Exploring definitions and predictors of response to biologics for severe asthma

Ghislaine Scelo, Trung n. Tran, Tham t. Le, Malin Faregås, Delbert Dorscheid, John Busby, Mona Al-Ahmad, Riyad Al-Lehebi, Alan Altraja, Aaron Beastall, Celine Bergeron, Leif Bjermer, Anne s. Bjerrum, Diana jimena Cano-Rosales, Giorgio walter Canonica, Victoria Carter, Jeremy Charriot, George c. Christoff, Borja g. Cosio, Eve DentonMaria jose Fernandez-Sanchez, João a. Fonseca, Peter g. Gibson, Celine Goh, Liam g. Heaney, Enrico Heffler, Mark Hew, Takashi Iwanaga, Rohit Katial, Mariko s. Koh, Piotr Kuna, Désirée Larenas-Linnemann, Lauri Lehtimäki, Bassam Mahboub, Neil Martin, Hisako Matsumoto, Andrew n. Menzies-Gow, Nikolaos g. Papadopoulos, Pujan Patel, Luis Perez-De-Llano, Matthew Peters, Paul e. Pfeffer, Todor a. Popov, Celeste m. Porsbjerg, Chin k. Rhee, Mohsen Sadatsafavi, Camille Taillé, Carlos.a. Torres-Duque, Ming-Ju Tsai, Charlotte s. Ulrik, John w. Upham, Anna Von bülow, Eileen Wang, Michael e. Wechsler, David b. Price

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Background: Biologic effectiveness is often assessed as ‘response’, a term which eludes consistent definition. Identifying those most likely to respond in real-life has proven challenging. 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 4 asthma outcome domains were assessed in the 1-year period pre- and post-biologic-initiation in patients with predefined level of pre-biologic impairment. Responder cut-offs were: ≥50% reduction in exacerbation rate, ≥50% reduction in long-term oral corticosteroid [LTOCS] daily dose, ≥1 category improvement in asthma control, and ≥100mL improvement in FEV1. Responders were defined using single- and multiple-domains. The association between pre-biologic characteristics and post-biologic-initiation response were examined by multivariable analysis. Results: 2,210 patients were included. Responder rate ranged from 80.7% (n=566/701) for exacerbation-response to 10.6% (n=9/85) for 4-domain-response. Many responders still exhibited significant impairment post-biologic-initiation: 46.7% (n=206/441) of asthma control-responders with uncontrolled asthma pre-biologic still had incompletely-controlled disease post-biologic-initiation. Predictors of response were outcome-dependent. Lung function-responders were more likely to have higher pre-biologic FeNO (OR:1.20 for every 25ppb increase), and shorter asthma duration (OR:0.81, for every 10-year increase in duration). Higher BEC and presence of T2-related comorbidities were positively associated with higher odds of meeting LTOCS-, control- and lung function-responder criteria. Conclusion: Our findings underscore the multi-modal nature of ‘response’, show that many responders experience residual symptoms post-biologic-initiation, and that predictors of response vary according to outcome assessed.


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