title: Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma.
abstract: Omalizumab is a subcutaneously administrated monoclonal anti-IgE antibody indicated in adults, adolescents and children 6 years of age and older with moderate to severe allergic asthma uncontrolled by conventional pharmacological treatments and sensitization to at least one perennial allergen. Area covered: This drug evaluation summarizes published data on pharmacokinetic and pharmacodynamic properties of omalizumab, on clinical efficacy and safety, including real-world evidence, and provides a medico-economic evaluation of the drug. Expert opinion: Omalizumab represents an efficient therapeutic option for the management of patients with uncontrolled moderate/severe allergic asthma. It provides a significant reduction in the asthma exacerbation rate with a steroid-sparing effect, an improvement in quality of life in adults and adolescents, despite a lack of evidence about its efficacy specifically in severe allergic asthma. Clinical trials have demonstrated its efficacy in the pediatric population but further real-life evidence is expected to better characterize long-term effects in this population. There is still some debate about the optimal treatment duration but, to date, it is recommended not to stop the treatment as cessation has resulted in symptom recurrence. Omalizumab is an expensive treatment, but a key therapeutic option when used for uncontrolled severe allergic asthma.
authors.affiliation: a Centre d'Investigations Cliniques 1432, module plurithématique (INSERM 1442) , CHU Dijon Bourgogne , Dijon , France.|b CRI U866, INSERM (Institut National de la Santé et de la Recherche Médicale) , Dijon , France.|c Université de Bourgogne , Dijon , France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Luu
authors.affiliation: a Centre d'Investigations Cliniques 1432, module plurithématique (INSERM 1442) , CHU Dijon Bourgogne , Dijon , France.|b CRI U866, INSERM (Institut National de la Santé et de la Recherche Médicale) , Dijon , France.|c Université de Bourgogne , Dijon , France.|d Service d'hépato-gastroentérologie , CHU Dijon Bourgogne , Dijon , France.
authors.forename: Marc
authors.initials: M
authors.lastname: Bardou
authors.affiliation: b CRI U866, INSERM (Institut National de la Santé et de la Recherche Médicale) , Dijon , France.|c Université de Bourgogne , Dijon , France.|e Service de Pneumologie , CHU Dijon Bourgogne , France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bonniaud
authors.affiliation: b CRI U866, INSERM (Institut National de la Santé et de la Recherche Médicale) , Dijon , France.|c Université de Bourgogne , Dijon , France.|f Laboratoire de Pharmacologie , CHU de Dijon , Dijon , France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Goirand
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007279:Injections, Subcutaneous; D000069444:Omalizumab / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011788:Quality of Life; D013997:Time Factors
chemical_list: D000485:Allergens; D018927:Anti-Asthmatic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E
keywords: IgE; Omalizumab; allergic asthma; monoclonal antibody