Phase I and Phase II clinical research has identified biomarkers for current, non-specific treatments for atopic dermatitis, suggesting that earlier diagnosis and treatment of the inflammatory skin disease are within reach.
A dramatic new improvement in treating eczema may be just five years away. So says Dr. Emma Guttman-Yassky, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York.
Yassky is one of several researchers conducting Phase I and Phase II clinical trials of new drug treatments that target eczema, also called atopic dermatitis (AD), a complex inflammatory skin disease.
Pointing out that four to seven percent of the adult population worldwide has AD, and that 15 to 20 percent of children have AD, Yassky told Healthline, “One third of those have moderate to severe disease, so it’s a huge number.”
The percentage of patients diagnosed with AD has increased over time, partly due to “more awareness, but also an increase in incidence,” said Yassky.
Industrialized countries have had the greatest increase in AD, and Japan is at the top of the list, Yassky explained. The disease, which is also associated with genetic factors and family history, tends to flare up when a patient is under stress, as do many other diseases that reflect disturbance in the immune system.
Neal Patel knows the symptoms of AD all too well. His AD was initially severe in childhood, but went into remission at age twelve. The disease flared up again while he was in medical school. “I was losing sleep at night. I was so itchy,” Patel told Healthline.
Patel said that even exercising was challenging because he needed extra time to reapply a thick layer of petroleum jelly to be comfortable enough to work all day. Patel was motivated to do his own research, and that’s how he learned that Dr. Yassky was recruiting patients.
The Phase II study is double-blinded, so Yassky and Patel do not know if he is receiving the study drug or an inert placebo.
“The results were dramatic. One week into the trial, my skin cleared up and now I am itching less and I can go about my daily activities without consequences,” said Patel. He noted that thus far, he has not experienced adverse effects. The trial lasts 36 weeks.
Treatments for AD have been non-specific, and serious adverse effects are possible.
Treatments include creams and petroleum jelly (to help improve the skin’s protective barrier); antihistamines; drugs that suppress the whole immune system, such as prednisone (a steroid) or cyclosporine; and other topical treatments, including tacrolimus (an immunomodulator), and phototherapy (light treatment).
Adverse effects range from insomnia, weight gain, and mood problems from prednisone, to an increased risk of skin cancer and lymphoma from tacrolimus. None of these treatments is a good choice for continuous long-term treatment.
Yassky’s research has identified biomarkers for current, non-specific treatments for AD. Biomarkers are biological molecules that are a measurable sign of the body’s response to a treatment, and they help researchers evaluate the effectiveness of a new drug. The development of a new drug for AD may also lead to the discovery of treatment-specific biomarkers in the future. This means the disease may be more clearly identified and diagnosed, moving patients toward earlier diagnosis and treatment.
Yassky is participating in studies in several sites, some of which are being carried out in multiple medical centers at the same time. Her work has been supported by the National Institutes of Health (NIH) grant funding.
A recent publication describes discoveries she and her colleagues made, including the identification of new cytokines (proteins that affect inflammation), which are made by new types of T cells (white blood cells).
According to Yassky, since there are several pathways that may be triggering AD, several drug therapies targeted at those different pathways are all being studied. “It’s an exciting time for atopic dermatitis research,” she said, adding, “It’s hard to predict how long it may take to complete Phase III studies, but we will probably see new drugs available to treat AD in the next three to five years.”