Initiation of Anti-TNF Therapy and the Risk of Optic Neuritis: From the Safety Assessment of Biologic ThERapy (SABER) Study

• Published in: American journal of ophthalmology 2013-01, Vol.155 (1), p.183-189.e1
• Main Authors: Winthrop, Kevin L, Chen, Lang, Fraunfelder, Frederick W, Ku, Jennifer H, Varley, Cara D, Suhler, Eric, Hills, William L, Gattey, Devin, Baddley, John W, Liu, Liyan, Grijalva, Carlos G, Delzell, Elizabeth, Beukelman, Timothy, Patkar, Nivedita M, Xie, Fenglong, Herrinton, Lisa J, Fraunfelder, Fritz T, Saag, Kenneth G, Lewis, James D, Solomon, Daniel H, Curtis, Jeffrey R
• Format: Article
• Language: English
• Subjects: Adalimumab; Adult; Algorithms; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antirheumatic Agents - administration & dosage; Antirheumatic Agents - adverse effects; Cohort Studies; Databases, Factual; Drug therapy; Etanercept; Female; Humans; Immunoglobulin G - administration & dosage; Immunoglobulin G - adverse effects; Incidence; Inflammatory bowel disease; Infliximab; Male; Middle Aged; Ophthalmology; Optic nerve; Optic Neuritis - chemically induced; Optic Neuritis - diagnosis; Optic Neuritis - epidemiology; Pharmaceutical industry; Psoriasis; Receptors, Tumor Necrosis Factor - administration & dosage; Retrospective Studies; Risk Assessment; Tumor Necrosis Factor-alpha - antagonists & inhibitors
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2012.06.023

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.