Hydroxychloroquine (Plaquenil, Sanofi-Aventis) therapy is no better than placebo for improving symptoms of dryness, pain and fatigue in patients with primary Sjögren’s syndrome, according to a study in the July 16 issue of JAMA.1

Sjögren’s is one of the leading underlying causes of dry eye disease, accounting for nearly 12% of all aqueous-deficient cases.2 Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome, but evidence of its efficacy is limited.

In this double-blind, parallel-group study, 120 patients with primary Sjögren’s syndrome were randomized to receive 400mg hydroxychloroquine per day or placebo for 24 weeks. The researchers documented and graded the severity of patients’ symptoms at baseline, 12-week and 24-week follow-up.

At the 24-week follow-up, 17.9% of patients who received hydroxychloroquine therapy experienced a 30% or more reduction in symptom severity, which was about the same percentage—17.2%—as those in the placebo group.

Further, hydroxychloroquine use was not associated with statistically significant improvements in certain lab tests (i.e., anti-SSA antibodies and immunoglobulin G levels) that are frequently used to monitor the activity and severity of Sjögren’s.
Although the result of the study was negative, the researchers say this drug could still work in some subsets of patients.

Specifically, they postulate that Sjögren’s patients with synovitis (inflammation of the joint lining) or purpura (purple-red spots on the skin) associated with high serum levels of immunoglobulin G might are most likely to still benefit from hydroxychloroquine use.

1. Gottenberg JE, Ravaud P, Puéchal X, et al. Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58.
2. Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren’s syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503.