Brian G. Feagan , Jean-Frederic Colombel , Remo Panaccione , Stefan Schreiber , Marc Ferrante , Koji Kamikozuru , Christopher Ma , Wan-Ju Lee , Jenny Griffith , Namita Joshi , Kristina Kligys , Jasmina Kalabic , Si Xuan , Marla Dubinsky
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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.</div></div><div><h3>Results</h3><div>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 <em>P</em> < .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 <em>P</em> = .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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 1","pages":"Article 100544"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11720434/pdf/","citationCount":"0","resultStr":"{\"title\":\"Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease\",\"authors\":\"Brian G. Feagan , Jean-Frederic Colombel , Remo Panaccione , Stefan Schreiber , Marc Ferrante , Koji Kamikozuru , Christopher Ma , Wan-Ju Lee , Jenny Griffith , Namita Joshi , Kristina Kligys , Jasmina Kalabic , Si Xuan , Marla Dubinsky\",\"doi\":\"10.1016/j.gastha.2024.08.022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background and Aims</h3><div>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).</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 <em>P</em> < .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 <em>P</em> = .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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>\",\"PeriodicalId\":73130,\"journal\":{\"name\":\"Gastro hep advances\",\"volume\":\"4 1\",\"pages\":\"Article 100544\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11720434/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastro hep advances\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2772572324001389\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastro hep advances","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772572324001389","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景和目的：我们评估了克罗恩病（CD）患者在52周的利桑单抗（两种剂量）维持治疗中内窥镜结果与随后住院和手术率之间的关系。方法：在3期FORTIFY维持试验中，对12周利桑单抗诱导有临床反应的中度至重度活动性CD患者被重新随机分配到继续治疗或停药组。通过52周的维持，比较了在诱导后达到与未达到预定内镜结果的患者之间与cd相关的住院和手术发生率（事件/100人年）以及两者的组合。结果：诱导后达到或未达到内窥镜反应或缓解，或没有溃疡（无溃疡内窥镜检查）的患者，通过52周的利桑单抗维持，cd相关住院率降低(内窥镜反应，1.7 vs 7.9/100人年；内镜下缓解，1.2 vs 6.9/100人年；无溃疡内窥镜检查，1.5 vs 6.4/100人年；P < 0.05)。在52周的利桑单抗维持期中，在诱导后达到或未达到内窥镜结果的患者中，没有观察到与cd相关的手术(内窥镜反应，0 vs 3.2/100人年；内镜下缓解，0 vs 2.6/100人年；无溃疡内窥镜检查，0 vs 2.4/100人年；P = 0.025)。相比之下，在维持期间接受安慰剂的患者与cd相关的住院率和手术率在统计上相似，无论诱导后的内窥镜结果如何。结论：在利桑单抗诱导后达到内镜治疗结果的患者，在持续积极治疗的52周维持期内，与cd相关的住院和手术次数减少。早期治疗的成功可能预示着疾病良好的长期预后。临床注册号：ADVANCE (NCT03105128)；MOTIVATE （NCT03104413）和FORTIFY （NCT03105102）。
Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease
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 P < .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 P = .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.
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