Maintenance risankizumab sustains induction response in patients with Crohn’s disease in a randomized phase 3Trial

Marc Ferrante*, Peter M. Irving, Maria T. Abreu, Jeffrey Axler, Xiang Gao, Qian Cao, Toshimitsu Fujii, Astrid Rausch, Joana Torres, Ezequiel Neimark, Alexandra Song, Kori Wallace, Kristina Kligys, Sofie Berg, Xiaomei Liao, Qing Zhou, Jasmina Kalabic, Brian Feagan, Remo Panaccione

*Autor correspondente para este trabalho

Resultado de pesquisarevisão de pares

Resumo

Background and Aims: Durable clinical remission, endoscopic healing, and biomarker normalization are key treatment goals for Crohn’s disease. The selective anti-interleukin-23 p19 inhibitor risankizumab has demonstrated efficacy and safety in moderately to severely active Crohn’s disease. This post-hoc analysis of data from the pivotal risankizumab maintenance study assessed whether risankizumab maintenance therapy sustained the clinical and endoscopic outcomes achieved with risankizumab induction therapy. Methods: We evaluated 462 patients who achieved a clinical response to risankizumab intravenous induction treatment and were re-randomized to receive subcutaneous risankizumab 360 mg, subcutaneous risankizumab 180 mg, or placebo [withdrawal] every 8 weeks for 52 weeks in the randomized, controlled FORTIFY maintenance study. Maintenance of clinical, endoscopic, and biomarker endpoints at week 52 among patients who achieved these endpoints after 12 weeks of induction treatment was evaluated. Results: A significantly higher proportion of patients receiving maintenance treatment with risankizumab 360 or 180 mg compared with placebo [withdrawal] maintained Crohn’s Disease Activity Index remission [68.6%, 70.8%, vs 56.3%; p < 0.05], stool frequency/abdominal pain remission [69.2%, 64.1%, vs 50.5%; p < 0.01], endoscopic response [70.2%, 68.2%, vs 38.4%; p < 0.001], endoscopic remission [74.4%, 45.5%, vs 23.9%; p < 0.05], and Simple Endoscopic Score for Crohn’s Disease of 0–2 [65.5%, 36.7%, vs 21.9%]. Most patients [56.8–83.3%] who achieved normalized faecal calprotectin or C-reactive protein during induction sustained them with maintenance risankizumab. Conclusions: Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over 1 year in patients with moderately to severely active Crohn’s disease. Clinical trial registration number: NCT03105102.

Idioma originalEnglish
Páginas (de-até)416-423
Número de páginas8
RevistaJournal of Crohn's and Colitis
Volume18
Número de emissão3
DOIs
Estado da publicaçãoPublicado - 1 mar. 2024
Publicado externamenteSim

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