title: Corticosteroid-related adverse events in patients with giant cell arteritis: A claims-based analysis.
abstract: Corticosteroids (CS) are standard treatment for giant cell arteritis (GCA), but concerns persist over toxicities associated with long-term use. In this retrospective study of medical claims data, we estimated risks for adverse events (AEs) in CS-treated GCA patients.
  
  
  
  Cox regression analyses with CS use as a time-dependent variable were conducted on data from the 2003 to 2012 Truven Health Analytics MarketScan Database. Patients 50 years of age and older who had ≥2 claims of newly diagnosed GCA, ≥1 filled oral CS prescription, and no AEs before GCA diagnosis were included. The primary outcome was presence of a new CS-related AE.
  
  
  
  In total, 2497 patients were included. Their mean age was 71.0 years, and 71% were women. Follow-up was 9680 patient-years (PY). CS treatment continued for a mean (SD) of 1.196 (729.2) days; mean (SD) prescribed cumulative CS dose was 6983.3mg (6519.9). The overall AE rate was 0.43 events/PY; the most frequent AEs were cataract and bone disease. For each 1000-mg increase in CS exposure, the hazard ratio (HR) increased by 3% (HR = 1.03; 95% CI: 1.02-1.05; P < 0.001). Additionally, statistically significant individual associations between increased CS exposure and AE risk were observed for bone-related AEs (P < 0.001), cataract (P < 0.001), glaucoma (P = 0.005), pneumonia (P = 0.003), and diabetes mellitus (P < 0.001 in a subset of patients with no previous history of diabetes).
  
  
  
  CS exposure significantly increased risk for potentially serious AEs, emphasizing a need for new treatment options for GCA patients.
authors.affiliation: Partnership for Health Analytic Research, LLC, Beverly Hills, CA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Broder
authors.affiliation: Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South San Francisco, CA 94080-4990. Electronic address: sarsourk@gene.com.
authors.forename: Khaled
authors.initials: K
authors.lastname: Sarsour
authors.affiliation: Partnership for Health Analytic Research, LLC, Beverly Hills, CA.
authors.forename: Eunice
authors.initials: E
authors.lastname: Chang
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Collinson
authors.affiliation: Roche Products Ltd., Welwyn Garden City, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Tuckwell
authors.affiliation: Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South San Francisco, CA 94080-4990.
authors.forename: Pavel
authors.initials: P
authors.lastname: Napalkov
authors.affiliation: Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South San Francisco, CA 94080-4990.
authors.forename: Micki
authors.initials: M
authors.lastname: Klearman
mesh_terms: D000305:Adrenal Cortex Hormones / Q000009:adverse effects* / Q000627:therapeutic use; D000368:Aged; D001847:Bone Diseases / Q000139:chemically induced*; D002386:Cataract / Q000139:chemically induced*; D016208:Databases, Factual; D005260:Female; D013700:Giant Cell Arteritis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D018570:Risk Assessment
chemical_list: D000305:Adrenal Cortex Hormones
keywords: Adverse events; Corticosteroids; Epidemiology; Giant cell arteritis; Health care insurance claims