Objective: To compare efficacy of the new drug divozilimab with other second-line treatment options for relapsing remitting multiple sclerosis (RRMS) that have been already included or submitted application to be included into the «14 high-cost nosologies» program in the Russian Federation.

Methods: We conducted systematic literature review (PROSPERO ID CRD42022310082) and frequentist network meta-analysis of 2-years efficacy of divozilimab and other second-line therapies to treat RRMS.

Results: Annualized relapse rate ratio in divozilimab vs fingolimod was 0.4 (95% CI 0.3-0.7), divozilimab vs cladribin 0.5 (95% CI 0.3-0.9), divozilimab vs alemtuzumab 0.7 (95% CI 0.3-1.7), divozilimab vs ocrelizumab 0.7 (95% CI 0.3-1.6), divozilimab vs ofatumumab 0.7 (95% CI 0.4-1.1), divozilimab vs natalizumab 0.4 (95% CI 0.4-1.1) respectively. Divozilimab had the highest SUCRA rank (0.9) while fingolimod had the lowest (0.4).

Conclusions: Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment.