On 25 June, Abbott announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Humira (adalimumab) in adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Upon final decision from the European Commission, Humira will be the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA).
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 non-radiographic axSpA can have similar signs and symptoms as AS, but do not have X-ray evidence of structural damage. AxSpA is most often seen in younger individuals and can go unrecognized for years.
Humira will be indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, 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. Humira is currently indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
The positive opinion for the nr-axSpA indication was based on clinical data from ABILITY-I, an ongoing multi-country Phase 3 study designed to evaluate the efficacy and safety of HUMIRA in axSpA patients without radiographic evidence of structural damage.