Faster ocrelizumab infusions appear to be safe

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Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Aug 18;46:102454.

COVID-19 has focused attention to the amount of time people are kept in the infusion room and hospital, Shorter infusion times means you are away quicker. On solution is not to have an infusion and the makers of ocrelizumab are testing this at the moment. They also had the foresight to reduce the infusion time and a trial was already set up. Surprised, well not really they haven’t tested fewer infusions, ProfG can comment but I am guessing shorter infusion times are happening as a result of COVID. However it is reassuring to be tolld that it appears relatively safe to do so.

Background: Ocrelizumab 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).

Methods: Eligible 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.

Results: Mean 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.

Conclusion: The 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.

COI multiple

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8 comments

  • I had faster infusion at Royal London in Aug, it didn’t feel any different. No reaction and whether it is related or not, actually felt less shit the week after than the first two! 🙂

    • The first cyclekills your B cells and you get reactions…..second cycle there are no B cells to kill. Thansk for your insight and experience

  • By “On solution is not to have an infusion and the makers of ocrelizumab are testing this at the moment,” do you mean that Genentech is testing (1) extended interval dosing (perhaps based on CD20 cell population) or (2) non-infusion (i.e., sub-Q) delivery? Just curious.

    • sorry it is” one solutlion” and the this they are testing is to use subcutaneous administration rather than have and infusion so they are tryinhg to saw the legs of ofatumumab

  • By “On solution is not to have an infusion and the makers of ocrelizumab are testing this at the moment,” do you mean that Genentech is testing (1) extended interval dosing (perhaps based on CD20 cell population) or (2) non-infusion (i.e., sub-Q) delivery? Just curious.

  • I’m in a Phase III ocrelizumab cognitive study in the US, they also tested shorter infusion times, pre-COVID. But post-COVID, they’ve approved the shorter infusion for all (~2hrs) if we so choose. I was not in the shorter test group but received my last dose faster and with no issues. Was told there were No issues reported across my study group during testing.

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