The Corrona Psoriasis Registry, a 16-year independent registry with no ownership links to the pharmaceutical industry and the leading sponsor of registries in autoimmune diseases, and the National Psoriasis Foundation (NPF), have announced a collaboration on the tracking of the drug safety reporting for ixekizumab – a new Eli Lilly-developed biologic medication recently approved for the treatment of moderate-to-severe plaque psoriasis.
“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, chair and professor of the University of Connecticut Health Center’s Department of Dermatology, who also serves as the 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.”
At least 4,000 psoriasis patients are expected to enroll in the ixekizumab registry, which will follow their treatment for a minimum of eight years. More than 1,200 psoriasis patients on several types of medications have already joined within the first year of the registry, from over 100 sites. These numbers are expected to increase to more than 10,000 psoriasis patients participating from over 200 sites.
Through the collection and analysis of data from thousands of people over this many years, the independent registry is meant to assist researchers in comparing the safety and effectiveness of psoriasis therapies; study other psoriasis-related diseases and medical conditions; as well as increase the understanding of the disease’s natural course.
“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, M.D., Eli Lilly USA’s senior medical director of Cardiovascular, Dermatology and Inflammation. “This registry affirms our ongoing commitment to assess the safety profile of ixekizumab in clinical practice settings.”
This is the second time that a drug manufacturer has selected 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, Corrona’s chief scientific officer, in a press release.