P0702 Efficacy of subcutaneous infliximab maintenance therapy according to disease location in patients with moderate-to-severe Crohn’s disease: A post hoc analysis of the Phase 3 LIBERTY-CD study
Authors: Schreiber S W , Colombel J F , Dubinsky M C , Sands B E , Abraham B P , Regueiro M , Danese S , Park H , Kim D H , Lee Y N , Hanauer S B 
Published: January 2025

Background

The impact of targeted therapies for patients (pts) with Crohn’s disease (CD) differs by disease location.1 Using data from the Phase 3 LIBERTY-CD study, which demonstrated the superiority of subcutaneous (SC) infliximab (IFX) maintenance therapy over placebo (PBO) in pts with moderate-to-severely active CD,2 this post hoc analysis examined the efficacy of IFX SC in pts according to disease location.

Methods

This analysis included Week (W) 10 responders to intravenous IFX induction therapy who were randomised to receive IFX SC 120 mg every other week (Q2W) or PBO during maintenance therapy. Pts were grouped by disease location at baseline (ileal, ileocolonic or colonic). Rates of clinical remission (Crohn’s Disease Activity index &lt;150) and endoscopic response (Simple Endoscopic Score for Crohn’s Disease change of ≥50% from baseline) at W54 were evaluated by location. Missing data and data from pts treated with an escalated dose of IFX SC (240 mg Q2W) were imputed as non-remitter/responder. Results were analysed descriptively with nominal P-values.

Results

Among 329 pts with disease location documented at initial screening (N=329; IFX SC: n=223; PBO: n=106), 52.6% (n=173) of pts had isolated colonic disease while the remaining pts had ileal involvement (ileal, n=51 [15.5%]; ileocolonic, n=105 [31.9%]) (Table). Patient characteristics at baseline were comparable within each disease location subgroup. At W54, pts who received IFX SC maintenance therapy achieved numerically and/or statistically significantly higher clinical remission rate than PBO across all disease locations (ileal: 45.5% vs 16.7%, P=0.065; ileocolonic: 68.1% vs 48.5%, P=0.083; colonic: 67.0% vs 29.1%, P&lt;0.001; Figure). A greater proportion of patients who received IFX SC achieved endoscopic response than those who received PBO across all disease locations (ileal: 36.4% vs 5.6%, P=0.019; ileocolonic: 61.1% vs 27.3%, P=0.006; colonic: 52.5% vs 18.2%, P&lt;0.001; Figure). Pts who achieved both clinical remission and endoscopic response at W54 showed similar proportional differences between IFX SC and PBO, irrespective of disease location (ileal: ∆30.3%, P=0.009; ileocolonic: ∆32.7%, P=0.003; colonic: ∆35.7%, P&lt;0.001; Figure).

Conclusion

IFX SC maintenance therapy was effective across all disease locations with statistically significant higher rate of endoscopic response at W54 compared to PBO. While this was also seen when analysing composite clinical remission and endoscopic response, numerical and/or statistically significant differences were seen for clinical remission. This highlights the strength of IFX SC in supporting endoscopic improvement and the importance of combining symptomatic response with objective endpoints like endoscopic response.

References

1.Dulai PS, et al. Clin Gastroenterol Hepatol. 2019;17(13):2634-2643.

2.Hanauer SB, et al. Gastroenterology. 2024;167(5):919-933.