title: New opportunities and challenges in the assessment of drugs for atopic diseases.
abstract: Atopic conditions (atopic dermatitis, rhinitis, and asthma) belong to the most common noncommunicable diseases and are driven by chronic inflammatory reactions. They have a strong impact on the quality of life and represent a substantial and growing socio-economic burden. Interestingly, there is an increasing interest in the development of new therapeutic options with a number of biologics and small molecules targeting potential key mechanisms in atopic conditions. However, besides the safety issue, most of the new active substances are still evaluated according to the traditional efficacy paradigm focusing on the success in treating exacerbations and flares. Instead, the future approaches in drug development and assessment should rather concentrate on the long-term control of these diseases and consider their potential as disease-modifying strategies in the era of precision medicine. To reach this goal, a number of unsolved issues have to be addressed and consensually accepted by the stakeholders in this field. Thus, a successful and rapid development of new treatments requests a paradigm shift and a new way of thinking in the mind of physicians, pharmaceutical industry, regulators, and HTAs. This seems mandatory in order to optimize drug development and to facilitate the accessibility of new therapies to the growing population of patients suffering from atopic conditions on a global level.
authors.affiliation: Department of Dermatology and Allergy, Christine Kühne-Center for Allergy Research and Education, University Medical Center, Bonn, Germany.|Center for Translational Medicine, Medical Faculty, University of Bonn, Bonn, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Bieber
authors.affiliation: Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Vieths
authors.affiliation: Center for Translational Medicine, Medical Faculty, University of Bonn, Bonn, Germany.|Federal Institute of Drug and Medical Devices (BfArM), Bonn, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Broich
mesh_terms: D018926:Anti-Allergic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D035843:Biomedical Research / Q000639:trends; D019468:Disease Management; D055808:Drug Discovery; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000175:diagnosis* / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D012042:Registries
chemical_list: D018926:Anti-Allergic Agents
keywords: asthma; atopic dermatitis; drug development; precision medicine; rhinitis