Evidence map›Paper›PMID 37042954›Full record

Observational studyDer Nervenarzt2023

[Over one year of B‑cell targeted therapy with Ofatumumab s.c.: first results of a prospective, patient-centered real-world observational study].

Rafael Klimas, Anna-Sophia Karl, Philip Lennart Poser, Melissa Sgodzai, Simon Theile-Ochel, Barbara Gisevius, Simon Faissner, Ilias Nastos, Ralf Gold, Jeremias Motte

Open access · hybridAbstract readObservational StudyEnglish Abstract
In one paragraph

Observational study in Der Nervenarzt, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 33% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
  3. Observational
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 1 institution in 1 country.

Rafael KlimasKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland. Rafael.Klimas@rub.de.
Anna-Sophia KarlKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Philip Lennart PoserKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Melissa SgodzaiKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Simon Theile-OchelKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Barbara GiseviusKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Simon FaissnerKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Ilias NastosFacharztpraxis für Neurologie, Bochum, Deutschland.
Ralf GoldKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
Jeremias MotteKlinik für Neurologie, St. Josef-Hospital, Ruhr-Universität Bochum, Gudrunstraße 56, 44791, Bochum, Deutschland.
St. Josef-Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOfatumumab (Kesimpta™) is a s.c. applicable anti-CD20 antibody, which has been used in Germany since 2021 for the treatment of relapsing multiple sclerosis (RMS). The self-application offers a high degree of independence from intravenous forms of application with highly effective immunotherapy. In this study we recorded the patient-centered experience in 99 out of 127 patients who were adjusted to the drug by us. The aim was to investigate the tolerability and acceptance from the patient's perspective.

methodsData collection was carried out using doctor documentation, questionnaires and telephone interviews.

resultsThe cohort consists of 127 patients. The patients received 2.8 (± SD 1.7) pre-therapies. The mean duration of therapy with Ofatumumab was 9.8 months (± SD 3.5). Structured data were collected from 99 patients. 23% of patients had no side effects during initial application. 19% rated the side effects as "very mild" and 18% as "mild". In addition to chills/fever (48%), headache (46%), limb pain (45%) and "other symptoms" (19%) also occurred. For subsequent injections, 72% of patients reported no side effects. 87% of patients found handling the medication "very easy". There was one relapse event during therapy.

conclusionOur study shows that Ofatumumab is well accepted and tolerated by patients. There was one relapse event during the observation period. The side effects are mild and occur during initial application. No increased tendency to infection could be observed. The data suggest that Ofatumumab is also an effective and safe treatment option for patients with relapsing remitting multiple sclerosis in real-world use.

Indexed as

Antibodies, MonoclonalB-LymphocytesMultiple Sclerosis, Relapsing-RemittingAdultAntibodies, Monoclonal, HumanizedFemaleGermanyHumansMaleMiddle AgedPatient-Centered CareProspective StudiesTreatment OutcomeYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedofatumumabAnti-CD20-TherapyImmunotherapyKesimptaMultiple sclerosisPatient reported outcomes

Identifiers

PMID37042954
PMCPMC10576000
OpenAlexW4365135061

What OpenQuestion holds

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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.