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, Ph.D., 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.