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Abstract Number: 2319

Comparative Safety Of Biological Agents Among Medicare Rheumatoid Arthritis Patients

Huifeng Yun1, Fenglong Xie2, Elizabeth S. Delzell1, Lang Chen3, Emily Levitan1, James Lewis4, Kenneth G. Saag5, Timothy Beukelman6, Kevin L. Winthrop7, John Baddley8, Paul M. Muntner1 and Jeffrey R. Curtis3, 1Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 2Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, 3Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 4Medicine, University of Pennsylvania, Philadelphia, PA, 5Immunology & Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, 6Pediatric Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 7Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, 8Medicine, University of Alabama at Birmingham, Birmingham, AL

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Biologic agents, Medicare and rheumatoid arthritis (RA)

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose:  Several new biologic disease-modifying antirheumatic drugs (DMARDs) have been approved for treatment of rheumatoid arthritis (RA) in United States. However, their comparative risks of serious infections are unclear. The objective of the current study is to determine if the risks of hospitalized infections associated with various biologics used for RA differs.

Methods: Using Medicare data from 2006-2011 for 100% of patients with RA, we identified new biologic users of etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, rituximab and tocilizumab.  New users were defined specific to each drug as no use of that therapy in the prior 12 month ‘baseline’ period. To increase homogeneity of patients for biologics typically not used as first line agents, patients were required to have used another biologic during baseline (i.e. they were ‘switchers’). Eligible subjects were continuously enrolled in Medicare Parts A, B and D in baseline and throughout follow up. Follow up started from the drug initiation date and ended at the earliest date of: a hospitalized infection, 12 months after biologic initiation, a 30 day gap in current exposure, death, or loss of Medicare coverage. We identified hospitalized infection using inpatient physician diagnosis codes in primary or secondary position. Confounding was controlled through a person-specific infection risk score that was separately derived among biologic-naïve new users of anti-TNF and non-biologic DMARDs. We calculated the incidence rate of hospitalized infection for each biologic and compared their hospitalized infection risks during follow-up using Cox regression adjusting for infection risk score decile, disability status, glucocorticoids use during baseline, methotrexate use during baseline, most recent biologic during baseline and Medicaid eligibility.

Results: Of 29,776 new biologic switchers, 11.9% were exposed to etanercept, 15.0% adalimumab, 5.9% certolizumab, 4.3% golimumab, 12.3% infliximab, 29.0% abatacept, 14.9% rituximab and 6.4% tocilizumab. During follow-up, we identified 2,224 hospitalized infections yielding infection incidence rates from a low of 12.3 (abatacept) to a high of 17.4 (infliximab) per 100 person years across different biologics. After adjustment for potential cofounders, etanercept, infliximab and rituximab users had significantly higher hazard ratios of hospitalized infection compared to abatacept users.  Adjusted HRs for all other drug-outcome comparisons were not significantly different from abatacept (table).

Conclusion: Among RA patients with exposure to biologic therapies, etanercept, infliximab and rituximab were associated with a higher one year risk of serious infection compared to abatacept.

Table : Events, absolute incidence rate and adjusted hazard rate of hospitalized infection by different types of biologic exposures during follow-up

Biologic Exposures

Events

Incidence rate per 100 person years

Adjusted Hazard Ratio* (95% CI)

Abatacept

624

12.3

1.00 (Ref)

Adalimumab

278

13.8

1.10 (0.94 – 1.29)

Certolizumab

93

13.2

1.08 (0.86 – 1.35)

Etanercept

238

14.8

1.26 (1.08 – 1.48)

Golimumab

77

13.5

1.17 (0.91 – 1.49)

Infliximab

325

16.1

1.39 (1.19 – 1.61)

Rituximab

477

17.4

1.37 (1.20 – 1.55)

Tocilizumab

112

13.8

1.10 (0.89 – 1.36)

* Adjusted for infection risk score decile, steroid use during baseline, methotrexate use during baseline, recent biologic use during baseline, original reason for Medicare coverage and Medicaid eligibility.  



Disclosure:

H. Yun,
None;

F. Xie,
None;

E. S. Delzell,

Amgen,

2;

L. Chen,
None;

E. Levitan,

Amgen,

2;

J. Lewis,

Pfizer, Prometheus, Lilly, Shire, Nestle, Janssen, AstraZeneca, Amgen,

5,

Centocor, Shire, Takeda,

2;

K. G. Saag,

Ardea; Regeneron; Savient; Takeda,

5,

Ardea; Regeneron; Savient: Takeda,

2;

T. Beukelman,

Genentech and Biogen IDEC Inc.,

5,

Novartis Pharmaceutical Corporation,

5,

Pfizer Inc,

2;

K. L. Winthrop,

Pfizer Inc,

2,

Pfizer, UCB, Genentech, Regeneron,

5;

J. Baddley,

BMS,

2,

Pfizer Inc,

2;

P. M. Muntner,

Amgen, Inc,

2,

Amgen, Inc,

5;

J. R. Curtis,

Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,

2,

Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,

5.

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