6533b834fe1ef96bd129cb2b

RESEARCH PRODUCT

Reslizumab for uncontrolled eosinophilic asthma in patients who experienced a single exacerbation in the previous year: sub-analysis of two phase 3 trials

subject

description

Background: Reslizumab (RES), a humanized anti-interleukin-5 monoclonal antibody, has been demonstrated to significantly reduce the risk of clinical asthma exacerbation (CAE), and improve lung function, asthma symptoms and quality of life (QOL) in patients (pts) with inadequately controlled eosinophilic asthma (ICEA) and ≥1 CAE in the prior 12 mos despite standard of care therapy (Castro et al., Lancet Respir Med 2015; 3:355-366). Aims/Objectives: To assess the efficacy of RES in a subgroup of pts with ICEA who experienced only 1 CAE in the 12 mos prior to trial enrolment. Methods: This was a post-hoc analysis of the two duplicate 52-wk, placebo (PBO)-controlled phase 3 trials of RES (3 mg/kg IV Q4W). Differences between PBO and RES groups in the rate of CAE, lung function (FEV1), asthma control (ACQ-7), QOL (AQLQ) and asthma symptoms (ASUI) are reported. Results: Of 953 pts, 559 (59%) experienced a single CAE in the 12 mos prior to enrolment (RES 282; PBO 277). In these pts, RES therapy vs PBO reduced the rate of CAE (rate ratio: 0.68 [95% CI: 0.49, 0.95], p=0.0242), and improved FEV1 (difference of 0.069 [0.015, 0.124], p=0.0124), ACQ-7 (difference of -0.190 [-0.311, -0.069], p=0.002), AQLQ (difference of 0.181 [0.028, 0.335], p=0.0208) and ASUI (difference of 0.037 [0.017, 0.057], p=0.0003). Conclusions: RES was effective in reducing CAE rate and improving lung function, asthma control, QOL, and symptoms in pts with ICEA who had experienced only 1 CAE in the previous year, suggesting that prescribers might consider starting RES therapy after the first CAE in these pts rather than waiting until multiple CAEs have occurred.