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Neuropediatrics
DOI: 10.1055/a-2683-1150
Original Article

Anti-CD20 versus Dimethyl Fumarate as First-Line Treatment for Pediatric Multiple Sclerosis: A Retrospective Cohort Study

Masoud Etemadifar
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Aryana Ramezani 
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Pantea Miralaei
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Nahad Sedaghat
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Amir M. Jozaie
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Mehrzad Ghorbani
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
,
Mehri Salari
2   Functional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran
,
Hasan Kaveyee 
1   School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
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Abstract

Background

Consensus on the first-line treatment of pediatric-onset multiple sclerosis (POMS) remains unresolved. Recently, dimethyl fumarate (DMF) and anti-CD20 therapies have been among the favorable options for pediatric multiple sclerosis (MS).

Objective

This study aimed to determine the effectiveness and safety of DMF versus anti-CD20 therapies for POMS.

Methods

We conducted a retrospective cohort study from July 2012 to July 2022 in the Isfahan MS clinic. MS cases under the age of 18 years old who received DMF or anti-CD20 agents as first-line treatment and were followed for at least 12 months were included.

Results

About 124 POMS cases were screened, of which 39 met the inclusion criteria. About 23 patients received DMF, while 16 patients received anti-CD20 (rituximab or ocrelizumab). The median (interquartile range, IQR) annualized relapse rate (ARR) decreased significantly (both with p < 0.0001) from 2.63 (0.68) to 0.0 (1.0) in the DMF group and from 2.89 (1.39) to 0.0 (1.0) in the anti-CD20 group. The median (IQR) expanded disability status score insignificantly changed from 1.0 (1.0) to 1.0 (0.5) in the DMF group, while it changed from 1.25 (1.0) to 1.0 (0.5) in the anti-CD20 group. After 12 months of follow-up, 12/16 in the anti-CD20 group and 17/23 in the DMF group were relapse-free. None of the treatment outcomes were different between the two treatment cohorts. Our study also assessed adverse events (AEs).

Conclusion

While subject to replication in future clinical trials, both DMF and anti-CD20 therapies had a significant effect on reducing ARR and disease activity with an acceptable safety profile, but in our study, there were no differences in their efficacy.

Keywords

pediatric-onset multiple sclerosis - anti-CD20 - dimethyl fumarate - rituximab - ocrelizumab - disease-modifying treatment

Data Availability Statement

The datasets generated and/or analyzed during the current study are not publicly available to ensure the privacy protection of the participants, but are available from the corresponding author on reasonable request.


Contributors' Statement

M.E. and M.S. were involved in the conceptualization of the study. H.K. and M.E. contributed to the design of the work. H.K., A.M.J., and M.G. contributed to the acquisition and analysis of the data. H.K., A.R., P.M., and N.S. contributed to the interpretation of data and drafting the initial manuscript. All of the authors contributed to the critical/intellectual review of the initial manuscript, and all have approved and accepted to be accountable for the integrity of the final manuscript.


Ethical Approval

Informed consent was obtained from all of the study participants or their parents or legal guardians, and all methods were carried out in accordance with relevant guidelines and regulations. The study protocol was registered and gained all the necessary approvals from the Isfahan University of Medical Sciences ethics committee (Approval ID: IR.MUI.MED.REC.1400.742).




Publication History

Received: 25 April 2025

Accepted: 13 August 2025

Accepted Manuscript online:
14 August 2025

Article published online:
25 August 2025

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