FDA Approves Abbott's HUMIRA For Moderate To Severe Chronic Plaque Psoriasis

Armen Hareyan's picture

Abbott received FDA approval to market HUMIRA (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.

"The approval of HUMIRA for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."


Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to visible symptoms, people with psoriasis may suffer from poor self-image and social isolation, and even feelings of depression, such as sadness and despair. Recent research also suggests psoriasis may be associated with other serious health risks. Up to 30 percent of psoriasis patients develop psoriatic arthritis, which combines skin symptoms with arthritis symptoms, including joint pain and inflammation.

"The approval of HUMIRA is excellent news for patients suffering from psoriasis, which can have a profound physical and emotional impact on a person's life," said Alan Menter, M.D., chairman, division of dermatology, Baylor University Medical Center, Dallas. "HUMIRA offers dermatologists an important new therapeutic option that has been shown to help alleviate a range of psoriasis signs and symptoms, including redness, scaling and itching, in many psoriasis patients."

HUMIRA for Plaque Psoriasis

The approval of HUMIRA is based on data from more than 1,400 adult patients in two pivotal trials -- REVEAL and CHAMPION. Both studies evaluated the efficacy and safety of HUMIRA in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo. In addition, CHAMPION compared a biologic medication to methotrexate, a standard systemic treatment for psoriasis. REVEAL results were published in the Journal of the American Academy of Dermatology in January 2008 and CHAMPION results were published online in the British Journal of Dermatology.

In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). The PASI score measures the extent and severity of psoriasis. PASI may be calculated before and after a treatment period to determine efficacy; for example, a PASI 75 correlates to a 75 percent improvement in signs and symptoms of psoriasis. PGA also measures efficacy of therapy. On a six-point scale, a zero score means no signs, one means minimal and a five means signs of very severe psoriasis.



hello! my name is Janet an I've had this problem for over 5years. Ihad been seeing the same Dr. for this skin problem and just 2mos. ago it was brougth to my attion that this is PLAQUE PSORIASIS, Ihad to find out from another Dr. at the heath center how serious this illness can be...But Iam glad that she made me aware of the serious this is the dermatigist never even told what was wrong until last month .I began to experance this problem 1year after my husband was dignose with BONECANCER. Before that I had beautiful skin. Ioften wonder if finding out he had CANCER OF THE BONES and he would die no matter what on set this disorder in my immune system? I miss my husband we had just had a baby when we found out he was dieing. my son is now 7years old and I'm all he have so I just want to do what I must to be here to see him to be a man an take care of possibly me and himself. So I want to get to know people like me and all treatments that is needed an aveilble to me. My little boy need his mommy to be around his DADpast away in 4-14-2007. So i will be starting HUMIRAon 10-30-2008 I,ll keep intouch hope to hear from someone in my shoes.