Association Between 1‐Year Endoscopic Outcomes and Long‐Term Clinical and Patient‐Relevant Outcomes in Crohn's Disease

ABSTRACT Background and Aims Achieving endoscopic response (ER), defined as a > 50% reduction from baseline in Simple Endoscopic Score for Crohn's disease (SES‐CD) score, following induction therapy for Crohn's disease (CD) has been linked to improved 1‐year outcomes. We evaluated the impact of ER at the end of maintenance (EOM) on long‐term clinical outcomes. Methods Data from a Phase 3 randomized trial (IM‐UNITI, ustekinumab) and a Phase 2 trial (GALAXI 1, guselkumab and ustekinumab) were analyzed using multivariable statistical methods. The relationship between ER at the EOM (Week 48) and outcomes at Week 96, including clinical remission, hospitalization, and surgery, was assessed. Results Endoscopic and clinical remission data at the EOM were available for 461 patients. ER at EOM was significantly associated with higher odds of clinical remission (odds ratio [OR] = 1.91; p < 0.05) at Week 96. ER was also linked to reduced inflammatory burden, with higher odds of C‐reactive protein normalization (OR = 2.19; p < 0.005). Forty‐one patients were hospitalized or required surgery during the long‐term extension, with higher event rates among those without ER at the EOM ( p = 0.1237). Conclusions ER after 48 weeks of maintenance therapy was associated with a greater likelihood of clinical remission and improved quality of life at 1 year. Data also suggest lower hospitalization and surgery rates for those who achieve ER. Larger studies are needed to substantiate long‐term reductions in hospitalizations and surgeries.