New Phase III Data Show Abbott's HUMIRA(R) (Adalimumab) Was Statistically Superior to Methotrexate in Patients With Psoriasis
Thursday October 5, 9:40 am ET
- First psoriasis study to feature a head-to-head comparison between a biologic agent versus standard systemic treatment -
RHODES, Greece, Oct. 5 /PRNewswire-FirstCall/ -- Positive Phase III data presented today at the European Academy of Dermatology and Venereology Congress showed that HUMIRA was statistically superior to methotrexate in patients with psoriasis. More than twice the percentage of patients (80 percent) with moderate to severe psoriasis receiving Abbott's HUMIRA (adalimumab) achieved at least 75 percent improvement in disease extent and severity after 16 weeks compared to patients receiving methotrexate (36 percent), a standard systemic treatment for psoriasis. The study met its primary efficacy endpoint, which was to determine whether HUMIRA would reduce disease activity more than methotrexate or placebo, as measured by a well- known psoriasis assessment tool. This is the first psoriasis study to feature a head-to-head comparison between a biologic agent and a standard systemic treatment.
Psoriasis is a chronic, non-contagious autoimmune skin disease characterized by very dry, scaly and cracked skin, skin pain, and patches of red, raised skin known as "plaques". There is currently no cure for the disease, which affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease symptoms.
"The results of this study strongly suggest the potential HUMIRA may have as a new treatment for psoriasis," said the study's primary investigator, Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "The scales and plaques of psoriasis can cause both physical and emotional distress, making it essential to identify new treatment options for these patients."
About the CHAMPION Study
CHAMPION (Comparative Study of HUMIRA vs. Methotrexate vs. Placebo In PsOriasis PatieNts) included 271 patients from eight European countries and Canada who were candidates for systemic therapy or phototherapy. The three- arm, 16-week study evaluated the treatment effect of HUMIRA in comparison to methotrexate (MTX) or placebo, each dosed as monotherapy. The comparison of HUMIRA and MTX was a non-inferiority analysis. Patients were randomized to receive either HUMIRA in its standard dose of 40 mg subcutaneous injection every other week (eow), beginning at one week following an initial single dose of 80 mg, or MTX or placebo.
The primary efficacy endpoint was the percentage of patients achieving at least a 75 percent reduction in disease activity at week 16 as measured by the Psoriasis Area and Severity Index score (PASI 75), which is a score ranging from 0-72 and measures the extent and severity of psoriasis. Physician's Global Assessment (PGA), another measurement tool used by physicians to assess disease severity, also was used in the study.
Results at week 16 showed that nearly 80 percent of patients receiving HUMIRA achieved PASI 75, compared to 35.5 percent receiving MTX (p<0.001) and 18.9 percent receiving placebo (p<0.001). Patient response to HUMIRA was rapid, with a mean PASI improvement of 57 percent achieved at week four, compared to baseline. PGA results, the study's secondary efficacy endpoint, showed 73 percent of patients taking HUMIRA had physician assessments of their psoriasis of "clear" or "minimal" compared to 30 percent of patients taking MTX (p<0.001) and 11 percent of patients taking placebo (p<0.001) at week 16.
The safety profile of the study was consistent with previously reported studies of HUMIRA. Adverse events occurring in more than five percent of HUMIRA patients included injection site reaction, hepatic events, nasopharyngitis (inflammation of the nose and pharynx), arthralgia (joint pain) and headache.
"These study results are very promising for patients whose lives continue to be negatively impacted by the effects of psoriasis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "We remain encouraged and optimistic about the potential of HUMIRA in the treatment of psoriasis."
Abbott expects to submit a regulatory application for a psoriasis indication in Europe and the United States during the first half of 2007. |
