Abbott's HUMIRA® Receives FDA Approval For Inhibiting Structural Joint Damage And Improving Physical Function In Patients With Arthritis

Abbott announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for HUMIRA® (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). The expanded indication is in addition to the psoriatic arthritis approval granted in October 2005.


HUMIRA is also approved in the U.S. for use in moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis (AS).


PsA is a chronic disease that combines symptoms of arthritis, including joint pain and inflammation, and those of psoriatic skin disease, such as painful, raised red lesions covered by silvery white scales. Approximately one million men and women suffer from PsA in the United States and, when left untreated, the disease can be potentially disabling. Early recognition, diagnosis and treatment of PsA can relieve pain and inflammation and possibly help inhibit extensive joint involvement and damage in later stages of the disease.


"Psoriatic arthritis can be debilitating for many people, hindering everyday activities. For these people, and others, the new indication for HUMIRA is welcome news to our community," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation.



Study Results


The expanded indication is based on results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the largest randomized, placebo-controlled biologic trial in PsA. ADEPT was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. Patients were randomized to receive either HUMIRA 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week open-label extension.



Progression of Structural Joint Damage


Patients taking HUMIRA experienced significantly less joint damage than patients taking placebo. Joint damage was assessed with X-rays taken at baseline and weeks 24 and 48, using the modified total Sharp score (mTSS), a measure of joint damage progression. A smaller change in mTSS reflects less progression of joint damage, with a positive score indicating worse radiographic damage. At week 24, the co-primary endpoint (the average change in joint damage, as measured by a mean change in mTSS) was 10 times greater in the placebo arm than in the HUMIRA arm (0.9 and -0.1, respectively; p








Physical Function


Patients taking HUMIRA showed significant improvement in physical function as assessed by the Health Assessment Questionnaire Disability Index (HAQ) score and the Short Form-36 Health Status Survey (SF-36). HAQ scores assess a patient's ability to perform daily activities such as getting dressed, walking and climbing stairs. Statistically significant improvements in HAQ were achieved by patients in the HUMIRA group compared to placebo at week 24 (p