50:
Association Between Asthma Exacerbations and Lung Function With Reslizumab Treatment In Patients With Uncontrolled Eosinophilic Asthma: Pooled Analysis of Two Phase 3 Trials
Saturday, March 3, 2018
South Hall A2 (Convention Center)
John M. Fahrenholz, MD FAAAAI, Mirna McDonald, Margaret Garin
RATIONALE: Reslizumab (RES), a humanized anti-interleukin-5 monoclonal antibody, significantly reduced the risk of clinical asthma exacerbation (CAE) in patients with inadequately controlled eosinophilic asthma and ≥1 CAE in the prior 12 months, with greater treatment effect in patients with more historical CAEs. The objective of this analysis was to assess the association between baseline CAE rate and lung function (FEV1 change from baseline).

METHODS: This was a post-hoc analysis of two duplicate 52-wk, placebo (PBO)-controlled phase 3 trials of RES (3 mg/kg IV Q4W). Differences between PBO and RES groups in change in FEV1 are reported for subgroups of prior CAE history (1 to ≥4 CAE in previous 12 months).

RESULTS: Of 953 patients, 559 had 1 historical CAE, 193 had 2 historical CAE, 80 had 3 historical CAE, and 115 had ≥4 CAE. Trends towards lower FEV1 at baseline and greater FEV1 treatment effect over 52 weeks were observed in RES vs PBO in patients with more historical CAEs: 1 historical CAE (baseline 2046mL, diff over 52 weeks 69mL, p=0.0124), 2 historical CAE (baseline 1972mL, diff over 52 weeks 139mL, p=0.0140), 3 historical CAE (baseline 1833mL, diff over 52 weeks 138mL, p=0.0494), ≥4 historical CAE (baseline 1837mL, diff over 52 weeks 205mL, p=0.0110).

CONCLUSIONS: RES was consistently effective at improving FEV1 in all historical CAE subgroups. RES treatment effects on CAE rate and FEV1 appear to be related, suggesting a possible physiologic association between exacerbations and lung function in patients with severe eosinophilic asthma.