Abbott has announced that the US Food and Drug Administration (FDA) have approved Humira (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints, which 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, AS over time can result in complete spinal fusion, causing extreme physical limitation and reduction in health-related quality of life.
AS is the third of six autoimmune diseases targeted for Humira therapy that has received FDA approval. Humira also is approved by the FDA to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and clinical trials are currently under way evaluating the potential of Humira in other autoimmune diseases. Humira received European approval to treat patients with severe, active AS on June 1, 2006.
"Medications like Humira represent another option, in the way we treat ankylosing spondylitis, a painful and potentially disabling disease, that tends to strike mostly young adults," stated Jane Bruckel, BSN, RN, Spondylitis Association of America co-founder and executive director.
AS affects young adults and commonly develops during the second and third decades of life. Because the pain and stiffness of AS are hard to distinguish from other common causes of back pain, patients may go undiagnosed for many years from the onset of their symptoms. AS is one of the most overlooked causes of persistent back pain in young adults.
The recommended dose of Humira for AS is 40 mg every other week, by subcutaneous injection (a shot beneath the skin), the usual dose recommended for Humira in the treatment of moderate to severe RA and PsA. Humira is available to patients with AS in the United States in a pre-filled syringe. Beginning in August, patients will be able to take advantage of the Humira Pen, a new delivery device for the self-administration of Humira. Approved by the FDA on June 23, 2006, the Humira Pen offers improved ease of use and a less painful experience compared to the Humira pre-filled syringe.