A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine–refractory chronic idiopathic urticaria - 28/08/11
, Karin E. Rosen, MD, PhD b, Hsin-Ju Hsieh, PhD b, Dennis A. Wong, MD b, Edward Conner, MD b, Allen Kaplan, MD c, Sheldon Spector, MD d, Marcus Maurer, MD e
Reprint requests: Sarbjit Saini, MD, Johns Hopkins Asthma and Allergy Center, Unit Office 2B. 71B, 5501 Hopkins Bayview Circle, Baltimore, MD 21224.Abstract |
Background |
Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs).
Objective |
We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H1-antihistamine therapy.
Methods |
This phase II, prospective, double-blind, placebo-controlled, dose-ranging study investigated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS over 7 days (UAS7) of 12 or greater despite antihistamine therapy. Patients were randomized 1:1:1:1 to receive a single subcutaneous dose of 75, 300, or 600 mg of omalizumab or placebo added to a stable dose of H1-antihistamine. The primary efficacy outcome was change from baseline to week 4 in UAS7. Patients were followed for an additional 12 weeks to monitor safety.
Results |
Ninety patients from the United States or Germany were enrolled. Both the 300-mg omalizumab group (−19.9 vs −6.9, P < .001) and the 600-mg omalizumab group (−14.6 vs −6.9, P = .047) showed greater improvement versus the placebo group in UAS7. No meaningful difference was observed for the 75-mg omalizumab group. Similar results were seen for key secondary end points of weekly hive and itch scores. Onset of effect occurred after 1 to 2 weeks. Omalizumab was well tolerated, and the incidence of adverse events was similar across treatment groups.
Conclusion |
This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H1-antihistamines.
El texto completo de este artículo está disponible en PDF.Key words : Chronic idiopathic urticaria, chronic spontaneous urticaria, H1-antihistamine, hive, itch, omalizumab, urticaria activity score, dose ranging
Abbreviations used : AE, CIU, nsAH, UAS, UAS7
Esquema
| Supported by Genentech, Inc (South San Francisco, Calif), and Novartis Pharmaceuticals Corporation (East Hanover, NJ). ClinicalTrials.gov registration no.: NCT00130234. |
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| Disclosure of potential conflict of interest: S. Saini has consulted for Genentech/Novartis, Pharmacyclics, MedImmune, Array, and Kendle and has received research support from Genentech/Novartis. K. E. Rosen, H.-J. Hsieh, D. A. Wong, and E. Conner are employees of Genentech. A. Kaplan has consulted for Sanofi-Aventis and Novartis, has given lectures for Viro Pharma (Robert Michael Educational Institute), and is on the speakers’ bureau for Shire and Dyax. S. Spector has consulted for and is a speaker for AstraZeneca; is a speaker for and has received research support from Novartis; has received research support from GlaxoSmithKline, TKL Perrigo, Amgen, AstraZeneca, Schering-Plough, Genentech, Boehringer Ingelheim, Merck, Medpoint, Sunovion, and KarmelSonix; has served on committees for the American College of Allergy, Asthma, and Immunology; and has been a speaker/moderator for the American Academy of Allergy, Asthma & Immunology. M. Maurer has consulted for BMWI (ProInno), the German Research Foundation (DFG), the European Centre for Allergy Research Foundation (ECARF), ProFit, and VolkswagenStiftung. |
Vol 128 - N° 3
P. 567 - septembre 2011 Regresar al número
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