1. After 24 weeks of treatment, hydroxychloroquine was no more effective than placebo in improving scores for dryness, pain, and fatigue in Sjogren’s Syndrome.
Evidence Rating Level: 2 (Good)
Study Rundown: Sjogren’s Syndrome (SS) is an autoimmune disease that results in dry eyes, dry mouth, joint and muscle pain, and less commonly, systemic complications. Hydroxychloroquine, an immunomodulatory medication, is frequently used to treat SS, however the evidence supporting its efficacy is inconsistent. This study (the JOQUER Trial) is the first randomized contolled trial to assess this issue. 120 individuals with SS were randomized to receive hydroxychloroquine or placebo for 24 weeks and measured the proportion of participants in each group with at least a 30% reduction in dryness, fatigue, and pain. Following the first 24 weeks of the study, all participants received hydroxychloroquine between weeks 24 to 48.There was no significant difference between the two groups at either the 24 or 48-week point.
This study demonstrates the limited efficacy of hydroxychloroquine in treating primary Sjogren’s Syndrome and may consequently affect the treatment choices pursued by clinicians for this disease. As prior studies examining this issue utilized less robust study designs, one strength of this study is its double blind, randomized, placebo-controlled methodology. Weaknesses of the study include the use of only three domains as outcomes, permitting participants to continue other medications, and the relatively small sample size and follow up times. Despite the fact that this study did not demonstrate efficacy of hydroxychloroquine use for primary SS, a larger and longer study may be warranted to assess for the potential long-term utility of this treatment in SS.
Relevant Reading: Treatment of primary Sjögren syndrome: a systematic review
In-Depth [randomized controlled trial]: This study randomized 120 individuals with SS to receive hydroxychloroquine or placebo for 24 weeks and measured their numeric analog scales on three domains: dryness, fatigue, and pain. The proportions of individuals in each group with at least a 30% reduction in at least 2 of 3 domains were compared. The second phase of the study involved treating all participants with hydroxychloroquine between weeks 24-48. At the conclusion of the first 24 weeks, 17.9% of individuals in the hydroxychloroquine group and 17.2% of participants in the placebo group had at least a 30% reduction in two of the three measured domains (OR 1.01, 95% CI 0.37-2.78, p=0.98). At week 48, 30.4% of those in the hydroxychloroquine group and 18.8% of those in the placebo group had at least a 30% reduction in at least 2 of 3 domains (OR 2.06, 95% CI 0.66-6.43, p=0.21).
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