The U.S. Food and Drug Administration (FDA) has approved adalimumab (Humira®, Abbvie), a potent blocker of tumor necrosis factor alpha (TNF-α), for the treatment of non-infectious intermediate, posterior, and panuveitis.1 Certain rheumatic diseases, including spondyloarthritis, are associated with the development of noninfectious, immune mediated uveitis as part of the extraarticular manifestations of disease.
Approval was granted after reviewing results of 2 clinical trials, Efficacy and Safety of Adalimumab in Patients With Active Uveitis (VISUAL l, ClinicalTrials.gov Identifier: NCT01138657) and Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (Visual II, ClinicalTrials.gov Identifier: NCT01124838). It was found that adalimumab decreased treatment failure (TF) in adults with both active and controlled non-infectious intermediate, posterior, or panuveitis.
In VISUAL-I, patients taking adalimumab were less likely have TF compared to those taking placebo (hazard ratio [HR]=0.5; 95% confidence interval [CI], 0.36–0.70; P<.001). Time to TF was analyzed using Kaplan-Meier methods. Median time to TF was prolonged from 3 months for placebo to 5.6 months for adalimumab.2
In VISUAL-II study, the median time to TF was 8.3 months for patients treated with placebo, as compared to those treated with adalimumab where median time to TF was not calculable within the study time frame (>18 months), as more than 50% of patients treated with adalimumab did not experiencing TF (HR=0.57; 95% Cl, 0.39-0.84; P=0.004).2 In both trials, no new safety risks with adalimumab were identified.
The European Commission has already approved adalimumab for use in the European Union for the treatment of noninfectious intermediate and posterior uveitis and panuveitis in adult patients who have had inadequate treatment response to corticosteroids, in patients who need to follow steroid-sparing regimens, and in patients with contraindications to steroid treatment.
“These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye,” said Glenn J. Jaffe, MD, Duke University, Durham, NC in the news release from Abbvie.
1. AbbVie Newsroom. HUMIRA® (adalimumab) Receives U.S. Food and Drug Administration Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis. https://news.abbvie.com/news/abbvies-humira-adalimumab-receives-us-food-and-drug-administration-approval-to-treat-adults-with-non-infectious-intermediate-posterior-and-panuveitis.htm. Published online June 30, 2016. Accessed July 1, 2016.
2. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.