Evidence map›Paper›PMID 37691530›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2023

Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.

Stephen L Hauser, Ronald Zielman, Ayan Das Gupta, Jing Xi, Dee Stoneman, Goeril Karlsson, Derrick Robertson, Jeffrey A Cohen, Ludwig Kappos

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03650114 (An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
10.2field-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.

NCT03650114 phase3active not recruitingnot on this map

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2018 to 2028Enrolled1,882ConditionsRelapsing Multiple SclerosisArmsOfatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV), 23-valent pneumococcal polysaccharide vaccine (23-PPV), Seasonal Quadrivalent influenza vaccine
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Investigations of remibrutinib in models pertinent to multiple sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Article
  11. Article
  12. Article
  13. Controversies in neuroimmunology: Multiple sclerosis and other demyelinating disordersBiomedica : revista del Instituto Nacional de Salud · 2026
    Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. 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

9 authors at 8 institutions in 5 countries.

Stephen L HauserUCSF Weill Institute for Neurosciences and Department of Neurology, University of California, San Francisco (UCSF), 1651 4th Street, Box 3126, San Francisco, CA 94143, USA.ORCID 0000-0002-4932-4001
Ronald ZielmanClinical Development, Novartis Pharma B.V., Amsterdam, The Netherlands.
Ayan Das GuptaAnalytics, Novartis Healthcare Pvt. Ltd., Hyderabad, India.
Jing XiChina Novartis Institutes for Biomedical Research Co. Ltd., Novartis, Shanghai, People's Republic of China.
Dee StonemanGlobal Medical, Novartis Pharma AG, Basel, Switzerland.
Goeril KarlssonGlobal Medical, Novartis Pharma AG, Basel, Switzerland.
Derrick RobertsonDepartment of Neurology, Multiple Sclerosis Division, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
Jeffrey A CohenDepartment of Neurology, Mellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Ludwig KapposMS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Department of Head, Spine and Neuromedicine, Biomedical and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.ORCID 0000-0003-4175-5509
Novartis (Switzerland) · CHCleveland Clinic · USNovartis (China) · CNNovartis (India) · INNovartis (Netherlands) · NLUniversity of Basel · CHUniversity of California, San Francisco · USUniversity of South Florida · US

Funding

The Role of B cells in the Origin and Progression of Multiple SclerosisR35NS111644 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEPHEN L HAUSER · 2019 to 2026
$9.1M
NINDS NIH HHS R35 NS111644
6 · The paper itself

Abstract

backgroundOfatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS).

objectiveFurther characterize efficacy and safety of ofatumumab in RMS.

methodsEfficacy set: patients randomized to ofatumumab/teriflunomide in ASCLEPIOS I/II (core). Safety set: patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide. Data cut-off: 25 September 2021.

resultsIn the efficacy set (

conclusionOfatumumab has a favorable longer-term benefit-risk profile in RMS. TRIAL REGISTRY: ALITHIOS (NCT03650114): https://clinicaltrials.gov/ct2/show/NCT03650114.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingAntibodies, Monoclonal, HumanizedCrotonatesHumansHydroxybutyratesNitrilesRecurrenceToluidinesAntibodies, Monoclonal, HumanizedCrotonatesHydroxybutyratesNitrilesofatumumabteriflunomideToluidinesfollow-upmonoclonal antibodiesofatumumabRelapsing-remitting multiple sclerosistreatment

Identifiers

PMID37691530
PMCPMC10580679
OpenAlexW4386592575

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.