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Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study
  1. Vanessa P Smith (vanessa.smith{at}ugent.be)
  1. Ghent University Hospital, Belgium
    1. Jens T Van Praet (jens.vanpraet{at}ugent.be)
    1. Ghent University Hospital, Belgium
      1. Bernard R M Vandooren (bernard.vandooren{at}ugent.be)
      1. Ghent University Hospital, Belgium
        1. Bert Vander Cruyssen (bert.vandercruyssen{at}ugent.be)
        1. Ghent University Hospital, Belgium
          1. Jean-Marie Naeyaert (jeanmarie.naeyaert{at}ugent.be)
          1. Ghent University Hospital, Belgium
            1. Saskia Decuman
            1. Ghent University Hospital, Belgium
              1. Dirk Elewaut (dirk.elewaut{at}ugent.be)
              1. Ghent University Hospital, Belgium
                1. Filip de Keyser (filip.dekeyser{at}ugent.be)
                1. Ghent University Hospital, Belgium

                  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.

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