Evidence map›Paper›PMID 42223889›Full record

ArticleDrugs - real world outcomes2026

Real-World Effectiveness and Safety of Ofatumumab in Relapsing Multiple Sclerosis: Comparison of Treatment-Naïve Patients and Switchers in a Multicenter Cohort.

Vincenzo Mangialardi, Giuseppe Macchitella, Rita Vitobello, Antonella Teofilo, Nicola Cavalli, Caterina Lapucci, Marco Vercellino, Elisa Idini, Jessica Frau, Pietro Iaffaldano and 4 more

Abstract read
In one paragraph

Article in Drugs - real world outcomes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Vincenzo MangialardiNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy.
Giuseppe MacchitellaNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy.
Rita VitobelloNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy.
Antonella TeofiloNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy.
Nicola CavalliDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, 16132, Genoa, Italy.
Caterina LapucciDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, 16132, Genoa, Italy.
Marco VercellinoMultiple Sclerosis Center and Neurologia I U, Department of Neuroscience and Mental Health, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Turin, Italy.
Elisa IdiniMultiple Sclerosis Centre, ASL Cagliari, Cagliari, Italy.
Jessica FrauMultiple Sclerosis Centre, ASL Cagliari, Cagliari, Italy.
Pietro IaffaldanoNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy.
Paola CavallaMultiple Sclerosis Center and Neurologia I U, Department of Neuroscience and Mental Health, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Turin, Italy.
Matilde M IngleseDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, 16132, Genoa, Italy.
Eleonora CoccoMultiple Sclerosis Centre, ASL Cagliari, Cagliari, Italy.
Damiano PaolicelliNeurology Unit, Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Piazza Giulio Cesare 11, 70124, Bari, Italy. damiano.paolicelli@uniba.it.ORCID http://orcid.org/0000-0002-8645-1763

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOfatumumab (OFA) is a fully human anti-CD20 monoclonal antibody approved for the treatment of relapsing multiple sclerosis (RMS). Real-world data on its effectiveness and safety remain limited.

objectiveTo assess the effectiveness and safety of OFA in a large Italian RMS cohort and to examine the impact of prior treatment exposure on clinical, radiological, and safety outcomes in routine clinical practice.

methodsThis retrospective, multicenter study included adults with RMS who initiated OFA and had at least one follow-up visit. Patients were classified as treatment-naïve, switching from moderate-efficacy therapies (MET), or switching from high-efficacy therapies (HET). Outcomes included annualized relapse rate (ARR), magnetic resonance imaging (MRI) activity, disability measures (including confirmed disability worsening and improvement), no evidence of disease activity (NEDA-3), and adverse events (AEs).

resultsA total of 424 patients were analyzed, with a mean follow-up of 1.32 (± 0.61) years: 101 (23.8%) treatment-naïve and 323 (76.2%) switchers, of whom 113 were previously treated with MET and 210 with HET. During treatment, ARR decreased significantly from 0.486 to 0.027 (94.5% reduction; p < 0.001), with comparable relative reduction observed across all subgroups. MRI activity was significantly diminished, and at 12 months, 79.3% of evaluable patients achieved NEDA-3, with no significant differences between naïve, MET, and HET subgroups. Overall, OFA was well tolerated, with predominantly mild injection-related reactions and low discontinuation rates, mainly related to pregnancy planning with favorable outcomes. Infections were the only safety outcome that differed significantly among groups, occurring in 0.9% of naïve patients, 1.7% of MET switchers, and 9.5% of HET switchers (p = 0.001). Prior exposure to HET was the only independent predictor of infections.

conclusionsThese findings support OFA as an effective and generally safe option for RMS across various treatment sequences, while suggesting enhanced infection monitoring in patients switching from HETs.

Identifiers

PMID42223889
PMCPMC13287510

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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 Socratic graph.