ABSTRACT
Title
Xolair, a New Monoclonal Drug Anti-IgE Antibody for the Treatment of Allergic Asthma
Authors
M. Di Domenico, A. Bisogno, *M. Polverino, *C. De Rosa, **V. Ricci, A. Capasso
Department of Pharmaceutical and Biomedical Sciences, University of Salerno,
*Respiratory and Physiopatology Department, Cava de’ Tirreni Hospital,
**S. Maria Immacolata dell’ Olmo Hospital, Italy.
Department of Pharmaceutical and Biomedical Sciences, University of Salerno,
*Respiratory and Physiopatology Department, Cava de’ Tirreni Hospital,
**S. Maria Immacolata dell’ Olmo Hospital, Italy.
Abstract
Asthma is a chronic lung inflammatory disease affecting from 5 to 10% of the population. It generally appears with periods of crisis alternating with free periods, but inflammation is always present. Allergic asthma manifests with paroxysmal crisis of bronchospasm, hissing-like respiratory noises, dyspnea, respiratory distress syndrome. Different studies have shown an increase of IgE serum levels in subjects suffering from allergic asthma.
Xolair is a monoclonal antibody that binds the Cε3 domain of IgEs, inducing a conformational change of the immunoglobulin, a concealment of FcεRI and FcεRII receptors binding sites, thus precluding binding by IgEs and therefore stopping the release of inflammation mediators.
Xolair is indicated as add-on therapy to improve/control asthma in adult and adolescent patients (12 years of age and above) suffering from severe persistent allergic asthma.
The aim of our work was appraise the persistence of answer to Xolair treatment and to evaluate the effect of its association to the optimal asthma therapy, compared with the asthma therapy alone. Besides, changes of clinical parameters and patients quality of life were evaluated, so to promote the development of clinical indications for the new drug administration.
Six patients (4 men and 2 women aged 30 to 60 years) were selected for the treatment with Xolair. Previously, they were treated with high doses of long-acting β2-agonists and inhaled corticosteroids, but they were unable to control their illness despite the assumption of such drugs. Xolair was administered for 32 weeks in addition to the traditional asthma therapy. Xolair dosage was calculated according to their weight and their IgE levels (IU/ml). The therapeutic answer was evaluated according to the GETE (Global Evaluation of Treatment Effectiveness) scale. The persistence of the answer was defined, instead, by the number of patients continuing to answer positively to the treatment between the 16th and the 32nd week.
Four of 6 patients concluded the study. Patient number 2, in fact, had a body weight higher than 150 kg, so it was impossible to establish the necessary drug dosage. Patient number 6, instead, still had too high IgE values at his fourth checkup.
Patient number 1 was fit in the efficacy level 2 (Good) at the 16th week, while at the 32nd week, he was in the level 1 (Excellent).
Patient number 3 was at an efficacy level 1 yet from the 16th week, and that level was confirmed at the 32nd. In patient number 4, as well in that number 1, an increase of treatment efficacy was proved with a passage from level 2 to level 1. Finally, for the patient number 5, the efficacy level was Good both at the 16th and at the 32nd week (level 2).
The results obtained were positive for all patients and not only the persistence of a therapeutic response was confirmed, but in some cases there was an improvement of efficacy. Therefore, we can conclude that Xolair, administrated as an additional therapy, decisively improves the management of severe persistent IgE-mediated asthma. The usage of anti-IgE reduces the frequency of riacutizations, admission and non-expected visits, improves patient’s quality of life, with positive effects on symptoms and pulmonary function.
Xolair is a monoclonal antibody that binds the Cε3 domain of IgEs, inducing a conformational change of the immunoglobulin, a concealment of FcεRI and FcεRII receptors binding sites, thus precluding binding by IgEs and therefore stopping the release of inflammation mediators.
Xolair is indicated as add-on therapy to improve/control asthma in adult and adolescent patients (12 years of age and above) suffering from severe persistent allergic asthma.
The aim of our work was appraise the persistence of answer to Xolair treatment and to evaluate the effect of its association to the optimal asthma therapy, compared with the asthma therapy alone. Besides, changes of clinical parameters and patients quality of life were evaluated, so to promote the development of clinical indications for the new drug administration.
Six patients (4 men and 2 women aged 30 to 60 years) were selected for the treatment with Xolair. Previously, they were treated with high doses of long-acting β2-agonists and inhaled corticosteroids, but they were unable to control their illness despite the assumption of such drugs. Xolair was administered for 32 weeks in addition to the traditional asthma therapy. Xolair dosage was calculated according to their weight and their IgE levels (IU/ml). The therapeutic answer was evaluated according to the GETE (Global Evaluation of Treatment Effectiveness) scale. The persistence of the answer was defined, instead, by the number of patients continuing to answer positively to the treatment between the 16th and the 32nd week.
Four of 6 patients concluded the study. Patient number 2, in fact, had a body weight higher than 150 kg, so it was impossible to establish the necessary drug dosage. Patient number 6, instead, still had too high IgE values at his fourth checkup.
Patient number 1 was fit in the efficacy level 2 (Good) at the 16th week, while at the 32nd week, he was in the level 1 (Excellent).
Patient number 3 was at an efficacy level 1 yet from the 16th week, and that level was confirmed at the 32nd. In patient number 4, as well in that number 1, an increase of treatment efficacy was proved with a passage from level 2 to level 1. Finally, for the patient number 5, the efficacy level was Good both at the 16th and at the 32nd week (level 2).
The results obtained were positive for all patients and not only the persistence of a therapeutic response was confirmed, but in some cases there was an improvement of efficacy. Therefore, we can conclude that Xolair, administrated as an additional therapy, decisively improves the management of severe persistent IgE-mediated asthma. The usage of anti-IgE reduces the frequency of riacutizations, admission and non-expected visits, improves patient’s quality of life, with positive effects on symptoms and pulmonary function.