重症哮喘患者T2相关合并症与生物制剂疗效的关系
2023/12/20
摘要
理由：先前调查共患病对生物有效性影响的研究相对较小，持续时间较短，并且没有比较生物治疗类别。
目的：确定成人重症哮喘（SA）患者T2相关合并症与生物治疗有效性之间的关系。
方法：该队列研究使用国际重症哮喘登记处的数据（n=21个国家，2017-2022）来量化患有/不患有过敏性鼻炎（AR）、慢性鼻窦炎+/-鼻息肉（CRS+/-NP）、NP、或湿疹/特应性皮炎（AD）。
主要结果：在1765名患者中，1257人、421人和87人分别开始了抗IL-5/5R、抗IgE和抗IL-4/13疗法。总的来说，在评估的所有四种哮喘结果中，无论共患病状态如何，都发现到了生物治疗前后的改善。然而，患有CRS+/-NP共患病的患者每年的急性发作减少23%（95%CI 10-35%，p＜0.001），并且与没有CRS+/-NPs的患者相比，具有更好的生物治疗后控制率59%（95%CI 26-102%，p＜001）。对于那些患有合并NP的患者，也发现了类似的结果（恶化减少22%，生物治疗后更好控制率增加56%）。SA和CRS+/-NP患者的ppFEV1额外改善了3.2%（95%CI 1.0-5.3；p=0.004），这一趋势在NP合并症患者中也有发现。AR或AD的存在与任何评估结果的生物治疗前后效应无关。
结论：这些发现突出了系统共患病评估的重要性。CRS+/-NP或NP的存在可被认为是重症哮喘患者生物治疗有效性的预测因素。
Association Between T2-related Comorbidities and Effectiveness of Biologics in Severe Asthma
Michael E Wechsler, Ghislaine Scelo, Désirée E S Larenas-Linnemann, Carlos A Torres-Duque, Jorge Maspero, Trung N Tran, Ruth B Murray, Neil Martin, Andrew N Menzies-Gow, Mark Hew, Matthew J Peters, Peter G Gibson, George C Christoff, Todor A Popov, Andréanne Côté, Celine Bergeron, Delbert Dorscheid, J Mark FitzGerald, Kenneth R Chapman, Louis Philippe Boulet, Mohit Bhutani, Mohsen Sadatsafavi, Libardo Jiménez-Maldonado, Mauricio Duran-Silva, Bellanid Rodriguez, Carlos Andres Celis-Preciado, Diana Jimena Cano-Rosales, Ivan Solarte, Maria Jose Fernandez-Sanchez, Patricia Parada-Tovar, Anna von Bülow, Anne Sofie Bjerrum, Charlotte S Ulrik, Karin Dahl Assing, Linda Makowska Rasmussen, Susanne Hansen, Alan Altraja, Arnaud Bourdin, Camille Taille, Jeremy Charriot, Nicolas Roche, Andriana I Papaioannou, Konstantinos Kostikas, Nikolaos G Papadopoulos, Sundeep Salvi, Deirdre Long, Patrick D Mitchell, Richard Costello, Concetta Sirena, Cristina Cardini, Enrico Heffler, Francesca Puggioni, Giorgio Walter Canonica, Giuseppe Guida, Takashi Iwanaga, Mona Al-Ahmad, Ulises García, Piotr Kuna, João A Fonseca, Riyad Al-Lehebi, Mariko S Koh, Chin Kook Rhee, Borja G Cosio, Luis Perez de Llano, Diahn-Warng Perng, Erick Wan-Chun Huang, Hao-Chien Wang, Ming-Ju Tsai, Bassam Mahboub, Laila Ibraheem Jaber Salameh, David J Jackson, John Busby, Liam G Heaney, Paul E Pfeffer, Amanda Grippen Goddard, Eileen Wang, Flavia C L Hoyte, Nicholas M Chapman, Rohit Katial, Victoria Carter, Lakmini Bulathsinhala, Neva Eleangovan, Con Ariti, Juntao Lyu, Celeste Porsbjerg, David B Price
Abstract
Rationale: Previous studies investigating comorbidity impact on biologic effectiveness have been relatively small, of short duration, and have not compared biologic classes.
Objectives: To determine the association between T2-related comorbidities and biologic effectiveness in adults with severe asthma (SA).
Methods: This cohort study used International Severe Asthma Registry data (n=21 countries, 2017-2022) to quantify pre- to post-biologic change for four outcomes (annual asthma exacerbation rate, % predicted FEV1 (ppFEV1), asthma control, and long-term oral corticosteroid daily dose [LTOCS]) in patients with/without allergic rhinitis (AR), chronic rhinosinusitis +/- nasal polyps (CRS+/-NP), NP, or eczema/atopic dermatitis (AD).
Main results: Of 1765 patients, 1257, 421, and 87 initiated anti-IL-5/5R, anti-IgE, and anti-IL-4/13 therapies, respectively. In general, pre- to post-biologic improvements were noted in all four asthma outcomes assessed, irrespective of comorbidity status. However, patients with comorbid CRS+/-NP experienced 23% (95% CI 10-35%, p<0.001) fewer exacerbations/year and had 59% (95% CI: 26-102%, p<0.001) higher odds of better post-biologic control than those without CRS+/-NP. Similar estimates were noted for those with comorbid NP (22% less exacerbations and 56% higher odds of better post-biologic control). Patients with SA and CRS+/-NP had an additional ppFEV1 improvement of 3.2% (95% CI: 1.0-5.3; p=0.004), a trend that was also noted in those with comorbid NP. The presence of AR or AD were not associated with pre- to post-biologic effect for any outcome assessed.
Conclusions: These findings highlight the importance of systematic comorbidity evaluation. The presence of CRS+/-NP or NP may be considered a predictor of biologic effectiveness in patients with severe asthma.
理由：先前调查共患病对生物有效性影响的研究相对较小，持续时间较短，并且没有比较生物治疗类别。
目的：确定成人重症哮喘（SA）患者T2相关合并症与生物治疗有效性之间的关系。
方法：该队列研究使用国际重症哮喘登记处的数据（n=21个国家，2017-2022）来量化患有/不患有过敏性鼻炎（AR）、慢性鼻窦炎+/-鼻息肉（CRS+/-NP）、NP、或湿疹/特应性皮炎（AD）。
主要结果：在1765名患者中，1257人、421人和87人分别开始了抗IL-5/5R、抗IgE和抗IL-4/13疗法。总的来说，在评估的所有四种哮喘结果中，无论共患病状态如何，都发现到了生物治疗前后的改善。然而，患有CRS+/-NP共患病的患者每年的急性发作减少23%（95%CI 10-35%，p＜0.001），并且与没有CRS+/-NPs的患者相比，具有更好的生物治疗后控制率59%（95%CI 26-102%，p＜001）。对于那些患有合并NP的患者，也发现了类似的结果（恶化减少22%，生物治疗后更好控制率增加56%）。SA和CRS+/-NP患者的ppFEV1额外改善了3.2%（95%CI 1.0-5.3；p=0.004），这一趋势在NP合并症患者中也有发现。AR或AD的存在与任何评估结果的生物治疗前后效应无关。
结论：这些发现突出了系统共患病评估的重要性。CRS+/-NP或NP的存在可被认为是重症哮喘患者生物治疗有效性的预测因素。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(Am J Respir Crit Care Med. 2023 Nov 28. doi: 10.1164/rccm.202305-0808OC.)
(Am J Respir Crit Care Med. 2023 Nov 28. doi: 10.1164/rccm.202305-0808OC.)
Association Between T2-related Comorbidities and Effectiveness of Biologics in Severe Asthma
Michael E Wechsler, Ghislaine Scelo, Désirée E S Larenas-Linnemann, Carlos A Torres-Duque, Jorge Maspero, Trung N Tran, Ruth B Murray, Neil Martin, Andrew N Menzies-Gow, Mark Hew, Matthew J Peters, Peter G Gibson, George C Christoff, Todor A Popov, Andréanne Côté, Celine Bergeron, Delbert Dorscheid, J Mark FitzGerald, Kenneth R Chapman, Louis Philippe Boulet, Mohit Bhutani, Mohsen Sadatsafavi, Libardo Jiménez-Maldonado, Mauricio Duran-Silva, Bellanid Rodriguez, Carlos Andres Celis-Preciado, Diana Jimena Cano-Rosales, Ivan Solarte, Maria Jose Fernandez-Sanchez, Patricia Parada-Tovar, Anna von Bülow, Anne Sofie Bjerrum, Charlotte S Ulrik, Karin Dahl Assing, Linda Makowska Rasmussen, Susanne Hansen, Alan Altraja, Arnaud Bourdin, Camille Taille, Jeremy Charriot, Nicolas Roche, Andriana I Papaioannou, Konstantinos Kostikas, Nikolaos G Papadopoulos, Sundeep Salvi, Deirdre Long, Patrick D Mitchell, Richard Costello, Concetta Sirena, Cristina Cardini, Enrico Heffler, Francesca Puggioni, Giorgio Walter Canonica, Giuseppe Guida, Takashi Iwanaga, Mona Al-Ahmad, Ulises García, Piotr Kuna, João A Fonseca, Riyad Al-Lehebi, Mariko S Koh, Chin Kook Rhee, Borja G Cosio, Luis Perez de Llano, Diahn-Warng Perng, Erick Wan-Chun Huang, Hao-Chien Wang, Ming-Ju Tsai, Bassam Mahboub, Laila Ibraheem Jaber Salameh, David J Jackson, John Busby, Liam G Heaney, Paul E Pfeffer, Amanda Grippen Goddard, Eileen Wang, Flavia C L Hoyte, Nicholas M Chapman, Rohit Katial, Victoria Carter, Lakmini Bulathsinhala, Neva Eleangovan, Con Ariti, Juntao Lyu, Celeste Porsbjerg, David B Price
Abstract
Rationale: Previous studies investigating comorbidity impact on biologic effectiveness have been relatively small, of short duration, and have not compared biologic classes.
Objectives: To determine the association between T2-related comorbidities and biologic effectiveness in adults with severe asthma (SA).
Methods: This cohort study used International Severe Asthma Registry data (n=21 countries, 2017-2022) to quantify pre- to post-biologic change for four outcomes (annual asthma exacerbation rate, % predicted FEV1 (ppFEV1), asthma control, and long-term oral corticosteroid daily dose [LTOCS]) in patients with/without allergic rhinitis (AR), chronic rhinosinusitis +/- nasal polyps (CRS+/-NP), NP, or eczema/atopic dermatitis (AD).
Main results: Of 1765 patients, 1257, 421, and 87 initiated anti-IL-5/5R, anti-IgE, and anti-IL-4/13 therapies, respectively. In general, pre- to post-biologic improvements were noted in all four asthma outcomes assessed, irrespective of comorbidity status. However, patients with comorbid CRS+/-NP experienced 23% (95% CI 10-35%, p<0.001) fewer exacerbations/year and had 59% (95% CI: 26-102%, p<0.001) higher odds of better post-biologic control than those without CRS+/-NP. Similar estimates were noted for those with comorbid NP (22% less exacerbations and 56% higher odds of better post-biologic control). Patients with SA and CRS+/-NP had an additional ppFEV1 improvement of 3.2% (95% CI: 1.0-5.3; p=0.004), a trend that was also noted in those with comorbid NP. The presence of AR or AD were not associated with pre- to post-biologic effect for any outcome assessed.
Conclusions: These findings highlight the importance of systematic comorbidity evaluation. The presence of CRS+/-NP or NP may be considered a predictor of biologic effectiveness in patients with severe asthma.
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