Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts

Bhatt, Surya P.; Rabe, Klaus F.; Hanania, Nicola A.; Vogelmeier, Claus; Cole, Jeremy; Bafadhel, Mona; Christenson, Stephanie A.; Papi, Alberto; Singh, Dave; Laws, Elizabeth; Mannent, Leda; Patel, Naimish; Staudinger, Heribert; Yancopouloš, George D.; Mortensen, Eric; Akinlade, Bolanle; Maloney, Jennifer; Lu, Xin; Bauer, Déborah; Bansal, Ashish; Robinson, Lacey B.; Abdulai, Raolat M.

doi:10.1056/nejmoa2303951

Cited by 190 publications

(68 citation statements)

References 27 publications

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“…Nowadays different biologics are still studied in Phase III trials in COPD. Preliminary data from one of this trial, BOREAS [39,40,41 && ], reported promising and interesting results that may open further scenarios in the treatment of selected COPD patients, as it seems Dupilumab could be the first monoclonal antibody that significatively reduce exacerbation rate and improve respiratory function and quality of life.…”

Section: Discussionmentioning

confidence: 99%

“…In the first (BOREAS), 939 adults with COPD, current or former smokers, with evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells/μL, were randomized to receive weather Dupilumab ( n = 468) or placebo ( n = 471), added to maximal standard-of-care inhaled therapy. Recently reported preliminary results [41 ▪▪ ] demonstrate clinically meaningful and statistically significant reduction of 30% ( P = 0.0005) in exacerbations over 52 weeks compared to placebo (primary endpoint), and rapid and significant improvement in lung function (160 mL in FEV1 vs 77 mL, P < 0.0001) compared to placebo at 12 weeks with persistence of benefits trough week 52 ( P = 0.0003), both secondary endpoints. Dupilumab met all endpoints, including improvement in quality of life as measured by St. George's Respiratory Questionnaire and reduction in the severity of respiratory symptoms of COPD, as measured by Evaluation Respiratory Symptoms: COPD Scale.…”

Section: Anti Interleukin-4 and Interleukin-13mentioning

confidence: 97%

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COPD and biologic treatment: state of the art

Ferri

Paoletti

Pelaia

et al. 2023

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of review Chronic Obstructive Pulmonary Disease (COPD) is a common, heterogeneous disease associated with abnormal inflammatory response of the lung to noxious particles and gases. The progression of disease leads to respiratory failure, disability and premature death. Although recent progress in reducing the global burden of many chronic disease, such as heart disease and cancer, mortality and morbidity due to COPD continue to increase despite of cigarette smoking worldwide policy. Additionally, diagnostic and therapeutic options have not changed in decades. While patients affected by other respiratory disease may benefit with a personalized precision medicine, thanks to the new biological treatment, to date, there is no biological treatment available for COPD. COPD is generally a neutrophils-predominant disease but approximately 40% of patients with COPD had also an eosinophilic airway inflammation. Recent findings different Phase III trials have been recently performed to evaluate the efficacy and safety of several biological treatments, mostly against eosinophilic inflammation and, to date, some of this trial, still ongoing have promising results. Summary This review resumes the rationale, the attempts of biological treatment in COPD and latest promising results.

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Section: Discussionmentioning

confidence: 99%

Section: Anti Interleukin-4 and Interleukin-13mentioning

confidence: 97%

COPD and biologic treatment: state of the art

Ferri

Paoletti

Pelaia

et al. 2023

Current Opinion in Allergy &Amp; Clinical Immunology

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“…there was a heterogeneous effect on OCS maintenance therapy suggesting that a reduction of maintenance OCS can be challenging in this population of older and multimorbid patients. There is now accumulating evidence from randomised controlled trials that biologics such as dupilumab [4], mepolizumab [10], or benralizumab [11] can be effective in patients who are classified as patients having COPD with elevated type 2 biomarkers. However, these studies do not address and discuss the fact that these patients can have concomitant asthma.…”

Section: Discussionmentioning

confidence: 99%

“…However, these studies do not address and discuss the fact that these patients can have concomitant asthma. Of note, the only difference between the "COPD" population described in the BOREAS trial [4] and a typical population of patients with severe asthma was a smoking history of ≥10 PY (which does not exclude asthma [5]) and a doctor's diagnosis of COPD (which does not exclude the presence of asthma either [12,13]). Our study demonstrates that various types of biologics (and not only one class of biologic) approved for the treatment of asthma [6] can, depending on the respective asthma phenotype, be effective in patients with typical and defined clinical features of both asthma and COPD.…”

Section: Discussionmentioning

confidence: 99%

“…Due to the very broad and confusing spectrum of different combinations of these features, the terms asthma-COPD overlap syndrome or asthma-COPD overlap are no longer recommended by international guidelines [2,3]. Instead, some authors postulate that patients with a physician's diagnosis of COPD, elevated type 2 biomarkers, and recurrent exacerbations despite inhaled triple therapy (inhaled corticosteroids plus a long-acting beta-agonist [LABA] plus a long-acting muscarinic antagonist [LAMA]) should be termed "COPD with type 2 inflammation" [4]. These concepts do not address the fact that severe asthma with a smoking history of ≥10 pack years (PY) [5] is often misclassified as COPD in clinical studies and in real life.…”

Section: Introductionmentioning

confidence: 99%

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Response to Various Biologics in Patients with Both Asthma and Chronic Obstructive Pulmonary Disease

Lommatzsch,

Mohme,

Stoll

et al. 2023

Respiration

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Introduction: Patients can have features of both chronic obstructive pulmonary disease (COPD) and asthma. However, there is still no consensus how to precisely define this patient population. In addition, there are little data on the effectiveness of biologics in these patients. Method: Presence of COPD was defined by a smoking history of ≥10 pack years (PY), a postbronchodilator FEV1/FVC ratio < lower limit of normal (LLN) and FEV1 < 80% predicted, a carbon monoxide diffusion capacity (DLCO) < LLN, and dyspnoea on exertion as a leading symptom. Presence of asthma was defined by high type 2 biomarkers (blood eosinophils ≥300 cells/μL and/or FeNO ≥50 ppb), typical clinical features of asthma (including nocturnal respiratory symptoms), and a documented history of a clinical benefit from inhaled and/or oral glucocorticoid treatment. We analysed data from 20 patients fulfilling the criteria for both COPD and asthma who were newly treated with a biologic due to recurrent exacerbations despite high-dose inhaled triple therapy. Results: Median values before treatment with a biologic were as follows: 40 PY, FEV1 42% predicted, DLCO 45% predicted, 475 eosinophils/μL blood, FeNO 48 ppb. Median duration of biologic treatment (mepolizumab, benralizumab, dupilumab, omalizumab, or tezepelumab) was 12 months. There were significant improvements in exacerbations (most prominent effect), asthma control, and lung function during biologic treatment. Conclusions: Various types of biologics approved for severe asthma treatment can be effective in patients with both COPD and asthma. We propose an easy-to-use definition of these patients for routine clinical practice.

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Thresholds for Exacerbation Risk in COPD—Threading the Needleoi

Bhatt

2024

JAMA Netw Open

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Exacerbations of chronic obstructive pulmonary disease (COPD) have significant short-and longterm impact on disease burden and trajectory. 1 After an exacerbation, recovery of symptoms and lung function to baseline can take up to 12 weeks. When lung function does not return to baseline, a stepwise worsening of lung function and emphysema may occur. Preventing these events by detecting individuals at high risk of exacerbations is therefore critical. The current evaluation paradigm, per the Global Initiative for Obstructive Lung Disease (GOLD) document, defines high exacerbation risk over the next 12 months as the occurrence of at least 2 moderate exacerbations or

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Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts

Cited by 190 publications

References 27 publications

COPD and biologic treatment: state of the art

COPD and biologic treatment: state of the art

Response to Various Biologics in Patients with Both Asthma and Chronic Obstructive Pulmonary Disease

Thresholds for Exacerbation Risk in COPD—Threading the Needleoi

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