This study, recently presented at the American College of Rheumatology 2018 Meeting.
Clinical trials in patients with primary Sjogren's Syndrome (pSS) using leflunomide (LEF) or
hydroxychloroquine (HCQ) previously showed that they inhibited B cell hyperactivity, but only with moderate effect.
The researchers wanted to study the potential of these 2 drugs when used together. They conducted a randomized, double–blind, placebo-controlled, mono-center proof of concept study to evaluate the efficacy, safety and tolerability of LEF/HCQ therapy in patients with pSS.
Twenty-nine patients were enrolled: 8 patients received placebo and 21 received LEF/HCQ combination therapy.
Overall, LEF/HCQ was safe and well-tolerated.
As anticipated, lymphopenia and elevated CK levels were significantly higher in the LEF/HCQ group.
There were significant improvements in other measures such as pain, fatigue, Physician’s Global Assessment, and Patient’s Global Assessment were also observed in the LEF/HCQ group but not in those receiving placebo