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

Abstract

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.