Development and Validation of the Risk of Exacerbation in Severe Asthma (RESA) Model.
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Chen Wenjia, Lee Tae Yoon, Price David, Beasley Richard, Janson Christer, Siyue Mariko Koh, Yadav Chandra Prakash, Müllerová Hana, Burgel Pierre-Regis, Tran Trung N, Emmanuel Benjamin, Wang Eileen, Wechsler Michael E, Jackson David J, Busby John, Heaney Liam G, Pfeffer Paul E, Mahboub Bassam, Perng Diahn-Warng, Cosio Borja G, Perez-de-Llano Luis, Al-Lehebi Riyad, Larenas-Linnemann Désirée, Al-Ahmad Mona, Rhee Chin Kook, Iwanaga Takashi, Heffler Enrico, Canonica Giorgio Walter, Costello Richard, Papadopoulos Nikolaos G, Papaioannou Andriana I, Porsbjerg Celeste M, Torres-Duque Carlos A, Christoff George C, Popov Todor A, Hew Mark, Peters Matthew, Gibson Peter G, Maspero Jorge, Bergeron Celine, Cerda Saraid, Contreras Elvia Angelica, Sadatsafavi Mohsen
Аннотация
OBJECTIVES: To develop and validate an individualized risk calculator for severe exacerbations in SA, and evaluate its clinical utility for guiding personalized clinical decisions.
METHODS: Patients with SA were identified from combined data from the International Severe Asthma Registry (2015-2022) and NOVEL observational longiTudinal studY (2016-2023) across 30 countries and regions. The prediction end point was the 12-month risk of 1 or more or 2 or more severe exacerbations. Using expert input and Bayesian network analysis, 11 routinely measured predictors were identified, measured within the past 12 months. A mixed-effects, zero-inflated negative binomial model was developed, adjusting for between-country variability and biologic drop-in effects. Internal-external cross-validation was performed using the natural clustering by country settings.
RESULTS: Data from 9911 patients with SA were used. Essential predictors included age, sex, past 12-month severe exacerbations, asthma control, chronic rhinosinusitis, FEV1 to forced vital capacity ratio, percent predicted FEV1, blood eosinophils, fractional exhaled nitric oxide, and long-term oral corticosteroid and macrolide use. The model also adapted setting-specific baseline risks. In the internal-external cross-validation, across broad geographical and health care variability, the model showed excellent calibration and informative, generalizable discrimination (pooled area under the time-dependent receiver-operating characteristics curve of 0.63 [95% CI, 0.60-0.66] for ≥1 and 0.68 [95% CI, 0.64-0.72] for ≥2 exacerbations). Decision curve analysis showed clear net benefit across risk thresholds.
CONCLUSIONS: The Risk of Exacerbation in Severe Asthma model quantifies SA exacerbation risk using routinely available predictors and demonstrates potential clinical utility.