Watanabe Kenji, Hirai Fumihito, Kobayashi Kiyonori, Takeuchi Ken, Kurosu Shinsuke, Inagaki Katsutoshi, Iwayama Ken-Ichi, Naganuma Makoto
Department of Internal Medicine for Inflammatory Bowel Disease, Toyama University Hospital, Toyama, Japan.
Department of Gastroenterology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
J Gastroenterol Hepatol. 2024 Nov;39(11):2367-2376. doi: 10.1111/jgh.16692. Epub 2024 Aug 4.
Early treatment response of ulcerative colitis (UC) symptom resolution is desirable. This post hoc analysis evaluated efficacy outcomes, including endoscopic remission, by responder status and the influence of once-daily (QD) versus twice-daily (BID) budesonide foam dosing in patients with UC.
Data were pooled from phase 2 and phase 3 clinical trials of budesonide rectal foam QD or BID or placebo for up to 12 weeks. Outcomes were evaluated by treatment and budesonide administration regimen and by responder group: early (rectal bleeding subscore [RBS] 0 from Week 2 through Week 6), delayed (RBS 0 at Week 6), and nonresponder (RBS > 0 at Week 6).
The main analysis set included 55 (QD) and 120 (BID) budesonide-treated patients and 116 placebo-treated patients. At Week 6, the trend in early response rate was significant among treatment groups (BID, 45.3%; QD, 32.1%; placebo, 12.8%; P < 0.0001). Among BID recipients, trends for complete endoscopic remission rate (Mayo endoscopic score [MES] = 0) and endoscopic remission rate (MES = 0 or 1) were significant among responder status groups (early responder, 67.4% and 95.4%, respectively; delayed responder, 48.1% and 85.2%; nonresponder, 24.0% and 64.0%; P < 0.001 for both). Regardless of the administration regimen, most early responders achieved endoscopic remission at Week 6. Among responder status groups, early responders' cumulative non-relapse period was greatest (P = 0.07).
A BID budesonide administration regimen is preferred to increase the probability of early response and, following endoscopic remission, a better prognosis after stopping treatment.
溃疡性结肠炎（UC）症状缓解的早期治疗反应是理想的。本事后分析评估了疗效结果，包括根据反应者状态的内镜缓解情况，以及每日一次（QD）与每日两次（BID）布地奈德泡沫剂给药对UC患者的影响。
汇总布地奈德直肠泡沫剂QD或BID或安慰剂的2期和3期临床试验数据，为期长达12周。通过治疗、布地奈德给药方案以及反应者组进行结果评估：早期（第2周至第6周直肠出血子评分[RBS]为0）、延迟（第6周RBS为0）和无反应者（第6周RBS>0）。
主要分析集包括55名（QD）和120名（BID）接受布地奈德治疗的患者以及116名接受安慰剂治疗的患者。在第6周时，各治疗组之间早期反应率的趋势具有显著性（BID，45.3%；QD，32.1%；安慰剂，12.8%；P<0.0001）。在接受BID治疗的患者中，完全内镜缓解率（梅奥内镜评分[MES]=0）和内镜缓解率（MES=0或1）在反应者状态组之间的趋势具有显著性（早期反应者分别为67.4%和95.4%；延迟反应者为48.1%和85.2%；无反应者为24.0%和64.0%；两者均P<0.001）。无论给药方案如何，大多数早期反应者在第6周时实现了内镜缓解。在反应者状态组中，早期反应者的累积无复发期最长（P=0.07）。
每日两次布地奈德给药方案更有利于提高早期反应的概率，在内镜缓解后，停药后的预后更佳。
