S1478 Treatment Outcomes of Risankizumab Dose Escalation in Crohn’s Disease

Introduction: Limited data exists evaluating outcomes of dosing risankizumab (RZB) above the FDA-approved maintenance dose (360 mg or 180 mg subcutaneous every 8 weeks) for the treatment of Crohn’s disease (CD). Methods: A retrospective observational single-center cohort study evaluated patients with CD who received at least one escalated dose of RZB between June 2022 and April 2024. Patients without follow-up within 8 months post-escalation were excluded from the analysis of follow-up outcomes. Outcomes included response to therapy (either endoscopic or patient-reported symptom improvement), medication changes, and changes in clinical measures (ESR, CRP, HBI, and SIBDQ) within 8 months of escalation. Descriptive statistics summarized continuous variables and categorical variables (median [IQR] or mean [SD] and frequencies as percents respectively). A multivariable logistic regression model evaluated patient improvement at any point within 8 months of escalation controlling for days from escalation to last evaluation in the study period, years since diagnosis, and number of previous treatments tried. Results: In the 63 included patients, over half (57%) were women, mostly White (94%), with an average disease duration of 17 years (SD ±11). Thirty-two patients (51%) were escalated due to symptoms and 28 (44%) were escalated due to endoscopic findings. All 63 patients received the 360 mg dose; 50 (79%) were escalated to every 6 weeks and 13 (21%) to every 4 weeks. Patients had tried and failed an average of 4 (IQR 2, 4.5) previous therapies. The median number of on-body injection doses before the decision to escalate was 3 (IQR 2, 3.5). Of 58 patients with a follow-up within 8 months of escalation, median last evaluation occurred at 157 (IQR 107, 180) days. Almost half of patients improved (n = 27, 47%), others remained stable (n = 15, 26%) or worsened (n = 16, 28%). Patients who did not respond had often previously failed multiple advanced therapies . No covariates in the multivariate regression analysis were significant. For the entire cohort, 34% of patients had additional medication changes within 8 months of escalation. With available data, improvements were seen in CRP (54%), ESR (46%), HBI (57%), and SIBDQ (60%) measures. Conclusion: In a heavily treatment experienced population of patients with CD, almost half had a clinical response to escalated dosing of RZB within 8 months. Patients who have previously failed numerous treatments may be more likely to not respond to RZB dose escalation.