Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study

Abstract

Objectives:The safety and potential efficacy of rituximab was examined in diffuse cutaneous systemic sclerosis (dc-SSc).Methods:A 24 week open-label study in which eight patients with dc-SSc received an infusion of 1000 mg rituximab administered at baseline and day 15, together with 100 mg methylprednisolone at each infusion. Assessment included CD19+ peripheral blood lymphocyte number, skin sclerosis score, indices of internal organ functioning, the health assessment questionnaire disability index, the 36-item Short Form health survey and histopathological evaluation of the skin.Results:Ritixumab induced effective B-cell depletion in all patients (<5 CD19+ cells/μl blood). There was a significant change in skin score at week 24 (p<0.001). Also, significant improvements were measured in the dermal hyalinised collagen content (p = 0.014) and dermal myofibroblast numbers (p = 0.011). Two serious adverse events occurred, which were thought to be unrelated to the rituximab treatment.Conclusions:Rituximab appears to be well tolerated and may have potential efficacy for skin disease in dc-SSc.This study is registered with ClinicalTrials.gov, number NCT00379431.