The European Commission (EC) has approved Abbott's Humira (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage.
Humira is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for Humira Humira opean Union since the product's first approval in 2003.
AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can also be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with nr-axSpA can have similar signs and symptoms as AS, including chronic pain and loss of function, but do not have X-ray evidence of structural damage. Non-radiographic axSpA is most often seen in younger individuals in their most productive point in life and can go unrecognized for years.
“This first approval of an anti-TNF for non-radiographic axial SpA is a significant step forward in the disease management of these patients,” said Joachim Sieper, MD, Head of Rheumatology, Campus Benjamin Franklin of the Charitè University Hospital, Berlin, Germany. “ Humira has demonstrated a positive benefit-risk profile in non-radiographic axial SpA and access to this treatment option may help physicians treat even more patients suffering from this disease.”
Humira is indicated for the treatment of adults with severe axSpA without radiographic evidence of AS, but with objective signs of inflammation by elevated c-reactive protein (CRP) and/or MRI who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Humira is currently indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.
“With this additional indication for Humira, physicians now have an option to help address an unmet need and treat a disease for which no medicine has previously been approved," said John Leonard, MD, senior vice president, Pharmaceuticals Research and Development, Abbott. “This approval marks another advancement in Abbott's commitment to the continued innovation of Humira in providing treatment for a broad scope of difficult-to-treat immune-mediated diseases.”
Spondyloarthritis (SpA) is a group of diseases that share common clinical, radiographic and genetic features. SpA can be categorized according to which part of the body is mainly affected – axial or peripheral. The Assessment of SpondyloArthritis international Society (ASAS) developed improved classification criteria for axial and peripheral SpA designed to facilitate identification and classification of people with a spondyloarthritis who share similar manifestations. Criteria for axial SpA incorporate the use of magnetic resonance imaging (MRI), in addition to traditional X-rays, for visualizing sacroiliitis (inflammation of the sacroiliac joint which connects the lower spine and pelvis), one of the hallmarks of axial spondyloarthritis.