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Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. DermNet Chief Editor in Chief: Adjunct A/Prof Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand. First published December 2013; updated April 2020. Copy edited by Gus Mitchell.
Omalizumab (trade name Xolair™) is a humanised monoclonal antibody that binds to circulating immunoglobulin E (IgE) and reduces the release of inflammatory mediators from mast cells and basophils. It is given by subcutaneous injection once every 4 weeks.
Omalizumab is licensed in New Zealand as an add-on therapy for patients with severe, persistent allergic asthma, and for patients 12 years of age or older with severe chronic spontaneous urticaria that remain symptomatic despite H1-antihistamine treatment. It is funded by New Zealand's Pharmaceutical Management Agency (PHARMAC) on special authority application under certain circumstances.
Results of three phase III trials ASTERIA I, ASTERIA II, and GLACIAL trials support the efficacy of omalizumab in chronic spontaneous urticaria.
This global, multicentre, randomised, double-blind, placebo-controlled study was funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473. It has shown that omalizumab reduces symptoms in chronic urticaria.
|Omalizumab 300 mg||−9.8||p < 0.001|
|Omalizumab 150 mg||−8.1||p = 0.001|
|Omalizumab 75 mg||−5.9||p = 0.46|
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 .
In this phase III double-blind randomised study patients aged 18-75 years, were randomised 1:1 to receive subcutaneous omalizumab 300 mg or placebo every 4 weeks for 28 weeks. 68 of the 91 patients randomised (omalizumab, n = 35; placebo, n = 33) completed the 28‐week treatment period. All had chronic spontaneous urticaria with at least 4 angioedema episodes during the 6 months before inclusion.
Angioedema‐related quality of life (QoL), skin‐related QoL impairment, and psychological well‐being were assessed. 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]) in the omalizumab and placebo groups, respectively.
Following omalizumab treatment initiation, the mean angioedema activity scores (AAS7); consisting of an opening question (Have you had a swelling episode in the last 24 hours?), followed by the five specific AAS questions to determine the severity and impact of the angioedema episode, decreased rapidly with significant differences observed as early as Week 4 through to Week 28.
The mean [SD] AAS7 scores increased to placebo levels at Week 36 (omalizumab, 10.2 [19.6]; placebo, 9.8 [12.0]) after discontinuation of omalizumab. The most severely affected subdomains of the AE‐QoL were fears/shame, fatigue/mood, and functioning.
The most severely affected subdomains of the DLQI score included daily activities and leisure. General psychological and well-being improved with omalizumab treatment. In the omalizumab group, the mean (SD) WHO‐5 score (The World Health Organization -5 Well-Being Index) was 10.0 (5.5) at baseline and increased above the depression threshold to 18.6 (5.1) by the end of the treatment period. The corresponding results in the placebo group were 7.7 (5.3) at baseline and 11.5 (5.8) at Week 28 (least square mean difference between groups at Week 28, p < 0.001).
This study studied the effectiveness of omalizumab in treating severe atopic dermatitis in children.
So far, there is no evidence that omalizumab is disease-modifying. When patients stopped the study drug, their symptoms recurred. At the end of 16 weeks off treatment, symptoms of urticaria were similar to patients treated with placebo. When omalizumab was restarted in patients that had previously responded, the omalizumab was again effective.
Omalizumab is administered by subcutaneous injection.
IgE autoantibodies are detected in some patients with bullous pemphigoid. In small numbers of individual case reports, omalizumab treatment has been reported to be effective in most patients, although recurrence is more common and occurs more rapidly compared to rituximab .
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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