Objectives: The objective of the study was to assess the safety and effectiveness of the chloroform/methanol extract of Tripterygium wilfordii Hook F (T2) plus methotrexate (MTX) in treating patients with rheumatoid arthritis (RA).
Methods: One hundred sixty-six patients with RA, who started the combination therapy of T2 (20 mg b.i.d. or t.i.d.) and MTX (10-12.5 mg/wk), were enrolled, and these patients were followed up for at least 1 year. Demographics, disease severity, markers of disease activity before and after the combination therapy, and incidence of adverse events were evaluated.
Results: The patients were predominantly female (n = 134, 81%) with a mean age of 58.0 (SD, 7.9) years (range, 39-79 years) and a mean disease duration of 55.0 (SD, 72.2) months (range, 0-456 months). A total of 161, 161, 146, and 85 patients had received at least 1, 3, 12, and 24 months of the combination of T2 and MTX, with a total of 4162 patient-months' exposure to the combination therapy. The combination therapy reduced tender and swollen joint counts, morning stiffness, inflammatory indices such as ESR and CRP, and improved disease activity as measured by the DAS28 significantly by 3 months as well as 12 months (P < 0.05). Most of the adverse events noted during this study were mild. Menstrual irregularity occurred in 72.7% (16/22) of premenopausal female. Only 10 (6.0%) and 8 (4.8%) subjects withdrew because of adverse events or lack of efficacy, respectively. Severe infections were very rare.
Conclusion: T2 plus MTX is an effective and relatively safe treatment for RA patients.