Humira (adalimumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2016

Specific Treatments:

uveitis

Therapeutic Areas

Find Related Trials for The Following Conditions

General Information

Humira (adalimumab) is a tumor necrosis factor (TNF) blocker.

Humira is specifically indicated for the treatment of non-infectious intermediate, posterior and panuveitis.

Humira is supplied as an injection for subcutaneous use. The recommended dose is 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Clinical Results

FDA Approval

The FDA approval of Humira for non-infectious intermediate, posterior and panuveitis was based on two randomized, double-masked, placebo-controlled studies (UV I and II). Patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. The primary efficacy endpoint in both studies was time to treatment failure. Study UV I evaluated 217 patients with active uveitis while being treated with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). All patients received a standardized dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15. Study UV II evaluated 226 patients with inactive uveitis while being treated with corticosteroids (oral prednisone 10 to 35 mg/day) at baseline to control their disease. Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19. Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo,(percentage in failure). Study UV I: Humira (54.5%) versus placebo (78.5%). Study UV II: Humira (39.1%) versus placebo (55%).

Side Effects

Adverse effects associated with the use of Humira may include, but are not limited to, the following:

  • infections (e.g. upper respiratory, sinusitis)
  • injection site reactions
  • headache
  • rash

Humira comes with a black box warning of an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Humira use may also lead to an increased risk for developing malignancy.

Mechanism of Action

Humira (adalimumab) is a tumor necrosis factor (TNF) blocker. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. 

Additional Information

For additional information regarding Humira or uveitis, please visit https://www.humira.com/