International Journal of Immunopathology and Pharmacology最新文献

{"title":"Construction and evaluation of glucocorticoid dose prediction model based on genetic and clinical characteristics of patients with systemic lupus erythematosus.","authors":"Xin Luo, Jinjun Zhao, Danfeng Zou, Xiaoning Luo, Meida Fan, Hongling Hu, Ping Zheng, Yilei Li, Renfei Xia, Liqian Mo","doi":"10.1177/03946320251331791","DOIUrl":"10.1177/03946320251331791","url":null,"abstract":"<p><p>Currently, no glucocorticoid dose prediction model is available for clinical practice. This study aimed to utilise machine learning techniques to develop and validate personalised dosage models. Participants were patients with SLE who were registered at Nanfang Hospital and received prednisone. Univariate analysis was used to confirm the feature variables. Subsequently, the random forest (RF) algorithm was utilised to interpolate the absent values of the feature variables. Finally, we assessed the prediction capabilities of 11 machine learning and deep-learning algorithms (Logistic, SVM, RF, Adaboost, Bagging, XGBoost, LightGBM, CatBoost, MLP, and TabNet). Finally, a confusion matrix was used to validate the three regimens. In total, 129 patients met the inclusion criteria. The XGBoost algorithm was selected as the preferred method because of its superior performance, achieving an accuracy of 0.81. The factors exhibiting the highest correlation with the prednisone dose were CYP3A4 (rs4646437), albumin (ALB), haemoglobin (HGB), anti-double-stranded DNA antibodies (Anti-dsDNA), erythrocyte sedimentation rate (ESR), age, and HLA-DQA1 (rs2187668). Based on validation, the precision and recall rates for low-dose prednisone (⩾5 mg but <7.5 mg/d) were 100% and 40% respectively. Similarly, for medium-dose prednisone (⩾7.5 mg but <30 mg/d), the accuracy and recall rates were 88% and 88%, and for high-dose prednisone (⩾30 mg but ⩽100 mg/d), the accuracy and recall rates were 62% and 100% respectively. A robust machine learning model was developed to accurately predict prednisone dosage by integrating the identified genetic and clinical factors.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251331791"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12032459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of HLA-DR, HLA-DQ, and HLA-B alleles with inclusion body myositis risk: A systematic review, a meta-analysis, a meta-regression and a trial sequential analysis.","authors":"Tarak Dhaouadi, Awatef Riahi, Taïeb Ben Abdallah, Yousr Gorgi, Imen Sfar","doi":"10.1177/03946320251321747","DOIUrl":"10.1177/03946320251321747","url":null,"abstract":"<p><strong>Introduction: </strong>Although, several studies have assessed the association of HLA Class I and II genes with inclusion body myositis (IBM), results were inconsistent and between-studies heterogeneity needs to be investigated.</p><p><strong>Objectives: </strong>The aim of this review was to summarize existing data on the contribution of HLA-DRB1 and HLA-B alleles to IBM susceptibility and to investigate the between-studies heterogeneity by subgroup analyses and meta-regressions.</p><p><strong>Design: </strong>This study was performed according to the PRISMA guidelines for systematic reviews and meta-analyses.</p><p><strong>Methods: </strong>An electronic literature search for eligible studies among all papers published prior to January 29, 2025, was conducted through PubMed, EMBASE, Web of science, and Scopus databases. Meta-analyses together with subgroup analyses and meta-regressions were performed for the two following HLA genes: HLA-DRB1 and HLA-B.</p><p><strong>Results: </strong>Combined analyses revealed a significant increase in IBM risk conferred by the HLA-DRB1*03 allele (9.21 (7.05-12.01)), the DRB*03:01 allele (8.44 (6.85-10.41)), the DRB1*01 allele (2.31 (1.82-2.93)), the DRB1*01:01 allele (2.63 (1.95-3.55)), the DRB1*15:02 allele (3.49 (2.12-5.75)), the B*08 allele (4.05 (2.58-6.38)), and the DQB1*02 allele (6.62 (4.5-9.74)), all <i>p</i>-values < 0.001. In addition, the DRB1*15:01 allele was found to be protective against IBM in all populations (0.48 (0.32-0.72)). Conversely, the DRB*11 allele was not associated with IBM risk, OR (95% CI) = 0.91 (0.54-1.51), <i>p</i> = 0.703.</p><p><strong>Conclusion: </strong>This meta-analysis demonstrated that HLA-DRB1, DQB1, and B loci could play a major role in IBM pathogenesis.</p><p><strong>Registration: </strong>This review has been registered on PROSPERO on June 25, 2024: CRD42024557948, Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024557948.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251321747"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11831637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retraction Notice: \"MUC1 expressing tumor growth was retarded after human mucin 1 (MUC1) plasmid DNA immunization\".","authors":"","doi":"10.1177/03946320241310709","DOIUrl":"10.1177/03946320241310709","url":null,"abstract":"","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320241310709"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142966780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A new way of the Coombs test using flow cytometry-based assay to assess erythrocytes-bound IgG antibodies in the human and rabbit model.","authors":"Anwar Ullah, Xuewei Ding, Xia Qi, Hui Liu","doi":"10.1177/03946320241305270","DOIUrl":"https://doi.org/10.1177/03946320241305270","url":null,"abstract":"<p><p>The Coombs test is important in hematology for detecting erythrocyte-bound IgG antibodies or in serm through agglutination methods, but its sensitivity and specificity are limited. Flow cytometry provides a more precise and sensitive alternative for quantitatively assessing RBC-bound IgG antibodies. This assessment is crucial for evaluating the risk of hemolytic reactions and ensuring safe transfusions. This study aimed to explore a new method for the detection of RBC-bound IgG antibodies in rabbits following the injection of human red blood cells. Rabbits serum treated with 2-mercaptoethanol (2-ME) were serially diluted at ratios of 1:1, 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, and 1:2048. These diluted samples were then reacted with O-type red blood cells (RBCs). Serum samples from healthy individuals were used as the control group. The tubes were kept in a water bath at 37°C for 30 min incubation. After incubation, the samples were analyzed using a flow cytometry-based assay. Additionally, the traditional Coombs tube method was used and the strength of IgG antibody and agglutination was graded. The results were analyzed using a flow cytometry-based assay, and the agglutination strength was determined using the Coombs traditional tube method for RBC-bound IgG antibodies. A significant difference was found between the rabbits serum and normal control groups (p < 0.001). IgG titers increased significantly after 1 month of immunization in rabbits compared to the titers observed after 1 week. The serum Anti-D stability test showed a coefficient of variation (CV) of 7.74%, indicating good stability of the test results. In this study, we concluded that the flow cytometry-based assay for detecting RBC-bound IgG antibodies was accurate, sensitive, and had positional value in clinical laboratories and research centers.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320241305270"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142933177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Myricetin enhances keratinocytes differentiation via TRPV4 channel activation in mouse primary keratinocytes.","authors":"Jie-Fang Gao, Tong-Xuan Li, Guo-Qiang Zhang","doi":"10.1177/03946320251317287","DOIUrl":"10.1177/03946320251317287","url":null,"abstract":"<p><p>The skin serves as the primary defensive barrier of the human body against external stimuli and damage. Keratinocytes, which are the predominant cell type in the human epidermis, undergo a differentiation process that is crucial for the formation of the skin barrier. Myricetin, a dietary flavonoid present in various fruits and vegetables, is known to play a significant role in maintaining intestinal barrier function; however, its impact on the skin barrier remains inadequately understood. Consequently, this study investigates the effects of myricetin on the differentiation of epidermal keratinocytes and the integrity of the skin barrier. Differentiation of primary mouse keratinocytes was induced using 1.8 mM CaCl₂. tudy demonstrated that myricetin effectively suppresses cell proliferation and induces both cell cycle arrest and calcium ion (Ca²⁺) influx, without influencing apoptosis. Concurrently, myricetin enhances the expression of differentiation markers, including K10, TGase1, Filaggrin, and Involucrin, and facilitates the formation of tight junctions. Upon examining the underlying mechanisms, we discovered that myricetin activates the TRPV4 channel, and the promotion of keratinocyte differentiation by myricetin is contingent upon the activation of this channel. In summary, these findings suggested that myricetin could promote keratinocytes differentiation and have well-established skin barrier protective function.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251317287"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of fecal microbiota transplantation on lung function and gut microbiome in an ARDS rat model: A multi-omics analysis including 16S rRNA sequencing, metabolomics, and transcriptomics.","authors":"Dongwei Zhang, Zhenqiang Zhang, Longxiong Liao, Biying Dong, Xia Xiong, Xuejun Qin, Xianming Fan","doi":"10.1177/03946320251333982","DOIUrl":"https://doi.org/10.1177/03946320251333982","url":null,"abstract":"<p><strong>Objective: </strong>Acute respiratory distress syndrome (ARDS) is a severe pulmonary condition characterized by inflammation and lung damage, frequently resulting in poor clinical outcomes. Recent studies suggest that the gut-lung axis, mediated by gut microbiota, is critical in ARDS progression. This study investigates the therapeutic potential of fecal microbiota transplantation (FMT) in an ARDS rat model (<i>n</i> = 6).</p><p><strong>Introduction: </strong>The pathogenesis of ARDS involves complex interactions between the lungs and gut, with microbiota playing a key role. Understanding the effects of FMT on lung function and gut microbiota may provide new therapeutic strategies for ARDS management.</p><p><strong>Methods: </strong>Sprague-Dawley rats were pre-treated with a broad-spectrum antibiotic cocktail to create a germ-free state and subsequently exposed to intranasal lipopolysaccharide to induce ARDS. The rats then received FMT treatment. Lung samples were analyzed using histopathology and transcriptomics. Fecal samples were analyzed using 16S rRNA sequencing and metabolomics.</p><p><strong>Results: </strong>FMT treatment significantly reduced lung injury and improved pulmonary function, as evidenced by increased partial pressure of arterial oxygen (PaO₂) and decreased partial pressure of arterial carbon dioxide (PaCO₂). FMT also significantly altered in gut microbiota composition by regulating the gut microbiota composition of <i>Akkermansia</i> and <i>Lactobacillus</i>, restoring the abundance of genera such as <i>Muribaculaceae</i>, <i>Clostridia_UCG-014</i>, <i>Prevotella</i>, and <i>Adlercreutzia</i>, while reducing <i>Romboutsia</i>. FMT restored key metabolic pathways involved in lipid metabolism, amino acid biosynthesis, and immune regulation, including the modulation of immune pathways like mTOR signaling. These alterations contribute to reduced lung injury and improved pulmonary function.</p><p><strong>Conclusion: </strong>These findings indicate that FMT may exert its beneficial effects in ARDS by modulating the gut microbiota and enhancing metabolic and immune responses. However, given that this study remains in the preclinical stage, further validation in clinical studies is necessary before considering clinical application.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251333982"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12035062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aurora-A promotes lenvatinib resistance experimentally through hsa-circ-0058046/miR-424-5p/FGFR1 axis in hepatocellular carcinoma.","authors":"Mubalake Abudoureyimu, Ni Sun, Weiwei Chen, Xinrong Lin, Fan Pan, Rui Wang","doi":"10.1177/03946320251316692","DOIUrl":"10.1177/03946320251316692","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate whether the dysregulation of Aurora-A is involved in lenvatinib resistance in hepatocellular carcinoma.</p><p><strong>Methods: </strong>Bioinformatics tools and drug sensitivity assays were used to investigate the association between Aurora-A expression level and lenvatinib resistance in hepatocellular carcinoma cell lines. Cell function experiments had performed after treatment with lenvatinib and/or a selective Aurora-A inhibitor (MLN-8237). CircRNA microarray, RIP, RNA pull-down, and dual-luciferace reporter assay were performed to identify the downstream molecular mechanism of Aurora-A dysregulation.</p><p><strong>Results: </strong>Aurora-A expression was positively correlated with lenvatinib resistance in hepatocellular carcinoma cells. The Aurora-A selective inhibitor MLN-8237, in combination with lenvatinib, synergistically inhibited hepatocellular carcinoma cell proliferation in vitro and vivo, suggesting the Aurora-A might be a potential therapeutic target for lenvatinib resistance. Mechanistically, Aurora-A induced FGFR1 expression through the hsa-circ-0058046/miR-424-5p/FGFR1 axis. Aurora-A promotes lenvatinib resistance through hsa-circ-0058046/miR-424-5p/FGFR1 axis in hepatocellular carcinoma cells. The simultaneous inhibition of FGFR1 by the Aurora-A inhibitor MLN-8237 and lenvatinib overcame lenvatinib resistance in hepatocellular carcinoma cells.</p><p><strong>Conclusion: </strong>Collectively, our findings indicate that Aurora-A promotes lenvatinib resistance through the hsa-circ-0058046/miR-424-5p/FGFR1 axis in hepatocellular carcinoma (HCC) cells. These results suggest that Aurora-A may serve as a therapeutic target for HCC patients exhibiting lenvatinib resistance. Furthermore, the combination of lenvatinib and MLN-8237 shows potential for clinical trials aimed at overcoming lenvatinib resistance.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251316692"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11789117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of tacrolimus on interferon gamma ELISpot assay results for the assessment of T-cell immunity: Proof-of-concept.","authors":"Aurélie Truffot, Jules Weinhard, Pauline Dessaud, Patrice Morand, Lionel Rostaing, Françoise Stanke-Labesque, Xavier Fonrose, Raphaële Germi, Thomas Jouve","doi":"10.1177/03946320251325062","DOIUrl":"10.1177/03946320251325062","url":null,"abstract":"<p><p>SOT patients require immunosuppressors to avoid graft rejection. Therapeutic drug monitoring is insufficient to find the optimal balance with immunosuppression. The evaluation of cell-mediated immunity by enzyme-linked immunospot (ELISpot) assay enumerating interferon-gamma (IFN-γ) is increasingly use. ELISpot assays are performed on peripheral blood mononuclear cells (PBMC) isolated from blood and brought into contact with specific peptides in an immunosuppressor-free environment. This study aims to determine the <i>in vitro</i> diffusion of tacrolimus in PBMC and to assess whether prior <i>in vitro</i> incubation of PBMC with tacrolimus modifies the IFN-γ ELISpot results when assessing the T-cell immune response. PBMC from healthy volunteers were obtained. Tacrolimus was added to the ELISpot wells at increasing concentration and quantification was obtained using liquid chromatography mass spectrometry. Results showed that the <i>in vitro</i> PBMC diffusion rate of tacrolimus was measured at 32%. A decrease in T-cell reactivity occurred with increasing tacrolimus concentration. The intra-PBMC concentration of tacrolimus able to inhibit 50% of T-cell reactivity was 163 pg/10⁶ PBMC, which is in the range of the <i>in vivo</i> intra-PBMC concentration in SOT recipients. T-cell functional assessment using ELISpot in patients treated with immunosuppressors may require the addition of immunosuppressors <i>in vitro</i> to better reflect the <i>in vivo</i> situation.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251325062"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Micronutrient deficiencies in patients with celiac disease: A systematic review and meta-analysis.","authors":"Saad Lamjadli, Ider Oujamaa, Ikram Souli, Fatima Ezzohra Eddehbi, Nadia Lakhouaja, Bouchra M'raouni, Abdelmouine Salami, Morad Guennouni, Moulay Yassine Belghali, Raja Hazime, Brahim Admou","doi":"10.1177/03946320241313426","DOIUrl":"10.1177/03946320241313426","url":null,"abstract":"<p><p>This study aimed to characterize micronutrient deficiencies, including iron, ferritin, folic acid, vitamin D, zinc (Zn), vitamin B₁₂, and copper, in patients with celiac disease, and evaluated the effects of these deficiencies on selected hematological parameters, including hemoglobin and mean corpuscular volume (MCV). Celiac disease (CeD), an immune-mediated disorder affecting the small bowel, is associated with genetic factors and micronutrient deficiencies. This meta-analysis was performed in accordance with the PRISMA guidelines. Literature searches of multiple databases retrieved 4140 studies, of which 45 were selected. Risk of Bias was performed in accordance with the STROBE checklist. Meta-analysis revealed a significant difference in hemoglobin levels between patients with CeD and controls (standardized mean difference (SMD) -0.59 (95% confidence interval (CI) -0.8459 to -0.3382); <i>P</i> = 0.0003). Iron levels were lower in patients with CeD (SMD ≈ -0.4 (95% CI -0.7385 to -0.0407); <i>P</i> = 0.0334), as were ferritin (SMD -0.6358 (95% CI -0.8962 to -0.3755); <i>P</i> = 0.0002), folic acid (SMD -0.5446 (95% CI -0.9749 to -0.1142); <i>P</i> = 0.0187), and vitamin D (SMD -0.4011 (95% CI -0.8020 to -0.0001); <i>P</i> = 0.0499) levels, while Zn levels were significantly reduced (SMD -1.1398 (95% CI -2.0712 to -0.2084); <i>P</i> = 0.0242). No significant differences were found in MCV, or copper or vitamin B₁₂ levels between patients with CeD and controls. This study highlighted significantly higher micronutrient deficiencies in patients diagnosed with CeD than in controls, underscoring the importance of systematic nutritional assessment and multidisciplinary management to address micronutrient deficiencies and minimize negative health impact(s).</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320241313426"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11831651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance study of immunomodulatory drug-related adverse events using spontaneous reporting system databases.","authors":"Satoshi Nakao, Mika Maezawa, Moe Yamashita, Koumi Miyasaka, Sakiko Hirofuji, Nanaka Ichihara, Yuka Nokura, Kana Sugishita, Tomofumi Yamazaki, Hirofumi Tamaki, Kimitaka Suetsugu, Masafumi Hashimoto, Toshikazu Tsuji, Kazuhiro Iguchi, Ichiro Ieiri, Mitsuhiro Nakamura","doi":"10.1177/03946320251327618","DOIUrl":"https://doi.org/10.1177/03946320251327618","url":null,"abstract":"<p><p>The aim of this study was to evaluate the country-specific reporting status profile of immunomodulatory drugs (IMiDs)-related adverse events (ImrAEs) in real-world clinical practice, using data from the Japanese Adverse Drug Event Report (JADER) and Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. Immunomodulatory drugs, including thalidomide and its derivatives, are a new class of anticancer and anti-inflammatory drugs. IMiD risk management programs have instituted sufficient measures to prevent fetal effects but do not address adverse effects experienced by patients themselves. To date, no study has compared ImrAE profiles across countries. Adverse events were defined using the preferred terms in the Medical Dictionary for Regulatory Activities. The number of reported adverse events related to IMiDs in each country (the United States and Japan) was investigated. In both Japan and the United States, myelosuppression, pneumonia, and neuropathy peripheral have been reported as adverse events suspected to be associated with IMiDs. Adverse event profiles differed between the countries. The number of adverse event reports for thalidomide increased transiently in the United States in 2008 following the multiple myeloma indication, and then exhibited a downward trend. The number of adverse event reports for lenalidomide and pomalidomide has increased in the United States since their launch. The number of transient reports increased in Japan in 2015, when pomalidomide was launched. In this study, the profile of ImrAEs was revealed using the FAERS and JADER databases. Our comparative safety study indicated the importance of comparing the safety profiles of IMiDs using post-marketing real-world data. It is important to focus on the adverse events experienced by patients taking IMiDs, as well as the effects of IMiDs on fetuses.</p>","PeriodicalId":48647,"journal":{"name":"International Journal of Immunopathology and Pharmacology","volume":"39 ","pages":"3946320251327618"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12032464/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144041180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}