TY - JOUR
T1 - Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study
AU - the PONENTE Study Group
AU - Menzies-Gow, Andrew
AU - Gurnell, Mark
AU - Heaney, Liam G.
AU - Corren, Jonathan
AU - Bel, Elisabeth H.
AU - Maspero, Jorge
AU - Harrison, Timothy
AU - Jackson, David J.
AU - Price, David
AU - Lugogo, Njira
AU - Kreindler, James
AU - Burden, Annie
AU - de Giorgio-Miller, Alex
AU - Faison, Sarai
AU - Padilla, Kelly
AU - Martin, Ubaldo J.
AU - Gil, Esther Garcia
AU - Ardusso, Ledit
AU - Bazerque, Rocio Fernandez
AU - Doreski, Pablo Alexis Christian
AU - Elias, Pedro Carlos
AU - Gattolin, Gabriel
AU - Medina, Andrea Cintia
AU - Ruiz, Xavier Bocca
AU - Salvado, Alejandro
AU - Del Olmo Sansone, Ricardo Alfonso
AU - Wehbe, Luis
AU - Verra, Fernando José Bartolomé
AU - Brusselle, Guy
AU - Pilette, Charles
AU - Martinot, Jean Benoît
AU - Antila, Martti Anton
AU - Blanco, Daniela Cavalet
AU - Cerci, Alcindo
AU - Cunha, Thulio Marquez
AU - Fiss, Elie
AU - Franza, Luciene
AU - Machado, Adelmir Souza
AU - De Mattos, Waldo Luis Leite Dias
AU - Grava, Sergio
AU - Minamoto, Suzana Erico Tanni
AU - De Oliveira, Carlos Alberto
AU - Cheema, Amarjit S.
AU - Dorscheid, Delbert
AU - Fera, Tharwat A.E.
AU - Gagnon, Remi
AU - Philteos, George
AU - Sussman, Gordon
AU - Yang, William Ho Ching
AU - Kuo, Han Pin
N1 - Publisher Copyright:
Copyright © The authors 2022.
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Background Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day-1 (median (range) 0.0 (0.0-40.0) mg). Methods The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ~6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events. Results 598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0-40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (-19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports. Conclusions Most patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.
AB - Background Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day-1 (median (range) 0.0 (0.0-40.0) mg). Methods The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ~6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events. Results 598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0-40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (-19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports. Conclusions Most patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.
UR - http://www.scopus.com/inward/record.url?scp=85144594269&partnerID=8YFLogxK
U2 - 10.1183/13993003.03226-2021
DO - 10.1183/13993003.03226-2021
M3 - 文章
C2 - 35896216
AN - SCOPUS:85144594269
SN - 0903-1936
VL - 60
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 6
M1 - 2103226
ER -