Open-label extension of a phase 2 trial of risankizumab in patients with moderate-to-severe Crohn's disease
| Autor: | Feagan, Brian G, Pan��s, Juli��n, Ferrante, Marc, Kaser, Arthur, D'Haens, Geert R, Sandborn, William J, Louis, Edouard, Neurath, Markus F, Franchimont, Denis, Dewit, Olivier, Seidler, Ursula, Kim, Kyung-Jo, Selinger, Christian, Padula, Steven J, Herichova, Ivona, Robinson, Anne M, Wallace, Kori, Zhao, Jun, Minocha, Mukul, Othman, Ahmed A, Soaita, Adina, Visvanathan, Sudha, Hall, David B, B��cher, Wulf O |
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| Přispěvatelé: | Apollo - University of Cambridge Repository |
| Popis: | Background: Risankizumab, an anti-interleukin-23 antibody, was superior to placebo in achieving clinical and endoscopic remission at week 12 in a randomised, phase 2 induction study in patients with moderately to severely active Crohn���s disease. The efficacy and safety of extended intravenous induction and/or subcutaneous maintenance therapy with risankizumab was assessed. Methods: Following 12-week, double-blind, randomised, induction treatment comparing 200 mg or 600 mg intravenous risankizumab to placebo every 4 weeks, patients without deep remission, defined as clinical (Crohn���s Disease Activity Index 50% CDEIS reduction from baseline) was achieved by 35% and 55% of patients, respectively, and 29% of patients achieved deep remission. Risankizumab was well tolerated with no new safety signals. Interpretation: Extended induction treatment with open-label intravenous risankizumab was effective in increasing clinical response and remission rates at week 26. Open-label subcutaneous risankizumab maintained remission till week 52 in most patients who were in clinical remission at week 26. Selective blockade of interleukin-23 warrants further evaluation as treatment for Crohn���s disease. Boehringer Ingelheim |
| Databáze: | OpenAIRE |
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