Timothy L Vollmer1, Jeffrey A Cohen2, Enrique Alvarez3, Kavita V Nair4, Aaron Boster5, Joshua Katz6, Gabriel Pardo7, Jinglan Pei8, Pranil Raut9, Sharmin Merchant10, Elizabeth MacLean11, Ashish Pradhan12, Brandon Moss13. 1. Department of Neurology, Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado Denver, Denver, CO, USA. Electronic address: timothy.vollmer@cuanschutz.edu. 2. Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA. Electronic address: cohenj@ccf.org. 3. Department of Neurology, Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado Denver, Denver, CO, USA. Electronic address: enrique.alvarez@ucdenver.edu. 4. Department of Neurology, Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado Denver, Denver, CO, USA. Electronic address: Kavita.Nair@ucdenver.edu. 5. OhioHealth Research Institute, Columbus, OH, USA. Electronic address: aaron.boster@bosterms.com. 6. The Elliot Lewis Center for Multiple Sclerosis Care, Wellesley, MA, USA. Electronic address: JoshuaKatz@ElliotLewisMS.org. 7. Multiple Sclerosis Center of Excellence, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA. Electronic address: gabriel-pardo@omrf.org. 8. Genentech, Inc., South San Francisco, CA, USA. Electronic address: pei.jinglan@gene.com. 9. Genentech, Inc., South San Francisco, CA, USA. Electronic address: raut.pranil@gene.com. 10. Genentech, Inc., South San Francisco, CA, USA. Electronic address: merchant.sharmin@gene.com. 11. Genentech, Inc., South San Francisco, CA, USA. Electronic address: maclean.elizabeth@gene.com. 12. Genentech, Inc., South San Francisco, CA, USA. Electronic address: pradhan.ashish@gene.com. 13. Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA. Electronic address: mossb@ccf.org.
Abstract
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.
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.
Authors: H-P Hartung; T Berger; R A Bermel; B Brochet; W M Carroll; T Holmøy; R Karabudak; J Killestein; C Nos; F Patti; A Perrin Ross; L Vanopdenbosch; T Vollmer; R Buffels; M Garas; K Kadner; M Manfrini; Q Wang; M S Freedman Journal: Mult Scler Relat Disord Date: 2020-09-24 Impact factor: 4.339
Authors: Enrique Alvarez; Kavita V Nair; Stefan Sillau; Ian Shelton; Rebecca Seale; Sean Selva; John Corboy; Timothy L Vollmer Journal: Mult Scler J Exp Transl Clin Date: 2022-01-05
Authors: Stephen L Hauser; Ludwig Kappos; Xavier Montalban; Licinio Craveiro; Cathy Chognot; Richard Hughes; Harold Koendgen; Noemi Pasquarelli; Ashish Pradhan; Kalpesh Prajapati; Jerry S Wolinsky Journal: Neurology Date: 2021-09-02 Impact factor: 9.910