Efficacy of montelukast as an adjuvant therapy in rheumatoid arthritis patients: A randomized controlled study

•Disease activity (DAS-28-CRP) decreased significantly in the montelukast arm.•The patients’ quality of life improved significantly in the montelukast arm.•Pain severity (VAS score) was lower in the montelukast arm compared to control arm.•Shorter duration of morning stiffness was reported in the montelukast arm.•The median serum levels of VCAM-1 were significantly lower in the montelukast arm. This study aimed to evaluate the efficacy of montelukast in conjunction with non-biologic disease modifying anti-rheumatic drugs (nDMARDs) in rheumatoid arthritis (RA) patients. This study was a single-center randomized double-blinded placebo-controlled study. Adult RA patients were included if they had moderate to severe disease activity and were receiving monotherapy or combination of nDMARDs. Eligible patients were randomized, in 1:1 ratio, to receive either 10 mg montelukast or placebo, once daily for 16 weeks. The primary endpoint was the change in the 28-joints disease activity score (DAS28) 16 weeks after treatment. The patients’ quality of life (QoL) was assessed by the Arabic version of the Health Assessment Questionnaire-Disability Index. Moreover, serum levels of vascular adhesion molecule-1 (VCAM-1) were measured. A total of 87 patients completed the study; 44 in the montelukast arm and 43 in the control arm. After 16 weeks of treatment, disease activity decreased significantly in the montelukast arm with mean change in DAS28 (95% CIs) of −1.5 (−1.7, −1.2) while the control arm showed no improvement (0.2 (0.0, 0.4), p