0219: Safety and Efficacy of Pre-Exposure Prophylaxis with Tixagevimab/Cilgavimab (Evusheld) in Patients with Autoimmune Diseases and Renal Involvement Who Received Rituximab
Savino Sciascia1, MARIA LETIZIA RILAT2, ROBERTA FENOGLIO2, SILVIA GRAZIETTA FODDAI3, MASSIMO RADIN3, IRENE CECCHI3, giacoma cinnirella2, paola crosasso2, maria gabriella guidetti2, ALICE BARINOTTI3, simone baldovino2, ELISA MENEGATTI4 and Dario Roccatello5, 1University of Turin, Torino, Italy, 2University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-net, ERN-Reconnect and RITA-ERN Member) with Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, Turin, Italy, 3University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERN-Reconnect and RITA-ERN Member) with Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy, 4School of Specialization of Clinical Pathology, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy, 5University of Torino, Torino, Italy
Background/Purpose: Patients on B-cell depleting agents may have a suboptimal response to vaccination, placing them at a higher risk of contracting SARS-CoV-2 or suffering from a more severe prognosis. Indeed, available data on pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in subjects with glomerular diseases (GD) who received rituximab is limited.
Methods: We conducted a prospective study analyzing the safety and efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis in patients with GD who received rituximab in the previous 12 months. Rate of symptomatic infections and hospitalizations were compared to patients with GD treated with rituximab who refused to receive tixagevimab/cilgavimab.
Results: Tixagevimab/cilgavimab was administered to 22 patients (12 females, mean age 58,4±19,6 years) with GD diagnoses including membranous nephropathy, lupus nephritis, ANCA-associated vasculitis and focal segmental glomerulosclerosis. No patient treated with tixagevimab/cilgavimab experienced symptomatic infection with SARS-CoV-2 during the follow-up (mean observation time follow-up was 112 ± 23 days), while 11 out 28 controls (39,3%) reported a symptomatic infection (p=0,001), requiring hospitalization in 2 cases. Reported adverse events were mild, namely self-limiting headache (4), discomfort at the injection site (3), flu-like symptoms/myalgia (3), and fever (1). No serious adverse event, (e.g., cardiac events, anaphylaxis) was reported.
Conclusion: Pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) seems safe and lowering of about 40% the risk of symptomatic SARS-CoV-2 infection in vaccinated subjects with GD who received anti-CD20 therapy. Possible applications in the subset of patients who need immunosuppressive therapy, especially with Rituximab, in a pandemic setting might be envisaged.
S. Sciascia: None; M. RILAT: None; R. FENOGLIO: None; S. FODDAI: None; M. RADIN: None; I. CECCHI: None; g. cinnirella: None; p. crosasso: None; m. guidetti: None; A. BARINOTTI: None; s. baldovino: None; E. MENEGATTI: None; D. Roccatello: None.
