We decided to determine the effectiveness of oral bromocriptine in patients with active rheumatoid arthritis (RA) who are in methotrexate (MTX) therapy.
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 (DAS28) at 3 months. Safety measures included adverse events and laboratory assessments.
On a background treatment of MTX, the percentage of patients with moderate and major DAS28 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.
In patients with active RA receiving stable doses of MTX, bromocriptine showed non-significant improvement in efficiency outcomes compared to placebo.