Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 May 15;16(9):1465-1468.
doi: 10.1093/ckj/sfad111. eCollection 2023 Sep.

Safety and efficacy of pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in patients with glomerular diseases who received rituximab

Savino Sciascia  1 , Maria Letizia Antonietta Rilat  1 , Roberta Fenoglio  1 , Silvia Grazietta Foddai  1 , Massimo Radin  1 , Irene Cecchi  1 , Giacoma Cinnirella  2 , Paola Crosasso  2 , Maria Gabriella Guidetti  1 , Alice Barinotti  1 , Simone Baldovino  1 , Elisa Menegatti  1 , Dario Roccatello  1
Affiliations

Safety and efficacy of pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in patients with glomerular diseases who received rituximab

Savino Sciascia et al. Clin Kidney J. .

Abstract

Background: Patients on B-cell-depleting agents may have a suboptimal response to vaccination, placing them at a higher risk of contracting severe acute respiratory syndrome coronavirus 2 (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 (GDs) who received rituximab are limited.

Methods: We conducted a prospective study analysing the safety and efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis in patients with GDs who received rituximab in the previous 12 months. The rates of symptomatic infections and hospitalizations were compared with those for 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, anti-neutrophil cytoplasmic antibody-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 of follow-up was 112 ± 23 days), while 11 of 28 controls (39.3%) reported a symptomatic infection (P = .0001), 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 events (e.g. cardiac events, anaphylaxis) were reported.

Conclusion: Pre-exposure prophylaxis with tixagevimab/cilgavimab seems safe and lowered the risk of symptomatic SARS-CoV-2 infection by ≈40% 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.

Keywords: Evusheld; glomerular diseases; glomerulonephritis; monoclonal antibodies; rituximab; tixagevimab/cilgavimab.

PubMed Disclaimer

Conflict of interest statement

This manuscript is not under consideration elsewhere. The authors declare no conflicts of interest, no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1:
Figure 1:
(A) Schematic representation of the mechanism of action of tixagevimab and cilgavimab. (B) Study design.
See this image and copyright information in PMC

References

    1. Smith JB, Gonzales EG, Li BHet al. . Analysis of rituximab use, time between rituximab and SARS-CoV-2 vaccination, and COVID-19 hospitalization or death in patients with multiple sclerosis. JAMA Netw Open 2022;5:e2248664. 10.1001/jamanetworkopen.2022.48664 - DOI - PMC - PubMed
    1. Schultz K, Jannat-Khah D, Spiera R. B cell reconstitution is associated with COVID-19 booster vaccine responsiveness in patients previously seronegative treated with rituximab. J Rheumatol 2023;50:420–5. 10.3899/jrheum.220475 - DOI - PMC - PubMed
    1. Singh N, Madhira V, Hu Cet al. . Rituximab is associated with worse COVID-19 outcomes in patients with rheumatoid arthritis: a retrospective, nationally sampled cohort study from the U.S. National COVID Cohort Collaborative (N3C). Semin Arthritis Rheum. 2023;58:152149. - PMC - PubMed
    1. Magliulo D, Wade SD, Kyttaris VC. Immunogenicity of SARS-CoV-2 vaccination in rituximab-treated patients: effect of timing and immunologic parameters. Clin Immunol 2022;234:108897. 10.1016/j.clim.2021.108897 - DOI - PMC - PubMed
    1. Tolf A, Wiberg A, Muller Met al. . Factors associated with serological response to SARS-CoV-2 vaccination in patients with multiple sclerosis treated with rituximab. JAMA Netw Open 2022;5:e2211497. 10.1001/jamanetworkopen.2022.11497 - DOI - PMC - PubMed