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P648 Anti-TNF-α therapy, use of corticosteroids, and colectomy among paediatric and adolescent patients with ulcerative colitis: a nationwide study

K. Lund*1,2, M. D. Larsen1, T. Knudsen3,4, J. Kjeldsen5,6, R. G. Nielsen7,8, B. M. Noergaard1,2

1Odense University Hospital, Center for Clinical Epidemiology, Odense, Denmark, 2University of Southern Denmark, Department of Clinical Research, Research unit of Clinical Epidemiology, Odense, Denmark, 3Hospital of Southwest Jutland, Department of Medicine, Esbjerg, Denmark, 4University of Southern Denmark, Institute for Regional Health Science, Center Southwest Jutland, Esbjerg, Denmark, 5Odense University Hospital, Department of Medical Gastroenterology S, Odense, Denmark, 6University of Southern Denmark, Department of Clinical Research, Research unit of Medical Gastroenterology, Odense, Denmark, 7Odense University Hospital, Hans Christian Andersen Children's Hospital, Odense, Denmark, 8University of Southern Denmark, Department of Clinical Research, Research unit of Pediatrics, Odense, Denmark

Background

The long-term beneficial effects of anti-TNF-α therapy are debatable referring to the need for corticosteroids and changes in colectomy rates among paediatric and adolescent patients with ulcerative colitis (UC). We aimed to investigate whether anti-TNF-α treatment reduced the use of corticosteroids and to examine colectomy rates in the era of anti-TNF-α therapy compared with a historical cohort.

Methods

The study population included an unselected nation-wide cohort of children and adolescents (0–20 years of age) diagnosed with UC through 1977–2016. The data were retrieved from the Danish National Patient Registry. We identified anti-TNF-α use as patients who had at least four anti-TNF-α treatments within a period of 4 months to examine a subsequent need of corticosteroid prescriptions (Figure 1). To examine the change of colectomies we calculated the cumulative risk 5 years following the diagnosis and used an adjusted Cox regression model in the comparison of colectomies between a historical cohort (1977–2003) and a cohort representing the era of anti-TNFα (2004–2016).

Figure 1. Anti-TNF-α use: individual patient timeline illustration.

Results

We identified totally 4449 patients with UC in the study period. We identified 334 children and adolescents treated with anti-TNF-α. A total of 20.7% (69 patients) was prescribed corticosteroids in a 3-month period calculated from the fourth anti-TNF-α treatment. The proportion of steroid dependent users declined after 6 and 12 months to 6.6% and 0.6%, respectively (Figure 2). The 5-year cumulative proportion of colectomy in the historical cohort was 9.12% (95% confidence interval [CI]: 8.01–10.37) and 7.76% (95% CI: 6.70–8.98) in the era of anti-TNF-α treatment (Figure 3). The adjusted hazard ratio was 0.84 (95% CI: 0.68–1.03) for colectomy within a 5-year period in the era of anti-TNF-α compared with the historical cohort.

Figure 2. Corticosteroid prescriptions among anti-TNF-α users with 3-, 6-, 9- and 12-month follow-up

Figure 3. Cumulative percentage for colectomy, a 5-year follow-up

Conclusion

The concomitant use of corticosteroid prescriptions was virtually terminated after 12 months among patients treated with anti-TNF-α. Within a period of 5 years from the time of diagnosis, the adjusted hazard ratio for colectomy in the era of anti-TNF-α treatment was reduced, but not significantly compared with a historical cohort.