Sustained Improvements in Health-Related Quality of Life Outcomes With Long-Term Risankizumab Treatment in Patients With Moderately to Severely Active Crohn’s Disease: Results from the FORTIFY Open-Label, Long-Term Extension

Background:
Due to the debilitating and progressive nature of Crohn’s disease (CD), the health-related quality of life (HRQoL) of affected individuals is often negatively impacted. Risankizumab (RZB) is an interleukin-23 p19 inhibitor approved for the treatment of moderately to severely active CD, with demonstrated efficacy in improving HRQoL outcomes through 52 weeks of treatment in the phase 3 trial.¹ Here, we evaluated the ability of RZB to sustain HRQoL improvements in patients with CD who completed 52 weeks of maintenance and 52 weeks of treatment in the ongoing FORTIFY open-label, long-term extension (OLE).
Methods:
The FORTIFY (NCT03105102) OLE enrolled patients who completed 52 weeks of RZB maintenance dosing in the FORTIFY substudies or RZB phase 2 OLE.² Patients received RZB 180 mg subcutaneous (SC) every 8 weeks, except for patients who had prior rescue therapy or who received rescue during OLE, who continued RZB 360 mg SC. This analysis pooled data from both treatment groups (RZB 180 mg and 360 mg) who completed 52 weeks of the OLE (week 104). HRQoL outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ) response (≥16-point increase in total score), IBDQ remission (total score ≥170 points), improvement in 36-Item Short Form Survey (SF-36) physical component score (PCS, ≥4.1-points) and mental component score (MCS, ≥3.9-points), and Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) response (≥9-points increase). Each HRQoL outcome was evaluated for the proportion of patients who achieved the meaningful within-person change (MWPC) threshold from induction trial baseline to week 52 (end of maintenance) and week 104 (1 year in OLE). Patients with missing observations for HRQoL outcomes at week 52 or week 104 were considered as nonresponders.
Results:
In total, 257 patients were assessed for achievement of HRQoL outcomes. At week 52 (end of the randomized double-blind withdrawal maintenance period), the majority of patients achieved the MWPC thresholds for IBDQ response (75.5%), IBDQ remission (65.0%), SF-36 PCS improvement (67.7%), SF-36 MCS improvement (60.7%), and FACIT-Fatigue response (80.5%). These improvements were sustained through week 104 in the OLE, with the majority of patients still sustaining MWPC thresholds for IBDQ response (70.8%), IBDQ remission (59.5%), SF-36 PCS (64.6%), SF-36 MCS (57.2%), and FACIT-Fatigue response (78.2%).
Conclusions:
Patients with CD who completed RZB treatment in the FORTIFY maintenance study and had an additional 52 weeks of treatment in the FORTIFY OLE, demonstrated sustained HRQoL improvements that were clinically meaningful.
References
1. Peyrin‐Biroulet, L. et al. Aliment Pharmacol Ther 57, 496–508 (2023)
2. Ferrante, M. et al. Journal of Crohn’s and Colitis 18, i168–i170 (2024)