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

• Published in: Allergy (Copenhagen) 2018-03, Vol.73 (3), p.576-584
• Main Authors: Staubach, P., Metz, M., Chapman‐Rothe, N., Sieder, C., Bräutigam, M., Maurer, M., Weller, K.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Angioedema; Angioedema - drug therapy; Angioedema - etiology; Anti-Allergic Agents - therapeutic use; Antihistamines; Asphyxia; chronic spontaneous urticaria; Dermatitis; Dermatology; Double-Blind Method; Edema; Female; H1‐antihistamine‐refractory; Humans; Immunoglobulin E; Immunotherapy; Male; Mental depression; Middle Aged; Monoclonal antibodies; omalizumab; Omalizumab - therapeutic use; Original; ORIGINAL ARTICLES; Quality of Life; Randomization; Skin; Urticaria; Urticaria - complications; Urticaria - drug therapy; Well being; Young Adult
• ISSN: 0105-4538; 1398-9995
• DOI: 10.1111/all.13339

Background The X‐ACT study aimed 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 were 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