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.
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The first three authors contributed equally to this work.
J-MN is deceased.
Funding JTVP is supported by a research grant from the Fund for Scientific Research, Flanders. SD is supported by a grant from the Nationale Vereniging voor Steun aan Gehandicapte Personen. BVdC is supported by a postdoctoral grant from the Fund for Scientific Research, Flanders.
Competing interests None.
Ethics approval The protocol and patient informed consent forms were approved by the Ethics Committee of Ghent University Hospital.
Patient consent Obtained.