Ankylosing spondylitis (AS) is a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pain and stiffness, but is also associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation.
This is the third in a series of autoimmune diseases targeted for Humira (adalimumab) therapy. Humira also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis.
The latest approval follows a positive opinion granted by the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP). Abbott's application for Humira for AS in the US is currently under review.
Humira will be available immediately to patients with ankylosing spondylitis in several EU countries, including Germany, Spain, Finland and Denmark. Availability in other EU countries will occur in subsequent months as each country adopts pricing and reimbursement policies.
The AS approval is based on data from the ATLAS trial, which showed that Humira was successful in reducing pain and inflammation in patients with AS. Other findings demonstrated the efficacy of Humira in many patients in reducing disease activity, inducing partial remission, improving physical function and improving physical quality of life.