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Rituximab did not excel over placebo in a randomized trial of 120 patients with primary Sjögren syndrome, but there were some favorable trends. An effect for more active disease can't be ruled out.
Devauchelle-Pensec V, Mariette X, Jousse-Joulin S, et al.Treatment of Primary SjÃ¶gren Syndrome With Rituximab: A Randomized Trial. Ann Intern Med. (2014) 160:233-242-242. doi:10.7326/M13-1085
In a placebo-controlled, randomized trial, rituximab did not improve symptoms or disease activity in patients with primary SjÃ¶gren syndrome (pSS) by 24 weeks.
The study involved 120 patients with pSS as measured on a visual analog scale (VAS) of 0 (no disease) to 100 mm (worst), on scales for global disease, pain, fatigue and dryness. Patients had active disease, including scores of at least 50 mm on at least two scales. The primary end point was improvement of at least 30 mm in two of four scales by week 24.
Although the data did not support widespread use of rituximab in pSS, there were some early benefits. Trends for improvements in fatigue and dryness reached statistical significance at certain times.
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