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Abstract Number: 2093

Rates of Opportunistic Infections Among Rheumatoid Arthritis Patients Switching Biologic Therapy

John Baddley1, Shuo Yang2, Klye Brizendine3, Scott DuVall4, Kevin L. Winthrop5, Mary J. Burton6, Nivedita M. Patkar7, Elizabeth S. Delzell8, Monika M. Safford9, Jasvinder A. Singh10, Iris E. Navarro11, Grant W. Cannon12, Ted R. Mikuls13, Lang Chen11, Kenneth G. Saag14, Kimberly Alexander15, Pavel Napalkov15, Aaron Kamauu16 and Jeffrey R. Curtis17, 1Medicine, University of Alabama at Birmingham, Birmingham, AL, 2Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 3Infectious Disease, Birmingham, AL, 4VA Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, UT, 5Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, 6VA Hospital, Jackson, MS, 7Immunology/Rheumatology, Univ of Alabama-Birmingham, Birmingham, AL, 8Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 9Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, 10Department of Medicine, University of Alabama, Tuscaloosa, AL, 11Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 12Division of Rheumatology, George E. Wahlen VA Medical Center, Salt Lake City, UT, 13Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, 14Div Clinical Immun & Rheum, Univ of Alabama-Birmingham, Birmingham, AL, 15Epidemiology, Genentech, Inc., South San Francisco, CA, 16Anolinx, Bountiful, UT, 17Rheumatology & Immunology, Univ of Alabama-Birmingham, Birmingham, AL

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: biologic response modifiers, opportunistic infections and rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects III: Infections/Risk Factors for Incident Rheumatoid Arthritis/Metrology/Classification/Biomarkers/Predictors of Rheumatolid Arthritis Activity & Severity

Session Type: Abstract Submissions (ACR)

Background/Purpose: The incidence of opportunistic infections (OIs) in patients on biologics is low, but may approach several cases per 100 person-years (PY). Data on risks for OIs associated with newer biologics and in those switching biologics among rheumatoid arthritis (RA) patients are limited.

Methods:

Using data from 1998-2011 from the U.S. Veteran’s Health Administration we identified a cohort of rheumatologist-diagnosed RA patients (n=36,433).  Patients eligible for this analysis started anti-TNF therapy (adalimumab, infliximab, etanercept) after previous anti-TNF exposure, or rituximab (RTX) or abatacept (ABA). To minimize confounding from channeling of patients to certain biologics, those patients with a history of hematologic malignancy in the past year were excluded.  Potential OIs were identified using ICD-9 codes and/or available laboratory results (cultures, serology). With the exception of zoster, where ICD-9 code alone identified a case, all other OIs were confirmed by chart review using standardized case definitions. Patients were censored at first OI event. Baseline co-morbidities were defined in the 1-year period prior to treatment initiation. Exposure was “as treated” on the basis of days supply or usual dosing intervals. Exposure was extended 60 days after the end of the day’s supply; RTX exposure was assumed to be 12 months after infusion. Frequencies of OIs were calculated and crude OI incidence rates were estimated using a Poisson distribution.

Results:

A total of 2917 unique RA patients contributed 3774 treatment episodes (ABA 338; RTX 511, TNFs 2925). Two-thirds of TNF use was adalimumab.  Mean age of the cohort was 60.8 ± 10.7 years; 87% were male.  Hypertension (55.5%), diabetes (25.6%) and COPD (14.2%) were common. Overall, 84 OIs (2.9%) in 2917 patients were identified, yielding an overall rate of 1.5 (95% CI 1.2, 1.9) OIs per 100 PY(Table). The most common OIs were zoster, rate 1.17 (0.9, 1.5) per 100 PY and tuberculosis, rate 0.05 (0.02, 1.6) per 100 PY. Crude rates of OIs per 100 PY among TNFs, ABA and RTX users were 1.5 (1.2, 1.9); 1.1 (0.4, 2.6), and 1.8 (1.0, 3.2), respectively.  Among TNFs, rates per 100 PY were infliximab 0.8 (0.3, 2.1), adalimumab 1.6 (1.2, 2.2) and etanercept 1.6 (1.0. 2.5). For the 19 confirmed OIs other than zoster, 7 (37%) were identified by screening lab data and were not identified by ICD-9 codes.   

Table: Frequency of Physician-Confirmed Opportunistic Infections (OIs) by Biologic Exposure

Opportunistic Infection

Abatacept

N=338

PY=486

Adalimumab

N=1826

PY=2727

Etanercept

N=741

PY=1181

Infliximab

N=358

PY=511

Rituximab

N=511

PY=651

TOTAL

 N=3774

PY=5538

Zoster

5

38

16

2

4

65

Tuberculosis

0

0

2

0

1

3

Pneumocystosis

0

0

0

0

3

3

Legionellosis

0

3

0

0

0

3

Coccidioidomycosis

0

0

1

0

2

3

Histoplasmosis

0

1

0

1

0

2

Non-tuberculous mycobacteria

0

1

0

0

1

2

Salmonellosis

0

1

0

0

1

2

Nocardiosis

0

0

0

1

0

1

Total OIs

5

44

19

4

12

84

IR (95% CI) per 100 p-years

1.1(0.4, 2.6)

1.6 (1.2, 2.2)

1.6 (1.0, 2.5)

0.8 (0.3, 2.1)

1.8 (1.0, 3.2)

1.5 (1.2, 1.9)

OI=opportunistic infection; IR=incidence rate

Conclusion:

In US veterans with RA, overall crude OI rates were low and similar among biologics. The most common OI was zoster. The availability of serologic and culture data for OI screening yielded a meaningfully higher proportion of OI cases compared to administrative data alone.


Disclosure:

J. Baddley,

Merck Pharmaceuticals,

5;

S. Yang,
None;

K. Brizendine,
None;

S. DuVall,

Anolinx LLC,

2,

Genentech Inc.,

2,

F. Hoffmann-La Roche Ltd,

2,

Amgen Inc,

2,

Shire PLC,

2,

Mylan Specialty PLC,

2;

K. L. Winthrop,

Pfizer Inc,

5,

Pfizer Inc, UCB, Abbott, Amgen,

2;

M. J. Burton,
None;

N. M. Patkar,
None;

E. S. Delzell,

Amgen,

2;

M. M. Safford,
None;

J. A. Singh,

research and travel grants from Takeda, Savient, Wyeth and Amgen,

2,

J.A.S. has received speaker honoraria from Abbott,

,

; aConsultant fees from URL pharmaceuticals, Savient, Takeda, Ardea, Allergan and Novartis.,

5;

I. E. Navarro,
None;

G. W. Cannon,
None;

T. R. Mikuls,

Amgen; Genentech ,

2;

L. Chen,
None;

K. G. Saag,

AHRQ, NIH/NIAMS,

2,

Amgen;Abbott;Ardea:Lilly:Merck:Novartis:Regeneron:Savient:URL,

5,

NOF;ACR,

6;

K. Alexander,

Roche Pharmaceuticals,

1,

Roche/Genetech,

3;

P. Napalkov,

Stock options in Roche and Genentech,

1,

full time employee in Roche and Genentech,

3;

A. Kamauu,

Anolinx LLC,

4,

Genetech Inc, Roche, Shire, Dey Pharma,

2;

J. R. Curtis,

Amgen,

5,

Merck Pharmaceuticals,

5,

Eli Lilly and Company,

5,

Amgen,

2,

Merck Pharmaceuticals,

2,

Eli Lilly and Company,

2.

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