Presented in part at the 68th Annual Scientific Meeting of the American College of Rheumatology, San Antonio, TX, October 2004.
Rituximab treatment in patients with primary Sjögren's syndrome: An open-label phase II study†
Article first published online: 2 SEP 2005
Copyright © 2005 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 52, Issue 9, pages 2740–2750, September 2005
How to Cite
Pijpe, J., van Imhoff, G. W., Spijkervet, F. K. L., Roodenburg, J. L. N., Wolbink, G. J., Mansour, K., Vissink, A., Kallenberg, C. G. M. and Bootsma, H. (2005), Rituximab treatment in patients with primary Sjögren's syndrome: An open-label phase II study. Arthritis & Rheumatism, 52: 2740–2750. doi: 10.1002/art.21260
- Issue published online: 2 SEP 2005
- Article first published online: 2 SEP 2005
- Manuscript Accepted: 3 JUN 2005
- Manuscript Received: 10 FEB 2005
- Innovation Fund of the University Medical Center Groningen
To investigate the safety and efficacy of B cell depletion treatment of patients with active primary Sjögren's syndrome of short duration (early primary SS) and patients with primary SS and mucosa-associated lymphoid tissue (MALT)–type lymphoma (MALT/primary SS).
Fifteen patients with primary SS were included in this phase II trial. Inclusion criteria for the early primary SS group were B cell hyperactivity (IgG >15 gm/liter), presence of autoantibodies (IgM rheumatoid factor, anti-SSA/SSB), and short disease duration (<4 years). Inclusion criteria for the MALT/primary SS group were primary SS and an associated MALT-type lymphoma (Ann Arbor stage IE) localized in the parotid gland. Patients were treated with 4 infusions of rituximab (375 mg/m2) given weekly after pretreatment with prednisone (25 mg) and clemastine. Patients were evaluated, using immunologic, salivary/lacrimal function, and subjective parameters, at baseline and at 5 and 12 weeks after the first infusion.
Significant improvement of subjective symptoms and an increase in salivary gland function was observed in patients with residual salivary gland function. Immunologic analysis showed a rapid decrease of peripheral B cells and stable levels of IgG. Human antichimeric antibodies (HACAs) developed in 4 of 15 patients (27%), all with early primary SS. Three of these patients developed a serum sickness–like disorder. Of the 7 patients with MALT/primary SS, complete remission was achieved in 3, and disease was stable in 3 and progressive in 1.
Findings of this phase II study suggest that rituximab is effective in the treatment of primary SS. The high incidence of HACAs and associated side effects observed in this study needs further evaluation.