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Abstract Number: 919

Glucocorticoid Exposure and Fracture Risk in a Large Cohort of Commercially-Insured Rheumatoid Arthritis Patients Under Age 65

Akhila Balasubramanian1, Sally Wade2, Robert A Adler3, Celia Fang (Lin)4, Michael Maricic5, Cynthia O'Malley1, Kenneth G. Saag6 and Jeffrey R. Curtis7, 1Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, 2Wade Outcomes Research and Consulting, Salt Lake City, UT, 3Internal Medicine, Hunter Holmes McGuire VA Medical Center, Richmond, VA, 4Amgen, Thousand Oaks, CA, 5Catalina Pointe Rheumatology, Tucson, AZ, 6Immunology & Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, 7The University of Alabama at Birmingham, Birmingham, AL

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Fracture risk, glucocorticoids, osteoporosis, outcomes and rheumatoid arthritis (RA)

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Session Information

Session Title: Osteoporosis and Metabolic Bone Disease - Clinical Aspects and Pathogenesis: Clinical Osteoporosis: Treatment and Safety

Session Type: Abstract Submissions (ACR)

Background/Purpose

Systemic glucocorticoid use can increase fracture risk, although dose-specific effects are not well understood, especially in younger adults.  Underlying diseases (e.g., rheumatoid arthritis [RA]) can confound these associations.  This study evaluated the impact of glucocorticoid exposure on risk of fragility fracture in RA patients.

Methods

The 42,034 study patients identified in the MarketScan® claims database were newly treated for RA (index date) between 1/1/2005 and 12/31/2011, aged 18-64 years at index, had benefits coverage for ≥12 months pre-index, and no pre-index cancer.  Patients with pre-index glucocorticoid use were glucocorticoid-free for ≥ 12 months prior to their first glucocorticoid pharmacy claim, and had continuous benefits coverage from first glucocorticoid claim to index date.  Glucocorticoid use (any; cumulative, peak, and average daily dose; cumulative days exposed; days of continuous exposure; days since most recent exposure) was assessed for each patient-day and censored at the earliest of post-index fragility fracture, cancer diagnosis, or end of follow-up.  Exposures were converted to prednisone equivalents and cumulative measures included pre-index use.  Patient demographics at index and pre-index clinical characteristics were assessed.  Incidence rates per 1,000 person-years for post-index fragility fracture were stratified by glucocorticoid exposure.  Cox’s proportional hazards models estimated age- and sex-adjusted fracture risk by exposure level.

Results

Patients averaged 738 (standard deviation [SD] 615) post-index follow-up days.  Most patients (82%) had glucocorticoid exposure during the study (43% with cumulative dose < 675 mgs; 73% had peak dose ≥ 15 mg/day).  Exposed and unexposed patients were demographically similar (74% female; mean age 49.4 [10.7] and 49.8 [10.2] years); 1% had pre-index fracture.  Fragility fracture incidence rates (95% confidence intervals) were 5.1 (4.6, 5.6) and 16.8 (11.4, 24.0) at daily doses of 0 mg/day and ≥ 15 mg/day, respectively, and 4.8 (3.8, 6.0) and 13.7 (10.6, 17.4) at cumulative doses of 0 mg and ≥ 5400 mgs, respectively.  Among patients ever-exposed to glucocorticoids, fracture risk was significantly elevated at cumulative dose ≥ 2700 mg and daily dose ≥ 15 mg/day (Table). Following glucocorticoid discontinuation, fracture risk (adjusted for age, sex, and cumulative dose) was 32% lower at 60-181 days since last exposure versus current exposure. Analyses restricted to patients younger than 50 years also showed highest fracture risk at highest exposures.

Conclusion

In this large, relatively young cohort of RA patients, fracture risk increased by 2- to 3-fold at high levels of daily and cumulative glucocorticoid dose, and began to decline within months of glucocorticoid discontinuation.

Table:  Risk of Post-Index Fragility Fracture among Rheumatoid Arthritis Patients Ever-Exposed to Systemic Glucocorticosteroids

 

 

Hazard
Ratio

95% C.I.

P-Value

Sex

Male (n=31,104)

Female (n=10,930)

ref

 

 

1.71

(1.33, 2.20)

<.0001

Age (years)

18 to 39 (n=7,230)

ref

 

 

40 to 44 (n=4,360)

1.81

(0.99, 3.31)

0.0524

45 to 49 (n=6,168)

2.45

(1.44, 4.17)

0.0009

50 to 54 (n=7,995)

2.94

(1.78, 4.86)

<.0001

55 to 59 (n=8,736)

3.86

(2.37, 6.29)

<.0001

60 to 64 (n=7,545)

5.57

(3.43, 9.04)

<.0001

Cumulative dose (mg)*†

> 0 to < 675

ref

 

 

675 to < 1350

1.07

(0.80, 1.44)

0.6504

1350 to < 2700

1.00

(0.74, 1.36)

0.9854

2700 to < 5400

1.41

(1.03, 1.93)

0.0317

≥ 5400

2.34

(1.68, 3.26)

<.0001

Average daily dose (mg/day)*

0‡

ref

 

 

> 0 to < 5

1.43

(0.92, 2.23)

0.1091

5 to < 7.5

1.00

(0.64, 1.55)

0.9891

7.5 to < 15

1.21

(0.82, 1.80)

0.3439

≥ 15

2.67

(1.78, 3.99)

<.0001

*Exposure metrics were quantified on a person-time basis so patient numbers are not available.

†As the analysis represented in this table was restricted to patients ever-exposed to systemic glucocorticosteroids, all cumulative dose values are greater than zero.

‡Average daily dose would have a value of zero during unexposed periods for this ever-exposed population.

 


Disclosure:

A. Balasubramanian,

Amgen,

3,

Amgen,

1;

S. Wade,

Amgen,

5;

R. A. Adler,

Amgen,

9;

C. Fang (Lin),

Amgen,

1,

Amgen,

3;

M. Maricic,

Amgen,

2;

C. O’Malley,

Amgen,

1,

Amgen,

3;

K. G. Saag,

Amgen,

5;

J. R. Curtis,

Amgen,

5.

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