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Abstract
To study the safety and efficacy of tixagevimab-cilgavimab (TIX-CIL) in reducing COVID-19 in patients with rheumatic diseases receiving rituximab. Patients with rheumatic diseases who were receiving rituximab for ≥12 months were invited for an injection of TIX-CIL (300 mg/300 mg) between November and December 2022. The occurrence of SARS-CoV2 infection in the subsequent 6 months was compared between those who did or did not receive TIX-CIL, adjusting for demographic characteristics, previous SAR2-CoV2 infection, COVID-19 vaccination and other factors by multivariate analyses. A total of 330 patients were studied: 142 received TIX-CIL (age 55.8 ±14.7 years, 80% women) and 188 refused TIX-CIL (age 54.3 ±14.3 years; 84% women). There were fewer SLE patients in the TIX-CIL group (27% vs. 39%; p=0.02) and patients in this group had received a significantly greater number of COVID-19 vaccine doses (2.9 ±0.9 vs. 2.6±1.2; p=0.02). At month 3 post-injection, significantly fewer patients who received TIX-CIL developed COVID-19 (7.7% vs. 19.1%; p=0.003). However, the incidence of COVID-19 at month 6 was not significantly lower in the TIX-CIL group (23.2% vs. 27.2%; p=0.42). Severe COVID-19 developed in 11(3.3%) patients by month 6 and there was no difference between the two groups. Logistic regression revealed that TIX-CIL injection (OR 0.35[0.17-0.73]), female sex (OR 0.40[0.18-0.87]) and previous COVID-19 (OR 0.26[0.12-0.59]) were independent factors protective against COVID-19 at month 3. Adverse events to TIX-CIL were exclusively mild and self-limiting, with musculoskeletal pain, headache and dizziness being the most common. TIX-CIL was well tolerated and effective in reducing the incidence of COVID-19 in the subsequent 3 months.
Published Version
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