What is the recommended dosage of Rituximab (rituximab) in patients with systemic sclerosis?

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Last updated: February 22, 2025 • View editorial policy

From the Research

The recommended dosage of rituximab for systemic sclerosis is 375 mg/m2 given intravenously, administered once per week for 4 weeks. To implement this treatment:

  • Administer 375 mg/m2 of rituximab intravenously on day 1
  • Repeat the dose on days 8, 15, and 22 This dosing regimen is based on the protocol used in the DESIRES trial, a double-blind, investigator-initiated, randomised, placebo-controlled trial that demonstrated the efficacy and safety of rituximab in patients with systemic sclerosis 1. Rituximab works by depleting B cells, which are thought to play a role in the pathogenesis of systemic sclerosis. Prior to each infusion, premedication with acetaminophen and an antihistamine is advised to reduce infusion-related reactions. Corticosteroids may also be given as premedication. Monitor patients for infusion reactions, infections, and changes in lung function, as rituximab can have significant side effects. Regular follow-ups to assess treatment efficacy and safety are essential. The most recent and highest quality study, the DESIRES trial, provides the strongest evidence for this dosing regimen, and it is recommended over other regimens due to its demonstrated efficacy and safety in patients with systemic sclerosis 1. Other studies, such as the meta-analysis by 2 and the cohort study by 3, also support the use of rituximab in systemic sclerosis, but the DESIRES trial provides the most direct and robust evidence for the recommended dosing regimen. Note that study 4 is not relevant to the question as it discusses the use of rituximab in multiple sclerosis, not systemic sclerosis. Similarly, studies 5 provide some evidence for the use of rituximab in systemic sclerosis, but they are not as recent or of the same quality as the DESIRES trial.

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