title: Initiation of anti-TNF therapy and the risk of optic neuritis: from the safety assessment of biologic ThERapy (SABER) Study.
abstract: OBJECTIVE
  To evaluate the incidence of optic neuritis (ON) in patients using anti-tumor necrosis factor (TNF) alpha therapy.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Optic neuritis is rare among those who initiate anti-TNF therapy and occurs with similar frequency among those with nonbiologic DMARD exposure.
authors.affiliation: Casey Eye Institute, Oregon Health & Science University, Portland, OR 97239, USA. Winthrop@ohsu.edu
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Winthrop
authors.forename: Lang
authors.initials: L
authors.lastname: Chen
authors.forename: Frederick W
authors.initials: FW
authors.lastname: Fraunfelder
authors.forename: Jennifer H
authors.initials: JH
authors.lastname: Ku
authors.forename: Cara D
authors.initials: CD
authors.lastname: Varley
authors.forename: Eric
authors.initials: E
authors.lastname: Suhler
authors.forename: William L
authors.initials: WL
authors.lastname: Hills
authors.forename: Devin
authors.initials: D
authors.lastname: Gattey
authors.forename: John W
authors.initials: JW
authors.lastname: Baddley
authors.forename: Liyan
authors.initials: L
authors.lastname: Liu
authors.forename: Carlos G
authors.initials: CG
authors.lastname: Grijalva
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Delzell
authors.forename: Timothy
authors.initials: T
authors.lastname: Beukelman
authors.forename: Nivedita M
authors.initials: NM
authors.lastname: Patkar
authors.forename: Fenglong
authors.initials: F
authors.lastname: Xie
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Herrinton
authors.forename: Fritz T
authors.initials: FT
authors.lastname: Fraunfelder
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Saag
authors.forename: James D
authors.initials: JD
authors.lastname: Lewis
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Solomon
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Curtis
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000465:Algorithms; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D015331:Cohort Studies; D016208:Databases, Factual; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects; D015994:Incidence; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D009902:Optic Neuritis / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology*; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage; D012189:Retrospective Studies; D018570:Risk Assessment; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept