Risankizumab should proceed to phase III trials for moderate-to-severe Crohn disease.
Polymorphisms in the interleukin-23 receptor gene affect Crohn disease risk, and inhibition of interleukin-12 and interleukin-23 by ustekinumab is beneficial in Crohn disease. Risankizumab is an investigational selective interleukin-23 inhibitor.
In an industry-funded phase II trial, 121 patients with moderate-to-severe Crohn disease, of whom 93% had been treated with one or more TNF blockers, were randomized to receive 600 mg of risankizumab, 200 mg of risankizumab, or placebo at weeks 0, 4, and 8. The primary outcome was clinical remission (Crohn disease activity index [CDAI] <150) at week 12.
Overall, both doses of risankizumab were effective, the larger dose was somewhat more effective, and no safety signal was identified. Clinical remiss…
Reviewing Author
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)