Real-world biologics response and super-response in the International Severe Asthma Registry cohort

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • João De Almeida Lopes Da Fonseca

    Autor

Participantes de fora da FMUP

  • Denton, Eve
  • Hew, Mark
  • Peters, Matthew J.
  • Upham, John W.
  • Bulathsinhala, Lakmini
  • Tran, Trung N.
  • Martin, Neil
  • Bergeron, Celine
  • Al-Ahmad, Mona
  • Altraja, Alan
  • Larenas-Linnemann, Desiree
  • Murray, Ruth
  • Celis-Preciado, Carlos Andres
  • Al-Lehebi, Riyad
  • Belhassen, Manon
  • Bhutani, Mohit
  • Bosnic-Anticevich, Sinthia Z.
  • Bourdin, Arnaud
  • Brusselle, Guy G.
  • Busby, John
  • Canonica, Giorgio Walter
  • Heffler, Enrico
  • Chapman, Kenneth R.
  • Charriot, Jeremy
  • Christoff, George C.
  • Chung, Li Ping
  • Cosio, Borja G.
  • Cote, Andreanne
  • Costello, Richard W.
  • Cushen, Breda
  • Fingleton, James
  • Gibson, Peter G.
  • Heaney, Liam G.
  • Huang, Erick Wan-Chun
  • Iwanaga, Takashi
  • Jackson, David J.
  • Koh, Mariko Siyue
  • Lehtimaki, Lauri
  • Maspero, Jorge
  • Mahboub, Bassam
  • Menzies-Gow, Andrew N.
  • Mitchell, Patrick D.
  • Papadopoulos, Nikolaos G.
  • Papaioannou, Andriana I.
  • Perez-de-Llano, Luis
  • Perng, Diahn-Warng
  • Pfeffer, Paul E.
  • Popov, Todor A.
  • Porsbjerg, Celeste M.
  • Rhee, Chin Kook
  • Roche, Nicolas
  • Sadatsafavi, Mohsen
  • Salvi, Sundeep
  • Schmid, Johannes Martin
  • Sheu, Chau-Chyun
  • Sirena, Concetta
  • Torres-Duque, Carlos A.
  • Salameh, Laila
  • Patel, Pujan H.
  • Ulrik, Charlotte Suppli
  • Wang, Eileen
  • Wechsler, Michael E.
  • Price, David B.
  • ISAR LUMINANT Working Grp

Unidades de investigação

Abstract

Background: Biologic asthma therapies reduce exacerbations and long-term oral corticosteroids (LTOCS) use in randomized controlled trials (RCTs); however, there are limited data on outcomes among patients ineligible for RCTs. Hence, we investigated responsiveness to biologics in a real-world population of adults with severe asthma. Methods: Adults in the International Severe Asthma Registry (ISAR) with >= 24 weeks of follow-up were grouped into those who did, or did not, initiate biologics (anti-IgE, anti-IL5/IL5R, anti-IL4/13). Treatment responses were examined across four domains: forced expiratory volume in 1 second (FEV1) increase by >= 100 mL, improved asthma control, annualized exacerbation rate (AER) reduction >= 50%, and any LTOCS dose reduction. Super-response criteria were: FEV1 increase by >= 500 mL, new well-controlled asthma, no exacerbations, and LTOCS cessation or tapering to <= 5 mg/day. Results: 5.3% of ISAR patients met basic RCT inclusion criteria; 2116/8451 started biologics. Biologic initiators had worse baseline impairment than non-initiators, despite having similar biomarker levels. Half or more of initiators had treatment responses: 59% AER reduction, 54% FEV1 increase, 49% improved control, 49% reduced LTOCS, of which 32%, 19%, 30%, and 39%, respectively, were super-responses. Responses/super-responses were more frequent in biologic initiators than in non-initiators; nevertheless, similar to 40-50% of initiators did not meet response criteria. Conclusions: Most patients with severe asthma are ineligible for RCTs of biologic therapies. Biologics are initiated in patients who have worse baseline impairments than non-initiators despite similar biomarker levels. Although biologic initiators exhibited clinical responses and super-responses in all outcome domains, 40-50% did not meet the response criteria.

© 2024 The Author(s). Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Dados da publicação

ISSN/ISSNe:
0105-4538, 1398-9995

ALLERGY  Wiley-Blackwell Publishing Ltd

Tipo:
Article
Páginas:
2700-2716

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Keywords

  • asthma; biologics; clinical response; International Severe Asthma Registry (ISAR); monoclonal antibodies; super-responders

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Ensaio Clínico Académico (mINSPIRERS) . 2021

Utilização em estudos observacionais do Registo de Asma Grave Portugal.

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Estudo Observacional Académico (RAG) . 2020

Clinical Research Collaboration Severe Heterogenous Asthma Research collaboration, Patient-centered (CRC SHARP).

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Estudo Clínico Observacional (SHARP) . European Respiratory Society . 2021

Multidimensional phenotyping of severe asthma patients and its impact on disease control and therapeutic response - analysis from the Portuguese Severe Asthma Registry.

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Estudo Clínico Observacional (RAG-SPP-GSK) . SPPneumologia . 2022

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Estudo Clínico Observacional (RAG-AZ-BREATHE) . AstraZeneca . 2022

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Using different data sources for the identification of asthma patients and those at high risk of adverse outcomes

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Estudo Clínico Académico . 2020

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Estudo Clínico Académico . 2020

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