Evidence map›Paper›PMID 39290861›Full record

ArticleJournal of central nervous system disease2024

Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments.

Erwan Muros-Le Rouzic, Yanic Heer, Sean Yiu, Viola Tozzi, Stefan Braune, Philip van Hövell, Arnfin Bergmann, Corrado Bernasconi, Fabian Model, Licinio Craveiro and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Journal of central nervous system disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01247324 phase3completednot on this map

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2022Enrolled821ConditionsRelapsing Multiple SclerosisArmsInterferon beta-1a, Ocrelizumab-matching placebo, Ocrelizumab, Interferon beta-1a-matching placebo
NCT01412333 phase3completednot on this map

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2022Enrolled835ConditionsRelapsing Multiple SclerosisArmsInterferon beta-1a, Ocrelizumab-matching placebo, Ocrelizumab, Interferon beta-1a-matching placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

11 authors.

Erwan Muros-Le RouzicF. Hoffmann-La Roche Ltd., Basel, Switzerland.ORCID https://orcid.org/0000-0002-8925-0481
Yanic HeerPricewaterhouseCoopers AG, Zürich, Switzerland.
Sean YiuRoche Products Limited, Welwyn Garden City, UK.
Viola TozziPricewaterhouseCoopers AG, Zürich, Switzerland.
Stefan BrauneNeuroTransData GmbH, Neuburg an der Donau, Germany.ORCID https://orcid.org/0000-0002-0541-8196
Philip van HövellPricewaterhouseCoopers AG, Zürich, Switzerland.
Arnfin BergmannNeuroTransData GmbH, Neuburg an der Donau, Germany.
Corrado BernasconiF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Fabian ModelF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Licinio CraveiroF. Hoffmann-La Roche Ltd., Basel, Switzerland.
NTD study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking. Objectives: To compare the treatment effect of OCR vs six DMTs' (IFN β-1a, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab) treatment pathways used in clinical practice by combining clinical trial and real-world data. Methods: Patient-level data from OPERA trials and open-label extension phase, and from the German NeuroTransData (NTD) MS registry, were used to build 1:1 propensity score-matched (PSM) cohorts controlling for seven baseline covariates, including brain imaging activity. Efficacy outcomes were time to first relapse and time to 24-week confirmed disability progression over 5.5 years of follow-up. Intention-to-treat analysis using all outcome data irrespective of treatment switch was applied. Results: The analyses included 611 OPERA patients and 7141 NTD patients. We built 12 paired-matched cohorts (six for each outcome, two for each DMT) to compare efficacy of OCR in OPERA with each DMT treatment pathway in NTD. Post-matching, baseline covariates and PS were well balanced (standardized mean difference <.2 for all cohorts). Over 5.5 years, patients treated with OCR showed a statistically significant reduction in the risk of relapse (hazard ratios [HRs] .30 to .54) and disability progression (HRs .51 to .67) compared with all index therapies and their treatment switching pathways in NTD. Treatment switch and/or discontinuation occurred frequently in NTD cohorts. Conclusion: OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period. These analyses suggest that high-efficacy DMTs and high treatment persistence are critical to achieve greatest clinical benefit in RMS. Registration: OPERA I (NCT01247324), OPERA II (NCT01412333).

Indexed as

comparative effectiveness researchMultiple sclerosisocrelizumabreal-world datatreatment pathways

Identifiers

PMID39290861
PMCPMC11406495

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.