J&J COMMENTS ON PUBLISHED RESULTS OF PSORIASIS TRIAL

Phase II data published in the New England Journal of Medicine showed that patients with moderate to severe plaque psoriasis receiving subcutaneous injections of CNTO 1275 experienced significant clearance of skin disease and significant improvements in quality of life, Johnson & Johnson (J&J) announced.

At week 12 of the study, 81 percent of patients receiving four weekly 90-mg doses of CNTO 1275 achieved at least 75 percent improvement in their psoriasis, as measured by the Psoriasis Area Severity Index (PASI), compared with 2 percent of patients receiving placebo. In addition, significantly more patients in each of the three additional CNTO 1275 dosing groups achieved at least a PASI 75 improvement in their psoriasis versus patients receiving placebo.

CNTO 1275, a fully human monoclonal antibody that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), is currently in Phase III development by Centocor for the treatment of moderate to severe plaque psoriasis.

Researchers believe that abnormal immune responses, mediated by type 1 T-helper cells, play a key role in the development of psoriasis. IL-12 and IL-23, naturally occurring proteins that are important in regulating the immune system, stimulate type 1 T-helper cells' responses, according to J&J. Preclinical studies suggest that blocking IL-12 and IL-23 may therapeutically benefit psoriasis patients, and CNTO 1275 has been shown to effectively block IL-12 and IL-23 interactions with the surface of immune cells.

At week 12 of the study, a double-blind, placebo-controlled trial enrolling 320 patients, 81 percent of patients receiving four weekly 90-mg doses of the drug, 67 percent receiving four weekly 45-mg doses, 59 percent receiving a single 90-mg dose and 52 percent receiving a single 45-mg dose achieved a PASI 75 response, versus 2 percent of patients receiving placebo. Among patients receiving CNTO 1275 in the outlined dosing groups, 52 percent, 44 percent, 30 percent and 23 percent achieved PASI 90, or almost complete skin clearance, versus 2 percent of patients receiving placebo.