New Drug Clears Psoriasis in Clinical Trials
Psoriasis is an immune-mediated inflammatory disease that affects about three percent of the world’s population. Moreover, it causes itchy, dry and red skin and has been associated with an increased risk of depression, heart disease and diabetes, among other conditions. And now, a series of three long-term clinical trials led by Kenneth Gordon, MD, professor of Dermatology at Northwestern University Feinberg School of Medicine, has shed light on a potential new source of relief: a medication called Ixekizumab.
Ixekizumab works by neutralizing a pathway in the immune system known to promote psoriasis. In the trials, it cleared the disease completely or almost completely in about 80 percent of patients with moderate or severe psoriasis. Moreover, the great majority of the responses lasted at least 60 weeks.
To test the drug’s efficacy over time – and to help clinicians determine whether its benefits outweigh any risks – the three studies enrolled a total of 3,736 adult patients at more than 100 study sites in 21 countries. All participants had moderate to severe psoriasis, which is defined as covering 10 percent or more of the body. Patients were randomly assigned to receive injections of Ixekizumab at various doses or a placebo over a period of more than a year.
The investigators assessed whether the drug reduced the severity of psoriasis symptoms compared to the placebo and evaluated safety by monitoring adverse events. By the 12th week, 76 to 82 percent of patients had their psoriasis classified as “clear” or “minimal” compared to 3 percent of patients on the placebo. By the 60th week, 69 to 78 percent of patients had maintained their improvement.
“Ten years ago, we thought complete clearance of this disease was impossible. It wasn’t something we would even try to do. Now with this drug, we’re obtaining response levels higher than ever seen before,” Gordon said.
Adverse events associated with Ixekizumab included slightly higher rates of neutropenia (low white blood cell count), yeast infection and inflammatory bowel disease compared to the placebo. The safety of therapy longer than 60 weeks will continue to be studied.