The Phase 2b study shows a higher proportion of ligelizumab-treated patients achieved complete response or lower severity score compared with omalizumab.
Findings from a randomized, double-blind core study show ligelizumab to be more effective in reducing chronic spontaneous urticaria (CSU) severity compared with omalizumab.
The study was led by Jonathan Bernstein, MD, of the University of Cincinnati College of Medicine and Bernstein Clinical Research Center, and data was presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience.
“In the Phase 2b core study, ligelizumab exhibited a dose-dependent response in terms of complete control of hives (HSS7 = 0) at Week 12 (primary endpoint) and achieved greater control of symptoms compared with omalizumab and placebo,” the investigators.
As such, the investigators also sought to analyze the shift of Weekly Urticaria Activity Score (UAS7) severity bands associated with both ligelizumab and omalizumab in patients with moderate to severe CSU (UAS ≥16).
In the trial, patients were randomized to ligelizumab 24 mg, 72 mg, 240 mg every 4 weeks (Q4W), 120 mg single dose, omalizumab 300 mg Q4W, or placebo.
For the purposes of this particular analysis, the investigators only evaluated patients in the ligelizumab 72 mg (n = 84), 240 mg (n = 85) Q4W and omalizumab 300 mg Q4W (n = 85) cohorts.
Patients were thus treated for a total of 20 weeks (with a follow-up period through at least week 44).
“At baseline, the distribution of patients in moderate or severe CSU disease activity bands was similar across treatment arms (moderate: 23.8%–37.6%; severe: 58.8%–75%),” Bernstein and colleagues noted. “However, the ligelizumab arms had a slightly higher proportion of severe patients compared with omalizumab.”
Results for Moderate CSU
At week 4, 35.0% and 25.9% of patients with moderate CSU on ligelizumab 72 mg and 240 mg, respectively, achieved UAS7 = 0—compared to 12.5% with omalizumab 300 mg.
Further, at week 12, 60.0% patients on ligelizumab 72 mg achieved an urticaria-free state, as did 40.7% on ligelizumab 240 mg, and 34.4% on omalizumab 300 mg.
The investigators also measured disease activity through week 20, showing 45.0% on ligelizumab 72 mg, 37.0% on legiluzumab 240 mg, and 31.3% on omazlizumab 300 mg achieving UAS7 = 0.
For those who received ligelizumab, up to 90% of patients saw a reduction in disease severity score of at least 1 activity band as early as week 4. This response was maintained through week 20.
Results for Severe CSU
In patients with severe disease, 28.6% on ligelizumab 72 mg and 32.1% on legiluzumab 240 mg achieved UAS7 = 0 at week 4—versus 22.0% on omalizumab.
At week 12, 38.1% on ligelizumab 72 mg, 41.1% on 240 mg, and 20.0% on omalizumab 300 mg achieved UAS7 = 0.
And finally, at week 20, 38.1%, 42.9%, and 30.0% of patients on ligelizumab 72 mg, 240 mg, and omalizumab 300 mg, respectively, reached complete response.
As many as 68% of patients saw improvements in disease severity by at least 1 severity band as early as week 4 with further improvements and maintenance through week 20.
“Treatment with ligelizumab achieved numerically higher response rates (decrease in disease severity bands), in patients with moderate and severe CSU compared with omalizumab, and a numerically higher rate of complete response compared with omalizumab,” the team concluded.
Bernstein and colleagues indicated such data have informed dose selection for the ongoing phase 3 clinical trial, which is still awaiting fuller results.
The study, “High rate of complete response achieved with ligelizumab in patients with moderate to severe chronic spontaneous urticaria throughout the Phase 2b core study,” was presented at AAD VMX 2021.