After investigating the reactions associated with dupilumab — a treatment for atopic dermatitis (AD)— researchers found that the most common adverse reactions are ocular complications. The findings were published in the Journal of the American Academy of Dermatology.
AD is among the most common inflammatory skin diseases and can cause aesthetic, physical, and emotional issues if untreated. Through multiple phase III clinical trials, dupilumab, a human monoclonal antibody, was approved by the United States Food and Drug Administration (FDA) to treat mild to severe AD. Despite these clinical trials, there is still a shortage of data on the long-term adverse events and immune-modulating effects associated with the drug, according to investigators.
The research team analyzed the FDA’s Adverse Event Reporting (FAERS) database for common adverse reactions associated with dupilumab. They found the most common adverse reactions associated with dupilumab are ocular complications, including conjunctivitis (4.96%), eye pruritus (4.95%), ocular hyperemia (4.30%), dry eye (3.87%), eye irritation (3.06%), and increased lacrimation (2.80%). In all of the clinical trials analyzed, patients receiving dupilumab had a significant increase in conjunctivitis (8.6% to 22.1%) vs the placebo group (2.1% to 11.1%). Further, patients with more severe baseline AD are more likely to develop conjunctivitis and other ocular complications, according to the study. However, researchers noted that patients who receive dupilumab to treat asthma don’t have a higher rate of conjunctivitis (0% to 1.7%) than with placebo (0% to 3.3%), which suggests that an interaction between AD and dupilumab causes ocular complications.
While it’s unclear why these ocular complications occur, reasons may include that dupilumab treatment unmasks pre-existing atopic or allergic ocular inflammation, causes a failure in tear production, or causes a local immunosuppressant effect that increases bacterial and viral infection. Most ocular complications associated with dupilumab are mild and have been shown to improve within 2 months of finishing a course of the medication, according to the findings. However, some adverse effects are severe enough to warrant the early discontinuation of the medication.
Limitations of this study include that prescribing information for dupilumab was not available and that adverse effects were reported by patients, health care providers, and pharmaceutical companies and were not corroborated.
Wang Y, Jorizzo JL. Retrospective analysis of adverse events with dupilumab reported to the United States Food and Drug Administration. J Am Acad Dermatol. 2021;84(4):1010-1014. doi:10.1016/j.jaad.2020.11.042.