6533b7cefe1ef96bd1257218

RESEARCH PRODUCT

Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data

Nadine Chapman-rotheChristian SiederMatthias BräutigamPetra StaubachMarcus MaurerKarsten WellerMartin Metz

subject

AdultMalechronic spontaneous urticariamedicine.medical_specialtyAdolescentUrticariaImmunologyOmalizumab600 Technik Medizin angewandte Wissenschaften::610 Medizin und Gesundheit::616 KrankheitenPlaceboYoung Adult030207 dermatology & venereal diseases03 medical and health sciences0302 clinical medicineDouble-Blind MethodRefractoryQuality of lifeInternal medicine616Anti-Allergic AgentsmedicineHumansH1-antihistamine-refractoryImmunology and AllergyDepression (differential diagnoses)AgedAngioedemaAdult patientsbusiness.industryangioedemaDermatology Life Quality IndexMiddle AgedSurgeryquality of life030228 respiratory systemExperimental Allergy and ImmunologyomalizumabOriginal ArticleFemaleORIGINAL ARTICLESH1‐antihistamine‐refractorymedicine.symptombusinessmedicine.drug

description

Background The X-ACT study aims to examine the effect of omalizumab treatment on quality of life (QoL) in chronic spontaneous urticaria (CSU) patients with angioedema refractory to high doses of H1-antihistamines. Methods In X-ACT, a phase III, double-blind, placebo-controlled study, CSU patients (18–75 years) with ≥4 angioedema episodes during the 6 months before inclusion were randomized (1:1) to receive omalizumab 300 mg or placebo every 4 weeks for 28 weeks. Angioedema-related QoL, skin-related QoL impairment, and psychological well-being were assessed. Results Ninety-one patients were randomized and 68 (omalizumab, n=35; placebo, n=33) completed the 28-week treatment period. At baseline, the mean (SD) total Angioedema QoL (AE-QoL; 56.2 [18.7] and 59.9 [19.2]) and Dermatology Life Quality Index (DLQI; 14.6 [5.7] and 16.6 [7.3]) score was high in the omalizumab and placebo group, respectively. At Week 4 (after the first treatment), the least squares mean difference in the AE-QoL and DLQI score between groups was −17.6 (P<0.001) and −7.2 (P<0.001), respectively. Significant QoL improvements in the omalizumab versus placebo groups continued until Week 28, but returned to placebo levels at the follow-up visit. The mean (SD) baseline 5-item World Health Organization Well-being Index was 10.0 (5.5, omalizumab) and 7.7 (5.3, placebo), which increased above the depression threshold (<13) from Week 4 and throughout with omalizumab but not placebo treatment. Compared to placebo, omalizumab was also associated with decreased fear of suffocation due to angioedema. Conclusions Our findings support omalizumab treatment in patients with severe H1-antihistamine-refractory CSU with angioedema. This article is protected by copyright. All rights reserved.

https://doi.org/10.1111/all.13339