Humira (Adalimumab) Appears to Provide Improvement in Disease Activity, Quality of Life for Patients

Psoriasis patients receiving Humira® (adalimumab) achieved significant improvement in disease activity and quality of life through 60 weeks of treatment, according to new Phase II study results released today. The study, which assessed Humira in patients with moderate to severe chronic plaque psoriasis, showed that nearly 70 percent of patients receiving Humira 40 mg every other week (eow) experienced a 75 percent improvement in disease activity (known as a PASI 75 response) at week 60.

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."

Despite many available treatment options for the disease, some biologic treatments that target specific aspects of the immune system and help prevent the rapid growth of skin cells and formation of plaques are proving to be effective for those with moderate to severe forms of psoriasis - which accounts for approximately one-third of the 4.5 million people in the U.S. who suffer from the disease.

"The findings of this study are significant, with nearly 70 percent of patients experiencing sustained improvement in their disease with Humira," said Richard Langley, M.D., lead study investigator, Dalhousie University, Halifax, Nova Scotia. "Psoriasis can be unpredictable and challenging to treat, which is why it is important that we continue to seek out additional treatment options for patients, especially those who suffer from moderate to severe forms of the disease."

In the study, 67 percent of patients taking Humira 40 mg eow achieved at least a 75 percent improvement in disease extent and severity after 60 weeks, as measured by the Psoriasis Area and Severity Index (PASI) score, which measures improvements in the severity and lesional characteristics of chronic plaque psoriasis. Furthermore, after 60 weeks more than one-third (36 percent) of patients taking Humira 40 mg eow achieved PASI 90 - a measurement that correlates to at least a 90 percent reduction in disease activity and severity score and is considered a significant skin measurement that goes beyond what is typically highlighted in clinical trials. Additionally, almost two-thirds (63 percent) of patients were determined to be "clear" or "almost clear" of their psoriasis as measured by the Physician's Global Assessment, another measurement tool used by physicians to assess severity of disease.

Patients also recorded significant improvement in quality of life measures after 60 weeks of treatment with Humira 40 mg eow with 34.3 percent of patients reporting their quality of life was "not at all" affected by their psoriasis, as measured by the Dermatology Life Quality Index (DLQI) - a measure of patient-reported outcomes in dermatology.

"The study results are encouraging for patients whose lives continue to be negatively impacted by the effects of psoriasis," said Rebecca Hoffman, M.D., global project head for Immunology Development at Abbott. "As we move forward into Phase III development, we are optimistic about the potential of Humira in the treatment of psoriasis."