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In this story, we revisit the clinical trials that led to the approval of adalimumab for uveitis.
Patients with uveitis now have a new option in drug treatment.
Adalimumab (Humira/AbbVie) has been approved by the U.S. Food and Drug Administration (FDA) for adults with non-infectious intermediate, posteriorand panuveitis.
AbbVie, the drug’s maker, made the announcement on June 30 in a news release stating that Humira is now the first and only FDA-approved non-corticosteroid therapy for non-infectious intermediate, posterior and panuveitis. Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids of which ocular or systemic adverse effects can accrue with long-term use.
Adalimumab works by targeting and helping to block TNF-a, a specific source of inflammation that can have a role in uveitis. The FDA approval is based on results from two pivotal Phase 3 studies, VISUAL-I and VISUAL-II, which demonstrated that adult patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with Humira had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo. No new safety risks were identified for adult patients with non-infectious uveitis treated with Humira every other week.
It's approval marks the 10th approved indication for Humira in the United States and follows recent European Commission marketing authorization for this indication. In 2014, the FDA granted Humira orphan drug designation for the treatment of certain forms of non-infectious uveitis. In June, the European Commission also approved Humira in the European Union for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Uveitis has been estimated to cause 10 percent of all blindness.
As previously reported in Rheumatology Network, a study presented at the 2015 American College of Rheumatology (ACR) annual meeting in San Francisco on Nov. 9 showed that treatment with adalimumab (80 mg loading, 50 mg Q2W maintenance) improved function and quality of life for patients with active non-infectious intermediate, posterior and panuveitis.
A second study presented at ACR 2015 researchers showed that adalimumab lowered the risk for uveitis recurrence, vision loss and macular edema in patients with active, noninfectious intermediate, posterior or panuveitis. The study included 217 patients who were prescribed adalimumab (80 mg loading dose, then 40 mg Q2W). The patients were randomized 1:1 to receive placebo or adalimumab (80 mg loading dose, 40 mg at week 1, followed by 40 mg every other week) for ≤80 weeks.
In a post-hoc analysis of macular edema, the risk for macular edema was reduced by 67% in the adalimumab group versus placebo (HR=0.33; 95% CI, 0.12-0.90; P=0.023).
Despite the use of corticosteroids, adalimumab significantly lowered the risk for recurrence of uveitic activity and vision loss.
"AbbVie's HUMIRA® (adalimumab) Receives U.S. Food and Drug Administration Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis." Abbvie news release. June 30, 2016. "Effect of Adalimumab on Visual Functioning (VFQ-25) in Visual-1 Trial Patients with Non-Anterior Non-Infectious Uveitis,"
John Sheppard. Nov. 9, 2015. ACR/ARHP 2015. Abstract number 2039. "Adalimumab in Patients with Active, Noninfectious Uveitis Using High-Dose Corticosteroids,"
James T. Rosenbaum, Nov. 9, 2015. ACR/ARHP 2015. Abstract number 2038.