| Title: |
Real-world biologics response and super-response in the International Severe Asthma Registry cohort. |
| Authors: |
Denton, E; Hew, M; Peters, MJ; Upham, JW; Bulathsinhala, L; Tran, TN; Martin, N; Bergeron, C; Al-Ahmad, M; Altraja, A; Larenas-Linnemann, D; Murray, R; Celis-Preciado, CA; Al-Lehebi, R; Belhassen, M; Bhutani, M; Bosnic-Anticevich, SZ; Bourdin, A; Brusselle, GG; Busby, J; Canonica, GW; Heffler, E; Chapman, KR; Charriot, J; Christoff, GC; Chung, LP; Cosio, BG; Côté, A; Costello, RW; Cushen, B; Fingleton, J; Fonseca, JA; Gibson, PG; Heaney, LG; Huang, EW-C; Iwanaga, T; Jackson, DJ; Koh, MS; Lehtimäki, L; Máspero, J; Mahboub, B; Menzies-Gow, AN; Mitchell, PD; Papadopoulos, NG; Papaioannou, AI; Perez-de-Llano, L; Perng, D-W; Pfeffer, PE; Popov, TA; Porsbjerg, CM; Rhee, CK; Roche, N; Sadatsafavi, M; Salvi, S; Schmid, JM; Sheu, C-C; Sirena, C; Torres-Duque, CA; Salameh, L; Patel, PH; Ulrik, CS; Wang, E; Wechsler, ME; Price, DB; ISAR LUMINANT Working Group |
| Publication Year: |
2024 |
| Collection: |
Queen Mary University of London: Queen Mary Research Online (QMRO) |
| Subject Terms: |
International Severe Asthma Registry (ISAR); asthma; biologics; clinical response; monoclonal antibodies; super‐responders; Humans; Registries; Biological Products; Male; Female; Middle Aged; Treatment Outcome; Adult; Anti-Asthmatic Agents; Severity of Illness Index; Cohort Studies; Aged |
| 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 |
| File Description: |
2700 - 2716 |
| Language: |
English |
| Relation: |
Allergy; https://qmro.qmul.ac.uk/xmlui/handle/123456789/100723 |
| DOI: |
10.1111/all.16178 |
| Availability: |
https://qmro.qmul.ac.uk/xmlui/handle/123456789/100723; https://doi.org/10.1111/all.16178 |
| Rights: |
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. ; © 2024 The Author(s). Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. |
| Accession Number: |
edsbas.D72B4CC9 |
| Database: |
BASE |