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Objective To describe the clinical efficacy of tixagevimab/cilgavimab in pre-exposure prophylaxis in patients at risk of severe coronavirus disease 2019 (COVID-19) and unresponsive to vaccination (anti-severe acute respiratory syndrome coronavirus 2 antibodies <260 binding antibody units/ml) in rheumatology. Methods In this multicentre observational study we included patients with autoimmune or inflammatory diseases who received pre-exposure prophylaxis with tixagevimab/cilgavimab between December 2021 and August 2022. The endpoint was incidence of COVID-19 and its severity. Results Tixagevimab/cilgavimab was administered to 115 patients with a median age of 62 years [interquartile range (IQR) 52–71], chronic arthritis (n  = 53), connective tissue disease (n  = 38) or vasculitis (n  = 11). The main background immunosuppressants were rituximab (n  = 98), corticosteroids [ n  = 62; median dose 5 mg (95% CI 5–8)] and methotrexate (n  = 48). During a median follow-up of 128 days (IQR 93–173), COVID-19 occurred in 23/115 patients (20%) and the omicron variant was identified for the eight genotyped patients. During the study period, the average weekly incidence was 1071/100 000 inhabitants in Île-de-France vs 588/100 000 in our patients. Patients who received a two-injection regimen had a lower risk of infection than those with a single injection [16/49 (33%) vs 5/64 (8%), P  = 0.0012]. The COVID-19-positive patients did not differ from uninfected patients concerning age, comorbidities, underlying rheumatic disease and immunosuppressants. All COVID-19 cases were non-severe. The tolerance of injections was excellent. Conclusion In a population with autoimmune or inflammatory diseases at risk of severe COVID-19 unresponsive to vaccination, pre-exposure prophylaxis withy tixagevimab/cilgavimab was associated with a lower incidence of COVID-19 and no severe infections. [ABSTRACT FROM AUTHOR]