Humira and Psoriatic Arthritis
10/13/2003
Abbott Laboratories is expanding its immunology clinical trials program to include an additional Phase III study evaluating the potential of Humira (adalimumab), a tumor necrosis factor-alpha medication (TNF-a), in psoriatic arthritis. This study is in addition to the Phase III study in psoriatic arthritis initiated earlier this year.
“Psoriatic arthritis patients experience symptoms of two often debilitating conditions, arthritis and psoriasis,” said Mark Genovese, MD, assistant professor of medicine at Stanford University School of Medicine. “This trial is designed to assess the effect of Humira on both the joint and skin manifestations of the disease.”
The Phase III trial will evaluate Humira in improving signs and symptoms of psoriatic arthritis in adults with moderate to severe disease who have had inadequate response to disease modifying antirheumatic drugs (DMARDs). Patients in the trial will randomly receive either Humira or a placebo, and responses will be measured by improvements in signs and symptoms as measured by American College of Rheumatology (ACR) response scores.
Defining TNF-a
Psoriatic arthritis is a disorder in which human protein, TNF-a, has been suggested to play a role in the disease development. The same is true for other spondyloarthropathie, such as ankylosing spondylitis, spondylitis of inflammatory bowel disease, reactive arthritis / Reiter’s syndrome, undifferentiated spondyloarthropathy, and juvenile spondyloarthropathy. Data from clinical studies suggest that treatments that inhibit TNF-a may be effective in these disease states. Humira is a human monoclonal antibody that resembles antibodies normally found in the body and works by specifically blocking TNF-a.
Currently, two other TNF-a medications are being used in the spondyloarthropathies. Remicade is Food and Drug Administration (FDA) approved for inflammatory bowel disease / crohn’s disease, and rheumatoid arthritis; Enbrel is FDA approved for use in ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis.
Psoriatic Arthritis
Psoriatic arthritis is one of the six spondyloarthropathies, explained above. If left untreated, psoriatic arthritis can be a progressively disabling disease. It involves the combination of skin manifestations (psoriasis) and arthritis of the spine and other areas in the body. As many as 30% of people with psoriasis also have psoriatic arthritis. It is a non-contagious, chronic skin disease characterized by red plaques covered with white scales.
For more information, please refer to the Psoriatic Arthritis section of our site -- http://www.spondylitis.org/about/whatispsoriatic.aspx.
What a Phase 3 Clinical Trial Means
The FDA groups clinical trials into four phases, each of which addresses a separate research question.
- Phase I: First, researchers test a new drug or device in about 20-100 healthy volunteers to determine whether it is safe and what side effects it may have. Researchers also study how long the drug stays in the body, which helps them decide what doses to test further. Phase I studies primarily address the question of safety.
- Phase II: Next, researchers test the new drug or device in about 100-300 people to determine whether or not it works and to learn more about possible side effects. So Phase II studies address safety and effectiveness.
- Phase III: Researchers compare the new intervention to current standard therapy to learn whether it offers any advantage. In a Phase III study, several hundred to several thousand people receive the new drug or device. The FDA will only approve drugs that complete Phase III testing.
- Phase IV: To monitor long-term side effects, effectiveness, and other potential uses, researchers continue to study new interventions after they are approved and in regular use.
(Courtesy of www.webmd.com)
About Humira
Abbott Laboratories’ Humira is the first monoclonal antibody approved by the FDA for reducing signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more traditional DMARDs and can be used alone or in combination with methotrexate or other DMARDs.
For important safety information, please refer to the appropriate press release found on http://abbott.com/news/press_release.cfm?id=623.
Clinical trials are underway in evaluating Humira in juvenile rheumatoid arthritis, psoriasis, Crohn’s disease, and early rheumatoid arthritis.
For additional information on Enbrel, please refer to www.humira.com, www.rxlist.com, and the Spondylitis Association of America's Message Boards to learn others' experiences with the medication. Contact Abbott Medical Information at 1-800-633-9110 for more information about Humira clinical trials.