Dupilumab in Patients With Chronic Spontaneous Urticaria: Phase 3 LIBERTY-CSU CUPID Randomized Clinical Trials

Area of Science:

• Immunology
• Dermatology
• Clinical Trials

Background:

• Chronic spontaneous urticaria (CSU) is an inflammatory skin condition causing hives and angioedema.
• Many CSU patients remain symptomatic despite standard histamine 1-receptor antagonist (H1-AH) treatment.
• Dupilumab targets IL-4/IL-13 signaling, relevant in type 2 inflammatory diseases.

Purpose of the Study:

• To evaluate dupilumab's efficacy and safety versus placebo in CSU patients uncontrolled by H1-AH.
• To replicate findings from the CUPID-A trial as per regulatory requirements.

Main Methods:

• A 24-week, randomized, placebo-controlled, double-blind phase 3 trial (CUPID-C) was conducted.
• Participants were anti-IgE-naive patients aged 6-80 years with CSU uncontrolled by H1-AH.
• Primary outcomes included changes in Itch Severity Score (ISS7) and Urticaria Activity Score (UAS7) at week 24.

Main Results:

• Dupilumab showed significant improvements in ISS7 and UAS7 compared to placebo at 24 weeks.
• Pooled analysis of CUPID-A and CUPID-C (289 participants) demonstrated enhanced efficacy.
• Adverse events were consistent with dupilumab's known safety profile.

Conclusions:

• The CUPID-C trial confirmed dupilumab's efficacy in reducing itch and hives severity in CSU.
• Dupilumab offers a significant treatment option for CSU patients symptomatic despite H1-AH therapy.
• Pooled data reinforce dupilumab's role in managing inadequately controlled CSU.