Evidence map›Paper›PMID 35266417›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022

Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II.

Jutta Gärtner, Stephen L Hauser, Amit Bar-Or, Xavier Montalban, Jeffrey A Cohen, Anne H Cross, Kumaran Deiva, Habib Ganjgahi, Dieter A Häring, Bingbing Li and 6 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. 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 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT02792218 phase3completednot on this map

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2020Enrolled930ConditionsRelapsing Multiple SclerosisArmsOfatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, Teriflunomide capsule, Matching placebo of ofatumumab subcutaneous injections
NCT02792231 phase3completednot on this map

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2020Enrolled955ConditionsRelapsing Multiple ScelrosisArmsOfatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, Teriflunomide capsule, Matching placebo of ofatumumab subcutaneous injections
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

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

16 authors at 11 institutions in 6 countries.

Jutta GärtnerDepartment of Paediatrics and Adolescent Medicine, Division of Paediatric Neurology, University Medical Centre Göttingen, Georg August University Göttingen, Göttingen, Germany.
Stephen L HauserUCSF Weill Institute for Neurosciences, Department of Neurology, University of California - San Francisco, San Francisco, CA, USA.ORCID 0000-0002-4932-4001
Amit Bar-OrCenter for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Xavier MontalbanDepartment of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Jeffrey A CohenDepartment of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Anne H CrossDepartment of Neurology, Section of Neuroimmunology, Washington University School of Medicine, St Louis, MO, USA.ORCID 0000-0003-0829-7569
Kumaran DeivaDepartment of Pediatric Neurology, University Hospitals Paris Saclay, Hôpital Bicêtre, National Reference Center for Rare Inflammatory Brain and Spinal Diseases, Le Kremlin-Bicêtre, France.
Habib GanjgahiOxford Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, Oxford, UK/Statistics Department, University of Oxford, Oxford, UK.
Dieter A HäringNovartis Pharma AG, Basel, Switzerland.
Bingbing LiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Ratnakar PingiliNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Krishnan RamanathanNovartis Pharma AG, Basel, Switzerland.
Wendy SuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Roman WilliNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0001-9612-9877
Bernd KieseierNovartis Pharma AG, Basel, Switzerland.
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, and Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital of Basel, University of Basel, Basel, Switzerland.ORCID 0000-0003-4175-5509
Novartis (Switzerland) · CHNovartis (United States) · USBicêtre Hospital · FRCentre d'Esclerosi Múltiple de Catalunya · ESCleveland Clinic · USUniversity of Basel · CHUniversity of California, San Francisco · USUniversity of Göttingen · DEUniversity of Oxford · GBUniversity of Pennsylvania · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide.

objectivesTo assess the efficacy and safety of ofatumumab versus teriflunomide in recently diagnosed, treatment-naive (RDTN) participants from ASCLEPIOS.

methodsParticipants were randomized to receive ofatumumab (20 mg subcutaneously every 4 weeks) or teriflunomide (14 mg orally once daily) for up to 30 months. Endpoints analysed post hoc in the protocol-defined RDTN population included annualized relapse rate (ARR), confirmed disability worsening (CDW), progression independent of relapse activity (PIRA) and adverse events.

resultsData were analysed from 615 RDTN participants (ofatumumab:

conclusionThe favourable benefit-risk profile of ofatumumab versus teriflunomide supports its consideration as a first-line therapy in RDTN patients.ASCLEPIOS I and II are registered at ClinicalTrials.gov (NCT02792218 and NCT02792231).

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingAntibodies, Monoclonal, HumanizedHumansRecurrenceToluidinesAntibodies, Monoclonal, HumanizedofatumumabToluidinesneurofilament light chainno evidence of disease activityprogression independent of relapse activityrecently diagnosedRelapsing multiple sclerosistreatment-naive

Identifiers

PMID35266417
PMCPMC9315184
OpenAlexW4220879604

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.