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Abstract Number: 493

A Real-World Risk Analysis Of Biological Treatment (Adalimumab and Etanercep) In Country With High Prevalence Of Tuberculosis and Hepatitis B/C

Ying-Ming Chiu1, Chao-Hsiung Tang2, Sheng-Tzu Hung3, Ya-Wen Yang4, Chi-Hui Fang4 and Hsiao-Yi Lin5, 1Changhua Christian Hospital, Changhua City, Taiwan, 2Taipei Medical University, Taipei, Taiwan, 3Formosa Biomedical Technology Corp., Taipei, Taiwan, 4Pfizer Limited, Taipei, Taiwan, 5Immunology and Rheumatology, Dept of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Adalimumab, Biologics, etanercept, hepatitis and tuberculosis

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Session Information

Session Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Biologics have been widely utilized in many rheumatic diseases. Risks associated with the use of biological treatments are revealed in many published studies. Nevertheless, it was lacking investigations in countries with high prevalence of tuberculosis (TB) and hepatitis B/C (HBC). This research aimed to analyze the difference of risk for adalimumab and etanercept in endemic areas.

Methods: National Health Insurance (NHI) Research Database was applied, which consists of administrative and claims records; covers over 99% of entire population in Taiwan. Patients who had used adalimumab or etanercept in between 2003 and 2011 were eligible for this analysis. Exposure of adalimumab or etanercept was quantified in treatment episode. Each patient could have multiple treatment episodes with different biologics. With same biologic, a new treatment episode was initiated when 6 months apart. The incidence rates of TB, HBC, acute myocardial infarction/heart failure (AMI/HF), infection hospitalization (IHP), herpes zoster (HZ) and lymphoma (Lym) were calculated in person year. All events were defined by corresponding ICD codes, medications related to events and diagnosis during hospitalization. Event was captured within 30 days posterior to the end of each treatment episode. Time to event was summarized by Kaplan-Meier curves. The Cox proportional model was conducted to estimate the hazard ratio (HR) with 95% confidence interval (CI) by adjusted covariates.

Results: From 2003 to 2011, there were 3,844 patients (4,049 episodes) treated with adalimumab and 5,933 patients (7,056 episodes) treated with etanercept. The average age of adalimumab and etanercept users were 50.8 (SD 14.58) and 51.5 (SD 15.29); about 61.4% and 73.1% were female respectively. In adalimumab group, incidence rates of TB, HBC, AMI/HF, IHP, HZ and Lym were 1.62, 0.75, 0.38, 3.05, 0.62 and 0.11 per 100 person-years. Conversely, incidence rates of TB, HBC, AMI/HF, IHP, HZ and Lym were 0.68, 0.4, 0.23, 2.16, 0.64 and 0.11 in etanercept group. Comparing adalimumab to etanercept, the crude HR of TB, HBC, AMI/HF, IHP, HZ and Lym were 2.03 (P<0.0001), 1.61 (0.03), 1.56 (0.14), 1.32 (0.01), 0.94 (0.78), 0.96 (0.94). The adjusted HR of TB, HBC, AMI/HF, IHP, HZ and Lym were 1.53 (P=0.01), 1.31, 1.27 (0.43), 1.12 (0.27), 0.90 (0.62), 0.76 (0.58).

Conclusion: Across different events, patients with adalimumab treatment tended to have an adverse event in a shorter time period relative to etanercept. Patients had a significant higher risk of TB if used adalimumab.

 

Table1. Incidence rates and Hazard ratios

Adalimumab

Etanercept

# person-year

# event

Incidence Rate

# person-year

# event

Incidence Rate

TB

5,317

86

1.62

13,143

89

0.68

HBC

5,311

40

0.75

13,148

53

0.4

AMI/HF

5,315

20

0.38

13,134

30

0.23

IHP

5,244

160

3.05

12,924

279

2.16

HZ

5,299

33

0.62

13,042

83

0.64

Lym

5,324

6

0.11

13,146

14

0.11

COX Proportion Hazard Model

Before Adjusted

After Adjusted

cHR3

95% CI

P value

aHR4

95% CI

P value

TB

2.03

1.50 ~ 2.74

<.0001

1.53

1.13 ~ 2.06

0.0058

HBC

1.61

1.06 ~ 2.44

0.0262

1.31

0.86 ~ 1.99

0.2076

AMI/HF

1.56

0.87 ~ 2.79

0.1362

1.27

0.71 ~ 2.28

0.4273

IHP

1.32

1.09 ~ 1.62

0.0058

1.12

0.92 ~ 1.37

0.2688

HZ

0.94

0.62 ~ 1.42

0.7783

0.9

0.59 ~ 1.37

0.6185

Lym

0.96

0.37 ~ 2.54

0.9404

0.76

0.29 ~ 2.00

0.5781

Note: 1. Per 100 person year

2. Hazard ratios were calculated for adalimumab versus etanercept (reference)

3. cHR: crude hazard ratio 

4. aHR: adjusted hazed ratio; demography, disease severity, disease history/duration were used for adjustment.


Disclosure:

Y. M. Chiu,

Pfizer Limited,

2;

C. H. Tang,

Pfizer Limited,

2;

S. T. Hung,

Pfizer Limited,

5;

Y. W. Yang,

Pfizer Limited,

3;

C. H. Fang,

Pfizer Limited,

3;

H. Y. Lin,

Pfizer Limited,

2.

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