Tripterygium Treatment Of Rheumatoid Arthritis Efficacy And Safety Assessment

Comparison of Tripterygium wilfordii Hook F versus Methotrexate in the Treatment of Rheumatoid ArthritisBackgroundRheumatoid arthritis is a chronic, systemic inflammatory disorder, and is characterized by symmetric, peripheral polyarthritis, if untreated, typically leads to deformity and destruction of joints through the erosion of cartilage and bone. Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China extensively to treat rheumatoid arthritis, however, the efficacy and safety is not evaluated clearly. This clinical trial aims to compare the efficacy and safety of oral TwHF in the treatment of active rheumatoid arthritis patients with that of Methotrexate (MTX).Design1. Multi-centered, open-labeled, randomized, controlled prospective trial. A computer-generated code with random was used to assign treatment. Observation period is24weeks.2. Patients:114patients with active rheumatoid arthritis from3general hospital with rheumatology subspecialty clinics(Peking Union Medical College Hospital, The Second Hospital of HeBei Medical University, The Third Hospital of HeBei Medical University) were included. The patients were randomly assigned into3arms, with TwHF or MTX or MTX combined with TwHF. Patients had to stop taking disease-modifying antirheumatic drugs (DMARDs) at least28days before randomization.3. Intervention:TwHF extract20mg tid. MTX starting from7.5mg qw increased to12.5mg qw (max0.3mg/kg) within4weeks with folic acid10mg on the day following each MTX administration. MTX combined with TwHF as above dosage. Nonsteroidal anti-inflammatory drugs (NSAID) and stable doses of oral corticosteroids were allowed. At12weeks, if patients in the MTX or TwHF arm reach DAS28partial remission (DAS28decrease30%of the first visit), then the monotherapy should be continued; if not, then the patients should be switched into MTX plus TwHF treatment. 4. Measurements:Primary efficacy endpoint was the rate of achievement of20%improvement in the American College of Rheumatology criteria (ACR20) at week24and the change of radiographic scores of joint damage. Secondary efficacy endpoint included the rate of achievement of ACR20%, ACR50%, ACR70%improvements and EULAR response(The European League Against Rheumatism response) at4,12and24weeks. Primary safety endpoint was the proportion of discontinuations due to adverse events. Secondary safety endpoints included percentage of all the adverse events.Results:74patients completed the4weeks study, but only16patients met the12weeks follow up. The study is carrying on while the article is written. In the intention to treat analysis,44.4%of both the TwHF group and MTX group met the ACR20response criteria, while the MTX+TwHF group had a slightly higher proportion of57.7%after4weeks follow up(P=0.540). Similarly for the EULAR response after12weeks follow up, patients receiving MTX+TwHF had higher response rate for EULAR moderate and good response, which was60.0%, the EULAR response rate for TwHF and MTX group was50.0%and28.6%respectively (P=0.527). Analyses of only completers showed similar results. No significant difference was seen among the components of the ACR criteria, including the HAQ, SF-36and DAS28, except for ESR at4th week, which TwHF group is significantly lower than MTX group (P=0.009). The frequency of adverse events was similar among the3different groups (P=0.228).Conclusion:There is no significant difference between the efficacy and safety of TwHF and that of MTX in treating active rheumatoid arthritis after the12weeks treatment.