Journal
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Volume 309, Issue 9, Pages 887-895Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/jama.2013.1099
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Funding
- Pfizer
- Amgen
- National Institutes of Health
- Novartis
- Genentech
- Horizon
- Merck
- Apollo Health Resources Ltd
- Centocor
- Procter and Gamble
- Lilly
- Consortium of Rheumatology Researchers of North America Inc.
- Takeda
- Shire
- Roche/Genentech
- UCB Pharma
- Bristol-Myers Squibb
- Crescendo
- Abbott
- US Food and Drug Administration (FDA)
- US Department of Health and Human Services (DHHS)
- Agency for Healthcare Research and Quality (AHRQ) [U18 HS17919]
- AHRQ [1K08HS017552-01, R01HS018517]
- National Institutes of Health (NIH) [AR053351]
- NIH via the University of Alabama at Birmingham Center for Clinical and Translational Science [5KL2 RR025776-03]
- National Institute of Arthritis and Musculoskeletal and Skin Diseases [5P60AR56116]
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Importance Herpes zoster reactivation disproportionately affects patients with rheumatoid arthritis (RA). It is unclear whether anti-tumor necrosis factor (anti-TNF) therapy elevates herpes zoster risk. Objectives To ascertain whether initiation of anti-TNF therapy compared with non-biologic comparators is associated with increased herpes zoster risk. Design, Setting, and Patients We identified new users of anti-TNF therapy among cohorts of patients with RA, inflammatory bowel disease, and psoriasis, psoriatic arthritis, or ankylosing spondylitis from 1998 through 2007 within a large US multi-institutional collaboration combining data from Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and national Medicaid/Medicare programs. We compared herpes zoster incidence between new anti-TNF users (n=33,324) and patients initiating nonbiologic disease-modifying antirheumatic drugs (DMARDs) (n=25 742) within each inflammatory disease cohort (last participant follow-up December 31, 2007). Within these cohorts, we used Cox regression models to compare propensity score-adjusted herpes zoster incidence between new anti-TNF and nonbiologic DMARD users while controlling for baseline corticosteroid use. Main Outcome Measures Incidence of herpes zoster cases occurring after initiation of new anti-TNF or nonbiologic DMARD therapy. Results Among 33 324 new users of anti-TNF therapy, we identified 310 herpes zoster cases. Crude incidence rates among anti-TNF users were 12.1 per 1000 patient-years (95% CI, 10.7-13.6) for RA, 11.3 per 1000 patient-years (95% CI, 7.7-16.7) for inflammatory bowel disease, and 4.4 per 1000 patient-years (95% CI, 2.8-7.0) for psoriasis, psoriatic arthritis, or ankylosing spondylitis. Baseline use of corticosteroids of 10 mg/d or greater among all disease indications was associated with elevated risk (adjusted hazard ratio [HR], 2.13 [95% CI, 1.64-2.75]) compared with no baseline use. For patients with RA, adjusted incidence rates were similar between anti-TNF and nonbiologic DMARD initiators (adjusted HR, 1.00 [95% CI, 0.77-1.29]) and comparable between all 3 anti-TNF therapies studied. Across all disease indications, the adjusted HR was 1.09 (95% CI, 0.88-1.36). Conclusion and Relevance Among patients with RA and other inflammatory diseases, those who initiated anti-TNF therapies were not at higher risk of herpes zoster compared with patients who initiated nonbiologic treatment regimens. JAMA. 2013;309(9):887-895 www.jama.com
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