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新发类风湿关节炎患者糖皮质激素暴露与骨折风险

Glucocorticoid exposure and fracture risk in patients with new-onset rheumatoid arthritis.

作者信息

Balasubramanian A, Wade S W, Adler R A, Lin C J F, Maricic M, O'Malley C D, Saag K, Curtis J R

机构信息

Amgen Inc., Thousand Oaks and San Francisco, CA, USA.

Wade Outcomes Research and Consulting, 358 South 700 East, Suite B-432, Salt Lake City, UT, USA.

出版信息

Osteoporos Int. 2016 Nov;27(11):3239-3249. doi: 10.1007/s00198-016-3646-z. Epub 2016 Jun 8.

Abstract

UNLABELLED

Retrospective claims analysis indicated that high levels of daily and cumulative doses of systemic glucocorticoids were associated with elevated fracture risk in a large cohort of new RA patients under age 65. Heightened risk began to decline within months of discontinuation. Findings were similar among patients age <50 years.

INTRODUCTION

We evaluated the impact of systemic glucocorticoid exposure on fracture risk among relatively young patients with new-onset rheumatoid arthritis (RA).

METHODS

Using administrative data, we identified 42,127 RA patients diagnosed January 1, 2005-December 31, 2012, age 18-64 years, with benefits coverage for ≥12 months before RA diagnosis. Follow-up extended to clinical fracture, cancer diagnosis, or December 31, 2012. Glucocorticoid users were new to therapy. Fracture incidence rates (IR) were stratified by glucocorticoid exposure expressed as prednisone equivalent doses. Cox's proportional hazards models estimated fracture risk adjusted for demographics and baseline clinical characteristics to assess dose-response relationships with current (daily) and prior (cumulative) dose, and by time since discontinuation.

RESULTS

Most patients (85 %) had glucocorticoid exposure. Exposed and unexposed patients were demographically similar (74 % female; mean age 49.7 and 48.8 years); 1 % had prior fracture. Fracture IRs (95 % confidence intervals) were 5 to 9 per 1000 person-years at doses <15 mg/day, 16.0 (11.0, 22.6) at doses ≥15 mg/day, and 13.4 (10.7, 16.7) at cumulative doses ≥5400 mg. Adjusted fracture risk was approximately 2-fold higher at highest dose levels compared with 0 mg/day current daily dose and <675 mg cumulative dose, respectively. Fracture risk was 29 % lower at 60-182 days post-discontinuation compared with ongoing use and was similar to unexposed patients by 12 months. Findings were similar among patients age <50 years.

CONCLUSIONS

Among younger, new-onset RA patients, fracture risk was significantly elevated at high levels of daily and cumulative dose, and was similar to unexposed patients by 12 months post-discontinuation.

摘要

未标注

回顾性索赔分析表明,在一大群65岁以下的类风湿关节炎(RA)新发病患者中,全身糖皮质激素的每日高剂量和累积剂量与骨折风险升高相关。停药后数月内,风险升高的情况开始下降。在年龄小于50岁的患者中,结果相似。

引言

我们评估了全身糖皮质激素暴露对相对年轻的类风湿关节炎(RA)新发病患者骨折风险的影响。

方法

利用管理数据,我们识别出42127例在2005年1月1日至2012年12月31日期间被诊断为RA、年龄在18至64岁之间、在RA诊断前有≥12个月医保覆盖的患者。随访期延长至临床骨折、癌症诊断或2012年12月31日。糖皮质激素使用者为新接受治疗者。骨折发病率(IR)按以泼尼松等效剂量表示的糖皮质激素暴露情况进行分层。Cox比例风险模型估计了经人口统计学和基线临床特征调整后的骨折风险,以评估与当前(每日)和既往(累积)剂量以及停药后时间的剂量反应关系。

结果

大多数患者(85%)有糖皮质激素暴露史。暴露组和未暴露组在人口统计学上相似(74%为女性;平均年龄分别为49.7岁和48.8岁);1%有既往骨折史。每日剂量<15mg时,骨折发病率(95%置信区间)为每1000人年5至9例,≥15mg/天时为16.0(11.0,22.6)例,累积剂量≥5400mg时为13.4(10.7,16.7)例。与每日当前剂量0mg和累积剂量<675mg相比,最高剂量水平下调整后的骨折风险分别高出约2倍。停药后60至182天的骨折风险比持续用药时低29%,到12个月时与未暴露患者相似。年龄小于50岁的患者中结果相似。

结论

在较年轻的RA新发病患者中,每日高剂量和累积剂量时骨折风险显著升高,停药后12个月时与未暴露患者相似。

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