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Record W4328107864 · doi:10.1016/j.jaip.2023.03.009

Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

2023· article· en· W4328107864 on OpenAlexafffund
Renaud Louis, Tim Harrison, Pascal Chanez, Francesco Menzella, George Philteos, Borja G. Cosío, Njira Lugogo, Gustavo de Luiz, Annie Burden, Timothy Adlington, N. Keeling, Justin Kwiatek, Esther García Gil, Wolfgang Pohl, Daniel Doberer, Jean Benoît Martinot, Maud Deschampheleire, Ulrike Himpe, Kenneth R. Chapman, Amarjit Cheema, Delbert R. Dorscheid, Clare D. Ramsey, Jeffrey Rolf, Brandie Walker, Ronald Olivenstein, Claude Poirier, Pierre Larivée, Anne Sofie Bjerrum, Ingrid Louise Titlestad, Ole Hilberg, Maritta Kilpeläinen, Philippe Bonniaud, Camille Taillé, Iuliana-Angelica Tiotiu, Pierre‐Olivier Girodet, F.–X. Blanc, J. Pradelli, A. Didier, Cecilia Nocent Ejnaini, Gaëtan Deslée, Christophe Pison, Y. Douadi, Guillaume Mahay, Gilles Devouassoux, B. Melloni, Pauline-Marie Roux, Arnaud Bourdin, Stéphanie Fry, Thomas Schaum, Christof Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Wolfgang Gleiber, Randolf Brehler, Jens Schreiber, Wolfgang Schuette, Juliane Kronsbein, R. Bonnet, Ekkehard Beck, Donato Lacedonia, Gianenrico Senna, Cristiano Caruso, Nunzio Crimi, Francesco Blasi, Pierachille Santus, Giorgio Walter Canonica, Gabriella Guarnieri, Girolamo Pelaia, Manlio Milanese, Claudio Micheletto, Angelo Guido Corsico, Nicola Scichilone, Giuseppe Spadaro, Bas Langeveld, Jurgen Holters, Jan Willem van den Berg, Arthur A J Smit, Lennart Conemans, Helena van Veen, Gerald Staaks, Sverre Lehmann, José Maria Echave-Sustaeta, Gustavo de Luíz Martinez, Ruperto González‐Pérez, Juan Luis García‐Rivero, José Gregorio Soto Campos, Paloma Campo Mozo, Carmen Vidal Pan, A. Gómez-Bastero Fernández, Sergio Campos Tellez, Carlos Martínez‐Rivera, Irina Bobolea, Raquel Morillo Guerrero, Ismael Ali García, Juan Luis Rodríguez Hermosa, Nikolai Stenfors, Alf Tunsäter, Dan Curiac, Christophe von Garnier, Jörg D. Leuppi, Peter Schmid‐Grendelmeier, Shuaib Nasser, Rekha Chaudhuri, Monica Nordstrom, Dinesh Saralaya, Paul Pfeffer, Adel Mansur, Philip Short, Sally E. Wenzel, W. Brett Cherry, Heidi Zafra, E. González González, Weily Soong, Benjamin G. Davis, Neil L. Kao, Iftikhar Hussain, Diego Jose Maselli Caceres, James B. Harris, William J. Calhoun, Ileana Rodicio, David Kaufman, Mark B. Moss, Eric Sztejman, Samuel DeLeon, Kaharu Sumino, Ravindra Kashyap, Jeffrey Leflein, Rizan Hajal, Faisal Fakih, David Hill, Robert P. Lin, Mikell Jarratt, Vijay Subramaniam, Robert W. Sussman, Nayla Mumneh, Joan Reibman, Jared I. Darveaux, Ricardo Tan, Tonny Tanus, Vinay Sikand, Gailen D. Marshall, Hemalini Mehta, Jeremy Cole, Brad Goodman, Deborah Goss, Jose Bardelas, Aaron M. Milstone, Vinay Mehta, Lee Clore, Mark Millard, Michael Palumbo, Dileep Puppala, Mila A. Leong, Bruce M. Prenner, Emory Robinette, Hengameh Heidarian Raissy, David A. Fost, Warren Pleskow, Michael B. Marcus, Jonathan Ilowite, Wendy C. Moore, G. Steven, Luis de la Cruz‐Merino, Geoffrey Chupp, William Berger, Christopher Randolph, Fernando Holguín, Shahrukh Kureishy, Edward M. Campbell, Rudi Peché, Laura Pini, Alberto Papi, Bianca Beghé, Silvia Peveri, Aythamy Henríquez Santa, Jacinto Ramos González, Ines Vinge, Roy St. John

Bibliographic record

VenueThe Journal of Allergy and Clinical Immunology In Practice · 2023
Typearticle
Languageen
FieldMedicine
TopicAsthma and respiratory diseases
Canadian institutionsUniversity of SaskatchewanRoyal University Hospital
FundersFogarty International CenterInstituto de Salud Carlos IIIKarl Landsteiner Privatuniversität für GesundheitswissenschaftenHumanitas UniversityUniversité de MontpellierUniversità degli Studi di BresciaUniversitat Autònoma de BarcelonaUniversità degli Studi di FerraraUniversité de LausanneSyddansk UniversitetGenentechSahlgrenska UniversitetssjukhusetAarhus UniversitetUniversität BaselTurun YliopistoUmeå UniversitetMaastricht Universitair Medisch CentrumMedizinischen Hochschule HannoverUniversity of TorontoUniversité de ToulouseUniversità degli Studi di PadovaUniversitätsklinikum RegensburgUniversità di CataniaUniversiteit MaastrichtUniversity of PittsburghUniversity of CambridgeMcGill UniversityAarhus UniversitetshospitalUniversità degli Studi di PaviaUniversidade de Santiago de CompostelaSanofiUniversità degli Studi di Napoli Federico IIUniversitetet i BergenUniversità degli Studi di PalermoTeva Pharmaceutical IndustriesAstraZeneca
KeywordsBenralizumabMedicineAsthmaStandard of careFamily medicineInternal medicine

Abstract

fetched live from OpenAlex

BACKGROUND: The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy. OBJECTIVE: Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab. METHODS: Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non-oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT. RESULTS: For non-OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT. CONCLUSIONS: These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.007
metaresearch head score (Gemma)0.006
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.007
Threshold uncertainty score0.038

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0070.006
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0020.003
Bibliometrics0.0000.001
Science and technology studies0.0010.001
Scholarly communication0.0010.001
Open science0.0010.001
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0030.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.029
GPT teacher head0.378
Teacher spread0.349 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations24
Published2023
Admission routes2
Has abstractyes

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