RISANKIZUMAB DOSE ESCALATION IN PATIENTS WITH CROHN'S DISEASE

Abstract

Abstract BACKGROUND Patients (pts) who do not achieve optimal response at standard dosing of biologic therapies or lose response over time often benefit from escalated doses of biologic therapies to manage moderate to severe Crohn’s disease (CD). Currently, no data exists on dose escalating risankizumab, an interleukin-23 inhibitor recently approved for the treatment of moderate to severe CD. This cohort study aimed to describe pt characteristics, insurance access, and response to therapy in pts prescribed risankizumab more frequently than the FDA-approved maintenance dosing of 180mg or 360mg every 8 weeks (wks). METHODS We conducted a retrospective single-center cohort study of pts with CD who were initiated on an escalated dose of risankizumab between June 2022 and July 2023. Pts must have received at least one escalated dose during the defined time frame for inclusion. Pt and disease characteristics, steps required to secure insurance access, and early treatment outcomes were collected from the electronic health record and reported descriptively. RESULTS A total of 211 pts completed three standard risankizumab intravenous induction infusions during the study period. Twelve pts were initiated on an escalated maintenance dosing frequency. All 12 pts received the 360mg dose. Seven pts were escalated to a frequency of every 6 wks (58%) and 5 pts were escalated to every 4 wks (42%). Pts were mostly female (67%) with a median age of 42 years (interquartile range [IQR] 30-52). The median number of previous biologic/small molecule drug failures was 4 (IQR 2-5). Eleven (92%) pts previously required a dose escalated biologic, the median years since diagnosis was 15 (IQR 10-17), and median body mass index was 25 kg/m2 (IQR 22-27). Six pts (50%) previously required surgical intervention. Pts received a median of 3 (IQR 2-3) risankizumab injections on standard dosing before a decision to escalate was made. Reasons for escalated dosing included colonoscopy/imaging/pathology results showing inflammation (n=7) or persistent symptoms (n=5). Five (42%) pts were able to access the escalated dose without an additional authorization, 5 (42%) required a prior authorization that was approved, and 2 (17%) required at least one level of appeal or peer to peer review. Through 10/03/2023, 6 pts had a documented improved response to the escalated dosing (50%), 3 remained stable (25%) and 3 had no change (25%) at a median of 88 days (IQR 72-103) from escalation. CONCLUSION This study demonstrated the need for heavily treatment-experienced pts with severe CD to dose escalate risankizumab, often requiring an additional insurance authorization. Most pts improved or remained stable on the escalated dosing, showing promise for risankizumab dose escalation outcomes. More research is needed to assess risankizumab dose escalation long-term outcomes and the role of trough levels.