Department of Medicine I, Christian Albrechts University, University Hospital Schleswig-Holstein, Kiel, Germany.
Aliment Pharmacol Ther. 2011 Jan;33(2):185-93. doi: 10.1111/j.1365-2036.2010.04509.x. Epub 2010 Nov 17.
Treatment options for fistulizing Crohn's disease (CD) are limited.
To examine whether fistula closure is maintained at week 26 following treatment with certolizumab pegol.
Patients with draining fistulas at baseline from PRECiSE 2 (n = 108) received open-label induction with certolizumab pegol 400 mg at weeks 0 (baseline), 2 and 4. Response was defined as ≥100-point decrease from baseline in the Crohn's Disease Activity Index. Nonresponders (50/108) were excluded. At week 6, responders with draining fistulas (N = 58) were randomised to certolizumab pegol 400 mg (n = 28) or placebo (n = 30) every 4 weeks across weeks 8-24. Fistula closure was evaluated throughout the study, with a final assessment at week 26.
The majority of patients (55/58) had perianal fistula. At week 26, 36% of patients in the certolizumab pegol group had 100% fistula closure compared with 17% of patients receiving placebo (P = 0.038). Protocol-defined fistula closure (≥50% closure at two consecutive post-baseline visits ≥3 weeks apart) was not statistically significant (P = 0.069) with 54% and 43% of patients treated with certolizumab pegol and placebo achieving this end point, respectively.
Continuous treatment with certolizumab pegol improves the likelihood of sustained perianal fistula closure compared with placebo.
瘘管性克罗恩病（CD）的治疗选择有限。
评估培塞丽珠治疗后第 26 周时瘘管是否仍保持闭合。
PRECiSE 2 研究中基线时存在有引流瘘管的患者（n=108）接受培塞丽珠 400mg 开放性诱导治疗，分别在第 0（基线）周、第 2 周和第 4 周给药。缓解定义为克罗恩病活动指数（CDAI）较基线下降≥100 分。未缓解者（50/108）被排除。第 6 周时，有引流瘘管的缓解者（n=58）被随机分为培塞丽珠 400mg（n=28）或安慰剂（n=30）组，两组均在第 8-24 周每 4 周给药 1 次。整个研究期间评估瘘管闭合情况，最终评估在第 26 周进行。
大多数患者（55/58）存在肛周瘘管。在第 26 周时，培塞丽珠组有 36%的患者瘘管完全闭合，而安慰剂组为 17%（P=0.038）。方案定义的瘘管闭合（两次连续随访≥3 周且较基线分别下降≥50%）没有统计学意义（P=0.069），分别有 54%和 43%的培塞丽珠组和安慰剂组患者达到这一终点。
与安慰剂相比，连续应用培塞丽珠治疗可提高持续性肛周瘘管闭合的可能性。
