Open-label extension of a phase 2 trial of risankizumab in patients with moderate-to-severe Crohn's disease
dc.contributor.author | Feagan, Brian G | |
dc.contributor.author | Panés, Julián | |
dc.contributor.author | Ferrante, Marc | |
dc.contributor.author | Kaser, Arthur | |
dc.contributor.author | D'Haens, Geert R | |
dc.contributor.author | Sandborn, William J | |
dc.contributor.author | Louis, Edouard | |
dc.contributor.author | Neurath, Markus F | |
dc.contributor.author | Franchimont, Denis | |
dc.contributor.author | Dewit, Olivier | |
dc.contributor.author | Seidler, Ursula | |
dc.contributor.author | Kim, Kyung-Jo | |
dc.contributor.author | Selinger, Christian | |
dc.contributor.author | Padula, Steven J | |
dc.contributor.author | Herichova, Ivona | |
dc.contributor.author | Robinson, Anne M | |
dc.contributor.author | Wallace, Kori | |
dc.contributor.author | Zhao, Jun | |
dc.contributor.author | Minocha, Mukul | |
dc.contributor.author | Othman, Ahmed A | |
dc.contributor.author | Soaita, Adina | |
dc.contributor.author | Visvanathan, Sudha | |
dc.contributor.author | Hall, David B | |
dc.contributor.author | Böcher, Wulf O | |
dc.date.accessioned | 2018-09-20T12:05:56Z | |
dc.date.available | 2018-09-20T12:05:56Z | |
dc.identifier.uri | https://www.repository.cam.ac.uk/handle/1810/280515 | |
dc.description.abstract | 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 <150) and endoscopic remission (Crohn’s Disease Endoscopic Index of Severity [CDEIS] ≤4 [≤2 for patients with isolated ileitis]), received open-label 600 mg intravenous risankizumab (every 4 weeks) and patients in deep remission underwent washout until week 26 (Period 2). At week 26, patients in clinical remission received maintenance treatment (Period 3) with 180 mg subcutaneous risankizumab (every 8 weeks). Efficacy endpoints included clinical and endoscopic response and remission at weeks 26 (Period 2) and 52 (Period 3) respectively; safety was assessed through both periods. Study registration: ClinicalTrials.gov, NCT02031276. Findings: In Period 2, 101 patients were treated with 600 mg risankizumab resulting in an increase in clinical remission rates at week 26 versus week 12 for all original designated treatment groups: 55% versus 18%, 59% versus 21%, and 47% versus 26% for placebo, 200, and 600 mg risankizumab, respectively. Of the 62 patients receiving maintenance treatment, 54 completed treatment. At week 52, clinical remission was maintained by 71% of patients; endoscopic remission and response (>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. | |
dc.description.sponsorship | Boehringer Ingelheim | |
dc.title | Open-label extension of a phase 2 trial of risankizumab in patients with moderate-to-severe Crohn's disease | |
dc.type | Article | |
prism.publicationName | The Lancet Gastroenterology & Hepatology | |
dc.identifier.doi | 10.17863/CAM.27885 | |
dcterms.dateAccepted | 2018-06-26 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2018-06-26 | |
rioxxterms.type | Journal Article/Review | |
rioxxterms.freetoread.startdate | 2019-09-17 |
Files in this item
This item appears in the following Collection(s)
-
Cambridge University Research Outputs
Research outputs of the University of Cambridge