PMID- 36811392 OWN - NLM STAT- MEDLINE DCOM- 20230426 LR - 20240202 IS - 2328-9503 (Electronic) IS - 2328-9503 (Linking) VI - 10 IP - 4 DP - 2023 Apr TI - Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis. PG - 579-588 LID - 10.1002/acn3.51745 [doi] AB - OBJECTIVE: This study aimed to evaluate safety (infusion-related reactions [IRRs]) and patient satisfaction (patient-reported outcomes [PROs]) for at-home ocrelizumab administration for patients with multiple sclerosis (MS). METHODS: This open-label study included adult patients with an MS diagnosis who had completed a >/= 600-mg ocrelizumab dose, had a patient-determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600-mg ocrelizumab home-based infusion over 2 h, followed by 24-h and 2-week post-infusion follow-up calls. IRRs and adverse events (AEs) were documented during infusions and follow-up calls. PROs were completed before and 2 weeks post infusion. RESULTS: Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)-similar to other shorter ocrelizumab infusion studies-and all AEs were mild/moderate. In total, 66.7% of patients experienced AEs, including itch, fatigue, and grogginess. Patients reported significantly increased satisfaction with the at-home infusion process and confidence in the care provided. Patients also reported a significant preference for at-home infusion compared with prior infusion center experiences. INTERPRETATION: IRRs and AEs occurred at acceptable rates during in-home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home-based ocrelizumab infusion over a shorter infusion period. CI - (c) 2023 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association. FAU - Barrera, Britney AU - Barrera B AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Simpson, Haley AU - Simpson H AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Engebretson, Eric AU - Engebretson E AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Sillau, Stefan AU - Sillau S AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Valdez, Brooke AU - Valdez B AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Parra-Gonzalez, Jose AU - Parra-Gonzalez J AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Winger, Ryan C AU - Winger RC AD - Genentech, Inc, South San Francisco, California, USA. FAU - Epperson, Lou Anne AU - Epperson LA AD - Amerita Specialty Infusion Services, Denver, Colorado, USA. FAU - Banks, Ashley AU - Banks A AD - Amerita Specialty Infusion Services, Denver, Colorado, USA. FAU - Pierce, Kathryn AU - Pierce K AD - University of Colorado Hospital, Aurora, Colorado, USA. FAU - Spotts, Melanie AU - Spotts M AD - University of Colorado Hospital, Aurora, Colorado, USA. FAU - O'Gean, Katie AU - O'Gean K AD - University of Colorado Hospital, Aurora, Colorado, USA. FAU - Alvarez, Enrique AU - Alvarez E AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Gross, Robert AU - Gross R AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Piquet, Amanda L AU - Piquet AL AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Schreiner, Teri AU - Schreiner T AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Corboy, John R AU - Corboy JR AUID- ORCID: 0000-0003-4169-1461 AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Pei, Jinglan AU - Pei J AD - Genentech, Inc, South San Francisco, California, USA. FAU - Vollmer, Timothy L AU - Vollmer TL AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. FAU - Nair, Kavita V AU - Nair KV AD - Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA. AD - Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. LA - eng GR - UL1 TR002535/TR/NCATS NIH HHS/United States GR - KL2 TR002534/TR/NCATS NIH HHS/United States GR - KL2 TR002534/NH/NIH HHS/United States GR - TLI TR002533/NH/NIH HHS/United States GR - UL1 TR002535/NH/NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20230222 PL - United States TA - Ann Clin Transl Neurol JT - Annals of clinical and translational neurology JID - 101623278 RN - 0 (Antibodies, Monoclonal, Humanized) RN - A10SJL62JY (ocrelizumab) SB - IM MH - Adult MH - Female MH - Humans MH - Male MH - Antibodies, Monoclonal, Humanized MH - Infusions, Intravenous MH - *Multiple Sclerosis/drug therapy/etiology MH - Patient Outcome Assessment PMC - PMC10109340 COIS- B. Barrera has nothing to disclose. H. Simpson has nothing to disclose. E. Engebretson has nothing to disclose. S. Sillau has nothing to disclose. B. Valdez has nothing to disclose. J. Parra-Gonzalez has nothing to disclose. R. C. Winger is an employee of Genentech, Inc, and a shareholder of F. Hoffmann-La Roche Ltd. L. A. Epperson has nothing to disclose. A. Banks has nothing to disclose. K. Pierce has nothing to disclose. M. Spotts has nothing to disclose. K. O'Gean has nothing to disclose. E. Alvarez has received compensation for activities such as advisory boards, lectures and consultancy from Actelion/Janssen, Alexion, Bayer, Biogen, Celgene/BMS, EMD Serono/Merck, Genentech/Roche, Novartis, Sanofi and TG Therapeutics; and research support from Biogen, Genentech/Roche, Novartis, TG Therapeutics, Patient-Centered Outcomes Research Initiative, National Multiple Sclerosis Society, National Institutes of Health and Rocky Mountain MS Center. R. Gross has nothing to disclose. A. Piquet reports research support and consulting fees from Genentech. Outside of this work, Dr. Piquet reports grants from the University of Colorado and Rocky Mountain MS Center, consulting fees from Alexion, honorarium from Medlink and publication royalties from Springer as a co-editor of a textbook. T. Schreiner has received research funding from the National MS Center, Roche, Rocky Mountain MS Center and Biogen; and consultant fees from Roche and MS Focus. J. R. Corboy has received research Support from the National Institutes of Health, Patient-Centered Outcomes Research Institute, National Multiple Sclerosis Society and Novartis; has served on an advisory committee for Bristol Meyers Squibb and on the editorial board for Annals of Neurology; and is a Medical Director at the Rocky Mountain Multiple Sclerosis Center. J. Pei is an employee of Genentech, Inc, and a shareholder of F. Hoffmann-La Roche Ltd. T. L. Vollmer has received compensation for lectures and consultancy from Biogen IDEC, Genentech/Roche, Celgene, EMD Serono, Bristol Meyers Squib and Novartis; and has received research support from the Rocky Mountain Multiple Sclerosis Center, Biogen, Actelion, Roche/Genentech, F. Hoffman-La Roche, Ltd and TG Therapeutics, Inc. K. V. Nair National MS Center has served as a consultant to Bristol Myers Squibb, Novartis, TG Therapeutics and PhRMA Foundation. She serves on the speakers' bureau of Sanofi-Genzyme and Alexion, and she has received research grants from Genentech, PhRMA Foundation, Bristol Myers Squibb and Novartis. EDAT- 2023/02/23 06:00 MHDA- 2023/04/19 06:41 PMCR- 2023/02/22 CRDT- 2023/02/22 15:38 PHST- 2023/01/30 00:00 [revised] PHST- 2022/10/18 00:00 [received] PHST- 2023/01/31 00:00 [accepted] PHST- 2023/04/19 06:41 [medline] PHST- 2023/02/23 06:00 [pubmed] PHST- 2023/02/22 15:38 [entrez] PHST- 2023/02/22 00:00 [pmc-release] AID - ACN351745 [pii] AID - 10.1002/acn3.51745 [doi] PST - ppublish SO - Ann Clin Transl Neurol. 2023 Apr;10(4):579-588. doi: 10.1002/acn3.51745. Epub 2023 Feb 22.