- Title
- Real-world biologics response and super-response in the International Severe Asthma Registry cohort
- Creator
- Denton, Eve; Hew, Mark; Larenas-Linnemann, Désirée; Murray, Ruth; Celis-Preciado, Carlos Andrés; Al-Lehebi, Riyad; Belhassen, Manon; Bhutani, Mohit; Bosnic-Anticevich, Sinthia Z.; Bourdin, Arnaud; Brusselle, Guy G.; Busby, John; Peters, Matthew J.; Canonica, Giorgio Walter; Heffler, E; Chapman, KR; Charriot, J; Christoff, GC; Chung, LP; Cosio, BG; Côté, A; Costello, RW; Cushen, B; Upham, John W.; Fingleton, J; Fonseca, JA; Gibson, Peter G.; Heaney, LG; Huang, EW-C; Iwanaga, T; Jackson, DJ; Koh, MS; Lehtimäki, L; Máspero, J; Bulathsinhala, Lakmini; Mahboub, B; Menzies-Gow, AN; Mitchell, PD; Papadopoulos, NG; Papaioannou, AI; Perez-de-Llano, L; Perng, D-W; Pfeffer, PE; Popov, TA; Porsbjerg, CM; Tran, Trung N.; Rhee, CK; Roche, N; Sadatsafavi, M; Salvi, S; Schmid, JM; Sheu, C-C; Sirena, C; Torres-Duque, CA; Salameh, L; Patel, PH; Martin, Neil; Ulrik, CS; Wang, E; Wechsler, ME; Price, DB; ISAR LUMINANT Working Group,; Bergeron, Celine; Al-Ahmad, Mona; Altraja, Alan
- Relation
- Allergy Vol. 79, Issue 10, p. 2700-2716
- Publisher Link
- http://dx.doi.org/10.1111/all.16178
- Publisher
- Wiley-Blackwell
- Resource Type
- journal article
- Date
- 2024
- Description
- 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, ~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.
- Subject
- asthma; biologics; clinical response; International Severe Asthma Registry (ISAR); monoclonal antibodies; super-responders; SDG 3; Sustainable Development Goal
- Identifier
- http://hdl.handle.net/1959.13/1511873
- Identifier
- uon:56564
- Identifier
- ISSN:0105-4538
- Rights
- © 2024 The Author(s). Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
- Language
- eng
- Full Text
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