Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials

Publication date: Available online 19 September 2019Source: The LancetAuthor(s): Claus Bachert, Joseph K Han, Martin Desrosiers, Peter W Hellings, Nikhil Amin, Stella E Lee, Joaquim Mullol, Leon S Greos, John V Bosso, Tanya M Laidlaw, Anders U Cervin, Jorge F Maspero, Claire Hopkins, Heidi Olze, G Walter Canonica, Pierluigi Paggiaro, Seong H Cho, Wytske J Fokkens, Shigeharu Fujieda, Mei ZhangSummaryBackgroundPatients with chronic rhinosinusitis with nasal polyps (CRSwNP) generally have a high symptom burden and poor health-related quality of life, often requiring recurring systemic corticosteroid use and repeated sinus surgery. Dupilumab is a fully human monoclonal antibody that inhibits signalling of interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation, and has been approved for use in atopic dermatitis and asthma. In these two studies, we aimed to assess efficacy and safety of dupilumab in patients with CRSwNP despite previous treatment with systemic corticosteroids, surgery, or both.MethodsLIBERTY NP SINUS-24 and LIBERTY NP SINUS-52 were two multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies assessing dupilumab added to standard of care in adults with severe CRSwNP. SINUS-24 was done in 67 centres in 13 countries, and SINUS-52 was done in 117 centres in 14 countries. Eligible patients were 18 years or older with bilateral CRSwNP and symptoms despite intranasal corticosteroid use, receiving systemic corticosteroids i...
Source: The Lancet - Category: General Medicine Source Type: research