Exploring Definitions and Predictors of Response to Biologics for Severe Asthma.
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Scelo Ghislaine, Tran Trung N, Le Tham T, Fagerås Malin, Dorscheid Delbert, Busby John, Al-Ahmad Mona, Al-Lehebi Riyad, Altraja Alan, Beastall Aaron, Bergeron Celine, Bjermer Leif, Bjerrum Anne S, Cano-Rosales Diana Jimena, Canonica Giorgio Walter, Carter Victoria, Charriot Jeremy, Christoff George C, Cosio Borja G, Denton Eve, Fernandez-Sanchez Maria Jose, Fonseca João A, Gibson Peter G, Goh Celine, Heaney Liam G, Heffler Enrico, Hew Mark, Iwanaga Takashi, Katial Rohit, Koh Mariko S, Kuna Piotr, Larenas-Linnemann Désirée, Lehtimäki Lauri, Mahboub Bassam, Martin Neil, Matsumoto Hisako, Menzies-Gow Andrew N, Papadopoulos Nikolaos G, Patel Pujan, Perez-De-Llano Luis, Peters Matthew, Pfeffer Paul E, Popov Todor A, Porsbjerg Celeste M, Rhee Chin K, Sadatsafavi Mohsen, Taillé Camille, Torres-Duque Carlos A, Tsai Ming-Ju, Ulrik Charlotte S, Upham John W, von Bülow Anna, Wang Eileen, Wechsler Michael E, Price David B
Аннотация
OBJECTIVE: To explore definitions of biologic responders in adults with severe asthma and investigate patient characteristics associated with biologic response.
METHODS: This was a longitudinal cohort study using data from 21 countries, which shared data with the International Severe Asthma Registry. Changes in four asthma outcome domains were assessed in the 1-year period before and after biologic initiation in patients with a predefined level of prebiologic impairment. Responder cutoffs were 50% or greater reduction in exacerbation rate, 50% or greater reduction in long-term oral corticosteroid daily dose, improvement in one or more category in asthma control, and 100 mL or greater improvement in FEV1. Responders were defined using single and multiple domains. The association between prebiologic characteristics and postbiologic initiation response was examined by multivariable analysis.
RESULTS: A total of 2,210 patients were included. Responder rate ranged from 80.7% (n = 566 of 701) for exacerbation response to 10.6% (n = 9 of 85) for a four-domain response. Many responders still exhibited significant impairment after biologic initiation: 46.7% (n = 206 of 441) of asthma control responders with uncontrolled asthma before the biologic still had incompletely controlled disease postbiologic initiation. Predictors of response were outcome-dependent. Lung function responders were more likely to have higher prebiologic FeNO (odds ratio = 1.20 for every 25-parts per billion increase), and shorter asthma duration (odds ratio = 0.81 for every 10-year increase in duration). Higher blood eosinophil count and the presence of type 2-related comorbidities were positively associated with higher odds of meeting long-term oral corticosteroid, control, and lung function responder criteria.
CONCLUSIONS: Our findings underscore the multimodal nature of response, showing that many responders experience residual symptoms after biologic initiation and that predictors of response vary according to the outcome assessed.