Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial.
Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial.
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DOI：
10.1136/annrheumdis-2013-203843
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发表时间：
2014-01
影响因子：
27.4
通讯作者：
Fleischmann R
中科院分区：
文献类型：
--
作者：
Schiff M;Weinblatt ME;Valente R;van der Heijde D;Citera G;Elegbe A;Maldonado M;Fleischmann R
比较皮下注射阿巴西普与阿达木单抗联合甲氨蝶呤（MTX）治疗类风湿性关节炎（RA）患者2年的安全性、疗效和影像学结局。 AMPLE是一项IIIb期、2年、随机化、药物设盲研究，主要终点为1年。活动性RA和MTX疗效不佳的生物制剂初治患者被随机分配至阿巴西普125 mg每周一次或阿达木单抗40 mg每两周一次，均接受稳定剂量的MTX。 在646例随机化患者中，79.2%的阿巴西普患者和74.7%的阿达木单抗患者完成了第2年治疗。在第2年，两组之间的疗效结局（包括影像学）与第1年的结果相似。第2年时，阿巴西普的美国大学流变学20、50和70分应答率分别为59.7%、44.7%和31.1%，阿达木单抗分别为60.1%、46.6%和29.3%。不良事件（AE）和严重不良事件（SAE）的发生率相似。阿达木单抗组发生了更严重的感染（3.8% vs 5.8%），包括阿达木单抗组的2例结核病例。阿巴西普组因AE（3.8% vs 9.5%）、SAE（1.6% vs 4.9%）和严重感染（0/12 vs 9/19例患者）而停药的患者较少。阿巴西普组注射部位反应（ISR）发生率较低（4.1% vs 10.4%）。在这项首个头对头研究中，在MTX疗效不佳的RA患者中，通过2年的盲法治疗，基于临床、功能和影像学结局，皮下注射阿巴西普和阿达木单抗的疗效相似。总体而言，两组的AE频率相似，但因AE、SAE、严重感染而停药的情况较少，阿巴西普的局部ISR较少。NCT 00929864。
To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%). Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept. NCT00929864.
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影响因子：
--
作者：
Keystone, EC;Kavanaugh, AF;Chartash, EK
通讯作者：
Chartash, EK
影响因子：
4.9
作者：
Aletaha D;Nell VP;Stamm T;Uffmann M;Pflugbeil S;Machold K;Smolen JS
通讯作者：
Smolen JS
影响因子：
--
作者：
Fleischmann, Roy;Cutolo, Maurizio;Zwillich, Samuel H.
通讯作者：
Zwillich, Samuel H.
影响因子：
27.4
作者：
Burmester, G. R.;Mease, P.;Pangan, A. L.
通讯作者：
Pangan, A. L.
影响因子：
27.4
作者：
Schoels, Monika;Aletaha, Daniel;Wong, John B.
通讯作者：
Wong, John B.