Treatment of primary Sjögren syndrome with rituximab: a randomized trial. - Université de Bretagne Occidentale Access content directly
Journal Articles Annals of Internal Medicine Year : 2014

Treatment of primary Sjögren syndrome with rituximab: a randomized trial.

Jean Sibilia
  • Function : Author
Eric Hachulla
Pierre Yves Hatron
  • Function : Author
Vincent Goeb
Jacques Morel
Jean Jacques Dubost
  • Function : Author
Jacques-Olivier Pers


BACKGROUND: Primary Sjögren syndrome (pSS) is an autoimmune disorder characterized by ocular and oral dryness or systemic manifestations. OBJECTIVE: To evaluate efficacy and harms of rituximab in adults with recent-onset or systemic pSS. DESIGN: Randomized, placebo-controlled, parallel-group trial conducted between March 2008 and January 2011. Study personnel (except pharmacists), investigators, and patients were blinded to treatment group. ( NCT00740948). SETTING: 14 university hospitals in France. PATIENTS: 120 patients with scores of 50 mm or greater on at least 2 of 4 visual analogue scales (VASs) (global disease, pain, fatigue, and dryness) and recent-onset (< 10 years) biologically active or systemic pSS. INTERVENTION: Randomization (1:1 ratio) to rituximab (1 g at weeks 0 and 2) or placebo. MEASUREMENTS: Primary end point was improvement of at least 30 mm in 2 of 4 VASs by week 24. RESULTS: No significant difference between groups in the primary end point was found (difference, 1.0% [95% CI, -16.7% to 18.7%]). The proportion of patients with at least 30-mm decreases in at least two of the four VAS scores was higher in the rituximab group at week 6 (22.4% vs. 9.1%; P = 0.036). An improvement of at least 30 mm in VAS fatigue score was more common with rituximab at weeks 6 (P < 0.001) and 16 (P = 0.012), and improvement in fatigue from baseline to week 24 was greater with rituximab. Adverse events were similar between groups except for a higher rate of infusion reactions with rituximab. LIMITATION: Low disease activity at baseline and a primary outcome that may have been insensitive to detect clinically important changes. CONCLUSION: Rituximab did not alleviate symptoms or disease activity in patients with pSS at week 24, although it alleviated some symptoms at earlier time points.


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Dates and versions

hal-00987652 , version 1 (06-05-2014)



Valérie Devauchelle-Pensec, Xavier Mariette, Sandrine Jousse-Joulin, Jean-Marie Berthelot, Aleth Perdriger, et al.. Treatment of primary Sjögren syndrome with rituximab: a randomized trial.. Annals of Internal Medicine, 2014, 160 (4), pp.233-42. ⟨10.7326/M13-1085⟩. ⟨hal-00987652⟩
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