Zachary S Wallace, Jenny Y Park, Elizabeth Serra, Patrick Gagnon-Sanschagrin, Annie Guérin, Kristina Patterson, Haridarshan Patel, Vikesh K Singh
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Patients were stratified according to glucocorticoid use during the 12-month study period following the first observed IgG4-RD-related diagnosis (index date): low glucocorticoid use (prednisone equivalent daily dose [PEDD] < 5 mg/day) or high glucocorticoid use (PEDD ≥ 5 mg/day). Incident glucocorticoid-related toxicities were assessed during the study period and incidence was compared between groups using Chi-square tests.</p><p><strong>Results: </strong>Among 295 patients with IgG4-RD, 150 (50.8%) had low glucocorticoid use, and 145 (49.2%) had high glucocorticoid use during the study period. In each glucocorticoid group, mean PEDD was highest in the 3 months post-index and subsequently decreased. At 12 months post-index, 24.7% of the low glucocorticoid use group and 60.7% of the high glucocorticoid use group were receiving glucocorticoids. The high glucocorticoid use group had a significantly higher mean (± standard deviation) number of incident glucocorticoid-related toxicities (1.8 ± 1.7 vs. 1.2 ± 1.3) and more frequently had ≥ 3 glucocorticoid-related toxicities (29.0% vs. 13.3%; both p < 0.01) compared to the low glucocorticoid use group. Specifically, cardiovascular- (29.0% vs. 18.7%), gastrointestinal- (29.7% vs. 16.0%), and infection-related (31.0% vs. 17.3%) toxicities were significantly more common in the high glucocorticoid use group than the low glucocorticoid use group (all p < 0.05).</p><p><strong>Conclusions: </strong>In this retrospective, claims-based analysis, high glucocorticoid use was seen in half of patients with IgG4-RD during the first year following diagnosis. 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引用次数: 0
摘要
糖皮质激素通常用于治疗免疫球蛋白g4相关疾病(IgG4-RD),但在这一人群中描述糖皮质激素相关毒性的真实证据有限。本研究评估了IgG4-RD患者诊断后第一年糖皮质激素的使用和毒性。方法:使用IQVIA PharMetrics®Plus数据库,使用经过验证的算法识别成人IgG4-RD。在首次观察到IgG4-RD相关诊断(指标日期)后的12个月研究期间,根据患者的糖皮质激素使用情况对患者进行分层:低糖皮质激素使用(泼尼松当量日剂量[PEDD])结果:295例IgG4-RD患者中,150例(50.8%)糖皮质激素使用低,145例(49.2%)糖皮质激素使用高。在每个糖皮质激素组中,平均PEDD在指数后3个月最高,随后下降。在指数后12个月,24.7%的低糖皮质激素使用组和60.7%的高糖皮质激素使用组接受糖皮质激素治疗。高糖皮质激素使用组发生糖皮质激素相关毒性事件的平均(±标准差)数显著高于对照组(1.8±1.7 vs 1.2±1.3),且更频繁地发生≥3次糖皮质激素相关毒性事件(29.0% vs 13.3%;结论:在这项基于索赔的回顾性分析中,一半的IgG4-RD患者在诊断后的第一年使用高糖皮质激素。在第一年,高糖皮质激素使用的患者明显比低糖皮质激素使用的患者发生更多的糖皮质激素相关毒性事件。
Burden of Glucocorticoid Use and Risk of Toxicities Among Patients with Immunoglobulin-G4-Related Disease: A Retrospective US-Based Claims Study.
Introduction: Glucocorticoids are commonly used to treat immunoglobulin G4-related disease (IgG4-RD), but there is limited real-world evidence describing glucocorticoid-related toxicities in this population. This study assessed glucocorticoid use and toxicities during the first year after diagnosis among patients with IgG4-RD.
Methods: The IQVIA PharMetrics® Plus database was used to identify adults with IgG4-RD using a validated algorithm. Patients were stratified according to glucocorticoid use during the 12-month study period following the first observed IgG4-RD-related diagnosis (index date): low glucocorticoid use (prednisone equivalent daily dose [PEDD] < 5 mg/day) or high glucocorticoid use (PEDD ≥ 5 mg/day). Incident glucocorticoid-related toxicities were assessed during the study period and incidence was compared between groups using Chi-square tests.
Results: Among 295 patients with IgG4-RD, 150 (50.8%) had low glucocorticoid use, and 145 (49.2%) had high glucocorticoid use during the study period. In each glucocorticoid group, mean PEDD was highest in the 3 months post-index and subsequently decreased. At 12 months post-index, 24.7% of the low glucocorticoid use group and 60.7% of the high glucocorticoid use group were receiving glucocorticoids. The high glucocorticoid use group had a significantly higher mean (± standard deviation) number of incident glucocorticoid-related toxicities (1.8 ± 1.7 vs. 1.2 ± 1.3) and more frequently had ≥ 3 glucocorticoid-related toxicities (29.0% vs. 13.3%; both p < 0.01) compared to the low glucocorticoid use group. Specifically, cardiovascular- (29.0% vs. 18.7%), gastrointestinal- (29.7% vs. 16.0%), and infection-related (31.0% vs. 17.3%) toxicities were significantly more common in the high glucocorticoid use group than the low glucocorticoid use group (all p < 0.05).
Conclusions: In this retrospective, claims-based analysis, high glucocorticoid use was seen in half of patients with IgG4-RD during the first year following diagnosis. Patients with high glucocorticoid use experienced significantly more incident glucocorticoid-related toxicities than those with low use during this first year.
期刊介绍:
Aims and Scope
Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed.
Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia.
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