Premium
Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema
Author(s) -
Maurer M.,
Sofen H.,
Ortiz B.,
Kianifard F.,
Gabriel S.,
Bernstein J.A.
Publication year - 2017
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.14075
Subject(s) - angioedema , medicine , omalizumab , placebo , dermatology life quality index , quality of life (healthcare) , randomization , refractory (planetary science) , incidence (geometry) , minimal clinically important difference , hereditary angioedema , randomized controlled trial , dermatology , surgery , immunoglobulin e , disease , immunology , pathology , antibody , alternative medicine , nursing , physics , astrobiology , optics
Background Approximately 50% of patients with chronic idiopathic/spontaneous urticaria ( CIU / CSU ) report hives and angioedema; some experience hives/angioedema only. Objective Assess omalizumab's effect on angioedema and quality of life (QoL) in subgroups with refractory CIU / CSU : those with and without angioedema. Methods Patients received omalizumab (75, 150 or 300 mg) or placebo every 4 weeks for 12/24 weeks. Angioedema and QoL were assessed [Urticaria Patient Daily Diary and Dermatology Quality of Life Index ( DLQI )]. Subgroups were based on the presence/absence of baseline angioedema 7 days prior to randomization. Results Patients with baseline angioedema randomized to omalizumab 300 mg had a greater reduction in mean weekly incidence of angioedema and mean number of days/week with angioedema vs. placebo at 12 and 24 weeks. A 3.3‐ to 4.5‐point greater mean reduction in DLQI score was achieved with omalizumab 300 mg treatment vs. placebo, above the minimal clinically important difference threshold. Results with lower doses vs. placebo were variable. Conclusion Compared with placebo, omalizumab 300 mg treatment over 12–24 weeks resulted in marked reduction in incidence and number of days/week with angioedema accompanied by clinically relevant improvement in QoL.