Therapeutic Advances in Chronic Disease最新文献

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Predictors of seizure outcomes in stereo-electroencephalography-guided radio-frequency thermocoagulation for MRI-negative epilepsy. 立体脑电图引导下射频热凝治疗核磁共振阴性癫痫的癫痫发作预后。
IF 3.3 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-03-15 eCollection Date: 2024-01-01 DOI: 10.1177/20406223241236258
Qi Huang, Pandeng Xie, Jian Zhou, Haoran Ding, Zhao Liu, Tianfu Li, Yuguang Guan, Mengyang Wang, Jing Wang, Pengfei Teng, Mingwang Zhu, Kaiqiang Ma, Han Wu, Guoming Luan, Feng Zhai
{"title":"Predictors of seizure outcomes in stereo-electroencephalography-guided radio-frequency thermocoagulation for MRI-negative epilepsy.","authors":"Qi Huang, Pandeng Xie, Jian Zhou, Haoran Ding, Zhao Liu, Tianfu Li, Yuguang Guan, Mengyang Wang, Jing Wang, Pengfei Teng, Mingwang Zhu, Kaiqiang Ma, Han Wu, Guoming Luan, Feng Zhai","doi":"10.1177/20406223241236258","DOIUrl":"10.1177/20406223241236258","url":null,"abstract":"<p><strong>Background: </strong>One-third of intractable epilepsy patients have no visually identifiable focus for neurosurgery based on imaging tests [magnetic resonance imaging (MRI)-negative cases]. Stereo-electroencephalography-guided radio-frequency thermocoagulation (SEEG-guided RF-TC) is utilized in the clinical treatment of epilepsy to lower the incidence of complications post-open surgery.</p><p><strong>Objective: </strong>This study aimed to identify prognostic factors and long-term seizure outcomes in SEEG-guided RF-TC for patients with MRI-negative epilepsy.</p><p><strong>Design: </strong>This was a single-center retrospective cohort study.</p><p><strong>Methods: </strong>We included 30 patients who had undergone SEEG-guided RF-TC at Sanbo Brain Hospital, Capital Medical University, from April 2015 to December 2019. The probability of remaining seizure-free and the plotted survival curves were analyzed. Prognostic factors were analyzed using log-rank tests in univariate analysis and the Cox regression model in multivariate analysis.</p><p><strong>Results: </strong>With a mean time of 31.07 ± 2.64 months (median 30.00, interquartile range: 18.00-40.00 months), 11 out of 30 patients (36.7%) were classified as International League Against Epilepsy class 1 in the last follow-up. The mean time of remaining seizure-free was 21.33 ± 4.55 months [95% confidence interval (CI) 12.41-30.25], and the median time was 3.00 ± 0.54 months (95% CI 1.94-4.06). Despite falling in the initial year, the probability of remaining seizure-free gradually stabilizes in the subsequent years. The patients were more likely to obtain seizure freedom when the epileptogenic zone was located in the insular lobe or with one focus on the limbic system (<i>p</i> = 0.034, hazard ratio 5.019, 95% CI 1.125-22.387).</p><p><strong>Conclusion: </strong>Our findings may be applied to guide individualized surgical interventions and help clinicians make better decisions.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223241236258"},"PeriodicalIF":3.3,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10943718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144071","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}
引用次数: 0
Photodynamic therapy of cervical cancer: a scoping review on the efficacy of various molecules. 宫颈癌的光动力疗法:各种分子疗效的范围综述。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-03-04 eCollection Date: 2024-01-01 DOI: 10.1177/20406223241233206
Nasrulla Abdullaevich Shanazarov, Afshin Zare, Nadiar Maratovich Mussin, Rustam Kuanyshbekovich Albayev, Asset Askerovich Kaliyev, Yerbolat Maratovich Iztleuov, Sandugash Bakhytbekovna Smailova, Amin Tamadon
{"title":"Photodynamic therapy of cervical cancer: a scoping review on the efficacy of various molecules.","authors":"Nasrulla Abdullaevich Shanazarov, Afshin Zare, Nadiar Maratovich Mussin, Rustam Kuanyshbekovich Albayev, Asset Askerovich Kaliyev, Yerbolat Maratovich Iztleuov, Sandugash Bakhytbekovna Smailova, Amin Tamadon","doi":"10.1177/20406223241233206","DOIUrl":"10.1177/20406223241233206","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer poses a considerable worldwide health issue, where infection with the human papillomavirus (HPV) plays a vital role as a risk factor. Photodynamic therapy (PDT) is a minimally invasive treatment for HPV-related cervical lesions, which uses photosensitizers and light to selectively destroy abnormal cells.</p><p><strong>Objectives: </strong>Our objective is to present a comprehensive overview of the different types of molecules employed in PDT to reduce the occurrence and fatality rates associated with cervical cancer.</p><p><strong>Design: </strong>Scoping review and bibliometric analysis.</p><p><strong>Methods: </strong>The article explores clinical trials investigating the efficacy of PDT in treating low-grade squamous intraepithelial lesion and high-grade squamous intraepithelial lesion, as well as preclinical approaches utilizing various molecules for PDT in cervical cancer. Furthermore, the article sheds light on potential molecules for PDT enhancement, examining their properties through computer modeling simulations, molecular docking, and assessing their advantages and disadvantages.</p><p><strong>Results: </strong>Our findings demonstrate that PDT holds promise as a therapeutic approach for treating cervical lesions associated with HPV and cervical cancer. Additionally, we observe that the utilization of diverse dye classes enhances the anticancer effects of PDT.</p><p><strong>Conclusion: </strong>Among the various molecules employed in PDT, functionalized fullerene exhibits a notable inclination toward overexpressed receptors in cervical cancer cells, making it a potential candidate for intensified use in PDT. However, further research is needed to evaluate its long-term effectiveness and safety.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223241233206"},"PeriodicalIF":3.5,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10910886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140029117","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}
引用次数: 0
Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea secukinumab 对中重度斑块状银屑病成年患者的实际安全性和有效性:韩国上市后监测结果
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-02-26 DOI: 10.1177/20406223241230180
Byung Soo Kim, Dong Hyun Kim, Bong Seok Shin, Eun-So Lee, Seong Jin Jo, Chul Hwan Bang, Yeojun Yun, Yong Beom Choe
{"title":"Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea","authors":"Byung Soo Kim, Dong Hyun Kim, Bong Seok Shin, Eun-So Lee, Seong Jin Jo, Chul Hwan Bang, Yeojun Yun, Yong Beom Choe","doi":"10.1177/20406223241230180","DOIUrl":"https://doi.org/10.1177/20406223241230180","url":null,"abstract":"Background:Secukinumab, a fully human monoclonal antibody, was approved in Korea for the treatment of moderate to severe psoriasis in September 2015.Objectives:To assess the safety and effectiveness of secukinumab in patients with moderate to severe psoriasis in Korea.Design:Multicenter, real-world, noninterventional study conducted over 6 years.Methods:Adults with moderate to severe psoriasis were enrolled. Safety was assessed by evaluating adverse events (AEs), treatment-related AEs, and serious AEs (SAEs). Effectiveness was assessed using the change in absolute Psoriasis Area and Severity Index (PASI) score, percentage of patients achieving PASI 75/90/100 and PASI ⩽2; at weeks 12 and 24.Results:Overall, 829 and 542 patients were included in the safety and effectiveness sets, respectively. AEs, treatment-related AEs, and SAEs occurred in 29.0%, 9.5%, and 4.1% of patients, with incidence rates of 39.43, 12.98, and 5.59 per 100 patient years, respectively. The absolute PASI score decreased from 16.1 ± 7.1 (baseline) to 1.6 ± 2.4 (week 24), with a similar reduction in biologic-naïve (16.4 ± 7.3 to 1.5 ± 2.2) and biologic-experienced (14.8 ± 5.9 to 2.4 ± 3.2) groups. At week 24, PASI 75/90/100 was achieved by 95.1%, 62.4%, and 24.9% of patients. At week 24, PASI 75/90 were higher in biologic-naïve (96.6%/65.8%) than biologic-experienced patients (88.3%/48.6%), whereas PASI 100 was similar in both cohorts (24.1% and 28.6%). A similar trend in PASI ⩽ 2 was observed in both cohorts.Conclusion:Secukinumab showed sustained effectiveness and favorable safety profile in adult patients with moderate to severe psoriasis in Korea.","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"1 1","pages":""},"PeriodicalIF":3.5,"publicationDate":"2024-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139980977","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}
引用次数: 0
Clinical and imaging findings in enteropathic spondyloarthritis with special emphasize in diagnostic delay: a cross-sectional study. 一项横断面研究:肠病性脊柱关节炎的临床和影像学发现,特别强调诊断延迟。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-02-19 eCollection Date: 2024-01-01 DOI: 10.1177/20406223241229843
Paola Conigliaro, Arianna D'Antonio, Andrea Wlderk, Federico Sabuzi, Mario Ferraioli, Leonardo Sichi, Valerio Da Ros, Livia Biancone, Alberto Bergamini, Maria Sole Chimenti
{"title":"Clinical and imaging findings in enteropathic spondyloarthritis with special emphasize in diagnostic delay: a cross-sectional study.","authors":"Paola Conigliaro, Arianna D'Antonio, Andrea Wlderk, Federico Sabuzi, Mario Ferraioli, Leonardo Sichi, Valerio Da Ros, Livia Biancone, Alberto Bergamini, Maria Sole Chimenti","doi":"10.1177/20406223241229843","DOIUrl":"10.1177/20406223241229843","url":null,"abstract":"<p><strong>Background: </strong>Enteropathic spondyloarthritides (eSpAs) are chronic inflammatory joint diseases associated with inflammatory bowel disease (IBD). Limited data are available on the prevalence since arthritis in IBD patients may be underestimated because medications may hide disease activity with a possible diagnostic delay.</p><p><strong>Objectives: </strong>We aimed to evaluate diagnostic delay in eSpA and explore associated demographic, clinical, and radiographic characteristics.</p><p><strong>Design: </strong>Single-centre cross-sectional study conducted on consecutive out-patients referred to the combined <i>Gi-Rhe</i> clinic (November 2018-October 2019).</p><p><strong>Methods: </strong>We analysed eSpA patients for diagnostic delay, disease activity, inflammatory markers, conventional radiography (CR) and magnetic resonance images (MRI) of sacroiliac joints/spine.</p><p><strong>Results: </strong>A total of 190 eSpA patients [118 peripheral SpA, 72 axial (Ax) SpA including 44 non-radiographic (nr)-axSpA] were enrolled. axSpA patients had a higher prevalence of men sex, HLA-B27 positivity, uveitis and pancolitis compared with peripheral eSpA. Median diagnostic delay in eSpA was 48 months (IQR 6-77) with no difference between axial and peripheral patients. Radiographic-axial SpA (r-axSpA) patients displayed a higher diagnostic delay compared with nr-axSpA (median/IQR 36/17-129 <i>versus</i> 31/10-57 months, <i>p</i> = 0.03) and were older, with longer disease duration, low education status and high rate of employment than patients with nr-axSpA. r-axSpA patients with sclerosis, syndesmophytes and bridge at CR had higher diagnostic delay than those without lesions. Men showed higher prevalence of spine damage lesions than women as sclerosis, squaring, syndesmophytes and bridges. Longer disease duration was detected in patients with radiographic damage as bridge and sacroiliitis grade 3. On MRI, sacroiliac bone oedema was associated with reduced diagnostic delay, whereas bone erosions were associated with higher diagnostic delay compared with that in patients without these lesions. Patients with psoriasis displayed a higher diagnostic delay compared to those without skin involvement.</p><p><strong>Conclusion: </strong>Diagnostic delay was higher in r-axSpA compared with nr-axSpA despite the same treatment. Demographic, clinical features and radiological lesions were associated with diagnostic delay.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223241229843"},"PeriodicalIF":3.5,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10878219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139913472","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}
引用次数: 0
Prevalence of major non-communicable diseases and their associated risk factors in Afghanistan: a systematic review and meta-analysis. 阿富汗主要非传染性疾病及其相关风险因素的流行情况:系统回顾和荟萃分析。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-02-14 eCollection Date: 2024-01-01 DOI: 10.1177/20406223241229850
Ahmad Siyar Noormal, Volker Winkler, Sneha Bansi Bhusari, Olaf Horstick, Valérie R Louis, Andreas Deckert, Khatia Antia, Zahia Wasko, Pratima Rai, Aline Frare Mocruha, Peter Dambach
{"title":"Prevalence of major non-communicable diseases and their associated risk factors in Afghanistan: a systematic review and meta-analysis.","authors":"Ahmad Siyar Noormal, Volker Winkler, Sneha Bansi Bhusari, Olaf Horstick, Valérie R Louis, Andreas Deckert, Khatia Antia, Zahia Wasko, Pratima Rai, Aline Frare Mocruha, Peter Dambach","doi":"10.1177/20406223241229850","DOIUrl":"10.1177/20406223241229850","url":null,"abstract":"<p><strong>Background: </strong>Non-communicable diseases (NCDs) are the leading cause of mortality worldwide, and increasingly so in low- and middle-income countries. Afghanistan is dealing with a double burden of diseases, yet there has been no evidence synthesis on the prevalence of major NCDs and their risk factors.</p><p><strong>Objective: </strong>This study aims to provide a comprehensive synthesis of the existing data on the prevalence of major NCDs and the common related risk factors in Afghanistan.</p><p><strong>Method: </strong>We systematically reviewed scientific articles from 2000 to 2022 that reported the prevalence of diabetes, chronic respiratory diseases (CRDs), cardiovascular diseases (CVDs) or cancer, and their risk factors in Afghanistan. Four online databases (PubMed, Web of Science, Cochrane and Google Scholar) and two local journals in Afghanistan (not indexed online) were systematically searched and screened. Two reviewers independently screened and appraised the quality of the articles. Data extraction and synthesis were performed using tabulated sheets.</p><p><strong>Results: </strong>Among 51 eligible articles, 10 (19.6%) focused on cancer, 10 (19.6%) on diabetes, 4 (7.8%) on CVDs, 4 (7.8%) on CRDs and 23 (45.1%) on risk factors as the primary outcome. Few articles addressed major NCD prevalence; no evidence of CVDs, cancer was 0.15%, asthma ranged between 0.3% and 17.3%, and diabetes was 12%. Pooled prevalence of hypertension and overweight were 31% and 35%, respectively. Central obesity was twice as prevalent in females (76% <i>versus</i> 40%). Similarly, gender differences were observed in smoking and snuff use with prevalence rates of 14% and 25% among males and 2% and 3% among females, respectively. A total of 14% of the population engaged in vigorous activity. Pooled prevalence for physical inactivity, general obesity, fruit and vegetable consumption, dyslipidaemia and alcohol consumption couldn't be calculated due to the heterogeneity of articles.</p><p><strong>Conclusion: </strong>Only little evidence is available on the prevalence of major NCDs in Afghanistan; however, the NCD risk factors are prevalent across the country. The quality of the available data, especially those of the local resources, is poor; therefore, further research should generate reliable evidence in order to inform policymakers on prioritizing interventions for controlling and managing NCDs.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223241229850"},"PeriodicalIF":3.5,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10868487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742092","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}
引用次数: 0
Epidemiological characteristics, etiological spectrum, and outcomes of adult patients with pericardial effusion at a Teaching Hospital in Somalia. 索马里一家教学医院心包积液成人患者的流行病学特征、病因谱和治疗效果。
IF 3.3 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-01-30 eCollection Date: 2024-01-01 DOI: 10.1177/20406223231225627
Mohamed Farah Yusuf Mohamud, Ishak Ahmed Abdi, Muzeyyen Uzel, Selim Turfan, Said Abdirahman Ahmed, Hussein Hassan Mohamed, Hassan Adan Ali Adan, Mohamed A M Ahmed
{"title":"Epidemiological characteristics, etiological spectrum, and outcomes of adult patients with pericardial effusion at a Teaching Hospital in Somalia.","authors":"Mohamed Farah Yusuf Mohamud, Ishak Ahmed Abdi, Muzeyyen Uzel, Selim Turfan, Said Abdirahman Ahmed, Hussein Hassan Mohamed, Hassan Adan Ali Adan, Mohamed A M Ahmed","doi":"10.1177/20406223231225627","DOIUrl":"10.1177/20406223231225627","url":null,"abstract":"<p><strong>Background: </strong>Pericardial effusion (PE) is an abnormal fluid volume in the pericardial space and is a common clinical entity. The incidence of PE is estimated diversely and depends on risk factors, etiologies, and geographic locations.</p><p><strong>Objectives: </strong>This study aimed to assess the clinical characteristics, etiologic spectrum, echocardiographic features, and outcomes among patients with different types of PE.</p><p><strong>Method: </strong>This retrospective observational study included 93 patients with confirmed PE. Their medical records were reviewed in the hospital information system of Mogadishu Somali Turkish Training and Research Hospital between April 2022 and September 2022. Patient demographics, clinical characteristics, chest X-rays, echocardiography, laboratory findings, management approaches, and outcome reports were reviewed and recorded.</p><p><strong>Results: </strong>Out of the 3000 participants, 3.1% (<i>n</i> = 93/3000) met the definition of definitive PE. In this study, we included 51 females and 42 males. Among the patients, 86% (<i>n</i> = 80) had at least one comorbidity, with diabetes (38.7%) and hypertension (37.6%) being the most common. The most frequently reported clinical presentation findings were shortness of breath (67.7%), chest pain (49.4%), cough (47.3%), and palpitations (47.3%). Cardiac tamponade developed in 9.7% (<i>n</i> = 9) of the patients. Pericardial taps were performed in 64.5% of the cases. Our analysis showed that the most common cause of PE was cardiac disease (<i>n</i> = 33, 35.4%), followed by tuberculosis (TB) (<i>n</i> = 25, 26.8%), uremic pericarditis (<i>n</i> = 24, 25.8%), and hypothyroidism (<i>n</i> = 10, 10.7%). Regarding the severity of PE based on echocardiographic findings, nearly half of the patients (<i>n</i> = 46, 49.4%) had mild PE, whereas 26.8% (<i>n</i> = 25) had moderate PE, and 23.6% (<i>n</i> = 22) had severe PE. Two-thirds of the cases (66.6%) were managed with furosemide, 48 (51.6%) patients were treated with an anti-inflammatory, hemodialysis was performed in 24 (25.8%) patients and antituberculous medications were administered to 7 (7.5%) patients. Out of the 93 patients, 24 (25.8%) died during the hospital stay. It was determined that the mortality risk of patients with renal failure was 7.518 times higher than those without (<i>p</i> = 0.004), and the risk for those with TB was 5.554 times higher than those without (<i>p</i> = 0.011). Other variables were not influential on mortality (<i>p</i> > 0.050).</p><p><strong>Conclusion: </strong>Our study results demonstrate the epidemiological profile of PE in Somalia. The leading causes of PE were cardiac diseases, uremic pericarditis, TB, and hypothyroidism. PE is a significant cause of morbidity and mortality in Somalia, especially in individuals with renal failure and TB infection.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223231225627"},"PeriodicalIF":3.3,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10829488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139651717","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}
引用次数: 0
The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira. AVT02 (阿达木单抗)是一种与 Humira 相似的生物仿制药。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-01-19 eCollection Date: 2024-01-01 DOI: 10.1177/20406223231223286
Joseph E McClellan, Sesselja Ómarsdóttir, Nivedita Roy, Verena Berger, Cecilia Michel, Fausto Berti
{"title":"The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira.","authors":"Joseph E McClellan, Sesselja Ómarsdóttir, Nivedita Roy, Verena Berger, Cecilia Michel, Fausto Berti","doi":"10.1177/20406223231223286","DOIUrl":"10.1177/20406223231223286","url":null,"abstract":"<p><p>The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the 'totality of evidence', which demonstrates no clinically meaningful differences between the biosimilar and the reference product (RP). Once biosimilarity has been established, provided there is suitable scientific justification, clinical data may be extrapolated to other indications of the RP. AVT02 has been developed as a biosimilar to high-concentration, low-volume Humira (adalimumab), an anti-tumour necrosis factor-alpha monoclonal antibody approved for various chronic inflammatory indications. The totality of evidence for AVT02 is described, supporting its approval as an adalimumab biosimilar for all approved indications globally. Analytical similarity assessments using mass spectrometry methods demonstrated identical amino acid sequences for AVT02 and the RP, with high similarity in terms of primary structure, post-translational modifications and higher-order structural attributes. The mechanism of action was assessed by various cell-based potency assays and binding assays, and the results demonstrated that AVT02 is highly similar to the RP. No clinically meaningful differences in terms of purity, potency and safety were observed, and minor differences in a few physiochemical attributes did not impact the <i>in vitro</i> biologic activity and were not considered clinically relevant. Clinical similarity was demonstrated by comparing the pharmacokinetic, efficacy, safety and immunogenicity profiles of AVT02 with those of the RP. Clinical studies supported similar pharmacokinetic and comparable immunogenicity profiles between AVT02 and the RP in healthy participants and participants with moderate-to-severe chronic plaque psoriasis, with no new safety signals detected. The totality of evidence described demonstrates the biosimilarity of AVT02 to the RP, thereby fulfilling the scientific and regulatory requirements for AVT02 as a high-concentration biosimilar for the treatment of chronic plaque psoriasis and all approved indications of the RP.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223231223286"},"PeriodicalIF":3.5,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10799607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139511306","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}
引用次数: 0
Effect of short-term cardiac function changes after cardiac resynchronization therapy on long-term prognosis in heart failure patients with and without diabetes. 心脏再同步化治疗后短期心功能变化对糖尿病和非糖尿病心衰患者长期预后的影响。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-01-18 eCollection Date: 2024-01-01 DOI: 10.1177/20406223231223285
Yu Yu, Ligang Ding, Hao Huang, Sijing Cheng, Yu Deng, Chi Cai, Min Gu, Xuhua Chen, Hongxia Niu, Wei Hua
{"title":"Effect of short-term cardiac function changes after cardiac resynchronization therapy on long-term prognosis in heart failure patients with and without diabetes.","authors":"Yu Yu, Ligang Ding, Hao Huang, Sijing Cheng, Yu Deng, Chi Cai, Min Gu, Xuhua Chen, Hongxia Niu, Wei Hua","doi":"10.1177/20406223231223285","DOIUrl":"10.1177/20406223231223285","url":null,"abstract":"<p><strong>Background: </strong>The relationship between short-term cardiac function changes and long-term outcomes in heart failure (HF) patients undergoing cardiac resynchronization therapy (CRT) remains uncertain, especially when stratified by diabetes status.</p><p><strong>Objectives: </strong>This study aims to assess the association between short-term cardiac function changes and outcomes such as all-cause mortality and HF hospitalization in patients undergoing CRT, stratified by diabetes status.</p><p><strong>Design: </strong>This is a cohort longitudinal retrospective study.</p><p><strong>Methods: </strong>A total of 666 HF patients, treated with CRT between March 2007 and March 2019, were included in this study. Among them, 166 patients (24.9%) were diagnosed with diabetes. Cardiac function was assessed at baseline and again at 6 months, incorporating evaluations of left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), left atrial diameter (LAD), N-terminal prohormone of brain natriuretic peptide (NT-proBNP), and QRS duration. The QRS duration represents the time required for a stimulus to spread through the ventricles (ventricular depolarization). The primary endpoints of the study were all-cause mortality and HF-related hospitalization.</p><p><strong>Results: </strong>During a median follow-up of 2.51 years, 172 (25.8%) patients died and 197 (29.6%) were hospitalized for HF. Changes in LVEF, LVEDD, and LAD within 6 months had similar effects on adverse outcomes in both diabetic and nondiabetic patients. However, the presence of diabetes significantly modified the association between changes in NT-proBNP and QRS duration and adverse outcomes. Short-term changes in NT-proBNP and QRS duration were positively associated with all-cause mortality and HF hospitalization in patients without diabetes. However, the relationship between short-term changes in NT-proBNP and QRS duration and adverse outcomes was non-linear in diabetic patients.</p><p><strong>Conclusion: </strong>Improvement of cardiac function after CRT implantation can reduce long-term risk of all-cause mortality and HF hospitalization in HF patients. However, the presence of diabetes may affect the association between short-term changes in NT-proBNP and QRS duration and adverse outcomes.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223231223285"},"PeriodicalIF":3.5,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139511236","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}
引用次数: 0
Tafamidis improves myocardial longitudinal strain in A97S transthyretin cardiac amyloidosis 塔法米地改善 A97S 转hyretin 心脏淀粉样变性的心肌纵向应变
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-01-11 DOI: 10.1177/20406223231222828
Y. Wu, An-Li Yu, Mei-Fang Cheng, Lung-Chun Lin, Ming-Jen Lee, Chia-Hung Chou, Chia-Tung Shun, Hsueh-Wen Hsueh, Jimmy Jyh-Ming Juang, Ping-Huei Tseng, Siao-Ping Lin, Mao-Yuan Su, C. Chao, S. Hsieh, Cheng-Hsuan Tsai, Yen-Hung Lin
{"title":"Tafamidis improves myocardial longitudinal strain in A97S transthyretin cardiac amyloidosis","authors":"Y. Wu, An-Li Yu, Mei-Fang Cheng, Lung-Chun Lin, Ming-Jen Lee, Chia-Hung Chou, Chia-Tung Shun, Hsueh-Wen Hsueh, Jimmy Jyh-Ming Juang, Ping-Huei Tseng, Siao-Ping Lin, Mao-Yuan Su, C. Chao, S. Hsieh, Cheng-Hsuan Tsai, Yen-Hung Lin","doi":"10.1177/20406223231222828","DOIUrl":"https://doi.org/10.1177/20406223231222828","url":null,"abstract":"Background: Transthyretin cardiomyopathy (ATTR-CM) is a debilitating disease that has received much attention since the emergence of novel treatments. The Transthyretin Cardiomyopathy Clinical Trial showed that tafamidis, a transthyretin tetramer stabilizer, effectively reduced the declines in functional capacity and quality of life. However, Ala97Ser (A97S) hereditary ATTR-CM is underrepresented in major ATTR-CM tafamidis trials. Objectives: We aim to investigate the change in global longitudinal strain (GLS) of A97S ATTR-CM patients after 12 months of tafamidis treatment. Methods: We retrospectively analysed a prospective cohort of patients with A97S ATTR-CM who received tafamidis meglumine (61 mg/day) at the National Taiwan University Hospital. Echocardiography with speckle tracking strain analysis was performed at baseline and 12 months after treatment. Results: In all, 20 patients were included in the cohort. The baseline left ventricular ejection fraction (LVEF) and interventricular septum (IVS) thickness were 59.20 ± 13.23% and 15.10 ± 3.43 mm, respectively. After 12 months of tafamidis treatment, the LVEF and IVS were 61.83 ± 15.60% (p = 0.244) and 14.59 ± 3.03 mm (p = 0.623), respectively. GLS significantly improved from −12.70 ± 3.31% to −13.72 ± 3.17% (p = 0.048), and longitudinal strain (LS) in apical and middle segments significantly improved from −16.05 ± 4.82% to −17.95 ± 3.48% (p = 0.039) and −11.89 ± 4.38% to −13.58 ± 3.12% (p = 0.039), respectively. Subgroup analysis showed that patients with LVEF < 50% had a better treatment response and improvement in GLS. The patients with an IVS ⩾ 13 mm had an improvement in two-chamber LS from −10.92 ± 4.25% to −13.15 ± 3.87% (p = 0.042) and an improvement in apical left ventricular LS from −15.30 ± 5.35% to −17.82 ± 3.99% (p = 0.031). Conclusion: Tafamidis significantly improved GLS, and particularly apical and middle LS in A97S ATTR-CM patients.","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"9 3","pages":""},"PeriodicalIF":3.5,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139437764","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}
引用次数: 0
Aortic arch calcification increases major adverse cardiac event risk, modifiable by echocardiographic left ventricular hypertrophy, in end-stage kidney disease patients. 主动脉弓钙化会增加终末期肾病患者发生重大心脏不良事件的风险,而超声心动图左心室肥厚可以改变这种风险。
IF 3.5 3区 医学
Therapeutic Advances in Chronic Disease Pub Date : 2024-01-09 eCollection Date: 2024-01-01 DOI: 10.1177/20406223231222817
Chia-Ter Chao, Min-Tser Liao, Chung-Kuan Wu
{"title":"Aortic arch calcification increases major adverse cardiac event risk, modifiable by echocardiographic left ventricular hypertrophy, in end-stage kidney disease patients.","authors":"Chia-Ter Chao, Min-Tser Liao, Chung-Kuan Wu","doi":"10.1177/20406223231222817","DOIUrl":"10.1177/20406223231222817","url":null,"abstract":"<p><strong>Background: </strong>The factors affecting cardiovascular risk associated with vascular calcification in patients with chronic kidney disease are less well addressed. Distinct risk factors may contribute synergistically to this elevated cardiovascular risk in this population.</p><p><strong>Objectives: </strong>We aimed to determine whether echocardiographic left ventricular hypertrophy (LVH) affects the risk of major adverse cardiac events (MACE) associated with vascular calcification in end-stage kidney disease (ESKD) patients.</p><p><strong>Methods: </strong>In this retrospective cohort study, ESKD patients underwent chest radiography and echocardiography to assess aortic arch calcification (AoAC) and LVH, respectively, and were classified into three groups accordingly: non-to-mild AoAC without LVH, non-to-mild AoAC with LVH, and moderate-to-severe AoAC. The risks of MACE, cardiovascular mortality, and overall mortality were assessed using Cox proportional hazard analysis.</p><p><strong>Results: </strong>Of the 283 enrolled ESKD patients, 44 (15.5%) had non-to-mild AoAC without LVH, 117 (41.3%) had non-to-mild AoAC with LVH, and 122 (43.1%) had moderate-to-severe AoAC. After 34.1 months, 107 (37.8%) participants developed MACE, including 6 (13.6%), 40 (34.2%), and 61 (50%) from each respective group. Those with moderate-to-severe AoAC (Hazard ratio, 3.72; 95% confidence interval, 1.58-8.73) had a significantly higher risk of MACE than did those with non-to-mild AoAC without LVH or with non-to-mild AoAC and LVH (Hazard ratio, 2.73; 95% confidence interval, 1.16-6.46). A similar trend was observed for cardiovascular and overall mortality.</p><p><strong>Conclusion: </strong>Echocardiographic LVH could modify the risk of adverse cardiovascular events associated with vascular calcification in ESKD patients. Interventions aiming to ameliorate both morbidities might be translated into a lower MACE risk in this population.</p>","PeriodicalId":22960,"journal":{"name":"Therapeutic Advances in Chronic Disease","volume":"15 ","pages":"20406223231222817"},"PeriodicalIF":3.5,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777800/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139425592","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}
引用次数: 0
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