Abstract Background Key determinants of therapy choice in Ulcerative colitis (UC) are disease severity and extent. The PROFILE study (Predicting Outcomes for Crohn’s Disease Using a Molecular Biomarker) demonstrated that early, top-down therapy with a combination of infliximab and an immunomodulator led to superior outcomes in patients with Crohn’s disease. It is uncertain whether this concept of early advanced therapy based intervention influences outcomes in real-world clinical practice for ulcerative colitis (UC). Methods Patients with UC initiated on biologics and small molecules were included. Timing of advanced therapy was defined related to their first steroid exposure – Very Early (with first course of steroid), Early (within six months of the first steroid course), Late (advanced therapy initiated ≥ 2 steroid courses or 6 months after the first steroid course), and Very Late (advanced therapy initiated of ≥ 2 steroids courses and 1 year after the first steroid course). We assessed disease outcomes -steroid free remission, colectomy at 12 months Results A total of 1,359 patients with inflammatory bowel disease (IBD) were screened, 362 ulcerative colitis (UC) were included in the analysis. The mean age at diagnosis was 37.9 years, while the median age was 34 years. Among UC patients, the median disease duration at presentation was 2 weeks, while the mean symptom duration across the cohort was 289 weeks. Most commonly used initial biologic was infliximab (53.0%, n = 192), followed by vedolizumab (23.8%, n = 86). 14.4% of patients started therapy very early, 14.1% early, 14.1% late, and 41.2% at a very late stage. Patients with complications within 1 year included 1.9% in the Very Early group, 2% in the Early group, 1.6% in the Late group and no complications in late stage. 6 months steroid-free remission was achieved by 21.2% of patients in the Very Early group, 9.8% in the Early group, 21.3% in the Late group, and 8.7% in the Very Late group. Colectomy rates were 3.8% in the Very Early group, 2% in the Early group, 3% in the Late group, and 1.3% in the Very Late group. Conclusion Early ‘PROFILE style ‘ initiation of biologics or small molecules in Ulcerative Colitis, did not confer significant differences in hospitalisations, complications, or colectomy rates compared to later initiation. These findings need to be confirmed in a randomized controlled trial Conflict of interest: Dr. Zacharias, Neha: No conflict of interest Robertson, Hayley: No conflict of interest Fitzgerald, Abbie-Lei: No conflict of interest Mcbride, Jodie: No conflict of interest Johnson, Bianca: No conflict of interest Thut, Jessica: No conflict of interest Whitehead, Emma: No conflict of interest Messiha, Maged: No conflict of interest Sebastian, Shaji: No conflict of interest
Zacharias et al. (Thu,) studied this question.