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Hydroxychloroquine no better than placebo at 24 weeks for primary Sjogren syndrome

Clinical Question:
Is hydroxychloroquine useful in the treatment of adults with primary Sjogren syndrome?

Bottom Line:
This study found no significant benefit of hydroxychloroquine over placebo in the treatment of adults with primary Sjogren syndrome. It remains uncertain whether longer treatment beyond 48 weeks is beneficial. (LOE = 1b)

Gottenberg JE, Ravaud P, Puechal X, et al. Effects of hydroxychloroquine on symptomatic improvement in primary Sjogren syndrome. The JOQUER randomized clinical trial. JAMA 2014;312(3):249-258.  [PMID:25027140]

Study Design:
Randomized controlled trial (double-blinded)

Industry + govt


Outpatient (specialty)

Classic symptoms of primary Sjogren syndrome include dry eyes and mouth, pain, and fatigue, as well as arthralgia and myalgia. The value of hydroxychloroquine as an immunomodulatory drug for improving symptoms remains uncertain despite its use as the most common immunosuppressant in primary Sjogren syndrome. These investigators identified patients (N = 120), aged 18 years or older, who met standard international criteria for primary Sjogren syndrome. Eligible patients randomly received (concealed allocation assignment) oral hydroxychloroquine (400 mg/day) or matched placebo for 24 weeks. After 24 weeks, all patients openly received hydroxychloroquine for an additional 24 weeks. Individuals who assessed outcomes using previously validated Sjogren syndrome disease activity scoring tools remained masked to treatment group assignment. Complete follow-up occurred for 98% of patients at 48 weeks. Using intention-to-treat analysis, no significant between group differences occurred at week 24 in the primary end point of the proportion of patients with a 30% or greater reduction in symptom scores from baseline (17.9% in the hydroxychloroquine group vs 17.2% in the placebo group). More patients in the 48-week hydroxychloroquine group than in the placebo/hydroxychloroquine group met the primary end point, but the difference was not significant (30.4% vs 18.8%, respectively; P = 0.21). There were also no group differences in other secondary clinical end points, including quality of life, psychological discomfort assessment, or systemic flares. The study was 80% powered to detect a predetermined clinically significant between-group difference.


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