- Research Article
1
- 10.14309/00000434-201810001-00587
Development of a Novel Longitudinal Observational Cohort of Adult and Pediatric Patients with Inflammatory Bowel Disease: TARGET-IBD
- Oct 01, 2018
- American Journal of Gastroenterology
- Millie D Long + 9 more +9
Introduction: Management of IBD is complex, commonly involving multidisciplinary care including chronic medications, surgery, and psychological support. The aim of this study is to characterize the natural history and management paradigms for IBD utilized in usual clinical practice. Methods: TARGET-IBD is a longitudinal, observational study of pediatric and adult patients with IBD managed according to local standards at academic (n=21) and community (n=14) sites in the US. In a combined retrospective/prospective design, the redacted medical record (structured and unstructured data) from consented patients, including narratives, laboratory, endoscopic, pathology, infusion records, and imaging data utilized for IBD diagnosis and treatment are abstracted into a unique centralized data core. Patient reported outcomes are assessed prospectively. Interventions for IBD, adverse events, and disease progression are longitudinally assessed. Results: Between 7/2017 and 5/2018, 667 patients were enrolled including 410 (61.5%) with Crohn's Disease (CD), 250 (37.5%) with Ulcerative Colitis (UC), and 7 (1.0%) with Indeterminate Colitis (IBDU). Median duration of disease is 10.0 yrs (0-62 range). Mean age is 45 yrs (18-91) with 16.1% older than age 65. 44.5% are male, with a racial distribution of White (85.3%), Black (8.8%), and Asian (1.3%). 1.8% are of Hispanic ethnicity. Distribution of disease involvement for those with CD was 18.7% colon, 56.7% ileocolon, and 22.4% ileum. Fistulizing disease and stricturing was noted in 24.6% and 27.1%, respectively. Upper GI tract involvement was reported in 16.8% of patients. Among those with UC, 48% had pancolitis, 41% had left sided colitis, and 9% had disease limited to proctitis. Frequent comorbid medical conditions included hypertension (20.7%), anemia (16.2%), and depression (13.8%). IBD treatment at enrollment by drug class and diagnosis includes 5-ASA (70.4% UC, 24.1% CD), Antibiotics (2.8%, 6.8%), Steroids (32.4%, 25.1%), Thiopurine (26.0%, 30.5%), Methotrexate (4.4%, 9.0%), Anti-TNF (31.6%, 50.5%), Anti-integrin (14.0%, 9.8%), and Anti-IL-12/23 (0.4%, 6.8%). Clinical characteristics between participating academic and community centers are shown in Table A. Conclusion: TARGET-IBD, a novel prospective observational cohort of patients with IBD, is evaluating treatment patterns in both academic and community settings. Ongoing recruitment and longitudinal follow up of this cohort will provide an important resource for comparative effectiveness and safety data.587 Figure 1 No Caption available.
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