The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid.
Bullous pemphigoid is a rare autoimmune, skin disorder characterized by large blisters usually located on the arms, legs, or torso. In some patients, the mouth or genitals are also affected. The blisters may break open and form ulcers or open sores and increase risk of infection. Bullous pemphigoid usually occurs in older persons and is rare in young people.
Dupilumab is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways. The treatment is a subcutaneous injection administered every other week following an initial loading dose, and in combination with a tapering course of oral corticosteroids.
The approval is supported by results from the ADEPT clinical trial, a randomized, phase 2/3, double-blind, placebo-controlled study evaluating the efficacy and safety of dupilumab in adults with Bullous pemphigoid. A total of 106 patients were enrolled for a 52-week treatment period.
At a follow-up of 36 weeks, 18.3% of patients treated with dupilumab experienced sustained disease remission compared to 6.1% in the placebo group, meeting the primary endpoint of the study. Additionally, 38.3% of patients on dupilumab achieved clinically meaningful itch reduction compared to 10.5% in the placebo group. The median cumulative oral corticosteroid dose was 2.8 grams in the dupilumab group versus 4.1 grams in the placebo group.
In the elderly population, the most common adverse events were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One case of acute generalized exanthematous pustulosis was reported in the dupilumab group.
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To learn more about Bullous pemphigoid and other rare skin disorders, visit https://checkrare.com/diseases/skin-conditions/
