PMID- 33978983 OWN - NLM STAT- MEDLINE DCOM- 20220401 LR - 20220401 IS - 1398-9995 (Electronic) IS - 0105-4538 (Linking) VI - 77 IP - 1 DP - 2022 Jan TI - Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis. PG - 150-161 LID - 10.1111/all.14902 [doi] AB - BACKGROUND: Clinically meaningful improvement in the Sino-Nasal Outcome Test-22 (SNOT-22) was observed in patients with severe, eosinophilic asthma, and nasal polyposis (NP) treated with benralizumab in the ANDHI trial. A post hoc assessment of the effects of benralizumab on SNOT-22 response and asthma efficacy measures in these patients was conducted for further characterization of the efficacy and safety of benralizumab for patients with severe asthma and NP. METHODS: Adults with severe, eosinophilic asthma who had experienced >/=2 prior-year exacerbations despite high-dosage inhaled corticosteroid plus additional controller[s] were randomized to 24 weeks of benralizumab or placebo. Patients with physician-diagnosed chronic rhinosinusitis with NP of any severity ongoing at baseline who consented to participate were included in the current ANDHI NP substudy population. Effect on NP symptoms was assessed by the SNOT-22, with an improvement of at least 8.9 defined as clinically significant (responder). Effects on chronic asthma outcomes were assessed by means of annualized asthma exacerbation rate (AER), St. George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in one second (FEV(1) ), and Asthma Control Questionnaire-6 (ACQ-6). All p-values were nominal. RESULTS: Of the ANDHI population (n = 656), 23% (n = 153) participated in the NP substudy (n = 96 benralizumab; n = 57 placebo). Patients were 50% female, with mean age of 53 years, had prior-year AER = 3.3; mean pre-bronchodilator FEV(1) = 55% predicted; and median blood eosinophil count ​= 510 cells/microl. For patients with high baseline SNOT-22 scores (>30), benralizumab treatment improved symptoms of NP as measured by SNOT-22 from baseline to Week 24 compared with placebo (Week 24: -10.44 [p = .0176]). Percentage of responders to SNOT-22 was greater for benralizumab vs. placebo (71.3% vs. 45.5%; p = .0036), and effect was enhanced for patients with high baseline SNOT-22 scores (>30). A 69% reduction vs. placebo in annualized AER (0.77 vs. 2.47; p < .0001) and greater clinically meaningful improvements from baseline in SGRQ total score (-16.7), FEV(1) (+0.32 L), and ACQ-6 (-0.88) were observed (p < .0001). Benralizumab was well-tolerated. Frequency of adverse events (AEs) was similar for benralizumab (76.0%) and placebo (73.7%) groups. Most common AEs (frequency >/=5%) reported at a greater frequency in benralizumab vs. placebo included headache, sinusitis, pyrexia, and influenza. CONCLUSIONS: These substudy data from ANDHI demonstrated the efficacy profile of benralizumab for patients with severe, eosinophilic asthma and NP, with improvement in SNOT-22 and asthma outcomes. CI - (c) 2021 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd. FAU - Canonica, Giorgio Walter AU - Canonica GW AUID- ORCID: 0000-0001-8467-2557 AD - Department of Biomedical Sciences, Humanitas University, Milan, Italy. AD - IRCCS Humanitas Research Hospital, Personalized Medicine, Asthma and Allergy, Milan, Italy. FAU - Harrison, Tim W AU - Harrison TW AD - Respiratory Research Unit, Nottingham NIHR BRC, University of Nottingham, Nottingham City Hospital, Nottingham, UK. FAU - Chanez, Pascal AU - Chanez P AD - Department of Respiratory CIC Nord INSERMINRAE C2VN, Aix Marseille University, Marseille, France. FAU - Menzella, Francesco AU - Menzella F AUID- ORCID: 0000-0003-3950-5789 AD - Pneumology Unit, Azienda USL di Reggio Emilia-IRCCS, Reggio Emilia, Italy. FAU - Louis, Renaud AU - Louis R AD - University and CHU of Liege, Liege, Belgium. FAU - Cosio, Borja G AU - Cosio BG AUID- ORCID: 0000-0002-6388-8209 AD - Hospital Son Espases-IdISBa and Ciberes, Palma de Mallorca, Spain. FAU - Lugogo, Njira L AU - Lugogo NL AD - University of Michigan Medical Center, Ann Arbor, Michigan, USA. FAU - Mohan, Arjun AU - Mohan A AD - East Carolina University Brody School of Medicine, Greenville, North Carolina, USA. FAU - Burden, Annie AU - Burden A AD - AstraZeneca, Cambridge, UK. FAU - Garcia Gil, Esther AU - Garcia Gil E AD - AstraZeneca, Barcelona, Spain. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210608 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 71492GE1FX (benralizumab) SB - IM MH - Adult MH - *Anti-Asthmatic Agents/adverse effects MH - Antibodies, Monoclonal, Humanized/adverse effects MH - *Asthma/chemically induced/diagnosis/drug therapy MH - Disease Progression MH - Double-Blind Method MH - Eosinophils MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Pulmonary Eosinophilia/drug therapy MH - Treatment Outcome OTO - NOTNLM OT - asthma OT - asthma treatment OT - biologics OT - eosinophils OT - sinusitis EDAT- 2021/05/13 06:00 MHDA- 2022/04/02 06:00 CRDT- 2021/05/12 12:38 PHST- 2021/04/13 00:00 [revised] PHST- 2020/07/17 00:00 [received] PHST- 2021/04/18 00:00 [accepted] PHST- 2021/05/13 06:00 [pubmed] PHST- 2022/04/02 06:00 [medline] PHST- 2021/05/12 12:38 [entrez] AID - 10.1111/all.14902 [doi] PST - ppublish SO - Allergy. 2022 Jan;77(1):150-161. doi: 10.1111/all.14902. Epub 2021 Jun 8.