NEW YORK (Reuters Health) Jan 25 - Rituximab can improve saliva secretion and other parameters in patients with primary Sjogren's syndrome, researchers report.
Rituximab binds to the B cell surface antigen CD20 and could become the first causal systemic treatment for this disease, the investigators say.
At the University of Groningen, the Netherlands, Dr. J.M. Meijer and colleagues tested the drug in 30 patients with active primary Sjogren's syndrome. To be included in the trial, patients were required to have disease-related autoantibodies and a stimulated whole saliva secretion of at least 0.15 mL/min.
Earlier studies had shown that patients with at least some residual secretory ability might benefit most from rituximab, the authors explain in their paper, which appeared online January 13th in Arthritis and Rheumatism,
Twenty patients were randomized to receive IV rituximab, 1000 mg, on days 1 and 15; the remaining 10 received placebo. On average, the patients were 43 years old, with a disease duration of 63 to 67 months.
For at least 6 to 9 months, rituximab-induced B cell depletion led to improvement in objective and subjective parameters, the researchers report. Compared to the placebo group, the rituximab group had significant improvements in the primary endpoint -- secretion of stimulated whole saliva (p = 0.004) -- and in various laboratory parameters (e.g., B cells and rheumatoid factor).
Rituximab-treated patients also had significant improvements in various subjective assessments, including multidimensional fatigue inventory (MFI), short-form 36 (SF-36), and visual analog scale scores. The rituximab group also had fewer extraglandular manifestations than control subjects.
One diabetic patient in the rituximab group developed a mild serum sickness-like disease.
Most significant rituximab-associated improvements were observed between 12 and 36 weeks following treatment. In the placebo group, improvement of most variables occurred 5 weeks after the first infusion.
The authors theorize that improvements in the placebo group might have been related to prednisone given before and after the infusions, although they admit that data on the effect of prednisolone on Sjogren's syndrome symptoms "are inconclusive."
The research team concludes: "This study indicates that rituximab could be an effective and safe treatment...for patients with primary Sjogren's syndrome."
Arthritis Rheum 2010.