Evidence map›Paper›PMID 30820738›Full record

Trial reportJournal of neurology2019

Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis.

Benjamin Turner, Bruce A C Cree, Ludwig Kappos, Xavier Montalban, Caroline Papeix, Jerry S Wolinsky, Regine Buffels, Damian Fiore, Hideki Garren, Jian Han and 1 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, 2019. 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 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
–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

47 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  4. Ocrelizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2022
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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.

Benjamin TurnerDepartment of Neurology, The Royal London Hospital, London, E1 1BB, UK. Benjamin.Turner@bartsandthelondon.nhs.uk.
Bruce A C CreeWeill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Ludwig KapposUniversity Hospital Basel, University of Basel, Basel, Switzerland.
Xavier MontalbanVall d'Hebron University Hospital, Barcelona, Spain.
Caroline PapeixPitié-Salpêtrière Hospital, Paris, France.
Jerry S WolinskyMcGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.
Regine BuffelsF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Damian FioreGenentech, Inc., South San Francisco, CA, USA.
Hideki GarrenGenentech, Inc., South San Francisco, CA, USA.
Jian HanGenentech, Inc., South San Francisco, CA, USA.
Stephen L HauserWeill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe efficacy and safety of ocrelizumab, versus interferon (IFN) β-1a, for the treatment of relapsing multiple sclerosis (RMS) from the identically designed OPERA I (NCT01247324) and OPERA II (NCT01412333) phase III studies has been reported; here we present subgroup analyses of efficacy endpoints from the pooled OPERA I and OPERA II populations.

methodsPatients with RMS were randomized to either ocrelizumab 600 mg administered by intravenous infusion every 24 weeks or subcutaneous IFN β-1a 44 µg three times per week throughout the 96-week treatment period. Relapse, disability, and MRI outcomes were analyzed for predefined and post hoc subgroups based on demographic and disease characteristics along with prior treatment using appropriate statistical tests to determine the treatment effect in subgroups and treatment-by-subgroup interactions.

resultsThe significant treatment benefit of ocrelizumab, versus IFN β-1a, observed in the overall OPERA I and OPERA II pooled populations was maintained across most subgroup strata for all endpoints, including annualized relapse rate, disability progression, and MRI outputs.

conclusionsThe treatment effect of ocrelizumab versus IFN β-1a, measured by clinical and MRI outcomes, was maintained across most of the subgroups and strata of interest, and the pattern of treatment benefit across all subgroups was consistent with that from the pooled OPERA studies.

Indexed as

AdolescentAdultAntibodies, Monoclonal, HumanizedDisability EvaluationDouble-Blind MethodDrug Administration RoutesFemaleGadoliniumHumansImage Processing, Computer-AssistedImmunologic FactorsInterferon-betaMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingAntibodies, Monoclonal, HumanizedGadoliniumImmunologic FactorsInterferon-betaocrelizumabInterferon β-1aMultiple sclerosisOcrelizumabPhase 3RelapsingSubgroup

Identifiers

PMID30820738
PMCPMC6469695

What OpenQuestion holds

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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.