Risk Associated with Cumulative Oral Glucocorticoid Use in Patients with Giant Cell Arteritis in Real-World Databases from the USA and UK

Sara Gale; Jessica C Wilson; Jenny Chia; Huong Trinh; Katie Tuckwell; Neil Collinson; Sophie Dimonaco; Susan Jick; Christoph Meier; Shalini V Mohan; Khaled Sarsour

doi:10.1007/s40744-018-0112-8

Risk Associated with Cumulative Oral Glucocorticoid Use in Patients with Giant Cell Arteritis in Real-World Databases from the USA and UK

Rheumatol Ther. 2018 Dec;5(2):327-340. doi: 10.1007/s40744-018-0112-8. Epub 2018 May 11.

Authors

Affiliations

¹ Genentech, Inc., South San Francisco, CA, USA. gale.sara@gene.com.
² Basel Pharmacoepidemiology Unit, University of Basel, Basel, Switzerland.
³ Genentech, Inc., South San Francisco, CA, USA.
⁴ Roche Products, Ltd., Welwyn Garden City, UK.
⁵ Boston Collaborative Drug Surveillance Program, Boston University School of Public Health, Lexington, MA, USA.

Abstract

Introduction: Treatment of giant cell arteritis (GCA) involves immediate initiation of high-dose glucocorticoid therapy with slow tapering of the dose over many months. Chronic exposure to glucocorticoids is associated with serious comorbidities. The objective of this analysis was to determine the glucocorticoid exposure and risk of glucocorticoid-related adverse events (AEs) in real-world patients with GCA.

Methods: Data from the Truven Healthcare MarketScan^® database (from January 1, 2000, to June 30, 2015) and the Clinical Practice Research Datalink (CPRD; from January 1, 1995, to August 31, 2013) were used to retrospectively analyze patients aged ≥ 50 years with GCA in the USA and UK, respectively. Outcomes included oral glucocorticoid use (cumulative prednisone-equivalent exposure), glucocorticoid-related AEs and the association of AE risk with glucocorticoid exposure over 52 weeks.

Results: Of the 4804 patients in the US MarketScan database and 3973 patients in the UK CPRD database included, 71.3 and 74.6% were women and mean age was 73.4 and 73.0 years, respectively. Median starting glucocorticoid dose and cumulative glucocorticoid dose at 52 weeks were 20-50 mg/day and 4000-4800 mg, respectively. The most frequent glucocorticoid-related AEs were hypertension and eye, bone health, and glucose tolerance conditions. In the first year after diagnosis, the likelihood of any glucocorticoid-related AE was significantly increased for each 1 g increase in cumulative glucocorticoid dose in the US and UK cohorts (odds ratio [95% CI], 1.170 [1.063, 1.287] and 1.06 [1.03, 1.09], respectively; P < 0.05 for both). Similar trends were observed for the risk of glucocorticoid-related AEs over full follow-up (mean, USA: 3.9 years, UK: 6.3 years).

Conclusions: In real-world patients with GCA, increased cumulative glucocorticoid exposure was associated with an increased risk of glucocorticoid-related AEs.

Funding: F. Hoffmann-La Roche Ltd. Plain language summary available for this article.

Keywords: Giant cell arteritis; Glucocorticoid; Safety; Toxicity; Vasculitis.