TY - JOUR T1 - Biologics in severe difficult-to-treat asthma: find the right niche! JF - European Respiratory Review JO - EUROPEAN RESPIRATORY REVIEW SP - 51 LP - 53 DO - 10.1183/09059180.00001509 VL - 18 IS - 112 AU - M. Humbert Y1 - 2009/06/01 UR - http://err.ersjournals.com/content/18/112/51.abstract N2 - As stated by Gaga et al. [1] in this issue of the European Respiratory Review, severe asthma still causes substantial mortality and morbidity and has a considerable economic impact worldwide. The burden of asthma is greatest in patients who are inadequately controlled despite therapy combining avoidance measures, inhaled corticosteroids, long-acting β2-agonists, and other asthma therapy administered according to guidelines [1–4]. These patients are at high risk for developing exacerbations and, possibly, severe consequences of airways remodeling. Therefore, they are candidates for more aggressive management [1].The mechanisms of asthma are complex and many molecular targets have been proposed [1]. Altogether, there is still no cure for asthma and there have been few new treatment innovations in recent years, despite major research in the field [1, 2]. Since the 1986 regulatory approval of a mouse monoclonal antibody (MAb) directed against the T-cell CD3ϵ antigen, MAbs have become an increasingly important class of therapeutic compounds in a variety of disease areas, ranging from cancer and autoimmune, infectious and cardiac diseases, as well as asthma [5, 6]. Other biological agents, such as cytokines and fusion proteins, as treatment modalities for a number of immune-mediated and malignant diseases have also yielded great promise, but very few trials in asthma have been conducted [6]. It is very difficult to predict the efficacy of biologics in severe asthma and only one MAb directed to immunoglobulin (Ig)E was found to be effective and approved by both the US Food and Drug Administration and the European Medicines Agency for the treatment of a subset of allergic asthmatics [6, 7]. Other pathways may prove to be of importance for the … ER -