- About 2% of the world’s population has the chronic inflammatory skin disease eczema.
- Researchers from the Icahn School of Medicine at Mount Sinai in New York report that a new eczema treatment rocatinlimab helped lower symptoms in people with moderate to severe atopic dermatitis.
- Scientists said they also found participants maintained their improved symptoms for at least 20 weeks after stopping treatment.
The chronic inflammatory skin disease atopic dermatitis — also known as eczema — affects about 2% of the global population.
Although there are some treatment options available for people with eczema, they do not always work for every person and can also have side effects. There is currently no cure for atopic dermatitis.
Now researchers from the Icahn School of Medicine at Mount Sinai in New York report promising results from a clinical trial of rocatinlimab — a new monoclonal antibody therapy — for the treatment of moderate to severe atopic dermatitis.
The study was recently published in the journal The Lancet.
What is rocatinlimab?
Rocatinlimab (KHK4083/AMG 451) is a new drug developed in collaboration by Kyowa Kirin US Research and the La Jolla Institute for Immunology in San Diego.
The drug is an anti-OX40 human monoclonal antibody. A monoclonal antibody contains a human-made protein designed to attack a specific target, called an antigen. When placed into the body, the monoclonal antibody binds to its antigen. In the case of rocatinlimab, binding inhibits the OX40 pathway.
Monoclonal antibody treatments are currently being used to treat certain conditions such as COVID-19 and certain cancers. They are also being researched to treat other diseases, including Alzheimer’s disease.
Rocatinlimab works by stopping and lowering the amount of OX40-expressing T cells in the body that cause inflammation.
“It inhibits and reduces activated T lymphocytes, and particularly those that are related to allergic inflammation,” said Dr. Emma Guttman, a professor and system chair in the Kimberly and Eric J. Waldman Department of Dermatology as well as director of the Center of Excellence in Eczema and director of the Laboratory of Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai.
She was also the lead author of this study.
Results from eczema treatment study
During the clinical trial, Guttman and her team administered either rocatinlimab or a placebo to 274 adults with moderate to severe atopic dermatitis. The trial was conducted at 65 sites in the United States, Japan, Canada, and Germany.
Sixteen weeks into the treatment, researchers said they discovered that participants who received rocatinlimab showed statistically greater improvements in change from baseline in their Eczema Area and Severity Index (EASI) scores.
Additionally, scientists found those who received the treatment maintained the improved symptoms for at least 20 weeks after treatment ended.
“At week 36, all participants had been on the treatment for at least 18 weeks,” Guttman told Medical News Today. “By this time, we saw that while the drug achieved the primary endpoints in all doses versus the placebo, it’s also a drug that improves over time, which is really unusual and unique among currently available treatment options.”
“The mechanism of action suggested that as it inhibits the activated T-cells (it) also works on T regulatory cells, but we did not know until the study’s results came out so it was a great proof of concept of something that we were not sure (was) possible,” she added.
Researchers reported the most common side effects in the rocatinlimab group included fever, nasopharyngitis, chills, headache, canker sores, and nausea.
When will rocatinlimab be available?
Guttmansaidthey are now initiating phase 3 of the clinical trial process for rocatinlimab.
She believes it may become available for doctors to prescribe in 3 to 4 years.
“(The) next step is to get it into children and approve the drug. Plans are on the way (for a) phase 3 and an adolescent study,” she added.
The importance of new eczema treatments
Medical News Today also spoke with Dr. Peter Lio, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago, about this clinical trial.
“Importantly, this appears to not only significantly improve eczema when it is being administered, but they specifically pointed out that it may have a remittive effect. Even 20 weeks after stopping the medication, most patients were able to maintain their response,” he said. “This concept of disease modification — actually changing things for the better in a longer-term way — takes us one step closer to the elusive cure that we have been seeking.”
Lio emphasized how important new treatments are for people with atopic dermatitis.
“Even for the most powerful medications we have, we truly never see 100 percent of the patients get 100 percent clear,” he explained. “And, frankly, even if there were such a medication, there is no such thing as a medication without potential side effects, and we know that sometimes medications that are helping can cause side effects or safety issues that mean we have to discontinue them. Without other good options, it can be terrifying for patients — some of whom have been struggling for years — to hear that the one thing that has worked for them isn’t a good fit anymore.”
For the next steps in this research on rocatinlimab, Lio is interested to see what the phase 3 clinical trial data shows.
“These larger studies over longer periods of time really help us get a better sense of the efficacy — the speed of the response, the depth or magnitude of the response, and the durability of the response — the tolerability, and the safety of the medication,” he said.
“I am also eager to see how they further explore the possibility of a remittive effect,” Lio added. “While the results we have seen here are very positive, there is no doubt that some drugs do not pass muster in the final rounds of testing, so we know to remain cautiously optimistic.”
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