Ligelizumab tops omalizumab for chronic spontaneous urticaria

  • Maurer M & al.
  • N Engl J Med
  • 3 Oct 2019

  • International Clinical Digest
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Takeaway

  • Ligelizumab is associated with a higher rate of complete symptom control compared with omalizumab or placebo in patients with chronic spontaneous urticaria.

Why this matters

  • Most currently available therapies do not result in complete symptom control.

Key results

  • At 12 weeks, ligelizumab 72 mg and 240 mg were associated with higher rates of complete control of hives vs omalizumab and placebo:
    • 51% for ligelizumab 72 mg (OR, 2.90; 95% CI, 1.52-5.55 vs omalizumab).
    • 42% for ligelizumab 240 mg (OR, 2.06; 95% CI, 1.08-3.95 vs omalizumab).
    • 26% for omalizumab.
    • 0% for placebo.
  • At 12 weeks, ligelizumab 72 mg was associated with higher rates of complete control of symptoms (weekly urticaria activity score of 0) vs omalizumab and placebo:
    • 44% for ligelizumab 72 mg (OR, 2.19; 95% CI, 1.14-4.19 vs omalizumab).
    • 26% for omalizumab.
    • 0% for placebo.
  • Adverse event rates were similar among all groups.

Study design

  • 382 patients with chronic spontaneous urticaria were randomly assigned to receive ligelizumab every 4 weeks at 24 mg (N=43), 72 mg (N=84), and 240 mg (N=85); omalizumab every week at 300 mg (N=85); placebo (N=43); or ligelizumab as a 120-mg single dose (N=42).
  • Funding: Novartis Pharma.

Limitations

  • Short study duration.