Barzolvolimab Improves Urticaria Control and Quality of Life

Martin Metz, MD

Credit: Charite-Universitatsmedizin Berlin, Germany

Barzolvolimab treatment yielded marked and sustained improvements in urticaria control and quality of life in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines.¹

These findings, from a 52-week analysis of a Phase-2 trial (NCT05368285), were presented at the 2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress, February 28-March 3, in San Diego, California, by Martin Metz, MD, Deputy Director, Head of Translational Research and Clinical Studies, Institute of Allergology, Charite-Universitatsmedizin Berlin, Germany.

“Barzolvolimab (anti-KIT monoclonal antibody) demonstrated rapid and durable improvement in urticaria activity, with up to 71% of patients achieving complete response (UAS750) in the 52-week analysis of a Phase-2 trial in patients with CSU refractory to antihistamines (NCT05368285). Here we describe the impact of barzolvolimab treatment on Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI) at 52 weeks,” Metz and colleagues wrote.¹

Metz and Colleagues analyzed data from 208 patients in the double-blind, placebo-controlled trial, randomized to receive barzolvolimab SC at 75mg once every 4 weeks (Q4W), 150mg Q4W, 300mg Q8W, or placebo during a 16-week placebo-controlled treatment phase followed by 36 weeks of active treatment and 24 weeks of follow up. The placebo and 75mg Q4W dose groups were re-randomized to 150mg Q4W or 300mg Q8W during the active treatment period.¹

Participants in the 150mg Q4W groups had mean baseline UCT scores of 3.7 (standard deviation [SD], 2.5) and participants in the Q8W groups had mean baseline UCT scores of 3.0 (SD, 2.6), indicating poorly treated urticaria in both dosage groups. The investigators found that barzolvolimab improved UCT with a mean change from baseline at 52 weeks of 10.5 (SD, 3.9) in the Q4W groups and 9.4 (SD, 5.0) in the Q8W groups.¹

Participants in the 150mg Q4W groups had mean baseline DLQI scores of 15.7 (SD, 7.6) and participants in the 300 mg Q8W groups had mean baseline DLQI scores of 17.4 (SD, 7.5), indicating a very large impact of disease on QoL. The investigators found that barzolvolimab improved DLQI with a mean change from baseline at 52 weeks of -14.2 (SD, 7.3) in the 150mg Q4W groups and -15.0 (SD, 8.5) participants in the 300 mg Q8W groups.¹

Other research on urticaria presented at the AAAAI meeting was led by Thomas Casale, MD, from the University of South Florida, examined dupilumab on itch relief and urticaria activity by pooling results from 2 replicate, 24-week, randomized, placebo-controlled phase 3 trials: LIBERTY-CSU CUPID Study A and Study C (NCT04180488).²

The pooled analysis revealed dupilumab improved itch severity and urticaria activity compared with placebo at week 24. The Itch Severity Score demonstrated patients on dupilumab had least squares mean change from baseline of -9.9, compared with -6.7 on placebo (difference, -3,2; P < .0001). Moreover, patients on dupilumab versus placebo had least squares mean change from baseline in the Urticaria Activity Score of - 19.3 vs -13.1 (difference, - 6.2; P < .0001).²

The study showed a greater proportion of patients on dupilumab compared with placebo achieved well-controlled disease status indicated by an Itch Severity Score of ≤ 6: 43.1% vs 23.4% (P < .0001). Additionally, more patients on dupilumab (30.6%) than placebo (15.9%) reached a complete response with an Itch Severity Score of 0 at week 24 (P < .001).²

REFERENCES

1. Maurer M, Metz M, Kobielusz-Gembala I, et al. Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Spontaneous Urticaria: 52-Week Data. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract L11.

2. Casale, T, Saini, S, Bernstein, J, et al. Dupilumab Improves Itch and Urticaria Activity In Patients With Chronic Spontaneous Urticaria: Pooled Results From Two Phase 3 Trials (LIBERTY-CSU CUPID Study A and Study C). Late-breaking abstract presented at AAAAI 2025 in San Diego from February 28 – March 3.