Outcomes of Early Versus Delayed Advanced Therapy Among Patients With Moderate Ulcerative Colitis in the United States: TARGET-IBD

Background: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the colon and rectum characterized by intermittent periods of disease relapse and remission with no single treatment pathway. An often-overlooked population is patients with UC and moderate disease severity, as this group is frequently combined with severe UC patients. The purpose of this study was to compare health outcomes between patients with early versus delayed advanced therapy (AT) initiation among adult patients with moderate UC. Methods: TARGET-IBD is a real-world observational, longitudinal cohort of patients receiving care for inflammatory bowel disease (IBD) at 1 of 34 participating academic and community-based gastroenterology sites in the United States beginning in 2017. Adult moderate severity patients with UC were included if they initiated a conventional therapy (5-ASA or immunomodulator) before AT, had no AT (biologic/JAK) use for at least 90 days after diagnosis, had no colectomy for at least 6 months after diagnosis, and had presence of at least 1 of the following before AT initiation: abdominal pain and blood in stools; abdominal pain, diarrhea, and stool frequency ≥4/day; or Mayo endoscopic score=2. AT initiators were divided into 2 groups; early initiators received treatment 0 to 2 years after diagnosis, while delayed initiators received treatment >2 years after diagnosis. Fisher exact tests were calculated to assess the association between variables and timing of AT initiation. Multivariable Cox regression models were fit to assess the association between early versus delayed initiation of AT and endoscopic remission after AT initiation. Results: Of the 4474 patients in TARGET-IBD, 179 patients met the criteria for moderate UC. Compared with delayed initiators, early initiators were younger (median 30 vs 33 years old) and female (51% vs 48%). Most early initiators had private insurance (80%) and were predominantly treated at academic sites (75%). The median time from initiation of AT to endoscopic remission for early initiators (0-2 years) was 10.8 months (interquartile range [IQR] 8.4-19.0) while the delayed group (>2 years) had a median of 15.4 months (IQR 10.6-21.7). In the multivariable Cox model, early initiation of AT (0-2 years after diagnosis) was associated with an increased likelihood of endoscopic remission compared with patients initiating >2 years after diagnosis (hazard ratio [HR] 2.44, 95% confidence interval [CI] 1.19-4.97). Patients who initiated an AT after < 1 year had about 3.5 times the likelihood of endoscopic remission compared with those who initiated an AT after >2 years (HR 3.44, 95% CI 1.45-8.15). Conclusions: Among patients with moderate UC, early initiators (< 2 years after diagnosis) of an AT were more than 2 times likely to experience endoscopic remission compared with delayed initiators. This suggests that by prioritizing early AT, healthcare providers may be able to optimize clinical outcomes in this group of patients.