Findings

What does this study add?

• Based on pooled adult data from both studies, UAS7 changes at Week 12 were –19.3 and –19.8 for ligelizumab 72 mg and 120 mg, compared to –19.8 for omalizumab, and –10.3 for placebo.
• This is almost twice the minimum clinically important difference.
• Ligelizumab 72 mg and 120 mg were superior to placebo (both p<0.0001), but not to omalizumab.
• The rate of complete response (UAS7=0) at Week 12 with ligelizumab 72 mg, 120 mg, omalizumab, and placebo was 31.0%, 33.8%, 34.1%, and 5.7%, respectively.
• In the placebo-controlled period to 24 weeks, at least one adverse event (AE) was noted in 59.3%, 60.7%, 61.4% and 56.0% of all patients on ligelizumab 72 mg, 120 mg, omalizumab and placebo, respectively, with headache the most common symptom.
• Incidence of injection-site reactions was 9.4%, 11.1%, 3.8%, and 1.8% for ligelizumab 72 mg, 120 mg, omalizumab, and placebo, respectively.
• At least one serious AE was noted in 3.1%, 3.2%, 2.7%, and 3.2% of patients on ligelizumab 72 mg, 120 mg, omalizumab, and placebo, respectively.
• Adjudication confirmed 3 cases of anaphylaxis in ligelizumab arms; 1 case in the 120 mg arm was deemed related to study drug.
• Discontinuations due to AEs were infrequent: 2.2% and 3.7% with ligelizumab 72 mg LIG 120 mg, compared to 1.4% with omalizumab and 3.2% with placebo.
• One death (suicide, not treatment related) occurred in the ligelizumab 120 mg arm.