Abstract
BackgroundThere has been a more pronounced shift toward earlier, more aggressive therapies in Crohn’s disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent.MethodsUC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial Database, a large US database. The date of the first recorded UC biologic exposure was defined as the index date, and ≥ 5 years of pre-index records were required to evaluate patients’ treatment, disease progression and overall health care utilization prior to initiating biologic agents.ResultsAmong the 1891 eligible patients, treatment with oral corticosteroids, 5-aminosalicylates, and other non-biologic immunomodulators, all increased progressively across the 5 years prior to the index. From within year-five to within year-one prior to the index, the median duration of oral corticosteroid treatment increased from 34 to 88 days per year and the proportion of patients who experienced more extensive/pancolitis disease increased from 16 to 59%. Overall, the frequency of all-cause health care visits also increased.ConclusionsPatients with UC experienced increasing morbidity and treatment burden in the 5 years prior to initiating biologic therapy. To achieve reduced corticosteroids in UC management, better risk stratification is needed to help identify patients for more timely biologic treatment.
Highlights
Crohn’s disease (CD) and ulcerative colitis (UC) are the two major forms of inflammatory bowel disease (IBD)
The present study aims to describe the treatment and health care utilization patterns of UC patients who initiated biologic therapies in the 5 years prior to the initiation of the first biologic agent, and to understand whether these patients had evidence of a refractory disease course of chronic recurrent flares in routine clinical practice before they were initiated on biologic therapies
The Commercial Database (CCAE) database has been converted to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) [18] version 5.3.1, which includes a standard representation of health care experiences, as well as common vocabularies for coding clinical concepts and enables consistent application of analyses across multiple disparate data sources [19]
Summary
Crohn’s disease (CD) and ulcerative colitis (UC) are the two major forms of inflammatory bowel disease (IBD). 5-aminosalicylates (5-ASA) have been used as first-line therapy in patients with moderately to severely active UC with or without the addition of corticosteroids. For adults with moderate to severe ulcerative colitis in the outpatient setting, the American Gastroenterological Association (AGA) suggests early use of biologic agents with or without immunomodulator therapy, rather than gradual stepup therapy after failure of 5-ASA [8]. Population-based inception cohort studies have reported 5-year cumulative risk of UC disease progression of about 13%, and significantly higher risk of colectomy in patients with extensive colitis [11]. There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn’s disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent
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