Koike Takao, Harigai Masayoshi, Ishiguro Naoki, Inokuma Shigeko, Takei Syuji, Takeuchi Tsutomu, Yamanaka Hisashi, Haruna Shigenori, Ushida Naoko, Kawana Katsuyoshi, Tanaka Yoshiya
NTT Sapporo Medical Center , Sapporo Hokkaido , Japan.
Mod Rheumatol. 2014 May;24(3):390-8. doi: 10.3109/14397595.2013.843760. Epub 2013 Nov 6.
To confirm the safety and effectiveness of adalimumab and to evaluate the influence of the concomitant use of methotrexate (MTX).
Postmarketing surveillance of 7740 Japanese rheumatoid arthritis (RA) patients was performed. All patients who received adalimumab in the registration period were followed for 28 weeks after starting treatment for safety and 24 weeks for effectiveness. Effectiveness was measured by duration of morning stiffness, swollen and tender joint counts (28 joints), patient global assessment of disease activity, erythrocyte sedimentation rate and serum C-reactive protein.
Comparable rates of adverse drug reactions (ADRs) were reported in this study and in the interim analysis. Age, pulmonary disease history or comorbidity, co-existing diabetes mellitus, concomitant MTX at doses of > 8 mg/week and concomitant glucocorticoids at doses of > 5 mg/day were risk factors for infections. All mean values of effectiveness measurements improved. Relatively lower disease activity at baseline, biologic-naïve, concomitant MTX use and early RA stage/low functional class were background factors contributing to the effectiveness. The combination of adalimumab with MTX improved the response to adalimumab treatment.
Adalimumab, especially with concomitant use of MTX, provided significant improvement in disease activity, without any unexpected ADRs in Japanese RA patients.
确认阿达木单抗的安全性和有效性，并评估甲氨蝶呤（MTX）联合使用的影响。
对7740例日本类风湿关节炎（RA）患者进行上市后监测。所有在注册期接受阿达木单抗治疗的患者在开始治疗后随访28周以评估安全性，随访24周以评估有效性。有效性通过晨僵持续时间、肿胀和压痛关节数（28个关节）、患者对疾病活动的整体评估、红细胞沉降率和血清C反应蛋白来衡量。
本研究和中期分析报告的药物不良反应（ADR）发生率相当。年龄、肺部疾病史或合并症、并存糖尿病、每周使用剂量>8 mg的MTX以及每天使用剂量>5 mg的糖皮质激素是感染的危险因素。所有有效性测量的平均值均有所改善。基线时疾病活动度相对较低、未使用过生物制剂、联合使用MTX以及处于RA早期/功能分级较低是影响有效性的背景因素。阿达木单抗与MTX联合使用可改善对阿达木单抗治疗的反应。
阿达木单抗，尤其是与MTX联合使用时，可显著改善日本RA患者的疾病活动度，且无任何意外的ADR。
