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Biosimilar Matches Reference Natalizumab for Efficacy, Safety in Relapsing-Remitting MS
The proposed biosimilar natalizumab matches reference natalizumab for efficacy, safety, and immunogenicity in patients with relapsing-remitting multiple sclerosis (MS), according to study results published in JAMA Neurology.
“The results from this phase 3 trial support biosimilarity of proposed biosimilar natalizumab PB006 to its reference medicine in relapsing-remitting MS,” wrote corresponding author Krzysztof Selmaj, MD, PhD, of the University of Warmia & Mazury Department of Neurology in Poland, and coauthors.
The first biosimilar monoclonal antibody therapy to be developed for MS, biosimilar natalizumab PB006 was tested in a double-blind, randomized clinical trial called Antelope, which was the focus of the study. The Antelope trial included 246 patients with relapsing-remitting MS at 48 centers across Belarus, Croatia, Georgia, Moldova, Poland, Serbia, and Ukraine. Patients received intravenous infusions every 4 weeks of biosimilar natalizumab or reference natalizumab over 48 weeks.
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For the cumulative number of new active lesions over 24 weeks, the study’s primary efficacy end point, biosimilar natalizumab demonstrated similarity to reference natalizumab, researchers reported.
“At week 24,” they wrote, “the model-based mean difference in cumulative number of new active lesions between the biosimilar natalizumab and reference natalizumab treatment groups was 0.17 (least square means [SE]: biosimilar natalizumab, 0.34 [0.34]; reference natalizumab, 0.45 [0.28]; 95% CI, –0.61 to 0.94 within the prespecified margins of ±2.1).”
No significant differences were observed between the biosimilar and reference natalizumab groups for the trial’s secondary efficacy end points, which included magnetic resonance imaging parameters, annualized relapse rate, and Kurtzke Expanded Disability Status Scale score. Additionally, safety, tolerability, or immunogenicity assessments revealed no relevant differences, according to the study.
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