Incidence of suboptimal response to tumor necrosis factor antagonist therapy in inflammatory bowel disease in newly industrialised countries: The EXPLORE study

Abstract

Background: Incidence of inflammatory bowel disease (IBD) is increasing in newly industrialised countries (NICs); however, data on suboptimal response to anti-tumor necrosis factor (anti-TNF) agents are limited.

Objectives: To assess incidence and indicators of suboptimal response to first anti-TNF therapy in IBD patients in NICs.

Methods: A chart review was conducted in ten countries from Asia-Pacific (APAC), Latin America (LatAm), and Russia and the Middle East (RME) regions among patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD), initiating anti-TNF therapy in 2010-2015. The cumulative incidence of suboptimal response to anti-TNF therapy was assessed using the following indicators: dose escalation or discontinuation, augmentation with non-biologic therapy, IBD-related hospitalization, or surgery.

Results: The study included 1,674 patients (570 UC; 1,104 CD). At 24 months, 32.9% of UC (APAC: 45.1%; LatAm: 38.2%; RME: 23.8%) and 41.2% of CD patients (APAC: 54.1%; LatAm: 42.5%; RME: 29.5%) had experienced suboptimal response. The most frequent first indicator was non-biologic therapy augmentation in LatAm (41.7%), IBD-related hospitalization in RME (UC: 50.7%; CD:37.3%) and in APAC for CD (39.1%), and anti-TNF discontinuation in APAC for UC (38.3%).

Conclusion: Suboptimal response to anti-TNF agents is common in IBD patients in NICs. Observed regional differences in the incidence and indicators may reflect local practice and anti-TNF restrictions in IBD management.

Nct registration number: NCT03090139.

Keywords: Anti-tumor necrosis factor; Crohn's disease; Suboptimal response; Ulcerative colitis.

Conflict of interest statement

Declaration of Competing Interests Qasim M Rana Khan, Olga Fadeeva and Dirk Demuth are employees of Takeda Pharmaceuticals Company Ltd. Morgane Guennec and Cecilia Sison are employees of IQVIA, which was funded by Takeda Pharmaceuticals Company Ltd to conduct this study. Jesús K. Yamamoto-Furusho is an advisory committee/board member for Takeda Pharmaceuticals Company Ltd; has received honoraria from AbbVie, Takeda, Janssen, Farmasa, Ferring, Alfasigma, Hospira, UCB, Danone, Almirall and Pfizer as a speaker, key opinion leader, and member of national and international advisory boards; has received research funds from Bristol, Shire, Pfizer and Takeda and former President of the Pan American Crohn's and Colitis organisation (PANCCO). Othman Al Harbi is a consultant or advisory committee/board member for AbbVie, Janssen, Pfizer and Takeda Pharmaceuticals Company Ltd. Alessandro Armuzzi is a consultant or advisory/board member for AbbVie, Allergan, Amgen, Biogen, Celgene, Celltrion, Ferring, Hospira, Janssen, Lilly, MSD, Mundipharma, Mylan, Pfizer, Roche, Samsung Bioepis, Sofar, and Takeda Pharmaceuticals Company Ltd; has received lecture fees from AbbVie, Amgen, AstraZeneca, Chiesi, Ferring, Hospira, Janssen, Medtronic, MSD, Mitsubishi Tanabe, Mundipharma, Nikkiso, Otsuka, Pfizer, Samsung Bioepis, Takeda, Tigenix, and Zambon; and research funding from MSD, Pfizer and Takeda. Webber Chan indicated no relevant financial relationships. Enrique Ponce de Leon is a consultant or advisory/board member for AbbVie, Janssen and Takeda Pharmaceuticals Company Ltd. Jiaming Qian is an advisory committee/board member for Takeda Pharmaceuticals Company Ltd. Marina Shapina is an advisory committee/board member for Takeda Pharmaceuticals Company Ltd. Murat Toruner is an advisory committee/board member for Takeda Pharmaceuticals Company Ltd; has received consulting fees from AbbVie Turkey, MSD Turkey, Janssen Turkey, Takeda Turkey and has received lecture fees from AbbVie Turkey, MSD Turkey, Janssen Turkey, Takeda Turkey, Ferring Turkey and UCB Turkey. Chia-Hung Tu is an advisory committee/board member for Takeda Pharmaceuticals Company Ltd. Byong Duk Ye has received a research grant from Celltrion and Pfizer Korea; is a consultant or advisory/board member for AbbVie Korea, Celltrion, Chong Kun Dang Pharm., Daewoong Pharma., Ferring Korea, Janssen Korea, Kangstem Biotech, Kuhnil Pharm., Medtronic Korea, Shire Korea, Takeda Korea, IQVIA, Cornerstones Health, Robarts Clinical Trials Inc. and Takeda; has received lecture fees from AbbVie Korea, Celltrion, Ferring Korea, Janssen Korea, Shire Korea, Takeda Korea, and IQVIA.

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