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Updated: Feb 23, 2026

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Rituximab in early systemic sclerosis.

Maaike Boonstra1, Jessica Meijs1, Annemarie L Dorjée1

  • 1Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.

RMD Open
|September 8, 2017
PubMed
Summary
This summary is machine-generated.

Rituximab (RTX) showed no unexpected safety issues in early systemic sclerosis (SSc) patients. This trial could not confirm RTX efficacy, but further studies in patients with lung involvement are warranted.

Keywords:
B CellsSystemic SclerosisTreatment

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Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Trials

Background:

  • Systemic sclerosis (SSc) is a chronic autoimmune disease characterized by fibrosis.
  • Early diagnosis and intervention are crucial for managing SSc.
  • Rituximab (RTX) is a monoclonal antibody targeting B cells, with potential immunomodulatory effects.

Purpose of the Study:

  • To test the efficacy of rituximab (RTX) in preventing fibrotic complications in early systemic sclerosis (SSc).
  • To assess the acceptability and feasibility of using RTX in patients with early SSc.

Main Methods:

  • A 24-month, randomized, double-blind, placebo-controlled trial involving 16 early SSc patients.
  • Patients received RTX or placebo infusions, with regular clinical evaluations, lung function tests, CT scans, and skin biopsies.
  • Immunophenotyping of peripheral blood mononuclear cells and B cell populations was performed.

Main Results:

  • No significant difference in mean skin score between RTX and placebo groups.
  • Slight, insignificant improvements in forced vital capacity and lung involvement with RTX.
  • Demonstrated B cell depletion in peripheral blood with RTX treatment.
  • No unexpected RTX-related adverse events were observed.

Conclusions:

  • Rituximab (RTX) appears safe for early systemic sclerosis (SSc) treatment.
  • This small trial did not confirm RTX efficacy for SSc.
  • Future placebo-controlled trials are recommended, particularly for SSc patients with pulmonary involvement.