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Corticosteroid-related AEs increased with drug exposure in patients with CIU
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Patients with chronic idiopathic urticaria or chronic spontaneous urticaria had an increased risk of oral corticosteroid-related adverse events with an increase in cumulative exposure to the drugs, according to research presented at the American Academy of Allergy, Asthma and Immunology Annual Meeting.
Researchers analyzed a commercial claims database from 2008 through 2012 to identify 12,647 patients with chronic idiopathic urticaria/spontaneous urticaria who had either two outpatient diagnoses at least 6 weeks apart in a calendar year or one outpatient urticaria diagnosis plus one angioedema diagnosis at least 6 weeks later. Diabetes mellitus, hypertension, lipid disorders, cataracts, depression and mania, skeletal conditions including osteoporosis and fractures, and pneumonia and opportunistic infections were adverse events (AEs) studied. Cumulative oral prednisone-equivalent exposure in milligrams and AE development risk were modeled through time-dependent Cox regression after adjustments for age, sex, Charlson Comorbidity Index and immunomodulator use.
Oral corticosteroids (OCS) were used by 55.4% patients during the first 12 months observed, with a mean treatment duration of 1.62 days and mean per-patient prednisone-equivalent dose exposure of 367.5 milligrams. There were 27.3 new AEs occurring per 100 patient-years after the initial 1-year observation. There was a 7% higher adjusted risk for developing any AE (HR=1.07; 95% CI, 1.05-10.8) per additional 1 gram of prednisone-equivalent exposure.
“As cumulative prednisone-equivalent exposure increased, so did the risks for each studied AE, except cataracts,” the researchers wrote. “The highest risks were associated with developing skeletal conditions and infections.”
Reference:
Ledford D, et al. Abstract 402. Presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting; Feb. 20-24, 2015; Houston.
Disclosure: Ledford reports financial ties with Circassia, Teva, Forest, Shook Hardy Bacon, Saieva and Stine, Genentech, Meda Pharmaceutical, Merck, Fowler White Burnett, Novartis and Richard Benjamin Wilkes.