Reinforce Ocrelizumab’s Role Across the Full Spectrum of More Advanced Progressive MS: Gavin Giovannoni, MBBCh, PhD, FCP, FRCP, FRCPath

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"When people reach a wheelchair, their hands become their legs—maintaining upper-limb function becomes everything. ORATORIO-HAND is the first major trial to truly address that unmet need and prove ocrelizumab can make a difference in advanced MS."

Prior to the ORATORIO-HAND trial (NCT04035005), OROTORIO was the only phase 3 trial in which a treatment, ocrelizumab (Ocrevus; Genentech), showed an ability to delay disability progression in patients with primary progressive multiple sclerosis (PPMS). ORATORIO-HAND, or O-HAND, is a new double-blind, placebo-controlled follow-up comprised of more than 1000 patients with PPMS, including those with more advanced forms of the disease. Patients in the study are randomly assigned to ocrelizumab 600 mg or placebo every 6 weeks for 144 weeks or until at least 340 progression events were observed, whichever occurred first.

Data from the trial was presented as a late-breaker at the recently concluded 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 24-26, in Barcelona, Spain. Led by Gavin Giovannoni, MBBCh, PhD, FCP, FRCP, FRCPath, findings showed that those with more advanced disease continued to see greater benefits from ocrelizumab than those on placebo, confirming the drug’s impact beyond ambulation and earlier disease stages.

Giovannoni, a professor of neurology at Barts and London School of Medicine and Dentistry, caught up with NeurologyLive® after the meeting to discuss the data and ocrelizumab’s effect on patients with more advanced PPMS. In the interview, the MS expert provided context on the reasons and benefits behind the Nine-Hole Peg Test as the primary end point, as well as how the trial addressed major unmet needs in older populations and less mobile patients. In addition, he touched on how the study overcame logistical challenges such as the COVID-19 pandemic and ongoing conflicts that disrupted trial sites.

Click here for more ECTRIMS 2025 coverage.

REFERENCE
1. Giovannoni G, Airas L, Bove R, et al. Ocrelizumab vs placebo in primary progressive MS: efficacy and safety results of the Phase IIIb ORATORIO-HAND study. Presented at ECTRIMS Congress; September 24-26, 2025; Barcelona, Spain. Late-Breaking Abstract O128.