Session Information
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 |
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|
Adalimumab |
Etanercept |
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|
# 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 |
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|
Before Adjusted |
After Adjusted |
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|
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. |
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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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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-real-world-risk-analysis-of-biological-treatment-adalimumab-and-etanercep-in-country-with-high-prevalence-of-tuberculosis-and-hepatitis-bc/