The Corrona Psoriasis Registry has announced that it will track drug-safety reporting for ixekizumab (Taltz, Eli Lilly and Company), a new biologic medication recently approved for the treatment of moderate-to-severe plaque psoriasis. The registry is a joint collaboration between the National Psoriasis Foundation and Corrona, LLC, the leading sponsor of registries in autoimmune disease.
The registry will enroll at least 4,000 people with psoriasis who are using ixekizumab and will follow their treatment for at least eight years. More than 1,200 people on various psoriasis medications from 100 sites have joined within the first year of the registry. Registry participation numbers are expected to grow to more than 10,000 people with moderate-to-severe psoriasis who are taking biologics or systemic medications at 200 sites. By collecting and analyzing data from thousands of people over many years, the registry will help researchers compare the safety and effectiveness of psoriasis therapies, study other diseases and medical conditions associated with psoriasis, and better understand the natural course of the disease.
“This is an exciting time for patients with psoriasis as new treatments become available, and this registry will provide the long-term data we need to understand the safety and effectiveness of these therapies,” said Dr. Bruce Strober, Professor and Chair of the University of Connecticut Health Center Department of Dermatology and Scientific Co-Director of the registry. “The information collected will also provide valuable insights into the relationship between psoriasis and other diseases, as well as the impact of psoriasis and its treatments on quality of life.”
Lilly is the second drug manufacturer to select the Corrona Psoriasis Registry to meet its regulatory post-approval safety commitments in psoriasis. “Particularly for newly approved drugs, these long-term safety studies by an independent organization can help provide patients, physicians, and regulators with the long-term safety data they need,” said Dr. Jeff Greenberg, Chief Scientific Officer of Corrona.
“Ixekizumab was approved by the FDA based on safety information drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials, and physicians are just beginning to use it in practice,” said Nayan Acharya, MD, Senior Medical Director of Cardiovascular, Dermatology, and Inflammation at Lilly USA, LLC. “This registry affirms our ongoing commitment to assess the safety profile of ixekizumab in clinical practice settings.”
Psoriasis is a chronic, immunodysregulatory disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious. As many as 7.5 million Americans have psoriasis.
Source: National Psoriasis Foundation; May 2, 2016.