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U.S. FDA: Humira does even more for psoriatic arthritis

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Based on a recently published study, the U.S. Food and Drug Administration has granted the TNF inhibitor an extended description, saying it can inhibit "structural joint damage and [improve] physical function in patients" with this form of arthritis.

The data regarding the Abbott Laboratories medication was generated during the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT).

According to the press release:

  • ADEPT was a Phase III trial involving 313 patients with moderate to severe psoriatic arthritis (PsA) who had an inadequate response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
  • It was the largest randomized, placebo-controlled biologic trial in PsA.
  • Results demonstrated that patients taking Humira experienced significantly less joint damage than patients taking placebo.
  • More than three times as many patients on placebo (29 percent) experienced joint damage compared to patients taking HUMIRA (9 percent) at week 24.
  • Results in the Humira group were maintained through 48 weeks.


What is psoriatic arthritis?

As Abbott explains, "PsA is a chronic disease that combines the symptoms of arthritis, including joint inflammation, which leads to pain and possible damage, with symptoms of psoriasis, such as painful, raised red lesions covered by silvery white scales."

Humira, TNF inhibitor by Abbott LaboratoriesAs medications are found to halt the progress of arthritis and allow for the body to heal (as much as it can), it is hoped that expanded, trial-supported indications by the FDA such as this one will help patients.  As Dr. Stephen Paget of the Hospital for Special Surgery told arthritis patients at CreakyJoints' Life Within Reach event in September -- we have to recognize these illnesses early and treat them aggressively.

The press release echoes that sentiment, saying, "It is thought that early recognition, diagnosis and treatment of PsA may help inhibit extensive joint involvement and damage in later stages of the disease, in addition to relieving pain and inflammation."

Humira is a TNF (tumor necrosis factor) inhibitor, meaning it binds to TNFα in the body and suppresses the body's inflammatory reactions -- the point at which autoimmune diseases use the body to damage itself.  By suppressing the immune system, patients are more susceptible to infection (constant communication should be ongoing with a primary care physician and rheumatologist if an infection of any sort is suspected).  Although, with many forms of arthritis, by not taking any medication, a patient's chances for infection are just as high.

More info on Humira from Abbott:

"Humira is currently approved to treat rheumatoid arthritis, PsA and ankylosing spondylitis, or arthritis of the spine, in both the United States and Europe. Humira is currently under regulatory review to treat Crohn's disease, and additional development work continues in psoriasis, ulcerative colitis and juvenile rheumatoid arthritis [also known as juvenile idiopathic arthritis]."

 

To read a press release on the study from Abbott, click on the link below:

 

 

Article References
Abbott's Humira (adalimumab) Receives FDA Approval for Inhibiting Structural Joint Damage and Improving Physical Function in Patients with Psoriatic Arthritis, site accessed on 10/06/08

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