Abbott has received approval from the European Commission to market Humira (adalimumab) as a treatment for severe, active ankylosing spondylitis (AS) in Europe.
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. It is estimated that nearly three million people in Europe are affected by a spinal arthritic disease such as AS.
This is the third in a series of autoimmune diseases targeted for Humira therapy. Humira also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis. This approval follows a positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Abbott's application for Humira for AS in the United States is currently under review.
"This approval of Humira in the European Union is important in the treatment of ankylosing spondylitis, a debilitating disease that strikes young, mostly male patients in their thirties and forties," said Désirée van der Heijde, M.D., co-lead investigator of the ATLAS Phase III clinical trial and Professor of Rheumatology at the Maastricht University, The Netherlands. "Treatments like Humira are changing how we can treat AS. The data in the clinical trial showed that treatment with Humira significantly reduced the pain and inflammation caused by AS, and in some patients, led to partial remission."
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.
Unlike many other rheumatic conditions, AS affects mostly young men, and commonly begins before the age of 35. AS is difficult to diagnose in its early stages and is the most overlooked cause of persistent back pain in young adults.
The approval of Humira for the treatment of AS 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 Humira was successful in reducing pain and inflammation in patients with AS - the study's primary endpoint. 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.
"Today's approval of Humira as a treatment for severe, active ankylosing spondylitis marks another milestone for Abbott, and more importantly for patients, in providing new treatment options for this potentially debilitating autoimmune disease," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "Tens of thousands of Europeans with rheumatoid arthritis and psoriatic arthritis have been prescribed Humira. Now thousands of Europeans with AS have the option of Humira as well."
A similar rate of treatment emergent adverse events leading to discontinuation of study drug was observed among placebo-treated (1.9 per cent) and Humira-treated (1.4 per cent) patients. The overall incidence of adverse events reported by patients treated with Humira was higher than the placebo treatment patients. The most common adverse events included nasopharyngitis, injection site reactions and headache.
Ankylosing spondylitis (AS), or arthritis of the spine, is an autoimmune disorder in which a human protein, tumour necrosis factor-alpha, has been suggested to play a role in the disease development. AS is a form of arthritis known as spondyloarthritis, which is a group of closely linked rheumatic diseases that can cause pain in the spine and joints as well as ligaments and tendons, and also can cause inflammation that predisposes patients to spinal vertebrae fractures. AS is a chronic disease that primarily affects the spine causing back stiffness and deformity over time.
AS is associated with a number of extra-axial manifestations including peripheral arthritis and enthesitis (inflammation of the muscle-bone insertion). Other associated affected organ systems may include the eyes, intestines and skin.