Hydroxychloroquine May Not Improve Symptoms of Primary Sjogren Syndrome in Adults

EBM Focus - Volume 9, Issue 32

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Reference: JAMA 2014 Jul 16;312(3):249 (level 2 [mid-level] evidence)

Sjogren syndrome is a chronic autoimmune disorder characterized by exocrine gland dysfunction resulting in dryness, pain, and fatigue (BMC Med. 2013 Apr 4;11:93 full-text). Hydroxychloroquine is an immunomodulator that is frequently prescribed for patients with primary Sjogren syndrome who present with general symptoms such as fatigue, arthralgia, and myalgia. However, despite its widespread use, clinical data supporting the efficacy of hydroxychloroquine are very limited. A recent randomized trial of 120 adults with primary Sjogren syndrome compared hydroxychloroquine 400 mg orally daily vs. placebo for 24 weeks.

All patients had been taking stable doses of NSAIDs, oral corticosteroids, pilocarpine, or topical cyclosporine for at least 4 weeks, and concurrent use of these agents was allowed throughout the trial. The primary outcome was a ≥ 30% decrease in symptom scores on at least 2 of 3 scales assessing each of dryness, pain, or fatigue. The proportion of patients achieving the primary outcome was 17.9% with hydroxychloroquine vs. 17.2% with placebo (odds ratio 1.01, 95% CI 0.37-2.78). Hydroxychloroquine was associated with a nonsignificant decrease in mean pain scores (p = 0.06), but there were no significant differences in mean scores for either fatigue or dryness. Serious adverse events were reported in 3.6% with hydroxychloroquine vs. 4.9% with placebo (no p value reported).

Clinical evidence supporting hydroxychloroquine for primary Sjogren syndrome has mostly been confined to small open-label studies. A randomized crossover trial previously failed to demonstrate any symptomatic improvement associated with hydroxychloroquine despite improvements in surrogate markers of disease (Ann Rheum Dis 1993 May;52(5):360 full-text). However, that trial was limited by a very small sample size. The results from this new and much larger trial confirm the previous findings and provide more compelling evidence that hydroxychloroquine does not appear to improve symptoms of primary Sjogren syndrome. Furthermore, use of hydroxychloroquine requires periodic ophthalmologic exams due to a dose-related risk of retinopathy (Ophthalmology 2002 Jul;109(7):1377).

For more information see the Sjogren syndrome topic in DynaMed.