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NewsA phase 3 trial shows ocrelizumab matches fingolimod for relapse control in pediatric MS patients — and then some. The drug showed significantly greater reductions in MRI lesion activity, and its safety profile mirrored what's seen in adults. The findings helped support the FDA's May 2026 approval of ocrelizumab for children aged 10 and older with relapsing-remitting MS.
A phase 3 clinical trial called OPERETTA 2 has found that ocrelizumab (Ocrevus) is at least as good as fingolimod (Gilenya) at controlling relapses in children and teens with relapsing-remitting multiple sclerosis (MS) — and significantly better when it comes to reducing brain lesions visible on MRI. The randomized, double-blind study enrolled 187 patients aged 10 to 17 years and was presented at the 2026 Child Neurology Society Annual Meeting in Montreal.
While both drugs performed similarly on the primary endpoint of annualized relapse rate, ocrelizumab pulled ahead on MRI measures of inflammatory disease activity. The safety profile was consistent with adult data, with most infusion-related reactions being mild to moderate, and no patients withdrew due to adverse events.
By the Numbers:
Why it matters: Pediatric MS is rare but aggressive, affecting an estimated 5,000–10,000 children and adolescents in the U.S. These findings supported the FDA's May 2026 approval of ocrelizumab for pediatric RRMS — giving clinicians a high-efficacy, well-characterized treatment option for a population with limited choices.
