Page 98 - Pharma News Letter - Vol2 Issue 1

Chapter V

Efficacy Of Montelukast As An Adjuvant Therapy In Rheumatoid
Arthritis Patients: A Randomized Controlled Study

International Immunopharmacology, 2023 Nov; 124(Pt B):110959.
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Basma M Ahmed , Noha O Mansour , Rehab A Sallam , Moetaza M Soliman

Abstract

Objective: 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.
Methods: 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.
Results: 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 < 0.01). The QoL of the patients improved significantly from
baseline in the montelukast arm (p < 0.01) but not in the control arm (p = 0.08). The median
(IQR) serum levels of VCAM-1 were significantly lower in the montelukast arm (22.8 (15.0–
32.7)) than in the control arm (28.9 (15.4–42.8), p = 0.004).
Conclusion: The co-administration of montelukast with nDMARDs in RA patients enhanced the
anti-rheumatic effect which was reflected clinically by decreased disease activity.

Reference:

https://doi.org/10.1016/j.intimp.2023.110959

98 Faculty of Pharmacy Newsletter