ATLANTA, GA—Reslizumab appears to improve clinical asthma exacerbation rates among patients with aspirin exacerbated respiratory disease (AERD), according to a pooled analysis of data from two previous trials, presented at the 2017 AAAAI Annual Meeting.
“Patients with inadequately controlled asthma, elevated blood eosinophils, and ASA [aspirin] sensitivity with or without CRSwNP [chronic rhinosinusitis with nasal polyps] received significant therapeutic benefit, providing further support for the use of reslizumab in this clinical setting,” reported lead study author Rohit Katial, MD, National Jewish Health, Denver, CO, and colleagues.
AERD involves ASA (or Samter’s) Triad: CRSwNP with asthma and aspirin intolerance. Patients are frequently also intolerant of other nonsteroidal anti-inflammatory drugs (NSAIDs). Reslizumab, a humanized, monoclonal, high-affinity antibody, works by targeting interleukin (IL)-5.
“Eosinophilic inflammation plays an important role in AERD,” Dr. Katial noted.
The study authors studied clinical asthma exacerbations (CAE) among patients with previously inadequately inhaled corticosteroid-controlled asthma and a history of ASA, after treatment with reslizumab. They analyzed data pooled from the 3082 and 3082 studies, representing 953 patients, 103 (11%) of whom had histories of ASA. Fifty-six patients (6%) had confirmed CRSwNP with aspirin sensitivity but sinus disease status data were unavailable for some other participants so that proportion might represent an underestimate; 93 patients (10%) had confirmed CRSwNP with no aspirin sensitivity. All patients enrolled in the studies had elevated blood eosinophils at baseline.
Patients had been randomized to receive either placebo or 3mg/kg intravenous reslizumab every 4 weeks for 52 weeks.
The 48 patients with ASA sensitivity who received reslizumab saw a 62% reduction in annual clinical asthma exacerbations (CAE) compared to patients in the placebo group (rate ratio [RR] 0.38, 95% CI: 0.21–0.70); of these patients, those with CRSwNP (n=28) saw a 79% reduction in CAE (RR 0.21, 95% CI: 0.08–0.58), Dr. Katial reported. Patients with CRSwNP without aspirin sensitivity saw a 85% reduction in annual CAE (RR 0.15, 95% CI: 0.07–0.32).
“Compared with placebo, add-on reslizumab provided large improvements in forced expiratory volume in 1 second [FEV1] among patients with aspirin sensitivity, CRSwNP without aspirin sensitivity, and CRSwNP with aspirin sensitivity,” Dr. Katial said. Reslizumab-treated patients in all 3 subgroups showed significant improvements in asthma control vs. placebo-treated patients by the end of the 52-week study period. Moreover, patients with clinical characteristics suggestive of AERD who received add-on reslizumab showed clinically improvements in asthma-related quality of life vs. placebo.
Dr. Katial concluded, “Patients with asthma and concurrent aspirin sensitivity and/or CRSwNP generally have significant eosinophilic inflammation, which may explain the dramatic treatment response to reslizumab.”