Sanofi and Regeneron’s interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor Dupixent has demonstrated positive pivotal results in chronic spontaneous urticaria (CSU) – a chronic inflammatory skin disease.

The Phase III trial evaluating Dupixent (dupilumab) in patients with moderate-to-severe CSU met its primary and all key secondary endpoints, with the IL-4/IL-13 inhibitor significantly reducing itch and hives for biologic-naive patients when added to standard-of-care.

Specifically, adding Dupixent to standard-of-care antihistamines reduced itch severity by 63% compared with placebo, as measured by a 0-21 point itch severity scale.

On top of that, Dupixent plus standard-of-care led to a 65% reduction in urticaria activity (itch and hive) severity versus 37% with placebo, according to a 0-42 point urticaria activity scale.

CSU is characterised by the sudden onset of hives on the skin and swelling deep under the skin – this swelling can often occur on the face, hand and feet, and can also affect the throat and upper airways.

Although the condition is typically treated with antihistamines, the disease remains uncontrolled for up to 50% of patients who have limited treatment options.

"[This] data add[s] to the increasing body of evidence that Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases,” said George D. Yancopoulos, president and chief scientific officer at Regeneron.

“By early 2022, we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well as other trial results in additional dermatologic diseases,” he added.

In a statement, the companies said CSU is the fifth disease for which Dupixent has positive Phase III data, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis.