IV risankizumab sustains improved endoscopic outcomes in Crohn’s
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IV risankizumab followed by maintenance therapy induced sustained improvement in endoscopic outcomes in patients with moderate to severe Crohn’s disease, according to research presented at ECCO.
“Mucosal healing has been shown to be associated with a number of positive outcomes, including fewer clinical relapses, decrease in the need for surgery and a lower chance of hospitalization,” Peter Miles Irving, MD, MA, FRCP, of the department of gastroenterology at Guy’s and St. Thomas’ Hospital in London, said. “We have seen already that risankizumab, both in induction and maintenance studies, results in significant improvements in mucosal healing over placebo; in this post-hoc analysis we are going to look at the mucosal healing rates at different time points, and in particular, look at the ability of risankizumab to maintain those endpoints once they have been achieved in the maintenance study.”
In the FORTIFY study, Irving and colleagues examined the durability of subcutaneous risankizumab (RZB) maintenance in patients from the ADVANCE and MOTIVATE trials who achieved clinical response to IV RZB induction therapy at 12 weeks. Patients either underwent RZB withdrawal and received replacement subcutaneous placebo or received 360 mg RZB subcutaneously for the remainder of the maintenance trial; researchers assessed endoscopic outcomes at week 52.
Among 141 patients in the study arm, 55 patients achieved endoscopic response, 39 patients achieved endoscopic remission and 29 patients achieved an SES-CD score of 0 to 2. Among 164 patients in the control arm, 73 patients achieved endoscopic response, 46 patients achieved endoscopic remission and 32 patients achieved an SES-CD score of 0 to 2.
At week 52, researchers observed maintained endoscopic response among 70.2% and 38.4% of patients, respectively, maintained endoscopic remission among 74.4% and 23.9% of patients and maintained SES-CD score from 0 to 2 among 65.5% and 21.9% of patients. They noted RZB was well-tolerated with no new safety signals.
“Endoscopic endpoints were more commonly achieved in patients who maintained on 360 mg of subcutaneous risankizumab compared with placebo, and we can see that they were more commonly maintained in those patients who achieved them at the end of induction by the end of maintenance,” Irving concluded. “Risankizumab was effective at maintaining important mucosal endpoints in the maintenance part of the program.”
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Irving PM, et al. Abstract DOP84. Presented at: Congress of European Crohn’s and Colitis Organization; Feb. 16-19, 2022 (virtual meeting).
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