Use of Omalizumab for Treatment of Antihistamine and Steroid Resistant Chronic Idiopathic Urticaria during Pregnancy

Abstract

RATIONALE: Information on the clinical profile of CIU/CSU in adolescents is limited. Baseline characteristics and demographics of an adolescent subgroup of CIU/CSU patients enrolled in randomized, placebo-controlled omalizumab trials are evaluated. METHODS: This is a post-hoc descriptive analysis of pooled baseline data from three omalizumab trials in CIU/CSU patients who remained symptomatic despite H 1 -antihistamine treatment [and H 2 -antihistamines and/or leukotriene receptor antagonists (LTRA) in one study]. Demographics and disease characteristics are summarized for overall and for adolescent patients (> _12 to <18 years). RESULTS: Of 975 patients [mean (standard deviation; SD) age, 42.3 (14.1) years], 39 were adolescents [15.1 (1.5) years]. Most patients were female (overall, 73.4%; adolescents, 69.2%) and white (85.4%; 84.6%), with a mean BMI (SD) of 29.6 (7.3) and 24.4 (4.7) kg/m 2 , respectively. A CU index test (functional anti-FcεR) was positive in 28.5% overall and 17.9% of adolescents. Mean urticaria activity score over 7 days (SD) was 30.9 (6.7) overall and 28.6 (5.7) for adolescents; weekly itch severity score, 14.1 (3.6) and 13.3 (3.4); weekly number of hives score, 16.8 (4.3) and 15.3 (4.0); and Dermatology Life Quality Index overall score, 13.2 (6.5) and 12.0 (5.2), respectively. Overall, patients experienced CIU/ CSU for mean duration (SD) of 6.9 (9.1) years and adolescents for 3.2 (3.7) years, and received 5.0 (2.8) and 4.2 (2.3) previous CIU/CSU medications, respectively. Except for one adult, all patients received antihistamines. Concomitant medications included: H 2 -receptor antagonists (overall, 48.4%; adolescents, 48.7%); LTRA (34.5%; 35.9%) and steroids (45.7%; 33.3%). CONCLUSIONS: Understanding the clinical profile of CIU/CSU in adolescents will guide clinical practice. Abstracts AB129SUNDAY

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria

“…A total of 67 observational studies on the effectiveness of omalizumab in CIU (with or without angioedema) were identified (Figure 1). As detailed in eTable 1 in the Supplement, there were 19 studies of patients with CIU or CSU specified, 2 of patients with chronic autoimmune urticaria (CAU), 5 of patients with chronic urticaria not otherwise specified (CU NOS), 38 of patients with CIU, CSU, or CU NOS with comorbidities, and another 3 of mixed samples of patients with urticaria. These articles on the effectiveness of omalizumab in CIU were included in our group’s systematic review, which also contains additional study description, narrative analysis, and tables of evidence …”