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Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.
Barrera, Britney; Simpson, Haley; Engebretson, Eric; Sillau, Stefan; Valdez, Brooke; Parra-González, José; Winger, Ryan C; Epperson, Lou Anne; Banks, Ashley; Pierce, Kathryn; Spotts, Melanie; O'Gean, Katie; Alvarez, Enrique; Gross, Robert; Piquet, Amanda L; Schreiner, Teri; Corboy, John R; Pei, Jinglan; Vollmer, Timothy L; Nair, Kavita V.
Afiliação
  • Barrera B; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Simpson H; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Engebretson E; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Sillau S; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Valdez B; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Parra-González J; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Winger RC; Genentech, Inc, South San Francisco, California, USA.
  • Epperson LA; Amerita Specialty Infusion Services, Denver, Colorado, USA.
  • Banks A; Amerita Specialty Infusion Services, Denver, Colorado, USA.
  • Pierce K; University of Colorado Hospital, Aurora, Colorado, USA.
  • Spotts M; University of Colorado Hospital, Aurora, Colorado, USA.
  • O'Gean K; University of Colorado Hospital, Aurora, Colorado, USA.
  • Alvarez E; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Gross R; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Piquet AL; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Schreiner T; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Corboy JR; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Pei J; Genentech, Inc, South San Francisco, California, USA.
  • Vollmer TL; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
  • Nair KV; Department of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Ann Clin Transl Neurol ; 10(4): 579-588, 2023 04.
Article em En | MEDLINE | ID: mdl-36811392
ABSTRACT

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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Tipo de estudo: Etiology_studies Limite: Adult / Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Tipo de estudo: Etiology_studies Limite: Adult / Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article