Evidence map›Paper›PMID 36811392›Full record

Trial reportAnnals of clinical and translational neurology2023

Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.

Britney Barrera, Haley Simpson, Eric Engebretson, Stefan Sillau, Brooke Valdez, José Parra-González, Ryan C Winger, Lou Anne Epperson, Ashley Banks, Kathryn Pierce and 10 more

Abstract readClinical Trial
In one paragraph

Trial report in Annals of clinical and translational neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Britney BarreraDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Haley SimpsonDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Eric EngebretsonDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Stefan SillauDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Brooke ValdezDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
José Parra-GonzálezDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Ryan C WingerGenentech, Inc, South San Francisco, California, USA.
Lou Anne EppersonAmerita Specialty Infusion Services, Denver, Colorado, USA.
Ashley BanksAmerita Specialty Infusion Services, Denver, Colorado, USA.
Kathryn PierceUniversity of Colorado Hospital, Aurora, Colorado, USA.
Melanie SpottsUniversity of Colorado Hospital, Aurora, Colorado, USA.
Katie O'GeanUniversity of Colorado Hospital, Aurora, Colorado, USA.
Enrique AlvarezDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Robert GrossDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Amanda L PiquetDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Teri SchreinerDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
John R CorboyDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.ORCID 0000-0003-4169-1461
Jinglan PeiGenentech, Inc, South San Francisco, California, USA.
Timothy L VollmerDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.
Kavita V NairDepartment of Neurology, Rocky Mountain MS Center, University of Colorado School of Medicine, Aurora, Colorado, USA.

Funding

NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Institutional Career Development CoreKL2TR002534 · NCATS · UNIVERSITY OF COLORADO DENVER · PI BURNHAM, ELLEN L · 2018 to 2022
$4.6M
NRSA Training CoreTL1TR002533 · NCATS · UNIVERSITY OF COLORADO DENVER · PI CICUTTO, LISA · 2018 to 2022
$3.0M
NCATS NIH HHS KL2 TR002534NCATS NIH HHS TL1 TR002533NCATS NIH HHS UL1 TR002535NIH HHS KL2 TR002534NIH HHS TLI TR002533NIH HHS UL1 TR002535
6 · The paper itself

Abstract

objectiveThis 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).

methodsThis 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.

resultsOverall, 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.

interpretationIRRs 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.

Indexed as

Multiple SclerosisAdultAntibodies, Monoclonal, HumanizedFemaleHumansInfusions, IntravenousMalePatient Outcome AssessmentAntibodies, Monoclonal, Humanizedocrelizumab

Identifiers

PMID36811392
PMCPMC10109340

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.