Patients could soon have access to a new injectable drug to treat atopic dermatitis, the most common form of eczema.
The drug, lebrikizumab, proved effectivein teenagers and adults in two clinical trials just published in the New England Journal of Medicine.
"Across both of these pivotal studies for atopic dermatitis, lebrikizumab was highly effective, with a subset of patients responding quite early and then experiencing very durable responses up until week 16 in the initial phase of the study," said lead researcher Dr. Jonathan Silverberg. He is an associate professor of dermatology at George Washington University School of Medicine & Health Sciences in Washington, D.C.
Subsequent data has shown a good response among patients out to a year, he added.
Based on these results, the U.S. Food and Drug Administration could approve lebrikizumab within a matter of months, Silverberg said.
"We're hoping that by mid-2023 that this will be FDA-approved and available to us to use, which is very exciting to have another highly effective option on the horizon," he said.
Lebrikizumab is an injectable monoclonal antibody designed to target interleukin-13, a biochemical expressed by immune cells that promotes an inflammatory response in the body.
"It increases inflammation within the skin. It can increase or amplify the sensation of itch," Silverberg said of interleukin-13. "And it also can lead to disruption of the skin barrier, which will then contribute to the dryness and vulnerability to skin bacteria and other outside world triggers."
The drug's method of action is similar to that of two other injectable biologic medications, dupilumab (Dupixent) and tralokinumab (Adtralza), that also target immune signaling chemicals that contribute to atopic dermatitis, said Dr. Lauren Eckert Ploch, a dermatologist in Augusta, Ga.
All three drugs are aimed at treating people with moderate to severe atopic dermatitis.
Atopic dermatitis affects about 20% of children and up to 7% of adults worldwide, the study authors said in background notes.
The condition causes itchy, patchy, scaly skin that is easily irritated, according to the American Academy of Dermatology (AAD).
"Most won't have moderate to severe disease requiring this type of advanced therapy," Silverberg said. "But we're talking about in total somewhere around 30 million children and adults in the United States with eczema, and maybe upwards of 2 million that could even be eligible for advanced therapy, perhaps more."
Silverberg and his colleagues recruited two groups of patients to participate in a pair of identically designed drug trials.
In the first trial, the team randomly assigned 283 patients to the lebrikizumab group and 141 patients to the placebo group. For the second trial, 281 patients got lebrikizumab and 146 patients got placebo.
All of the patients got one shot every two weeks. They all went through a 16-week induction period followed by a 36-week maintenance period.
By week 16, 43% of lebrikizumab patients in the first trial and 33% in the second had clear or almost clear skin, compared with 13% and 11% of the placebo groups, the results showed.
Lebrikizumab also produced at least a 75% improvement in eczema area and severity in 59% of trial one participants and 52% of those in trial two, the researchers reported.
"The efficacy is certainly on par at the very least with the efficacy of those other medications," Silverberg said. "I think ultimately we will have a better sense of the comparative effectiveness between the various medications from real-world use once it's FDA approved."
The NEJM report did not cover the full year's results of treatment, but the data show that the effects last past the induction period, he said.
The drug produced no serious adverse events, Silverberg said.
The most common side effect was redness or itchiness around the eye, as with other medications that target interleukin-13, Ploch said.
"At this point, there is only anecdotal data about which of the three medications I mentioned above cause less conjunctivitis than the others," she said. "I'm looking forward to more studies comparing this."
Ploch said she also looks forward to having lebrikizumab available as a treatment option for atopic dermatitis.
"I'm always happy when new medications are developed because I want my patients to have a myriad of options when treating atopic dermatitis," she said. "Also, competition is good for pricing and availability for patients."
Silverberg presented the findings, which were published online March 15, on Friday at an AAD meeting in New Orleans.
Dermira, a subsidiary of Eli Lilly, developed the drug and sponsored the two clinical trials. The company also designed the trials and analyzed the data.