(RxWiki News) Psoriasis can be a painful and uncomfortable disease. A few products currently on the market may ease symptoms of this skin condition. Now, a new medication is showing promise in clinical trials.
The results of two phase 3 clinical trials showed that secukinumab effectively reduced the rash and severity of plaque psoriasis by at least 75 percent in the majority of patients who received the medication.
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These trials were led by Richard Langley, MD, of Dalhousie University in Halifax, Nova Scotia, Canada.
Plaque psoriasis is the most common form of psoriasis. The condition causes raised red patches on areas of the skin, covered with a silvery buildup of dried skin. People with psoriasis may experience pain or itchiness or find that their skin cracks and bleeds. Plaque psoriasis is typically found on the outside of knees, elbows, the scalp and other areas of the skin.
Secukinumab is part of a class of medications called an anti-interleukin-17A monoclonal antibodies. Researchers have thought that interleukin-17A is central in the development of psoriasis. Interleukin is a group of naturally-occurring proteins that help with the function of the immune system.
These two phase 3, double-blind trials were called ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis).
The participants were at least 18 years of age with moderate-to-severe plaque psoriasis diagnosed at least six months before the start of the trial. All of the participants had psoriasis that was poorly controlled with other treatments, and all received a psoriasis area-and-severity index score (PASI), which measures the severity of psoriasis. In addition, all participants scored a 3 or 4 on another scale that rates clearness of skin from 0 to 5, with 0 being absolutely clear.
The trials lasted 52 weeks, and participants did not know if they were receiving secukinumab, placebo (mock medication) or etanercept (for those in FIXTURE). Etanercept is a medication approved to treat psoriasis.
There were 738 patients in ERASURE and 1,306 in FIXTURE. Patients were randomly given an injection under the outer layer of skin of 300 milligrams of secukinumab, 150 milligrams of secukinumab or a placebo. Some patients in FIXTURE received 50 milligrams of etanercept.
At 12 weeks into the study, more patients met the criteria for a reduction in psoriasis area and severity of 75 percent or more (PASI 75) with secukinumab than with placebo or etanercept.
In the ERASURE study, the criteria were met by 81.6 percent of those receiving 300 milligrams of secukinumab, 71.6 percent of those receiving 150 milligrams of secukinumab and only 4.5 percent of those receiving placebo. In the FIXTURE study, the criteria were met by 77.1 percent of those receiving 300 milligrams of secukinumab, 67 percent of those receiving 150 milligrams of the medication, 44 percent of those receiving etanercept and 4.9 percent of those on placebo.
More patients on secukinumab also had lower scores on the clear skin scale than those receiving placebo or etanercept.
Many patients receiving secukinumab experienced at least one side effect. The most common side effects were headache, upper respiratory tract infections, diarrhea and nose and throat inflammation. Secukinumab also presented a risk of infection.
Dr. Langley and colleagues noted that one limitation of these trials was that few patients continued to receive the placebo after 12 weeks. However, they concluded that these phase 3 studies showed the effectiveness of secukinumab.
“Many patients fail current therapies and need another option," Boni Elewski, MD, professor of dermatology at the University of Alabama at Birmingham, told dailyRx News. She served as principal investigator on one of two investigations evaluating the effectiveness, safety and tolerability of secukinumab to treat moderate to severe plaque psoriasis. "Secukinumab may be effective in these patients and actually completely clear a person who failed current treatments.
“I have no idea when the FDA will approve this medication, but I am hoping that secukinumab will be out in this calendar year or early next year,” she said.
She added that those with psoriasis do not have to suffer with psoriasis.
“There are many options for them and they should see their dermatologist,” she said.
"Over the years, as a pharmacist, I have seen physicians treat patients suffering with psoriasis with many different oral disease-modifying anti-rheumatic drugs. These treatments have maintained little success for patients while at the same time causing many side effects," Steve Leuck, PharmD, President of AudibleRx, a company that provides patient medication education and counseling, told dailyRx News.
"Based on this study, secukinumab appears to be a reasonably tolerable alternative that provides promising results for patients suffering with severe psoriasis. I would caution patients using this medication to keep in mind that their immune system may be compromised and they will be more at risk for contracting infections," he said.
This study was published online July 9 in The New England Journal of Medicine.
The funding for the study was provided by Novartis Pharmaceuticals, which manufactures secukinumab.
Additional reporting by Don Rauf.