Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU.

secondary_objectives

to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse.

评估停用anti-TNF对无复发生存时间、内镜和放射学活动性、安全性、生活质量及工作生产力的影响；并识别复发的预测因素。

Methods

Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn's disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn's disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)).

前瞻性、四重盲、多中心、随机对照试验。临床缓解超过6个月的溃疡性结肠炎或克罗恩病患者，且无严重内镜（克罗恩病还包括放射学）病变，被随机分配至维持抗TNF治疗（维持治疗组（MA））或停药（停药组（WA））。

All patients maintained immunomodulators.

所有患者均维持免疫调节剂治疗。

Patients were followed-up until month 12 or up to clinical relapse.

患者随访至第12个月或至临床复发。

Results

One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA.

共140名患者被随机分配：70名被分配到MA组，70名被分配到WA组。

The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%.

在12个月时，MA和WA中持续临床缓解的患者比例相似：MA为59/70（84%），95%置信区间为74%至92%；WA为53/70（76%），95%置信区间为64%至85%。

The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01).

随访结束时，MA中显著内镜病变的患者比例为8.5%，而WA为19%（p=0.1）；随访结束时，WA中粪便钙卫蛋白>250 µg/g的患者比例更高（p=0.01）。

The same percentage of patients in both groups had at least one adverse event(69%).

两组患者中至少发生一次不良事件的比例相同（69%）。

The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA).

两组中发生严重不良事件的患者比例也相似（MA组为4%，WA组为7%）。

Conclusions

Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.

在临床、内镜和放射学缓解的炎症性肠病（IBD）患者中，选择性停用抗TNF治疗对1年后持续临床缓解没有影响，尽管活动性客观标志物在停药患者中更高。

trial_registration_number

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.