Abstract
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 ≤ 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.
| Original language | English |
|---|---|
| Pages (from-to) | 160-167 |
| Number of pages | 8 |
| Journal | Annals of Allergy, Asthma and Immunology |
| Volume | 91 |
| Issue number | 2 |
| State | Published - Aug 1 2003 |
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All Science Journal Classification (ASJC) codes
- Immunology and Allergy
Cite this
Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. / Chervinsky, Paul; Casale, Thomas; Townley, Robert; Tripathy, Ita; Hedgecock, Simon; Fowler-Taylor, Angel; Shen, Henry; Fox, Howard.
In: Annals of Allergy, Asthma and Immunology, Vol. 91, No. 2, 01.08.2003, p. 160-167.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis
AU - Chervinsky, Paul
AU - Casale, Thomas
AU - Townley, Robert
AU - Tripathy, Ita
AU - Hedgecock, Simon
AU - Fowler-Taylor, Angel
AU - Shen, Henry
AU - Fox, Howard
PY - 2003/8/1
Y1 - 2003/8/1
N2 - 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 ≤ 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.
AB - 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 ≤ 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.
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M3 - Article
VL - 91
SP - 160
EP - 167
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
SN - 1081-1206
IS - 2
ER -