Dupilumab Shows Long-Term Safety in Atopic Dermatitis Treatment
A recent analysis of over 6,000 patients with moderate-to-severe atopic dermatitis (AD), both pediatric and adult, has shown that dupilumab is safe and well-tolerated for up to five years of treatment.
This importent details was presented at the revolutionizing Atopic Dermatitis Conference Mid-Year Virtual update on December 8, 2024. The study, titled “Integrated safety of dupilumab up to 5 years for the treatment of moderate‑to‑severe atopic dermatitis in infants, children, adolescents, and adults,” was authored in part by Dr. Richard Langley from Dalhousie University’s department of medicine.
The analysis examined data from eight phase 3 clinical trials evaluating dupilumab’s effectiveness in treating AD. These trials included both randomized, double-blind, placebo-controlled studies and open-label extension trials, encompassing a range of ages and treatment durations. Dupilumab was originally approved by the U.S. Food and drug Governance (FDA) for AD in 2017.
Understanding the Need for Long-Term Safety Data
As Dr. Langley and his colleagues emphasized, “Atopic dermatitis (AD) is a chronic pruritic and inflammatory disease that is highly prevalent in both adult and pediatric patients and requires long-term treatment; thus, safety is an critically important consideration for physicians and patients/caregivers when making decisions on treatment options.”
primarily on safety
The team investigated adverse events (AEs) in patients receiving dupilumab with or without topical corticosteroids. They found that dupilumab exposure exceeded 7,000 patient-years across the studies, with the longest documented use of the drug reaching 1,938 days in the adult open-label extension study.
Long-Term Safety of Dupilumab for Atopic Dermatitis Confirmed in New Analysis
new research confirms the long-term safety of dupilumab, a medication used to treat moderate-to-severe atopic dermatitis (eczema). The analysis, presented at the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update, evaluated data from clinical trials involving infants, children, adolescents, and adults treated with dupilumab for up to five years.
Safety Profile Comparable or Better Than Placebo
The study found that treatment-emergent adverse events (TEAEs) in patients taking dupilumab were generally comparable to or lower than those observed in individuals receiving a placebo across all age groups. serious adverse events, including infections and various skin conditions, were also less frequent in the dupilumab group compared to the placebo group.
Specifically, the 16-week trials showed serious TEAEs in 0.8% of infants and children taking dupilumab compared to 3.0% in the placebo group. Similar trends were observed in adults and adolescents, with rates of 2.0-2.2% for dupilumab versus 4.6% for placebo in the 16-week trials. the 52-week trials showed comparable results: 3.2-3.6% for dupilumab versus 5.1% for placebo.
Most TEAEs were mild to moderate and did not require treatment discontinuation. While conjunctivitis and injection site reactions were more common in the dupilumab group, no anaphylactic reactions were associated with the medication.
Confirming Previous Findings
“This complete analysis of pediatric and adult patients with moderate-to-severe atopic dermatitis treated with dupilumab for up to 5 years confirms that dupilumab is well tolerated, with an acceptable safety profile across all age groups,” concluded the research team. These findings align with previous safety data from shorter-term studies.
About Dupilumab
Dupilumab was initially approved by the U.S. Food and Drug administration (FDA) in March 2017 for the treatment of moderate-to-severe atopic dermatitis in adults.
