Monoclonal antibody reduces asthma attacks in urban youth NIAIDNews TheLancet
, which is available with the full text of this article at NEJM.org, was developed by the sponsor, GlaxoSmithKline. The first draft of the manuscript was written by the first author, an employee of GlaxoSmithKline; editorial support funded by GlaxoSmithKline was provided by Gardiner-Caldwell Communications. Data were collected by the investigators and analyzed by employees of the sponsor.
Exacerbations were confirmed by objective changes that patients recorded daily in an electronic diary .At each clinic visit, we evaluated results of spirometric and hematologic tests and administered the 5-item Asthma Control Questionnaire , on which scores range from 0 to 6, with higher scores indicating worse function, and 0.5 is the minimal clinically important difference between scores. At randomization and the final study visit, we administered the St.
Safety was evaluated by an assessment of adverse events, vital signs, electrocardiographic findings, and immunogenicity, along with clinical laboratory testing. Levels of antibodies against mepolizumab were measured before randomization and at three time points after randomization.All patients who received at least one dose of a study drug were included in a modified intention-to-treat analysis.
that included covariates for treatment, use of maintenance oral glucocorticoids, geographic region, number of exacerbations in the previous year, and baseline percentage of the predicted FEV. We estimated that with 180 patients in each group, the study would have a power of 90% to detect a 40% decrease in the exacerbation rate, from 2.40 per year in the placebo group to 1.44 per year in each of the mepolizumab groups, at a two-sided significance level of 0.05.
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