Dupilumab Proves Effective in Chronic Spontaneous Urticaria

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Fundamental reduction in hives and itch in antihistamine-resistant patients

by
Mike Bassett, Workers Creator, MedPage Currently

October 27, 2024

BOSTON — Add-on dupilumab (Dupixent) enormously reduced itching and urticaria in patients with persistent spontaneous urticaria (CSU) whose indicators had been uncontrolled with H1-antihistamine therapy.

The portion III LIBERTY-CUPID stumble on C showed that amongst early life and adults randomized to receive both dupilumab or placebo added to usual-of-care (SoC) H1 antihistamines, these receiving dupilumab experienced an 8.64-point reduction in itch severity versus a 6.10-point reduction with placebo (-2.5 distinction, P=0.02) from baseline to week 24, reported Thomas B. Casale, MD, of the University of South Florida in Tampa. Itch severity used to be measured on the 21-point Itch Severity Earn over 7 days (ISS7; 21=severe itching every day of the week).

In addition, treatment with dupilumab resulted in a 15.86-point reduction in urticaria job (itch and hive) severity from baseline versus an 11.21-point reduction with placebo (-4.7 distinction, P=0.02), per the 42-point Urticaria Process Earn over 7 days (UAS7; rankings 28-42 over 7 days=severe urticaria).

In a presentation at the American College of Allergy, Bronchial asthma & Immunology annual meeting, Casale highlighted that the tips at week 24 showed that just about about twice as many patients had a UAS7 rating of ≤6 (40.5% with dupilumab vs 23.5% with placebo), “meaning successfully-controlled urticaria. And if you gape even extra at patients who had a UAS7 rating of 0 — that is total remission — at 24 weeks you are taking a gape at about 30% with dupilumab versus 18% with placeb0. So, or not it is miles extremely reassuring knowledge that the predominant and secondary endpoints are being finished.”

Other folks with CSU make hives and/or angioedema, can experience intense itching, and absorb a low quality of lifestyles, Casale explained, with about half of patients unresponsive to SoC H1 antihistamines.

LIBERTY-CUPID stumble on C is designed to replicate LIBERTY-CUPID stumble on A, wherein dupilumab used to be shown to attenuate itch and hive severity in omalizumab (Xolair)-naive patients. Mediate about A supported the approval of dupilumab in Japan for the treatment of CSU in folks ages 12 years and older whose disease will not be adequately controlled with existing therapy.

Mediate about C will toughen regulatory resubmission in the U.S. per an FDA Full Response Letter requesting extra efficacy knowledge. If accredited, dupilumab might per chance well be the predominant focused therapy for CSU in a decade, per developer Sanofi.

The stumble on used to be a placebo-controlled, double-blind, 24-week portion III trial that included 151 patients, ages 6 years or older, who had been randomized to receive add-on dupilumab at 300 mg for adults and early life ≥60 kg, or 200 mg for early life <60 kg and early life ≥30 kg, or matching placebo subcutaneously every 2 weeks.

In response to Casale, the stumble on’s demographics “had been equal to almost every urticaria stumble on” the set up the predominant population used to be female (70%), with a median age of about forty five, and a BMI 27. The baseline ISS7 rating used to be 15.1, and baseline USA7 rating used to be 28.3. About half of patients had been receiving a usual dose of antihistamines, and the different half a 2-to-4-fold usual dose.

Security used to be usually per the identified security profile of dupilumab. Medication-emergent negative events (TEAEs) had been the identical for every teams (fifty three%), with nasopharyngitis being essentially the most total (8.1% with dupilumab and 5.2% with placebo). Injection jam erythema used to be considered in 5.4% of patients in the dupilumab team. Severe TEAEs occurred in three patients in the dupilumab team and one in the placebo team, while serious TEAEs occurred in 5 patients in the dupilumab team and one on placebo.