Takeuchi Tsutomu, Miyasaka Nobuyuki, Inui Takashi, Yano Toshiro, Yoshinari Toru, Abe Tohru, Koike Takao
From the Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University; Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo; Mitsubishi Tanabe Pharma Corporation, Osaka; Saitama Medical Center, Saitama Medical University, Saitama; and the Sapporo Medical Center NTT EC, Hokkaido, Japan.T. Inui, T. Yano, and T. Yoshinari are employees of Mitsubishi Tanabe Pharma. T. Takeuchi, MD, PhD, Professor, Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University; N. Miyasaka, MD, PhD, Professor Emeritus, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University; T. Inui, DVM; T. Yano, PhD; T. Yoshinari, MS, Mitsubishi Tanabe Pharma Corporation; T. Abe, MD, PhD, Professor Emeritus, Saitama Medical Center, Saitama Medical University; T. Koike, MD, PhD, Chief Executive, Sapporo Medical Center NTT EC.
J Rheumatol. 2015 Apr;42(4):599-607. doi: 10.3899/jrheum.140572. Epub 2015 Feb 15.
To investigate the probability of clinical remission (REM) or low disease activity (LDA) after 1 year of infliximab (IFX) therapy based on disease activity at 3 months in patients with rheumatoid arthritis (RA).
Methotrexate-refractory patients with RA received 3 mg/kg of IFX at weeks 0, 2, and 6, followed by 3 mg/kg, 6 mg/kg, or 10 mg/kg every 8 weeks from Week 14 (W14) to Week 46. Correlation of disease activity at W14 with disease activity at W54 and probability of REM/LDA at W54 were analyzed in each dosing group.
Disease activities at W14 were significantly correlated with both disease activity at W54 and probability of REM/LDA at W54 in patients continuing 3 mg/kg as well as in those receiving 6 mg/kg or 10 mg/kg therapy from W14. Results showed that, if approximate REM or LDA had not been achieved by W14, > 50% of patients continuing 3 mg/kg therapy would not be able to achieve REM or LDA at W54. However, even in patients with high or moderate disease activity at W14, dose escalation to 6 mg/kg or 10 mg/kg enabled many to achieve REM/LDA.
Disease activity at W14 in standard-dose IFX therapy enabled the prediction of longterm clinical response at continued standard dose, as well as subsequent escalated-dose regimens. Disease activity at W14 was hypothesized to be an important index for IFX treatment strategy.
基于类风湿关节炎（RA）患者3个月时的疾病活动度，调查英夫利昔单抗（IFX）治疗1年后临床缓解（REM）或低疾病活动度（LDA）的概率。
对甲氨蝶呤治疗无效的RA患者在第0、2和6周接受3mg/kg的IFX治疗，随后从第14周（W14）至第46周每8周分别接受3mg/kg、6mg/kg或10mg/kg的治疗。分析每个给药组中W14时的疾病活动度与W54时的疾病活动度以及W54时REM/LDA的概率之间的相关性。
在继续接受3mg/kg治疗的患者以及从W14开始接受6mg/kg或10mg/kg治疗的患者中，W14时的疾病活动度与W54时的疾病活动度以及W54时REM/LDA的概率均显著相关。结果表明，如果到W14时未达到近似的REM或LDA，继续接受3mg/kg治疗的患者中超过50%在W54时无法达到REM或LDA。然而，即使在W14时疾病活动度高或中度的患者中，将剂量增加至6mg/kg或10mg/kg也能使许多患者达到REM/LDA。
标准剂量IFX治疗中W14时的疾病活动度能够预测继续标准剂量以及随后增加剂量方案的长期临床反应。假设W14时的疾病活动度是IFX治疗策略的一个重要指标。
