Rituximab in early systemic sclerosis
- Boonstra, M. (Maaike)
- Meijs, Jessica
- Dorjée, A.L. (Annemarie L)
- Marsan, Nina Ajmone
- Schouffoer, A. (Anne)
- Ninaber, M.K. (Maarten K)
- Quint, Koen
- Bonte-Mineur, Femke
- Huizinga, Tom
- Scherer, H.U. (Hans U)
- Vries-Bouwstra, Jeska
DOIAbstract
textabstractObjectives (1) Hypothesis testing of the potency of rituximab (RTX) in preventing fibrotic complications and (2) assessing acceptability and feasibility of RTX in early systemic sclerosis (SSc). Methods A small, 24-month, randomised, double-blind, placebo-controlled, single-centre trial in patients with SSc diagnosed <2 years was conducted. Patients received RTX or placebo infusions at t=0, t=15 days and t=6 months. Patients were clinically evaluated every 3 months, with lung function tests and high-resolution CT every other visit. Skin biopsies were taken at baseline and month 3. Immunophenotyping of peripheral blood mononuclear cells was performed at every visit, except at months 9 and 18. Adverse events, course of skin and pu...
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