Analysis Group, Inc., 1500-1190 Av des Canadiens-de-Montreal, Montreal, QC, H3B 0M7, Canada.
Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Adv Ther. 2024 Oct;41(10):3922-3933. doi: 10.1007/s12325-024-02963-1. Epub 2024 Aug 20.
Fistula is a common complication of Crohn's disease (CD). Treatment with biologics has been associated with fistula healing. Long-term persistence is an important factor for a chronic inflammatory process such as fistula. This study described 24-month persistence and time-to-surgery endpoints among bio-naïve patients with CD and intestinal fistula who were initiated on ustekinumab.
Adults with CD and any enteric or perianal fistula initiated on ustekinumab (index date) between September 23, 2016, and March 2, 2022, were selected from the IQVIA PharMetrics Plus database and followed up to 24 months. Persistence on ustekinumab (no gaps in days of supply of > 120 days) and composite endpoints of being persistent while on monotherapy and persistent while corticosteroid free were also assessed. The date of surgery was defined as the date of first claim for any CD-related surgeries. Persistence and time-to-surgery endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or other biologic use (event), corticosteroid use (event), date of surgery (event), 24-month follow-up or data end (censoring) using Kaplan-Meier analyses.
The sample included 445 patients (mean age: 42.8 years; 56.6% female). The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI] 55.8-71.4). Furthermore, 53.3% of patients were persistent while on monotherapy (95% CI 45.1-60.7), and 45.6% of patients were persistent while being corticosteroid free (95% CI 36.9-53.8). At 24 months, 22.8% (95% CI 17.0-30.3) of patients underwent any CD-related surgery.
This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after initiation. Time-to-surgery estimate was comparable to existing evidence. These findings support ustekinumab as a treatment option for long-term management of CD with fistula.
瘘管是克罗恩病（CD）的常见并发症。生物制剂治疗与瘘管愈合有关。长期存在是瘘管等慢性炎症过程的一个重要因素。本研究描述了在接受乌司奴单抗治疗的 CD 伴肠内或肠外瘘的生物初治患者中，24 个月的持续性和手术时间终点。
2016 年 9 月 23 日至 2022 年 3 月 2 日期间，从 IQVIA PharMetrics Plus 数据库中选择接受乌司奴单抗（索引日期）治疗的任何肠内或肠外瘘的 CD 成年患者，并随访 24 个月。评估乌司奴单抗的持续性（无供应天数超过 120 天的空白期）和单药治疗时持续和无皮质类固醇治疗时持续的复合终点。手术日期定义为首次进行任何与 CD 相关手术的日期。使用 Kaplan-Meier 分析，从索引日期到停药（事件）、免疫调节剂或其他生物制剂使用（事件）、皮质类固醇使用（事件）、手术日期（事件）、24 个月随访或数据结束（删失）的最早日期评估持续性和手术时间终点。
样本包括 445 名患者（平均年龄：42.8 岁；56.6%为女性）。最常见的瘘管类型为肛痿（36.0%）。乌司奴单抗治疗后 24 个月，64.2%的患者持续存在（95%置信区间[CI] 55.8-71.4）。此外，53.3%的患者单药治疗时持续存在（95%CI 45.1-60.7），45.6%的患者无皮质类固醇治疗时持续存在（95%CI 36.9-53.8）。24 个月时，22.8%（95%CI 17.0-30.3）的患者接受了任何与 CD 相关的手术。
本研究量化了生物初治 CD 伴瘘管患者乌司奴单抗的长期持续性。超过一半的接受乌司奴单抗治疗的患者在开始治疗后 24 个月时持续存在，且在单药治疗时持续存在。手术时间估计与现有证据相当。这些发现支持乌司奴单抗作为治疗 CD 伴瘘管的长期管理选择。
