Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial.

Abstract

BACKGROUND:

Chronic spontaneous urticaria (CSU) severely impacts quality of life (QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied.

OBJECTIVE:

The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives.

METHODS:

X-ACT was a phase III, randomized, double-blind study conducted in 24 centres (Germany), which selectively included CSU patients with angioedema and wheals. Patients were randomized (1 : 1) to omalizumab 300 mg or placebo (every 4 weeks up to week 24) (ClinicalTrials.gov number: NCT01723072).

RESULTS:

Of the 91 patients randomized to omalizumab (n = 44) or placebo (n = 47) at baseline, 68 completed the 28-week treatment phase (omalizumab, 35; placebo, 33). Omalizumab was superior to placebo in improving CU-Q2oL scores at week 28 (P < 0.001). There was a threefold improvement in angioedema-burdened days/week with omalizumab (0.3) vs placebo (1.1). The median time to first recurrence of angioedema was 57-63 days with omalizumab and <5 days with placebo. Omalizumab significantly improved angioedema-specific QoL (P < 0.001). The adverse events reported are in line with the established safety profile of omalizumab.

CONCLUSION:

Omalizumab was an effective treatment option for patients with moderate-to-severe CSU symptoms and angioedema unresponsive to high doses of antihistamine treatment.

• Authors: P Staubach, M Metz, N Chapman-Rothe, C Sieder, M Bräutigam, J Canvin, M Maurer
• Journal: Allergy (Allergy) Vol. 71 Issue 8 Pg. 1135-44 (08 2016) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 27010957 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Anti-Allergic Agents
• Histamine H1 Antagonists
• Omalizumab

Topics

• Adolescent
• Adult
• Aged
• Angioedema (diagnosis, drug therapy)
• Anti-Allergic Agents (administration & dosage, adverse effects, therapeutic use)
• Chronic Disease
• Drug Resistance
• Female
• Histamine H1 Antagonists (therapeutic use)
• Humans
• Male
• Middle Aged
• Omalizumab (administration & dosage, adverse effects, therapeutic use)
• Quality of Life
• Retreatment
• Treatment Outcome
• Urticaria (diagnosis, drug therapy)
• Young Adult