European journal of clinical pharmacology | 2021
Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis.
Abstract
PURPOSE\nInvestigating the efficacy and safety of rupatadine (RUP) versus montelukast (MON) as adjuvant therapy for patients with rheumatoid arthritis (RA).\n\n\nMETHODS\nFrom December 2018 to December 2019, 75 patients with active RA were enrolled in this randomized double-blind placebo-controlled study. The patients were randomized into three groups (n\u2009=\u200925 in each group); methotrexate (MTX) group which received MTX 15-25\xa0mg/week plus placebo tablet once daily; MTX/RUP group which received MTX plus RUP 10\xa0mg once daily; and MTX/MON group which received MTX plus MON 10\xa0mg once daily. The treatment duration was 3\xa0months. At baseline and 3\xa0months after treatment, blood samples were collected for the biochemical analysis of high-sensitivity C-reactive protein (hs-CRP), interleukins 8 and 17 (IL-8, IL-17), E-selectin, and clusterin (CLU) levels. Clinical and functional assessments using Disease Activity Score-CRP (DAS28-CRP) and Multidimensional Health Assessment Questionnaire (MDHAQ) were performed.\n\n\nRESULTS\nBoth RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ. Rupatadine significantly reduced all measured parameters (P\u2009<\u20090.05) except for IL-17 and CLU. Montelukast significantly decreased all measured variables (P\u2009<\u20090.05) except for E-selectin. Interleukin-8 was positively correlated with IL-17 and CLU, while hs-CRP was positively correlated with E-selectin and body mass index (BMI). Both drugs were well tolerated; somnolence was the common side effect for RUP. No neuropsychiatric events were reported with MON.\n\n\nCONCLUSION\nRupatadine or montelukast may serve as a potential adjuvant therapy for patients with rheumatoid arthritis secondary to the preliminary evidence of efficacy and safety. ClinicalTrials.gov identifier NCT03770923, December 10, 2018.