In the United States alone, an estimated 300,000 people have moderate-to-severe chronic idiopathic urticaria (CIU), or chronic hives which are either recurrent or last for over 6 weeks, which fails to respond to antihistamine treatment. However, Dupixent (dupilumab) could be used to improve quality of life (QoL) for these patients; however this story does not discuss QoL endpoints specifically, as they have yet to be disclosed. According to a July 29 news release from biopharmaceutical company Sanofi and biotechnology company Regeneron Pharmaceuticals, Inc. (“Regeneron”), Dupixent achieved all primary and key secondary endpoints (at 24 weeks) in a Phase 3 clinical trial evaluating the treatment for patients with moderate-to-severe CIU.
The National Eczema Foundation describes Dupixent as an injectable biologic which:
works to inhibit two interleukins…IL-4 and IL-13, which can be produced by many cells of the immune system and have been found to contribute to the inflammatory processes and decreased barrier functions. By blocking IL-4 and IL-13 from binding to their cell receptors, dupilumab can lessen inflammation.
Regeneron developed Dupixent, a fully human monoclonal antibody, using its proprietary VelocImmune technology. In the past, researchers have explored IL-4 and IL-13 inhibitors in relation to asthma, eosinophilic esophagitis (EoE), and atopic dermatitis, among others. The treatment is even approved for patients with moderate-to-severe atopic dermatitis and asthma, as well as chronic rhinosinusitis with nasal polyposis (CRSwNP).
Most recently, researchers evaluated Dupixent for patients with CIU within Study A of the Phase 3 LIBERTY-CUPID trial. During the trial, 138 patients (aged 6+) enrolled. Despite taking antihistamines, their symptoms had not waned. To join the trial, patients also had to have never been treated with omalizumab.
Researchers wanted to determine the safety, efficacy, and tolerability of Dupixent in conjunction with antihistamines, as compared to antihistamine treatment alone. During the trial, endpoints included the change in itching and hives according to UAS7 score, and the change of itch severity according to ISS7 score. Findings from the trial include:
- Patients with CIU receiving both antihistamines and Dupixent saw a 63% reduction in itch severity. The severity of the hives and itch also greatly reduced by around 65%.
- Although some side effects did occur, Dupixent with antihistamines was relatively safe and well-tolerated. Though additional side effects have been observed in treatment, the most common effect seen during the trial was an injection site reaction.
Outside of the trial, Dupixent has been observed to cause a variety of potential side effects. These include:
- Eye and eyelid inflammation
- Cold sores
- Note: Dupixent treatment alone cannot cause cold sores. However, if you have HSV 1, Dupixent may cause an outbreak following treatment.
- Throat, tooth, and joint pain
- Difficulty sleeping
To learn more about Dupixent, head over to the Dupixent website.
Chronic Idiopathic Urticaria (CIU)
Chronic idiopathic urticaria (CIU), also sometimes called chronic spontaneous urticaria, is an unpredictable form of chronic hives. While there is no discernible cause, hence the “idiopathic” marker. Some doctors believe CIU could be the result of an autoimmune condition. CIU manifests as the sudden appearance of itchy hives or welts on the skin, or inflammation under the skin, which can last for weeks, months, or even years. Because of its nature, patients with CIU may experience “flares” without warning. However, certain triggers – such as infection, insect bites, temperature changes, or stress – could prompt these flares to occur. Women are 2x more likely to have CIU than men. Symptoms associated with CIU include:
- Moderate-to-severe itching
- Persistent pain or burning
- Face, hand, and feet inflammation
- Red or white welts on the body