Tixagevimab/cilgavimab (Evusheld) for pre-exposure prophylaxis of COVID-19 in patients with ANCA-associated vasculitis: a prospective study

Litvinova M.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University

Bulanov N.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Novikov P.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Filatova E.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Skvortsov A.: Moscow State University, Moscow

Klimkina I.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

Moiseev S.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

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Summary

Aim

To evaluate the efficacy of tixagevimab/cilgavimab (Evusheld) for pre-exposure prophylaxis of COVID-19 in patients with ANCA-associated vasculitis in a prospective study.

Material and methods

In a prospective observational study that was conducted from May 1, 2022 to March 31, 2023, we recruited adult (≥18 years old) patients with ANCAassociated vasculitis, that is, granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis. All patients who received tixagevimab/cilgavimab were followed for at least 6 months after its administration (monthly visits or phone contacts). The primary endpoint was defined as the occurrence of clinically evident COVID-19 confirmed by PCR or antigen test over 6-month follow-up, whereas the secondary endpoint was severe COVID19 (hospitalization, transfer to the intensive care unit, intubation and/or death).

Results

94 patients with ANCA-associated vasculitis were enrolled in the study. 88 (94%) of them were treated with immunosuppressive agents, including rituximab in 27 patients. Passive immunization with tixagevimab/cilgavimab was performed in 32 out of 94 patients. At 6 month after the first infusion, tixagevimab/cilgavimab was re-administered in 5 patients. The occurrence of COVID-19 in the study group was about two-fold lower (2/37; 5.4%) than in the control group of patients who did not underwent pre-exposure prophylaxis (7/62; 11.3%). However, the reduction in the risk of the primary endpoint did not reach statistical significance (odds ratio 0.429; 95% confidence interval 0.084-2.188). Among patients who were treated rituximab, administration of tixagevimab/cilgavimab was associated with a trend to a lower occurrence of COVID-19 compared to control (2/16;12.5% vs. 2/9; 22.2%; р=0,6). Adverse events after administration of monoclonal antibodies were registered in 2 (5.4%) of 37 cases. Both of them were mild and did not require medical intervention.

Conclusion

The results of the study showed the favorable safety profile and potential efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis of COVID-19 in patients with ANCA-associated vasculitis.

Key words

ANCA-associated vasculitis, tixagevimab/cilgavimab, Evusheld, COVID-19.