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Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis

2020; Elsevier BV; Volume: 46; Linguagem: Inglês

10.1016/j.msard.2020.102454

2211-0356

Timothy Vollmer, Jeffrey A. Cohen, Enríque Alvarez, Kavita Nair, Aaron Boster, Joshua Katz, Gabriel Pardo, Jinglan Pei, Pranil Raut, Sharmin Merchant, Elizabeth A. MacLean, Ashish Pradhan, Brandon Moss,

Peripheral Neuropathies and Disorders

BackgroundOcrelizumab is an approved MS treatment administered as two 300-mg intravenous infusions 2 weeks apart (Dose 1), each lasting approximately 2.5 hours, followed by single 600-mg infusions every 6 months lasting approximately 3.5 hours. Our objective was to evaluate shorter-duration ocrelizumab infusions in the Phase IIIb open-label SaROD study (NCT03606460).MethodsEligible patients received ocrelizumab 600-mg Dose 2 or 3 infused over approximately 2 hours (Cohort 1) or ocrelizumab 300-mg Dose 1, Infusion 2 over approximately 1.5 hours (Cohort 2). The primary endpoint was the number and proportion of patients experiencing Grade 3–4 infusion-related reactions (IRRs) in Cohort 1. Secondary endpoints included Grade 1–4 IRRs in both cohorts and Grade 3–4 IRRs in Cohort 2.ResultsMean infusion times decreased by approximately 1.09 and 0.79 hours in Cohorts 1 and 2, respectively, compared with US prescribing information. IRRs, reported by 36% of 141 patients, were mild-to-moderate, with no observed Grade 3–4 IRRs. No IRR-related discontinuations occurred. No serious AEs, deaths, or new safety signals were observed.ConclusionThe IRR rate with ocrelizumab shorter-duration infusions was similar to that observed in the pivotal Phase III trials. Ocrelizumab can be infused over a shorter time without sacrificing patient safety.