Ben-Horin Shomron, Lahat Adi, Ungar Bella, Ukashi Offir, Yablecovitch Doron, Amitai Marianne M, Haberman Yael, Selinger Limor, Talan-Asher Adi, Kriger-Sharabi Ofra, Naftali Timna, Ron Yulia, Yanai Henit, Dotan Iris, Kopylov Uri, Eliakim Rami
Department of Gastroenterology, Sheba Medical Center, Ramat-Gan, Israel; Faculty of Medical and Health Sciences, Tel-Aviv University, Tel-Aviv, Israel.
Department of Gastroenterology, Sheba Medical Center, Ramat-Gan, Israel; Faculty of Medical and Health Sciences, Tel-Aviv University, Tel-Aviv, Israel.
Gastroenterology. 2025 Jul;169(1):85-93.e3. doi: 10.1053/j.gastro.2025.02.031. Epub 2025 Mar 17.
BACKGROUND & AIMS: Optimal treat-to-target strategies for Crohn's disease (CD) are still being sought. The value of video capsule endoscopy (VCE) to guide proactive treat-to-target optimization in CD was examined.
A randomized controlled trial of patients with small bowel-involved (L1/L3) CD in corticosteroid-free clinical remission (Crohn's Disease Activity Index < 150). Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) ≥ 350 were designated "high risk" and randomized to either treat-to-target treatment optimization or continued standard care. Treat-to-target was optimized by means of repeat VCE results every 6 months. Patients with LS < 350 ("low risk") continued standard care. The primary outcome was the rate of disease exacerbation (Crohn's Disease Activity Index increase > 70 points and score > 150 or hospitalization/surgery) in high-risk standard care vs treat-to-target groups at 24 months.
Of 118 patients screened, 60 were enrolled. Treatment intensification in patients in the high-risk group allocated to proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20). The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio, 0.14; 95% CI, 0.04-0.57; P = .006). Mucosal healing was significantly more common among the treat-to-target group when determined by a cutoff LS < 350 (odds ratio, 4.5; 95% CI, 1.7-17.4; nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350. Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225-900 vs 225, 135-600, respectively; P = .07). Of 221 VCEs ingested, there was a single (0.4%) temporarily retained spontaneously resolved event.
A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care.
gov, Number: NCT03555058.
仍在探寻克罗恩病（CD）的最佳达标治疗策略。本研究探讨了视频胶囊内镜（VCE）在指导CD患者积极进行达标治疗优化中的价值。
一项针对小肠受累（L1/L3）且处于无糖皮质激素临床缓解期（克罗恩病活动指数<150）的CD患者的随机对照试验。患者在基线时摄入VCE，Lewis炎症评分（LS）≥350的患者被指定为“高风险”，并随机分为达标治疗优化组或继续接受标准治疗。通过每6个月重复VCE结果来优化达标治疗。LS<350（“低风险”）的患者继续接受标准治疗。主要结局是高风险标准治疗组与达标治疗组在24个月时疾病加重的发生率（克罗恩病活动指数增加>70分且评分>150或住院/手术）。
在118例筛查患者中，60例入组。分配到积极策略的高风险组患者的治疗强化包括生物制剂剂量增加（20例中的11例）、开始使用生物制剂（20例中的8例）或更换生物制剂（20例中的1例）。主要结局，即24个月时的临床复发，在20例高风险达标治疗患者中有5例（25%）发生，而在20例高风险标准治疗组中有14例（70%）发生（优势比，0.14；95%置信区间，0.04 - 0.57；P = 0.006）。当以LS<350为界值时，达标治疗组黏膜愈合明显更常见（优势比，4.5；95%置信区间，1.7 - 17.4；名义P值 = 0.03），但以总LS<450和最高节段LS<350的综合评分则不然。在所有继续接受标准治疗的患者（n = 40）中，复发者的基线LS在数值上高于未复发者（分别为450, 225 - 900与225, 135 - 600；P = 0.07）。在摄入的221次VCE中，有1次（0.4%）出现暂时滞留后自发缓解事件。
与继续接受标准治疗相比，VCE指导的缓解期CD患者达标治疗策略具有更好的临床结局。
美国国立医学图书馆临床试验注册中心，编号：NCT03555058
