Trial reportEuropean journal of neurology2025
Rituximab in New-Onset Generalized Myasthenia Gravis: Long-Term Follow-Up of the RINOMAX Clinical Trial.
Trial report in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02950155 (A Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab), which is not on this map. Cited by 4 papers.
What it found
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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.
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.
A Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG)
Who cites it
4 citing papers in PubMed.
- Rituximab in New-Onset Generalized Myasthenia Gravis: Long-Term Follow-Up of the RINOMAX Clinical Trial.European journal of neurology · 2025Trial
- Exosomes in Myasthenia Gravis-Review.Cells · 2026Review
- Italian recommendations for the diagnosis and treatment of myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- A case report of sequential efgartigimod and rituximab treatment for tSNMG.Frontiers in immunology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
Abstract
backgroundThe 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.
methodsRINOMAX 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.
resultsCompared to the placebo arm, lower mean time-weighted QMG scores at 12 months (mean difference [MD]: 2.9, 95% CI: 0.9, 4.9; p = 0.005) and 24 months (MD: 2.6, 95% CI: 0.3, 4.9; p = 0.027) were observed in the RTX arm. The incidence rate of rescue from 48 weeks up to 5 years was numerically higher in the placebo arm than RTX (0.16 vs. 0.09/person-year; p = 0.121). Compared to delayed RTX, early exposure displayed lower QMG, risk of hospitalization (HR 0.24, 95% CI 0.07, 0.83), and rescue (HR 0.46, 95% CI 0.14, 1.57), but also the six patients never receiving RTX showed lower hospitalization risk (HR 0.08, 95% CI 0.01, 0.96). Corticosteroid doses were low globally throughout. Overall, 12.5% and 18.8% and of patients with early and delayed RTX, respectively, suffered a severe infection.
conclusionDisease activity and treatment burden, including hospitalization and rescue treatments, remained low, indicating a potential benefit of rituximab on the long-term disease trajectory. Infection risk with B cell depletion, however, remains a concern.
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