TY - JOUR
T1 - S117 Clinical remission in patients with severe eosinophilic asthma
T2 - an analysis of SIROCCO and CALIMA trial data
AU - Menzies-Gow, A
AU - Hoyte, FL
AU - Price, David
AU - Swisher, S
AU - Cohen, D
AU - Shavit, A
PY - 2023/11/6
Y1 - 2023/11/6
N2 - Introduction Efficacy and safety of benralizumab were evaluated in patients with severe eosinophilic asthma (SEA) in phase 3 SIROCCO (SIR; NCT01928771) and CALIMA (CAL; NCT01914757) trials. Prior studies have shown clinical remission (CR) is achievable with benralizumab; this post-hoc analysis evaluated baseline characteristics of patients in SIR/CAL who achieved CR or did not achieve CR (non-CR).Methods Eligible patients for SIR/CAL were aged 12textendash75 years with >=2 exacerbations within the previous year despite medium- to high-dose ICS plus additional controllers. CR was defined as zero exacerbations, zero OCS, and an ACQ-6 score lt;1.5 after 12 months; patients on OCS at baseline were excluded. We compared baseline patient characteristics (SIR/CAL) of CR patients (i.e., met all 3 components) with non-CR patients.Results Among 1123 patients from SIR/CAL, 39.2213/544) on benralizumab achieved CR compared with 26.6154/579) on placebo (table 1). Baseline median [range] blood eosinophil counts were higher for patients achieving CR (benralizumab, 412 cells/textmuL [0, 2095 cells/textmuL]; placebo, 402 cells/textmuL [10, 3640 cells/textmuL]) than for non-CR patients (benralizumab, 365 [0, 3100 cells/textmuL]; placebo, 360 cells/textmuL [0, 2610 cells/textmuL]). The percentage of patients achieving CR with a forced expiratory volume in 1 second (FEV1) >=65benralizumab, 38.7 placebo, 40.9 than for non-CR patients (benralizumab, 29.4 placebo, 33.8. Of patients with nasal polyps receiving benralizumab, a higher percentage achieved CR (19.7 than non-CR (11.5. Lower percentages of CR patients had gt;2 exacerbations within 12 months of baseline (benralizumab, 28.6 placebo, 26.0 than non-CR patients (benralizumab, 34.7 placebo, 38.8. Mean [SD] baseline ACQ-6 scores were lower for CR patients (benralizumab, 2.5 [0.86]; placebo, 2.5 [0.87]) than non-CR patients (benralizumab, 3.0 [0.85]; placebo, 2.9 [0.88]).View this table:Abstract S117 Table 1 Patient demographics and baseline clinical characteristicsConclusions Our analysis shows greater likelihood of CR in patients with higher blood eosinophil counts, better lung function, lower ACQ-6 score, and fewer exacerbations at baseline. CR was more likely to be achieved in patients with a history of nasal polyps who received benralizumab. These data highlight the importance of diagnosing and appropriately treating SEA as early as possible.Please refer to page A287 for declarations of interest related to this abstract.
AB - Introduction Efficacy and safety of benralizumab were evaluated in patients with severe eosinophilic asthma (SEA) in phase 3 SIROCCO (SIR; NCT01928771) and CALIMA (CAL; NCT01914757) trials. Prior studies have shown clinical remission (CR) is achievable with benralizumab; this post-hoc analysis evaluated baseline characteristics of patients in SIR/CAL who achieved CR or did not achieve CR (non-CR).Methods Eligible patients for SIR/CAL were aged 12textendash75 years with >=2 exacerbations within the previous year despite medium- to high-dose ICS plus additional controllers. CR was defined as zero exacerbations, zero OCS, and an ACQ-6 score lt;1.5 after 12 months; patients on OCS at baseline were excluded. We compared baseline patient characteristics (SIR/CAL) of CR patients (i.e., met all 3 components) with non-CR patients.Results Among 1123 patients from SIR/CAL, 39.2213/544) on benralizumab achieved CR compared with 26.6154/579) on placebo (table 1). Baseline median [range] blood eosinophil counts were higher for patients achieving CR (benralizumab, 412 cells/textmuL [0, 2095 cells/textmuL]; placebo, 402 cells/textmuL [10, 3640 cells/textmuL]) than for non-CR patients (benralizumab, 365 [0, 3100 cells/textmuL]; placebo, 360 cells/textmuL [0, 2610 cells/textmuL]). The percentage of patients achieving CR with a forced expiratory volume in 1 second (FEV1) >=65benralizumab, 38.7 placebo, 40.9 than for non-CR patients (benralizumab, 29.4 placebo, 33.8. Of patients with nasal polyps receiving benralizumab, a higher percentage achieved CR (19.7 than non-CR (11.5. Lower percentages of CR patients had gt;2 exacerbations within 12 months of baseline (benralizumab, 28.6 placebo, 26.0 than non-CR patients (benralizumab, 34.7 placebo, 38.8. Mean [SD] baseline ACQ-6 scores were lower for CR patients (benralizumab, 2.5 [0.86]; placebo, 2.5 [0.87]) than non-CR patients (benralizumab, 3.0 [0.85]; placebo, 2.9 [0.88]).View this table:Abstract S117 Table 1 Patient demographics and baseline clinical characteristicsConclusions Our analysis shows greater likelihood of CR in patients with higher blood eosinophil counts, better lung function, lower ACQ-6 score, and fewer exacerbations at baseline. CR was more likely to be achieved in patients with a history of nasal polyps who received benralizumab. These data highlight the importance of diagnosing and appropriately treating SEA as early as possible.Please refer to page A287 for declarations of interest related to this abstract.
U2 - 10.1136/thorax-2023-BTSabstracts.123
DO - 10.1136/thorax-2023-BTSabstracts.123
M3 - Article
SN - 0040-6376
VL - 78
SP - A84-A84
JO - Thorax
JF - Thorax
IS - Suppl 4
ER -