| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Saini, Sarbjit S. Bindslev-Jensen, Carsten Maurer, Marcus Grob, Jean-Jacques Bülbül Baskan, Emel Bradley, Mary S. Canvin, Janice Rahmaoui, Abdelkader Georgiou, Panayiotis Alpan, Oral Spector, Sheldon Rosén, Karin |
| Description |
Country affiliation: United States Author Affiliation: Saini SS ( Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.); Bindslev-Jensen C ( Department of Dermatology and Allergy Centre, Odense University Hospital, Odense C, Denmark.); Maurer M ( Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.); Grob JJ ( Dermatology Department, Timone Hospital and Aix-Marseille University, Marseille, France.); Bülbül Baskan E ( Dermatology Department, Uludag University Medical Faculty, Bursa, Turkey.); Bradley MS ( Genentech, Inc., South San Francisco, California, USA.); Canvin J ( Novartis Pharmaceuticals UK, Horsham, UK.); Rahmaoui A ( Genentech, Inc., South San Francisco, California, USA.); Georgiou P ( Novartis Pharmaceuticals UK, Horsham, UK.); Alpan O ( Section on Immunopathogenesis, O&O Alpan, Fairfax, Virginia, USA.); Spector S ( California Allergy and Asthma Medical Group and the University of California Medical Center, Los Angeles, California, USA.); Rosén K ( Genentech, Inc., South San Francisco, California, USA.) |
| 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. |
| File Format |
HTM / HTML |
| ISSN |
0022202X |
| e-ISSN |
15231747 |
| DOI |
10.1038/jid.2014.306 |
| Journal |
Journal of Investigative Dermatology |
| Issue Number |
1 |
| Volume Number |
135 |
| Language |
English |
| Publisher |
Elsevier |
| Publisher Date |
2015-01-01 |
| Publisher Place |
United States |
| Access Restriction |
Open |
| Subject Keyword |
Discipline Dermatology Anti-allergic Agents Administration & Dosage Antibodies, Anti-idiotypic Antibodies, Monoclonal, Humanized Histamine H1 Antagonists Urticaria Drug Therapy Adolescent Adverse Effects Chronic Disease Double-blind Method Drug Resistance Omalizumab Placebos Etiology Clinical Trial, Phase Iii Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Cell Biology Biochemistry Molecular Biology Dermatology |
