Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Pediatric-onset Relapsingremitting MS: Results of the Phase III OPERETTA Two Study (S40.005)

Brenda Banwell; Katarzyna Kotulska; Kevin Rostásy; Kumaran Deiva; Henry Sato; Massimo Filippi; Tanuja Chitnis; Maria Pia Sormani; Lauren Krupp; Amit Bar-Or; Joanna Evershed; B El Azzouzi; Qing Wang; Chien-Ju Lin; Alexandra Hogea; Hans‐Martin Schneble; Corinne Manlius; Emmanuelle Waubant

doi:10.1212/wnl.0000000000216038

Key Points

To assess the safety and efficacy of ocrelizumab compared to fingolimod in pediatric-onset multiple sclerosis.
Randomized Phase III noninferiority trial
Participants aged 10–17 years with pediatric-onset multiple sclerosis
Intravenous ocrelizumab versus fingolimod comparison.
Ocrelizumab demonstrated comparable efficacy to fingolimod in reducing relapse rates.
Safety profiles of ocrelizumab and fingolimod were similar, with no significant adverse effects reported.

Implication

Evaluates ocrelizumab's efficacy in pediatric-onset MS, suggesting strong potential for treatment.

Abstract

OPERETTA 2 (NCT05123703), a Phase III, randomized, noninferiority study, evaluated the safety and efficacy of intravenous (IV) ocrelizumab compared with fingolimod in patients with pediatric-onset multiple sclerosis (POMS) aged 10–17 years.

Discussion

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Cite This Study

Banwell et al. (2026) studied this question.

synapsesocial.com/papers/6a2cf34dfaef96ed7f055c6c https://doi.org/10.1212/wnl.0000000000216038

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Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Pediatric-onset Relapsingremitting MS: Results of the Phase III OPERETTA Two Study (S40.005)

Key Points

Implication

Abstract

Discussion

Cite This Study

Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Pediatric-onset Relapsingremitting MS: Results of the Phase III OPERETTA Two Study (S40.005)

Key Points

Implication

Abstract

Discussion

Cite This Study

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