Portal de investigação
Real-world biologics response and super-response in the International Severe Asthma Registry cohort
Data de publicação:
Data Ahead of Print:
Autores da FMUP
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
- Tipo:
- Article
- Páginas:
- 2700-2716
- DOI:
- 10.1111/all.16178
- PubMed:
- 38923444
ALLERGY Wiley-Blackwell Publishing Ltd
Documentos
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Filiações
Keywords
- asthma; biologics; clinical response; International Severe Asthma Registry (ISAR); monoclonal antibodies; super-responders
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