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

Vanessa P Smith ^1*, Jens T Van Praet ¹, Bernard R M Vandooren ¹, Bert Vander Cruyssen ¹, Jean-Marie Naeyaert ¹, Saskia Decuman ¹, Dirk Elewaut ¹ and Filip de Keyser ¹

¹ Ghent University Hospital, Belgium

^* To whom correspondence should be addressed. E-mail: vanessa.smith{at}ugent.be.

Accepted 14 December 2008

Abstract

Objectives: We examined the safety and potential efficacy of rituximab in diffuse cutaneous systemic sclerosis (dc-SSc).

Methods: We conducted a 24 week open-label study in which 8 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, HAQ-DI, SF-36, and histopathological evaluation of the skin. This study is registered with ClinicalTrials.gov, number NCT00379431.

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.