Phase III Trial Confirms Benefits of Abbott’s Humira Against Nonradiographic Axial Spondyloarthritis

Abbott reported positive data from Phase III studies evaluating Humira™ (adalimumab) in the treatment of patients with active nonradiographic axial spondyloarthritis (axSpA), and from two long-term open extensions to studies in patients with moderate to severe rheumatoid arithritis.

The Ability-1 trial showed that in comparison with treatment using placebo, therapy using the anti-TNF drug Humira more than doubled the number of patients (from 14.9% to 36.3%) who achieved the primary endpoint of a 40% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 40) at week 12.

Positive data from the long-term open-label extensions of the Premier and DE019 Phase III trials, meanwhile, confirmed the benefits of either Humira monotherapy, or Humira plus methotrexate, for up to 10 years in patients with early or long-standing RA. Long-term data from the open-label extension to the Premier study showed that about 50% of patients experienced an absence of swollen or tender joints.

Abbott says the ongoing Ability-1 inpatients with axSpA is the first large pivotal study to use the ASAS criteria to classify nonradiographic axial SpA patients, as well as evaluate an anti-TNF therapy in treating patients with nonradiographic axSpA. The firm points out that Ability-1 also used the ASAS 40 response criteria for the primary endpoint, instead of the less stringent ASAS 20 response criteria.

Humira is currently approved for the treatment of ankylosing spondylitis, and for reducing the signs and symptoms of psyoriatic arthritis, two other diseases in the same spondyloarthritides disorders. The drug is also approved for treating moderate to severe Crohn disease, rheumatoid arthritis, and chronic plaque psoriasis, and polyarticular juvenile idiopathic arthritis. Humira achieved worldwide sales of $6.5 billion in 2010, compared with $5.5 billion in 2009, and $4.5 billion in 2008. In its 2010 annual report, Abbott forecasted mid-teen growth in sales of Humira during 2011.