Omalizumab Demonstrates Improved Efficacy and Safety Among Patients With Angioedema

Key Takeaways:

• Among 148 patients with angioedema (AE), 77% achieved a good or complete response to omalizumab, with no difference observed between AE-only and AE-wheals cohorts.
• Out of the 41% of patients who discontinued omalizumab, 63% did so due to well-controlled disease, which further demonstrates the therapy’s effectiveness in disease management.
• These findings showcase how omalizumab can be used to treat patients with AE, which can be approached as a chronic spontaneous urticaria (CSU) phenotype.

Mast cell–mediated angioedema (AE-MC), a subtype of chronic spontaneous urticaria (CSU), is managed using urticaria guidelines. Omalizumab, branded as either Xolair or Omlyclo, is a treatment option for patients with CSU, but its long-term impact on AE-MC has not been as widely studied. Researchers conducted a multicenter real-world study assessing the efficacy and safety of omalizumab for patients with AE-MC.

The study included 148 patients across 14 international urticaria centers who initiated omalizumab treatment between June 2014 and February 2022. Within the study population, 67 patients (45%) had isolated AE, and 81 (55%) had AE with minor wheals (AE-wheals).

Impact of Omalizumab on AE

Seventy-seven percent of patients had good or complete responses to omalizumab, 14% had a partial response, and 9% had poor responses. No notable difference in response was observed between AE-only and AE-wheals patients.

During the study, 41% of patients discontinued omalizumab. Within this group, 63% discontinued treatment due to well-controlled disease, 18% discontinued due to ineffectiveness, and 5% discontinued due to side effects. Out of the patients who discontinued omalizumab due to well-controlled disease, 53% restarted treatment after 5 months.

Drug survival due to well-controlled disease was observed at 1-year, 2-year, and 5-year follow-ups, which were 82%, 67%, and 58%, respectively. Patients with AE-only and AE-wheals had similar rates of drug survival, showing omalizumab’s efficacy and safety.

Patients with AE for at least 2 years before starting omalizumab had a longer treatment duration. Patients with a faster response to omalizumab had a shorter time to discontinuation.

Implication for Managed Care

These findings demonstrate that omalizumab may be an effective and safe treatment option for patients with AE, with or without minor wheals.

The researchers concluded, “Despite incomplete understanding of its underlying mechanisms, our results demonstrate that AE-MC responds similarly to omalizumab as other CU phenotypes and support the management of AE-MC as part of a unified CU disease entity.”

Reference

Van der Kamp S, Soegiharto R, Sørensen JA, et al. Performance of omalizumab in patients with mast cell–mediated angioedema with and without wheals. J Allergy Clin Immunol Pract. 2026;14(6):1457-1460. doi:10.1016/j.jaip.2026.03.004