S117 Clinical remission in patients with severe eosinophilic asthma: an analysis of SIROCCO and CALIMA trial data

• Published in: Thorax Vol. 78; no. Suppl 4; p. A84
• Main Authors: Menzies-Gow, A, Hoyte, FL, Price, DB, Swisher, S, Cohen, D, Shavit, A
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and British Thoracic Society 06.11.2023; BMJ Publishing Group LTD
• Subjects: Asthma; Patients; Polyps; Remission (Medicine); ‘The winner takes it all’ – Therapy in asthma
• ISSN: 0040-6376; 1468-3296
• DOI: 10.1136/thorax-2023-BTSabstracts.123

IntroductionEfficacy 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).MethodsEligible patients for SIR/CAL were aged 12–75 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 <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.ResultsAmong 1123 patients from SIR/CAL, 39.2% (213/544) on benralizumab achieved CR compared with 26.6% (154/579) on placebo (table 1). Baseline median [range] blood eosinophil counts were higher for patients achieving CR (benralizumab, 412 cells/µL [0, 2095 cells/µL]; placebo, 402 cells/µL [10, 3640 cells/µL]) than for non-CR patients (benralizumab, 365 [0, 3100 cells/µL]; placebo, 360 cells/µL [0, 2610 cells/µL]). The percentage of patients achieving CR with a forced expiratory volume in 1 second (FEV1) ≥65% predicted was higher (benralizumab, 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 >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]).Abstract S117 Table 1Patient demographics and baseline clinical characteristics Benralizumab Placebo Remission (N=213) Non-remission (N=331) Remission (N=154) Non-remission (N=425) Age, years, mean (SD) 47.6 (13.92) 50.5 (13.75) 47.1 (16.63) 50.1 (13.84) ≥12–<18 10 (4.7) 10 (3.0) 12 (7.8) 14 (3.3) ≥18–<50 93 (43.7) 134 (40.5) 62 (40.3) 169 (39.8) ≥50–<65 90 (42.3) 141 (42.6) 59 (38.3) 185 (43.5) ≥65–75 20 (9.4) 46 (13.9) 21 (13.6) 57 (13.4) Sex, female, n (%) 121 (56.8) 218 (65.9) 91 (59.1) 277 (65.2) Local baseline bEOS count cells/µL, median 412.0 365.0 402.0 360.0 (range) (0, 2095) (0, 3100) (10, 3640) (0, 2610) Local baseline bEOS ≥300 cells/µL, n (%) 152 (72.0) 208 (63.8) 113 (73.9) 275 (65.3) Time since asthma diagnosis, years, mean (SD) 18.3 (14.82) 20.0 (15.05) 19.5 (16.22) 19.6 (14.78) Age at asthma onset, years, mean (SD) 29.9 (18.04) 31.1 (19.25) 28.3 (20.95) 31.1 (18.52) Total IgE, IU/mL, median (range) 166.3 206.1 185.3 179.7 (4, 5782) (2, 12754) (5, 10029) (2, 17317) Phadiatop, positive at baseline, n (%) N=211 N=323 N=153 N=418 136 (64.5) 209 (64.7) 98 (64.1) 246 (58.9) ACQ-6 score, mean (SD) 2.5 (0.86) 3.0 (0.85) 2.5 (0.87) 2.9 (0.88) History of nasal polyps, n (%) 42 (19.7) 38 (11.5) 22 (14.3) 76 (17.9) FEV1% predicted normal n (%) <65% 130 (61.3) 233 (70.6) 91 (59.1) 274 (66.2) ≥65% 82 (38.7) 97 (29.4) 63 (40.9) 140 (33.8) Exacerbations at baseline, n (%) 2 151 (70.9) 216 (65.3) 114 (74.0) 260 (61.2) >2 61 (28.6) 115 (34.7) 40 (26.0) 165 (38.8) ACQ-6, Asthma Control Questionnaire 6-item; bEOS, blood eosinophil; FEV1, forced expiratory volume, 1 second; IgE, immunoglobulin E; IU, international unit; µL, micro liter; SD, standard deviation.ConclusionsOur 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.