Original articleInitiation of Anti-TNF Therapy and the Risk of Optic Neuritis: From the Safety Assessment of Biologic ThERapy (SABER) Study
Section snippets
National Registry of Drug-Induced Ocular Side Effects
The National Registry of Drug-Induced Ocular Side Effects passively collects reports of ocular toxic drug events from physicians within the United States and abroad.3 In addition, the registry is linked with the Food and Drug Administration's (FDA) Medwatch system (Rockville, Maryland, USA) and the World Health Organization's (WHO) Spontaneous Event Reporting Systems (Uppsala, Sweden) such that events reported to all 3 systems are retrievable within the National Registry of Drug-Induced Ocular
National Registry of Drug-Induced Ocular Side Effects
From the national registry collecting passively reported data, we identified 358 reports of optic neuritis occurring in association with anti-TNF therapy. Seventy-five percent were female, median age 44 years (range, 6–78 years), with median time between anti-TNF start and diagnosis of 182 days (range, 2–388 days). Cases were most numerous with etanercept (n = 169), with fewer reported with monoclonal antibodies infliximab (n = 122), adalimumab (n = 55), golimumab or certolizumab (n = 5), or
Discussion
Within SABER, a large US multi-institutional research initiative, we performed a large population-based cohort study specifically examining optic neuritis incidence in patients starting biologic therapy with anti-TNF agents. We found the incidence of optic neuritis to be low in this group, approximately 5–10 per 100 000 patient-years, and comparable to published rates from other population-based studies estimating the incidence of optic neuritis.1 Importantly, optic neuritis rates were not
Kevin L. Winthrop MD, MPH, is Assistant Professor of Infectious Diseases, Ophthalmology, and Public Health and Preventative Medicine at Oregon Health and Science University, Portland, Oregon. He is an infectious disease epidemiologist whose research and clinical interests include onchocerciasis elimination, as well as drug safety and pharmacovigilance with specific focus upon the epidemiology, prevention, and therapy of serious infections that occur in patients with autoimmune inflammatory
References (10)
- et al.
Adverse ocular drug reactions recently identified by the national registry of drug-induced ocular side effects
Ophthalmology
(2004) - et al.
Optic neuritis: A population-based study in Olmsted County, Minnesota
Neurology
(1995) - et al.
Optic neuritis occurring with anti-tumour necrosis factor alpha therapy
Ann Rheum Dis
(2007) - et al.
Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis
JAMA
(2011) - et al.
Receipt of disease-modifying antirheumatic drugs among patients with rheumatoid arthritis in Medicare managed care plans
JAMA
(2011)
Cited by (58)
Prevalence of iatrogenic CNS inflammation at a tertiary neuroimmunology clinic
2022, Journal of NeuroimmunologyCitation Excerpt :The exact time interval that would qualify an event as iatrogenic is unknown. However, to account for more restrictive timeframes reported in the literature for CNS inflammatory events occurring after TNFAIs, ICIs, and vaccinations, we performed a separate sensitivity analysis and analyzed data only from iatrogenic events meeting the following criteria: within two years of TNFAI exposure (Dreyer et al., 2016; Simsek et al., 2007; Winthrop et al., 2013); within one year of ICI exposure (Guidon et al., 2021); and within six weeks of vaccination (Butler et al., 2021). We then compared the new results using the more restrictive criteria to our original analysis including all potentially iatrogenic events to determine if differences between the three iatrogenic groups remained statistically-significant.
Erdheim-Chester disease: a comprehensive review from the ophthalmologic perspective
2022, Survey of OphthalmologyCitation Excerpt :Thromboembolic events, congestive heart failure, and malignancies can also emerge.220,258 Although optic neuritis has been reported in patients using antitumor necrosis factor alpha therapies, including etanercept, infliximab, or adalimumab, the incidence is low (3.3–32.2 cases per 100,000 person-years).74,334 Cladribine (2-chloro-20-deoxy- b -D-adenosine) is an FDA-approved purine analogue for the treatment of hairy cell leukemia.
CNS demyelination with TNFα inhibitor exposure: A retrospective cohort study
2021, Journal of NeuroimmunologyDefining the disease course of TNFα blockers-associated Multiple Sclerosis
2021, Journal of NeuroimmunologyCitation Excerpt :Different studies further investigated the association between TNFα blockers and inflammatory CNS disorders. The SABER study, including 61,433 patients with autoimmune disease suitable for treatment with TNFα blockers, found no association between optic neuritis rate and TNF inhibitors exposure (Winthrop et al., 2013). By contrast, a Scandinavian study reported an increased risk of neuroinflammatory events among patients with PsA or ankylosing spondylitis exposed to TNFα blockers (Kopp et al., 2020).
Analgesics, Narcotic Antagonists, and Drugs Used to Treat Arthritis
2020, Drug-Induced Ocular Side Effects, Eigtht Edition
Kevin L. Winthrop MD, MPH, is Assistant Professor of Infectious Diseases, Ophthalmology, and Public Health and Preventative Medicine at Oregon Health and Science University, Portland, Oregon. He is an infectious disease epidemiologist whose research and clinical interests include onchocerciasis elimination, as well as drug safety and pharmacovigilance with specific focus upon the epidemiology, prevention, and therapy of serious infections that occur in patients with autoimmune inflammatory disease.