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

Abstract

Objective/Purpose Optic neuritis (ON) cases have been reported in patients using anti-tumor necrosis factor (TNF) alpha therapy. However, no population-based studies have been conducted to assess the risk of this complication associated with anti-TNF drugs. Design Cohort study Participants New users of anti-TNF therapy (etanercept, infliximab, or adalimumab) or non-biologic disease modifying agents (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. Methods We used validated algorithms to identify ON cases occurring after onset of new drug exposure. We calculated and compared ON rates between exposure groups. Main outcome measures ON incidence rates by medication exposure group Results We identified 61,227 eligible inflammatory disease patients with either new anti-TNF or new non-biologic DMARD use. Among this cohort, we found three ON cases among anti-TNF new users, occuring a median 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 non-biologic DMARD exposure.

Irreversible optic neuritis after infliximab treatment in a patient with ulcerative colitis

“…In the current literature, there are more than 15 cases of ON caused by TNF-a inhibitor treatment, the majority with partial or total recovery of the vision after high dosage steroid therapy [2][3][4][5][6]. In our case, the vision did not improve despite therapy with high dosage steroids.…”

Using Registries to Identify Adverse Events in Rheumatic Diseases

“…10 Other events of interest in children treated with immunomodulatory products include opportunistic infections, lupus or lupuslike illnesses, demyelinating diseases, pulmonary hypertension, inflammatory bowel disease, and uveitis. [11][12][13][14] Historically children were excluded from clinical trials and most products lacked adequate pediatric safety and efficacy data. However, appropriate labeling of clinical safety and efficacy data for children has improved in the United States over the last decade through a series of federal legislative actions, culminating in the permanent authorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (PREA) under theFDASafetyandInnovationActof 2012.…”

Ocular complications of tumour necrosis factor alpha inhibitors

“…The most common diseases being treated were rheumatoid arthritis and inflammatory bowel disease. Many of the registry cases of optic neuritis were included in the study of Winthrop et al who reported 358 cases of optic neuritis in new users of anti‐TNFα therapies in the USA between 2000 and 2007. In contrast, Alexandre et al’s registry analysis of optic neuritis occurring in patients with inflammatory bowel disease receiving TNF inhibition found an association but could not answer the question as to whether anti‐TNF treatment generates higher risk of optic neuritis in patients with inflammatory bowel disease .…”