Amgen announced that a phase 3 clinical study assessing the efficacy and tolerability of Enbrel (etanercept) in the treatment of moderate to severe plaque psoriasis had positive results, achieving the primary and all key secondary endpoints. Psoriasis is an inflammatory disease affecting nearly 7 million people in the United States.
"It is encouraging to see that nearly half of the patients in the study quickly and significantly responded to Enbrel with at least a 75 per cent improvement of their Psoriasis Area and Severity Index (PASI) score after 12 weeks," said Dr. Beth Seidenberg, Amgen's senior vice president of development. "In addition, patients continued to show improvement over the entire treatment period with nearly 60 per cent of patients treated with Enbrel achieving this endpoint after 24 weeks."
Enbrel was generally well tolerated in the study and adverse events at 12 weeks were similar to those occurring in patients receiving placebo.
"These results are gratifying and advance our understanding of Enbrel as a potential future therapy for patients with this life-impacting disease," said Dr. Alice Gottlieb, professor of medicine at the University of Medicine and Dentistry of the Robert Wood Johnson Medical School, and a primary investigator in the study. "Dermatologists will likely welcome seeing the complete results of this study when they are presented at a scientific meeting later this spring."
Psoriasis, a disease that can significantly impact a patient's quality of life, is characterized by chronic inflammation of the skin. This inflammation drives the formation of skin plaques that are painful and disfiguring. Tumor necrosis factor (TNF) is found at high levels in psoriatic plaques, and plays a critical role in their formation and maintenance.
Enbrel is not approved by the U.S. Food and Drug Administration for the treatment of psoriasis but clinical development continues with a second Phase 3 study that is currently underway.