Clinical Efficacy of Leflunomide/Hydroxychloroquine Combination Therapy in Patients with Primary Sjogren’s Syndrome

This study, Clinical Efficacy of Leflunomide/Hydroxychloroquine Combination Therapy in Patients with Primary Sjogren’s Syndrome: Results of a Placebo-Controlled Double-Blind Randomized Clinical Trial was recently presented at the American College of Rheumatology 2018 Meeting.

BACKGROUND
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.

RESULTS
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

CONCLUSION

This pilot Randomized Clinical Trial (RCT) suggests clinical efficacy for LEF/HCQ combination therapy in almost half of the patients with primary Sjögren`s syndrome. 

Larger RCT’s are needed to confirm the observed effects and to identify potential biomarkers for response.