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P610 Penetration, short- and long-term efficacy of anti-TNF-α therapy for ulcerative colitis between 2010–2016 in Hungary

T. Molnár*1, F. Nagy1, Z. Szepes1, K. Farkas1, R. Bor1, A. Bálint1, Á. Milassin1, A. Fábián1, M. Rutka1, K. Szántó1

1University of Szeged, First Department of Medicine, Szeged, Hungary

Background

Anti-TNF therapy showed high efficacy in the maintenance of remission in ulcerative colitis (UC) based on study results. However, there is still high need for long-term assessment of biological treatments based on full population analysis.

Methods

This is an observational/non-interventional, retrospective, epidemiological study using the National Health Insurance Fund social security databases and the special drug reimbursement database of patients. Study population contained all of the adult Hungarian patients suffering from UC who are observable in the database between 2010 and 2016. Patients were treated with anti-TNF therapy during the study period were eligible. Our aim was to analyse patient characteristics and therapeutic outcome of UC patients treated with anti-TNF agents in Hungary.

Results

In total, 0.24% of total Hungarian population suffered from UC in 2016. This is more than 23000 patients. The median age of the patients with UC is 51 (male 49, female 53) in the examined period. Annual prevalence of anti-TNF therapy was increasing continuously from 1.1% to 2.1%; 497 patients with UC were on anti-TNF therapy at the end of 2016. The prevalence of infliximab and adalimumab was similar in 2016 (1.2 and 1.1%, respectively). The onset of anti-TNF therapy in UC is between 20 and 39 years, the average age is 37 years. This is 16 years less compared with the average age of total UC population. Anti-TNF therapy was started within 3 years after the diagnosis in 35% of the patients, while disease duration was more than 10 years in every third cases. Top-down therapy was applied only in 0.1% of the patients. Primary non-response was observed in 9.7% of anti-TNF therapy. Ratio of dose escalation was 13.6%. Dose escalation was equally common among patients on infliximab and adalimumab therapy; however it occurred significantly later in case of infliximab. Frequency of switch was 15.7% and 83.1% of switch was performed after dose escalation. Ratio of infliximab to adalimumab switch was 6.7%, adalimumab to infliximab switch was 0.8% in 2016. Thirty-two point four% of the patients received azathioprine and anti-TNF combination therapy in the first 5 month of anti-TNF therapy. Steroid therapy was prescribed significantly less frequently in the subsequent 2 years after starting anti-TNF.

Conclusion

Both the prevalence and incidence of UC are high in Hungary. Patients receiving anti-TNF therapy are significantly younger than the other part of the total UC population. Our results show the steroid-sparing effect of anti-TNF in a real-life, population-based setting.