Abstract
BackgroundRegistries are providing real-life, long-term data relevant to safety, efficacy and long-term outcomes in patients with various rheumatic diseases. The Romanian Registry of Rheumatic Diseases (RRBR) collects efficacy and safety data, for patients with inflammatory rheumatic conditions treated with biologics and targeted synthetic DMARDs in the country. Infections are the most frequently adverse events associated with biologics exposure.ObjectivesTo analyze the distribution, severity class and outcome of infection with SARS-CoV-2 in inflammatory arthritides during the last 2 years of COVID-19 pandemic.MethodsWe collected data for the past 2 years (2020 and 2021) from the RRBR, for the three main inflammatory rheumatic diseases (Rheumatoid Arthritis - RA, Spondyloarthritis - SpA and Psoriatic Arthritis - PsA): treatment exposure (drug class) at the time of COVID-19 diagnosis, severity class (mild, moderate, severe), the disease outcome (recovered, disabled, death). Finally, we compared those data to reported numbers of COVID - 19 infections in the general population, aiming to observe if there is a significant difference between the two groups.ResultsThe study included 9469 patients with inflammatory rheumatic disease, in 298 (3.14%) patients a history of COVID-19 infection was recorded: 160 (53.69%) were diagnosed with RA, 116 (38.92%) with SpA and 22 (7.28%) with PsA. At the moment of COVID-19 infection, 200 patients were receiving anti-TNF inhibitors (67.11%), 27 JAK inhibitors (9.06%), 24 tocilizumab (8.05%), 23 rituximab (7.71%), 9 anti-IL17A monoclonal antibodies (3.02%) and 4 abatacept (1.34%). More than half of the cases were mild - 59.39% (177), whereas moderate forms were noted in 26.17% (78) and severe in 14.09% (42) of the total infected patients. Out of the 42 severe COVID-19 cases, 11 (26.19%) were treated with rituximab, 18 (42.85%) with TNF inhibitors, 7 (16.66%) with JAK inhibitors, 4 (9.52%) with tocilizumab, 1 (2,38%) with secukinumab and 1 (2.38%) with abatacept. Almost all cases recovered: 286 (95.97%) patients, while 12 (4.02%) deaths were recorded. The patients who died were on treatment with rituximab (5), tofacitinib (3), etanercept (2), secukinumab (1) and tocilizumab (1).Data from the National Public Health Institute showed a rate of COVID-19 infection in the general population of 9.36%, out of which 96.7% had a favorable outcome, while 3.26% deaths were reported.ConclusionThis study confirms that patients receiving treatment with rituximab are at risk for a worse COVID-19 outcome. The increased number of severe cases and deaths related to COVID19 in patients receiving TNF inhibitors may be explained by the large use of this therapeutic option. Surprisingly, we noted 4 severe cases and one death related to COVID19, in patients treated with tocilizumab.We observed no significant differences in death rates and the outcomes of COVID-19 in patients with rheumatic diseases treated with biological therapies and the general population. The low rate of SARS-CoV-2 reported infections in the registry, compared to the general population, is most probably due to the commonly found underreporting of adverse events in registries.
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