Hospital Clínic, Barcelona, Spain.
J Crohns Colitis. 2013 Oct;7(9):717-22. doi: 10.1016/j.crohns.2012.10.004. Epub 2012 Nov 8.
Information on efficacy and predictors of response to adalimumab in ulcerative colitis (UC) clinical practice is limited.
Assessment of response to adalimumab and its predictors in an observational cohort study.
Retrospective cohort study based on data obtained from ENEIDA registry. All patients diagnosed with UC treated with adalimumab were included. Response to adalimumab was evaluated at weeks 12, 28, and 54 according to the partial Mayo score, and requirement of colectomy until end of follow-up.
48 patients with UC treated with adalimumab were included; 39 (81.3%) had previously received infliximab. Response rates at weeks 12, 28 and 54 were 70.8%, 43.2% and 35% respectively. Response to prior treatment with infliximab was the only predictive factor of response to adalimumab at week 12, which was obtained in 90% of infliximab remitters, 53.8% of responders and 33.3% of primary non-responders (p=0.01). Colectomy was required in 11 patients (22.9%), after a mean time of 205 days. The only clinical independent predictor of colectomy was non-response to adalimumab at week 12: colectomy rates were 5/34 (14.7%) in responders and 6/14 (42.9%) in non-responders (p=0.035), time free of colectomy was significantly reduced in non-responders (p=0.01). Adalimumab withdrawal due to adverse events occurred in 4.2% of patients.
This study shows that adalimumab is an effective treatment in patients with UC. If used as a second anti-TNF, previous achievement of remission with the first anti-TNF predicts response, and failure to achieve response at week 12 predicts colectomy.
在溃疡性结肠炎（UC）的临床实践中，关于阿达木单抗疗效和应答预测因素的信息有限。
在一项观察性队列研究中评估阿达木单抗的应答及其预测因素。
这是一项基于 ENEIDA 注册中心数据的回顾性队列研究。纳入所有接受阿达木单抗治疗的 UC 患者。根据部分 Mayo 评分，在第 12、28 和 54 周评估阿达木单抗的应答，并在随访结束时评估是否需要结肠切除术。
纳入 48 例接受阿达木单抗治疗的 UC 患者；其中 39 例（81.3%）既往接受过英夫利昔单抗治疗。第 12、28 和 54 周的应答率分别为 70.8%、43.2%和 35%。既往接受英夫利昔单抗治疗的应答是第 12 周对阿达木单抗应答的唯一预测因素，在英夫利昔单抗缓解者、应答者和原发性无应答者中分别获得 90%、53.8%和 33.3%（p=0.01）。11 例（22.9%）患者需要结肠切除术，平均时间为 205 天。第 12 周对阿达木单抗无应答是结肠切除术的唯一独立临床预测因素：应答者的结肠切除术率为 5/34（14.7%），无应答者为 6/14（42.9%）（p=0.035），无应答者的免于结肠切除术时间显著缩短（p=0.01）。由于不良反应，有 4.2%的患者停用阿达木单抗。
本研究表明，阿达木单抗是 UC 患者的有效治疗方法。如果将其用作第二种抗 TNF，首次抗 TNF 获得缓解预示着对阿达木单抗的应答，第 12 周无应答预示着需要结肠切除术。
