What health issue did this study examine?
Researchers are studying a potential new treatment option for moderate-to-severe eczema. The drug is called dupilumab. It belongs to a class of drugs known as biologics. Dupilumab is thought to work by blocking the inflammation that causes eczema, or atopic dermatitis.
What do we know about this issue so far?
There is no cure for eczema. In extreme cases, it can cause bleeding and infections, affect sleep, and hurt one’s quality of life. Current treatment options include skin moisturizers, topical steroids and immune modulators.
What question did researchers try to answer?
In the latest study, researchers sought to determine:
- how well did dupilumab clear patients’ skin lesions compared to placebo (no active treatment)
- how safe was the treatment
Who did the study include?
The study enrolled a total of 1,379 adult patients into different treatment regimes.
For these adult patients, current skin medications either did not work well, or they could not take them.
What methods did the researchers use?
Researchers randomly assigned patients into different groups. Some patients received the active drug and some people received a placebo (no active treatment). In these studies, dosages ranged from 300 milligram (mg) to 600 mg. The drug was given by injection once a week or every other week.
What did the researchers find?
Overall, there was significant improvement. Patients on the drug did better than patients receiving no active treatment. This was true in all groups: 36-38% of subjects on the weekly dose or biweekly dose of the study achieved the endpoint of clear or almost clear, as compared to 8.5-10% in placebo groups.
What does this study mean for me?
This was a late-stage study. This type of study is usually one of the last conducted before a drug company seeks FDA approval. The FDA granted dupilumab “breakthrough therapy designation” in 2014. The special designation is given when a comparable treatment option does not currently exist.
Biotechnology company Regeneron Pharmaceuticals developed the drug. If the drug is approved by the FDA, it will be sold by Sanofi. The companies plan to seek formal FDA approval for the drug later this year.
The drug is also being studied for severe asthma, eosinophilic esophagitis, and nasal polyps in people with chronic sinusitis.
If you have moderate-to-severe eczema, dupilumab would be the first biologic drug designed for eczema that works throughout the body to reduce inflammation.