In a Phase 3 clinical trial in Germany, the therapy Xolair (omalizumab) was shown to improve the quality of life and psychological well-being of chronic idiopathic urticaria (CIU) patients with angioedema who were resistant to treatment with antihistamines.
Results were highlighted in the study, “Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data,” published in the journal Allergy.
CIU, known outside the U.S. as chronic spontaneous urticaria, is characterized by the recurrence of itchy hives and angioedema, or severe swelling under the skin, for more than six weeks.
H1-antihistamines usually are used to treat CIU, but they aren’t effective for this condition in about half of patients.
Xolair, developed by Genentech and Novartis Pharmaceuticals, is the only add-on therapy approved in the U.S. and Europe for H1-antihistamine-resistant CIU. Several clinical trials have consistently shown that Xolair significantly improves disease-related symptoms and quality of life in antihistamine-resistant CIU patients.
Angioedema, which develops in the face, tongue, larynx, abdomen, arms, and legs, can severely affect quality of life.
A randomized, double-blind, multicenter, Phase 3 clinical trial in Germany (NCT01723072), called X-ACT, showed that Xolair reduces the frequency and severity of angioedema in antihistamine-resistant CIU patients. A standard questionnaire also showed that quality of life improved after treatment with Xolair.
However, specific information about quality-of-life issues affected by the disease and improved by Xolair was still needed.
So, researchers examined in detail the quality-of-life scores of 91 adult antihistamine-resistant CIU patients who participated in the X-ACT study. Participants — who had at least four episodes of angioedema within six months prior to enrollment in the study — were randomized to receive either 300 mg of Xolair or a placebo every four weeks for six months. Of the total, 68 patients completed the study, with 35 receiving Xolair and 33 receiving a placebo.
Angioedema-related quality of life, skin-related quality-of-life impairment, and psychological well-being were assessed using the Angioedema Quality of Life questionnaire, the Dermatology Life Quality Index, and the five‐item World Health Organization Well‐being Index, respectively.
Antihistamine-resistant CIU patients with angioedema were found to have significant impairment of quality of life and psychological well-being, with an increased risk of depression and a fear of life-threatening angioedema episodes.
The high risk for signs of depression in these patients led researchers to propose that chronic idiopathic urticaria with angioedema not be classified as “a trivial disease” or “a cosmetic problem.”
Xolair treatment significantly improved quality of life related to angioedema after the first treatment. Symptoms continued to improve through the end of therapy. Patients’ psychological well-being also improved, and angioedema-related fears were reduced with Xolair compared to a placebo.
The rapid improvement in quality of life with Xolair appeared to be directly associated with a rapid reduction of angioedema symptoms.
“Based on these findings, we recommend that omalizumab is prescribed for the treatment of patients with severe H1‐antihistamine‐refractory CSU with angioedema,” the researchers wrote.
They noted that the findings should be confirmed in chronic idiopathic urticaria patients with angioedema without hives and in children and adolescents — groups that were not included in the study.