司库奇尤单抗治疗后的早期内镜结果与克罗恩病患者较少的住院和手术相关。

Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease.

作者信息

Feagan Brian G, Colombel Jean-Frederic, Panaccione Remo, Schreiber Stefan, Ferrante Marc, Kamikozuru Koji, Ma Christopher, Lee Wan-Ju, Griffith Jenny, Joshi Namita, Kligys Kristina, Kalabic Jasmina, Xuan Si, Dubinsky Marla

机构信息

Western University, Alimentiv Inc, London, Ontario, Canada.

Icahn School of Medicine at Mt Sinai, New York, New York.

出版信息

Gastro Hep Adv. 2024 Sep 5;4(1):100544. doi: 10.1016/j.gastha.2024.08.022. eCollection 2025.

DOI:10.1016/j.gastha.2024.08.022

PMID:39802486

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11720434/

Abstract

BACKGROUND AND AIMS

We evaluated the association between endoscopic outcomes following risankizumab induction and subsequent rates of hospitalization and surgery through 52 weeks of risankizumab (both doses) maintenance therapy in patients with Crohn's disease (CD).

METHODS

Patients with moderately to severely active CD and clinical response to 12-week risankizumab induction were rerandomized to continued therapy or drug withdrawal in the phase 3 FORTIFY maintenance trial. Incidence rates (events/100 person-years) of CD-related hospitalization and surgery, and the composite of both, through 52 weeks of maintenance were compared between patients achieving vs not achieving predefined endoscopic outcomes following induction.

RESULTS

Patients who achieved vs did not achieve endoscopic response or remission, or absence of ulcers (ulcer-free endoscopy) after induction had reduced rates of CD-related hospitalization through 52 weeks of risankizumab maintenance (endoscopic response, 1.7 vs 7.9/100 person-years; endoscopic remission, 1.2 vs 6.9/100 person-years; ulcer-free endoscopy, 1.5 vs 6.4/100 person-years; all < .05). No CD-related surgeries were observed through 52 weeks of risankizumab maintenance among patients who achieved vs did not achieve endoscopic outcomes following induction (endoscopic response, 0 vs 3.2/100 person-years; endoscopic remission, 0 vs 2.6/100 person-years; ulcer-free endoscopy, 0 vs 2.4/100 person-years; all = .025). In contrast, patients who received placebo during maintenance had statistically similar rates of CD-related hospitalizations and surgeries regardless of achievement of endoscopic outcomes after induction.

CONCLUSION

Patients achieving endoscopic outcomes following risankizumab induction experienced less CD-related hospitalizations and surgeries through 52 weeks of maintenance when continuing active therapy. Early treatment success may predict favorable long-term outcomes of disease.

CLINICAL REGISTERATION NUMBER

ADVANCE (NCT03105128); MOTIVATE (NCT03104413) and FORTIFY (NCT03105102).

摘要

背景与目的

我们评估了在克罗恩病（CD）患者中，瑞莎珠单抗诱导治疗后的内镜检查结果与后续住院率和手术率之间的关联，这些患者接受了52周的瑞莎珠单抗（两种剂量）维持治疗。

方法

在3期强化维持试验中，中度至重度活动性CD患者且对12周瑞莎珠单抗诱导治疗有临床反应的患者被重新随机分组，分别继续治疗或停药。比较诱导治疗后达到与未达到预定义内镜检查结果的患者在52周维持治疗期间CD相关住院和手术的发生率（事件/100人年），以及两者的综合发生率。

结果

诱导治疗后达到内镜反应或缓解、或无溃疡（无溃疡内镜检查）的患者与未达到的患者相比，在52周瑞莎珠单抗维持治疗期间，CD相关住院率降低（内镜反应：1.7 vs 7.9/100人年；内镜缓解：1.2 vs 6.9/100人年；无溃疡内镜检查：1.5 vs 6.4/100人年；均P<0.05）。诱导治疗后达到与未达到内镜检查结果的患者在52周瑞莎珠单抗维持治疗期间均未观察到CD相关手术（内镜反应：0 vs 3.2/100人年；内镜缓解：0 vs 2.6/100人年；无溃疡内镜检查：0 vs 2.4/100人年；均P = 0.025）。相比之下，维持治疗期间接受安慰剂的患者，无论诱导治疗后是否达到内镜检查结果，CD相关住院和手术率在统计学上相似。