Academic Journal
Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies.
| Title: | Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. |
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| Authors: | Panaccione, Remo, Louis, Edouard, Colombel, Jean-Frederic, D'Haens, Geert, Peyrin-Biroulet, Laurent, Dubinsky, Marla, Takeuchi, Ken, Rubin, David T, Kalabic, Jasmina, Chien, Karen B, Chen, Su, Cheng, Ling, Zhang, Yafei, Duan, W Rachel, Vladea, Ramona, Hecht, Patrick M, Morisset, Pierre, Schreiber, Stefan, Ferrante, Marc |
| Source: | Journal of Crohn's and Colitis, 19 (1) (2025-01-11) |
| Publisher Information: | Oxford University Press |
| Publication Year: | 2025 |
| Collection: | University of Liège: ORBi (Open Repository and Bibliography) |
| Subject Terms: | Risankizumab, clinical trials, ulcerative colitis, Antibodies, Monoclonal, Sphingosine 1 Phosphate Receptor Modulators, Humans, Male, Female, Adult, Middle Aged, Double-Blind Method, Treatment Outcome, Sphingosine 1 Phosphate Receptor Modulators/therapeutic use, Remission Induction/methods, Injections, Subcutaneous, Monoclonal/therapeutic use, Monoclonal/adverse effects, Colitis, Ulcerative/drug therapy, Ulcerative, Remission Induction, Medicine (all), Human health sciences, Gastroenterology & hepatology, Sciences de la santé humaine, Gastroentérologie & hépatologie |
| Description: | peer reviewed ; [en] BACKGROUND AND AIMS: Treating ulcerative colitis (UC) in patients with prior advanced therapy (AT) exposure may be challenging. We report the efficacy and safety of risankizumab, a monoclonal interleukin 23p19 antibody, in patients with UC and prior inadequate response or intolerance to AT (AT-IR). METHODS: In the 12-week phase 3 INSPIRE induction study, patients were randomized to intravenous risankizumab 1200 mg or placebo. Clinical responders were randomized to subcutaneous risankizumab 180 mg, risankizumab 360 mg, or placebo (risankizumab withdrawal) in the 52-week phase 3 COMMAND maintenance study. This post hoc analysis assessed outcomes by AT-IR status, number, and mechanism of action. AT included biologics, Janus kinase inhibitors, and sphingosine-1-phosphate receptor modulators. RESULTS: Efficacy analyses included 472 non-AT-IR and 503 AT-IR patients (induction), and 137 non-AT-IR and 411 AT-IR patients (maintenance). More patients achieved clinical remission per Adapted Mayo score with risankizumab 1200 mg versus placebo at induction week 12 (non-AT-IR, 29.7% versus 8.4%, nominal P < .0001; AT-IR, 11.4% versus 4.3%, nominal P = .0083); consistent with risankizumab 180 mg or risankizumab 360 mg versus placebo (withdrawal) at maintenance week 52 (non-AT-IR, 50.9% or 61.7% versus 31.1%, nominal P = .057 or P = .0033, respectively; AT-IR, 36.6% or 29.5% versus 23.2%, nominal P = .0159 or P = .2334, respectively). Risankizumab had increased efficacy over placebo, regardless of AT-IR number or mechanism of action, with higher efficacy rates for non-AT-IR compared to AT-IR. Safety results in non-AT-IR and AT-IR patients were generally comparable in both induction and maintenance. CONCLUSIONS: Risankizumab was effective and well tolerated, regardless of prior AT-IR status. CLINICAL TRIAL REGISTRATION NUMBERS: INSPIRE [NCT03398148], COMMAND [NCT03398135]. |
| Document Type: | article in journal/newspaper |
| Language: | English |
| ISSN: | 1873-9946 1876-4479 |
| Relation: | urn:issn:1873-9946; urn:issn:1876-4479; https://orbi.uliege.be/handle/2268/338683; info:hdl:2268/338683; https://orbi.uliege.be/bitstream/2268/338683/1/Risankinumab%20efficacity%20and%20safety%20based%20on%20prior.post%20hoc%20analysis%20of%20the%20INSPIRE%20and%20COMMAND%20phase%203%20studies_JCC.pdf; info:pmid:39804294 |
| DOI: | 10.1093/ecco-jcc/jjaf005 |
| Availability: | https://orbi.uliege.be/handle/2268/338683 https://orbi.uliege.be/bitstream/2268/338683/1/Risankinumab%20efficacity%20and%20safety%20based%20on%20prior.post%20hoc%20analysis%20of%20the%20INSPIRE%20and%20COMMAND%20phase%203%20studies_JCC.pdf https://doi.org/10.1093/ecco-jcc/jjaf005 |
| Rights: | open access ; http://purl.org/coar/access_right/c_abf2 ; info:eu-repo/semantics/openAccess |
| Accession Number: | edsbas.F1505116 |
| Database: | BASE |
| ISSN: | 18739946 18764479 |
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| DOI: | 10.1093/ecco-jcc/jjaf005 |