• Jacques-Eric Gottenberg, Philippe Ravaud, Xavier Puéchal, Véronique Le Guern, Jean Sibilia, Vincent Goeb, Claire Larroche, Jean-Jacques Dubost, Stéphanie Rist, Alain Saraux, Valérie Devauchelle-Pensec, Jacques Morel, Gilles Hayem, Pierre Hatron, Aleth Perdriger, Damien Sene, Charles Zarnitsky, Djilali Batouche, Valérie Furlan, Joelle Benessiano, Elodie Perrodeau, Raphaele Seror, and Xavier Mariette.
• Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.
• JAMA. 2014 Jul 16;312(3):249-58.

ImportancePrimary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.ObjectiveTo evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjögren syndrome: dryness, pain, and fatigue.Design, Setting, And ParticipantsFrom April 2008 to May 2011, 120 patients with primary Sjögren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind, parallel-group, placebo-controlled trial. Participants were assessed at baseline, week 12, week 24 (primary outcome), and week 48. The last follow-up date for the last patient was May 15, 2012.InterventionsPatients were randomized (1:1) to receive hydroxychloroquine (400 mg/d) or placebo until week 24. All patients were prescribed hydroxychloroquine between weeks 24 and 48.Main Outcomes And MeasuresThe primary end point was the proportion of patients with a 30% or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales (from 0 [best] to 10 [worst]) evaluating dryness, pain, and fatigue.ResultsAt 24 weeks, the proportion of patients meeting the primary end point was 17.9% (10/56) in the hydroxychloroquine group and 17.2% (11/64) in the placebo group (odds ratio, 1.01; 95% CI, 0.37-2.78; P = .98). Between weeks 0 and 24, the mean (SD) numeric analog scale score for dryness changed from 6.38 (2.14) to 5.85 (2.57) in the placebo group and 6.53 (1.97) to 6.22 (1.87) in the hydroxychloroquine group. The mean (SD) numeric analog scale score for pain changed from 4.92 (2.94) to 5.08 (2.48) in the placebo group and 5.09 (3.06) to 4.59 (2.90) in the hydroxychloroquine group. The mean (SD) numeric analog scale for fatigue changed from 6.26 (2.27) to 5.72 (2.38) in the placebo group and 6.00 (2.52) to 5.94 (2.40) in the hydroxychloroquine group. All but 1 patient in the hydroxychloroquine group had detectable blood levels of the drug. Hydroxychloroquine had no efficacy in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. During the first 24 weeks, there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group; in the last 24 weeks, there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group.Conclusions And RelevanceAmong patients with primary Sjögren syndrome, the use of hydroxychloroquine compared with placebo did not improve symptoms during 24 weeks of treatment. Further studies are needed to evaluate longer-term outcomes.Trial Registrationclinicaltrials.gov Identifier: NCT00632866.

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