Effect of multiple sclerosis disease-modifying therapies on the real-world effectiveness of two doses of BBIBP-CorV (Sinopharm) vaccine

Abstract

BACKGROUND: Immunogenicity data shows blunted responses to COVID-19 vaccination among people with MS (pwMS) on certain disease-modifying therapies (DMTs). Still, it is uncertain how this data translates into the clinic. OBJECTIVE: To assess the effect of DMTs and other factors on the effectiveness of inactivated vaccination in pwMS. METHODS: This cohort study was conducted in a period in which Iran experienced two COVID-19 peaks caused by the Delta variant. We used multivariable cox regression to compare COVID-19-free survivals, and an ordinal logistic model to compare COVID-19 severity between vaccinated pwMS on different DMTs. RESULTS: A total of 617 pwMS were included in the final analysis, with a mean SD follow-up of 25.59 weeks 5.48 after their second dose. Laboratory/imaging-confirmed breakthrough COVID-19 occurred in 15/277 (5.41%) of injectable-treated (reference), 10/61 (16.39%) of fingolimod-treated (adjusted hazard ratio (aHR) 95% confidence interval (CI): 2.80 1.24, 6.29; P = 0.01), 9/128 (7.03%) of other oral-treated (aHR 95%CI: 1.16 0.50, 2.68; P = 0.73), 19/145 (13.10%) of anti-CD20-treated (aHR 95%CI: 2.11 1.05, 4.22; P = 0.04), and 6/56 (10.71%) of non-treated pwMS (aHR 95%CI: 1.52 0.57, 4.04; P = 0.40). Age (adjusted Odds Ratio aOR 95%CI: 1.05 1.00, 1.10, P = 0.05) number of comorbidities (aOR 95%CI: 2.05 1.06, 3.96, P = 0.03), fingolimod therapy (aOR 95%CI: 10.39 2.47, 43.62, P < 0.01), and anti-CD20 therapy (aOR 95%CI: 4.44 1.49, 13.23, P < 0.01) were independently associated with a more severe COVID-19 course. CONCLUSION: The observed results stress the importance of developing personalized vaccination schedules and reservation of COVID-19 treatment resources for older pwMS with comorbidities receiving fingolimod or anti-CD20 therapies.