Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody.

Omalizumab (Xolair) is a humanized monoclonal antibody designed to bind specifically to immunoglobulin (Ig)E. It is indicated in the United States for the treatment of adolescent and adult patients (>or=12 yr) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. Omalizumab was evaluated in an extensive clinical development program that included 12 controlled phase IIB/III clinical trials with more than 5,243 patients who were appropriate for inclusion in the safety analysis (all ages in all controlled studies).

Exhaled nitric oxide in children with asthma receiving Xolair (omalizumab), a monoclonal anti-immunoglobulin E antibody.

Objective: To evaluate the effect of a humanized monoclonal antibody to immunoglobulin E, omalizumab (Xolair, Novartis Pharmaceuticals, East Hanover, NJ; Genentech Inc, South San Francisco, CA), on airway inflammation in asthma, as indicated by the fractional concentration of exhaled nitric oxide (FE(NO)), a noninvasive marker of airway inflammation. Xolair was approved recently by the US Food and Drug Administration for moderate-to-severe allergic asthma in adolescents and adults.

Study Design: As an addendum at 2 sites to a randomized, multicenter double-blind, placebo-controlled trial, FE(NO) was assessed in children with allergic asthma over 1 year.

Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis.

Two randomized, placebo-controlled, double-blind studies have shown clinical benefit with omalizumab (Xolair), a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody, at a dose of 300 mg every 3 or 4 weeks in patients with seasonal allergic rhinitis. The present open-label, 12-week study was designed to assess the safety and tolerability of retreatment with omalizumab in 287 patients previously treated with this agent in one of the latter studies. Omalizumab, 300 mg, was administered subcutaneously every 4 weeks (three injections) to patients with IgE levels < or = 150 IU/mL (n = 182) and every 3 weeks (four injections) to patients with IgE levels > 150 IU/mL (n = 105) at screening before retreatment.

Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma.

Objective: To evaluate the long-term effects of the anti-IgE antibody omalizumab in children with asthma.

Methods: This was a 28-week, double-blind, randomized, placebo-controlled trial with a 24-week open-label extension. In the core trial 225 children (ages 6 to 12 years) with moderate-to-severe allergic asthma requiring inhaled beclomethasone dipropionate (BDP) received omalizumab every 2 or 4 weeks, and 109 received placebo.

Omalizumab is effective in the long-term control of severe allergic asthma.

Background: Previous reports show that addition of omalizumab to standard therapy reduces asthma exacerbations and simultaneously decreases use of inhaled corticosteroids (ICSs) and rescue medication in patients with allergic asthma.

Objective: To determine the effect of omalizumab on long-term disease control in patients with severe allergic asthma.

Methods: The present study concerns the 24-week, double-blind extension phase to a previous 28-week core study in which patients received subcutaneous omalizumab or matching placebo (at least 0.

Omalizumab improves asthma-related quality of life in patients with severe allergic asthma.

Background: We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled corticosteroid (ICS) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs.

Objective: The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life (QOL).

Methods: These analyses were part of a multicenter, 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of subcutaneous omalizumab (> or =0.

Omalizumab improves asthma-related quality of life in children with allergic asthma.

Background And Objective: Omalizumab is a recombinant, humanized, monoclonal anti-immunoglobulin E (IgE) antibody, developed for the treatment of IgE-mediated diseases. In children with allergic asthma, it was shown to reduce the requirement for inhaled corticosteroids while protecting against disease exacerbation. Here we report the effects of treatment with omalizumab on asthma-related quality of life (AQoL) in children with allergic asthma.