ClinicalTrials.gov identifier: NCT00363350.
Effectiveness of rituximab treatment in primary Sjögren's syndrome: A randomized, double-blind, placebo-controlled trial†
Article first published online: 13 JAN 2010
Copyright © 2010 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 62, Issue 4, pages 960–968, April 2010
How to Cite
Meijer, J. M., Meiners, P. M., Vissink, A., Spijkervet, F. K. L., Abdulahad, W., Kamminga, N., Brouwer, E., Kallenberg, C. G. M. and Bootsma, H. (2010), Effectiveness of rituximab treatment in primary Sjögren's syndrome: A randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatism, 62: 960–968. doi: 10.1002/art.27314
- Issue published online: 30 MAR 2010
- Article first published online: 13 JAN 2010
- Accepted manuscript online: 13 JAN 2010 12:00AM EST
- Manuscript Accepted: 9 DEC 2009
- Manuscript Received: 31 JUL 2009
- Roche, Woerden, The Netherlands
To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sjögren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial.
Patients with active primary SS, as determined by the revised American–European Consensus Group criteria, and a rate of stimulated whole saliva secretion of ≥0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables.
Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean ± SD age of the patients receiving rituximab was 43 ± 11 years and the disease duration was 63 ± 50 months, while patients in the placebo group were age 43 ± 17 years and had a disease duration of 67 ± 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P = 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor [RF] levels), subjective parameters (Multidimensional Fatigue Inventory [MFI] scores and visual analog scale [VAS] scores for sicca symptoms), and extraglandular manifestations. Moreover, in comparison with baseline values, rituximab treatment significantly improved the stimulated whole saliva flow rate (P = 0.004) and several other variables (e.g., B cell and RF levels, unstimulated whole saliva flow rate, lacrimal gland function on the lissamine green test, MFI scores, Short Form 36 health survey scores, and VAS scores for sicca symptoms). One patient in the rituximab group developed mild serum sickness–like disease.
These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.