Jessica C Wilson1, Khaled Sarsour2, Neil Collinson3, Katie Tuckwell3, David Musselman2, Micki Klearman2, Pavel Napalkov2, Susan S Jick4, John H Stone5, Christoph R Meier6. 1. Basel Pharmacoepidemiology Unit, Hospital Pharmacy, University of Basel, Basel, Switzerland. 2. Genentech, Inc, South San Francisco, CA. 3. Roche Products Ltd, Welwyn Garden City, United Kingdom. 4. Boston Collaborative Drug Surveillance Program (BCDSP), Boston University School of Public Health, Lexington, MA. 5. Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA. 6. Basel Pharmacoepidemiology Unit, Hospital Pharmacy, University of Basel, Basel, Switzerland; Boston Collaborative Drug Surveillance Program (BCDSP), Boston University School of Public Health, Lexington, MA; Hospital Pharmacy, University Hospital Basel, Basel, Switzerland. Electronic address: Christoph.Meier@usb.ch.
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 (ptrend < 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.
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 (ptrend < 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.
Authors: Dan Pugh; Maira Karabayas; Neil Basu; Maria C Cid; Ruchika Goel; Carl S Goodyear; Peter C Grayson; Stephen P McAdoo; Justin C Mason; Catherine Owen; Cornelia M Weyand; Taryn Youngstein; Neeraj Dhaun Journal: Nat Rev Dis Primers Date: 2022-01-06 Impact factor: 65.038
Authors: Lisa Duff; Andrew F Scarsbrook; Sarah L Mackie; Russell Frood; Marc Bailey; Ann W Morgan; Charalampos Tsoumpas Journal: J Nucl Cardiol Date: 2022-03-23 Impact factor: 5.952
Authors: John H Stone; Helen Spotswood; Sebastian H Unizony; Martin Aringer; Daniel Blockmans; Elisabeth Brouwer; Maria C Cid; Bhaskar Dasgupta; Juergen Rech; Carlo Salvarani; Robert Spiera; Min Bao Journal: Rheumatology (Oxford) Date: 2022-07-06 Impact factor: 7.046
Authors: Sara Gale; Jessica C Wilson; Jenny Chia; Huong Trinh; Katie Tuckwell; Neil Collinson; Sophie Dimonaco; Susan Jick; Christoph Meier; Shalini V Mohan; Khaled Sarsour Journal: Rheumatol Ther Date: 2018-05-11