Dai Cong, Liu Wei-Xin, Jiang Min, Sun Ming-Jun
Department of Gastroenterology, First Affiliated Hospital, China Medical University, Shenyang City, Liaoning Province, China.
PLoS One. 2014 Oct 20;9(10):e110797. doi: 10.1371/journal.pone.0110797. eCollection 2014.
To assess the endoscopic activity and Clinical activity after a one-year period of infliximab therapy and to evaluate the association between mucosal healing and need for retreatment after stopping infliximab in patients with Inflammatory bowel disease (IBD).
The data from 109 patients with Crohn's disease (CD) and 107 patients with Ulcerative colitis (UC) received one-year infliximab were assessed. The primary endpoint of the study was the proportion of clinical remission, mucosal healing and full remission in IBD after the one-year period of maintenance infliximab therapy. The secondary endpoint was the frequency of relapses in the next year.
A total of 84.4% (92/109) CD patients and 81.3% (87/107) UC patients achieved clinical remission, 71.56% (78/109) of CD patients and 69.16% (74/107) of UC patients achieved mucosal healing, 56.88% (62/109) of CD patients and 54.21% (58/107) of UC patients achieved full remission at the end of the year of infliximab therapy. Infliximab therapy was restarted in the 10.19% (22/216) patients (13 CD, 9 UC) who achieved mucosal healing, and 13.89% (30/216) patients (18 CD, 12 UC) who achieved clinical remission and 6.48% (14/216) patients (8 CD, 6 UC) who achieved full remission had to be retreated within the next year. Neither clinical remission nor mucosal healing was associated with the time to restarting Infliximab therapy in IBD.
Mucosal healing did not predict sustained clinical remission in patients with IBD in whom the infliximab therapies had been stopped. And stopping or continuing infliximab therapy may be determined by assessing the IBD patient's general condition and the clinical activity.
评估英夫利昔单抗治疗一年后的内镜活动度和临床活动度,并评估炎症性肠病(IBD)患者停用英夫利昔单抗后黏膜愈合与再次治疗需求之间的关联。
评估了109例克罗恩病(CD)患者和107例溃疡性结肠炎(UC)患者接受一年英夫利昔单抗治疗的数据。该研究的主要终点是维持英夫利昔单抗治疗一年后IBD患者临床缓解、黏膜愈合和完全缓解的比例。次要终点是次年复发的频率。
在英夫利昔单抗治疗一年结束时,共有84.4%(92/109)的CD患者和81.3%(87/107)的UC患者实现了临床缓解,71.56%(78/109)的CD患者和69.16%(74/107)的UC患者实现了黏膜愈合,56.88%(62/109)的CD患者和54.21%(58/107)的UC患者实现了完全缓解。在实现黏膜愈合的患者中,10.19%(22/216)(13例CD,9例UC)重新开始使用英夫利昔单抗治疗,在实现临床缓解的患者中,13.89%(30/216)(18例CD,12例UC)以及在实现完全缓解的患者中,6.48%(14/216)(8例CD,6例UC)在次年必须再次接受治疗。在IBD患者中,临床缓解和黏膜愈合均与重新开始英夫利昔单抗治疗的时间无关。
对于停用英夫利昔单抗治疗的IBD患者,黏膜愈合并不能预测持续的临床缓解。停用或继续使用英夫利昔单抗治疗可通过评估IBD患者的一般状况和临床活动度来确定。