Mepolizumab (nucala°) and severe asthma in patients aged 6 years and older

摘要

Inadequate evaluation, and unknowns concerning cardiovascular effects, effects on growth and long-term cancer risk.In children with persistent severe asthma, when high-dose inhaled corticosteroids are inadequately effective, an oral corticosteroid at the minimum effective dose and for the shortest possible duration is a first-choice treatment, despite its numerous adverse effects, such as growth retardation (1,2). Mepolizumab (Nucala°, GlaxoSmithKline), a monoclonal antibody directed against interleukin-5, was initially authorised in the European Union for use in adults with severe, so-called eosinophilic, asthma inadequately controlled by a high-dose inhaled corticosteroid. In this situation, it does not represent a substantial advance: its efficacy is at best modest (about one fewer exacerbation per patient per year and a reduction in oral corticosteroid doses in a minority of patients), whereas it carries a risk of serious adverse effects, including infections, allergic reactions and perhaps cardiovascular disorders and cancer in the long-term (3-5). Mepolizumab has also been authorised for use in children aged 6 years or older with severe "eosinophilic" asthma, not controlled by an inhaled corticosteroid. In this context, comparative evaluation is limited to a compilation of data obtained from 34 asthmatic adolescents, aged at least 12 years, who took part in two placebo-controlled, randomised, double-blind trials that lasted 24 and 32 weeks, respectively (2).