The results of the two phase III trials, published in an article in the New England Journal of Medicine, show that Novartis’ secukinumab, a fully human anti-interleukin-17A monoclonal antibody, is effective in patients with moderate to severe plaque psoriasis.
According to the National Psoriasis Foundation, as many as 7.5 million Americans have psoriasis. Psoriasis is a noncontagious, chronic autoimmune disease that affects the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis causes patches of thick red skin and silvery scales, which are typically found on the elbows, knees, scalp, lower back, face, palms, and feet, but can also affect fingernails, toenails, and the mouth. There are different types of psoriasis, but the most common is called plaque psoriasis.
A total of 2,000 patients were involved in the studies, said study co-author and investigator Dr. Mark Lebwohl, a professor and chairman of the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York.
“This is the pivotal trial for secukinumab, which was tested by Novartis," Lebwohl told Healthline. "They published a combination of two double-blind placebo controlled trials and two Enbrel controlled trials, where they compared secukinumab to Enbrel, which is one of the market leaders for the treatment of psoriasis.”
Passing with Flying Colors
Lebwohl said that secukinumab was not only shown to be superior to Enbrel and to a placebo, but that it “achieved a degree of improvement that we are not used to achieving with other psoriasis drugs.”
Improvement in psoriasis is measured by a PASI score, Lebwohl said. “PASI 75, which is 75 percent improvement, is considered an excellent degree of improvement. Over three-quarters of patients in every trial achieved PASI 75," he said. "But in this trial, not only did patients achieve PASI 75, but they actually looked at numbers that we don’t usually look at, which was PASI 90 and PASI 100. PASI 100 means there’s not even a dot of psoriasis left. Over a quarter of patients in the trials achieved PASI 100, and over 50 percent achieved PASI 90, which means there’s almost no psoriasis left.”
Fast Response, No Major Side Effects
Another promising result of the trials, according to Lebwohl, is that patients responded to the drug very quickly. “Within three weeks there is a 50 percent reduction in the severity of psoriasis,” he said, adding, “They followed patients up to a year; and with continued treatment, patients continued to respond for up to a year, which means they continued to maintain that excellent degree of response for up to a year.”
Lebwohl also said that there were no “stand out” side effects seen in patients. “The side effects were the same you’d see in a placebo group,” he said.
Less Impact on the Immune System
Emphasizing that ten years ago, powerful drugs like methotrexate and cyclosporine were used to treat psoriasis, Lebwohl said, “These drugs have a major impact on many parts of the immune system, and because of that, they have many side effects. In the last ten years, biologics, which target specific molecules, were introduced. Enbrel is one of three biologics that block a molecule called TNF alpha. That molecule does have a bigger impact on several parts of the immune system than I7-A, which only blocks one little arm of the immune system. Secukinumab blocks a very small part of the immune system compared to the currently available treatments.”
He added, “Theoretically, you hope it will be safer. Of course, we won’t know that until it’s been used in thousands of patients for years. But the premise behind this is that we would be coming out with a very focused, targeted drug that can treat psoriasis, and hopefully, minimize the impact on the immune system and reduce side effects.”
Novartis is expected to seek approval for the drug from the U.S. Food and Drug Administration soon. “Hopefully, it will be approved within this year,” said Lebwohl.
“People with psoriasis who aren't adequately controlled, now have a drug on the horizon that is extremely effective," Lebwohl added. "For those patients it will change their lives.”