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Abstract Number: 1058

Concomitant Methotrexate Use and The Risk Of Drug Discontinuation For Adalimumab Compared With Etanercept In Anti-TNF-Naïve Rheumatoid Arthritis Patients: A Nationwide Population-Based Cohort Study

Hsin-Hua Chen1,2, Der-Yuan Chen1, Chao-Hsiung Tang3, Ya-Wen Yang4, Chi-Hui Fang4 and Nicole Huang5, 1Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan, 2nstitute of Public Health and Community Medicine Research Center, National Yang-Ming University, Taipei, Taiwan, 3Taipei Medical University, Taipei, Taiwan, 4Pfizer Limited, Taipei, Taiwan, 5Institute of Hospital and Health Care Administration, National Yang-Ming University, Taipei, Taiwan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Adalimumab, anti-TNF therapy, etanercept and rheumatoid arthritis (RA)

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Session Information

Session Title: Epidemiology and Health Services II & III

Session Type: Abstract Submissions (ACR)

Background/Purpose: To evaluate possible interaction effect by concomitant methotrexate (MTX) use on the risk of drug discontinuation for adalimumab (ADA) compared with etanercept (ETN) in anti-tumor necrosis factor (anti-TNF)-naïve patients with rheumatoid arthritis (RA).

Methods: This retrospective nationwide population-based cohort study identified 4592 anti-TNF-naïve RA patients (age at diagnosis ≥ 16 years) in whom ETN (n = 2,609) or ADA (n = 1,983) was initiated using administrative data. The outcome was the time to anti-TNF drug discontinuation. We defined drug discontinuation as non-persistence of prescription for more than 84 days. After adjusting for baseline characteristics and concomitant use of disease modifying anti-rheumatic drugs (DMARDs), the risk of drug discontinuation for ADA compared with that of ETN was quantified by calculating relative risk (RR) with 95% confidence intervals (CI) using Cox proportional hazard regression analysis for the follow-up time before and after one year. Subgroup analysis was conducted based on the average weekly dose of concomitant methotrexate use (i.e. not use, ≤10 mg, >10mg).

Results: During the first year of follow-up, 562 of 1,982 ADA users and 682 of 2,609 ETN users withdrew anti-TNF drugs after 1,507 and 2,094 person-years of follow-up respectively, and the incidence rates of drug withdrawal were 0.37 and 0.33 case per person-year. The crude and adjusted RRs of drug discontinuation for ADA compared with ETN were 1.16 (95% CI, 1.04–1.30) and 1.10 (95% CI, 0.98–1.23). The adjusted RR with 95% CIs for those with 0, ≤10mg/week and >10 mg/week concomitant MTX use were 0.83 (0.64–1.06), 0.91 (0.75–1.11) and 1.53 (1.28–1.82) respectively (p for interaction <0.001). If the follow-up time exceeded one year, 376 of 969 ADA users and 616 of 866 ETN users discontinued anti-TNF drugs after 1,012 and 1,846 person-years of follow-up respectively, and the incidence rates of drug discontinuation were 0.37 and 0.33 case per person-year. The crude and adjusted RRs of drug discontinuation for ADA compared with ETN were 1.07 (95% CI, 0.94–1.22) and 0.98 (95% CI, 0.86–1.12). The adjusted RRs with 95% CIs for those with 0, ≤10mg/week and >10 mg/week concomitant MTX use were 0.85 (0.68–1.06), 0.93 (0.77–1.15) and 1.42 (1.06–1.90) respectively (p for interaction 0.026).

Conclusion: Among anti-TNF naïve RA patients, compared with ETN users, ADA users had a significantly higher risk of drug discontinuation if the concomitant MTX dose was more than 10 mg/week.

Table 1. The adjusted relative risks with 95% confidence intervals of drug discontinuation for ADA compared with ETN

Follow-up time

No MTX use

≤10 mg/week

>10 mg/week

P value for interaction

Within 1 year

0.83 (0.64–1.06)

0.91 (0.75–1.11)

1.53 (1.28–1.82)

<0.001

After 1 year

0.85 (0.68–1.06)

0.93 (0.77–1.15)

1.42 (1.06–1.90)

0.026

Note: Cox proportional hazard regression analyses per conducted after adjusting for the variables with p values less than 0.2 in univariate comparisons between adalimumab and etanercept, including sex, age at anti-TNF initiation, RA duration, Charlson comorbidity index (≤1, >2) within one year before anti-TNF use, the use of MTX (not use, ≤10 mg/week, >10 mg/week), leflunomide, salazopyrin, non-steroid anti-inflammatory drugs within one year before and after anti-TNF use, and average daily prednisolone equivalent (≤5 mg, >5 mg) within one year before anti-TNF use.


Disclosure:

H. H. Chen,

Pfizer Limited,

2;

D. Y. Chen,

Pfizer Limited,

2;

C. H. Tang,

Pfizer Limited,

2;

Y. W. Yang,

Pfizer Limited,

3;

C. H. Fang,

Pfizer Limited,

3;

N. Huang,

Pfizer Limited,

2.

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