TOPLINE:

In patients with chronic spontaneous urticaria (CSU) unresponsive to H1-antihistamines, re-treatment with ligelizumab was effective and mostly well tolerated, with both 72-mg and 120-mg doses yielding positive responses in over half of the patients at 12 weeks. 

METHODOLOGY:

• Researchers conducted a phase 3b extension study to evaluate long-term safety and efficacy of ligelizumab re-treatment in patients with CSU who had relapsed despite H1-antihistamine treatment.
• They enrolled 1033 patients with CSU (mean age, 42.7 years; 69.2% women) from four preceding trials of ligelizumab including the PEARL 1 and 2 studies.
• The primary objective was to assess the efficacy of ligelizumab re-treatment, defined as the proportion of patients achieving a weekly urticaria activity score (UAS7) ≤ 6, in two patient groups from the PEARL studies:
  • All re-treated patients (72 mg-120 mg, n = 290; 120 mg-120 mg, n = 276)
  • Prior responders, defined as those with UAS7 ≤ 6 at week 12 (72 mg-120 mg, n = 148; 120 mg-120 mg, n = 151)
• UAS7 is a weekly score that measures urticaria severity; a UAS7 ≤ 6 indicates well controlled disease activity.

TAKEAWAY:

• Among re-treated patients, 53.5% of patients treated with 72 mg ligelizumab and 57.5% treated with 120 mg ligelizumab achieved a UAS7 ≤ 6 at 12 weeks.
• Among prior responders, 81.9% of patients treated with 72 mg ligelizumab and 82.6% treated with 120 mg ligelizumab achieved UAS7 ≤ 6 after 12 weeks of re-treatment.
• Overall, treatment-emergent adverse events were mostly mild (72 mg: 21.5%; 120 mg: 24.2%) or moderate (72 mg: 6.9%; 120 mg: 12.3%).

IN PRACTICE:

“[Our study] results reinforce the efficacy, along with good tolerability, of anti-IgE [immunoglobulin E] therapy in patients with antihistamine-refractory CSU,” the authors of the study wrote. 

SOURCE:

Ana M. Gimenez-Arnau, MD, PhD, with Universitat Pompeu Fabra, Barcelona, Spain, was the corresponding author of this study, which was published online on December 8 in Allergy.

LIMITATIONS:

This study was limited by the absence of a placebo control group, and the early termination of the study led to a reduction in sample size for later treatment periods.

DISCLOSURES:

This study was funded by Novartis Pharma AG. Several authors reported serving as investigators, speakers, or consultants/advisory board members, or as principal or sub-investigators in clinical trials, and/or receiving research funding and lecture fees from various pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.