Tildrakizumab Performs Well in Two Phase 3 Psoriasis Studies

Two Phase 3 trials show that tildrakizumab is efficacious and well-tolerated in patients with moderate-to-severe chronic plaque psoriasis.

Specifically more than 60 percent of all patients who received the active medication showed improvement, compared to less than 10 percent of patients who received placebos. The findings appear in the journal Lancet.

Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody that binds specifically to IL-23p19 and is therefore designed to selectively block the cytokine IL-23.

The parallel double-blind randomized controlled studies, known as reSURFACE 1 and 2, tested an antibody called tildrakizumab for its ability to clear up and control psoriasis in patients with moderate to severe disease. Together, more than 1,800 patients were enrolled in trials conducted at 250 sites in Austria, Australia, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, the United Kingdom and the United States. Patients were randomized to one of three groups; one group received 200 mg tildrakizumab, one received 100 mg and one received an inactive placebo.

On average, patients started the study with 30 percent of their body covered with psoriasis; 12 weeks later, 65 percent emerged with skin that was clear or almost clear – a 75 percent improvement as measured by the standard Psoriasis Area Severity Index (PASI). Fewer than 10 percent of those given a placebo achieved this level of improvement.

“The breakthrough here is that we have continued to refine our treatments to those that are likely to be most effective against psoriasis but less likely to affect other important pathways at the same time,” says lead study author Alexa B. Kimball, MD, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and a Professor of Dermatology at Harvard Medical School, in a news release. “The study also suggests that the 12-week end point may be too early to see optimal efficacy. Patients may continue to improve and that’s going to be important to show over time.”

The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for Sun Pharma’s tildrakizumab in May 2017. The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA. Sun Pharmaceutical Industries Ltd.'s wholly owned subsidiary acquired worldwide rights to tildrakizumab from Merck (through a Merck subsidiary), known as MSD outside the United States and Canada, in 2014.

The news follows acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017.

This Lancet study was funded by Merck & Co., Inc. The study funder had roles in study design, data analysis and data interpretation. Safety data were reviewed at regular intervals by an independent data monitoring committee. All authors had full access to the study data.

Photo Credit: Beth Israel Deaconess Medical Center

Photo Caption: Alexa B. Kimball, MD, President and CEO of Harvard Medical Faculty Physicians (HMFP) at Beth Israel Deaconess Medical Center (BIDMC) and a Professor of Dermatology at Harvard Medical School