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, randomized, double-blind, placebo-controlled, parallel-group phase 3 trials
The Lancet Nov 12, 2019
Bachert C, Han JK, Desrosiers M, et al. - Via two multinational, multicentre, randomized, double-blind, placebo-controlled, parallel-group studies (LIBERTY NP SINUS-24 [conducted in 67 centers in 13 countries] and LIBERTY NP SINUS-52 [carried out in 117 centers in 14 countries]) evaluating dupilumab added to standard of care in adults who were 18 years or older with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) and symptoms irrespective of intranasal corticosteroid use, receiving systemic corticosteroids in the preceding 2 years, or having had sinonasal surgery, researchers evaluated efficiency and safety of dupilumab in individuals with CRSwNP notwithstanding former treatment with systemic corticosteroids, surgery, or both. A total of 276 persons were recruited in SINUS-24 and randomized into dupilumab group; n = 143 and placebo group; n = 133 receiving at least one study drug dose. In adult people with severe CRSwNP, dupilumab decreased polyp size, sinus opacification, and severity of symptoms and was well tolerated. Thus, for people with severe CRSwNP who otherwise have few therapeutic options, these results establish the advantages of adding dupilumab to the daily standard of care.
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