6533b833fe1ef96bd129b60f

RESEARCH PRODUCT

Clinically meaningful FEV1 response with reslizumab achieved early and sustained over 52 weeks

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description

Background: Reslizumab (RES) is a humanized anti-interleukin-5 monoclonal antibody that significantly reduces the risk of asthma exacerbations and improves asthma control, lung function, and quality of life in patients with uncontrolled eosinophilic asthma. The mean difference in FEV 1 in RES treated patients vs placebo (PBO) at 16 and 52 weeks has been shown to be statistically and clinically significant (Castro et al., Lancet Respir Med. 2015; 3:355–366), but individual responders have not been assessed. Aims/Objectives: To assess the proportion of RES-treated patients who achieved a ≥0.1L increase in FEV 1 from baseline and the duration of treatment before response occurs. Methods: This was a post-hoc analysis of the two duplicate, multicenter, randomized, 52-week, PBO-controlled phase 3 trials of RES (3 mg/kg IV Q4W) (Castro 2015). Proportion of patients achieving 0.1L FEV 1 increase at each visit in each group are reported. Results: The trials included 953 patients (RES 477; PBO 476). As early as 4 weeks, 255 patients (54%) in the RES-treated group and 188 (40%) in the PBO group achieved ≥0.1L FEV 1 increase (p Conclusions: RES was effective in producing a clinically meaningful improvement of ≥0.1L in FEV 1 as early as 4 weeks, which was sustained up to week 52. Although onset of improvement in FEV 1 was early in most patients, additional clinically important response may occur through week 24.