Efficacy and safety of monoclonal antibodies in the treatment of relapsing remitting multiple sclerosis: a systematic review

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Superior efficacy for monoclonal antibodies

• Primary Outcome: Annual relapse rate reduction with monoclonal antibodies versus conventional treatments

• Nnt Or Sensitivity: Not calculated

• Confidence Interval: Not reported

Clinical Application

Requires specialised monitoring due to significant adverse effects including infections and autoimmune reactions Relevant to Australian neurologists; several monoclonal antibodies listed on PBS for RRMS with specific criteria and monitoring requirements Adult patients with RRMS, particularly those with highly active disease

Abstract

INTRODUCTION: In relapsing-remitting multiple sclerosis (RRMS), conventional immunomodulatory and immunosuppressive therapies are widely used. However, in many cases, optimal control of inflammatory activity and disease progression is not achieved, which has led to the use of biological drugs such as monoclonal antibodies that act specifically on key components of the immune system. The aim was to evaluate the efficacy and safety of monoclonal antibodies compared to other drugs or placebo in adult patients with RRMS. METHODS: A systematic review was performed based on randomized, double-blind, phase III controlled clinical trials published between 2012 and 2025 in the PubMed, Cochrane Library, and Web of Science databases, assessing efficacy and safety in adult patients with RRMS. The review was carried out following the PICO methodology and PRISMA guidelines. RESULTS: A total of 11 studies were included, evaluating 5 monoclonal antibodies: alemtuzumab, daclizumab, ocrelizumab, ofatumumab, and ublituximab. These therapies showed superior efficacy compared to conventional treatments in reducing the annual relapse rate, MRI inflammatory activity and MRI activity, particularly in patients with highly active disease. However, effects on disability progression were heterogeneous across trials and not consistently significant. In addition, decreases in biomarkers of axonal damage were observed. Nevertheless, relevant adverse effects were identified, including infections, autoimmune reactions, hepatic and cutaneous toxicity, whose incidence varies depending on the drug, requiring close clinical monitoring. CONCLUSIONS: Monoclonal antibodies are an effective option in RRMS, with clinical and radiological benefits superior to those of conventional treatments. Their use requires individualized assessment and close follow-up due to the risk of adverse effects, especially in high-risk patients.

References

1. 1.Avedillo-Salas, A., Martínez, L. B., Fanlo-Villacampa, A., & Vicente-Romero, J. (2026). Efficacy and safety of monoclonal antibodies in the treatment of relapsing remitting multiple sclerosis: a systematic review. Journal of Neurology. https://doi.org/10.33588/rn.6608.2018083