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

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
ALLERGY Wiley-Blackwell Publishing Ltd
Documentos
- Não há documentos
Filiações
Keywords
- asthma; biologics; clinical response; International Severe Asthma Registry (ISAR); monoclonal antibodies; super-responders
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Citar a publicação
Denton E,Hew M,Peters MJ,Upham JW,Bulathsinhala L,Tran TN,Martin N,Bergeron C,Al M,Altraja A,Larenas D,Murray R,Celis CA,Al R,Belhassen M,Bhutani M,Bosnic SZ,Bourdin A,Brusselle GG,Busby J,Canonica GW,Heffler E,Chapman KR,Charriot J,Christoff GC,Chung LP,Cosio BG,Cote A,Costello RW,Cushen B,Fingleton J,Fonseca JA,Gibson PG,Heaney LG,Huang EW,Iwanaga T,Jackson DJ,Koh MS,Lehtimaki L,Maspero J,Mahboub B,Menzies AN,Mitchell PD,Papadopoulos NG,Papaioannou AI,Perez L,Perng D,Pfeffer PE,Popov TA,Porsbjerg CM,Rhee CK,Roche N,Sadatsafavi M,Salvi S,Schmid JM,Sheu C,Sirena C,Torres CA,Salameh L,Patel PH,Ulrik CS,Wang E,Wechsler ME,Price DB,ISAR LUMINANT Working GRP. Real-world biologics response and super-response in the International Severe Asthma Registry cohort. Allergy. 2024. 79. (10):p. 2700-2716. IF:12,400. (1).