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Introduction Oral glucocorticoids (GC) have been the mainstay of treatment for giant cell arteritis (GCA). We estimated the risk and dose–effect relationship of potential GC-related adverse events (AEs) in patients with GCA. Methods This retrospective, observational cohort study utilized data from the IBM Explorys Electronic Health Records database from 2008 through 2016. Inclusion criteria included the presence of at least two GCA diagnostic codes in subjects aged 50 or older along with supporting laboratory [C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)], prescription data on oral GCs, and at least 12 months of follow-up before and after the first oral GC prescription for GCA (index date). Potential AEs captured on the basis of new diagnoses, prescriptions, and laboratory tests were assessed during the 12 months post-index date. Results were descriptively summarized across cohorts according to quartiles (Q) of mean daily GC dose measured over the first 6 months of follow-up (Q1, ≥ 1.00 to ≤ 13.75 mg; Q2, > 13.75 to ≤ 25.00 mg; Q3, > 25.00 to ≤ 40.00 mg; Q4, > 40.00 mg). Results We identified 785 eligible patients with GCA. The mean (SD) age of the cohort was 76 (9) years and 70% were female. The mean oral GC dose during the first 6 months post-index was 28.9 mg/day. A dose–effect response was observed from Q1 to Q4 in the following potential GC-related AEs: newly diagnosed type 2 diabetes/HbA1c > 7.5% (range 7.5–24.5%), blood glucose ≥ 200 mg/dL (range 7.5–15%), serious infection (range 16.8–24.8%), cataracts (range 12.0–21.7%), gastrointestinal bleed/ulcer (range 6.0–11.8%), and increase in BMI ≥ 5 units (range 4.1–6.4). Conclusions In patients with GCA, potential GC-related AEs increased with higher daily oral GC doses. This highlights the need for effective therapies that reduce GC exposure and toxicity. Funding Genentech, Inc.

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are two related forms of systemic vasculitis. Patients with these conditions often experience relapses affecting various body systems. Here we describe rates of relapse and review healthcare costs resulting from relapse among patients with GPA/MPA. Two groups of patients with GPA and MPA were selected from the MarketScan claims databases between 2011 and 2013 based on diagnosis codes. Patients were followed for 12 months to identify relapses based on an algorithm of diagnoses in medical and medication claims. Relapses were categorized into one of the following groups: renal relapse, pulmonary relapse, other relapse-associated condition relapse, GPA or MPA utilization relapse, and mixed relapse. The final sample of patients with GPA and MPA consisted of 2707 and 740 patients, respectively. In both groups, approximately one-quarter of patients experienced relapse during the 12-month follow-up period. The mean all-cause healthcare costs in the 4-month period after relapse were $38,313 (SD, $54,120) for patients with GPA and $35,947 (SD, $48,065) for patients with MPA. In both groups, renal relapses were the costliest. Costs during the 4 months immediately following relapses were substantially higher than what could be expected over a 4-month follow-up among patients who did not experience relapse based on 12-month all-cause costs (GPA, $32,005 [SD, $64,570]; MPA, $61,044 [SD, $125,093]). Relapses are common among patients with GPA and MPA, and treatment of relapses can be costly. More effective therapies are needed to prevent relapses. Genentech, Inc.