Progress and clinical application of biologics in chronic obstructive pulmonary disease:based on the 2026 GOLD guideline

doi:10.19983/j.issn.2096-8493.20260077

Abstract

Abstract:

Chronic obstructive pulmonary disease (COPD) imposes a heavy global disease burden. Conventional therapeutic regimens achieve unsatisfactory disease control in refractory patients with high type 2 inflammation phenotypes. The advent of biologics has provided a novel targeted therapeutic approach for such patients, and the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have incorporated biologics into the standardized diagnosis and treatment system of COPD. This paper reviews the mechanism key clinical studies, guideline recommendations and clinical practice specifications of COPD-related biologics in the past three years. Combined with the medication characteristics of the Chinese population and the research status of integrated traditional Chinese and Western medicine, it analyzes the existing problems in current clinical application and future development directions, so as to provide a reference for the accurate clinical selection and rational use of biologics.

Key words: Pulmonary disease,chronic obstructive, Pharmaceutical preparations, Inflammation, Review

CLC Number:

R563

Hu Yunqu, Ren Haibo. Progress and clinical application of biologics in chronic obstructive pulmonary disease:based on the 2026 GOLD guideline[J]. Journal of Tuberculosis and Lung Disease , 2026, 7(4): 439-442. doi: 10.19983/j.issn.2096-8493.20260077

References 35

[1]	吴煜芳, 林凯洵, 熊珈艺, 等. 《2026年GOLD慢性阻塞性肺疾病诊断、管理及预防全球策略》更新要点解读[J]. 实用心脑肺血管病杂志, 2026, 34(2):1-11. doi:10.12114/j.issn.1008-5971.2026.00.045.
[2]	刘升明. 《GOLD 2026报告》关于慢性阻塞性肺疾病诊断、治疗、管理及预防全球策略更新要点解读[J]. 实用医学杂志, 2026, 42(4):541-550. doi:10.3969/j.issn.1006-5725.2026.04.001.
[3]	中华医学会呼吸病学分会慢性阻塞性肺疾病学组, 中国医师协会呼吸医师分会慢性阻塞性肺疾病工作委员会. 慢性阻塞性肺疾病诊治指南(2024年修订版)[J]. 中华结核和呼吸杂志, 2024, 47(3):181-219. doi:10.3760/cma.j.cn112147-20231215-00369.
[4]	Bhatt S P, Rabe K F, Hanania N A, et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts[J]. N Engl J Med, 2023, 389(3):205-214. doi:10.1056/NEJMoa2303951.
[5]	Sciurba F C, Criner G J, Christenson S A, et al. Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype[J]. N Engl J Med, 2025, 392(17):1710-1720. doi:10.1056/NEJMoa2413181.
[6]	Tancevski I, Sonnweber T. Targeting IL-33 in COPD:mechanistic lessons from clinical trials and the path forward[J]. Respir Res,2026[2026-04-10]. doi:10.1186/s12931-026-03763-7.Onlineaheadofprint.
[7]	陈典, 隆寰宇, 褚岚和, 等. 2026年GOLD慢性阻塞性肺疾病诊断、治疗、管理及预防全球策略更新要点解读[J]. 中国全科医学, 2026, 29(21):2913-2932. doi:10.12114/j.issn.1007-9572.2026.0041.
[8]	Yadav A K, Gu W, Zhang T, et al. Current Perspectives on Biological Therapy for COPD[J]. COPD, 2023, 20(1):197-209. doi:10.1080/15412555.2023.2187210. pmid: 37394963
[9]	Jia N, Jin M, Liu Y, et al. The Management of Type 2 Inflammatory Respiratory Diseases:a Chinese Expert Consensus[J]. J Thorac Dis, 2025, 17(4):1807-1831. doi:10.21037/jtd-2024-2092.
[10]	Bhatt S P, Rabe K F, Hanania N A, et al. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation[J]. N Engl J Med, 2024, 390(24):2274-2283. doi:10.1056/NEJMoa2401304.
[11]	中国临床试验注册中心.一项描述接受度普利尤单抗治疗的中国成人慢性阻塞性肺疾病(COPD)患者的患者特征、临床结局、治疗模式、医疗资源利用情况和安全性的前瞻性、观察性研究(ChiCTR2500107155)[EB/OL]. [2026-04-10]. https://www.chictr.org.cn.
[12]	Kostikas K, Gogali A. Biologics in COPD:The Road is Still Long and Winding[J]. COPD, 2025, 22(1):2467657. doi:10.1080/15412555.2025.2467657.
[13]	Ramakrishnan S, Russell R E K, Mahmood H R, et al. Treating Eosinophilic Exacerbations of Asthma and COPD with Benralizumab (ABRA):a Double-blind, Double-dummy, Active Placebo-controlled Randomised Trial[J]. Lancet Respir Med, 2025, 13(1):59-68. doi:10.1016/S2213-2600(24)00299-6. pmid: 39615502
[14]	Hu K C, Chuang M H, Lai C C, et al. Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients[J]. Clin Ther, 2025, 47(3):226-234. doi:10.1016/j.clinthera.2024.12.001.
[15]	Venkatesan P. GOLD COPD report:2026 update[J]. Lancet Respir Med, 2025,26: S2213-2600(25)00432-1. doi:10.1016/S2213-2600(25)00432-1.
[16]	Singh D, Brightling C E, Rabe K F, et al. Efficacy and Safety of Tezepelumab versus Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COURSE):a Randomised, Placebo-controlled, Phase 2a Trial[J]. Lancet Respir Med, 2025, 13(1):47-58. doi:10.1016/S2213-2600(24)00324-2. pmid: 39653044
[17]	Sinclair De Frías J, Velo A, Olivero L, et al. Efficacy and safety of mepolizumab for eosinophilic chronic obstructive pulmonary disease:A systematic review and meta-analysis[J]. Expert Rev Respir Med, 2026, 20(4):437-455. doi:10.1080/17476348.2025.2581347.
[18]	葛兰素史克中国. 新可来(美泊利珠单抗注射液)在中国获批用于治疗成人慢性阻塞性肺疾病(COPD)[EB/OL]. [2026-04-10]. https://www.gsk-china.com/zh-cn/media/press-releases/nucala-copd-china-approval/.
[19]	Gogali A, Kostikas K. Biologics in COPD:Do We Need a Divide and Conquer Approach?[J]. Lung, 2025, 203(1):45. doi:10.1007/s00408-025-00803-9.
[20]	Bhatt S P, Rabe K F, Hanania N A, et al. Dupilumab Improves Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation:BOREAS and NOTUS[J]. Chest, 2025, 168(1):56-66. doi:10.1016/j.chest.2025.01.029.
[21]	Christenson S A, Hanania N A, Bhatt S P, et al. Type 2 Inflammation Biomarkers and Their Association with Response to Dupilumab in COPD (BOREAS):an Analysis of a Randomised, Placebo-controlled, Phase 3 Trial[J]. Lancet Respir Med, 2025, 13(8):687-697. doi:10.1016/S2213-2600(25)00044-X. pmid: 40651490
[22]	Mari P V, Carriera L, Ielo S, et al. Beyond Triple Therapy:Anti-Type 2 Biologic Therapies for Eosinophilic COPD and Respiratory Comorbidities-a Review of Clinical Evidence[J]. Curr Allergy Asthma Rep, 2026, 26(1):37. doi:10.1007/s11882-026-01281-6.
[23]	Rabe K F, Martinez F J, Bhatt S P, et al. AERIFY-1/2:Two Phase 3, Randomised, Controlled Trials of Itepekimab in Former Smokers with Moderate-to-Severe COPD[J]. ERJ Open Res, 2024, 10(5):00718-2023. doi:10.1183/23120541.00718-2023.
[24]	Bhatt S P, Freemantle N, Soliman M, et al. Dupilumab Versus Mepolizumab for COPD:Evaluating Efficacy Outcomes Using Placebo-Adjusted Indirect Treatment Comparison[J]. Pulm Ther, 2026, 12(1):201-217. doi:10.1007/s41030-025-00322-1.
[25]	Chen Y, Yang T, Zhang J, et al. Type 2 Inflammation in Chronic Obstructive Pulmonary Disease:A Promising Treatable Trait and Practice Recommendations[J]. Chin Med J Pulm Crit Care Med, 2025, 3(4):225-245. doi:10.1016/j.pccm.2025.11.004.
[26]	中国临床试验注册中心.使用度普利尤单抗治疗的慢性阻塞性肺病疾病患者的真实世界研究(ChiCTR2500107743)[EB/OL]. [2026-04-10]. https://www.chictr.org.cn.
[27]	宋俊义, 郑梦凝, 张程, 等. 细胞因子拮抗剂在慢性阻塞性肺疾病治疗中的临床应用[J]. 中华结核和呼吸杂志, 2025, 48(8):772-779. doi:10.3760/cma.j.cn112147-20250315-00145.
[28]	白昊东, 沙炳先, Ambedkar Kumar Yadav, 等. 慢性阻塞性肺病的生物靶向治疗[J]. 中国临床药理学与治疗学, 2024, 29(4):377-382. doi:10.12092/j.issn.1009-2501.2024.04.003.
[29]	宋俊义, 郑梦凝, 张程, 等. 细胞因子拮抗剂在慢性阻塞性肺疾病治疗中的临床应用[J]. 中华结核和呼吸杂志, 2025, 48(8):772-779. doi:10.3760/cma.j.cn112147-20250315-00145.
[30]	廖艺璇, 郭岩斐. 《全球慢性阻塞性肺疾病诊断、管理及预防策略(2026版)》解读:生物制剂治疗[J]. 国际呼吸杂志, 2026, 46(3):196-201. doi:10.3760/cma.j.cn131368-20260113-00017.
[31]	郭万金, 陈亚红. ST2/IL-33信号通路在慢性气道炎症性疾病中的作用研究进展[J/OL]. 中国全科医学, 1-7[2026-06-29]. https://link.cnki.net/urlid/13.1222.R.20260421.1450.004.
[32]	周杉京, 诸葛金科, 王芳芳, 等. 补肺活血胶囊对COPD患者cCor、ALD、Ang-Ⅱ的影响[J]. 中华肺部疾病杂志(电子版), 2023, 16(4):517-519. doi:10.3877/cma.j.issn.1674-6902.2023.04.015.
[33]	葛彦, 朱华, 颜琰. 补肺活血胶囊治疗慢性阻塞性肺疾病肺肾气虚兼血瘀证的临床疗效[J]. 中药材, 2024, 47(11):2890-2893. doi:10.13863/j.issn1001-4454.2024.11.037.
[34]	王琳琳, 庞立健, 吕晓东, 等. 应用补肺活血胶囊治疗慢性阻塞性肺疾病疗效的Meta分析[J]. 中华中医药学刊, 2021, 39(7):39-45. doi:10.13193/j.issn.1673-7717.2021.07.011.
[35]	Bhatt S P, Rabe K F, Hanania N A, et al. Dupilumab for Chronic Obstructive Pulmonary Disease with Type 2 Inflammation:a Pooled Analysis of Two Phase 3, Randomised, Double-blind, Placebo-controlled Trials[J]. Lancet Respir Med, 2025, 13(3):234-243. doi:10.1016/S2213-2600(24)00409-0.