The role of bromocriptine in the treatment of patients with active rheumatoid arthritis

Aim We decided to determine the effectiveness of oral bromocriptine in patients with active rheumatoid arthritis ( RA ) who are in methotrexate ( MTX ) therapy. Methods Patients receiving stable doses of MTX were randomized to one of two groups and received 3 months of double‐blind bromocriptine (5 mg/day) or matching placebo. The moderate and major outcome measures were the proportion of patients with > 0.6 and > 1.2 improvement in RA based on the Disease Activity Score 28 ( DAS 28) at 3 months. Safety measures included adverse events and laboratory assessments. Results On a background treatment of MTX , the percentage of patients with moderate and major DAS 28 responses at 3 months in the bromocriptine group (73.8%/59.5%) was not significantly different from placebo (63.1%/31.6%). Side effects were typically mild and included mild nausea and sleep disturbance; we did not have any adverse events resulting in discontinuation of the study drug. Conclusion In patients with active RA receiving stable doses of MTX , bromocriptine showed non‐significant improvement in efficiency outcomes compared to placebo.