title: Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study.
abstract: ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H1 antihistamine treatment at licensed doses. Patients aged 12-75 years with CIU/CSU who remained symptomatic despite treatment with approved doses of H1 antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneous omalizumab 75 mg, 150 mg, or 300 mg or placebo every 4 weeks for 24 weeks followed by 16 weeks of follow-up. The primary end point was change from baseline in weekly itch severity score (ISS) at week 12. Among randomized patients (N=319: placebo n=80, omalizumab 75 mg n=78, 150 mg n=80, 300 mg n=81), 262 (82.1%) completed the study. Compared with placebo (n=80), mean weekly ISS was reduced from baseline to week 12 by an additional 2.96 points (95% confidence interval (CI): -4.71 to -1.21; P=0.0010), 2.95 points (95% CI: -4.72 to -1.18; P=0.0012), and 5.80 points (95% CI: -7.49 to -4.10; P<0.0001) in the omalizumab 75-mg (n=77), 150-mg (n=80), and 300-mg groups (n=81), respectively. The omalizumab 300-mg group met all nine secondary end points, including a significant decrease in the duration of time to reach minimally important difference response (⩾5-point decrease) in weekly ISS (P<0.0001) and higher percentages of patients with well-controlled symptoms (urticaria activity score over 7 days (UAS7) ⩽6: 51.9% vs. 11.3%; P<0.0001) and complete response (UAS7=0: 35.8% vs. 8.8%; P<0.0001) versus placebo. During the 24-week treatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, and placebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administered subcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSU patients who remained symptomatic despite treatment with approved doses of H1 antihistamines.
authors.affiliation: Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.
authors.forename: Sarbjit S
authors.initials: SS
authors.lastname: Saini
authors.affiliation: Department of Dermatology and Allergy Centre, Odense University Hospital, Odense C, Denmark.
authors.forename: Carsten
authors.initials: C
authors.lastname: Bindslev-Jensen
authors.affiliation: Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.affiliation: Dermatology Department, Timone Hospital and Aix-Marseille University, Marseille, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Grob
authors.affiliation: Dermatology Department, Uludağ University Medical Faculty, Bursa, Turkey.
authors.forename: Emel
authors.initials: E
authors.lastname: Bülbül Baskan
authors.affiliation: Genentech, Inc., South San Francisco, California, USA.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Bradley
authors.affiliation: Novartis Pharmaceuticals UK, Horsham, UK.
authors.forename: Janice
authors.initials: J
authors.lastname: Canvin
authors.affiliation: Genentech, Inc., South San Francisco, California, USA.
authors.forename: Abdelkader
authors.initials: A
authors.lastname: Rahmaoui
authors.affiliation: Novartis Pharmaceuticals UK, Horsham, UK.
authors.forename: Panayiotis
authors.initials: P
authors.lastname: Georgiou
authors.affiliation: Section on Immunopathogenesis, O&O Alpan, Fairfax, Virginia, USA.
authors.forename: Oral
authors.initials: O
authors.lastname: Alpan
authors.affiliation: California Allergy and Asthma Medical Group and the University of California Medical Center, Los Angeles, California, USA.
authors.forename: Sheldon
authors.initials: S
authors.lastname: Spector
authors.affiliation: Genentech, Inc., South San Francisco, California, USA. Electronic address: rosen.karin@gene.com.
authors.forename: Karin
authors.initials: K
authors.lastname: Rosén
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D010919:Placebos; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy* / Q000209:etiology; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D006634:Histamine H1 Antagonists; D010919:Placebos; D000069444:Omalizumab