Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves HUMIRA for Non-Infectious Uveitis

AbbVie news release; 2016 Jun 30

The FDA has approved HUMIRA (adalimumab) for the treatment of non-infectious intermediate, posterior, and panuveitis. Non-infectious uveitis is an immune-mediated disease that can flare and impair vision. Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids.

Indications: HUMIRA is recommended for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Dosage/administration: HUMIRA is given by injection under the skin. Recommended treatment is an 80 mg initial dose, followed by 40 mg every other week, starting 1 week after initial dose.

Adverse reactions: Most common adverse reactions (incidence >10%) include infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.

Citation: AbbVie’s HUMIRA (adalimumab) receives US Food and Drug Administration approval to treat adults with non-infectious intermediate, posterior and panuveitis. [news release]. North Chicago, IL: AbbVie; June 30, 2016: www.abbvie.com. Accessed July 5, 2016.