Effectiveness of anti-tumour necrosis factor-α therapy in Danish patients with inflammatory bowel diseases

IntroductIon: The objective of this study was to evaluate the outcome of anti-tumour necrosis factor-α (anti-TNF) treatment in a large cohort of patients with inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC) in clinical practice and to establish a cohort for future studies of genetic markers associated with treatment response. Methods: A national, clinically based cohort of previously naive anti-TNF treated patients from 18 medical depart ments was established. The patients were screened for tuberculosis prior to treatment initiation. By combining the unique personal identification number of Danish citizens (the CPR number) from blood samples with data from the National Patient Registry, patients with International Classification of Diseases, Version 10 (ICD-10) codes K50-K63 were identified. Treatment efficacy reflected the maximum response within 22 weeks. results: Among 492 patients with CD and 267 patients with UC, 74%/13%/14% and 65%/12%/24% were respond ers, partial responders and non-responders to anti-TNF therapy, respectively. More patients with UC than with CD were non-responders (odds ratio (OR) = 1.96, 95% confi dence interval (CI): 1.34-2.87, p = 0.001). Young age was as sociated with a beneficial response (p = 0.03), whereas smoking ≥ 10 cigarettes/day was associated with non-re sponse among patients with CD (OR = 2.33, 95% CI: 1.134.81, p = 0.03). conclusIon: In this clinically based cohort of Danish patients with IBD treated with anti-TNF, high response rates were found. Heavy smoking was associated with non-response, whereas young age at treatment initiation was associated with a beneficial response among patients with CD. Thus, the results obtained in this cohort recruited from clinical practice were similar to those previously obtained in clinical trials. FundIng: The work was funded by Health Research Fund of Central Denmark Region, Colitis-Crohn Foreningen and the University of Aarhus (PhD grant). trIal regIstratIon: Clinicaltrials NCT02322008.