MONDAY, April 26, 2021 (HealthDay News): A breakthrough psoriasis The drug is better for treating skin disease with itching and pain than drugs that already exist 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 medications, secukinumab (Cosentyx) and adalimumab (Humira), said Dr. Mark Lebwohl, co-researcher in one of the clinical trials.
“We have never had any drug that in its phase 3 trials has reached more than 50% of patients” with a 100% reduction symptoms of psoriasis, said Lebwohl, dean of clinical therapy at the Icahn School of Medicine in Mount Sinai, New York City.
“We are now at a time when we can eliminate the vast majority of psoriasis patients with very effective and very safe medications,” he added.
Based on these results, Lebwohl expects Belgian pharmaceutical company UCB Pharma to pursue the rapid approval of bimekizumab with the US Food and Drug Administration.
“I hope it’s on the market this summer,” he said.
Psoriasis affects more than eight million people in the United States, according to the National Psoriasis Foundation.
It is a autoimmune disease which accelerates the growth of skin cells, causing the cells to pile up on the surface of the skin and form plaques that itching, burn and chop. These plaques can appear on any part of the body, but are most often found on the elbows, knees, and scalp.
A proinflammatory biochemist 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, called IL-17A.
Bimekizumab blocks both IL-17A and another form of chemical called IL-17F, Lebwohl said. The injectable medicine is given once a month.
“Biology [of the two forms of IL-17] overlaps: 17A is more powerful, but 17F is more abundant, “Lebwohl said.” Although 17A is stronger when it comes to causing psoriasis, there are more than 17F. By blocking both, you will get the full effect “.
After 48 weeks of treatment, approximately 67% of patients with bimekizumab had a complete clearance of psoriasis plaques, compared with 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, with 478 patients, offered similar results. After 16 weeks, 86% of patients with bimekizumab had experienced a 90% reduction in their psoriasis plaques, almost double the 47% who achieved the same response with adalimumab.
“They block IL-17A, while this blocks both IL-17A and IL-17F,” Lebwohl said. “That’s probably why it’s so effective. Blocking that little bit of IL-17 will actually get you added 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 ten times more likely to reduce symptoms of arthritis than a placebo group, with increasing response with dose size, according to the results published in The Lancet.
IL-17 blockade causes a higher risk of yeast infection and the risk is stronger with bimekizumab than the other two drugs, according to the results.
“Nature has done an experiment for us by giving us people who have IL-17 deficiency and have terrible 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,” he said.
However, Green sounded a cautionary note and urged further study of the drug.
“A larger sample size needs to be used because, in addition to candidiasis, interleukin inhibitors have been associated with higher rates of other opportunistic infections, severe infections, and cancer,” Green said.
The results of the clinical trial were published on April 23 in New England Journal of Medicine, and were also presented at an online meeting of the American Academy of Dermatology.
UCB Pharma funded both trials.
The National Psoriasis Foundation has more information psoriasis.
SOURCES: Mark Lebwohl, MD, Dean of Clinical Therapy, Icahn School of Medicine at Mount Sinai, New York; Michele Green, MD, dermatologist, Lenox Hill Hospital, New York; New England Journal of Medicine, April 23, 2021