813 Incidence and Indicators of Suboptimal Response to Tumor Necrosis Factor Antagonist Therapy in Inflammatory Bowel Disease in Newly Industrialized Countries: Results From the EXPLORE Study

• Published in: The American journal of gastroenterology Vol. 114; no. 1; p. S470
• Main Authors: Al Harbi, Othman, Armuzzi, Alessandro, Chan, Webber, Ponce de Leon, Enrique, Qian, Jiaming, Shapina, Marina, Toruner, Murat, Tu, Chia-Hung, Ye, Byong Duk, Guennec, Morgane, Sison, Cecilia, Demuth, Dirk, Fadeeva, Olga, Khan, Rana Qasim, Yamamoto-Furusho, Jesús
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.10.2019
• Subjects: Inflammatory bowel disease; Tumor necrosis factor-TNF; Russia
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/01.ajg.0000592788.27677.ec

INTRODUCTION:Inflammatory bowel disease (IBD) patients in Western countries frequently experience suboptimal response to anti-tumor necrosis factor (TNF) treatment (Tx). The EXPLORE study aimed to assess the incidence and indicators of suboptimal response to first-line anti-TNF agents in IBD patients in real-world practice in newly industrialized countries, where data are limited.METHODS:A retrospective chart review study was conducted in Asia-Pacific (APAC; South Korea, China, Taiwan, Singapore), Latin America (LatAm; Argentina, Colombia, Mexico) and Russia-Middle East (RME; Russia, Saudi Arabia, Turkey) in adult patients diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD), who initiated anti-TNF Tx between March 2010 and March 2015. The cumulative incidence (CI) of suboptimal response (Kaplan-Meier method) was assessed over the first 24 months of Tx, as the occurrence of a first indicator of: IBD-related hospitalization, dose escalation (increase in frequency and/or dose), discontinuation including switch to another anti-TNF, non-biologic Tx augmentation, or IBD-related surgery. Primary non-response (PNR) and secondary loss of response (SLOR) were defined as any suboptimal response indicator at < 4 and ≥4 months after anti-TNF initiation (excluding PNR patients), respectively.RESULTS:Overall, 1674 first-line anti-TNF treated patients (570 UC; 1104 CD) were included: male, UC 56.1%, CD 61.2%; median (min-max) age (years), UC 39.0 (18-82), CD 31.0 (19-83); median (min-max) disease duration (years), UC 3.0 (0-34), CD 1.0 (0-33); median (min-max) follow-up (months), UC 45.9 (24-60), CD 46.5 (14-60). At 24 months, the CI of suboptimal response to first anti-TNF Tx was 32.9% in UC and 41.2% in CD patients (unadjusted log-rank: P < 0.01); the APAC region had the highest CI (UC 45.1%; CD 54.1%) (Table 1). The CI of PNR was 13.6% and 16.9% in UC and CD patients, respectively. The CI of SLOR was 22.3% in UC and 29.2% in CD patients at 24 months. The most frequent first suboptimal response indicator was ‘IBD-related hospitalization’ (UC 33.0%; CD 36.1%) followed by ‘non-biologic augmentation’ (UC 30.3%; CD 23.8%) (Table 1).CONCLUSION:Suboptimal response to first-line anti-TNF agents is common in IBD patients in newly industrialized countries and is more frequently experienced in CD than in UC. Observed regional differences in the rates of suboptimal response, PNR and SLOR, may reflect local practice variations and restrictions in the management of anti-TNF treated patients.