https://immattersacp.org/weekly/archives/2014/02/25/4.htm

Rituximab may not benefit patients with primary Sjögren's syndrome

Rituximab offered some short-term benefits to patients with primary Sjögren's syndrome, but none by 24 weeks, a study found.


Rituximab offered some short-term benefits to patients with primary Sjögren's syndrome, but none by 24 weeks, a study found.

Researchers conducted a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and harms of rituximab in adults with recent-onset or systemic Sjögren's syndrome from March 2008 and January 2011. Coming from 14 university hospitals in France, participants were 120 patients with scores of 50 mm or greater (with 0 mm representing none to 100 mm being the worst) on at least 2 of 4 visual analogue scales (VAS) of global disease, pain, fatigue, and dryness, and less than 10 years' history of biologically active or systemic Sjögren's syndrome. Patients were randomized 1:1 to rituximab, 1 g at baseline and week 2, or to placebo.

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Results appeared in the Feb. 18 Annals of Internal Medicine.

Rituximab alleviated some symptoms, particularly fatigue, early in the trial but did not reduce symptoms or disease activity at 24 months. Decreases of at least 30 mm in at least 2 of the 4 VAS scores occurred in 9.1% of patients in the placebo group at 6 weeks, 17.0% at 16 weeks, and 22.0% at 24 weeks. The same measures were 22.4% at 6 weeks, 26.3% at 16 weeks, and 23.0% at 24 weeks in the rituximab group. The percentage was larger in the rituximab group only at week 6 (difference, 13.3 percentage points; 95% CI, 0.8 to 25.8 percentage points; P=0.036). For the primary outcome (decrease at week 24), the difference (1.0 percentage point; 95% CI, −16.7 to 18.7 percentage points) was not significant.

More infusion reactions occurred with rituximab than placebo, but no other differences in adverse events occurred. The researchers noted that although the data provide some support for the efficacy of rituximab reported in 2 previous preliminary studies, the size and duration of the benefit argue against using the drug to treat Sjögren's syndrome.

“Rituximab was associated with clinically significant improvements at week 6, suggesting transient efficacy that was not maintained throughout the 24-week period with our regimen,” they wrote. “Fatigue was alleviated early, whereas effects on dryness were delayed.”