Rituximab may offer a promising option for managing new-onset generalized myasthenia gravis MG, but further research is still needed to fully assess its long-term benefit-risk profile, according to a recent study published in the European Journal of Neurology.
The study followed up on the RINOMAX clinical trial, which examined the effects of rituximab — a drug that inhibits B cells, thereby preventing antibody production — in patients who had been experiencing MG symptoms for no more than 12 months. It found that a single infusion of rituximab improved the trajectory of new‑onset generalized MG when it was used early on.
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The initial RINOMAX trial was limited to 12 months. In this follow-up study, the authors aimed to assess the risks and benefits of rituximab over a longer timeframe.
The study included nearly 50 patients from the RINOMAX clinical trial who received either rituximab from the start of the trial, rituximab after a delay of several months or who never received rituximab. The primary outcome was achieving minimal disease manifestations (defined as a low Quantitative Myasthenia Gravis, or QMG, score, and needing only low‑dose steroids) without needing rescue treatments.
Results showed that patients receiving rituximab continued to have significantly better QMG scores over the long term than those receiving placebo, and were less likely to require rescue treatment or be hospitalized. Patients who took rituximab early on had lower mean time-weighted QMG scores through 60 months compared to the patients who took a placebo for several months before being given rituximab.
Adverse effects included severe infection, although due to the sample size no direct causality could be established; the authors hypothesize that the infections were a consequence of rituximab-associated B cell depletion.
The authors suggest expanding the sample size, conducting longer follow-ups, refining patient stratification by antibody type and disease duration and improving subgroup analyses in future studies.
“Early exposure to B cell-depleting therapies may be associated with better long-term outcomes. Further studies are needed to shed light on the long-term benefit–risk balance with RTX [rituximab] in generalized MG, as well as to define predictive markers for disease severity early in the disease course,” the authors concluded.
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