The impact of anti-TNFα therapy on colectomy rates and corticosteroid treatment among 3001 paediatric and adolescent patients with ulcerative colitis-a nationwide study from 1995 to 2015

Background The long-term effects of anti-TNF alpha therapy in ulcerative colitis are debatable. Aim To examine whether anti-TNF alpha therapy changed the colectomy proportion and reduced the use of corticosteroids. Methods A nationwide cohort study among patients (age 0-20) diagnosed with ulcerative colitis through 1995-2015 from Danish health registries. We calculated the cumulative 5-year risk of colectomy after diagnosis and used a Cox regression model for comparison between a historical pre-anti-TNF alpha cohort 1 (1995-2003) and a cohort 2 for the era of anti-TNF alpha (2004-2015). Based on anti-TNF alpha users, defined as patients who had at least four anti-TNF alpha treatments within 4 months, we examined the subsequent need for corticosteroids. Results We identified 3001 patients from 1995 to 2015. The 5-year cumulative proportion of colectomy in cohort 2 was 9.7% (95% confidence interval [CI] 8.4-11.1) and 12.3% (95% CI 10.4-14.6) in cohort 1. The adjusted 5-year hazard ratio (HR) was 0.76 (95% CI 0.60-0.96) for colectomy in cohort 2 compared to cohort 1. A total of 334 patients received anti-TNF alpha treatments, and 16.8% (56/334) were prescribed corticosteroids in the subsequent 3-month period. Corticosteroid treatment declined with follow-up after 6 and 12 months, 5.4% and 1.2%, respectively. Conclusion In patient's <= 20 years, the HR for colectomy within a period of 5 years from the time of diagnosis was reduced in the era of anti-TNF alpha compared to a historical cohort. In patients treated with anti-TNF alpha, prescriptions of corticosteroids were virtually ceased after 12 months.