S4854 Patient Outcomes With Intensified Risankizumab Maintenance Dosing for Crohn’s Disease: A Case Series

Introduction: Risankizumab (RSA), an interluekin-23 inhibitor, is approved for the treatment of moderate-to-severe Crohn’s disease (CD). The standard maintenance dose of RSA is subcutaneous injection every 8 weeks. We present a series of patients with Crohn’s disease who had initial response to RSA but later required dose escalation to improve and/or recapture response to RSA. Case Description/Methods: Due to partial or waning response to RSA at standard dosing, 5 CD patients at a tertiary inflammatory bowel disease center underwent intensification of maintenance therapy to receive RSA every 4 weeks. All had ileocolonic disease; 2 also had perianal fistulizing CD. Two escalated due to partial response, 2 due to loss of response after an average of 13 months, and 1 had refractory disease. Patients had failed an average of 2 prior advanced therapies. One patient received concurrent Upadacitinib in addition to q 4 weekly RSA. Three required steroids at the time of intensification. Extraintestinal manifestations were present in 1 patient. Four of 5 reported clinical improvement at follow-up with a follow-up range of 6 to 14 months. The fifth patient has not had scheduled follow up since intensification of regimen. Fecal calprotectin data was available for 3 patients and decreased by 50% or greater in all of them. Endoscopic follow-up was available for 3 patients and showed improvement in each. All 3 patients who were on steroids at time of dose intensification were able to wean off. The only patient with extraintestinal manifestations reported significant improvement in her arthralgia. No significant adverse safety concerns were noted with 4- weekly dosing. Discussion: While dose escalation of other biologic therapies has been associated with improved outcomes in certain patients with CD, comparable data for RSA are currently limited. This case series supports clinical response to 4-weekly RSA in patients who relapsed or only partially improved on the q 8-weekly regimen, with no increase in adverse events. These findings encourage further exploration of intensified RSA dosing in select CD patients.