Literature DB >> 22967869

Initiation of anti-TNF therapy and the risk of optic neuritis: from the safety assessment of biologic ThERapy (SABER) Study.

Kevin L Winthrop1, Lang Chen, Frederick W Fraunfelder, Jennifer H Ku, Cara D Varley, Eric Suhler, William L Hills, Devin Gattey, John W Baddley, Liyan Liu, Carlos G Grijalva, Elizabeth Delzell, Timothy Beukelman, Nivedita M Patkar, Fenglong Xie, Lisa J Herrinton, Fritz T Fraunfelder, Kenneth G Saag, James D Lewis, Daniel H Solomon, Jeffrey R Curtis.   

Abstract

PURPOSE: To evaluate the incidence of optic neuritis (ON) in patients using anti-tumor necrosis factor (TNF) alpha therapy.
DESIGN: Retrospective, population-based cohort study.
METHODS: We identified new users of anti-TNF therapy (etanercept, infliximab, or adalimumab) or nonbiologic disease-modifying antirheumatic drugs (DMARDs) during 2000-2007 from the following data sources: Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and National Medicaid/Medicare. Within this cohort, we used validated algorithms to identify ON cases occurring after onset of new drug exposure. We then calculated and compared ON incidence rates between exposure groups.
RESULTS: We identified 61 227 eligible inflammatory disease patients with either new anti-TNF or new nonbiologic DMARD use. Among this cohort, we found 3 ON cases among anti-TNF new users, occurring a median of 123 days (range, 37-221 days) after anti-TNF start. The crude incidence rate of ON across all disease indications among anti-TNF new users was 10.4 (95% CI 3.3-32.2) cases per 100 000 person-years. In a sensitivity analysis considering current or past anti-TNF or DMARD use, we identified a total of 6 ON cases: 3 among anti-TNF users and 3 among DMARD users. Crude ON rates were similar among anti-TNF and DMARD groups: 4.5 (95% CI 1.4-13.8) and 5.4 (95% CI 1.7-16.6) per 100 000 person-years, respectively.
CONCLUSION: Optic neuritis is rare among those who initiate anti-TNF therapy and occurs with similar frequency among those with nonbiologic DMARD exposure.
Copyright © 2013 Elsevier Inc. All rights reserved.

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Year:  2012        PMID: 22967869      PMCID: PMC4142597          DOI: 10.1016/j.ajo.2012.06.023

Source DB:  PubMed          Journal:  Am J Ophthalmol        ISSN: 0002-9394            Impact factor:   5.258


  14 in total

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