Document Detail

Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis.
MedLine Citation:
PMID:  12952110     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Treatment with omalizumab, an anti-IgE antibody, improves symptoms and quality of life in patients with seasonal allergic rhinitis but has not previously been investigated in patients with perennial symptoms.
OBJECTIVE: To investigate the efficacy, safety, and tolerability of omalizumab in the treatment of perennial allergic rhinitis (PAR).
METHODS: Two hundred eighty-nine patients (aged 12 to 70 years) with moderate-to-severe symptomatic PAR were randomized to 16 weeks' double-blind subcutaneous treatment with either placebo (n = 145) or omalizumab (at least 0.016 mg/kg/IgE [IU/mL] per 4 weeks; n = 144). The primary efficacy variable was the mean daily nasal severity score, as determined from patient daily diary cards. Secondary efficacy variables included use of rescue antihistamine, rhinoconjunctivitis-specific quality of life (RQoL), and patients' evaluation of treatment efficacy. Safety and tolerability were evaluated from adverse event reports and laboratory safety parameters.
RESULTS: Throughout 16 weeks of treatment, the mean daily nasal severity score was significantly lower in omalizumab-treated patients than with placebo (P < 0.001). The improvement in symptoms when taking omalizumab was paralleled by a reduction in use of rescue antihistamine (P < or = 0.005 overall) and improved RQoL relative to placebo. Patients' evaluation of treatment efficacy significantly favored omalizumab over placebo (P = 0.001). Omalizumab therapy was well tolerated. There were no safety concerns.
CONCLUSIONS: Omalizumab was safe and well tolerated in the treatment of patients with PAR, providing effective control of symptoms and improved RQoL while simultaneously minimizing reliance on rescue antihistamines.
Paul Chervinsky; Thomas Casale; Robert Townley; Ita Tripathy; Simon Hedgecock; Angel Fowler-Taylor; Henry Shen; Howard Fox
Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology     Volume:  91     ISSN:  1081-1206     ISO Abbreviation:  Ann. Allergy Asthma Immunol.     Publication Date:  2003 Aug 
Date Detail:
Created Date:  2003-09-03     Completed Date:  2003-09-30     Revised Date:  2013-01-18    
Medline Journal Info:
Nlm Unique ID:  9503580     Medline TA:  Ann Allergy Asthma Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  160-7     Citation Subset:  IM    
Northeast Medical Research Associates, Dartmouth, Massachusetts 02747, USA.
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MeSH Terms
Anti-Asthmatic Agents / therapeutic use*
Antibodies, Anti-Idiotypic / therapeutic use*
Antibodies, Monoclonal / therapeutic use*
Antibodies, Monoclonal, Humanized
Double-Blind Method
Injections, Subcutaneous
Middle Aged
Nasal Mucosa / pathology
Patient Satisfaction
Quality of Life / psychology
Rhinitis, Allergic, Perennial / drug therapy*
Terfenadine / analogs & derivatives*,  therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Anti-Asthmatic Agents; 0/Antibodies, Anti-Idiotypic; 0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/anti-IgE antibodies; 0/omalizumab; 138452-21-8/fexofenadine; 50679-08-8/Terfenadine

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