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Rethinking asthma therapy, part 1: transdermal delivery of β2-agonists. 反思哮喘治疗,第一部分:β2激动剂的经皮递送。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15713
Joseph Correa, Nicole K Brogden
{"title":"Rethinking asthma therapy, part 1: transdermal delivery of β<sub>2</sub>-agonists.","authors":"Joseph Correa, Nicole K Brogden","doi":"10.3389/jpps.2026.15713","DOIUrl":"10.3389/jpps.2026.15713","url":null,"abstract":"<p><p>Asthma and allergies are closely related conditions affecting millions of people around the world. Current treatment options cover many classes of drugs for both acute and ongoing conditions. β2-agonists, leukotriene modifiers, and corticosteroids represent some of the common types of drugs utilized in asthma management. These medications are often delivered via inhalation, oral, or parenteral methods, but each of these modalities faces challenges due to improper technique with inhalers, lessened oral bioavailability due to first-pass metabolism, and reduced compliance of injectable medicines. Transdermal drug delivery may offer a beneficial route of administration that overcomes these barriers as a painless, self-administered form that bypasses first-pass metabolism and can reduce dosing frequency with longer drug release profiles and reduced fluctuations in plasma drug levels. In this two-part mini-review series we will summarize the current literature on transdermal systems for asthma and allergy therapy. Here in Part 1, we cover β2-agonists and discuss the potential of transdermal systems for these drugs. While the body of work with transdermal β2-agonists for asthma treatment is limited, there is still evidence that transdermal systems for asthma has potential to greatly shift the field of asthma therapeutics.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"29 ","pages":"15713"},"PeriodicalIF":5.5,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12995819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147488277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rethinking asthma therapy, part 2: transdermal strategies for adjunct asthma and allergy treatments. 反思哮喘治疗,第2部分:辅助哮喘和过敏治疗的透皮策略。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15714
Joseph Correa, Nicole K Brogden
{"title":"Rethinking asthma therapy, part 2: transdermal strategies for adjunct asthma and allergy treatments.","authors":"Joseph Correa, Nicole K Brogden","doi":"10.3389/jpps.2026.15714","DOIUrl":"10.3389/jpps.2026.15714","url":null,"abstract":"<p><p>Asthma and allergies affect millions of people globally. Avoiding triggers and allergens is a basic management technique for all asthma subtypes (>80% of asthma patients also suffer from allergies), and pharmacological treatment is the cornerstone for acute exacerbations and ongoing maintenance. Typical treatment options for asthma include inhaled, oral, or injectable dosage forms. However, transdermal drug delivery has great potential to provide an alternative route of administration of necessary asthma and allergy therapies that have traditionally been given in other dosage forms. In Part 1 of this two-part series, we discussed the work done towards incorporating short- and long-acting β2-agonists into transdermal drug delivery systems. Here in part 2, we describe the current literature for transdermal applications of leukotriene antagonists, theophylline, and other adjunct medications that do not fall into one specific drug class. A brief overview of biologics, particularly monoclonal antibodies, and the role in asthma is also included, including some context of transdermal mAb delivery for disease states beyond asthma. Because of the relatedness of asthma and allergies, transdermal applications for allergen immunotherapy is also discussed.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"29 ","pages":"15714"},"PeriodicalIF":5.5,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12995823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147488222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Editorial: Volume 2: real world evidence (RWE): paths to enhancing patient access to new medications. 编辑:第2卷:真实世界证据(RWE):促进患者获得新药的途径。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.16236
Allison Wills, Catherine Y Lau
{"title":"Editorial: Volume 2: real world evidence (RWE): paths to enhancing patient access to new medications.","authors":"Allison Wills, Catherine Y Lau","doi":"10.3389/jpps.2026.16236","DOIUrl":"10.3389/jpps.2026.16236","url":null,"abstract":"","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"29 ","pages":"16236"},"PeriodicalIF":5.5,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12995811/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147488244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum: Optimized Ginkgo biloba extract EGb 761®: boosted therapeutic benefits with minimized CYP enzyme interference. 勘误:优化银杏叶提取物EGb 761®:提高治疗效益与最小化CYP酶干扰。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-02-17 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15563
Sunbeom Kwon, Suji Jeong, Seulah Lee
{"title":"Corrigendum: Optimized <i>Ginkgo biloba</i> extract EGb 761<sup>®</sup>: boosted therapeutic benefits with minimized CYP enzyme interference.","authors":"Sunbeom Kwon, Suji Jeong, Seulah Lee","doi":"10.3389/jpps.2026.15563","DOIUrl":"10.3389/jpps.2026.15563","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.3389/jpps.2025.14614.].</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"29 ","pages":"15563"},"PeriodicalIF":5.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12954404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147357025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The effect of cryoprotectant and storage conditions on the aggregation of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) nanoparticles. 研究了低温保护剂和贮存条件对聚乙二醇-聚α-羧酸苄酯-ε-己内酯纳米粒子聚集的影响。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-02-13 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15721
Nasim Sarrami, Soheyla Honary, Mohammad Reza Vakili, Afsaneh Lavasanifar
{"title":"The effect of cryoprotectant and storage conditions on the aggregation of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) nanoparticles.","authors":"Nasim Sarrami, Soheyla Honary, Mohammad Reza Vakili, Afsaneh Lavasanifar","doi":"10.3389/jpps.2026.15721","DOIUrl":"10.3389/jpps.2026.15721","url":null,"abstract":"<p><strong>Introduction: </strong>The preparation of nanoparticles (NPs) in aqueous media leads to thermodynamic instability and aggregation during storage. The objective of this study was to identify an optimum condition for the storage of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) (PEG-PBCL) NPs with minimum to no NP aggregation.</p><p><strong>Methods: </strong>Nanoparticles were prepared from PEG-PBCL of varied PBCL degrees of polymerization. Prepared NPs were either subjected to freeze-thaw or lyophilization with the addition of sugars or polyethylene glycols (PEGs) of varying molecular weight. The average diameter and polydispersity of NPs before and after freeze-thaw or lyophilization/reconstitution in water was assessed by dynamic light scattering and transmission electron microscopy (TEM). Differential Scanning Calorimetry (DSC) was used to compare the thermal behaviour of NPs before and after selected storage conditions.</p><p><strong>Results: </strong>Irrespective of the DP of PBCL, minimum size growth in the freeze-drying method was achieved when PEG3350 and methoxy-PEG 5000 were used as cryoprotectant at a w/w ratio of 4:1 to PEG-PBCL. Under this condition, NP size increased about 2-fold after reconstitution. In the freeze-thaw method, both sucrose and PEGs of different molecular weights, protected the PEG-PBCL NPs of different PBCL length from significant size growth where average particle size growth was not more than 1.20 folds.</p><p><strong>Conclusion: </strong>Our findings suggest that freeze-thawing of PEG-PBCL NP using sucrose or PEG can prevent the NP aggregation and is the best method for PEG-PBCL NP storage.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"29 ","pages":"15721"},"PeriodicalIF":5.5,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12945844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147327322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Targeted therapy and biomarker-guided applications of ecofriendly silver nanoparticles in precision oncology. 生态友好银纳米颗粒在精准肿瘤学中的靶向治疗和生物标志物引导应用。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-01-13 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15403
Haider Hamzah
{"title":"Targeted therapy and biomarker-guided applications of ecofriendly silver nanoparticles in precision oncology.","authors":"Haider Hamzah","doi":"10.3389/jpps.2025.15403","DOIUrl":"10.3389/jpps.2025.15403","url":null,"abstract":"<p><p>Eco-friendly silver nanoparticles (eco-AgNPs) represent a promising convergence of green nanotechnology and precision medicine for cancer treatment. This minireview examines the therapeutic potential of silver nanoparticles (AgNPs) synthesized through eco-friendly methods using plant extracts and microorganisms. These eco-friendly AgNPs demonstrate enhanced biocompatibility and selective cytotoxicity against malignant cells. These nanoparticles target cancer through multiple mechanisms including reactive oxygen species generation, apoptosis induction, and cell cycle disruption. Selectivity is achieved through surface functionalization with targeting moieties such as antibodies and aptamers that recognize overexpressed tumor receptors. The integration of biomarker-guided design enables tumor-specific delivery by exploiting unique metabolic signatures and cellular markers characteristic of different cancer types. Furthermore, AgNP-based theranostic platforms offer simultaneous diagnostic imaging and therapeutic intervention, providing real-time assessment of treatment response and enabling personalized dosing strategies. However, clinical translation faces significant challenges including potential long-term toxicity, standardization of synthesis protocols, and regulatory approval pathways. Successful clinical implementation will require interdisciplinary collaboration to optimize nanoparticle design, establish safety profiles, and develop combination therapies that maximize therapeutic benefits while minimizing side effects. Eco-AgNPs thus offer a transformative approach to cancer treatment that combines environmental sustainability with precision targeting capabilities.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"28 ","pages":"15403"},"PeriodicalIF":5.5,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12834829/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146094594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database. 罗氟司特的真实安全概况:使用FDA不良事件报告系统和加拿大警戒数据库进行药物警戒分析。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-01-12 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15678
Rui Xu, Hui Peng, Chang Shu, Maochang Liu, Ping Gao
{"title":"Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database.","authors":"Rui Xu, Hui Peng, Chang Shu, Maochang Liu, Ping Gao","doi":"10.3389/jpps.2025.15678","DOIUrl":"10.3389/jpps.2025.15678","url":null,"abstract":"<p><strong>Background: </strong>Roflumilast, a highly selective phosphodiesterase 4 inhibitor, is used to treat with chronic obstructive pulmonary disease and psoriasis. We aim to determine potential roflumilast-associated adverse events (AEs) and the differences in AE signals among diverse populations.</p><p><strong>Methods: </strong>Roflumilast's AE reports between the first quarter of 2011 and the fourth quarter of 2024 were obtained from the FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Database (CVARD). The signal strength was measured by four disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).</p><p><strong>Results: </strong>In FAERS, population aged ≥65 years and oral medication users accounted for a predominant proportion in the reported cases. FDA-unlabeled respiratory, thoracic and mediastinal disorders was the only one signal categorized by system organ class met all four algorithms. Newly identified AEs such as dyspnea, condition aggravated, cough, and tachycardia could contribute valuable safety considerations for clinical practice. The analysis of the available time-to-onset data suggested that cases often occurred within the first 30 days post-treatment. These results were externally validated in CVARD, suggesting consistent findings. Notably, headache was more frequently reported among users of topical formulations and female patients, while suicidal ideation and weight loss were more commonly reported in male patients and oral medications, respectively.</p><p><strong>Conclusion: </strong>This study confirmed established adverse reactions and identified novel AEs in real-world clinical practice by dual-database pharmacovigilance analysis. Clinicians should remain vigilant for AEs that differ by gender and route to enable early intervention and improve prognosis. The findings highlight personalized safety management, while underscoring the necessity of prospective studies to validate results and further characterize roflumilast's safety profile.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"28 ","pages":"15678"},"PeriodicalIF":5.5,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12832561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146068354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
UPLC-Q-TOF/MS and network pharmacology identify β-sitosterol as a key component of Saussureae involucratae against epidermal barrier damage UPLC-Q-TOF/MS和网络药理学鉴定,β-谷甾醇是天山雪莲抗表皮屏障损伤的关键成分
4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-01-07 DOI: 10.1007/s44395-025-00034-0
Yanju Zhou, Luhao Wang, Rongrong Jing, Lusheng Wang
{"title":"UPLC-Q-TOF/MS and network pharmacology identify β-sitosterol as a key component of Saussureae involucratae against epidermal barrier damage","authors":"Yanju Zhou, Luhao Wang, Rongrong Jing, Lusheng Wang","doi":"10.1007/s44395-025-00034-0","DOIUrl":"https://doi.org/10.1007/s44395-025-00034-0","url":null,"abstract":"Epidermal barrier damage represents a persistent challenge in dermatology, with limited treatment options currently available. Saussureae involucratae (SI) has demonstrated potential in dermatological applications, yet its bioactive constituents and underlying mechanisms remain largely unclear. This study employed an integrated approach combining ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF/MS), network pharmacology, molecular docking, and experimental validation to identify key components of SI and their roles in mitigating epidermal barrier damage. Network pharmacology analysis identified 102 potential targets, with peroxisome proliferator-activated receptor gamma (PPAR-γ) emerging as a pivotal mediator of SI’s protective effects. In in vitro validation experiments, β-sitosterol—the key bioactive from SI—markedly eased oxidative stress by reducing reactive oxygen species (ROS) levels by approximately 52% under UVB irradiation (p < 0.0001). It also boosted lipid synthesis by over 50% in UVB-exposed cells (p = 0.0027), while upregulating PPAR-γ expression. These shifts curbed inflammation, improved hydration, and overall fortified the epidermal barrier against UVB insult. These findings suggest that SI may exerts protective effects against UVB-induced epidermal barrier dysfunction through multi-target mechanisms, with β-sitosterol as a key mediator. While the network pharmacology analysis provides valuable insights into potential mechanisms, these results are preliminary and need to be experimentally validated to confirm their relevance.","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s44395-025-00034-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147912436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enhancement of oral bioavailability of risedronate through xyloglucan rafts. 通过木聚糖筏提高利塞膦酸盐的口服生物利用度。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-01-07 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15525
Nader I Namazi, Rawan Bafail, Abdulkareem Ali Alanezi, Afaf F Almuqati, Mohammed Salem Alshammari, Majed A Alghamdi
{"title":"Enhancement of oral bioavailability of risedronate through xyloglucan rafts.","authors":"Nader I Namazi, Rawan Bafail, Abdulkareem Ali Alanezi, Afaf F Almuqati, Mohammed Salem Alshammari, Majed A Alghamdi","doi":"10.3389/jpps.2025.15525","DOIUrl":"10.3389/jpps.2025.15525","url":null,"abstract":"<p><p>Bisphosphonates irritate the stomach and oesophagus and have a very limited absorption. The purpose of this study was to increase risedronate (RDN) oral bioavailability by causing a raft to form in the stomach. The creation of a raft prevents the irritation of the stomach and oesophagus caused by bisphosphonates. FTIR, TGA, and DSC were used to characterise the RDN, XLG, and the created formulation. In addition to a cell viability analysis utilising Caco-2 cells, the release of RDN was investigated in 0.1 N HCl, 0.5 N HCl, 1 N HCl, and simulated gastric fluid (SGF). For the pharmacokinetic investigation, the XR5 formulation and the Actonel® tablet were chosen as the test and reference formulations, respectively. Using a parallel design, twelve healthy albino rats were split into two groups, and blood samples were gathered for a whole day. RDN was distributed uniformly throughout the raft and demonstrated chemical stability by the FTIR. The formulation's thermal stability was demonstrated by the TGA and DSC. At 20 min, the SGF showed a 99.97% RDN release. When compared to the RDN suspension, the pharmacokinetics revealed better RDN values from the XLG raft. The RDN from the recently developed XR5 has a better bioavailability than the Actonel® tablet.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"28 ","pages":"15525"},"PeriodicalIF":5.5,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12819339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Refined pharmacovigilance assessment of immune checkpoint inhibitors-related bullous pemphigoid: a multi-methodological approach utilizing FAERS database. 免疫检查点抑制剂相关大疱性类天疱疮的精细药物警戒评估:利用FAERS数据库的多方法方法。
IF 5.5 4区 医学
Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2026-01-07 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15597
Yan Wang, Liu-Yi-Yi Yang, Ya-Gang Zuo
{"title":"Refined pharmacovigilance assessment of immune checkpoint inhibitors-related bullous pemphigoid: a multi-methodological approach utilizing FAERS database.","authors":"Yan Wang, Liu-Yi-Yi Yang, Ya-Gang Zuo","doi":"10.3389/jpps.2025.15597","DOIUrl":"10.3389/jpps.2025.15597","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the potential risk of bullous pemphigoid (BP) in patients treated with immune checkpoint inhibitors (ICIs) and to characterize ICI-related BP (irBP) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>The present study conducted a disproportionality analysis leveraging FAERS database, spanning the first quarter (Q1) of 2004-2025 Q1. To ensure robust signal detection, we employed a quadruple analytical approach incorporating: (1) reporting odds ratio (ROR), (2) proportional reporting ratio, (3) Bayesian confidence propagation neural network, and (4) multi-item gamma Poisson shrinker algorithms. These methodologies were systematically applied to assess the potential risk of BP in patients treated with ICIs. Furthermore, temporal characteristics of adverse event emergence were quantitatively assessed to delineate the time-to-onset patterns.</p><p><strong>Results: </strong>There are 850 irBP cases identified, comprising reports associated with the following agents: nivolumab (n = 530), pembrolizumab (n = 180), ipilimumab (n = 44), atezolizumab (n = 40), cemiplimab (n = 24), durvalumab (n = 19), tislelizumab (n = 10), and avelumab (n = 3). Affected patients were predominantly males (67.8%) and over 60 years of age (70.1%). All eight ICIs showed positive disproportionality signals, with ROR values ranked descendingly as: cemiplimab > nivolumab > tislelizumab > pembrolizumab > ipilimumab > durvalumab > atezolizumab > avelumab. The median time of irBP onset was 165.2 (IQR: 56-410) days.</p><p><strong>Conclusion: </strong>The study establishes a significant link between ICIs and BP. All ICIs increase BP risk. CTLA-4 inhibitors exhibited the most marked early risk concentration, highlighting the importance of early dermatologic evaluation after initiating CTLA-4 blockade.</p>","PeriodicalId":50090,"journal":{"name":"Journal of Pharmacy and Pharmaceutical Sciences","volume":"28 ","pages":"15597"},"PeriodicalIF":5.5,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12819333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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