S1053 Characteristics, Medication and Healthcare Utilization of Crohn’s Disease Patients Stratified by Short-CDAI Status: Descriptive Results From the IBD PLEXUS and IQVIA Linked Dataset

Abstract

Introduction: Crohn’s disease (CD) is a life-long chronic inflammatory disorder. CD studies in real-world settings usually do not include disease severity measures since few longitudinal databases with robust clinical data and long-term administrative claims exist. We describe the demographics, clinical characteristics, medications and healthcare utilization of patients with CD stratified by the short Crohn's Disease Activity Index (sCDAI) with a unique CCF and IQVIA linked dataset. Methods: This retrospective analysis used data from the Crohn’s & Colitis Foundation (CCF) SPARC IBD and IBD QORUS data linked with IQVIA’s prescription and medical claims (LRx/Dx), to identify a cohort of CD patients with up to 24 months pre-enrollment and at least 18 months of follow-up. Enrollment date into CCF studies was used as the Index date and CD patients were stratified into three disease activity cohorts based on enrollment sCDAI scores: Remitters (R) sCDAI < 150, Non-remitters and non-moderate-severe (nRnMS, a.k.a. ‘Mild’) sCDAI = 150-219, and Moderate-Severe (MS) sCDAI ≥220. Medication use for biologics, immunomodulators and 5-ASAs was based on a hierarchy of highest step achieved. Descriptive analyses were performed for baseline period clinical characteristics, medications and healthcare utilization. Results: Of the 1756 CD patients included, 1027 were in R, 361 were nRnMS and 368 were in MS disease activity. Mean age for the three groups was around 43 years. Time since CD diagnosis was more than 10yrs in 54.5%, 52.9% and 58.4% of the R, nRnMS and MS groups, respectively. Mean (±SD) sCDAI scores at enrollment were 96.2 (±28.1) for R, 182.0 (±20.3) for nRnMS and 302.0 (±77.7) for the MS group. Biologics were used in 37.5% of R, 39.3% of nRnMS and 33.4% of MS patients. High use of corticosteroids and opioids was seen across all three groups. Emergency room visits increased across the R (7.1%), nRnMS (12.2%) and MS (27.2%) cohorts. Hospitalizations were highest in the MS group. (Table) Conclusion: We utilized a unique longitudinal dataset linked to administrative claims, to provide an initial description of characteristics between three severity-based CD cohorts. We observed generally more severe disease features, medication and healthcare utilization in CD patients who were not in remission. Future research will evaluate relationships between disease characteristics, treatment patterns and poor outcomes during follow-up. Table 1. - Demographics, Disease Characteristics, Medications and Healthcare Utilization* Characteristic Remitters (n = 1027) nRnMS (n = 361) Mod/Sev (n = 368) Female (n, %) 545 (53.1%) 230 (63.7%) 250 (67.9%) Age in years (mean +/- SD) 42.9 (15.2) 43.2 (15.2) 43.1 (13.9) Age at First Diagnosis (n, %) < =11 60 (5.8%) 25 (6.9%) 25 (6.8%) 12-17 161 (15.7%) 50 (13.9%) 50 (13.6%) 18-39 557 (54.2%) 206 (57.1%) 210 (57.1%) >=40 202 (19.7%) 66 (18.3%) 63 (17.1%) unknown/missing/other 47 (4.6%) 14 (3.9%) 20 (5.4%) Time since diagnosis (Mean Yrs +/- SD) 14.2 (10.8) 14.7 (11.4) 15.6 (12.2) Race (n, %) African American (Black or African American) 79 (7.7%) 43 (11.9%) 29 (7.9%) Asian 69 (6.7%) 24 (6.6%) 22 (6.0%) Other 103 (10.0%) 37 (10.2%) 42 (11.4%) White 776 (75.6%) 257 (71.2%) 275 (74.7%) CD Phenotype (n, %) Both stricturing and penetrating 105 (10.2%) 36 (10.0%) 42 (11.4%) Non-stricturing and non-penetrating 371 (36.1%) 124 (34.3%) 115 (31.3%) Penetrating and non-stricturing 129 (12.6%) 47 (13.0%) 47 (12.8%) vStricturing and non-penetrating 218 (21.2%) 77 (21.3%) 92 (25.0%) vUnknown / Missing 204 (19.9%) 77 (21.3%) 72 (19.6%) Other Current IBD Manifestations (n, %) Intestinal inflammation 43 (5.6%) 21 (7.4%) 36 (12.1%) Extra-intestinal manifestations 24 (3.1%) 14 (4.9%) 23 (7.7%) None / unknown / missing 711 (92.2%) 254 (89.8%) 255 (85.6%) sCDAI at Enrollment (mean +/- SD) 96.2 (28.1) 182 (20.3) 302 (77.7) Abdominal Pain (mean +/- SD) 0.3 (0.5) 1.0 (0.7) 1.7 (0.8) Stool Frequency (mean +/- SD) 2.6 (1.4) 4.4 (2.4) 8.1 (4.6) General Well-Being (mean +/- SD) 0.1 (0.3) 0.9 (0.5) 1.7 (0.9) Medication Utilization (n, %) Current Biologic users 385 (37.5%) 142 (39.3%) 123 (33.4%) Current IMS users (Never Biologic) 173 (16.8%) 63(17.5%) 62 (16.8%) Current 5-ASA (Never Biologic or IMS) 57 (5.6%) 23(6.4%) 12 (3.3%) Any Corticosteroid user 278 (27.1%) 133 (36.8%) 173 (47.0%) Any Opioid user 202 (19.7%) 120(33.2%) 163 (44.3%) No therapy (at least 6 months) 249 (24.2%) 71 (19.7%) 62 (16.8%) Healthcare Utilization (n, %) ER Visits (in 12 months prior to enrollment) 73 (7.1%) 44 (12.2%) 100 (27.2%) Hospitalization Visits (in 6 months prior to enrollment) 49 (4.8%) 17 (4.7%) 38 (10.3%) Prior CD-related Surgery 18 (1.8%) 5 (1.4%) 2 (0.5%) Office visits (in 24 months prior to enrollment) 853 (83.1%) 315 (87.3%) 330 (89.7%) Table: Percentages may not always add up to 100% due to missing/unknown/none values for some variables