Alejandro Freixes
Nov 7, 2011

Humira shown to be an effective treatment for non-radiographic axial spondyloarthritis


Abbott announced today, at the American College of Rheumatology Annual Scientific Meeting  in Chicago, the results of their Phase-3 ABILITY-1 trial for the study of HUMIRA. The drug is used to treat patients who suffer from the disease active non-radiographic axial spondyloarthritis (axSpA) in addition to related conditions.

HUMIRA proved its efficacy with more than twice as many HUMIRA patients than those receiving placebo showing improvement by the 12th week of the study. Those patients achieved the primary endpoint of 40 percent improvement in the Assessment of SpondyloArthritis International Society; this society is dedicated to the validation of assessment tools and the evaluation of treatments that may eradicate the disease.

Spondyloarthritis (SpA) is a cluster of diseases that cause inflammation of the spine, joints, tendons, ligaments and surrounding areas. The set of disorders includes: ankylosing spondylitis (AS), psoriatic arthritis (PsA), reactive arthritis, and enteropathic or inflammatory bowel disease (IBD). These conditions affect the eyes, gut, urinary tract, skin, and, in severe cases, the heart and lungs.  

SpA is usually treated with anti-inflammatory medication to relieve the painful symptoms and is  categorized by which part of the human body it effects - mainly axial or peripheral . Studies suggest  SpA is correlated with a family history and people with the genetic marker Human Leukocyte Antigen (HLA) B27 have a greater susceptibility. This crippling disease tends to be severe and progressive in nature, with onset occurring between the ages of 20 to 30 years old.

Ability 1 is the first trial of this scale to not only use the Assessment of Spondyloarthiris International Society criteria to classify patients with non-radiographic axSpA, but also to evaluate an anti-tumor necrosis factor medication in treating patients. The subtle changes in spondyloarthritis are difficult to detect, and therefore make it difficult to arrive at a conclusive diagnosis. People who have contracted non-radiographic arthritis express symptoms similar to those with AS, but do not have X-Ray evidence of damage.

ASAS offered a validated new classification criteria for axial and peripheral SpA that incorporates the use of Magnetic resonance imaging (MRI) in addition to x-rays to obtain an accurate visual representation of the inflammation of the sacroiliac joint (joint that connects the lower spine and the pelvis). The immediate result is facilitated diagnoses for patients who would have otherwise been left undiagnosed.

The study showed an increase in percentage of HUMIRA patients that achieved the primary endpoint compared to other clinical trial patients and placebo treated patients(36.3 percent vs. 14.9 percent, respectively). In the double blind period, all 192 patients showed comparable results for HUMIRA and placebo.

Dr. Philip Mease, Chief of Swedish Hospital Rheumatology Clinical Research Division in Seattle, Washington, says, “There is a tremendous unmet need for effective treatments for patients with non-radioactive axSpA. Adalimumab (HUMIRA) has been shown to be an effective treatment for two other spondyloarthritides... the results of this study are encouraging for its potential in treating another condition within this group of diseases.”