DOP03 The use and efficacy of biological therapies 2010-2020 for Inflammatory Bowel Disease in a Danish tertiary centre
Wewer, M.D.(1);Arp, L.(1);Melek, S.(1);Oluf Krautwald, F.(1);Vind, I.(1);Pedersen, G.(1);Nielsen, A.M.(1);Kiszka-Kanowitz, M.(1);Boysen, T.(1);Theede, K.(1);Nordgaard-Lassen, I.(1);Bendtsen, F.(1);Burisch, J.(1);
(1)Hvidovre Hospital, Gastro unit medical department, Copenhagen, Denmark;
Background
Direct health care costs have shifted towards drug-related expenditures in patients with inflammatory bowel disease (IBD). Frequently, patients will have to switch to a second- or third-line biological therapy due to no response or loss of response. The aim of this study was to describe the use and efficacy of biological therapy in a tertiary centre during a 10-year period and investigate the need for surgery.
Methods
The study population consisted of all bio-naïve IBD patients who initiated biological therapy between January 1, 2010 and February 19, 2020 at the Gastro unit, Hvidovre Hospital, Denmark. The electronic medical records were reviewed, and data were systematically registered. Failure of the biological therapy as no response and loss of response was defined by the need for surgery, steroid or shift in biological therapy.
Results
The study population consisted of 291 (46.9%) patients with ulcerative colitis (UC), 327 (52.7%) with Crohn’s disease (CD) and 3 with (0.5%) IBD Unclassified (IBDU), who initiated biological therapy with a median follow-up of 3 (IQR=2-5) years from initiation of therapy. The annual number of patients who initiated biological therapy was increasing throughout the study period.
Most patients (457, 73.6%) received one biological drug, 126 (20.3%) received two, and 38 (6.1%) received three or more different types of biological drugs during the study period. Systemic steroid was required in 99 patients (15.9%) and the 5-year surgery-free survival was 76.5% (120 patients with surgery). 302 patients (54.3%) had effect of the first biological therapy at one year follow-up.
In multivariate Cox-regression analyses, concurrent treatment with thiopurines decreased the risk of failure of the first biological therapy in UC patients (hazard ratio (HR) 0.745, 95% CI: 0.559-0.992) but not in CD patients (HR 0.969, 95% CI: 0.722-1.300). Male gender decreased the risk of failure (HR: 0.677, 95% CI: 0.505-0.908) while higher age at initiation of biological therapy increased the risk (HR: 1.0152, 95% CI: 1.004-1.027) in CD patients. These factors had no impact in UC patients. Prior surgery, disease duration and location were not associated with increased risk of failure of first biological therapy.
Conclusion
In conclusion, an increasing number of IBD patients received biological therapy during the 10-year period at our tertiary centre. A considerable part of IBD patients in biological therapy will require surgery, additional steroids, or second line biological therapy. Our findings suggest a beneficial role of thiopurine in combination with biological therapy. Improved identification of patients not responding to first line biological therapy is of great importance.