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

Academic Article

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.
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    Keywords

  • Adalimumab, Adult, Algorithms, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Cohort Studies, Databases, Factual, Etanercept, Female, Humans, Immunoglobulin G, Incidence, Infliximab, Male, Middle Aged, Optic Neuritis, Receptors, Tumor Necrosis Factor, Retrospective Studies, Risk Assessment, Tumor Necrosis Factor-alpha
  • Digital Object Identifier (doi)

    Author List

  • Winthrop KL; Chen L; Fraunfelder FW; Ku JH; Varley CD; Suhler E; Hills WL; Gattey D; Baddley JW; Liu L
  • Start Page

  • 183
  • End Page

  • 189.e1
  • Volume

  • 155
  • Issue

  • 1