Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) to treat adults and adolescents with chronic spontaneous urticaria (CSU) who are 12 years of age or older and who continue to experience symptoms after taking histamine-1 (H1) antihistamines.
People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease.
Kenneth Mendez
CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living. This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.
Alyssa Johnsen
The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which evaluated Dupixent as an adjuvant therapy to standard-of-care antihistamines, as opposed to antihistamines alone, and included biologic-naïve patients aged 12 years and older who were symptomatic despite using antihistamines. At 24 weeks, Dupixent showed reductions in urticaria activity (a composite of itching and hives) and itch severity when compared to placebo. Both studies achieved their primary and important secondary objectives. When compared to a placebo at 24 weeks, dupixent also raised the chance of a fully recovered or well-controlled illness. Additional safety information was supplied by Study B (n=108), which assessed Dupixent in patients 12 years of age and older who were either intolerant to anti-IgE or inadequate responders.
The established safety profile of Dupixent in its recognized indications was mostly supported by the safety findings from Studies A, B, and C. Injection site reactions were the most prevalent adverse event (≥2%) seen in individuals taking Dupixent as opposed to a placebo, according to the combined data from the three trials.
Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease. With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.
George D. Yancopoulus
Dupixent CSU Phase 3 Study Program
Studies A, B, and C make up the LIBERTY-CUPID phase 3 program that is assessing Dupixent for CSU. The effectiveness and safety of Dupixent as an adjuvant treatment to standard-of-care antihistamines were assessed in these randomized, double-blind, placebo-controlled clinical trials in comparison to antihistamines alone. Patients six years of age and older who continued to have symptoms after taking antihistamines were evaluated in replication trials A and C. Patients 12 years of age and older who had symptoms despite taking antihistamines and were either intolerant of or insufficiently responsive to anti-IgE medication were the subjects of Study B. With the exception of pediatric patients weighing less than 60 kg, who received 200 mg every two weeks, patients in all three trials received an initial loading dosage and then 300 mg of Dupixent every two weeks for the duration of the 24-week treatment period.
The primary endpoint in each of the three studies evaluated the change in itching from baseline at 24 weeks, as determined by the weekly itch severity score on a scale of 0 to 21. Change from baseline in itching and hives (weekly urticaria activity score [UAS7], 0-42 scale) was one of the primary secondary outcomes (also evaluated at 24 weeks). The percentage of patients who achieved well-controlled illness state (UAS7 ≤6) and the percentage of patients who had a complete response (UAS7=0) were examined by additional secondary endpoints measured at 24 weeks.
The results of the study were published in the journal The Journal of Allergy and Clinical Immunology.
Dupixent (dupilumab) is a subcutaneous injection that is given at various injection locations beneath the skin. Dupixent 300 mg is given every two weeks following an initial loading dose to people with CSU who continue to exhibit symptoms after receiving H1 antihistamine therapy. After an initial loading dosage, Dupixent is given every two weeks based on weight (200 mg for adolescents ≥30 to <60 kg, 300 mg for adolescents ≥60 kg) to patients with CSU who are 12 to 17 years old and still exhibiting symptoms after receiving H1 antihistamine medication. Dupixent can be administered in a clinic or at home following instructions by a healthcare provider, and it is meant to be used under their supervision. Adolescents between the ages of 12 and 17 should only take Dupixent under an adult’s supervision. Dupixent is a completely human monoclonal antibody that does not suppress the immune system; rather, it blocks the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways. IL4 and IL13 are two of the main and central drivers of type 2 inflammation, which is a major factor in a number of related and frequently co-morbid disorders. Phase 3 studies of the Dupixent development program have demonstrated a significant therapeutic benefit and a decrease in type 2 inflammation.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
