| Title: |
Real-world biologics response and super-response in the International Severe Asthma Registry cohort |
| Authors: |
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 |
| Contributors: |
The University of Newcastle. College of Health, Medicine & Wellbeing, School of Medicine and Public Health |
| Publisher Information: |
Wiley-Blackwell |
| Publication Year: |
2024 |
| Collection: |
NOVA: The University of Newcastle Research Online (Australia) |
| Subject Terms: |
asthma; biologics; clinical response; International Severe Asthma Registry (ISAR); monoclonal antibodies; super-responders; SDG 3; Sustainable Development Goal |
| 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
Allergy Vol. 79, Issue 10, p. 2700-2716; http://hdl.handle.net/1959.13/1511873; uon:56564 |
| Availability: |
http://hdl.handle.net/1959.13/1511873 |
| 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. |
| Accession Number: |
edsbas.8DFAF7A |
| Database: |
BASE |