Drugs - Real World Outcomes最新文献

{"title":"Impact of Modern Systemic Therapies on Survival in Patients with Anaplastic Thyroid Cancer: A Single-Center Retrospective Cohort Review.","authors":"Austin Luong, Darin Poei, Lydia Chow, Ming Li, Qi Nie, Trevor Angell, Liyang Tang, Robert Hsu, Jacob Thomas","doi":"10.1007/s40801-025-00493-y","DOIUrl":"https://doi.org/10.1007/s40801-025-00493-y","url":null,"abstract":"<p><strong>Background: </strong>Anaplastic thyroid carcinoma (ATC) is a highly aggressive cancer historically associated with a median survival of about 5 months. Recent advances in tumor genomic testing have identified targetable BRAF mutations in about 35-40% of ATC cases and have shown high levels of programmed death ligand-1 (PD-L1) expression in ATC. These observations have led to clinical trials showing favorable outcomes with targeted therapy and immunotherapy for ATC.</p><p><strong>Objective: </strong>We aimed to evaluate treatments and outcomes of patients diagnosed with anaplastic thyroid cancer treated at our institution in order to determine the impact of targeted therapy and immunotherapy.</p><p><strong>Methods: </strong>A retrospective review of ATC patients at a single institution was performed. Data were collected from institutional electronic medical records, including demographic information, treatments administered, and outcomes including survival.</p><p><strong>Results: </strong>A total of 28 patients were identified within the period under study. Systemic therapy was initiated in 61% of patients. The median overall survival for all patients was 7.3 months. There was a statistically significant improvement in overall survival for patients who received targeted therapy or immunotherapy compared to those who did not.</p><p><strong>Conclusions: </strong>In this single-institution cohort of 28 patients with ATC, patients who received either targeted therapies or immunotherapy demonstrated markedly improved outcomes. Further clinical trials are required to determine the optimal systemic therapy for this patient population.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Pattern of Heart Failure Patients in Sweden During 2021-2023 in Relation to Updated Treatment Recommendations.","authors":"Michaela Eklund, Magnus Husberg, Therese Eriksson, Mattias Enoksson, Staffan Gustavsson, Lars-Åke Levin, Lars Bernfort","doi":"10.1007/s40801-025-00494-x","DOIUrl":"https://doi.org/10.1007/s40801-025-00494-x","url":null,"abstract":"<p><strong>Background: </strong>In early 2022, new treatment recommendations for heart failure (HF) were introduced in Sweden.</p><p><strong>Objective: </strong>This study aims to evaluate and analyze the pharmaceutical treatment patterns of HF patients over time in Sweden, in relation to the updated treatment recommendations.</p><p><strong>Methods: </strong>This observational study is based on registry data. The study population consisted of patients ≥18 years old who, at any time between 2017 and 2023, had an HF diagnosis, defined using ICD-10 code I50 (n = 212,757). Descriptive statistics were presented for the study population. Based on data from the national drug prescription registry, the treatment patterns between 2021 and 2023 were analyzed using biannual datasets before and after the introduction of treatment recommendations.</p><p><strong>Results: </strong>The mean age of the study population was 79 years and 56% were men. The utilization of quadruple therapy and SGLT2 inhibitors, both as monotherapy and in combination, increased over time, with a rising trend already apparent prior to the introduction of the updated treatment recommendations. At the end of 2023, about 30% of the incident HF population had at least tried quadruple therapy. Furthermore, a growing number of diverse treatment pathways among HF patients was observed over time, which may indicate an increased consideration for individualized treatment.</p><p><strong>Conclusions: </strong>Even though the implementation of the treatment recommendations for HF is not yet optimal, this study found a notable adoption of quadruple therapy in Sweden. There was an increased use of SGLT2 inhibitors and quadruple therapy, beginning even before the introduction of the updated Swedish treatment recommendations.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study.","authors":"Panisa Manasirisuk, Somsak Tiamkao, Chaiyasith Wongvipaporn, Nanthaphan Chainirun, Kittisak Sawanyawisuth","doi":"10.1007/s40801-025-00491-0","DOIUrl":"https://doi.org/10.1007/s40801-025-00491-0","url":null,"abstract":"<p><strong>Introduction: </strong>High levels of low-density lipoprotein-cholesterol (LDL) is a major risk factor for cardiovascular diseases. While treatment with atorvastatin is beneficial, the original atorvastatin may be cost prohibitive to some patients. Currently, a second brand of generic atorvastatin is available on the market. This study aimed to evaluate the effectiveness of the second generic brand of atorvastatin.</p><p><strong>Methods: </strong>This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator^® (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz^® (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat^® (Siam Pharmaceutical, Thailand). The study period was between 1 April 2022 and 30 June 2023. The primary outcome of this study was a change in LDL 6 months after switching therapy from either the original (Xarator^®) or generic atorvastatin (Atorvastatin Sandoz^®).</p><p><strong>Results: </strong>There were 683 patients who switched therapy from the original atorvastatin (Xarator^®), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz^®), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator^®) resulted in a slightly lower but not significant decrease in LDL at 6 months (- 0.96 mg/dL; 95% CI of - 3.20, 1.28), while switching therapy from generic atorvastatin (Atorvastatin Sandoz^®) led to significantly lower LDL at - 3.30 mg/dL (95% CI of - 5.25, - 1.36). The original (Xarator^®) and generic atorvastatin (Atorvastatin Sandoz^®) group also resulted in a significantly lower estimated glomerular filtration rate at - 0.90 and - 1.21 mL/min/1.73 m², respectively, from baseline.</p><p><strong>Conclusions: </strong>The second generic atorvastatin (Lipostat^®) resulted in comparable outcomes on LDL compared with the original (Xarator^®), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz^®) 6 months after switching therapy. However, renal function should be closely monitored.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Clinical Characteristics, Treatment Patterns, and Clinical Outcomes in US Patients with Stage I-III Resected NSCLC Without Known EGFR Mutations: The RESECT Study.","authors":"Jhanelle E Gray, Rachel J Salomonsen, Ignacio Diaz Perez, Alice Wang, Ling Cai, Graham Wetherill, Yang Xiao, Claire Fielden, Nefeli Georgoulia","doi":"10.1007/s40801-025-00487-w","DOIUrl":"https://doi.org/10.1007/s40801-025-00487-w","url":null,"abstract":"<p><strong>Background: </strong>Immunotherapy has altered the treatment landscape for resectable non-small cell lung cancer, increasing the complexity of treatment planning. Understanding treatment patterns and outcomes prior to the advent of immunotherapy can provide context for assessing the benefit of immunotherapies and other novel agents.</p><p><strong>Objective: </strong>We aimed to characterize real-world demographics, clinical characteristics, treatment patterns, and clinical outcomes of patients with early-stage non-small cell lung cancer before widespread immunotherapy use.</p><p><strong>Methods: </strong>Analyses included patients from the US CancerLinQ Discovery^® database diagnosed with stage I-III non-small cell lung cancer between 2014 and 2020 without known EGFR mutations who underwent surgical resection within 140 days of diagnosis. The primary outcome was treatment patterns by disease stage.</p><p><strong>Results: </strong>Analyses included 3077 patients with stage I (n = 1673), II (n = 853), and III (n = 551) disease. Most (92.8%, 52.3%, and 36.5% of stage I, II, and III patients) received surgery without systemic therapy. Among stage I, II, and III patients, 7.2%, 44.8%, and 46.6% received adjuvant therapy only. Of stage II and III patients, 2.0% and 10.2% received neoadjuvant therapy only, and 0.9% and 6.7% received both (stage I patients who received neoadjuvant only or perioperative therapy were excluded because of low numbers [n = 4]). Five-year overall survival rates were 73.4%, 61.9%, and 50.5% in stage I, II, and III patients; 5-year real-world relapse-free survival rates were 35.4%, 23.1%, and 14.0%. In an exploratory multivariate analysis, neoadjuvant treatment was associated with improved overall survival and real-world relapse-free survival in stage II-III patients (stage I patients not evaluable). Adjuvant treatment was associated with improved real-world relapse-free survival, but not overall survival, in stage II-III patients.</p><p><strong>Conclusions: </strong>Most patients received surgery alone, though the proportion receiving systemic treatment increased with disease stage. Modest 5-year, real-world relapse-free survival rates indicate a need for more effective neoadjuvant or adjuvant treatments in this setting.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Analysis of Survival in Pulmonary Arterial Hypertension for Patients Treated with Selexipag in Clinical Practice (EXPOSURE Study).","authors":"Stefan Söderberg, Pilar Escribano-Subias, Ciara Archey, Audrey Muller, Martina Fontana, Tobias J Lange, Sean Gaine","doi":"10.1007/s40801-025-00488-9","DOIUrl":"https://doi.org/10.1007/s40801-025-00488-9","url":null,"abstract":"<p><strong>Background: </strong>In pulmonary arterial hypertension (PAH), comparative assessment of treatment effect on survival in randomized controlled settings of contemporary patients has not been feasible.</p><p><strong>Objective: </strong>The aim of this study was to use EXPOSURE, the ongoing, real-world, post-authorization safety study, and commitment to the European Medicines Agency to perform pre-specified comparative survival analyses between patients that newly initiated selexipag versus other PAH-specific therapies by applying statistical methods to account for population differences.</p><p><strong>Methods: </strong>EXPOSURE (EUPAS19085) is an observational study comprising patients with PAH who initiated selexipag or other PAH-specific therapy. To balance characteristics of patients in the other PAH therapy cohort with the selexipag cohort at PAH therapy initiation (baseline), propensity score weighting was applied. Mortality rate ratios (MRRs) were calculated.</p><p><strong>Results: </strong>2014 patients were available for analysis. Prior to applying propensity score weighting, patients in the selexipag cohort were more likely to have longer time from diagnosis, less functional impairment, and treatment with combination background therapy versus the other PAH therapy cohort. Following weighting, baseline variables for both cohorts were well balanced. Weighted treatment exposure was 827.9 and 840.5 person-years for the selexipag and modelled other PAH therapy cohort, respectively. Weighted proportion of deaths was lower in the selexipag versus modelled other PAH therapy cohort; MRR showed a higher survival rate for selexipag-treated patients (MRR [95% confidence interval]: 0.55 [0.31-0.99]).</p><p><strong>Conclusions: </strong>Survival analyses in EXPOSURE suggest a reduced risk of mortality among the cohort of patients newly initiated on selexipag compared with the modelled cohort newly initiated with other PAH-specific therapies. Further research is needed to confirm this observation.</p><p><strong>Trial registry: </strong>Trial registration: EUPAS19085.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Association Between Postpartum Hemorrhage and Antidepressant Use: A Mendelian Randomization Study.","authors":"Zhenzhen Chen, Qingqing Lv, Shiteng Lin, Wanlong Lin, Wei Zhuang","doi":"10.1007/s40801-025-00490-1","DOIUrl":"https://doi.org/10.1007/s40801-025-00490-1","url":null,"abstract":"<p><strong>Background: </strong>The relationship between antidepressants, depression, and the incidence of postpartum hemorrhage (PPH) has been reported in observational studies, but the causal link between these factors remains unknown. Clarifying this relationship is important for treating depression during pregnancy and managing PPH.</p><p><strong>Objective: </strong>We aimed to assess the causal relationship between antidepressants, depression, and PPH using a two-sample Mendelian randomization method.</p><p><strong>Methods: </strong>Single nucleotide polymorphisms were identified from publicly available genetics summary databases (FinnGen database, access date: 28 December, 2023, version R9, phenocode: ANTIDEPRESSANTS, 195,321 participants; the genome-wide association studies [GWAS] catalog, access date: 3 April, 2024, GWAS ID: ebi-a-GCST90016607; Integrative Epidemiological Unit database, access date: 3 April, 2024, GWAS ID: ieu-a-1187) as alternative exposure factors for antidepressants and depression. Subsequently, inverse variance weighting, Mendelian randomization-Egger regression, weighted median, simple method, and weighted method were employed for Mendelian randomization analyses, and the results were validated for pleiotropy, heterogeneity, and sensitivity.</p><p><strong>Results: </strong>The analyses employed three sets of genetic tools, comprising two sets of 9 and 32 single nucleotide polymorphisms that are strongly associated with depression and another set of 26 single nucleotide polymorphisms that are associated with antidepressants. The inverse variance weighting indicated that antidepressants are associated with PPH (odds ratio = 1.36, 95% confidence interval 1.10-1.69, p = 0.005). Conversely, none of the five methods of Mendelian randomization analysis identified an effect of depression on PPH.</p><p><strong>Conclusions: </strong>This Mendelian randomization analysis indicated that antidepressant use is associated with PPH. However, the evidence does not support a causal relationship between depression and PPH.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Treatment Patterns Among Pediatric and Adult Patients with Crohn's Disease in the United States.","authors":"Art Kastl, Theresa Hunter Gibble, Debbie Tinsley, Wallace V Crandall, Wendy J Komocsar, Yu Du, Casey K Choong, Payal Jha, Wai Man Maria Chan","doi":"10.1007/s40801-025-00489-8","DOIUrl":"https://doi.org/10.1007/s40801-025-00489-8","url":null,"abstract":"<p><strong>Background: </strong>The advent of biologics has expanded treatment options for Crohn's disease (CD). This study assessed treatment patterns in pediatric and adult patients with CD in the United States during 1- and 3-year follow-up periods.</p><p><strong>Methods: </strong>This retrospective, claims-based cohort study utilized the Merative™ MarketScan^® Research Databases from January 1, 2014, to December 31, 2021. The index date was the date of the first CD diagnosis during the identification period. Among pediatric and adult CD cohorts, patients were stratified into two subgroups: (a) previously diagnosed (presence of a CD claim) and (b) newly diagnosed (absence of a CD claim) in the 12-month pre-index period. Results were summarized descriptively.</p><p><strong>Results: </strong>Data from 2809 pediatric and 25,940 adult patients were analyzed at 1-year follow-up. Mean age in years was 13.5 for pediatric and 46.0 for adult patients. Combination therapies were more common in pediatric versus adult patients, especially among those newly diagnosed with CD (38.2% vs 13.9%). A higher percentage of pediatric patients were prescribed biologics than adults (35.1% vs 24.3%). Numerically shorter time from diagnosis to corticosteroid initiation was observed in pediatric versus adult patients (9.5 vs 35 days). Higher persistence to biologics was observed in pediatric versus adult patients (94.6% vs 87.1%).</p><p><strong>Conclusions: </strong>Combination therapies with biologics were more frequent among pediatric patients than adults. Although the overall treatment pattern among pediatric and adult patients was similar, early initiation of corticosteroids and adoption of biologics were more frequently observed in pediatric than adult patients, consistent with pediatric CD presenting with more aggressive disease.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influenza Vaccination Among Patients with Noncommunicable Diseases: A Survey About Awareness, Usage, and Unmet Needs in the Czech Republic.","authors":"Zdeněk Zadražil, Lenka Cesneková, Jan Kynčl, Zuzana Krištúfková, Laura Colombo, Sanjay Hadigal","doi":"10.1007/s40801-025-00483-0","DOIUrl":"https://doi.org/10.1007/s40801-025-00483-0","url":null,"abstract":"<p><strong>Background: </strong>People with noncommunicable diseases (NCDs) are at a higher risk of contracting vaccine-preventable diseases, such as influenza, with a higher likelihood of severity and complications. However, the immunization rates for the influenza vaccine among this population in the Czech Republic are very low.</p><p><strong>Objective: </strong>This survey, among adults with NCDs in the Czech Republic, assessed the knowledge, attitudes, and gaps toward vaccination in general and influenza vaccination in particular.</p><p><strong>Methods: </strong>The survey was conducted between February 2023 and March 2023 among patients with NCDs in the Czech Republic. A structured web-based questionnaire with open-ended questions was administered. This study is a preplanned subgroup ancillary analysis of a previous multicentric study conducted on 1106 patients.</p><p><strong>Results: </strong>In all, 120 patients were enrolled, with 62% (74) aged between 41 and 60 years. Approximately 30% (36) had taken the influenza vaccine in the last 2 years and 70% (84) had not. Of the total sample, only 46% (55) had a positive opinion about influenza vaccines; this increased to 91% (33) among those vaccinated against the influenza virus. The main drivers of influenza vaccination were general physician (GP) recommendation [50% (18)] and patient initiative [47% (17)]. The main barriers to the influenza vaccine were lack of belief regarding its need [52% (44)], experience of mild severity of influenza [30% (25)], and lack of GP recommendation [25% (21)]. Physicians, dedicated websites, and family members are the most common sources of information regarding influenza. Even among those vaccinated for influenza, only 17% (6) had information about the risk of not taking the vaccine. A high level of dissatisfaction with the information was found among patients not vaccinated against influenza. People wanted more information on who should not receive the influenza vaccination. Unvaccinated patients sought information on side effects and efficacy. Only 40% (48) of the respondents said that they are likely/extremely likely to take an influenza vaccination in the future.</p><p><strong>Conclusions: </strong>Healthcare practitioners are the key influencers for people to get vaccinated. The dissemination of information about the importance of influenza vaccines for people with NCDs needs to be increased in the Czech Republic.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence and Patterns of Use of Natural Health Products and Medicines in New Zealand: A Pilot Study Using an Online Market Research Panel.","authors":"E Lyn Lee, Jeff Harrison, Joanne Barnes","doi":"10.1007/s40801-025-00482-1","DOIUrl":"https://doi.org/10.1007/s40801-025-00482-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Traditional, complementary and alternative medicine (TCAM), including natural health products (NHPs), are used by many consumers to address their [perceived] health needs. While many developed countries have national data on NHPs use, limited information is available for New Zealand (NZ). Current, robust data on the prevalence and patterns of NHPs use in NZ are required.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This project explored the feasibility of conducting a national study and collecting preliminary data on the prevalence and patterns of use of NHPs, including access to and expenditure on NHPs, and of the use of conventional medicines in NZ using a newly designed bespoke questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An online cross-sectional survey was administered to a sample of the adult population in NZ via an online market research panel in November 2021. Self-reported data on participants' use of NHPs (including photographs of products), consultations with TCAM practitioners and use of conventional medicines were collected. Data on the prevalence and patterns of use of NHPs were analysed and reported using descriptive statistics. Multivariable logistic regression was applied to assess the impact of sociodemographic variables on NHPs, TCAM practitioners and conventional medicines use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The final sample comprised 992 participants. Sociodemographic data for these participants were comparable to those reported for the NZ Census 2018. The frequency of missing data was &lt; 10% for most of the questions; data quality for broad-level prevalence analysis was good, but was moderate to poor for analysis at the specific NHP or TCAM practitioner level. The specific product(s) and their respective ingredient list(s) could not be determined for most NHPs described as photographs were not uploaded, rendering product names unverifiable. Preliminary data indicate that 57.6% of participants have used NHPs and 22.9% consulted a TCAM practitioner in the last 12 months. Among current NHP users, 71.1% concurrently used one or more conventional medicines. Over half (53%) of the NHPs were self-selected (not recommended by a health practitioner). The median daily cost per NHP was NZD 0.28 (interquartile range NZD 0.14-0.50) and the median cost for visits to a TCAM practitioner over the last 12 months was NZD 120 (interquartile range NZD 40-270). Female participants, younger individuals and conventional medicine users were more likely to use NHPs/consult a TCAM practitioner/use any TCAM. Higher-income participants were more inclined to consult a TCAM practitioner. Individuals born overseas were more likely to use any type of TCAM.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;There was a high prevalence of use of NHPs and of consultations with TCAM practitioners, which may reflect the extent of use in the general NZ population. Recognising the potential impact on patients' health outcomes, there is a need for a larger","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Evaluation of Effectiveness and Immunological Implications of Ocrelizumab in a Real-World Cohort.","authors":"Tommaso Guerra, Francesca Caputo, Antonella Bianco, Damiano Paolicelli, Pietro Iaffaldano","doi":"10.1007/s40801-025-00486-x","DOIUrl":"https://doi.org/10.1007/s40801-025-00486-x","url":null,"abstract":"<p><strong>Background and objectives: </strong>Extended follow-up data from real-world cohorts of patients with multiple sclerosis treated with ocrelizumab (OCR) are becoming widely available. This monocentric retrospective study aimed to evaluate the long-term effectiveness of OCR and its impact on immunoglobulin (Ig) levels, lymphocyte subsets, and infections in a cohort of patients with relapsing remitting, primary progressive, and secondary progressive multiple sclerosis.</p><p><strong>Methods: </strong>Patients followed at the Multiple Sclerosis Center of Bari with ≥ 2 years of OCR treatment were retrospectively recruited in 2024. Twelve-month confirmed disability worsening, improvement, and the annualized relapse rate before and after treatment start were estimated and follow-up magnetic resonance imaging scans were collected. Changes in IgG/IgM/IgA levels from baseline for up to 6 years of OCR treatment and serum levels of T CD4+, T CD8+, and natural killer lymphocytes were assessed. Infection occurrence, type, and outcomes were investigated. Multivariable Cox models examined the association of clinical and radiological baseline factors with the risk of confirmed disability worsening and the relationship of infections with clinical-laboratoristic risk factors.</p><p><strong>Results: </strong>The final cohort retrieved 140 patients (80 relapsing remitting, 37 primary progressive, 23 secondary progressive) with a median (interquartile range) follow-up after treatment start of 4.62 (4.10-5.04) years. In the entire cohort, the mean annualized relapse rate decreased from 0.61 in the year before the start of OCR treatment to 0.02 in the second year, thereafter all patients in our cohort remained free of relapses and magnetic resonance imaging activity. The overall percentage of stable patients increased from the second to the fourth year, in parallel with a reduction in patients with confirmed disability worsening. A multifocal onset and the presence of at least two relapses before the start of OCR treatment were significant (p < 0.05) risk factors of confirmed disability worsening. During the follow-up, a reduction in the IgG serum level was observed, which further decreased, becoming stable after the third year. Immunoglobulin M levels slightly decreased over time, whereas IgA levels remained stable. No changes for T CD4+, natural killer cell absolute number, and a slight reduction in T CD8+ lymphocytes during follow-up were observed. Ocrelizumab did not determine a significant infection risk in the long term and no association was observed with Ig levels and severe infections.</p><p><strong>Conclusions: </strong>Ocrelizumab prevented disease activity over the long term and its effect on the immune system did not determine a significant infection risk in most patients.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}