{"title":"Response to \"Frontiers in bibliometric analysis: the overrepresentation of bibliometric analyses in grey publisher journals\".","authors":"Jimmy Li, Charles Deacon, Mark Robert Keezer","doi":"10.1080/03007995.2025.2488948","DOIUrl":"10.1080/03007995.2025.2488948","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"669-670"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chi Nguyen, Hanke Zheng, Michael Grabner, John Barron, Ruth Wangia Dixon, Mark Cziraky, Brian Sweet, Nathan Hill
{"title":"Integration of administrative claims and clinical data to advance real-world evidence generation in oncology.","authors":"Chi Nguyen, Hanke Zheng, Michael Grabner, John Barron, Ruth Wangia Dixon, Mark Cziraky, Brian Sweet, Nathan Hill","doi":"10.1080/03007995.2025.2482665","DOIUrl":"10.1080/03007995.2025.2482665","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study is to evaluate capabilities of the Generating Evidence Excellence (GEx) research environment using Non-Small Cell Lung Cancer (NSCLC) as a use-case.</p><p><strong>Methods: </strong>Patients with incident NSCLC were identified in GEx from 01/01/2015 to 12/31/2019. Two GEx data containers were used: (1) claims from the Healthcare Integrated Research Database (HIRD) linked to clinical data from a Cancer Care Quality Program (CCQP) (HIRD+CCQP); (2) claims data from the HIRD and a second large commercially insured claims dataset (CD2) linked to electronic medical records from IntrinsiQ Specialty Solutions (IQSS) (HIRD+CD2 + IQSS). Patient demographics and all-cause mortality were contrasted with the American Community Survey and the United States Cancer Statistics (USCS) public use database. Descriptive analyses were completed <i>via</i> SAS Enterprise Guide 7.12 and SEER*stat.</p><p><strong>Results: </strong>The study sample comprised of 6,233 (HIRD+CCQP) and 1,176 (HIRD+ CD2 + IQSS) patients with NSCLC. Both GEx data containers had similar patient demographics with a mean age 63 years and 71% White, while 70% of USCS patients were ≥65 years and 85% White. Most patients resided in the South/Midwest regions of the US (74% (HIRD+CCQP) and 86% (HIRD+CD2 + IQSS). Patients in GEx over-represented the working-age group, i.e. 65% were between 18 and 65 years old. Stage IV disease was frequently recorded at diagnosis (59.4% HIRD+CCQP, 44.0% HIRD+CD2 + IQSS, 46.1% USCS). All-cause mortality rate was 38.8 (HIRD+CCQP) and 27.3 (HIRD+CD2 + IQSS) per 100 person-years.</p><p><strong>Conclusions: </strong>The analysis of NSCLC as a use-case demonstrated that GEx is a valuable data ecosystem with a generalizable working-age patient population and comprehensive data to facilitate timely real-world evidence generation in oncology.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"671-681"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Aspiration risk and strategic approach for patients receiving GLP-1 receptor agonists undergoing elective surgery.","authors":"Juan Li, Basma Mohamed, Shun Huang, Yong G Peng","doi":"10.1080/03007995.2025.2494646","DOIUrl":"10.1080/03007995.2025.2494646","url":null,"abstract":"<p><p>Perioperative management of patients receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA) remains challenging for the anesthesiologist. Despite the approval of GLP-1 RAs 2 decades ago, the recent reports of aspiration and postoperative pulmonary complications drew attention to this group of medications and resulted in multiple societal guidelines that would provide recommendations for anesthesiologists and proceduralists on the appropriate perioperative management of GLP-1 RAs. However, despite these guidelines and proposed options, there was a lack of adequate evidence to support holding versus continuing the medication, as well as data related to the role of gastric ultrasound in that decision-making process. The release of multiple societal guidelines and studies evaluating the impact of GLP-1 RAs on perioperative outcomes resulted in more controversy and uncertainty for the clinician anesthesiologist to follow. The ultimate goal for perioperative management of these medications is to evaluate an individual patient's risk of aspiration, rather than assuming the risk is low when holding the medication appropriately or high if not holding it. Furthermore, it is unclear whether holding these types of medicines or unnecessary postponing of surgery may result in adverse outcomes. In this narrative review, we present a summary of the existing literature on the topic with a focus on the risk of aspiration and a recommendation for perioperative management to include the utilization of gastric ultrasound for surgery patients based on their risks.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"699-712"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Weijia Wang, Pamela A Moise, Michael Wong, Wei Gao, Cheryl Xiang, Abigail Zion, Flavio Vincenti, Andrew P Beyer
{"title":"Healthcare resource use and clinical events associated with neutropenia among adult kidney transplant recipients receiving valganciclovir or ganciclovir prophylaxis: a matched case-control cohort study.","authors":"Weijia Wang, Pamela A Moise, Michael Wong, Wei Gao, Cheryl Xiang, Abigail Zion, Flavio Vincenti, Andrew P Beyer","doi":"10.1080/03007995.2025.2498674","DOIUrl":"10.1080/03007995.2025.2498674","url":null,"abstract":"<p><strong>Background: </strong>Cytomegalovirus prophylaxis with valganciclovir and ganciclovir is associated with increased neutropenia risk in kidney transplant recipients. This study assessed the association between neutropenia and short-term healthcare resource utilization (HCRU) and clinical events for adults receiving valganciclovir and/or ganciclovir prophylaxis post-kidney transplantation in the United States.</p><p><strong>Methods: </strong>Adult kidney transplant recipients from 2012 to 2020 who received valganciclovir and/or ganciclovir prophylaxis were identified in the TriNetX database. Patients with a neutropenia event during the 1-year post-kidney transplant were identified as cases and those without were identified as controls. Cases and controls were matched 1:1 on patient characteristics in the 1-year period before the kidney transplant. HCRU and clinical event rates in the year following the first neutropenia event were compared between the cases and controls.</p><p><strong>Results: </strong>Of 3564 identified case-control pairs, the average age was 52 years and 59.57% were male. Cases had higher HCRU in the first year after neutropenia than controls, characterized by 1.40-, 1.28-, and 1.33-times higher rates of inpatient, outpatient, and emergency department visits (all <i>p</i> < 0.001). Cases also had higher incident rates for cytomegalovirus-related events, use of granulocyte colony stimulating factor, and opportunistic infections (all adjusted incident rate ratios >1 with <i>p</i> < 0.01), and greater risks of death, graft loss, and acute graft rejection (all adjusted hazard ratios >1 with <i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>Higher HCRU and clinical burden were observed within the first year following post-transplant neutropenia. New options for cytomegalovirus prophylaxis that are less likely to induce neutropenia are needed to improve patient outcomes.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"639-646"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prajakta Bhounsule, Keith Boundy, Susan Mehle, Matt Chang, Robert Sedgley, Joe Vasey
{"title":"Influenza burden among chronic condition and immunocompromised patients in the United States.","authors":"Prajakta Bhounsule, Keith Boundy, Susan Mehle, Matt Chang, Robert Sedgley, Joe Vasey","doi":"10.1080/03007995.2025.2492646","DOIUrl":"10.1080/03007995.2025.2492646","url":null,"abstract":"<p><strong>Objective: </strong>This retrospective cohort study examined influenza-like illness (ILI) in the United States during the 2017-2018 season among vaccinated adults who are immunocompromised or have high-risk chronic conditions. Results among adults with no evidence of vaccination (NEoV) were included to help contextualize study findings.</p><p><strong>Methods: </strong>The Veradigm Network EHR linked to claims data were used to identify adults (≥18 years old) with continuous enrollment in claims between 1 October 2016 and 20 May 2018. Patients were stratified by evidence of influenza vaccination between 1 August 2017 and 6 May 2018 (vaccinated or no evidence of vaccination [NEoV]). Individuals were classified as immunocompromised or with a high-risk chronic condition based on diagnoses and treatments between 1 October 2016 through 1 October 2017. The main outcome of interest was influenza-like illness (ILI) during the influenza season.</p><p><strong>Results: </strong>A total of 2,763,671 vaccinated individuals and 7,702,021 individuals with NEoV were identified, of whom 2.5% and 1.2%, respectively, were in the immunocompromised subgroup, while 6.7% and 3.2% had at least one high-risk chronic condition. The percentages of patients with an ILI were 2.5% and 2.7% in the overall vaccinated and NEoV cohorts, 3.1% and 3.5% in the immunocompromised subgroups, and 3.0% and 3.2 in the chronic conditions subgroups. Multivariable modeling of odds of ILI among vaccinated individuals found that chronic obstructive pulmonary disease, rheumatoid arthritis, and end stage renal disease were the diagnoses most strongly associated with increased odds of ILI.</p><p><strong>Conclusion: </strong>There remains an unmet need for additional prophylactic agents that reduce the incidence and severity of ILI among patients who are immunocompromised or have chronic conditions.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"607-615"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hafiza Noor Ul Ain Baloch, Yoshiko Ishisaka, Robert Lookstein, Omar Lattouf, Madeline Ehrlich, Samuel Acquah, Jeeyune Bahk, Abdul Rehman, Janet Shapiro, David Steiger
{"title":"Outcomes of catheter-directed embolectomy and surgical embolectomy for intermediate- to high-risk pulmonary embolism: a retrospective observational study.","authors":"Hafiza Noor Ul Ain Baloch, Yoshiko Ishisaka, Robert Lookstein, Omar Lattouf, Madeline Ehrlich, Samuel Acquah, Jeeyune Bahk, Abdul Rehman, Janet Shapiro, David Steiger","doi":"10.1080/03007995.2025.2494639","DOIUrl":"10.1080/03007995.2025.2494639","url":null,"abstract":"<p><strong>Objective: </strong>Intermediate risk (IR)- and high risk (HR)-pulmonary embolism (PE) are associated with mortality rates that span 1.8% to 17% and greater than 31% respectively. Catheter-directed embolectomy (CDE) and surgical embolectomy (SE) for IR- and HR-PE offer alternatives to systemic thrombolysis, but data comparing CDE versus SE is limited. We assessed the outcomes of patients with acute PE who received CDE or SE for IR- and HR-PE.</p><p><strong>Methods: </strong>A retrospective review of all adult patients who had undergone CDE or SE for IR- and HR-PE in the Mount Sinai Health System between August, 2019 to June, 2022 was performed. Fisher's exact test and Student's <i>t</i>-test (or Mann-Whitney U-test) were used for comparing qualitative and quantitative outcomes respectively between the CDE and SE groups.</p><p><strong>Results: </strong>Fifteen (15) patients received SE, and 25 patients received CDE. Patients who received SE included 53% IR- and 47% HR-PE, while those who received CDE included 60% IR- and 40% HR-PE. CDE and SE had 96% and 100% technical success rates respectively. The 30-day all-cause mortality rates were 13.3% and 8% in the SE and CDE groups respectively (<i>p</i> > 0.05). The rates of major hemorrhagic complications in the CDE and SE groups were 4% and 26.7% respectively (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>CDE and SE were associated with high technical success rates in patients with IR- and HR-PE along with a low risk of major complications and acceptable 30-day all-cause mortality rates. In the absence of significant contraindications, CDE may provide a less invasive alternative to SE.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"713-720"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The real-world effectiveness of ustekinumab in patients with ulcerative colitis in the United States.","authors":"Sabree Burbage, Hannah Knight, Bridget Godwin, Rachael Meadows, William Jones, Ruizhi Zhao, Sumesh Kachroo","doi":"10.1080/03007995.2025.2494642","DOIUrl":"10.1080/03007995.2025.2494642","url":null,"abstract":"<p><strong>Background: </strong>Ustekinumab was approved for use in the treatment of moderate/severe ulcerative colitis (UC) in 2019. Though it has proven effective in clinical trials, evidence of its effectiveness in clinical practice is limited to the published reports of use in clinical practice. This study assessed ustekinumab effectiveness in patients with UC presenting in real-world clinical practice.</p><p><strong>Methods: </strong>Data were drawn from the Adelphi Real World Inflammatory Bowel Disease (IBD) Disease Specific Programme, a cross-sectional survey of physicians and their IBD patients in the USA from December 2022 to January 2024. Physicians provided demographics and clinical characteristics, treatment patterns, symptoms, and remission status for UC patients aged ≥18 years old who were prescribed ustekinumab for >1 day. Analyses were descriptive; McNemar's test was used to compare symptoms and disease severity before and after ustekinumab prescription.</p><p><strong>Results: </strong>Overall, 56 physicians reported on 185 patients. Mean (standard deviation) patient age was 39.7 (12.9) years and 53.0% were female. Most patients were advanced therapy-naïve at ustekinumab initiation (65.9%) and had taken ustekinumab for ≥3 months (84.6%). At survey, 53.0% were in remission defined by Mayo score, and 61.9% were in physician-stated clinical remission. Reports of abdominal pain, bowel urgency, nighttime urgency, and bloody diarrhea were more than halved at survey compared to pre-ustekinumab, with reductions in fatigue and non-bloody diarrhea also seen (all <i>p</i> < 0.0001).</p><p><strong>Conclusion: </strong>Overall, ustekinumab is an effective treatment for UC in real-world clinical practice capable of inducing and maintaining long-term remission. Future work should assess how ustekinumab impacts quality of life.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"683-689"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ahmad Alhuraiji, Amar Lal, Amna Al Mehairi, Arif Alam, Deena Mudawi, Faraz Khan, Ibrahim Al Nabhani, Inas El-Najjar, Khalil Al-Farsi, Shabeeha K Rana, Tharwat Wagdy, Mohamed A Yassin, Paula Rodríguez Otero, Haya Haddadin, Ali Aljabban
{"title":"Epidemiology and approaches for management of relapsed and refractory multiple myeloma in Gulf Countries: a narrative review and insights from the Gulf multiple myeloma experts.","authors":"Ahmad Alhuraiji, Amar Lal, Amna Al Mehairi, Arif Alam, Deena Mudawi, Faraz Khan, Ibrahim Al Nabhani, Inas El-Najjar, Khalil Al-Farsi, Shabeeha K Rana, Tharwat Wagdy, Mohamed A Yassin, Paula Rodríguez Otero, Haya Haddadin, Ali Aljabban","doi":"10.1080/03007995.2025.2502125","DOIUrl":"10.1080/03007995.2025.2502125","url":null,"abstract":"<p><p>Multiple myeloma (MM) is a hematologic malignancy characterized by the clonal proliferation of plasma cells, resulting in considerable morbidity and mortality. Although therapeutic advancements have improved clinical outcomes, this has been restricted to some high-income nations. Countries in the Gulf region, despite significant rises in gross domestic product (GDP), have resource-constrained environments and hence face unique challenges when it comes to the management of MM mainly because of the limited spending on healthcare (as a percentage of the GDP) in these countries. This narrative analysis explores the epidemiology, patient demographics, and therapeutic landscape of relapsed and refractory multiple myeloma (RRMM) in Gulf nations, including the United Arab Emirates (UAE), Qatar, Bahrain, Kuwait, and Oman. Our findings emphasize the growing incidence of MM in the region, with increased mortality rates owing to delayed diagnosis, restricted access to some of the advanced medicines in few areas, and disparities in care. Patients in the Gulf countries usually present at a younger age than their global counterparts, with median ages of diagnosis ranging from 43 to 58 years. Access to innovative treatments like CAR T-cell therapy and bispecific antibodies has been limited by high costs and infrastructural barriers. Stem-cell transplantation, although available in most countries, is insufficiently utilized, and treatment approaches frequently depend on conventional medicines. Obstacles to prompt diagnosis, difficulty in accessing treatment centers, limited availability of innovative treatment, and inadequate regional monitoring protocols, impede efficient illness management. Insights from the Gulf MM Advisory Board highlight the need for individualized treatment protocols, enhanced accessibility to novel treatments, and improvements in healthcare infrastructure. Cooperative initiatives among healthcare professionals, decision makers, and industry stakeholders are crucial for formulating regional treatment protocols and enhancing clinical trial networks. Reflecting on these shortcomings will be critical to improving patient outcomes and aligning MM care in the Gulf region with international standards.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"593-600"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tomohiro Tanaka, Taisuke Kojima, Swathi Pathadka, Swarna Khare, Andrea Leith, Victoria Higgins, Tomotaka Shingaki
{"title":"Real-world cross-sectional study evaluating patient characteristics, disease burden, and treatment approaches in people with obesity disease in Japan.","authors":"Tomohiro Tanaka, Taisuke Kojima, Swathi Pathadka, Swarna Khare, Andrea Leith, Victoria Higgins, Tomotaka Shingaki","doi":"10.1080/03007995.2025.2486167","DOIUrl":"10.1080/03007995.2025.2486167","url":null,"abstract":"<p><strong>Aim: </strong>To describe clinical characteristics, disease burden, and treatment patterns among people with obesity disease (PwOD) in Japan, using data from the Adelphi Real World Obesity Disease Specific Programme™ (DSP).</p><p><strong>Methods: </strong>Secondary data from the Japanese DSP cohort (July to December 2022) were analyzed. PwOD had a BMI ≥25 kg/m<sup>2</sup> and ≥1 obesity-related complications (ORCs). Outcomes were summarized for all PwOD or stratified by obesity class (BMI ≥25-<35 or ≥35 kg/m<sup>2</sup> [high-degree obesity disease]) and use of anti-obesity medications (AOMs).</p><p><strong>Results: </strong>The study included 442 PwOD (mean age: 52.8 years; 54.8% males; BMI ≥25-<35 kg/m<sup>2</sup>: 64.5%; BMI ≥35 kg/m<sup>2</sup>: 35.5%; AOM users: <i>n</i> = 228; non-AOM users: <i>n</i> = 214). High-degree obesity disease was associated with worsened SF-36v2 scores (Physical Component Summary, Physical Functioning, Bodily Pain, and General Health), greater activity impairment, and reduced work productivity. Common weight management approaches were diet (79.9%) and exercise (51.1%). Common prescription AOMs included traditional herbal medicine (67.5%) and mazindol (21.1%). People with high-degree obesity disease (BMI ≥35 <i>vs.</i> ≥25-<35 kg/m<sup>2</sup>) used more prescription AOMs (57.3 <i>vs.</i> 48.4%), behavioral therapy (9.6 <i>vs.</i> 1.8%), and weight loss surgery (2.6 <i>vs.</i> 0.4%). The difference in weight reduction between AOM and non-AOM users was modest.</p><p><strong>Conclusions: </strong>People with high-degree obesity disease experienced greater disease burden. Diet and exercise are common for weight management, while behavioral therapy is less frequently implemented. These findings highlight the challenges and unmet medical needs in treating obesity in Japan and could inform better treatment strategies in Japan and globally among the Asian population.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"617-626"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tetsuya Ishida, Isamu Yokoe, Hirozumi Obata, Soyeon Park, SooKyoung Kim, Nobuaki Nishimata
{"title":"A real-world, observational, prospective cohort study evaluating the safety and effectiveness of CT-P13 in inflammatory bowel disease and rheumatoid arthritis: the MEGA-J study.","authors":"Tetsuya Ishida, Isamu Yokoe, Hirozumi Obata, Soyeon Park, SooKyoung Kim, Nobuaki Nishimata","doi":"10.1080/03007995.2025.2492638","DOIUrl":"10.1080/03007995.2025.2492638","url":null,"abstract":"<p><strong>Objective: </strong>The primary objective of the MEGA-J study (UMIN-CTR number: UMIN000057308) was to assess the safety of CT-P13, an infliximab biosimilar, in Japanese patients with Crohn's disease (CD), ulcerative colitis (UC), and/or rheumatoid arthritis (RA) after switching from reference infliximab.</p><p><strong>Methods: </strong>Data were collected over 5 years, following initiation of CT-P13 treatment within routine clinical practice. Interim findings are reported (cut-off: last patient's Year 2 visit). The primary endpoint was the incidence of uncommon adverse drug reactions (ADRs), including tuberculosis and serious infections.</p><p><strong>Results: </strong>Overall, 220 patients were enrolled (123 CD; 74 UC; 23 RA). Forty-eight (39.0%), 37 (50.0%), and 3 (13.0%) patients reported ≥1 uncommon ADR in the CD, UC, and RA groups, respectively. The majority (94.3%) were unrelated to CT-P13. No cases of tuberculosis and one unrelated case of serious infection were reported. Nineteen (8.6%) patients discontinued treatment for reasons related to CT-P13.</p><p><strong>Conclusions: </strong>Overall, CT-P13 was well tolerated, demonstrating the safety of long-term treatment in real-world practice.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"601-606"},"PeriodicalIF":2.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}