Abstract
Oral corticosteroid dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's oral corticosteroid-reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day-1 (median, 0.0 mg [range, 0.0-40.0]).The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For approximately 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 oral corticosteroid dosage, Asthma Control Questionnaire 6 (ACQ-6), and St. George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations, and adverse events.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 oral corticosteroid dosage was unchanged (0.0 mg; [range, 0.0-40.0]), 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.Most patients successfully maintained maximal oral corticosteroid reduction whilst achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.
| Original language | English |
|---|---|
| Article number | 2103226 |
| Number of pages | 13 |
| Journal | European Respiratory Journal |
| Volume | 60 |
| Issue number | 6 |
| Early online date | 1 Dec 2022 |
| DOIs | |
| Publication status | Published - 1 Dec 2022 |
Bibliographical note
AcknowledgmentsWriting and editing assistance, including preparation of a draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by Jennifer Gibson, PharmD (Kay Square Scientific, Newtown Square, PA, USA). This support was funded by AstraZeneca.
The PONENTE Study Group investigators (by country): Argentina: National University of Rosario, Rosario: Ledit Ardusso; Fundacion Respirar Salud, Buenos Aires: Rocio Fernandez Bazerque; Fundacion Respirar, Buenos Aires: Pablo Alexis Christian Doreski; INSARES, Mendoza: Pedro Carlos Elias; Hospital Italiano, Rosario: Gabriel Gattolin; Hospital Dr. Isidoro G. Iriarte, Buenos Aires: Andrea Cintia Medina; Clínica Monte Grande, Buenos Aires: Xavier Bocca Ruiz; British Hospital of Buenos Aires,
Buenos Aires: Alejandro Salvado; Hospital María Ferrer and IDIM CR, Buenos Aires: Ricardo Alfonso Del Olmo Sansone; Fundación Enfisema, Buenos Aires: Luis Wehbe; Centro de investigaciones Clínicas WM, Sante Fe: Fernando José Bartolomé Verra; Belgium: Ghent University Hospital, Ghent: Guy Brusselle; Université catholique de Louvain, Brussels: Charles Pilette; UCL Bruxelles Woluwe, Brussels:
Jean-Benoît Martinot; Brazil: Clinica de Alergia Martti Antila, Sorocaba: Martti Anton Antila; Pontifical Catholic University of Rio Grande do Sul, Porto Alegre: Daniela Cavalet Blanco; Universidade Estadual de Londrina, Paraná: Alcindo Cerci; Universidade Federal de Uberlândia, Uberlândia: Thulio Marquez Cunha; Hospital Alemão Oswaldo Cruz, São Paulo: Elie Fiss; São Bernardo do Campo: Luciene Franza;
Universidade Federal da Bahia, Salvador: Adelmir Souza Machado; Hospital Nossa Senhora da Conceição, Porto Algre: Waldo Luis Leite Dias De Mattos; Paraná Medical Research Center, Maringá, Paraná: Sergio Grava; Faculdade de Medicina de Botucatu, Botucatu, São Paulo: Suzana Erico Tanni Minamoto; Cremesp, São Paulo: Carlos Alberto De Oliveira; Canada: Cheema Research Inc., Mississauga: Amarjit S. Cheema; The University of British Columbia, Vancouver: Delbert Dorscheid and Tharwat A.E. Fera; Clinique spécialisée en allergie de la capitale, Quebec: Remi Gagnon; Royal
University Hospital, University of Saskatchewan, Saskatoon: George Philteos; University of Toronto, Toronto: Gordon Sussman; University of Ottawa, Ottawa: William Ho-Ching Yang; Colombia: Caja de Compensación Familiar de Caldas, Manizales: Carlos Dario Aguilar; Centro Médico Vital, Barranquilla: Rodolfo Jaller; Centro Médico Gastropack, Cartagena:Myrna Liliana Jazime; Bluecare Salud SAS, Bogotá: Francisco Orlando Serrano; Medellín: Ana Catalina Vanegas; Instituto Neumológico del Oriente, Bucaramanga: Leslie Katherine Vargas; Centro de Investigaciones Clinicas SA, Cali: Maria Fernanda Villegas; Denmark: Vejle Hospital, Vejle: Ole Hilberg; Novo Nordisk, Bagsværd: Henning Bay Nielsen; Sanos Clinic, Herlev: Jakob Nielsen; Aalborg University Hospital, Aalborg: Ulla Møller Weinreich; Copenhagen University Hospital Hvidovre, Hvidovre: Charlotte Suppli Ulrik; France: INSERM U1100, Tours: Sylvain Marchand Adam; University Hospital of Reims, Reims: Gaëtan Deslee; European Hospital Marseille, Marseille: Hervé Pegliasco; CHU de Nice, Nice: Johana Pradelli; CHRU Jean Minjoz, Besançon: Pauline-Marie Roux; Center Hospitalier Régional d'Orléans, Orléans: Maud Russier; Germany: Pneumologenzentrum Leipzig - Dres. Deckelmann/ Eckhardt/ Kratzsch, Leipzig: Regina Deckelmann; IKF Pneumologie GmbH & Co. KG, Institut für klinische Forschung Pneumologie, Frankfurt: Andreas Eich; Lungenzenzentrum Darmstadt, Darmstadt: Andreas Forster; University of Heidelberg, Heidelberg: Felix Herth; Gemeinschaftspraxis für Herz und Lunge und ambulantes Schlaflabor am Bruderwald, Bamberg: Joachim Kirschner; Pulmonary Research Institute at LungClinic Grosshansdorf, Grosshansdorf: Anne-Marie Kirsten; Lungenarzte Kasper & Schuhmann, Konstanz: Maren Schuhmann; MECS Research GmbH, Berlin: Thomas K. Schultz; KLB Gesundheitsforschung Lübeck, Lübeck: Andrea Ludwig-Sengpiel; Lungenarztpraxis - Dr. Evelin Liefring/ Ishak Teber, Berlin: Ishak Teber; Technische Universität München, München: Gregor S. Zimmermann; Italy: University of Florence, Florence: Fabio Almerigogna; University of Pisa, Pisa: Alessandro Celi; Monaldi Hospital, Napoli: Maria D’Amato; University of Pisa, Pisa: Pierluigi Paggiaro; Sapienza University of Rome, Rome: Paolo Palange; University of Sassari, Sassari: Pietro Pirina; Istituto Maugeri IRCCS, Tradate: Antonio Spanevello; Mexico: Instituto Jalisciense de Investigación Clínica, Guadalajara, Jalisco: Dante Daniel Hernandez Colin; Arke SMO SA de CV, Ciudad de Mexico: Amado Ramírez Hernández; Instituto
Nacional de Enfermedades Respiratorias, Ciudad de México: Edgar Alejandro Reyes García; Centro de Investigacion Medico Biologica y Terapia Avanzada, Jalisco: Efrain Montaño Gonzalez; Hospital de la Paz, Durango: Ricardo Alberto Ramirez Terrones; Hospital Angeles Villahermosa, Villahermosa, Tabasco: Ruth Cerino Javier; Centro de Desarrollo Biomedico, Yucatán: Juan Francisco Rubio Suarez; Poland: University of Gdańsk, University Clinical Center, Gdańsk: Marta Chełmińska; Ostrowieckie Centrum Medyczne spółka cywilna, Ostrowiec Świętokrzysk: Krzysztof Cudzik and Anna Olech-Cudzik; Indywidualna Specjalistyczna Praktyka Lekarska, Sosnowiec: Krzysztof Filipek; Centrum Nowoczesnych Terapii "Dobry Lekarz,‖ Kraków: Łukasz Goliński; Centrum Diagnostyczno Terapeutyczne Medicus, Lubin: Artur Kwaśniewski; ALERGO-MED Poradnia Specjalistyczna, Warsaw: Danuta Mądra-Rogacka;
Bialystok Medical University Kilińskiego, Bialystok: Robert Mróz; Wroclaw Medical University, Wroclaw: Marita Nittner-Marszalska; Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz, Rzeszów: Małgorzata Pawlukiewicz; Prywatna Praktyka Lekarska, Gabinet Pediatryczno-Alergologiczny, Białystok: Anna Płoszczuk; SNZOZ Alergologia Plus, Poznań: Ewa Springer; SANMED, Wieluń: Anna Świderska; Specjalistyczne Centrum Medyczne, Sosnowiec: Małgorzata Żurowska-Gębala; Russian Federation: Mechnikov North-Western State Medical University, Saint Petersburg:Alexander Viktorovich Emelyanov; SSC Institute of immunology FMBA of Russia, Moscow: Oksana Kurbacheva; Kirov State Medical University, Kirov: Alla Odegova; Ulyanovsk State University, Ulyanovsk: Andrey Peskov; Omsk city clinic hospital №1 n.a. Kabanov A.N, Omsk: Dmitriy Vladimirovich Petrov; St. Petersburg State Budgetary Healthcare Institution, Saint Petersburg: Tamara Vsevolodovna Rubanik; Alliance Biomedical-Ural Group, Izhevsk: Maksim Vasilev; Omsk State Medical University, Omsk: Maria Vershinina; Spain: University of Santiago de Compostela, Santiago de Compostela: Francisco Javier González Barcala; Complejo Hospitalario Universitario de Santiago (CHUS), Santiago: Vanessa
Riveiro Blanco; Mérida Hospital, Mérida: Antonio Manuel Pérez Fernández; University Hospital Complex of Ourense, Ourense: Coral González Fernández; Hospital Quirónsalud Marbella, Marbella, Málaga: José María Ignacio García; Hospital Universitario Puerta del Mar, Cádiz: Aurelio Victor Arnedillo Muñoz; Universitat de Barcelona, Barcelona: Concepción Cañete Ramos; Universidad de Zaragoza, Zaragoza: Carlos Colás Sanz; Sweden: Skane University Hospital, Malmö: Leif Bjermer; Taiwan: National Taiwan University Hospital Yunlin Branch, Yunlin County: Chung-Yu Chen; Kaohsiung Chang Gung Memorial Hospital, Kaohsiung: Wen-Feng Fang; China Medical University Hospital, Taichung: Liang-Wen Hang; Chung-Shan Medical University, Taichung: Jeng-Yuan Hsu; Taipei Medical University, Taipei: Han-Pin Kuo and Kang-Yun Lee; MacKay Memorial Hospital, Taipei: Sheng-Yeh Shen; Kaohsiung Medical University, Kaohsiung: Chau-Chyun Sheu; United Kingdom: Cambridge University Hospital NHS Foundation Trust, Cambridge: Robin Gore; University of Bradford, Bradford: Dinesh Saralaya; United States of America: Clinical Research Trials of Florida, Inc., Tampa, FL: Sady A. Alpizar; Penn highlands Healthcare, Dubois, PA: Sandeep Bansal; White Clay Medical Center, Newark, DE: Hummayun Ismail; Lowcountry Lung and Critical Care, Charleston, SC: Thomas D. Kaelin; Kentucky Lung Clinic, Hazard, KY: Firas Koura; Wilmington Health, Wilmington, NC: Mitchell Douglas Lee; East Carolina University, Greenville, NC: Veeranna Maddipati and Anagha Malur; HealthPartners Institute, Bloomington, MN: Charlene E. McEvoy; Clinical Research Institute, Minneapolis, MN: Hemalini Mehta; Virginia Commonwealth University, Richmond, VA: Arjun Mohan; Wake Forest School of Medicine, Winston Salem, NC: Wendy C. Moore, Jeffery Krings, Anna Pippins, Isaac Deaton, Bob Hmieleski, and Paige Field; New York University School of Medicine, New York, NY: Joan Reibman; Sneeze Wheeze & Itch Associates, LLC, Normal, IL: Dareen D. Siri; Washington University School of Medicine, St. Louis, MO: Kaharu Sumino; Emory University, Atlanta, GA: Colin Swenson; University of North Carolina at Chapel Hill, Chapel Hill, NC: Stephen Lloyd Tilley; Abraham Research, PLLC, Fort Mitchell, KY: Manuel Villareal
Keywords
- Ashtma
- asthma control
- corticosteroids
- health-related quality of life