Dupilumab notably reduces hives and hitch in patients with chronic spontaneous urticaria: Study
USA: Results from a phase 3 trial revealed that dupilumab is well-tolerated and causes significant improvement in patients with H1 antihistamine-resistant chronic spontaneous urticaria (CSU). The findings of the trial were presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology and subsequently published in the Journal of Allergy and Clinical Immunology.
Chronic spontaneous urticaria (CSU) causes recurrent itchy hives and/or angioedema and significantly impacts the quality of life. Many patients experience a substantial disease burden despite treatment with recommended and escalated doses of H1 antihistamines. Considering this, Marcus Maurer, Charite-Universitatsmedizin Berlin, and colleagues aimed to evaluate the safety and efficacy of dupilumab in patients aged d >_6 years with CSU who remained symptomatic despite treatment with H1 antihistamines in LIBERTY-CSU CUPID Study A -- a randomized, placebo-controlled, 24-week, phase 3 trial.
The trial included patients on a standard or <_ 4-fold dose of antihistamines. They were randomized to receive add-on dupilumab (n 5 70) 300 mg (adults/adolescents >_ 60 kg) or 200 mg (adolescents < 60 kg/children >_ 30 kg) or matching placebo (n 5 68) subcutaneously every 2 weeks. change from baseline at Week 24 in Itch Severity Score over 7 days (ISS7) was the primary endpoint. Key secondary endpoints included Urticaria Activity Score over 7 days (UAS7).
Key findings of the study include:
- Baseline characteristics were generally balanced across treatment groups.
- Mean ISS7 and UAS7 (dupilumab/placebo) at baseline were 16.1/15.7 and 31.9/30.8, respectively.
- At Week 24, least squares (LS) mean change in ISS7 (range:0-21) from baseline was -10.2/-6.0 for dupilumab/placebo, respectively (LS mean difference -4.2, P50.0005) and for UAS7 (range:0-42) was -20.5/-12.0 (difference -8.5).
- Overall treatment-emergent adverse events (TEAEs) were comparable between dupilumab and placebo: 35 (50.0%)/40 (58.8%); occurrence of injection site reactions was 8 (11.4%)/9 (13.2%), conjunctivitis 0/1 (1.5%), and serious TEAEs 2 (2.9%)/5 (7.4%).
The researchers conclude, "dupilumab demonstrated clinically meaningful and statistically significant improvements in patients with H1 antihistamine- resistant CSU and was well tolerated."
Reference:
The study titled, "Dupilumab Significantly Reduces Itch and Hives in Patients With Chronic Spontaneous Urticaria: Results From a Phase 3 Trial (LIBERTY-CSU CUPID Study A)," was published in the Journal of Allergy and Clinical Immunology.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.