| Autor: |
Vollmer, Timothy L., Cohen, Jeffrey A., Alvarez, Enrique, Nair, Kavita V., Boster, Aaron, Katz, Joshua, Pardo, Gabriel, Pei, Jinglan, Raut, Pranil, Merchant, Sharmin, MacLean, Elizabeth, Pradhan, Ashish, Moss, Brandon |
| Zdroj: |
Multiple Sclerosis & Related Disorders; Nov2020, Vol. 46, pN.PAG-N.PAG, 1p |
| Abstrakt: |
• US prescribing information recommends ocrelizumab be infused over 2.5 to 3 hours. • Shortening infusion time can reduce patient burden and optimize healthcare resources. • Patients showed good tolerability with ≈31% shorter infusion times. 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). 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. 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. 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. [ABSTRACT FROM AUTHOR] |
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