Therapeutic preferences and outcomes in newly diagnosed patients with Crohn’s diseases in the biological era in Hungary: a nationwide study based on the National Health Insurance Fund database

Abstract Background Accelerated treatment strategy, including tight disease control and early aggressive therapy with immunosuppressives (IS) and biological agents have become increasingly common in inflammatory bowel disease (IBD). The aim of the present study was to estimate the early treatment strategy and outcomes in newly diagnosed patients with Crohn’s disease (CD) between 2004 and 2008 and 2009–2015 in the whole IBD population in Hungary based on the administrative database of the National Health Insurance Fund (OEP). Methods We used the administrative database of the OEP, the only nationwide state-owned health insurance provider in Hungary. Patients were identified through previously reported algorithms using the ICD-10 codes for CD in the out-, inpatient (medical, surgical) non-primary care records and drug prescription databases between 2004 and 2015. Patients were stratified according to the year of diagnosis and maximum treatment steps during the first 3 years after diagnosis. Results A total of 6173 (male/female: 46.12%/53.87%) newly diagnosed CD patients with physician-diagnosed IBD were found in the period of 2004–2015. The use of 5-ASA and steroids remained common in the biological era, while immunosuppressives and biologicals were started earlier and became more frequent among patients diagnosed after 2009. The probability of biological therapy was 2.9%/6.4% and 8.4%/13.7% after 1 and 3 years in patients diagnosed in 2004–2008/2009–2015. The probability of hospitalization in the first 3 years after diagnosis was different before and after 2009, according to the maximal treatment step (overall 55.7%vs. 47.4% (p = 0.001), anti-TNF: 73%vs. 66.7% (p = 0.103), IS: 64.6% vs. 56.1% (p = 0.001), steroid: 44.2%vs. 36.8% (p < 0.007), 5-ASA: 32.6% vs. 26.7% p = 0.157)). In contrast, surgery rates were not significantly different in patients diagnosed before and after 2009 according to the maximum treatment step (overall 16.0%vs.15.3%(p = 0.672) anti-TNF 26.7%vs.27.2% (p = 0.993), IS: 24.1%vs22.2% (p = 0.565), steroid 8.1%vs.7.9% (p = 0.896), 5-ASA 10%vs. 11% (p = 0.816)). Conclusions IS and biological exposure became more frequent, while hospitalization decreased and surgery remained low but constant during the observation period. Use of steroids and 5-ASA remained high after 2009. The association between the maximal treatment step and hospitalization/surgery rates suggests that maximal treatment step can be regarded as proxy severity marker in patients with IBD

Biosimilars in ulcerative colitis: When and for who?

The introduction of biological agents has revolutionized the management of ulcerative colitis (UC). Biosimilars are considered to be equivalent to the reference biologic products in terms of pharmacokinetic properties, clinical effectiveness and safety and have now been approved in inflammatory bowel diseases (IBD). CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the EMA and US FDA. Accumulating data on biosimilars led to an increased acceptance amongst practicing gastroenterologists and their use can be associated with a potential reduction in healthcare costs. This review discusses the current state of knowledge on biosimilar use in UC. Authors review the existing data on clinical efficacy, safety and immunogenicity of biosimilar infliximab and adalimumab agents. Emerging data suggests that switching from originator to biosimilar is safe for CT-P13 infliximab, however data on other biosimilars, multiple-switching, reverse-switching, or cross-switching between biosimilars is lacking. The pathway for interchangeability of biosimilars is different in the US and Europe and many aspects have yet to be clarified by federal regulators. Since the approval of the first biosimilar, the biosimilar concept seems to be successful and has led to an increased use of biosimilar drugs in the treatment of UC worldwide with a better access for patients to biologic. Real-world data from prospective observational studies for 'follow-on' biosimilars is needed to ensure that safety, efficacy and immunogenicity is comparable to the originator in IBD, and that switching from the originator or among biosimilars is a safe option. (C) 2018 Elsevier Ltd. All rights reserved