There’s hope around the corner for those who suffer from eczema, an infuriatingly itchy skin condition with no cure and little consensus on the best course of treatment.
The inflammatory skin condition has been historically difficult to treat because the medicines on the market just aren’t that effective, especially for moderate to severe cases. They also have serious side effects and can be toxic.
But now a new medicine called Dupilumab has shown great promise in current clinical trials. Up to 38 percent of trial participants were completely cleared or almost cleared of their inflamed red and scaly skin patches after a 16-week course of treatment. As a group, they experienced significant decreases in itchiness, severity of rash and improvements in depression, anxiety and quality of life.
The medicine, which can be self-administered via injection, had already been designated a “breakthrough therapy” by the FDA, which means it’s on the fast-track to government approval.
An estimated three percent of all U.S. adults have moderate to severe eczema that requires systemic therapy, according to the National Eczema Association. And because there is no reliably safe, convenient and effective way to treat their skin lesions, the need for something like Dupilumab is huge ― especially if long-term trials validate its safety.
Oregon Health & Science University researcher Dr. Eric Simpson, lead investigator of the phase three clinical trial, said that if all goes well, the FDA will make their decision on Dupilumab by the end of March. If approved, the drug, which is made by Sanofi and Regeneron, will hit the market shortly after that.
How fast is this track? Typically, new drugs can take up to two years to approve after a successful phase three trial.
What the trials showed
Simpson and co-investigators from around the world conducted two independent, randomized and double-blind trials to test Dupilumab in a total of 1,379 participants with moderate to severe atopic dermatitis, which is the most common form of eczema.
The subjects were randomized into three groups: those who received a placebo injection, those who received weekly Dupilumab shots, and those who received Dupilumab shots every other week.
At the end of 16 weeks, researchers in both trials found that 36 to 38 percent of the participants who received the weekly or fortnightly shot either saw eczema lesions completely cleared from their body, or saw almost all of them cleared.
And even if a participant didn’t experience complete remission of their symptoms, on average, those who received the real medicine saw a significant decrease in the surface area of their skin lesions, as well as decreased itchiness, swelling, thickness and redness of the skin.
The psychological benefits were just as striking
The drug also had a significant impact on patients’ psychological state.
Serious eczema can lead to profound misery in people who have the condition. They sometimes experience social isolation because others don’t understand that eczema isn’t contagious. The itch can be so intense that people struggle to sleep or concentrate at work or school. But trial participants who received the real medicine reported improvements in sleep, anxiety, depression and quality of life after going through the trial.
“When you have the disease in a moderate to severe way, it really affects every aspect of your life,” said Dr. Emma Guttman-Yassky, a professor of dermatology and immunology at the Icahn School of Medicine in New York, and one of the investigators that recruited and cared for participants in the trial.
“We heard many times that patients even considered suicide because their disease was so bad. Some said they were about to destroy their marriage, and one patient was about to close his law office,” she continued. “But this drug basically enabled them to have a life.”
The status quo for eczema patients
Currently, people with moderate to severe eczema have only a few options for treatment, and they’re either extremely toxic, have serious side effects or are very inconvenient.
Phototherapy uses ultraviolet rays to help improve skin symptoms, but patients have to access the treatment by visiting a clinic at least a few times a week — making it very difficult for full-time workers or students to fit therapy into their schedule. Another drawback is that some patients can’t tolerate the heat and sweating caused by phototherapy units.
Oral steroids, which are another way to control symptoms, produce side effects like severe mood swings, personality change, extreme fatigue, low sex drive and changes in body fat distribution. Guttman-Yassky also noted that if a patient stops oral steroids, the eczema symptoms rebound with a vengeance ― so much so that she doesn’t bother prescribing this medication anymore.
Immunosuppressants are another way to combat eczema symptoms, but they are toxic and can cause an increased risk of certain kinds of cancers and kidney and liver damage.
How Dupilumab works
Dupilumab targets a single axis in the immune system that contributes to the development of eczema. It is a biologic therapy, which means it is made of substances derived from living organisms, and in this case those substances are used to alter the body’s immune system. In contrast, Simpson explained, the immunosuppressants that are currently available to eczema patients depress the entire immune system.
“The data shows so far that [Dupilumab] is not going to have any toxicity on any organ,” said Simpson. “And with the more targeted treatment, the thought is that you’re suppressing less of the immune system, so you’re not at risk for any immune suppression side effects like infections.”
Although the trials don’t indicate whether Dupilumab should be taken for the rest of a person’s life or for only a short period of time, Guttman-Yassky predicts that because eczema is a lifelong disease, the medicine will require lifelong administration.
“Not only are we excited about the drug because we think it’ll be wonderful for our patients, but I think it’ll open the door for more therapeutic development,” she concluded. “We saw with psoriasis that once you have one successful drug, you’ll have others.”