MONDAY April 26, 2021 (HealthDay News) – A breakthrough psoriasis drug is more effective at treating itchy and painful skin disease than drugs already on the market, according to the results of two clinical trials.
There was a “day and night difference” in the results of bimekizumab compared to two established psoriasis drugs, secukinumab (Cosentyx) and adalimumab (Humira), said co-investigator Dr. Mark Lebwohl. in one of the clinical trials.
“We have never had a drug that, in its Phase 3 trials, had allowed more than 50% of patients to achieve” a 100% reduction in their psoriasis symptoms, said Lebwohl, dean of therapeutics clinic at the Icahn School of Medicine at Mount Sinai in New York City.
“We are now at a point where we can eliminate the vast majority of psoriasis patients with very effective and very safe drugs,” he added.
Based on these results, Lebwohl expects Belgian pharmaceutical company UCB Pharma to pursue rapid approval of bimekizumab with the United States Food and Drug Administration.
“I hope it will hit the market this summer,” he said.
Psoriasis affects more than 8 million people in the United States, according to the National Psoriasis Foundation.
It is an autoimmune disease that accelerates the growth of skin cells, causing the cells to build up on the skin’s surface and form patches that itch, burn and sting. These plaques can appear on any part of the body, but are most often found on the elbows, knees, and scalp.
A pro-inflammatory biochemistry called interleukin-17 (IL-17) has been implicated in the development of psoriasis, Lebwohl said. Secukinumab and adalimumab work by blocking the most potent form of the chemical, IL-17A.
Bimekizumab blocks both IL-17A and another form of the chemical called IL-17F, Lebwohl said. The injectable drug is administered once a month.
“Biology [of the two forms of IL-17] overlaps – 17A is more powerful but 17F is more abundant, “Lebwohl said.” Even though 17A is stronger at causing psoriasis, there is more than 17F. By blocking both, you get the full effect. “
After 48 weeks of treatment, approximately 67% of patients taking bimekizumab had complete clearance of their psoriasis plaques, compared to 46% of patients receiving secukinumab, according to the results of the trial co-authored by Lebwohl. A total of 743 patients participated.
The other clinical trial, involving 478 patients, offered similar results. After 16 weeks, 86% of patients taking bimekizumab had experienced a 90% reduction in their psoriasis plaques, almost double the 47% who had achieved the same response with adalimumab.
“They block IL-17A, while it blocks both IL-17A and IL-17F,” Lebwohl said. “That’s probably why it’s so effective. Blocking that little extra IL-17 actually gives you extra effectiveness.”
Bimekizumab has also been shown to effectively treat psoriatic arthritis, a condition that affects 1 in 3 people with psoriasis, Lebwohl said.
People taking bimekizumab were four to 10 times more likely to have a reduction in their arthritis symptoms than a placebo group, with the response increasing with the size of the dose, according to results published in The Lancet.
Blocking IL-17 carries a greater risk of yeast infections, and the risk is greater with bimekizumab than with the other two drugs, the results showed.
“Nature has done an experiment for us giving us people who are deficient in IL-17, and they have terrible yeast infections,” Lebwohl said. “We predicted before the study that the only side effect we would see was yeast infections, and that’s what happened.
Mild to moderate cases of yeast infection that occurred in clinical trials were “easily treated with fluconazole,” an oral antifungal drug, Lebwohl said.
Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York, reviewed the results.
“This is an impressive study showing significant results using an interleukin-17 inhibitor to treat plaque psoriasis,” she said.
However, Green issued a note of caution, calling for further study of the drug.
“A larger sample size should be used because in addition to candidiasis, interleukin inhibitors have been associated with higher rates of other opportunistic infections, serious infections and cancer,” Green said. .
The results of the clinical trials were published on April 23 in the New England Journal of Medicine, and were also presented at an American Academy of Dermatology online meeting.
UCB Pharma funded both trials.
The National Psoriasis Foundation has more on psoriasis.
SOURCES: Mark Lebwohl, MD, dean of clinical therapeutics, Icahn School of Medicine in Mount Sinai, New York City; Michele Green, MD, dermatologist, Lenox Hill Hospital, New York; New England Journal of Medicine, April 23, 2021
Our sincere thanks to