Abbott announced the first long-term patient-reported health outcomes data from an open-label analysis of the ongoing, Phase 3 ABILITY-1 trial of Humira (adalimumab). The study evaluated improvements in physical function and health-related quality of life (HRQOL) after 52 weeks in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). These results are being presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Washington, D.C.
"There are many adults, especially younger, with nr-axSpA whose disease can be as painful, and have similar adverse impact on the ability to function, as those with more classic ankylosing spondylitis," said Professor Philip Mease, University of Washington and Swedish Medical Center, Seattle, Washington. "This study evaluated adalimumab treatment on reduction of signs and symptoms in nr-axSpA patients and the improvement of important patient-reported outcomes including physical function and health-related quality of life, goals we all want for this often inadequately recognized and treated patient group."
An exploratory, post-hoc analysis of data from the open-label extension showed that nr-axSpA patients taking Humira continued to experience improvement in physical function and HRQOL measures at week 52. In both the double-blind and open-label phases of the study, physical function was assessed using the disability index of the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S). Approximately 62 percent of patients met the minimum important difference (MID) for the HAQ-S of 0.26 at week 52.
The HRQOL was assessed using the Short Form 36 Health Survey (SF-36) score. 77 percent of patients met the MID for SF-36 Physical Component Summary (PCS) score of 3.0 at week 52. Placebo patients who switched to open-label Humira experienced improvements in HRQOL comparable to patients who received Humira through week 52. By week 52, patients in both groups achieved SF-36 scores (42.8 and 44.1, respectively), expressed on a scale of 0-100, where higher scores indicate better health and well-being.
AxSpA can be a debilitating disease most often seen in younger individuals in their most productive time of life, and can go unrecognized for years. AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, 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 nr-axSpA can have similar signs and symptoms as AS - including inflammation that can lead to chronic pain and loss of function - but do not have X-ray evidence of structural damage.
"Patient-reported outcomes data focusing on physical function and health-related quality of life help measure the impact treatment has on patients in their day-to-day life," said John R. Medich, PhD, divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, Abbott. "Because there are currently so few treatment options available to help patients with non-radiographic axSpA, Abbott remains committed to exploring ways Humira can help improve the care and outlook for this patient population."
In the open-label extension, both the investigator and patient knew that patients were receiving Humira. Additionally, open-label extension data may be enriched as patients who remain in the study long-term tend to do better than those who drop out. Physical function and SF-36 PCS were two of nine secondary endpoints evaluated in the double-blind portion of the study, all of which were statistically significant for Humira versus placebo.
Additional results from the double-blind period showed that nr-axSpA patients taking Humira experienced a statistically significantly greater improvement in HAQ-S as compared to placebo (-0.3 versus -0.1 respectively; P=0.025.) at week 12, as well as a statistically significantly greater improvement in SF-36 PCS (5.5 versus 2.0, respectively; p<0.001) at week 12. Patients were then entered into an open-label period, in which all participants (n=179) could receive Humira, and were asked to again complete the health assessment questionnaires at week 52.
In July 2012, the European Commission approved Humira for the treatment of adults with severe nr-axSpA, making it the first biologic and only approved medication available for this disease in Europe. In the U.S., Humira is being investigated for the treatment of nr-axSpA and is not approved for the treatment of spondyloarthritides other than AS and psoriatic arthritis.
Date: November 12, 2012