BACKGROUND: Despite their long-term risks, corticosteroids are often used in the management of ulcerative colitis (UC) to help patients achieve and maintain disease remission. The aim of this study was to describe the frequency of high-level corticosteroid exposure and the association between this exposure and both clinical and economic outcomes. METHODS: This retrospective analysis used the IQVIA Real-World Data Adjudicated Claims—US database from January 1, 2006 to June 30, 2017. Patients aged ≥18 years with ≥2 medical claims for UC (ICD9:556.* or ICD10 K51.*) who initiated their first UC therapy (considered the “index” date) between July 1, 2006 and June 30, 2013 and had continuous enrollment 6 months prior to (pre-index) and 4 years after (post-index) this therapy were included. The first 3 years of the post-index window was the corticosteroid exposure observation period; the fourth (and last) year was the outcomes assessment period. Patients were categorized into one of 2 corticosteroid use cohorts: “frequent” (>30 days of continuous corticosteroid exposure in at least 2 of the 3 observation years) versus “infrequent” (all others). Cohorts were compared with respect to the incidence of clinical outcomes (known disease and corticosteroid-related sequelae including infections, osteoporosis etc.), healthcare resource utilization, and costs in the outcomes assessment period. Analyses included chi-square tests and 2-sample t tests. RESULTS: A total of 22,841 patients with UC were included (53.1% female; mean age = 45.2 years [SD = 11.5]). Among them, 4,098 (17.9%) patients met criteria for frequent corticosteroid use. Compared with patients in the infrequent cohort, patients in the frequent cohort were significantly more likely to be younger (28.0% vs 22.7% were 18–39 years), male (48.9% vs 46.5%), and had greater total pre-index costs ($17,294 vs $8,257) (all P < 0.05). Patients in the frequent cohort were significantly more likely to develop gastrointestinal conditions (e.g., ulcers, gastrointestinal bleeding; 87.5% vs 74.0%), infections (e.g., herpes zoster; 53.5% vs 44.3%), musculoskeletal conditions (e.g., osteoporosis; 59.7% vs 51.5%), and dermatologic conditions (e.g., acne, abdominal striae; 34.9% vs 29.8%) (all P < 0.05) during the subsequent outcomes assessment period compared with patients in the infrequent cohort. Patients in the frequent cohort were also more likely to experience a future emergency room visit (24.8% vs 17.9%), an inpatient hospitalization (16.9% vs 8.2%), longer average length of hospital stays (5.9 vs 5.4 days), and higher costs (pharmacy: $17,243 vs $7,939; outpatient: $9,998 vs $6,363; inpatient: $7,299 vs $2,769) compared with patients in the infrequent cohort (all P < 0.05). CONCLUSION(S): Frequent corticosteroid exposure was common among patients with UC and subsequently associated with an increased likelihood of adverse clinical outcomes and greater healthcare resource utilization, and costs.
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