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. 2025 Aug;13(8):2033-2048.
doi: 10.1016/j.jaip.2025.04.032. Epub 2025 Apr 26.

Impact of Biologics Initiation on Oral Corticosteroid Use in the International Severe Asthma Registry and the Optimum Patient Care Research Database: A Pooled Analysis of Real-World Data

Wenjia Chen  1 , Trung N Tran  2 , John Townend  3 , George C Christoff  4 , Ming-Ju Tsai  5 , Alan Altraja  6 , Belinda Cochrane  7 , Borja G Cosio  8 , Martin Sivori  9 , Ruth B Murray  3 , Michael P Makris  10 , Ghislaine Scelo  3 , Lakmini Bulathsinhala  3 , Ledit R F Ardusso  11 , María Eugenia Franchi  12 , Jorge Máspero  13 , Fernando Saldarini  14 , Ana María Stok  15 , Ana Giselle Tomaszuk  16 , Anahí Yañez  17 , Benjamin Emmanuel  2 , Cathy Emmas  18 , Konstantinos Kostikas  19 , Andrew N Menzies-Gow  20 , Neda Stjepanovic  21 , Sinthia Z Bosnic-Anticevich  22 , Eve Denton  23 , Peter G Gibson  24 , Mark Hew  25 , Christine Jenkins  26 , Peter G Middleton  27 , Matthew J Peters  28 , John W Upham  29 , Guy G Brusselle  30 , Renaud Louis  31 , Florence Schleich  32 , Paulo Márcio Pitrez  33 , Todor A Popov  34 , Celine Bergeron  35 , Mohit Bhutani  36 , Kenneth R Chapman  37 , Andréanne Côté  38 , Simon Couillard  39 , Delbert R Dorscheid  40 , M Diane Lougheed  41 , Mohsen Sadatsafavi  42 , Carlos Andrés Celis-Preciado  43 , Libardo Jiménez-Maldonado  44 , Bellanid Rodríguez-Cáceres  45 , Diana Jimena Cano Rosales  46 , Ivan Solarte  43 , Carlos A Torres-Duque  47 , Susanne Hansen  48 , Celeste M Porsbjerg  49 , Charlotte Suppli Ulrik  50 , Arnaud Bourdin  51 , Petros Bakakos  52 , Konstantinos P Exarchos  19 , Athena Gogali  19 , Aggelos A Ladias  53 , Nikolaos G Papadopoulos  54 , Andriana I Papaioannou  55 , Richard W Costello  56 , Breda Cushen  57 , Patrick D Mitchell  58 , Giorgio Walter Canonica  59 , Enrico Heffler  59 , Francesca Puggioni  60 , Takashi Iwanaga  61 , Tatsuya Nagano  62 , Yuji Tohda  63 , Mona S Al-Ahmad  64 , Désirée Larenas-Linnemann  65 , Bernt Bøgvald Aarli  66 , Sverre Lehmann  67 , Piotr Kuna  68 , José Alberto Ferreira  69 , João A Fonseca  70 , Cláudia Chaves Loureiro  71 , Riyad Al-Lehebi  72 , Adeeb A Bulkhi  73 , Yah Ru Juang  1 , Mariko Siyue Koh  74 , Anqi Liu  1 , Chin Kook Rhee  75 , Luis Perez-de-Llano  76 , Pin-Kuei Fu  77 , Diahn-Warng Perng  78 , Chau-Chyun Sheu  5 , Hao-Chien Wang  79 , Bassam Mahboub  80 , Laila Salameh  81 , John Busby  82 , Liam G Heaney  83 , David J Jackson  84 , Pujan H Patel  85 , Paul E Pfeffer  86 , Flavia Hoyte  87 , Rohit K Katial  87 , Njira Lugogo  88 , Roy Alton Pleasants  89 , Eileen Wang  90 , Michael E Wechsler  91 , Aaron Beastall  3 , Victoria Carter  3 , Nevaashni Eleangovan  3 , Kirsty Fletton  3 , David B Price  92 ; ISAR SOLAR I Working Group
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Free article

Impact of Biologics Initiation on Oral Corticosteroid Use in the International Severe Asthma Registry and the Optimum Patient Care Research Database: A Pooled Analysis of Real-World Data

Wenjia Chen et al. J Allergy Clin Immunol Pract. 2025 Aug.
Free article

Abstract

Background: For severe asthma (SA) management, real-world evidence on the effects of biologic therapies in reducing the burden of oral corticosteroid (OCS) use is limited.

Objective: To estimate the efficacy of biologic initiation on total OCS (TOCS) exposure in patients with SA from real-world specialist and primary care settings.

Methods: From the International Severe Asthma Registry (ISAR, specialist care) and the Optimum Patient Care Research Database (OPCRD, primary care, United Kingdom), adult biologic initiators were identified and propensity score-matched with non-initiators (ISAR, 1:1; OPCRD, 1:2). The impact of biologic initiation on TOCS (including bursts for exacerbations) daily dose in the first- and second-year follow-up period was estimated using multivariable generalized linear models.

Results: Among 5,663 patients (ISAR 48%, OPCRD 52%), the odds ratios (ORs) of biologic initiators achieving TOCS cessation in the first and second years of follow-up were 2.38 (95% CI, 1.87-3.04) and 2.11 (95% CI, 1.65-2.70), whereas the ORs of low (0- to 5-mg) TOCS intake were 1.62 (95% CI, 1.40-1.86) and 1.40 (95% CI, 1.21-1.61), respectively. Compared with non-initiators, biologic initiators had a substantially higher chance of achieving greater than 75% reduction from baseline (OR [95% CI] = 2.35 [2.06-2.68] and 1.53 [1.35-1.73] in first and second years, respectively). These findings remained persistent and robust when analyses were repeated with one country setting removed at a time.

Conclusions: Biologic initiation in patients with SA led to substantial reduction in TOCS exposure, particularly in the first year. Future analyses will explore the impact on OCS-related adverse health events.

Keywords: Anti-IL-4/13; Anti-IL-5; Anti-IgE; Biologics; Corticosteroids; Difficult-to-treat asthma; Monoclonal antibody; Oral corticosteroids; Real-world evidence; Severe asthma.

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