Real-World Efficacy of COVID-19 Pre-Exposure Prophylaxis with Tixagevimab/Cilgavimab in People with Multiple Sclerosis

• Published in: Vaccines (Basel) Vol. 11; no. 12; p. 1855
• Main Authors: Elias, Luke B, Jaber, Aliya, Manzano, Margarita, Leekoff, Mark, Sylvester, Andrew, Tremblay, Matthew A
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.12.2023; MDPI
• Subjects: Antibodies; Brand names; Brief Report; cilgavimab; Consent; COVID-19; COVID-19 vaccines; Disease prevention; Dosage and administration; Drug therapy; Drug therapy, Combination; Effectiveness; Infections; Monoclonal antibodies; Morbidity; Multiple sclerosis; Omicron; Patient outcomes; Prophylaxis; Reduction; Regression analysis; Severe acute respiratory syndrome coronavirus 2; tixagevimab; Viral diseases; United States; United States > US; COVID-19; Omicron; cilgavimab; multiple sclerosis; tixagevimab
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines11121855

Vaccines against the SARS-CoV-2 virus were authorized for use by the Food and Drug Administration (FDA) in the United States and have proven effective for the prevention of morbidity and death from COVID-19. Certain immunosuppressant medications prevent the development of protective immunity following COVID-19 vaccination. In December 2021, the FDA issued an emergency use authorization (EUA) for a monoclonal-antibody combination of tixagevimab and cilgavimab, under the brand name Evusheld, for pre-exposure prophylaxis (PrEP) against COVID-19 for individuals with moderate-to-severe immune compromise. While a 77% reduction in symptomatic COVID-19 was observed in the PROVENT study, the trial was conducted prior to emergence of the B.1.1.529 Omicron variant. We suspected reduced efficacy of PrEP against Omicron subvariants. We conducted a retrospective cohort study comparing the prevalence of symptomatic COVID-19 infections between 1 January 2022 and 1 July 2022 in eligible patients treated with PrEP versus untreated using a questionnaire administered with the REDCap survey tool. Responses from 235 participants were included in the final analysis, with 176 untreated respondents and 59 in the PrEP cohort. Symptomatic COVID-19 infections were reported in 50 (28.4%) untreated participants and only 9 (15.3%) of those who received PrEP ( = 0.0557; OR 0.4536; 95% CI 0.2046 to 0.9599). Only two participants were hospitalized for COVID-19 infection, both in the untreated cohort. The reduction in COVID-19 infections did not achieve statistical significance, indicating diminished efficacy against Omicron variants.