Efficacy of Raloxifene as Add-on Therapy on Disease Activity of Postmenopausal Women with Rheumatoid Arthritis: A Double-blind, Randomized, Placebo-controlled Clinical Trial.

ABSTRACT

OBJECTIVE: The current study aimed to evaluate the effect of raloxifene on the disease activity of postmenopausal patients with rheumatoid arthritis (RA) and the prevention of glucocorticoid- induced osteoporosis. METHODS: This double-blind, randomized clinical trial was conducted at the Rheumatic Diseases Research Center affiliated with Mashhad University of Medical Sciences from 2015 to 2016. Postmenopausal women with RA were randomly treated with raloxifene or placebo after discontinuation of alendronate. Disease activity was evaluated using DAS28ESR, HAQ, and VAS before and every two months after the intervention. In addition, bone mineral densitometry was performed for patients before and 14 months after the intervention. The disease activity and densitometric criteria were compared between the two groups at a significant level of p <0.05. RESULTS: A total of 17 patients were allocated to each group. The two groups were similar at baseline in underlying disease, age, duration of RA, duration of alendronate use, laboratory findings, and rheumatoid arthritis drugs. Moreover, the mean scores of DAS28ESR, HAQ, and VAS during visits were not significantly different between the intervention and control groups (p >0.05). CONCLUSION: The current study results could not prove any clinical benefits of adding raloxifene to standard therapies for patients with rheumatoid arthritis in improving their disease activity compared to placebo. CLINICAL TRIAL REGISTRATION NUMBER Trial registration number is NCT02982083.