An Overview of the Safety and Efficacy of Monoclonal Antibodies for the Chronic Obstructive Pulmonary Disease

Cazzola, Mario; Ora, Josuel; Cavalli, Francesco; Rogliani, Paola; Matera, Maria Gabriella

doi:10.2147/btt.s295409

Cited by 11 publications

(13 citation statements)

References 88 publications

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“…The time-to-onset of adverse events used the formula as follows: , after we removed the reports with obvious errors such as illogical dates, such as missing data and the negative number of time-to-onset. The onset time of AEs induced by pertuzumab was calculated and shown as the percentage, expressed as “%” [ 50 ].…”

Section: Methodsmentioning

confidence: 99%

A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

Zou,

Yang,

Ouyang

et al. 2023

BMC Pharmacol Toxicol

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Background Pertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So, we evaluated the safety of pertuzumab by pharmacovigilance analyze based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) and find whether potential or uncertain adverse events were present. Methods In disproportionality analysis, four algorithms were employed to detect the signals of pertuzumab from the FAERS between 2012 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the potential and high-ROR (reporting odds ratio) signals of pertuzumab. We also collected the onset times of pertuzumab-associated AEs. Results From January 2012 to December 2022, there are 39,190,598 AEs reported from the FAERS database, of which 14,707 AEs listed pertuzumab as the ‘primary suspected (PS)’ drug. A total of 115 (46 potential) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained. Finally, we detected that the pertuzumab-induced AEs occurred in 12 organ systems. For pertuzumab, unexpected and significant PTs of AEs were found, including but not limited to below PTs: haematotoxicity, cardiotoxicity, cardiomyopathy, mitral valve incompetence, tachycardia, intestinal perforation, hemorrhoids, erysipelas, dehydration, pneumonitis, skin toxicity, onychomadesis, cyanosis, and circulatory collapse. We found there were 9 strong signals (5 potential safety signals) and 68 medium intensity signals (21 potential safety signals) according to IC025 (information component). The potential strong signals (IC025 > 3.0) were myelosuppression, cardiotoxicity, cardiac dysfunction, ejection fraction decreased, interstitial lung disease, and onychomadesis. Excluding unreported or unreasonable onset time reports, a total of 2016 AEs reported onset time and the median onset time was 117 days (4, 96), as median (Q1, Q3). Notably, most of the all AEs (n = 1133, 56%) and cardiac-related events (n = 405, 53%) all occurred within one month after pertuzumab therapy. Conclusion Analysis of FAERS data identified pertuzumab-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of pertuzumab. A significant association was detected between pertuzumab and some potential adverse events which should be regarded with some care. We have to pay attention to the first month after pertuzumab therapy and prepare emergency measures, especially for the elderly and patients with cardiovascular diseases.

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Section: Methodsmentioning

confidence: 99%

A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

Zou,

Yang,

Ouyang

et al. 2023

BMC Pharmacol Toxicol

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“…Anti-IL-17A mAbs, collectins, anti-IL-5 mAbs, anti-IL13/IL4 mAbs, anti-TSLP mAbs, and anti-IL-33 mAbs are among the biological therapies that have the potential to treat COPD. 24,76 Anti-IL-17A mAbs Along with IL-22, IL-17A and IL-17F are linked to an increase in neutrophils in the airways, which results in chronic inflammation and increased mucus production and smooth muscle mass in the airways. 76 To reduce neutrophil recruitment and airway inflammation, many anti-IL-17A and anti-IL-17 receptor A (IL-17RA) mAbs are being developed, 77 but CNTO 6785 is the only anti-IL-17A mAb that has been investigated in patients with COPD.…”

Section: Biologic Therapiesmentioning

confidence: 99%

Novel Anti-Inflammatory Approaches to COPD

Cazzola¹,

Hanania²,

Page³

et al. 2023

COPD

Self Cite

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Airway inflammation, driven by different types of inflammatory cells and mediators, plays a fundamental role in COPD and its progression. Neutrophils, eosinophils, macrophages, and CD4 + and CD8 + T lymphocytes are key players in this process, although the extent of their participation varies according to the patient's endotype. Anti-inflammatory medications may modify the natural history and progression of COPD. However, since airway inflammation in COPD is relatively resistant to corticosteroid therapy, innovative pharmacological anti-inflammatory approaches are required. The heterogeneity of inflammatory cells and mediators in annethe different COPD endo-phenotypes requires the development of specific pharmacologic agents. Indeed, over the past two decades, several mechanisms that influence the influx and/or activity of inflammatory cells in the airways and lung parenchyma have been identified. Several of these molecules have been tested in vitro models and in vivo in laboratory animals, but only a few have been studied in humans. Although early studies have not been encouraging, useful information emerged suggesting that some of these agents may need to be further tested in specific subgroups of patients, hopefully leading to a more personalized approach to treating COPD.

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“…Interleukins -4, -5 and -13 all contribute to eosinophil recruitment and can be therapeutically targeted with mABs [ 83 ]. The IL-5 pathway can be targeted with mepolizumab, a mAB against free IL-5, and benralizumab, a mAB against its receptor (IL-5R) [ 84 ]. Multiple large, randomized studies have evaluated these two agents in COPD; a Cochrane systematic review and meta-analysis of six studies (three each for mepolizumab and benralizumab) concluded both agents are likely to reduce the rate of exacerbations in COPD patients with high eosinophil counts [ 85 ].…”

Section: Non-cholinergic Targets For Copd Treatmentmentioning

confidence: 99%

“…TSLP is an upstream cytokine involved in type 2 inflammation and other pathogenic processes in COPD [ 90 ]. Tezepelumab (anti-TSLP) is being evaluated in a phase II placebo-controlled randomized study (COURSE) in COPD patients with exacerbations on triple therapy [ 84 ].…”

Section: Non-cholinergic Targets For Copd Treatmentmentioning

confidence: 99%

Pathophysiology, Therapeutic Targets, and Future Therapeutic Alternatives in COPD: Focus on the Importance of the Cholinergic System

Gomes

Cheng

2023

Biomolecules

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Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by airway limitation and changes in airway structure. It has a high global burden of mortality and morbidity. The etiology of COPD is complex, but exposure to tobacco smoke and other inhaled lung oxidants are major risk factors. Both pharmacological and non-pharmacological approaches are used to manage COPD, but there remains an urgent unmet need for drugs that can modify the course of the disease. This review focuses on the role of acetylcholine and other components of the pulmonary cholinergic system in the pathogenesis of COPD, and the inhaled pharmacological agents that target it. In addition to its role as a neurotransmitter, acetylcholine regulates diverse aspects of COPD pathogenesis including bronchoconstriction, airway remodeling, mucus secretion and inflammation. Inhaled antimuscarinic drugs are a key component of therapy for COPD, as monotherapy or in combination with inhaled β2 agonists or corticosteroids. We review the evidence supporting the use of current anticholinergic agents in COPD and preview novel drugs targeting the cholinergic system and agents from other classes in clinical development, such as phosphodiesterase-4 inhibitors and monoclonal antibodies targeting inflammatory mediators.

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An Overview of the Safety and Efficacy of Monoclonal Antibodies for the Chronic Obstructive Pulmonary Disease

Cited by 11 publications

References 88 publications

A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)

Novel Anti-Inflammatory Approaches to COPD

Pathophysiology, Therapeutic Targets, and Future Therapeutic Alternatives in COPD: Focus on the Importance of the Cholinergic System

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