Dig Liver Dis. 2013 Sep;45(9):738-43. doi: 10.1016/j.dld.2013.03.018. Epub 2013 May 15.
The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres.
All patients with active disease treated with adalimumab were retrospectively reviewed. Co-primary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need for colectomy.
Eighty-eight patients were included. Most patients had received previous infliximab treatment. Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twenty-two patients required colectomy. Clinical remission and low C-reactive protein at week 12 predicted clinical remission at week 54 (OR 4.17, 95% CI 2.36-19.44; OR 2.63, 95% CI 2.32-14.94, respectively). Previous immunosuppressant use was associated with a lower probability of clinical remission at week 54 (OR 0.67, 95% CI 0.08-0.66) and with a higher rate of colectomy (HR 9.7, 95% CI 1.46-9.07).
In this large "real-life" experience adalimumab appears effective in patients with otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.
阿达木单抗治疗溃疡性结肠炎的疗效存在争议。虽然对照试验表明阿达木单抗明显优于安慰剂，但绝对临床获益有限。我们报告了在意大利 22 个中心治疗的溃疡性结肠炎患者队列中阿达木单抗的有效性数据。
回顾性分析所有接受阿达木单抗治疗的活动性疾病患者。主要终点是第 4、12、24 和 54 周时的临床缓解。次要终点是持续临床缓解、类固醇停药、内镜缓解和结肠切除的需要。
纳入 88 例患者。大多数患者曾接受过英夫利昔单抗治疗。第 4、12、24 和 54 周时的临床缓解率分别为 17%、28.4%、36.4%和 43.2%。22 例患者需要结肠切除。第 12 周时的临床缓解和低 C 反应蛋白预测第 54 周时的临床缓解（OR 4.17，95%CI 2.36-19.44；OR 2.63，95%CI 2.32-14.94）。先前使用免疫抑制剂与第 54 周时临床缓解的可能性降低（OR 0.67，95%CI 0.08-0.66）和结肠切除率升高相关（HR 9.7，95%CI 1.46-9.07）。
在这项大型“真实世界”研究中，阿达木单抗似乎对其他药物难治性溃疡性结肠炎患者有效。早期缓解的患者可以预期更好的长期结果。
