Efficacy and safety evaluation of combination of iguratimod and methotrexate therapy for active rheu

• 作 者: Xin-Wang Duan Xiu-Ling Zhang Shao-Yuan Mao Jing-Jing Shang Xiao-Dong Shi
• 机 构: Department of Rheumatology, The Second Affiliated Hospital of Nanchang University, Nanchang 330006,
• 出 处: 第七届类风湿关节炎国际论坛
• 发表日期: 2015年4期
• 关键词: Rheumatoid arthritis Methotrexate Iguratimod

　　This study aimed to investigate efficacy and safety of iguratimod (T-614) in combination with methotrexate (MTX) for active rheumatoid arthritis (RA) patients.Sixty active RA patients were enrolled according to the 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) classification criteria, and were randomized into MTX + T-614 group and MTX group.T-614 was orally administered at dosage of 50 mg/day (25 mg twice daily) for 24 weeks.MTX was orally administered to RA patients at stable weekly dosage of l0 mg/week for the first 4 weeks and subsequent 12.5 mg/week for later 20 weeks.Clinical features at baseline and efficacy endpoints of the ACR 20% response (ACR20), ACR50, ACR70 and adverse events at 24 weeks were evaluated, respectively.After 24 weeks treatment, clinical features at baseline, including counts for tender joints and swelling joints, visual analogue scale for pain, patient and physicians global assessment, erythrocyte sedimentation rate, C-reactive protein, disease activity score 28, health assessment questionnaire, simplified disease activity index and ACR50 in MTX + T-614 group showed statistically significant differences comparing with MTX group (P < 0.05).There was no significantly increase in adverse events in MTX + T-614 group comparing with MTX group (P > 0.05).The combination of MTX and T-614 therapy appeared a good efficacy and safety for active RA and was superior to MTX alone therapy after 24 weeks treatment.