Evidence map›Paper›PMID 30415593›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2018

Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial.

Edward J Fox, Clyde Markowitz, Angela Applebee, Xavier Montalban, Jerry S Wolinsky, Shibeshih Belachew, Damian Fiore, Jinglan Pei, Bruno Musch, Gavin Giovannoni

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% of its field
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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Ocrelizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Recurrent disability progression endpoints in multiple sclerosis clinical trials.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Impact of Age on Multiple Sclerosis Disease Activity and Progression.Current neurology and neuroscience reports · 2020
    Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
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

10 authors at 7 institutions in 5 countries.

Edward J FoxCentral Texas Neurology Consultants and Dell Medical School, The University of Texas at Austin, Round Rock, TX, USA.
Clyde MarkowitzDepartment of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Angela ApplebeeDepartment of Neurology, St. Peter's Health Partners, Albany, NY, USA.
Xavier MontalbanDivision of Neurology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada/ Department of Neurology/Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (CEMCAT), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Jerry S WolinskyMcGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.ORCID 0000-0002-8197-2762
Shibeshih BelachewF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Damian FioreGenentech, Inc., South San Francisco, CA, USA.
Jinglan PeiGenentech, Inc., South San Francisco, CA, USA.
Bruno MuschGenentech, Inc., South San Francisco, CA, USA.
Gavin GiovannoniDepartment of Neurology, Queen Mary University of London, London, UK.
Central Texas Neurology Consultants · USQueen Mary University of London · GBRoche (Switzerland) · CHSt. Michael's Hospital · CASt Peter's Hospital · USThe University of Texas Health Science Center at Houston · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUpper extremity (UE) impairment is common with primary progressive multiple sclerosis (PPMS).

objectiveThis exploratory analysis examined the effects of ocrelizumab on confirmed progression (CP) and confirmed improvement (CI) in UE impairment in patients from ORATORIO.

methodsPatients with PPMS received ocrelizumab 600 mg or placebo every 24 weeks for ⩾120 weeks. The Nine-Hole Peg Test (9HPT) was administered at baseline (BL) and every 12 weeks thereafter. Prespecified exploratory endpoints included change in 9HPT time and proportion of patients with CP of ⩾20% in 9HPT. Analysis populations included intention-to-treat (ITT) patients and subgroups stratified by BL 9HPT time and Expanded Disability Status Scale. Post hoc analyses included the proportion of patients achieving more severe thresholds of CP and the proportion achieving CI in 9HPT.

resultsAmong ITT patients, ocrelizumab significantly reduced the change in 9HPT time over 120 weeks, the risk of CP of ⩾20% in 9HPT time for both hands and the risk of more severe 9HPT progression versus placebo. Numerical trends also favoured ocrelizumab versus placebo with respect to achieving CI. Consistent directional trends were observed in subgroup analyses.

conclusionOcrelizumab reduces the risk of UE disability progression and may increase the possibility of improvement versus placebo in PPMS.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDisease ProgressionDouble-Blind MethodFemaleHandHumansInfusions, IntravenousMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveTreatment OutcomeUpper ExtremityAntibodies, Monoclonal, Humanizedocrelizumabdisease-modifying therapiesdisease progressionMultiple sclerosisocrelizumabprogressiveupper extremity impairment

Identifiers

PMID30415593
PMCPMC6282157
OpenAlexW2901155618

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.