Epidemiological data and utilization patterns of anti-TNF alpha therapy in the Hungarian ulcerative colitis population between 2012-2016

ABSTRACT

Background: Anti-TNF therapy is efficacious in the maintenance of remission in ulcerative colitis (UC); however, long-term data on real-life use of these agents are lacking.

Methods: This observational, retrospective, epidemiological study using the National Health Insurance Fund social security database aimed to understand patient characteristics and therapeutic patterns of anti-TNF therapy. Data of adult Hungarian, UC patients treated with anti-TNF agents (IFX-infliximab, ADA-adalimumab) between 2012 and 2016 were analyzed.

Results: Five hundred and sixty-eight UC patients were identified. Approximately 70-80% of the patients reached maintenance therapy. A large proportion of patients stopped therapy after 10 to 12 months due to the reimbursement policy. Corticosteroid use decreased significantly after the initiation of biological therapy. The dose-escalation rate was 19.8% for ADA and 10.9% for IFX, respectively, and was performed earlier along the treatment timeline for patients on ADA. In the present study, the rate of primary non-response (PNR) was 11.6% and the rate of secondary loss of response (LOR) was 36.5%.

Summary: Treatment length is in correspondence with the Hungarian reimbursement policies. The mandatory stop of treatment in the reimbursement policy is suboptimal in UC patients requiring biological therapy. The corticosteroid-sparing effect of biological therapy was demonstrated.

KEYWORDS:

• Anti-TNF therapy
• corticosteroids
• loss of response
• primary non response
• ulcerative colitis

Authors’ contributions

P Kunovszki: Research plan, research protocol, statistical analysis plan, data analysis, methods review, publication plan, publication writing and summary, approval of final publication

K Szántó: Research plan, research overview, methods review, critical review of results and publication, final approval of publication

J Gimesi-Országh: Research plan, research protocol, statistical analysis plan, data analysis, methods review, publication plan, publication writing and summary, approval of final publication, project coordination

P Takács: Research plan, research overview, methods review, critical review of results, manuscript review, approval of final publication

A Borsi: Research plan, research overview, methods review, critical review of results, manuscript review, approval of final publication

A Bálint: Research plan, research overview, methods review, approval of final publication

K Farkas: Research plan, research overview, methods review, approval of final publication

Á Milassin: Literature overview, research plan, medical support at all steps of research, final approval of publication

P Lakatos: Methods review, medical plan and review, manuscript review, approval of final publication

T Szamosi: Literature overview, research plan, medical support at all steps of research, final approval of publication

T Molnár: Methodology review, medical plan and review, manuscript review, approval of final publication

Declaration of interest

P Kunovszki, J Gimesi-Országh, A Borsi, P Takács are employees/contractors of Janssen.

P Lakatos has been a speaker and/or advisory board member: AbbVie, Arena Pharmaceuticals, Celltrion, Falk Pharma GmbH, Ferring, Genetech, Janssen, Merck, Pharmacosmos, Pfizer, Roche, Shire and Takeda and has received unrestricted research grant: AbbVie, MSD and Pfizer. T Szamosi has served as advisory board member for AbbVie, EGIS, Pfizer and Takeda, received speaker’s honoraria from Abbvie, Takeda and Ferring and served as part time medical advisor for Hungarian National Health Insurance Fund (OEP-NEAK). T Molnár received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer and Teva. K Farkas received speaker’s honoraria from AbbVie, Janssen and Ferring. A Bálint received speaker’s honoraria from Janssen and Ferring. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This study was funded by Janssen: Pharmaceutical Companies of Johnson & Johnson. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.