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Clinical and epidemiological research
Concise report
Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study
  1. V Smith1,
  2. J T Van Praet1,
  3. B Vandooren1,
  4. B Van der Cruyssen1,
  5. J-M Naeyaert2,
  6. S Decuman1,
  7. D Elewaut2,
  8. F De Keyser1
  1. 1
    Department of Rheumatology, Ghent University Hospital, Belgium
  2. 2
    Department of Dermatology, Ghent University Hospital, Belgium
  1. Correspondence to Dr V Smith, Department of Rheumatology, Ghent University Hospital 0K12-IB, De Pintelaan 185, B-9000, Gent, Belgium; Vanessa.Smith{at}ugent.be

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.

https://doi.org/10.1136/ard.2008.095463

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    Footnotes

    • 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.