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JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682.

Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.

Author information

  • 1Department 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.
  • 2Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
  • 3Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.
  • 4Department of Rheumatology, Amiens University Hospital, Amiens, France.
  • 5Department of Internal Medicine, Avicenne Hospital, AP-HP, Bobigny, France.
  • 6Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
  • 7Department of Rheumatology, Orléans Hospital, Orléans, France.
  • 8Department of Rheumatology, Brest University Hospital, Brest, France.
  • 9Department of Rheumatology, Montpellier University Hospital, Montpellier, France.
  • 10Department of Rheumatology, Hôpital Bichat, AP-HP, Paris, France.
  • 11Department of Internal Medicine, Lille University Hospital, Lille, France.
  • 12Department of Rheumatology, Rennes University Hospital, Rennes, France.
  • 13Department of Internal Medicine, Lariboisère Hospital, AP-HP, Paris, France.
  • 14Department of Rheumatology, Le Havre Hospital, Le Havre, France.
  • 15Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.
  • 16Department of Pharmacy, Hôpitaux Universitaires Paris-Sud, AP-HP, Le Kremlin Bicêtre, France.
  • 17Department of Centre de Ressources Biologiques, Bichat Hospital, AP-HP, Paris, France.

Abstract

IMPORTANCE:

Primary 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.

OBJECTIVE:

To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjögren syndrome: dryness, pain, and fatigue.

DESIGN, SETTING, AND PARTICIPANTS:

From 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.

INTERVENTIONS:

Patients 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 MEASURES:

The 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.

RESULTS:

At 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 RELEVANCE:

Among 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 REGISTRATION:

clinicaltrials.gov Identifier: NCT00632866.

PMID:
25027140
[PubMed - indexed for MEDLINE]
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