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

Xintong Xu; Lindan Xie; Lili Wei; Meixuan Li; Hao Wang; Huanfen Zhou; Mingming Sun; Mo Yang; Quangang Xu; Kehu Yang; Shihui Wei

doi:10.1016/j.aopr.2022.100064

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

Adv Ophthalmol Pract Res. 2022 May 18;2(3):100064. doi: 10.1016/j.aopr.2022.100064. eCollection 2022 Nov-Dec.

Authors

Xintong Xu^{1

2}, Lindan Xie², Lili Wei^{3

4

5}, Meixuan Li^{3

4

5}, Hao Wang⁶, Huanfen Zhou², Mingming Sun², Mo Yang², Quangang Xu², Kehu Yang^{3

4

5}, Shihui Wei²

Affiliations

¹ Medical School of Chinese PLA, Beijing, China.
² Department of Ophthalmology, Chinese PLA General Hospital, Beijing, China.
³ Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China.
⁴ Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, China.
⁵ Gansu Medical Guideline Technology Center, Lanzhou University, Lanzhou, China.
⁶ Department of Ophthalmology, Lanzhou University Second Hospital, Lanzhou, China.

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.

Keywords: Adverse events; Free-relapse; Meta-analysis; Monoclonal antibody; NMOSD; Randomized controlled trials.

Publication types

Review