According to a news release from the U.S. Food and Drug Administration (FDA) in early November 2022, Dupixent (dupilumab) is now approved for the treatment of adults living with prurigo nodularis, a chronic skin disorder.
Dupixent is an injectable biologic treatment, administered subcutaneously, that targets underlying drivers of inflammation. Outside of its approval within this realm, Dupixent is also approved for a number of other conditions. These include chronic rhinosinusitis with nasal polyposis, atopic dermatitis, and eosinophilic esophagitis (EoE). Generally, Dupixent is relatively safe and well-tolerated. In individuals with prurigo nodularis, common side effects related to Dupixent include blurry vision, injection site reactions, inflammation of the eye(s) and eyelid(s), nasopharyngitis, dizziness, diarrhea, throat discomfort, muscle and joint pain, and herpes simplex virus (HSV) infections. Learn more about Dupixent here.
The Dupixent approval for prurigo nodularis hinged on data from the PRIME and PRIME2 clinical studies. Within the studies, researchers analyzed safety, tolerabiity, and efficacy. Patients received 300mg Dupixent every 2 weeks after an initial loading dose of 600mg. They were then evaluated over a 24-week period.
What is Prurigo Nodularis?
The National Organization for Rare Disorders (NORD) describes prurigo nodularis as:
A chronic inflammatory skin disease where an extremely itchy, symmetrically distributed rash appears most commonly on the arms, legs, the upper back and/or the abdomen. The itch associated with PN is so severe that it often interferes with sleep and psychological wellbeing.
Currently, doctors and researchers don’t know the exact cause of prurigo nodularis. However, it is hypothesized that this disorder results from immune and nerve dysregulation in the skin. Researchers believe that this altered function and dysregulation could enhance sensations of itchiness. As people scratch, pick, and itch, the skin lesions thicken and firm bumps (nodules) form. This skin disorder is more common in those between ages 40 to 69, the elderly, women, and those of African American descent. It is also more prevalent in those with HIV, as well as people with other pruritic skin conditions.
Prurigo nodularis causes the development of a rash which varies in appearance between patients. It’s believed that excessive, chronic scratching causes the rash. Symptoms and characteristics include:
- A rash with several or a few hundred lesions ranging from 0.5-2cm in size
- Firm, dome-shaped papules, nodules, or plaques
- Intense itchiness that lasts longer than 6 weeks
- Thickened skin
- Itchiness that worsens with stress, heat, and sweating
- Skin burning or stinging