OP0275 REAL-WORLD CLINICAL BURDEN AND GLUCOCORTICOID USE IN PATIENTS WITH GIANT CELL ARTERITIS
Authors: R. Punekar, P. Lafontaine, J. H. Stone
Journal: Annals of the Rheumatic Diseases (2020)

Background: Giant cell arteritis (GCA) is a rare form of vasculitis usually manifesting in people aged ≥50 yr and is more common in women. Symptoms include headache, jaw claudication, fatigue, polymyalgia; and blindness if untreated. While risks of complications can be reduced with promptly administered high-dose glucocorticoids (GC; 20-60 mg for 2-4 wk, then slowly tapered), further risks of high GC exposure and related complications over the course of therapy remain. Objectives: To compare GC use and GC-related complications in GCA patients (pts) vs a general population (GnP) cohort. Methods: This retrospective, observational cohort study was based on Optum’s de-identified Clinformatics ® Data Mart Database (01/01/06-30/06/18, study period). The GCA cohort included pts with ≥1 inpatient or ≥2 outpatient claims ≥30 days apart with GCA-related diagnosis codes (ICD-9: 446.5x/ICD-10: M31.6x) between 01/01/06-30/06/17 (pt identification period) during which first occurrence of a GCA-related medical claim was set as index date (ID). The GnP cohort included pts without any medical claims for rheumatoid arthritis, GCA or polymyalgia rheumatica diagnosis codes during the study period, with their ID set as 12 mo from start of continuous health plan enrollment. Pts in both cohorts were required to be age ≥50 yr (on the ID) with continuous health plan enrollment ≥12 mo pre- and post-ID. Cohorts were 1:1 propensity score matched. GC use and incidence of GC-related complications were assessed from GC initiation, starting from the baseline period (12-mo pre-ID) to the end of GC use during the post-index period (ie the end of data availability, end of the study period, or death, whichever occurred first). Descriptive analyses included mean, standard deviation (SD) and median values for continuous variables, and frequency (n and %) for categorical variables. Continuous variables were compared between matched cohorts using t -tests and Wilcoxon sum rank tests. Categorical variables were compared between matched cohorts using Chi-square tests or Fisher’s exact tests. Duration of GC use was analyzed using the Kaplan-Meier method and compared between matched cohorts using log-rank tests. Results: There were 6071 pts included in each of the GCA and matched GnP cohorts; median age per cohort was 76 yr, median Elixhauser comorbidity index score was 3.0, and the majority (~75%) were women. The median follow-up duration was 44 and 48 mo in the GCA and GnP cohorts, respectively. A higher proportion of pts in the GCA cohort than the GnP cohort (90.6 vs 63.8%; p &lt;0.001) used GC. The mean (SD) duration of GC therapy was 230.5 (±326.8) days in the GCA cohort vs 36.3 (±107.2) days in the GnP cohort ( p &lt;0.001). Although the mean (SD) daily dose of GC (prednisone equivalent) was similar in both cohorts (27.6 [±28.20] vs 27.7 [±25.18] mg), the mean (SD) cumulative GC dose was significantly higher in the GCA cohort than the GnP cohort (3503.0 (±4622.6) mg vs 503.7 (±1593.51) mg; p &lt;0.001). This indicates that GCA pts had chronic GC exposure over the study period while GnP pts likely utilized higher dose GC burst therapy less frequently. The number of incident complications associated with GC use were significantly greater in the GCA cohort, and included hypertension, diabetes, skin toxicity, infections, neuropsychiatric effects, gastrointestinal complications, ocular effects, and cardiovascular disease ( p &lt;0.05). Conclusion: The overall GC burden in pts with GCA is significantly higher than the general population and may result in downstream complications related to GC exposure. The incidence of GC-related complications was statistically significantly higher in GCA pts compared with GnP pts, even with a short duration of GC use. The early onset of these complications may be a significant contributor to long-term healthcare costs in GCA pts. Acknowledgments: Study and medical writing (provided by Gauri Saal, MA, Economics, Prime, Knutsford, UK, under the direction of authors) were funded by Sanofi, Inc. Disclosure of Interests: Rajeshwari Punekar Shareholder of: Sanofi, Employee of: Sanofi, Patrick LaFontaine Shareholder of: Sanofi, Employee of: Sanofi, John H. Stone Grant/research support from: Roche, Consultant of: Roche