Evidence map›Paper›PMID 37829441›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

Tolerability of subcutaneous ofatumumab with long-term exposure in relapsing multiple sclerosis.

John Kramer, Ralf Linker, David Paling, Adam Czaplinski, Olaf Hoffmann, V Wee Yong, Noreen Barker, Amy Perrin Ross, Elisabeth Lucassen, Mohammad Gufran and 4 more

Open access · goldAbstract read
In one paragraph

Article in Multiple sclerosis journal - experimental, translational and clinical. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Ofatumumab-mediated CD20Frontiers in pharmacology · 2025
    Article
  4. B-cell Depletion Therapy in Pediatric Neuroinflammatory Disease.Current neurology and neuroscience reports · 2024
    Review
  5. 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

14 authors at 11 institutions in 7 countries.

John KramerVanderbilt MS Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-1799-8623
Ralf LinkerKlinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg, Regensburg, Germany.
David PalingAcademic Department of Neuroscience, Sheffield NIHR Neuroscience BRC, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.
Adam CzaplinskiNeurologie FMH, Bellevue Medical Group, Zürich, Switzerland.
Olaf HoffmannKlinik für Neurologie, Alexianer St. Josefs-Krankenhaus Potsdam, Potsdam, Germany.
V Wee YongClinical Neurosciences and Oncology, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada.
Noreen BarkerThe National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.
Amy Perrin RossNeuroscience Program, Loyola University Medical Center, Maywood, IL, USA.
Elisabeth LucassenNovartis Pharma AG, Basel, Switzerland.
Mohammad GufranNovartis Healthcare Pvt. Ltd, Hyderabad, India.
Xixi HuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Ronald ZielmanNovartis Pharma AG, Basel, Switzerland.
Gustavo SeiferNovartis Pharma AG, Basel, Switzerland.
Patrick VermerschUniv. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.
Novartis (Switzerland) · CHFoederatio Medicorum Helveticorum · CHInserm · FRLoyola University Medical Center · USNational Hospital for Neurology and Neurosurgery · GBNovartis (India) · INNovartis (United States) · USSheffield Teaching Hospitals NHS Foundation Trust · GBSt. Josef Krankenhaus · DEUniversity Hospital Regensburg · DEUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Ofatumumab is approved for treating relapsing multiple sclerosis (RMS). Examining tolerability will enable understanding of its risk-benefit profile. Objective: Report the tolerability profile of ofatumumab in RMS during treatment of up to 4 years and the effect of pre-medication. Methods: Cumulative data from the overall safety population included patients taking continuous ofatumumab or being newly switched from teriflunomide. Injection-related reactions (IRRs) by incidence and severity, and post-marketing surveillance data, with an exposure of 18,530 patient-years, were analyzed. Results: Systemic IRRs affected 24.7% of patients (487/1969) in the overall safety population; most (99.2% [483/487]) were mild (333/487) to moderate (150/487) in Common Terminology Criteria for Adverse Events severity; most systemic IRRs occurred after first injection. Local-site IRRs affected 11.8% (233/1969) and most (99.6% [232/233]) were mild/moderate. Incidence and severity of systemic and localized IRRs were similar between continuous and newly switched patients across repeated injections. Systemic IRR incidence and severity were not substantially affected by steroidal or non-steroidal pre-medication. Post-marketing surveillance identified no new tolerability issues. Conclusion: Ofatumumab is well tolerated, displays a consistent safety profile during continuous use or after switching from teriflunomide and does not require pre-medication. This enables home management of RMS with a high-efficacy treatment.

Indexed as

anti-CD20injection-related reactionmultiple sclerosisOfatumumabpost-marketing surveillancepre-medicationrelapsing multiple sclerosistolerability

Identifiers

PMID37829441
PMCPMC10566276
OpenAlexW4387477724

What OpenQuestion holds

Textmetadata
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.