Initiative on Crohn and Colitis, Amsterdam/Leiden, The Netherlands.
Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands.
J Crohns Colitis. 2021 Nov 8;15(11):1920-1930. doi: 10.1093/ecco-jcc/jjab081.
Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease [CD].
Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index≤ 4 points], biochemical remission (faecal calprotectin ≤ 200 μg/g and/or C-reactive protein ≤5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104.
In total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed.
After 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.
乌司奴单抗是一种单克隆抗体，能选择性地靶向细胞因子白细胞介素[IL]-12 和 IL-23 的共同亚单位 p40。它被注册用于治疗炎症性肠病。我们评估了乌司奴单抗在克罗恩病[CD]的真实世界前瞻性队列患者中的 2 年有效性和安全性。
开始使用乌司奴单抗的患者前瞻性地纳入全国克罗恩病和结肠炎倡议[ICC]登记处。在第 0、12、24、52 和 104 周时，评估临床缓解（Harvey Bradshaw 指数≤4 分）、生化缓解（粪便钙卫蛋白≤200μg/g 和/或 C 反应蛋白≤5mg/L）、肛周瘘管缓解、肠外表现、乌司奴单抗剂量和安全性结果。主要结局是第 104 周时无皮质类固醇的临床缓解。
共有 252 例至少随访 2 年的 CD 患者纳入研究。在所有纳入的患者中，无皮质类固醇的临床缓解率分别为第 12、24、52 和 104 周时的 32.3%（81/251）、41.4%（104/251）、39%（97/249）和 34.0%（84/247）。在基线时同时存在临床和生化疾病活动的患者[n=122]中，无皮质类固醇的临床缓解率分别为第 12、24、52 和 104 周时的 23.8%（29/122）、35.2%（43/122）、40.0%（48/120）和 32.8%（39/119）。所有患者在第 52 和 104 周时继续使用乌司奴单抗治疗的概率分别为 64.3%和 54.8%。在第 52 周后停止治疗的主要原因是无应答[66.7%]。未观察到新的安全性问题。
在乌司奴单抗治疗 104 周后，三分之一的 CD 患者达到无皮质类固醇的临床缓解。
