Efficacy and Safety of Rituximab for New-Onset Generalized Myasthenia Gravis: The RINOMAX Randomized Clinical Trial.

ABSTRACT:

Importance

Rituximab is a third-line option for refractory generalized myasthenia gravis (MG) based on empirical evidence, but its effect in new-onset disease is unknown.

Objective

To investigate the efficacy and safety of rituximab compared with placebo as an add-on to standard of care for MG.

Design, setting, and participants

This randomized, double-blind, placebo-controlled study took place throughout 48 weeks at 7 regional clinics in Sweden. Key inclusion criteria were age older than 18 years, onset of generalized symptoms within 12 months or less, and a Quantitative Myasthenia Gravis (QMG) score of 6 or more. Patients were screened from October 20, 2016, to March 2, 2020. Key exclusion criteria included pure ocular MG, suspected thymoma, previous thymectomy, and

SUBMITTER: Piehl F 

PROVIDER: S-EPMC9486640 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature