Huda Jassim Muhammad, Radhwan M Hussein, Muntadher Zmezim, Ali Fawzi Al-Hussainy, Haneen Hussein Farhood, Iman Hussein Naser, Hamid Alghurabi
{"title":"Predictors of insulin adherence among patients with type 2 diabetes: a cross-sectional study.","authors":"Huda Jassim Muhammad, Radhwan M Hussein, Muntadher Zmezim, Ali Fawzi Al-Hussainy, Haneen Hussein Farhood, Iman Hussein Naser, Hamid Alghurabi","doi":"10.1080/03007995.2025.2517697","DOIUrl":"10.1080/03007995.2025.2517697","url":null,"abstract":"<p><strong>Objective: </strong>Type 2 diabetes (T2D) is a chronic metabolic disorder requiring insulin therapy as β-cell function declines. Despite insulin's proven efficacy, adherence remains a significant challenge. This study aims to identify factors influencing insulin adherence among patients with T2D to inform targeted clinical interventions.</p><p><strong>Methods: </strong>A cross-sectional study was conducted at a tertiary diabetes clinic, recruiting adult patients with T2D on insulin therapy for at least six months. A structured, validated questionnaire was administered in person to collect demographic, clinical, and treatment-related data, along with patient beliefs about insulin. Insulin adherence was defined as taking ≥80% of prescribed doses over the past month. Statistical analysis included univariate and multivariate logistic regression to identify independent predictors of adherence.</p><p><strong>Results: </strong>Among 111 patients, 49 (44.1%) were adherent, while 62 (55.9%) were non-adherent. Adherence was associated with male gender, higher education levels, smoking abstinence, and adherence to recommended diet and exercise regimens. Non-adherent patients had a higher prevalence of family history of diabetes, more diabetic complications, increased comorbidities, and more frequent hospitalizations. Self-injection of insulin and regular self-monitoring of blood glucose were linked to better adherence, whereas fear of injections and the use of herbal medicine were associated with lower adherence. Negative beliefs about insulin were not significantly different between groups.</p><p><strong>Conclusion: </strong>Insulin adherence in T2D is influenced by lifestyle, clinical, and practical treatment factors rather than negative beliefs alone. Addressing practical barriers, such as fear of injection and alternative treatment use, through patient education and supportive interventions may improve adherence rates.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"925-937"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257518","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}
Oscar Herrera-Restrepo, Jasjit K Multani, Zifan Zhou, Queenie Paltanwale, Tosin Olaiya, Anna D Coutinho, Rajeev B Shah, Chi-Chang Chen
{"title":"Meningococcal B vaccine co-administration in older adolescents and young adults and potential missed opportunities for vaccination in the United States: a retrospective claims database analysis.","authors":"Oscar Herrera-Restrepo, Jasjit K Multani, Zifan Zhou, Queenie Paltanwale, Tosin Olaiya, Anna D Coutinho, Rajeev B Shah, Chi-Chang Chen","doi":"10.1080/03007995.2025.2522806","DOIUrl":"10.1080/03007995.2025.2522806","url":null,"abstract":"<p><strong>Background: </strong>In the United States (US), meningococcal serogroup B (MenB) vaccination is currently recommended under shared clinical decision-making for 16-23-year-olds to prevent invasive meningococcal disease; the MenB vaccine may be co-administered with other vaccines recommended for this age group.</p><p><strong>Research design and methods: </strong>A retrospective analysis of two US health insurance claims databases was conducted to estimate the proportion of commercially insured and Medicaid-insured 16-23-year-olds with potential missed opportunities for MenB vaccine series initiation <i>via</i> co-administration. Potential missed opportunities were defined as visits with healthcare providers during which other recommended vaccines (MenACWY, Tdap, HPV, influenza, and/or COVID-19) were administered, but not the initial MenB vaccine dose.</p><p><strong>Results: </strong>In 2022, 74.5% of commercially insured and 67.1% of Medicaid-insured 16-23-year-olds had potential missed opportunities for MenB vaccination initiation <i>via</i> co-administration. The proportion of missed opportunities was higher among 19-23-year-olds (versus 16-18-year-olds) and lower for visits with pediatricians (versus internists or general practitioners/family physicians). The most frequently co-administered vaccine was the MenACWY vaccine.</p><p><strong>Conclusions: </strong>Many 16-23-year-olds had potential missed opportunities for MenB series initiation <i>via</i> co-administration. Increasing awareness of the opportunity to initiate the MenB series <i>via</i> co-administration may improve meningococcal vaccination coverage in the US.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1121-1133"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474163","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}
Marla C Dubinsky, Alison Potts Bleakman, Stefan Schreiber, David T Rubin, Remo Panaccione, Toshifumi Hibi, Cem Kayhan, Theresa Hunter Gibble, Eoin J Flynn, Angelo D Favia, Tommaso Panni, Christian Atkinson, Sonal Saxena, Simon Travis
{"title":"Impact of moderate-to-severe ulcerative colitis and Crohn's disease on sexual activity: United States and European patient perspectives from the communicating needs and features of IBD experiences (CONFIDE) survey.","authors":"Marla C Dubinsky, Alison Potts Bleakman, Stefan Schreiber, David T Rubin, Remo Panaccione, Toshifumi Hibi, Cem Kayhan, Theresa Hunter Gibble, Eoin J Flynn, Angelo D Favia, Tommaso Panni, Christian Atkinson, Sonal Saxena, Simon Travis","doi":"10.1080/03007995.2025.2530736","DOIUrl":"10.1080/03007995.2025.2530736","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC) and Crohn's disease (CD) negatively affect patients' quality-of-life, and their impact on patients' sexual health is rarely addressed. This study assessed the impact of moderate-to-severe UC and CD on sexual activity using United States (US) and European data from the Communicating Needs and Features of IBD Experiences (CONFIDE) survey.</p><p><strong>Methods: </strong>Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe UC or CD and health care professionals (HCPs). Moderate-to-severe UC or CD were defined using criteria based on previous treatment, steroid use, and/or hospitalization. The surveys were developed with input from HCPs and patient advisors and included questions on demographics, UC- or CD-related symptoms, and the impact of UC or CD on sexual health. Patients were asked whether they had avoided/decreased sexual activity in the past 3 months and their UC- or CD-related reasons. Patients and HCPs rated levels of impact of UC or CD on sex life/sexual intimacy and patients rated how bowel urgency interferes with their relationship with spouse/partner. Additionally, questions assessing the psychosocial health of patients and identifying gaps and barriers in HCP-patient communication were also included. Descriptive statistics were used to summarize the data.</p><p><strong>Results: </strong>Surveys were completed by 200 US and 556 European patients with UC and 215 US and 547 European patients with CD. Of these, most US (UC: 63%, CD: 69%) and European (UC: 53%, CD: 56%) patients reported avoiding or decreasing sexual activity due to UC or CD in the past 3 months; however, the proportion was significantly greater among US patients (<i>p</i> <.05). Among patients with UC, a significantly greater proportion of female patients reported altered sexual activity due to their disease. A similar proportion of male and female patients with CD reported impaired sexual activity. Most common UC-related reasons for avoidance of sexual activity were bowel urgency among US patients and fear of faecal seepage among European patients. Among patients with CD, the most common reason was fear of bowel urgency-related accidents in both US and European patients. Patients reported a negative impact of bowel urgency on their relationship with spouse/partner.</p><p><strong>Conclusions: </strong>In the US and Europe, most patients reported avoiding or decreasing sexual activity due to moderate-to-severe UC or CD, with bowel urgency and bowel urgency-related accidents being common reasons. Assessing and addressing sexual health in routine clinical care should be considered when treating UC and CD.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1017-1030"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599567","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}
Mallik Greene, Timo Pew, Lakshya Sakthisivabalan, Jorge Zapatier, Jeffrey Arroyo, Juliana Vanessa Rincón López, Jordan J Karlitz, Martha Duarte
{"title":"Adherence to colorectal cancer screening with multi-target stool DNA testing among first-time average-risk users in federally qualified health centers.","authors":"Mallik Greene, Timo Pew, Lakshya Sakthisivabalan, Jorge Zapatier, Jeffrey Arroyo, Juliana Vanessa Rincón López, Jordan J Karlitz, Martha Duarte","doi":"10.1080/03007995.2025.2529984","DOIUrl":"10.1080/03007995.2025.2529984","url":null,"abstract":"<p><strong>Introduction: </strong>Federally Qualified Health Centers (FQHC) provide healthcare services to nearly 30 million people across the United States. Despite this critical role, substantial gaps in colorectal cancer (CRC) screening persist in FQHC populations compared to the general U.S. population. This study evaluated the adherence to multi-target stool DNA (mt-sDNA) screening among average-risk patients undergoing their first CRC screening at FQHCs.</p><p><strong>Methods: </strong>Patients aged 45-75 years that received care at FQHC clinics and had a valid mt-sDNA test kit shipped between January 1 and December 31, 2023, were included. Patient adherence was defined as the completion and return of the test kit, with a valid test result obtained within 365 days of the initial shipment date. Logistic regression analysis was performed to determine patient characteristics associated with adherence.</p><p><strong>Results: </strong>A total of 264,465 patients had a mt-sDNA test kit shipped to them during the study period. The overall adherence to screening was 55.9%, with an average of 37 days from initial shipment date to valid test result. Predictors associated with increased adherence included being commercially insured, having lower social vulnerability scores, older age, female sex, digital patient outreach, living outside a metropolitan area, and living in a ZIP code with higher median household income.</p><p><strong>Conclusion: </strong>The current study found that the adherence to mt-sDNA testing in a patient population receiving care at FQHCs was higher than previously reported. This research highlighted several important predictors of improved adherence to mt-sDNA testing, including digital patient outreach as an inexpensive and increasingly utilized tool to enhance CRC screening adherence.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"983-993"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144574990","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}
Elizabeth D Bacci, Christina M Charriez, Christina Slota, Mousumi Biswas, Kathleen W Wyrwich, Carla L Zema, Claudia H M C De Oliveira, Vrunda Patel, Karin S Coyne, Ikuo Hirano
{"title":"Development of the modified Daily Symptom Diary (mDSD): a patient-reported outcome measure of dysphagia for eosinophilic esophagitis.","authors":"Elizabeth D Bacci, Christina M Charriez, Christina Slota, Mousumi Biswas, Kathleen W Wyrwich, Carla L Zema, Claudia H M C De Oliveira, Vrunda Patel, Karin S Coyne, Ikuo Hirano","doi":"10.1080/03007995.2025.2533935","DOIUrl":"10.1080/03007995.2025.2533935","url":null,"abstract":"<p><strong>Objective: </strong>Eosinophilic esophagitis (EoE) is a progressive, chronic, Type 2 inflammatory and fibrostenotic disease causing dysphagia among other symptoms. Patient-reported outcome (PRO) measures are essential for the assessment of EoE symptoms. One such PRO measure is the Daily Symptom Diary (DSD), but its content validity has not been established. This study modified the DSD based on participants' feedback and assessed the content validity of the modified DSD (mDSD).</p><p><strong>Methods: </strong>Combined qualitative concept elicitation and cognitive interviews were conducted with adolescents (12-17 years) and adults (18-75 years) with a clinician-confirmed EoE diagnosis. Participants were asked about their symptoms and impacts. They were then asked to complete the DSD/mDSD and discuss its comprehensibility, relevance, and ease-of-use.</p><p><strong>Results: </strong>Twenty-one patients (<i>n</i> = 17 adults [mean age: 33.1 years, <i>n</i> = 13 males], <i>n</i> = 4 adolescents [mean age: 15.5 years, <i>n</i> = 3 males]) participated. The most frequently mentioned EoE symptoms were food getting stuck in the throat (<i>n</i> = 21), vomiting/throwing up (<i>n</i> = 17), and difficulty swallowing (<i>n</i> = 13). Following feedback from the first four interviews, the DSD was modified to include two more items, including a separate item for food going down slowly; the mDSD was used thereafter. Participants noted that the mDSD captured their major symptoms (<i>n</i> = 20) and was clear and understandable (<i>n</i> = 20). When asked about meaningful change in symptoms, eight (40%) would consider a reduction of 1-2 days with dysphagia per 7-day period as meaningful.</p><p><strong>Conclusion: </strong>This study confirms the content validity of the mDSD. The measure captured the symptom experience of adolescents and adults with EoE and was relevant and easy to use, supporting its use in clinical research.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1031-1039"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642036","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}
Nagesh Kamat, Gaurav Patil, Ankit Dalal, Sanil Parekh, Amit Maydeo
{"title":"Affordability issues and the need for a reimbursement process of advanced therapy for inflammatory bowel diseases in India.","authors":"Nagesh Kamat, Gaurav Patil, Ankit Dalal, Sanil Parekh, Amit Maydeo","doi":"10.1080/03007995.2025.2534471","DOIUrl":"10.1080/03007995.2025.2534471","url":null,"abstract":"<p><p>Inflammatory bowel disease (IBD) is an aggressive relapsing condition that can develop at a young age and carries a high lifetime risk of medical expenses. Patients with moderate-to-severe Crohn's disease or Ulcerative colitis need biologic therapy for induction and maintenance of remission. The cost of treating these has moved from hospitalization and surgery to biologics, which are partly reimbursed. This review identifies that a handful of insurance companies provide daycare coverage for the biologic infusion, while the injections get reimbursed only on 24-hour admission in India. This varies from patient to patient and from one insurance company to another. The biosimilars of anti-TNFs drive savings but not overall costs. Patients are made to accept substantial costs through deductibles, copayments, and coinsurance. While insurance partially covers the financial risk, healthcare in IBD remains affordable to only some. The manufacturers need to comprehend payers' perspectives to deliver the best possible patient outcomes. The pricing strategies should be indication-specific/volume-based pricing. Small molecules adoption has the potential to disrupt infusion-based reimbursement policies by shifting care to pharmacy-based models, improving access for rural populations. There is a need to implement universal health coverage post which the mortgage model can be used to spread the cost of biologics over time in IBD. The payers' perspective must be considered while determining the cost of the product and include patients in healthcare policy decision-making.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"959-967"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648790","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":"Economic consequences of premature mortality due to brain cancer in Spain: a human capital approach.","authors":"Josep Darbà, Meritxell Ascanio","doi":"10.1080/03007995.2025.2538755","DOIUrl":"10.1080/03007995.2025.2538755","url":null,"abstract":"<p><strong>Objective: </strong>Although primary malignant brain and central nervous system (CNS) tumours are relatively rare, they contribute disproportionately to cancer-related mortality due to their high fatality rates and aggressive progression. This study quantifies the economic impact of brain cancer-related premature deaths in Spain from a societal perspective.</p><p><strong>Methods: </strong>We employed the human capital approach to estimate productivity losses from brain cancer mortality. Age- and sex-specific mortality, employment rates, and average salaries (2013-2022) were obtained from the Spanish National Statistics Institute. We calculated years of potential labour productive life lost (YPLPLL) and applied a 3% discount rate to estimate the present value of future income losses. Sensitivity analyses were conducted using alternative discount rates (0 and 6%) and varying assumptions about retirement age, wage, and employment rates.</p><p><strong>Results: </strong>Brain cancer accounted for 2-3% of all cancer-related deaths in Spain, with a higher burden in men. Approximately 44% of deaths occurred in working-age individuals, resulting in an estimated 157,396 YPLPLL and €2.78 billion in productivity losses over the study period. Sensitivity analyses showed a range of €2.08-3.48 billion. On average, this equates to €309 million annually, or around €8 per working-age individual.</p><p><strong>Conclusion: </strong>Despite its low incidence, brain cancer imposes a substantial economic burden due to premature mortality during peak productive years. These findings underscores the importance of enhancing prevention, early diagnosis, and care delivery, particularly in ageing populations and high-income countries such as Spain.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"949-958"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144689168","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}
Dana M Dijkgraaf, Pantea Kiani, Maureen N Zijlstra, Joris C Verster
{"title":"Cross-cultural treatment preferences: a call for diversity in drug development.","authors":"Dana M Dijkgraaf, Pantea Kiani, Maureen N Zijlstra, Joris C Verster","doi":"10.1080/03007995.2025.2537298","DOIUrl":"10.1080/03007995.2025.2537298","url":null,"abstract":"<p><p>Patient preferences for treatment characteristics-such as dosage form, taste, smell, and ingredients-play a key role in adherence, yet these preferences differ widely across cultures and are frequently overlooked in pharmaceutical development. Prescription medicines must meet strict safety and effectiveness standards, restricting flexibility, whereas over-the-counter supplements allow more freedom, though often without proven benefits. Developing diverse formulations is expensive and time-consuming, and patients need clear guidance to make informed choices without feeling overwhelmed or questioning their doctors. This tension highlights a disconnect between patient desires, scientific validation, and practical feasibility. We urge healthcare providers, pharmaceutical companies, and patients to engage in dialogue to discuss patient preferences and diversity in drug development. By creating treatments that reflect cultural needs and improving patient education, adherence and equity in healthcare can improve, provided the scientific, economic, and logistical hurdles are addressed effectively.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1047-1051"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674077","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":"Why wastewater-based epidemiology must tackle noncommunicable diseases.","authors":"Patrick M D'Aoust","doi":"10.1080/03007995.2025.2529991","DOIUrl":"10.1080/03007995.2025.2529991","url":null,"abstract":"<p><p>The global wastewater-based epidemiology (WBE) landscape has primarily concentrated on high-profile diseases, creating a narrow scope of application. However, there's a significant and significant untapped potential in using WBE to address chronic and noncommunicable diseases (NCDs), particularly in developing nations. NCDs, including heart disease and diabetes, now significantly impact low- and middle-income nations, straining their healthcare systems and economies. WBE offers a cost-effective, real-time health monitoring solution and presents a real opportunity for change in global research policy focus to hone into these diseases. By prioritizing research on the detection of chronic illness health markers in wastewater, WBE has the potential to provide accurate community-level health data and guide equitable resource allocation, addressing both high-profile infectious diseases and NCDs simultaneously. However, the potential of WBE in addressing NCDs remains largely untapped by the research community. Effective implementation requires the development of standardized methodologies, effective ethical frameworks, and robust international cooperation. This approach is essential to address the silent epidemic of NCDs effectively and ensure that developing nations are equipped with the tools necessary for sustainable healthcare management and evidence-based policymaking.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"977-981"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590635","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}
Marcia Cruz-Correa, Rui-Hua Xu, Markus Moehler, Do-Youn Oh, Ken Kato, David Spigel, Hendrik-Tobias Arkenau, Josep Tabernero, Anastasia V Zimina, Yuxian Bai, Jianhua Shi, Keun-Wook Lee, Hidekazu Hirano, Lucjan Wyrwicz, Roberto Pazo Cid, Hui Xu, Tao Sheng, Gisoo Barnes
{"title":"Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma: patient-reported outcomes in the RATIONALE-305 study.","authors":"Marcia Cruz-Correa, Rui-Hua Xu, Markus Moehler, Do-Youn Oh, Ken Kato, David Spigel, Hendrik-Tobias Arkenau, Josep Tabernero, Anastasia V Zimina, Yuxian Bai, Jianhua Shi, Keun-Wook Lee, Hidekazu Hirano, Lucjan Wyrwicz, Roberto Pazo Cid, Hui Xu, Tao Sheng, Gisoo Barnes","doi":"10.1080/03007995.2025.2501588","DOIUrl":"10.1080/03007995.2025.2501588","url":null,"abstract":"<p><strong>Objective: </strong>RATIONALE-305 (NCT03777657) demonstrated that tislelizumab plus chemotherapy statistically improved overall survival versus placebo plus chemotherapy as first-line treatment in patients with advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). This analysis examined patient-reported outcomes (PROs) at final analysis.</p><p><strong>Methods: </strong>Adults with previously untreated, unresectable, or metastatic GC/GEJC were randomized (1:1) to tislelizumab or placebo intravenously once every 3 weeks plus chemotherapy. PROs assessed health-related quality of life (HRQoL) using EORTC QLQ-C30 and EORTC QLQ-STO22. A mixed model for repeated measures was used for PRO endpoints at treatment cycles 4 and 6, and time to deterioration was analyzed.</p><p><strong>Results: </strong>Tislelizumab arm had improved outcomes over placebo arm in least-squares (LS) mean change from baseline to cycle 6 for QLQ-C30 global health status/quality of life (GHS/QoL) (LS mean difference, 2.52 [95% CI: 0.29-4.74]), physical functioning (2.46 [0.49-4.43]), fatigue (-3.01 [-5.78 to -0.24]), and STO22 index score (-1.62 [-3.12 to -0.12]) as well as maintenance of upper gastrointestinal symptoms (-1.74 [-3.55-0.06]) and pain/discomfort (-1.88 [-4.03-0.27]). Patients receiving tislelizumab plus chemotherapy had a lower risk for deterioration of GHS/QoL (hazard ratio 0.77 [95% CI: 0.60-0.98]), physical functioning (0.72 [0.57-0.92]), STO22 index score (0.64 [0.45-0.92]), pain/discomfort (0.74 [0.58-0.96]), and upper gastrointestinal symptoms (0.73 [0.56-0.95]).</p><p><strong>Conclusions: </strong>Advanced GC/GEJC patients treated with tislelizumab plus chemotherapy versus placebo plus chemotherapy in first-line had sustained and improved HRQoL. These results, along with previous efficacy and safety data, support tislelizumab plus chemotherapy as a first-line treatment option for GC/GEJC.</p><p><strong>Trial registration: </strong>The RATIONALE-305 trial is registered on ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT03777657).ClinicalTrials.gov identifier: NCT03777657.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1007-1016"},"PeriodicalIF":2.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316064","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}