Efficacy of montelukast as an adjuvant therapy in rheumatoid arthritis patients: A randomized controlled study. 2023

Basma M Ahmed, and Noha O Mansour, and Rehab A Sallam, and Moetaza M Soliman
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt. Electronic address: basma_mohamed@mans.edu.eg.

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). CONCLUSIONS The co-administration of montelukast with nDMARDs in RA patients enhanced the anti-rheumatic effect which was reflected clinically by decreased disease activity.

UI MeSH Term Description Entries
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001172 Arthritis, Rheumatoid A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated. Rheumatoid Arthritis
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D018501 Antirheumatic Agents Drugs that are used to treat RHEUMATOID ARTHRITIS. Anti-Rheumatic Agent,Anti-Rheumatic Drug,Antirheumatic Agent,Antirheumatic Disease-Modifying Second-Line Drug,Antirheumatic Drug,DMARD,Disease-Modifying Antirheumatic Drug,Disease-Modifying Antirheumatic Drugs,Anti-Rheumatic Agents,Anti-Rheumatic Agents, Non-Steroidal,Anti-Rheumatic Drugs,Antirheumatic Disease-Modifying Second-Line Drugs,Antirheumatic Drugs,Antirheumatic Drugs, Disease-Modifying,Disease-Modifying, Antirheumatic Second-Line Drugs,Agent, Anti-Rheumatic,Agent, Antirheumatic,Anti Rheumatic Agent,Anti Rheumatic Agents,Anti Rheumatic Agents, Non Steroidal,Anti Rheumatic Drug,Anti Rheumatic Drugs,Antirheumatic Disease Modifying Second Line Drug,Antirheumatic Disease Modifying Second Line Drugs,Antirheumatic Drug, Disease-Modifying,Antirheumatic Drugs, Disease Modifying,Disease Modifying Antirheumatic Drug,Disease Modifying Antirheumatic Drugs,Disease Modifying, Antirheumatic Second Line Drugs,Drug, Anti-Rheumatic,Drug, Antirheumatic,Drug, Disease-Modifying Antirheumatic,Non-Steroidal Anti-Rheumatic Agents
D019010 Vascular Cell Adhesion Molecule-1 Cytokine-induced cell adhesion molecule present on activated endothelial cells, tissue macrophages, dendritic cells, bone marrow fibroblasts, myoblasts, and myotubes. It is important for the recruitment of leukocytes to sites of inflammation. (From Pigott & Power, The Adhesion Molecule FactsBook, 1993, p154) Antigens, CD106,CD106 Antigens,VCAM-1,CD106 Antigen,INCAM-110,Inducible Cell Adhesion Molecule 110,Vascular Cell Adhesion Molecule,Antigen, CD106,Vascular Cell Adhesion Molecule 1

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