About 80% of patients with moderate to severe psoriasis saw their disease completely or almost completely cleared with Ixekizumab ( Taltz ), according to three large, long-term clinical trials led by Northwestern Medicine investigator Kenneth Gordon.
The results of these phase III trials were published in the New England Journal of Medicine ( NEJM ).
Affecting about 3% of the world’s population, psoriasis is an immune-mediated inflammatory disease that causes itchy, dry and red skin. It is also associated with an increased risk for depression, heart disease and diabetes, among other conditions.
Ixekizumab works by neutralizing a pathway in the immune system known to promote psoriasis.
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% 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, 76.4 to 81.8% of patients has their psoriasis classified as clear or minimal compared to 3.2% of patients on the placebo.
By the 60th week, 68.7 to 78.3% of patients had maintained their improvement.
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 need to be monitored in the future. ( Xagena )
Source: Northwestern University Feinberg School of Medicine, 2016