Reslizumab Efficacy Examined in Severe Eosinophilic Asthma
This article is part of MPR's coverage of the American Academy of Allergy, Asthma & Immunology, taking place in Orlando, Florida. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI/WAO 2018.
ORLANDO — Reslizumab reduced the risk for asthma exacerbations compared with placebo in patients with severe eosinophilic asthma, according to a post hoc pooled analysis of 2 phase 3 clinical trials presented at the 2018 Joint Congress of the American Academy of Allergy, Asthma & Immunology, held March 2-5, in Orlando, Florida.
The 2 multinational trials (ClinicalTrials.gov Identifiers: NCT01287039; NCT01285323) were conducted in 232 centers and enrolled 953 patients with asthma inadequately controlled with medium to high doses of inhaled corticosteroids (Asthma Control Questionnaire-7 score ≥1.5). In order to be eligible for inclusion, participants had at least 1 clinical asthma exacerbation (CAE) in the past year and forced expiratory volume in 1 second (FEV1) reversibility of ≥12% with a short-acting beta-agonist. All participants were between the ages of 12 and 75 with blood eosinophils ≥400 cells/μL.
Patients were randomly assigned 1:1 to receive either intravenous reslizumab 3 mg/kg (n=477) or placebo (n=476) every 4 weeks for 1 year. At baseline, patients were receiving at least a medium dose of inhaled corticosteroids (fluticasone propionate ≥440 μg/d or equivalent) with or without another controller drug (including oral corticosteroids, ≤10 mg/d of prednisone or equivalent). Patients continued their usual treatment throughout the study and prebronchodilator spirometry was measured every 4 weeks.
Study participants who had a great number of asthma exacerbations had lower FEV1 values at baseline. Overall, participants who had more asthma exacerbations had lower FEV1 values at baseline: FEV1 1837 mL with at least 4 asthma exacerbations, FEV1 1883 mL with 3 exacerbations, FEV1 1972 mL with 2 exacerbations, and FEV1 2040 mL with 1 exacerbation.
Overall least square mean treatment differences in FEV1 over 16 weeks for patients were greater in patients with more historical CAEs. For patients with 1 historical CAE, a treatment difference of 77 (28) mL was found with reslizumab compared with placebo (P =.0061). For patients with 2 historical CAEs, a treatment difference of 135 (50) mL (P=.0072) was observed. For patients with 3 historical CAEs, a treatment difference of 141 (70) mL was observed (P =.0480). The mean treatment difference increased to 220 (81) mL (P =.0080) in patients with at least 4 historical CAEs.
The researchers categorized patients by number of exacerbations and found that those who had more exacerbations also experienced a greater treatment difference in FEV1 after 52 weeks of treatment: 205 mL (P =.0110) with at least 4 asthma exacerbations, 138 mL (P =.0494) with 3 exacerbations, 139 mL (P =.0140) with 2 exacerbations, and 69 mL (P =.0124) with 1 exacerbation.
The treatment effects of reslizumab on asthma exacerbation rate and FEV1 may be related, the researchers concluded, which suggests “a possible physiologic association between exacerbations and lung function in patients with severe eosinophilic asthma.”Disclosures: This study was funded by Teva Pharmaceuticals.
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Fahrenholz JM, McDonald M, Garin M. Association between asthma exacerbations and lung function with reslizumab treatment in patients with uncontrolled eosinophilic asthma: pooled analysis of two phase 3 trials. Presented at: 2018 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress; March 2-5, 2018; Orlando, FL. Poster 50.