Chikungunya Arthritis Treatment with Methotrexate and Dexamethasone: A Randomized, Double-blind, Placebo-controlled Trial

Background: Chikungunya fever is a reemerging epidemic disease caused by a single-stranded RNA alphavirus transmitted throughout by Aedes mosquitoes. Chikungunya virus infection is a biphasic disease in which 72% to 95% of affected individuals manifest acute chikungunya fever. Following the acute phase, more than 40% of affected individuals develop arthritis, often lasting more than 3 months, referred to as chronic chikungunya arthritis, which frequently mimics rheumatoid arthritis. Objective: This study aimed to evaluate the efficacy and safety of treatment of chronic chikungunya arthritis with methotrexate and dexamethasone in a randomized, double-blind, placebo-controlled clinical trial. Methods: The patients were reassessed for treatment response by the DAS28-ESR, tender joint count and swollen joint count, Patient Global Assessment, and for secondary measures, including the Health Assessment Questionnaire Disability Index and Pain Visual Analog Scale. Results: Thirty-one subjects were randomized (placebo, n = 16; methotrexate, n = 15); 27 completed treatment and 4 discontinued during the 8-week blinded period. Among the participants, 96.8% were female, with mean ± SD age was 52.9 ± 13. The mean ± SD disease duration prior to treatment was 220.9 ± 51.2 days. At 8 weeks, methotrexate-treated subjects showed a greater numerical trend towards improvement, but there were no significant differences between methotrexate- dexamethasone group and dexamethasone (placebo) group. Conclusion: In this relatively small cohort, all of whom received background dexamethasone, there was a greater numerical improvement trend in prespecified outcome measures, but methotrexate in combination with dexamethasone was not superior to dexamethasone in chronic chikungunya arthritis.