Efficacy and safety of monoclonal antibodies in neuromyelitis optica spectrum disorders: A survival meta-analysis of randomized controlled trials

BACKGROUND: Monoclonal antibodies such as rituximab (RTX), eculizumab, inebilizumab, satralizumab, and tocilizumab have been found to be effective therapies for neuromyelitis optica spectrum disease ​(NMOSD) in several clinical randomized controlled trials. OBJECTIVE: The purpose of this meta-analysis of randomized controlled trials was to assess the efficacy and safety of monoclonal antibodies in the treatment of NMOSD. METHODS: We searched the following databases for relevant English language literature from the establishment of the database to June 2021: PubMed, Embase, Cohorane Library, the Central Register of Controlled Trials (CENTRAL), and Web of Science. Randomized controlled trials of monoclonal antibodies were the targets of the review. RESULTS: We included seven trials containing 775 patients (485 in the monoclonal antibody group and 290 in the control group). Patients in the monoclonal group (HR 0.24, 95% CI: 0.14 to 0.40, P ​< ​0.00001), as well as patients with seropositive AQP4-IgG (HR 0.18, 95% CI: 0.11 to 0.29, P ​< ​0.00001), both had a higher free recurrence rate than that in the control group. In the first year (HR 0.25, 95% CI: 0.09 to 0.71, P ​= ​0.009) and the second year (HR 0.32, 95% CI: 0.13 to 0.81, P ​= ​0.02), no relapses were documented. The average changes of the expanded disability status scale (EDSS) score decreased by 0.29 (95% CI: −0.09 to 0.51, P ​= ​0.005). Upper respiratory tract infection (OR 1.52, 95% CI: 0.76 to 3.04, P ​= ​0.24), urinary tract infection(OR 0.79, 95% CI: 0.51 to 1.21, P ​= ​0.27), and headache (OR 1.30, 95% CI: 0.78 to 2.17, P ​= ​0.31) were three most frequent adverse reactions. CONCLUSIONS: Monoclonal antibodies are particularly effective treatments in avoiding recurrence for NMOSD patients, according to this meta-analysis. The associated adverse responses are not significantly different from those seen with traditional immunosuppressants.