Albshesh Ahmad, Bannon Lian, Sharar Fischler Tali, Truyens Marie, Vavricka Stephan R, Tepes Katja, Pugliese Daniela, Savarino Edoardo V, Zittan Eran, Drobne David, Roblin Xavier, Bar-Gil Shitrit Ariella, Armuzzi Alessandro, Lobaton Triana, Maharshak Nitsan, Yanai Henit, Ben-Horin Shomron, Kopylov Uri
Sheba Medical Center, Department of Gastroenterology, Tel Hashomer, Ramat Gan 5262100, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv 52621, Israel.
J Clin Med. 2023 Mar 26;12(7):2503. doi: 10.3390/jcm12072503.
The effectiveness of anti-TNF or ustekinumab (UST) as a second-line biologic after vedolizumab (VDZ) failure has not yet been described.
In this retrospective multicenter cohort study, We aim to investigate the effectiveness of anti-TNF and UST as second-line therapy in patients with Crohn's disease (CD) who failed VDZ as a first-line treatment. The primary outcome was clinical response at week 16-22. Secondary outcomes included the rates of clinical remission, steroid-free clinical remission, CRP normalization, and adverse events.
Fifty-nine patients who failed on VDZ as a first-line treatment for CD were included; 52.8% patients received anti-TNF and 47.2% UST as a second-line therapy. In initial period (Week 16-22), the clinical response and remission rate was similar between both groups: 61.2% vs. 68%, = 0.8 and 48.3% vs. 56%, = 0.8 on anti-TNF and UST therapy, respectively. Furthermore, in the maintenance period the rate was similar: 75% vs. 82.3%, = 0.8 and 62.5% vs. 70.5%, = 0.8, respectively. Of the patients, 12 out of the 59 stopped the therapy, without a significant difference between the two groups ( = 0.6).
Second-line biological therapy after VDZ failure therapy was effective in >60% of the patients with CD. No differences in effectiveness were detected between the use of anti-TNF and UST as a second line.
抗TNF或优特克单抗(UST)作为维多珠单抗(VDZ)治疗失败后的二线生物制剂的有效性尚未见报道。
在这项回顾性多中心队列研究中,我们旨在调查抗TNF和UST作为一线治疗失败的克罗恩病(CD)患者的二线治疗的有效性。主要结局是第16 - 22周的临床缓解。次要结局包括临床缓解率、无激素临床缓解率、C反应蛋白(CRP)正常化率和不良事件发生率。
纳入59例一线使用VDZ治疗失败的CD患者;52.8%的患者接受抗TNF作为二线治疗,47.2%的患者接受UST作为二线治疗。在初始阶段(第16 - 22周),两组的临床缓解率和缓解率相似:抗TNF治疗组和UST治疗组分别为61.2%对68%,P = 0.8和48.3%对56%,P = 0.8。此外,在维持阶段,该比率也相似:分别为75%对82.3%,P = 0.8和62.5%对70.5%,P = 0.8。59例患者中有12例停止治疗,两组之间无显著差异(P = 0.6)。
VDZ治疗失败后的二线生物治疗对超过60%的CD患者有效。抗TNF和UST作为二线治疗在有效性方面未检测到差异。