Rituximab in New-Onset Generalized Myasthenia Gravis: Long-Term Follow-Up of the RINOMAX Clinical Trial.

ABSTRACT:

Background

The placebo-controlled RINOMAX trial (NCT02950155) demonstrated superiority up to 12 months of rituximab over standard-of-care in new-onset generalized myasthenia gravis (MG), but benefit-risk over longer time frames remains unknown.

Methods

RINOMAX included 47 participants with a Quantitative Myasthenia Gravis (QMG) score ≥ 6. Twenty-five patients were randomized to a single intravenous infusion of 500 mg rituximab, and 22 to placebo of which 16 received rituximab after the double-blinded phase (7 ± 2.9 months). Data were extracted from the Swedish MG registry to track hospitalizations, treatments including rescue, and disease activity scores.

Results

Compared to the placebo arm, lower mean time-weighted QMG scores at 12 months (mean difference [MD]: 2.9,

SUBMITTER: Wu J 

PROVIDER: S-EPMC12589805 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature