients from 23 countries were included in the analyses. 10 178 (72·5%) individuals were female and 3866 (27·5%) were male, with a mean age of 54·4 years (SD 15·6). Air pollution (odds ratio 1·10 per 10 μg/m 3 [95% CI 1·01-1·17]; p=0·0105), proportion of the population aged 65 years or older (1·19 per 1% increase [1·10-1·30]; p<0·0001), and population mobility (1·03 per 1% increase in number of visits to grocery and pharmacy stores [1·02-1·05]; p<0·0001 and 1·02 per 1% increase in number of visits to workplaces [1·00-1·03]; p=0·032) were independently associated with higher odds of mortality. Number of hospital beds (0·94 per 1-unit increase per 1000 people [0·88-1·00]; p=0·046), human development index (0·65 per 0·1-unit increase [0·44-0·96]; p=0·032), government response stringency (0·83 per 10-unit increase in containment index [0·74-0·93]; p=0·0018), as well as follow-up time (0·78 per month [0·69-0·88]; p<0·0001) were independently associated with lower odds of mortality. These factors sufficiently explained country-level variations in death attributable to COVID-19 (intraclass correlation coefficient 1·2% [0·1-9·5]; p=0·14)., Interpretation: Our findings highlight the importance of environmental and societal factors as potential explanations of the observed regional disparities in COVID-19 outcomes among people with rheumatic disease and lay foundation for a new research agenda to address these disparities., Funding: American College of Rheumatology and European Alliance of Associations for Rheumatology., Competing Interests: MID reports research support from Pfizer for unrelated work. AS reports grants from a consortium of 13 companies (AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Lilly, Mylan, Hexal, Merck, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB) supporting the German RABBIT register, and personal fees from lectures for AbbVie, Merck, Roche, Bristol Myers Squibb, and Pfizer, outside of the submitted work. EFM reports that the Portuguese League Against Rheumatic Diseases received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal SA, Merck, Celgene, Medac, Pharmakern, the Global Alliance for Patient Access; grants and non-financial support from Pfizer; and non-financial support from Grünenthal GmbH, outside of the submitted work. KLH reports receiving speaker fees from Abbvie and grant income from Bristol Myers Squibb, UCB, and Pfizer, unrelated to this work. KLH is also supported by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre. LG reports research grants from Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, and Sanofi; and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB, all unrelated to this work. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, SA Pharma, Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi, Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH, and UCB Pharma. JAS has performed consultancy for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Inova Diagnostics, Janssen, and Optum, unrelated to this work. LW has received consulting or speaking fees from Aurinia Pharma, outside of the submitted work. MFU-G reports grant or research support from Jannsen and Pfizer, unrelated to this work. The Swedish Rheumatology Quality Register, with LL as register holder, has agreements with Abbvie, Amgen, Eli Lilly, Gilead, Novartis, Pfizer, Sanofi, Sobi, and UCB for register data analyses, unrelated to this work. CR has received consulting or speaker fees from Abbvie, Amgen, AstraZeneca, BMS, Biogen, Eli Lilly, Glenmark, GlaxoSmithKline, Merck, Mylan, and Pfizer; and grants from Biogen, Lilly, and Nordic Pharma, all unrelated to this work. MJS has received speaker fees from Abbvie, AstraZeneca, Novartis, and Pfizer. AR has received speaker fees from Janssen, Pfizer, and Novartis. GP-E reports reports personal consulting fees, speaking fees, or both from Pfizer, GlaxoSmithKline, Janssen, Sandoz, and Sanofi, outside of the submitted work. PCR reports personal consulting fees, speaking fees, or both from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and travel assistance from Roche. PMM has received consulting fees, speaker fees, or both from Abbvie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, and UCB, unrelated to this work. PMM is supported by the NIHR University College London Hospitals Biomedical Research Centre. ES is a Board Member of the Canadian Arthritis Patient Alliance, a patient-run, volunteer-based organisation whose activities are largely supported by independent grants from pharmaceutical companies. JWL has received research funding from Pfizer, outside of the submitted work. JSH is supported by grants from the Rheumatology Research Foundation and has salary support from the Childhood Arthritis and Rheumatology Research Alliance. JSH has performed consulting for Novartis, Sobi, and Biogen, unrelated to this work. PS reports honorarium for doing social media for American College of Rheumatology journals. RG reports personal fees, speaking fees, or both from Abbvie, Janssen, Novartis, Pfizer, and Cornerstones; and travel assistance from Pfizer. SB reports non-branded consulting fees for AbbVie, Horizon, and Novartis; and is employed by Pfizer. ZSW reports grant support from Bristol Myers Squibb and Principia–Sanofi; and performed consultancy for Viela Bio and MedPace, outside of the submitted work. ZSW's work is supported by grants from the National Institutes of Health. JY has performed consulting for Eli Lilly, Pfizer, Aurinia, and AstraZeneca, outside of the submitted work. All other authors declare no competing interests., (Published by Elsevier Ltd.)

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, Behçet'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 Behçet'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., Competing Interests: SES reports funding from a Vasculitis Clinical Research Consortium (VCRC)–Vasculitis Foundation Fellowship (the VCRC is part of the Rare Diseases Clinical Research Network, an initiative of the Office of Rare Diseases Research, National Center for Advancing Translational Science [NCATS], and is funded by a collaboration between NCATS and the National Institute of Arthritis and Musculoskeletal and Skin Diseases [NIAMS; U54 AR057319]). RC reports speaker's fees from Janssen, Roche, Sanofi, and Abbvie outside the submitted work. CH received funding under a sponsored research agreement from Vifor Pharmaceuticals, outside the submitted work. SLM has received consulting fees from AbbVie; consulting fees from AstraZeneca; other from Roche-Chugai; consulting fees from Sanofi; and non-financial support from Roche, all outside the submitted work; and is a patron of the patient charity PMRGCAuk. PM is a Medical Research Council-GlaxoSmithKline (MRC-GSK) EMINENT clinical training fellow, who has received project funding from this organisation, outside the submitted work; has received funding from the National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre (UCLH BRC); reports grants from MRC-GSK; reports personal fees from Swedish Orphan Biovitrum and Lilly; and reports consultancy fees from Abbvie and Pfizer, all outside the submitted work. LN reports being a trustee of the charity PMR-GRA Scotland. JSA reports grants from the National Institute of Health (NIH) and NIAMS, the Rheumatology Research Foundation, the Brigham Research Institute, the R Bruce and Joan M Mickey Research Scholar Fund, and Amgen; grants and personal fees from Bristol-Myers Squibb; and personal fees from Gilead, Inova, Janssen, Optum, and Pfizer, all outside the submitted work. AD-G is supported by the US Centers for Disease Control and Prevention, the Rheumatology Research Foundation Scientist Development Award, the Robert D and Patricia E Kern Center for the Science of Health Care Delivery, and the Women's Health Career Enhancement Award outside the submitted work. KLH reports receiving speaker's fees from Abbvie; grant income from Bristol-Myers Squibb, UCB Pharma, and Pfizer, all outside the submitted work; and is supported by the NIHR Manchester Biomedical Research Centre outside the submitted work. RG reports non-financial support from Pfizer Australia and Janssen Australia; and personal fees from Pfizer Australia, Cornerstones, Janssen New Zealand, and Novartis, all outside the submitted work. UM-L is supported by grants from the German Ministry of Research and Education and the German Research Foundation outside the submitted work. MAG reports funding from the NIH and the NIAMS. PCR reports personal fees from Abbvie and Gilead; grants and personal fees from Janssen, Novartis, UCB Pharma, and Pfizer; non-financial support from Bristol-Myers Squibb and Pfizer; and personal fees from Lilly and Roche, all outside the submitted work. JY reports no competing interests related to this work; is supported by grants from NIH (K24 AR074534 and P30 AR070155); and reports consulting fees from Eli Lilly, Pfizer, Aurinia, and AstraZeneca, all outside the submitted work. PMM has received consulting or speaker's fees from Abbvie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB Pharma, all outside the submitted work (all <$10 000); and is supported by the NIHR UCLH BRC outside the submitted work. ES is a board member of the Canadian Arthritis Patient Alliance, which is a patient-run, volunteer-based organisation, whose activities are largely supported by independent grants from pharmaceutical companies. JWL reports grants from Pfizer, outside the submitted work. JSH reports no competing interests related to this work; is supported by grants from the Rheumatology Research Foundation; receives salary support from the Childhood Arthritis and Rheumatology Research Alliance; and reports consulting fees for Novartis, Swedish Orphan Biovitrum, and Biogen, all outside the submitted work (<$10 000). PS reports no competing interests related to this work, but reports receiving honorarium for editing social media for the American College of Rheumatology journals (<$10 000). SBh reports receiving non-branded consulting fees from AbbVie, Amgen, Horizon, Novartis, and Pfizer (<$10 000 from each)outside the submitted work. ZSW reports receiving grant support from Bristol-Myers Squibb and Principia-Sanofi; has consulted for Viela Bio and MedPace; and is supported by grants from the National Institutes of Health, all outside the submitted work. AS reports personal fees for lectures from AbbVie, Celltrion, Lilly, Merck Sharp & Dohme, Roche, Bristol-Myers Squibb, and Pfizer outside the submitted work. EFM has received grants from Abbvie, Novartis, Lilly Portugal, Amgen Biofarmacêutica, Grünenthal SA, Merck Sharp & Dohme, Medac, and A Menarini Portugal-Farmacêutica SA; grants and non-financial support from Pfizer; and non-financial support from Grünenthal, all outside the submitted work. LG reports research grants from Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, and Sanofi; consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB Pharma, all outside the submitted work. LC declares no competing interests related to this study, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España SA, Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal, and UCB Pharma. NJP reports grants from NIH during the conduct of the study. MU-G reports grants from Pfizer and Janssen, outside the submitted work. SBa reports grants and personal fees from Alexion Pharma, outside the submitted work. RV reports grants from Novartis, Pfizer, and Bristol-Myers Squibb, outside the submitted work. All other authors declare no competing interests., (© 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., Funding: Pfizer, Sanofi, Amgen, Galapagos, and Lilly., Competing Interests: DS has received grant or research support from Amgen, Galapagos, Sanofi, Janssen, Lilly, Pfizer, Roche Chugai, Mylan, GlaxoSmithKline, and Hifibio, and consulting fees from AbbVie, Amgen, Janssen, Celgene, Sanofi, and UCB outside the submitted work. ES has received research support from AbbVie outside the submitted work. LG has received grant or research support from Amgen, Lilly, Janssen, Pfizer, Sandoz, Sanofi, and Galapagos, and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Biogen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB outside the submitted work. PMM has received consulting or speaker's fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB outside the submitted work, and is supported by the UK National Institute for Health Research and University College London Hospitals Biomedical Research Centre. XB has received grant or research support from AbbVie and Novartis, and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Celltrion, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB outside the submitted work. JMAG is partially supported by the Instituto de Salud Carlos III. All other authors declare no competing interests., (© 2021 Elsevier Ltd. All rights reserved.)