(284) Development of Real-World Cohorts Using Electronic Health Records (EHR) Supplemented with Administrative Claims Data for Pharmacoepidemiology Studies of Patients with IBD Initiating Biologic Therapy

Publication Number: 958

Background: Prior studies characterizing IBD patients initiating a biologic treatment have relied on administrative claims data for accurate dispensing medication information. EHRs include rich clinical data and health behavior information that are lacking in administrative claims data. Linking EHR with claims data could supplement the individual databases and offer increased value to pharmacoepidemiology studies.

Objectives: To describe cohorts of IBD patients initiating biologic therapy in EHR data supplemented with claims for future pharmacoepidemiology research

Methods: We conducted a retrospective cohort study of adult patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) using Optum’s EHR database with integrated administrative claims from open and closed sources. Index was defined as the date of the first biologic administration in the EHR or claim between January 1, 2007, through June 30, 2020. Cohorts were described with respect to their demographics, clinical characteristics, comorbidities, medication use, measured signs and symptoms and occurrence of relevant IBD-related outcomes (IBD-related hospitalization, major abdominal surgery and new or escalation of steroid use for disease flare) within 12 months after biologic initiation. Steroid use was assessed in a subpopulation with sufficient capture of claims activity.

Results: Out of N=14,170 biologic initiators, 3,538 (25%) had previously used another biologic. Among patients initiating their first biologic, mean age was 42 (SD 15.6) years among CD patients (N=6,347) and 44 (SD 15.9) years among UC patients (N=4,285). Over half were female (57.3% in CD, 51.8% in UC). Abdominal pain (86.1% in CD, 87.2% in UC) and diarrhea (82.2% in CD, 82.4% in UC) were commonly reported disease symptoms. Thirty percent of CD patients had disease confined to the small intestine. In UC, pancolitis (43.1%) was more common than left-sided colitis (10.1%). After initiating therapy, 6.2% of CD patients had abdominal surgery, 22.6% had a CD-related hospitalization, and 38.6% had steroid dose escalation within 12 months. After initiating therapy, 5.3% of UC bio-naïve patients had abdominal surgery, 19.7% had a UC-related hospitalization, and 48.4% had a steroid dose escalation within 12 months.

Conclusions: EHR integrated with claims data can be used to curate real-world IBD treated cohorts and describe patient characteristics, disease features, and measures of IBD-related healthcare activity.