Clinical Drug Investigation最新文献

{"title":"Correction to: Association Between Antidiabetic Drugs and Delirium: A Study Based on the Adverse Drug Event Reporting Database in Japan.","authors":"Yukiko Ishibashi, Rintaro Sogawa, Kenji Ogata, Ayaka Matsuoka, Haruna Yamada, Toru Murakawa-Hirachi, Yoshito Mizoguchi, Akira Monji, Chisato Shimanoe","doi":"10.1007/s40261-024-01340-8","DOIUrl":"10.1007/s40261-024-01340-8","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"121"},"PeriodicalIF":3.2,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Antidiabetic Drugs and Delirium: A Study Based on the Adverse Drug Event Reporting Database in Japan.","authors":"Yukiko Ishibashi, Rintaro Sogawa, Kenji Ogata, Ayaka Matsuoka, Haruna Yamada, Toru Murakawa-Hirachi, Yoshito Mizoguchi, Akira Monji, Chisato Shimanoe","doi":"10.1007/s40261-023-01337-9","DOIUrl":"10.1007/s40261-023-01337-9","url":null,"abstract":"<p><strong>Background and objective: </strong>Several associations between diabetes mellitus and delirium have been reported; however, they have been inconsistent, and evidence on the effects of antidiabetic medications on delirium is also limited. This study aimed to investigate whether the use of antidiabetic drugs is a risk factor for delirium development.</p><p><strong>Methods: </strong>Using the Japanese Adverse Event Reporting Database, we analyzed 662,899 reports between 2004 and 2022. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) for delirium associated with diabetes and using each antidiabetic medication were calculated after adjusting for potential confounders.</p><p><strong>Results: </strong>Overall, 8892 of the reports analyzed were associated with delirium. A comparison of the incidence of delirium between patients with and without diabetes showed no significant difference, with 1.34% in patients without diabetes and 1.37% in those with diabetes. In each antidiabetic medication, signals for delirium were detected for sulfonylurea (crude ROR, 1.35; 95% CI 1.21-1.51) and insulin (crude ROR, 1.28; 95% CI 1.13-1.44). These results were maintained even after adjusting for factors with potential confounders (sulfonylurea: adjusted ROR, 1.75; 95% CI 1.54-2.00, insulin: adjusted ROR, 1.35; 95% CI 1.20-1.54).</p><p><strong>Conclusions: </strong>Our results suggest no association between diabetes and delirium; however, using sulfonylurea and insulin may be associated with delirium development. Nonetheless, these findings should be validated in future studies.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"115-120"},"PeriodicalIF":3.2,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138884639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the Incidence of Adverse Events Between Japanese and Non-Japanese Healthy Subjects in Phase I Studies: A Systematic Review and Meta-Analysis.","authors":"Satomi Sakurai, Kazuhiro Matsui, Mamoru Narukawa","doi":"10.1007/s40261-023-01327-x","DOIUrl":"10.1007/s40261-023-01327-x","url":null,"abstract":"<p><strong>Background and objective: </strong>Ethnic and racial differences are key factors affecting the results of clinical studies. However, the influence of these factors on the efficacy and safety of medicinal products remains unclear. Race-dependent nature is considered to be one of the factors causing differences in clinical findings, and we investigated its influence on the safety evaluation of drugs.</p><p><strong>Methods: </strong>We searched PubMed and a Japan drug approval list to find relevant studies, and extracted phase I studies conducted with Japanese and non-Japanese participants using the same protocol and at the same study site. Pooled estimates of odds ratios (ORs) for the incidence of major adverse events in Japanese and non-Japanese participants were calculated, using a DerSimonian-Laird method with a random-effects model.</p><p><strong>Results: </strong>Odds ratios for some adverse events in the active drug arm were significantly lower in Japanese participants: headaches [OR 0.65 (95% confidence interval [CI] 0.52-0.82), p = 0.0003], neurological disorders NEC [OR 0.70 (95% CI 0.53-0.93), p = 0.0135] in a High-Level Group Term, nervous system disorders [OR 0.64 (95% CI 0.49-0.82), p = 0.0004], infections and infestations [OR 0.71 (95% CI 0.53-0.95), p = 0.0202], and musculoskeletal and connective tissue disorders [OR 0.66 (95% CI 0.48-0.91, p = 0.0107] in the System Organ Class.</p><p><strong>Conclusions: </strong>Our research suggested that racial factors such as race-dependent nature influence a drug safety assessment. With knowledge of these differences, it is expected that Japan will actively conduct multi-regional clinical trials, in which more diverse populations are included.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"11-19"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138470037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness and Safety of Baricitinib in Patients with Atopic Dermatitis.","authors":"Egídio Freitas, Maria João Paiva Lopes, Maria João Cruz, Diogo Sousa, Ana Clara Valente, Bruno Duarte, Laetitia Teixeira, Gilberto Rosas, Mónica Caetano, Alberto Mota, Paulo Filipe, Tiago Torres","doi":"10.1007/s40261-023-01335-x","DOIUrl":"10.1007/s40261-023-01335-x","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"87-90"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138800796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of the Pharmacokinetics and Mass Balance of a Single Oral Dose of Trofinetide in Healthy Male Subjects.","authors":"Mona Darwish, Rene Nunez, James M Youakim, Philmore Robertson","doi":"10.1007/s40261-023-01322-2","DOIUrl":"10.1007/s40261-023-01322-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objective: &lt;/strong&gt;Trofinetide is the first drug to be approved for the treatment of Rett syndrome, a neurodevelopmental disorder. The purpose of the study is to fully characterize the metabolic and excretion profiles of trofinetide in humans.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This Phase 1, open-label, single-dose trial conducted in healthy male adults was designed to characterize the pharmacokinetics of trofinetide (absorption, metabolism, and excretion), mass balance of [&lt;sup&gt;14&lt;/sup&gt;C]-trofinetide, and safety profile of trofinetide following administration of an oral 12-g dose administered as a mixture of trofinetide and [&lt;sup&gt;14&lt;/sup&gt;C]-trofinetide. Blood, urine, and fecal samples were collected at prespecified timepoints. The pharmacokinetics of trofinetide were assessed in blood and urine samples using high-performance liquid chromatography (HPLC) with tandem mass spectrometric detection. Bioanalysis of radioactivity was conducted in blood, plasma, urine, and fecal samples using liquid scintillation counting. Metabolite profiling was conducted in blood, plasma, urine, and fecal samples using HPLC with liquid scintillation counting of chromatographic fractions. Safety and tolerability, including treatment-emergent adverse events (TEAEs), were assessed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Blood concentration-time profiles of trofinetide and total radioactivity were almost superimposable up to ~12 h after dosing. Urine concentration-time profiles of trofinetide and total radioactivity were similar. Trofinetide was rapidly absorbed into the circulation with an initial rapid decline (half-life [t&lt;sub&gt;½&lt;/sub&gt;] &lt;sub&gt;alpha&lt;/sub&gt; ~2.6 h), followed by a relatively slow terminal elimination phase (t&lt;sub&gt;½ beta&lt;/sub&gt; ~20 h). The blood-to-plasma total radioactivity ratios were 0.529-0.592, indicating a lack of affinity for the cellular portion of blood. Renal excretion accounted for 83.8% of the administered radiochemical dose; 15.1% was recovered in feces. Urine and fecal recovery of radioactivity accounted for 99% of the administered dose at 168 h after dosing. Parent [&lt;sup&gt;14&lt;/sup&gt;C]-trofinetide was the major radiolabeled entity in blood and plasma (88.4% and 93.1% in area under the concentration-time curves from 0 to 12 h [AUC&lt;sub&gt;0-12&lt;/sub&gt;] in pooled blood and plasma samples, respectively) and the major entity excreted in urine (91.5% in 0-48-h pooled urine samples) and in feces (52.7% in 0-192-h pooled fecal samples). Only small levels of metabolites were present. In blood and plasma, only two minor metabolites were identified (each metabolite ≤ 2.24% of the AUC&lt;sub&gt;0-12&lt;/sub&gt; pool). These two metabolites were also observed in urine and fecal samples (≤ 2.41% of dose). In feces, one additional metabolite (0.84% of dose) was identified. Two mild TEAEs were reported in two participants and were not considered related to trofinetide. There were no clinically meaningful changes in individual laboratory parameters, vital signs, ph","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"21-33"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10769996/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138451024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Key Drivers of Coagulation Factor Use in Von Willebrand Disease During Hospitalization: An Overview of the French BERHLINGO Cohort.","authors":"Valérie Horvais, Philippe Beurrier, Vincent Cussac, Brigitte Pan-Petesch, Solène Schirr-Bonnans, Johann Rose, Sophie Bayart, Catherine Ternisien, Marc Fouassier, Marianne Sigaud, Antoine Babuty, Nicolas Drillaud, Benoît Guillet, Marc Trossaërt","doi":"10.1007/s40261-023-01323-1","DOIUrl":"10.1007/s40261-023-01323-1","url":null,"abstract":"<p><strong>Background: </strong>Von Willebrand disease (VWD) is the most common inherited bleeding disorder. However, studies of hospitalisation patterns with replacement treatment are scarce.</p><p><strong>Objectives: </strong>The aim of this study was to investigate the current therapeutic management of VWD and determine the key drivers of coagulation factor uses in patients during hospitalisation.</p><p><strong>Methods: </strong>Hopscotch-WILL was a multi-centric retrospective study conducted over a 48-month period in any patients with VWD. The data were collected from the BERHLINGO Research Database and the French Hospital database.</p><p><strong>Results: </strong>A total of 988 patients were included; 153 patients (15%) were hospitalised during 293 stays requiring treatment with von Willebrand factor (VWF) concentrates-pure or in association with Factor VIII (FVIII). Their median basal concentrations of VWF and FVIII were significantly lower than in untreated patients: VWF antigen < 30 IU/dL, VWF activity < 20 IU/dL and FVIII:C < 40 IU/dL. The median (interquartile range) concentrate consumption was similar between highly purified VWF or VWF combined with FVIII (72 [110] vs 57 [89] IU/kg/stay, p = 0.154). The use of VWF was highly heterogeneous by VWD type; type 3 had a particularly high impact on VWF consumption in non-surgical situations. The main admissions were for ear/nose/throat, hepato-gastroenterology, and trauma/orthopaedic conditions, besides gynaecological-obstetric causes in women.</p><p><strong>Conclusions: </strong>The use of VWF concentrates is mostly influenced by low basal levels of VWF and FVIII, but also by VWD type or the cause for hospitalisation. These results could inform future studies of newly released recombinant VWF.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"35-49"},"PeriodicalIF":3.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138458317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects","authors":"Linlin Hu, Qiuyue Sun, Lu Tang, Mingmin Cai, Wei Qian, Ting Dou, Huiping Wang, Yong Wu, Yongqiang Liu","doi":"10.1007/s40261-023-01334-y","DOIUrl":"https://doi.org/10.1007/s40261-023-01334-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>VC004 is a novel next-generation tropomyosin receptor kinase (TRK) inhibitor that is approved for the treatment of advanced or metastatic NTRK fusion-positive solid tumors and abrogated the drug resistance of the first-generation TRK inhibitors. The objective of the present study was to evaluate the effect of food on the pharmacokinetics and safety of VC004.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The study was a randomized, open-label, two-period crossover, single-dose, phase I clinical trial. A total of 16 healthy subjects participated the trial. Subjects fasted for 10 h before drug administration in both fasting and fed states. Subjects received VC004 50 mg orally in the fasting state and after a high caloric food in the fed state. Blood samples at the designated time points were collected to determine the plasma concentration of VC004. Safety evaluation in both the fasted and fed periods were assessed via vital sign monitoring and clinical laboratory tests.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The maximum plasma concentration (<i>C</i>_max) of VC004 in fed group decreased by 32.8%, corresponding with the slower absorption rate (time to <i>C</i>_max (<i>T</i>_max) delayed by almost 3 h) compared with the fasting group. Ratios of geometric means (GMRs) and 90% confidence intervals (90% CIs) of <i>C</i>_max, the area under the curve of plasma concentration-time from zero to the last measurable concentration (<i>AUC</i>_0–<i>t</i>), and <i>AUC</i> from zero to infinity (<i>AUC</i>_{0–<i>∞</i>}) for VC004 between the two states were 67.18 (58.16–77.60), 103.59 (95.04–112.92) and 103.55 (95.63–112.11), respectively. No serious adverse events (AEs) occurred; only three grade 1 or grade 2 adverse events occurred in the fasted group, who recovered by the end of the study.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>The intake of high calorie food decreased the absorption rate and increased the<i> T</i>_max of VC004, while the AUC values were similar in both groups. No serious adverse event was reported. In conclusion, food does not alter the pharmacokinetics and safety profile of VC004 in a clinically meaningful manner.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ClinicalTrials.gov ID: NCT055528120.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":"234 2 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138743171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Long-Term Effectiveness and Safety of Upadacitinib for Atopic Dermatitis Between Dupilumab-Exposed and Dupilumab-Naïve Patients","authors":"","doi":"10.1007/s40261-023-01336-w","DOIUrl":"https://doi.org/10.1007/s40261-023-01336-w","url":null,"abstract":"<h3>Abstract</h3> <span> <h3>Background and Objectives</h3> <p>Upadacitinib is an oral selective Janus kinase-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD) in patients <span> <span>(ge)</span> </span> 12 years of age. In real life, upadacitinib currently represents a valid therapeutic option for patients failing available systemic therapies, in particular patients who discontinued dupilumab because of lack of efficacy or occurrence of adverse events. The objectives of the present study were to compare the effectiveness and safety of upadacitinib in patients affected by AD who had previously failed dupilumab therapy versus biologic naïve patients.</p> </span> <span> <h3>Methods</h3> <p>A retrospective, multi-centre, observational, real-life study was conducted in four Italian dermatological referral centres (Milan, Perugia, Naples and Vicenza). Baseline characteristics included age, sex, AD history and severity, prior treatments, comorbidities and concomitant therapies. AD severity was assessed at baseline and at week 4 (W4), W16, W24 and W52, using Eczema Area Severity Index (EASI), Dermatology Life Quality Index (DLQI) and Pruritus Numerical Rating Scale (P-NRS) scores. Full blood count, hepatic and renal function, lipid panel, and muscle enzymes [lactate dehydrogenase (LDH) and creatine phosphokinase (CPK)] were assessed at baseline and at each follow-up visit.</p> </span> <span> <h3>Results</h3> <p>A total of 113 patients (72 males, 63.7%; mean age: 37.22 ± 16.8 years) were included in the analysis, all patients were in treatment and underwent follow-up period until W16, whilst 91 (80.5%) and 75 (66.4%) patients were in treatment and in follow-up period until W24 and W52, respectively.</p> <p>Mean EASI score significantly changed from 24.30 ± 10.27 to 1.28 ± 4.34, 0.74 ± 2.31 and 0.25 ± 1.34 at W16, W24 and W52, respectively (<em>p</em> &lt; 0.0001). Specifically, at W16 the percentage of patients achieving EASI-75, EASI-90 and EASI-100 was 85.21, 76.35 and 66.11%, respectively. At W24, EASI-75, EASI-90 and EASI-100 were reached by 88.54, 85.42, and 78.37% of patients, respectively. Finally, 90.1% of patients achieved EASI-75, 88.3% achieved EASI-90 and 83.0% achieved EASI-100 at W52.</p> </span> <span> <h3>Conclusions</h3> <p>This study confirmed the clinical effectiveness of upadacitinib treatment in adult patients in a real-world setting with moderate-to-severe AD who had discontinued dupilumab due to poor effectiveness or adverse events and who were biologic naïve; therefore, previous treatments do not seem to affect the response to upadacitinib treatment.</p> </span>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":"19 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138688657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost Effectiveness of Tofacitinib for the Treatment of Active Ankylosing Spondylitis in Greece","authors":"","doi":"10.1007/s40261-023-01333-z","DOIUrl":"https://doi.org/10.1007/s40261-023-01333-z","url":null,"abstract":"<h3>Abstract</h3> <span> <h3>Background and Objective</h3> <p>Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece.</p> </span> <span> <h3>Methods</h3> <p>A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients’ quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty.</p> </span> <span> <h3>Results</h3> <p>In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations.</p> </span> <span> <h3>Conclusions</h3> <p>Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.</p> </span>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":"24 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138688648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lecanemab: More Questions Than Answers!","authors":"Upinder Kaur, Jaideep Reddy, Ashutosh Tiwari, Sasanka Chakrabarti, Sankha Shubhra Chakrabarti","doi":"10.1007/s40261-023-01331-1","DOIUrl":"https://doi.org/10.1007/s40261-023-01331-1","url":null,"abstract":"<p>The approval of lecanemab by the US Food and Drug Administration has been touted as a defining moment in the treatment of Alzheimer’s disease. Lecanemab, an anti-amyloid beta monoclonal antibody, is the first Alzheimer’s disease drug targeting amyloid beta that has shown statistically significant cognitive benefits in phase III trials. However, there have been many questions raised over the clinical relevance of the otherwise minimal cognitive improvements. Furthermore, its rapid approval has been mired in controversy, in addition to the reports of adverse events such as amyloid-related imaging abnormalities and several deaths of participants in the lecanemab trials. Here, we analyze the evidence supporting lecanemab as an amyloid beta therapy and also discuss the concerns raised about its efficacy and safety.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":"36 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631178","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}