To Stay, or Not to Stay, on Natalizumab in MS

Pauline Anderson

DALLAS — Switching to fingolimod (Gilenya, Novartis) or an injectable therapy after 2 years of treatment with natalizumab (Tysabri, Biogen Idec Inc) is associated with a statistically significant increase in disability progression reported by patients with multiple sclerosis (MS), a new study has found.

The study is important because the risk for progressive multifocal leukoencephalopathy (PML) tends to peak at 2 years of natalizumab therapy, so it’s at this time that doctors might want to raise the issue of changing therapy.

“Discussions on continuing, switching, or stopping medications should happen frequently between MS patients and their physician,” said lead researcher Stacey S. Cofield, PhD, associate professor, School of Public Health, University of Alabama at Birmingham. “The conversation should weigh the benefits and the risks for each individual patient.”

Dr. Cofield presented results of the study during the 6th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS). It was funded in part by Biogen Idec.

Infection Risk

Natalizumab is an effective treatment against disability progression in patients with relapsing-remitting MS (RRMS), the authors note. Two major studies — AFFIRM (Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis) and TOP (Tysabri Observational Program) — showed decreased risks in 6-month confirmed disability progression of 54% and 84% (5-year interim analysis), respectively, said Dr. Cofield.

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