Tripterygium WILFORDII multiglycoside combined regimen as long-term maintenance therapy in chinese rheumatoid arthritis patients

Abstract

Background Long-term use of traditional and biologic disease-modifying anti-rheumatic drugs (DMARDs) has been applied to achieve the goal of rheumatoid arthritis (RA) treatment. Despite the proven efficacy of DMARDs, there is concern of increased risk of side effects in the long-term therapy. DMARD sparing agents with lower toxicity were required to be identified for modification of the therapeutic strategies. Tripterygium wilfordii multiglycoside (GTW), an authorized Chinese patent drug, has been used for the treatment of autoimmune diseases for decades in China[1]. We retrospectively reviewed 268 RA patients treated with GTW combined DMARDs or DMARDs without GTW for maintenance therapy, compared the efficacy, observed side effects and preliminarily explore the dose reduction or discontinuation protocol of some label DMARDs.

Objectives To evaluate the efficacy and safety of Tripterygium wilfordii multiglycoside combined therapy as long-term maintenance therapy in the treatment of rheumatoid arthritis.

Methods We retrospectively reviewed 268 patients with rheumatoid arthritis between 2006 and 2008 in south China who received MTX, etanercept, or GTW combined MTX/etanercept regimens as maintenance therapy. After a standard treatment to target based on MTX or MTX in combination with etanercept as induction therapy, GTW (target dose: 1.8 g/day) were given to the patients with sufficient response to baseline DMARDs. Baseline MTX and/or etanercept was continued for another three months after remission, then stepped down every three months until discontinuation of etanercept and half of the MTX dose at the onset. The patients were followed up for 3 years. Details of the clinical presentation, serological, immunological variables and side effects were collected.

Results In patients receiving maintenance therapy with combined GTW, disease activity score (DAS28) and x-ray changes were similar to the patients receiving usual treatment. More than half of the patients treated with combined GTW had no radiographic progression over 3 years, compared with those treated with usual dose of MTX and/or etanercept (63.4% vs 69.6%; p>0.05). Improvements in laboratory measurements and physical functions were comparable. Drug related toxicities including abnormal liver function, infection and gastrointestinal intolerance, etc were significantly lower in GTW group.

Conclusions GTW was a well tolerated and effective DMARD sparing agents in the maintenance therapy of rheumatoid arthritis. Concomitant GTW decreased the exposure to MTX and etanercept, thus reduced the correlative side effects.