The FDA ( Food and Drug Administration ) has approved Humira ( Adalimumab ) for reducing signs and symptoms in patients with active ankylosing spondylitis.

Ankylosing spondylitis is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain and stiffness and also can be associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, ankylosing spondylitis over time can result in complete spinal fusion, causing extreme physical limitation and reduction in health- related quality of life.

Ankylosing spondylitis is the third of six autoimmune diseases targeted for Adalimumab therapy that has received FDA approval.
Humira also is approved by the FDA to treat rheumatoid arthritis and psoriatic arthritis.

Ankylosing spondylitis affects young adults and commonly develops during the second and third decades of life. Because the pain and stiffness of ankylosing spondylitis are hard to distinguish from other common causes of back pain, patients may go undiagnosed for many years from the onset of their symptoms. Ankylosing spondylitis is one of the most overlooked causes of persistent back pain in young adults.

The recommended dose of Humira for ankylosing spondylitis is 40 mg every other week, by subcutaneous injection.

The approval of Humira for the treatment of patients with active ankylosing spondylitis is based on data from the ATLAS ( Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS ) trial.

ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in Europe and the United States. Results showed that Adalimumab was successful in reducing pain and inflammation in patients with ankylosing spondylitis after 12 weeks of treatment, the study's primary endpoint. Other findings demonstrated significant improvement in measures of disease activity for many patients treated with Adalimumab that were first observed at week two and maintained through 24 weeks.

ATLAS also explored the impact of Adalimumab on enthesitis, a condition in ankylosing spondylitis characterized by inflammation of the ligaments that attach to the bone. At week 24, the mean change in the enthesitis symptom score as measured by Maastricht Ankylosing Spondylitis Enthesitis Score ( MASES ) in patients treated with Adalimumab showed significant reduction. MASES is an index that assesses enthesitis in certain locations, such as the rib cage, lower back, and Achilles tendons.

In the ATLAS trial, a similar rate of treatment-emergent adverse events leading to discontinuation of study drug was observed among placebo-treated ( 1.9 percent ) and Adalimumab-treated ( 1.4 percent ) patients.
The overall incidence of adverse events reported by patients treated with Adalimumab was higher than the placebo-treated patients.
The most common adverse events included nasopharyngitis, injection site reactions and headache.

Source: Abbott Laboratories, 2006


XagenaMedicine2006