BACKGROUND Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. There are limited but favourable data regarding its possible use in patients with inflammatory bowel disease (IBD). AIMS To evaluate the efficacy and safety of tacrolimus in patients with IBD in clinical practice. METHODS We performed a retrospective, multicentre study in 22 centres in Spain. All adult patients who received oral tacrolimus for luminal or perianal IBD were included. Clinical response was assessed by Harvey-Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment. RESULTS One hundred and forty-three patients were included (mean age 38 years; 51% male; median disease duration 110 months). In ulcerative colitis (UC) (n = 58), the partial Mayo score decreased after 3 months from median 6 to 3 (P = 0.0001), whereas in Crohn's disease (CD) (n = 85), the Harvey-Bradshaw index decreased after 3 months from median 9 to 7 (P = 0.011). In CD patients, blood tacrolimus concentrations during induction (>10 ng/mL vs <10 ng/mL; odds ratio 0.23, 95% CI 0.05-0.87) and the concomitant use of thiopurines (odds ratio 0.18, 95% CI 0.04-0.81) were associated with lower clinical disease activity at 3 months. Of 62 patients with perianal disease, complete closure was observed in 8% (n = 5) of patients with perianal fistulas, with 34% (n = 21) showing partial response. Treatment was maintained for a median of 6 months (IQR, 2-16). After a median clinical follow-up of 24 months (IQR, 15-57), the rate of treatment-related adverse events was 34%, correlating with blood drug concentrations (P = 0.021). Finally, 120 patients (84%) discontinued tacrolimus, usually due to absence or loss of response. Three patients (2%) were subsequently diagnosed with cancer. The overall rate of surgery was 39%, with a 33% colectomy rate in UC. CONCLUSIONS Tacrolimus shows a clinical benefit in both CD and UC after 3 months of treatment, but its long-term effectiveness and frequent adverse events remain relevant issues in clinical practice.

中文翻译：

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他克莫司在炎症性肠病中引起短期而非长期临床反应。

背景技术他克莫司是一种钙调神经磷酸酶抑制剂，通常用于预防肾脏和肝脏移植的排斥反应。关于其在炎性肠病（IBD）患者中的可能用途的资料有限，但令人满意。目的在临床实践中评估他克莫司对IBD患者的疗效和安全性。方法我们在西班牙的22个中心进行了一项回顾性，多中心研究。所有接受口服他克莫司腔内或肛周IBD治疗的成人患者均包括在内。3个月后通过Harvey-Bradshaw指数和部分Mayo评分评估临床反应。通过瘘管引流评估评估肛周疾病。结果共纳入143例患者（平均年龄38岁；男性51％；中位病程110个月）。在溃疡性结肠炎（UC）（n = 58）中，3个月后，部分Mayo评分从中位数6降至3（P = 0.0001），而在克罗恩病（CD）（n = 85）中，3个月后，Harvey-Bradshaw指数从中位数9降至7（P = 0.011） ）。在CD患者中，诱导过程中他克莫司的血药浓度（> 10 ng / mL vs <10 ng / mL;比值比0.23，95％CI 0.05-0.87）和同时使用硫嘌呤（比值比0.18，95％CI 0.04-0.81） ）与3个月时临床疾病活动降低有关。在62例肛周疾病患者中，有8％（n = 5）的肛周瘘患者观察到完全闭合，其中34％（n = 21）表现出部分缓解。维持治疗的中位数为6个月（IQR，2-16）。经过24个月的中位临床随访（IQR，15-57），与治疗相关的不良事件发生率为34％，与血药浓度相关（P = 0.021）。最后，有120例患者（84％）停用他克莫司，通常是由于缺乏反应或失去反应。随后三名患者（占2％）被诊断出患有癌症。UC的总体手术率为39％，结肠切除率为33％。结论他克莫司治疗3个月后对CD和UC均有临床益处，但其长期有效性和频繁的不良事件仍是临床实践中的相关问题。