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 moderatel...
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Elsevier
2025-01-01
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| Series: | Gastro Hep Advances |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772572324001389 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Brian G. Feagan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-cd4d3d835ecc4c679cb17bc761a48617 |
| institution | Kabale University |
| issn | 2772-5723 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Gastro Hep Advances |
| spelling | doaj-art-cd4d3d835ecc4c679cb17bc761a486172025-01-18T05:05:34ZengElsevierGastro Hep Advances2772-57232025-01-0141100544Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s DiseaseBrian G. Feagan0Jean-Frederic Colombel1Remo Panaccione2Stefan Schreiber3Marc Ferrante4Koji Kamikozuru5Christopher Ma6Wan-Ju Lee7Jenny Griffith8Namita Joshi9Kristina Kligys10Jasmina Kalabic11Si Xuan12Marla Dubinsky13Western University, Alimentiv Inc, London, Ontario, Canada; Correspondence: Address correspondence to: Brian G. Feagan, MD, Western University, 100 Dundas Street, Suite 200, London, Ontario N6A 5B6, Canada.Icahn School of Medicine at Mt Sinai, New York, New YorkUniversity of Calgary, Calgary, Alberta, CanadaDepartment Medicine I, University Hospital Schleswig-Holstein, Kiel, GermanyDepartment Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, BelgiumHyogo College of Medicine, Nishinomiya, JapanWestern University, Alimentiv Inc, London, Ontario, Canada; University of Calgary, Calgary, Alberta, CanadaAbbVie Inc., North Chicago, IllinoisAbbVie Inc., North Chicago, IllinoisAbbVie Inc., North Chicago, IllinoisAbbVie Inc., North Chicago, IllinoisAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, GermanyAbbVie Inc., North Chicago, IllinoisIcahn School of Medicine at Mt Sinai, New York, New YorkBackground 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.http://www.sciencedirect.com/science/article/pii/S2772572324001389Clinical trialsCrohn’s DiseaseEndoscopySurgery |
| spellingShingle | 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 Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease Gastro Hep Advances Clinical trials Crohn’s Disease Endoscopy Surgery |
| title | Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease |
| title_full | Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease |
| title_fullStr | Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease |
| title_full_unstemmed | Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease |
| title_short | Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn’s Disease |
| title_sort | early endoscopic outcomes after risankizumab are associated with fewer hospitalizations and surgeries in crohn s disease |
| topic | Clinical trials Crohn’s Disease Endoscopy Surgery |
| url | http://www.sciencedirect.com/science/article/pii/S2772572324001389 |
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