While it is common for the most side effects of a new medication to be reported during the clinical trial phase of medication development, there may be more side effects discovered later as medications become available to a greater number of people. Sometimes these side effects are dangerous and can lead to a medication being taken off the market. More often, these side effects are milder and easily treated.
Common side effects of Dupixent
On March 28, 2017, the United States Food and Drug Administration (FDA) approved the use of Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis (AD), in patients not otherwise controlled by topical prescriptions.1 At the time of the approval of Dupixent, the medication had been tested in three trials that reached over 2000 patients.2 At the time the medication was released there were some common side effects documented by researchers. These effects included cold sores, eye inflammation (including pink eye and inflammation of the cornea), and injection site reactions.
Flares in new locations
Dermatology researchers at the University of Stanford recently looked at the medical records of AD patients taking Dupixent and noticed a trend in a newly reported side effect. They discovered that approximately 25% of patients who received Dupixent to treat AD had outbreaks of dermatitis in a new region of their body other than the original site of the patient’s AD.3 Researchers were looking at outbreaks on patients who had been treated with Dupixent without any interruption in therapy, and which had occurred after a patient’s initial AD outbreak had responded to Dupixent. Researchers were also looking for secondary outbreaks that did not respond to usual topical treatments, and that couldn’t be explained by another disease process.3
While there were only 73 patients reviewed in this study, 17 of these patients (about 23%) had secondary outbreaks in a new region of their body.3 All 17 of these patients reported having childhood AD, and seven of them had autoimmune diseases (about 40% of the patients). Fourteen of these patients reported secondary outbreaks in the facial regions, 11 were treated successfully with topical corticosteroids, and 4 patients discontinued Dupixent due to the secondary outbreak.3
What do the researchers think?
The dermatology researchers believed that most of the facial outbreaks were related to allergic contact dermatitis, which can be tested by a simple patch test.3 The researchers believe that the patients who had secondary outbreaks on the facial area may have always had allergic contact dermatitis, but that is usually controlled by their immune system. When patients are treated with Dupixent, their immune system becomes suppressed, making them more susceptible to allergic contact dermatitis outbreaks. This theory, however, would not explain all of the secondary outbreak cases. The researchers believe that there are other immune factors that may be causing these outbreaks.
Is it significant?
While this study was rather small, it did give some significant information about new side effects of Dupixent. Researchers will need to look at larger populations of patients taking Dupixent to see if there are other factors that may have caused these secondary outbreaks, such as environmental factors or other secondary factors. It is important to remember in studies such as these that even though there is a correlation between Dupixent and secondary AD outbreaks, this doesn’t mean that the Dupixent is causing the outbreaks. More research is needed on the cause of secondary AD outbreaks.
Finding new side effects
As Dupixent continues to be used, more trends in side effects will continue to be followed, both by researchers and the FDA. These may change over time, so if you or someone you love is treated with Dupixent, be sure to speak with your medical team about any new side effects that you may experience. Your team will help you decide if the benefit of continued treatment will outweigh any risks of side effects you may encounter.
FDA Approves Dupixent (dupilumab) for Eczema. Drugs.com. https://www.drugs.com/newdrugs/fda-approves-dupixent-dupilumab-eczema-4505.html. Published 2019. Accessed June 11, 2019.
Zhu GA, Chen JK, Chiou A, Ko J, Honari G. Assessment of the Development of New Regional Dermatoses in Patients Treated for Atopic Dermatitis With Dupilumab. JAMA Dermatol. Published online May 01, 2019. doi:10.1001/jamadermatol.2019.0109