Abbott announced results from the open-label extension of the Phase 3 ABILITY-1 investigational study of Humira (adalimumab), which assessed the improvement in signs and symptoms of disease for patients with active axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Results were presented at the European League Against Rheumatism (EULAR) 2012 Congress in Berlin, Germany.
ABILITY-1 is the first large, pivotal study to use the Assessment of SpondyloArthritis international Society (ASAS) criteria to classify non-radiographic axial SpA patients, and to evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with non-radiographic axSpA. ABILITY-1 used the ASAS 40 response criteria for the primary endpoint, which is a more stringent outcome measure than the ASAS 20 response criteria used in pivotal AS clinical trials. ASAS 40 is defined as at least a 40% improvement from baseline using the ASAS criteria.
The initial 12-week results from this study showed that a significantly higher percentage of Humira patients, compared to those receiving placebo, achieved ASAS 40 (36.3% vs. 14.9%, P<0.001). Following this 12-week, double-blind period, 67% of Humira patients who continued into the open-label extension and had data available for the analysis at 68 weeks (n=144) achieved ASAS 40.
AxSpA can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can 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 ankylosing spondylitis (AS) – including inflammation in the back joints that can lead to severe, chronic pain and discomfort – but do not have X-ray evidence of structural damage. AxSpA is most often seen in younger individuals and can go unrecognized for years.
“It often takes years to be diagnosed with non-radiographic axial SpA, and a patient suffering the debilitating effects of the disease has likely spent several more years trying what few conventional therapies are available,” said Joachim Sieper, M.D., Head of Rheumatology, Campus Benjamin Franklin of the Charite University Hospital, Berlin, Germany. “In this trial, we are encouraged to see that of the patients who received Humira up to week 68, which was approximately three-quarters of those who initiated the trial, more than two-thirds achieved at least a 40% improvement in the ASAS criteria, an important clinical milestone for this underserved patient population.”
Patients were also evaluated for level of disease activity according to the ankylosing spondylitis disease activity score (ASDAS), a measure used to assess disease activity in spondyloarthritides. In this group, 47% of patients achieved an inactive disease state, defined by an ASDAS score of less than 1.3.
“Biologics like Humira have advanced the care for patients who may have dealt with unresolved disease symptoms for a variety of immunological conditions,” said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. “Abbott continues to explore new indications for Humira, such as non-radiographic axSpA, that would potentially provide rheumatologists with more treatment options to choose from and help even more patients around the world.”
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. ASAS developed improved classification criteria for axial and peripheral SpA designed to facilitate identification and classification of people with a spondyloarthritis who share similar symptoms. 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.
Humira is not approved for the treatment of spondyloarthritides other than ankylosing spondylitis and psoriatic arthritis.
Date: June 6, 2012