EVUSHELD EFFICACY AND SAFETY IN AUTOIMMUNE RHEUMATIC DISEASES TREATED BY RITUXIMAB: A PROSPECTIVE OBSERVATIONAL TRIAL

Authors

  • Lisa Kaly Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author
  • Mark Volevich Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author
  • Shiri Keret Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author
  • Aniela Shoval Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author
  • Itzhak Rosner Faculty of Medicine, Technion, Haifa, Israel Author
  • Michael Rozenbaum Faculty of Medicine, Technion, Haifa, Israel Author
  • Nina Boulman Faculty of Medicine, Technion, Haifa, Israel Author
  • Emilia Hardak Pulmonary Unit, Bnai Zion Medical Center Author
  • Gleb Slobodin Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author
  • Doron Rimar Rheumatology Unit, Bnai Zion Medical Center, Haifa, Israel Author

DOI:

https://doi.org/10.61841/jvcavz40

Keywords:

Evusheld, COVID-19 infection, B-cell depletion therapy, autoimmune rheumatic disease

Abstract

Background: B cell depleting therapy (rituximab) results in impaired ability to mount a humoral immune response. Evusheld, tixagevimab 150mg co-packaged with cilgavimab 150mg, is a passive vaccine against SARS-CoV-2.

Objective: Evaluate prospectively the efficacy and safety of Evusheld vaccine for preventing or mitigating SARS-COV2 infection in patients with autoimmune rheumatic diseases (AIRD) treated with rituximab.

Methods: We compared patients treated with rituximab, who agreed to receive Evusheld, to patients who refused. The primary outcome was the risk of severe COVID19 infection from omicron variant.

Results: 45 AIRD patients in the intervention group and 26 in the control group, were recruited. There was no difference between the groups with regard to sex, age, years of rituximab treatment, previous mRNA vaccination and serum immunoglobulins level. No difference in the infection rate was found between intervention group and control group (21 (49%) versus 12 (48%). Four patients had a severe infection, 3 in the control group and 1 in the intervention group. Evusheld reduced the risk for severe infection by 94% (HR 0.06, 95% CI 0.01-0.76, p-value 0.017). No adverse events were reported. 

Conclusions: Evusheld decreased the risk for severe COVID19 infection in patients with AIRD treated with rituximab in a period in which Omicron BA.5, BQ1 and BQ.1.1 variants were prevalent in Israel, with a favorable safety profile.

References

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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.

Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188-2200.

Ocon AJ, Mustafa SS. Real-World Experience of Tixagevimab and Cilgavimab (Evusheld) in Rheumatologic Patients on Rituximab. J Clin Rheumatol. 2023 Mar 1;29(2):109-111.

Marshall, John C., et al. "A minimal common outcome measure set for COVID-19 clinical research." The Lancet Infectious Diseases 20.8 (2020): e192-e197.

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Published

2024-09-18

How to Cite

Kaly , L. ., Volevich, M. ., Keret, S. ., Shoval, A. ., Rosner, I. ., Rozenbaum , M. ., Boulman , N. ., Hardak , E. ., Slobodin , G. ., & Rimar, D. . (2024). EVUSHELD EFFICACY AND SAFETY IN AUTOIMMUNE RHEUMATIC DISEASES TREATED BY RITUXIMAB: A PROSPECTIVE OBSERVATIONAL TRIAL. Journal of Advanced Research in Medical and Health Science (ISSN 2208-2425), 10(9), 1-5. https://doi.org/10.61841/jvcavz40

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