Evidence map›Paper›PMID 40085374›Full record

ArticleDrugs - real world outcomes2025

Long-Term Evaluation of Effectiveness and Immunological Implications of Ocrelizumab in a Real-World Cohort.

Tommaso Guerra, Francesca Caputo, Antonella Bianco, Damiano Paolicelli, Pietro Iaffaldano

Abstract read
In one paragraph

Article in Drugs - real world outcomes, 2025. 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
–field-weighted citation impact
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.

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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

5 authors.

Tommaso GuerraDepartment of Translational Biomedicine and Neurosciences (DiBraiN), Multiple Sclerosis Center - Policlinico of Bari, University of Bari "Aldo Moro", Bari, Italy.
Francesca CaputoDepartment of Translational Biomedicine and Neurosciences (DiBraiN), Multiple Sclerosis Center - Policlinico of Bari, University of Bari "Aldo Moro", Bari, Italy.
Antonella BiancoDepartment of Translational Biomedicine and Neurosciences (DiBraiN), Multiple Sclerosis Center - Policlinico of Bari, University of Bari "Aldo Moro", Bari, Italy.
Damiano PaolicelliDepartment of Translational Biomedicine and Neurosciences (DiBraiN), Multiple Sclerosis Center - Policlinico of Bari, University of Bari "Aldo Moro", Bari, Italy.
Pietro IaffaldanoDepartment of Translational Biomedicine and Neurosciences (DiBraiN), Multiple Sclerosis Center - Policlinico of Bari, University of Bari "Aldo Moro", Bari, Italy. pietro.iaffaldano@uniba.it.ORCID http://orcid.org/0000-0003-2308-1731

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesExtended follow-up data from real-world cohorts of patients with multiple sclerosis treated with ocrelizumab (OCR) are becoming widely available. This monocentric retrospective study aimed to evaluate the long-term effectiveness of OCR and its impact on immunoglobulin (Ig) levels, lymphocyte subsets, and infections in a cohort of patients with relapsing remitting, primary progressive, and secondary progressive multiple sclerosis.

methodsPatients followed at the Multiple Sclerosis Center of Bari with ≥ 2 years of OCR treatment were retrospectively recruited in 2024. Twelve-month confirmed disability worsening, improvement, and the annualized relapse rate before and after treatment start were estimated and follow-up magnetic resonance imaging scans were collected. Changes in IgG/IgM/IgA levels from baseline for up to 6 years of OCR treatment and serum levels of T CD4+, T CD8+, and natural killer lymphocytes were assessed. Infection occurrence, type, and outcomes were investigated. Multivariable Cox models examined the association of clinical and radiological baseline factors with the risk of confirmed disability worsening and the relationship of infections with clinical-laboratoristic risk factors.

resultsThe final cohort retrieved 140 patients (80 relapsing remitting, 37 primary progressive, 23 secondary progressive) with a median (interquartile range) follow-up after treatment start of 4.62 (4.10-5.04) years. In the entire cohort, the mean annualized relapse rate decreased from 0.61 in the year before the start of OCR treatment to 0.02 in the second year, thereafter all patients in our cohort remained free of relapses and magnetic resonance imaging activity. The overall percentage of stable patients increased from the second to the fourth year, in parallel with a reduction in patients with confirmed disability worsening. A multifocal onset and the presence of at least two relapses before the start of OCR treatment were significant (p < 0.05) risk factors of confirmed disability worsening. During the follow-up, a reduction in the IgG serum level was observed, which further decreased, becoming stable after the third year. Immunoglobulin M levels slightly decreased over time, whereas IgA levels remained stable. No changes for T CD4+, natural killer cell absolute number, and a slight reduction in T CD8+ lymphocytes during follow-up were observed. Ocrelizumab did not determine a significant infection risk in the long term and no association was observed with Ig levels and severe infections.

conclusionsOcrelizumab prevented disease activity over the long term and its effect on the immune system did not determine a significant infection risk in most patients.

Identifiers

PMID40085374
PMCPMC12173971

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