Serious adverse effects associated with glucocorticoid therapy in patients with giant cell arteritis (GCA): A nested case-control analysis

Journal: Seminars in Arthritis and Rheumatism

Authors: Jessica C Wilson ¹, Khaled Sarsour ², Neil Collinson ³, Katie Tuckwell ³, David Musselman ², Micki Klearman ², Pavel Napalkov ², Susan S Jick ⁴, John H Stone ⁵, Christoph R Meier ⁶

NLM Citation: Wilson JC, Sarsour K, Collinson N, Tuckwell K, Musselman D, Klearman M, Napalkov P, Jick SS, Stone JH, Meier CR. Serious adverse effects associated with glucocorticoid therapy in patients with giant cell arteritis (GCA): A nested case-control analysis. Semin Arthritis Rheum. 2017 Jun;46(6):819-827. doi: 10.1016/j.semarthrit.2016.11.006. Epub 2016 Nov 28. PMID: 28040244.

Abstract

Objective: Giant cell arteritis (GCA) is an inflammatory vasculitis preferentially affecting large and medium-sized arteries. High-dose oral glucocorticoids (GCs) are the mainstay of GCA therapy. Using data from the UK Clinical Practice Research Datalink (CPRD), we examined the risk of oral GC-related serious adverse events (SAEs) in a UK population of patients with giant cell arteritis (GCA).

Methods: We conducted a series of nested case-control analyses in GCA patients to examine the effect of increasing dose of prednisolone on the risk of developing diabetes, glaucoma, osteoporosis, fractures, serious infection requiring hospitalization, and death. We used conditional logistic regression to calculate the unadjusted and multivariate odds ratios (ORs) with 95% CIs for the associations between prednisolone use and the risks of all outcomes of interest. We stratified the analyses by increasing cumulative prednisolone use and average daily dose.

Results: In the multivariate analyses, we observed a trend of increasing risk of diabetes and osteoporosis with increasing cumulative dose of oral prednisolone (p^trend < 0.05). GCA patients in the highest daily dose category (30mg/d) had an increased risk of diabetes (adjusted OR, 95% CI) (4.7, 2.8-7.8), osteoporosis (1.9, 1.2-2.9), fractures (2.6, 1.6-4.3), glaucoma (3.5, 2.0-6.1), serious infection (3.3, 2.2-5.2), and death (2.1, 1.3-3.5) compared to those with lower average daily prednisolone doses (5mg/d).

Conclusion: Compared to lower average daily prednisolone doses, high average daily doses were associated with an increased risk of serious adverse effects.

Keywords: Giant cell arteritis; Glucocorticoids; Health services research; Outcomes research; Serious adverse events.

Copyright © 2017 Elsevier Inc. All rights reserved.