Clinical therapeutics最新文献

{"title":"Early Feasibility Studies for Medical Devices: Goldmine or Fool's Gold?","authors":"Giuditta Callea, Carlo Federici","doi":"10.1016/j.clinthera.2026.10.003","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.10.003","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149294916","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":"Real-World Dose Titration Patterns Across Age Groups in Patients Treated With Delayed-Release/Extended-Release Methylphenidate in the United States.","authors":"Ryan Gregg, Karl Weddige, Jordyn Stuart, Vamshi Ruthwik Anupindi, Swapna Munnangi, Mitch DeKoven, Randy Sallee","doi":"10.1016/j.clinthera.2026.09.013","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.013","url":null,"abstract":"<p><strong>Purpose: </strong>Delayed-release/extended-release methylphenidate (DR/ER-MPH) (JORNAY PM®; formerly HLD 200) is the first evening-dosed formulation of MPH approved for individuals ≥6 years with attention-deficit/hyperactivity disorder (ADHD). Designed for colonic absorption, DR/ER-MPH is expected to provide symptom control upon awakening, throughout the day, and into the evening. While clinical trials have established its efficacy in children aged 6-12 years, less is known about how this medication is titrated and maintained in real-world practice, particularly among adolescents and adults. This study aimed to characterize real-world titration and maintenance dosing patterns of DR/ER-MPH across age groups.</p><p><strong>Methods: </strong>This retrospective observational study analyzed prescribing patterns using linked IQVIA's U.S. professional fee claims and prescription claims databases. Patients aged ≥4 years who initiated DR/ER-MPH between July 2019 and August 2022 were included if they had at least 6 months of baseline data and 12 months of follow-up. Dosing trends were evaluated for each prescription fill among patients with at least four prescription fills and the maintenance dose was defined as two consecutive prescriptions of the same dose. Analyses were descriptive in nature.</p><p><strong>Findings: </strong>Among 2,831 eligible patients (mean age: 18.3 years; 58% male), the average titrating dose at initiation was 33.2 mg, with 60% of patients initiating treatment at 20 mg. By the fourth prescription, the average titrating dose increased to 49.4 mg, reflecting gradual upward titration over time. Maintenance dose, was achieved by 99% of patients, with higher average maintenance doses in adults (61.4 mg) compared to children and adolescents (51.8 mg).</p><p><strong>Implications: </strong>Findings from this study highlight real-world titration patterns that differ from those observed in clinical trials, with more conservative up-titration and stabilization at lower doses. Importantly, this is the first large-scale analysis to include adult patients, expanding the evidence base for DR/ER-MPH use across age groups. Further research is warranted to assess how these real-world dosing patterns influence treatment outcomes and functional improvement in patients with ADHD.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149285655","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":"Postmarketing reporting profile of mirikizumab in ulcerative colitis: a disproportionality analysis of FAERS reports.","authors":"Yongli Jin, Yan Jin, Yan Cui","doi":"10.1016/j.clinthera.2026.09.006","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.006","url":null,"abstract":"<p><strong>Purpose: </strong>Mirikizumab was approved for ulcerative colitis (UC) in 2023, and its early postmarketing reporting pattern remains incompletely characterized. We described indication-restricted reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS) and evaluated signals of disproportionate reporting (SDRs), while distinguishing established reactions from sparse, hypothesis-generating observations.</p><p><strong>Methods: </strong>Standardized FAERS data were queried for 2023Q1 through 2025Q4. Reports containing an exact mirikizumab or OMVOH name mapping as the primary-suspect drug and a UC indication term were included. System organ class (SOC) frequencies were counted once per report; preferred-term (PT) disproportionality used 299,281 UC reaction records as the disease-specific background. The reporting odds ratio (ROR) was the primary measure; proportional reporting ratio, empirical Bayes geometric mean, and information component were supportive measures. Bonferroni correction covered 338 PTs. Exploratory report-level subgroup comparisons and time-to-onset (TTO) analyses were also performed.</p><p><strong>Findings: </strong>The cohort contained 408 reports; 402 (98.5%) were submitted in 2024 to 2025, 377 (92.4%) were from consumers, and 223 (54.7%) were classified as serious. The leading SOCs were general disorders and administration site conditions (138 reports) and gastrointestinal disorders (110). Injection site pain had the largest count and ROR among the displayed PTs (n = 46; ROR = 29.47; 95% CI, 21.66-40.10). Six of the 15 displayed PTs had Bonferroni-adjusted P < 0.05: injection site pain, maternal exposure during pregnancy, injection site bruising, pulmonary embolism, spontaneous abortion, and flushing. Most nonadministration-site findings were based on fewer than 10 reports. No age- or sex-based PT difference survived multiplicity correction; injection site pain and arthralgia differed by report seriousness. TTO was evaluable in 83/408 reports (20.3%); the median was 34 days (IQR, 12-68.5), and 71/83 (85.5%) occurred within 90 days.</p><p><strong>Implications: </strong>Injection site pain, arthralgia, headache, and rash were concordant with labeled or trial-observed reactions. Venous thromboembolic and pregnancy-related findings were sparse and confounded; maternal exposure during pregnancy is an exposure circumstance, not an adverse event. These SDRs cannot establish causality, incidence, or comparative safety. The TTO pattern applies only to reports with complete dates and a positive interval. The findings warrant continued surveillance and validation in clinically adjudicated, denominator-based studies.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149285652","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":"Real-World Safety Profile of Mirvetuximab Soravtansine: A Population-Based Pharmacovigilance Study Leveraging FAERS and EudraVigilance Databases.","authors":"Zhiwei Cui, Ping Song, De Xie, Fan Zou, Yingge Ao, Yuyang Cui, Gongming Dong, Zhen Zhai","doi":"10.1016/j.clinthera.2026.09.015","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.015","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Purpose: &lt;/strong&gt;Mirvetuximab soravtansine (MIRV) is the first FDA-approved antibody-drug conjugate targeting folate receptor-α (FRα)-positive platinum-resistant ovarian cancer. Despite its clinical adoption, comprehensive post-marketing real-world evidence regarding its safety profile remains limited. This study aimed to systematically characterize the adverse event (AE) profile of MIRV in real-world settings and to identify potential safety signals using large-scale pharmacovigilance databases.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A retrospective pharmacovigilance analysis was conducted using adverse event reports from the FDA Adverse Event Reporting System (FAERS, 2022-2025). We excluded all reports submitted for male patients. Safety signals were assessed at the system organ class (SOC), standardized MedDRA query (SMQ), and preferred term (PT) levels. Disproportionality analyses were performed using 4 algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Time-to-onset (TTO) analysis was conducted to evaluate onset patterns. External validation was performed using the EudraVigilance database.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;A total of 1,249 MIRV-related reports corresponding to 2,577 AEs were identified in FAERS. At the SOC level, eye disorders were the most frequently reported AEs (n = 593) and demonstrated the strongest disproportionality signal (ROR: 13.79, 95% CI: 12.58-15.12). At the PT level, the 3 most frequently reported AEs were vision blurred (n = 97), neuropathy peripheral (n = 95), and cataract (n = 75). Among detected safety signals, the strongest disproportionality signals (ranked by IC025 value) were observed for keratitis (ROR: 390.64, PRR: 383.08, EBGM05: 269.06, IC025: 5.06), keratopathy (ROR: 487.9, PRR: 479.78, EBGM05: 323.68, IC025: 4.87), and pneumonitis (ROR: 56.93, PRR: 55.37, EBGM05: 43.35, IC0254.64). Overall, 44 positive PT-level signals were identified. Common labeled AEs included blurred vision, peripheral neuropathy, cataract, diarrhoea, and abdominal pain. Potentially novel (unlabeled) signals included blindness, colitis, pulmonary fibrosis, glaucoma, intestinal perforation, and astigmatism. Time-to-onset analysis showed that 42.9% of AEs occurred within the first month after treatment initiation, indicating an early-onset pattern. In the EudraVigilance database, 527 MIRV-related reports were identified. At the SOC level, eye disorders again demonstrated the strongest disproportionality signal, consistent with the findings from FAERS. At the PT level, the most frequently reported AEs were pneumonitis (n = 47), peripheral neuropathy (n = 45), and vision blurred (n = 43), whereas keratitis, keratopathy, and pneumonitis exhibited the strongest disproportionality signals. A total of 29 overlapping positive signals were identified between FAERS and EudraVigilance, further supporting the r","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149285661","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 First Notes of Injury: Biomarkers of Aminoglycoside Nephrotoxicity in Young CF Patients (PIANO-CF) Compared to Healthy Controls.","authors":"Courtney B Munro, Elena K Schneider-Futschik, Catherine Quinlan, Sarath Ranganathan","doi":"10.1016/j.clinthera.2026.09.010","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.010","url":null,"abstract":"<p><strong>Purpose: </strong>People with CF (pwCF) have historically been treated often and with prolonged intravenous aminoglycosides courses, which are known to cause nephrotoxicity. Despite this, kidney impairment in pwCF is often under-recognised, in part due to limitations of traditional serum markers such as creatinine. This study aimed to explore the utility of urinary biomarkers in detecting aminoglycoside-induced nephrotoxicity in pwCF, and to compare biomarker profiles with healthy children.</p><p><strong>Methods: </strong>In the PIANO-CF study we evaluated renal biomarkers in three groups: (A) children with cystic fibrosis aged 0 to less than 7 years receiving intravenous aminoglycoside, (B) clinically stable children with cystic fibrosis not receiving intravenous aminoglycoside, and (C) age-matched healthy controls (HC). A total of 29 pwCF were prospectively recruited during hospital admissions for intravenous aminoglycoside, and 65 pwCF provided urine samples from a biobank. We also recruited 269 healthy children. To compare biomarkers between groups, we used a generalised estimating equation.</p><p><strong>Findings: </strong>Children with cystic fibrosis had significantly lower urinary kidney injury molecule-1 (uKIM-1; 126.7 pg/mL lower) and urinary neutrophil gelatinase-associated lipocalin (uNGAL; 7.07 ng/mL lower) than healthy controls (HC). For pwCF receiving intravenous aminoglycosides, uKIM-1 and uNGAL increased 1.9-fold and 2.05-fold respectively, despite stable serum creatinine (sCr); however, only three children (10%) met pRIFLE criteria for acute kidney injury (AKI), precluding formal assessment of biomarker sensitivity or specificity for AKI detection. No correlation was found between serum and urinary biomarker levels. No association was found between prior aminoglycoside exposure and uKIM-1 levels.</p><p><strong>Implications: </strong>These exploratory findings reveal a distinct urinary biomarker signature in children with cystic fibrosis compared to healthy controls, and demonstrate that uKIM-1 and uNGAL increase with intravenous aminoglycoside exposure despite stable sCr. These observations support the need to establish CF-specific biomarker reference ranges and to design adequately powered prospective studies to formally assess the utility of these biomarkers in detecting aminoglycoside-induced nephrotoxicity.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149285726","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":"Treatment Patterns and Change in Pain Medication Utilization in Pediatric Patients Treated With Selumetinib: A US Claims Database Analysis.","authors":"Genevieve Lyons, Julia Meade, Theresa Dettling, Michelle Erdmann, Benjamin Guikema, Ayo Adeyemi","doi":"10.1016/j.clinthera.2026.09.003","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.003","url":null,"abstract":"<p><strong>Purpose: </strong>Selumetinib first received US FDA approval on April 10, 2020, for treatment of pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN). This noninterventional, retrospective cohort study evaluated selumetinib treatment patterns and pain medication utilization in pediatric patients.</p><p><strong>Methods: </strong>Merative MarketScan Research Databases were used to identify patients aged 2-18 years with ≥2 selumetinib prescription fills. Eligible patients had continuous enrollment 6-months prior to and following the first selumetinib prescription claim (index). Proportion of days covered (PDC; days covered/days in follow-up) was assessed to evaluate adherence (PDC ≥80%). Time to discontinuation and time to reinitiation of selumetinib (≥84 days post-discontinuation) were determined. Prescription pain medication utilization was assessed pre- and post-initiation.</p><p><strong>Findings: </strong>Median (IQR) age was 13.0 (8.0-15.0) years, N = 89. Mean PDC was 83.5%, and patient adherence was 69.7%. At 6-months postindex, the probability of persistence was 85.4% (median time to discontinuation: 2.25 years). Approximately 20% of patients who discontinued treatment later reinitiated. Pain medication decreased marginally postindex (adjusted odds ratio [OR]: 0.62; 95% confidence interval [CI]: 0.30-1.28). In selumetinib-adherent patients (n = 62), utilization decreased (adjusted OR: 0.46; 95% CI: 0.18-1.16); there was no difference in utilization for nonadherent patients postindex (adjusted OR: 1.00; 95% CI: 0.30-3.37).</p><p><strong>Implications: </strong>Most pediatric patients adhered to selumetinib and persisted with treatment for ≥6 months. There was a small reduction in pain medication utilization 6-months post-selumetinib initiation.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149263732","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":"Evaluation of Inpatient Epoetin Alfa Dosing in Patients With Anemia of Chronic Kidney Disease: A Retrospective Cohort Study.","authors":"Rita Elhamra, Timothy Streck, Tomona Iso, Lisa T Hong","doi":"10.1016/j.clinthera.2026.10.001","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.10.001","url":null,"abstract":"<p><strong>Purpose: </strong>Epoetin alfa labeling and clinical guidelines recommend weight-based dosing for the management of patients with anemia and chronic kidney disease (CKD). However, fixed dosing continues to be used in inpatient practice, and comparative data in hospitalized populations are limited. This study aimed to compare fixed versus weight-based dosing in hospitalized patients with CKD.</p><p><strong>Methods: </strong>This retrospective cohort study included hospitalized adult patients with anemia of CKD who were initiated on epoetin alfa at a large academic medical center between January 2014 and August 2024. The primary outcome was hemoglobin exceeding targets (>10 g/dL for non-dialysis-dependent CKD and >11 g/dL for dialysis-dependent CKD). Secondary outcomes included 90-day all-cause mortality, rehospitalization, major adverse cardiovascular events, packed red blood cell transfusion, new or worsening hypertension, and iron deficiency.</p><p><strong>Findings: </strong>Among 100 patients (50 in the fixed-dose group and 50 in the weight-based dose group), hemoglobin exceeded targets in 8% and 4% of patients, respectively (P = 0.678). Ninety-day all-cause mortality occurred in 18% and 4% of patients, respectively (P = 0.160); no statistically significant differences were observed in other secondary outcomes. Fixed-dose regimens resulted in higher weight-normalized epoetin alfa doses than weight-based dosing (119.8 vs 67.1 units/kg; P < 0.001).</p><p><strong>Implications: </strong>Among hospitalized patients with CKD, fixed-dose epoetin alfa was associated with substantially higher weight-normalized doses and numerically higher rates of hemoglobin exceeding targets and mortality, though differences in clinical outcomes were not statistically significant. These findings suggest that adherence to guideline-recommended weight-based dosing may minimize excessive epoetin alfa dosing. Larger prospective studies are needed to clarify optimal inpatient erythropoiesis-stimulating agent dosing.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149223469","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":"Time-matched Secondary Fracture Prevention in Older Adults: A Narrative Review of Imminent Risk, Time-to-Benefit, and Treatment Sequencing.","authors":"Zudong Huang, Dongbiao Ren, Dongdong Xu","doi":"10.1016/j.clinthera.2026.09.014","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.014","url":null,"abstract":"<p><strong>Purpose: </strong>After a fragility fracture, subsequent fracture risk is highest during the first 6 to 12 months and remains elevated for 1 to 2 years. Anti-osteoporosis therapies differ in onset, persistence, discontinuation kinetics, and safety constraints, yet guidelines rarely operationalize treatment timing within this imminent-risk period. This narrative review examines temporal mismatch between post-fracture risk and treatment effect and proposes a time-matched secondary fracture prevention framework.</p><p><strong>Methods: </strong>We conducted an argument-driven narrative review using a structured, non-systematic search of PubMed/MEDLINE and Google Scholar from January 2000 through July 26, 2026. English-language guidelines, pivotal randomized trials, systematic reviews/meta-analyses, and implementation or health-services studies relevant to secondary fracture prevention were included, with priority given to 2024 to 2026 publications. Selection was purposive; no formal risk-of-bias assessment or pooled statistical analysis was performed.</p><p><strong>Findings: </strong>The evidence base comprised 103 publications and one trial-registry record. Subsequent fractures consistently clustered within the first 12 to 24 months after an index fracture. A pooled meta-analysis of bisphosphonate trials in postmenopausal osteoporosis estimated 12.4 months (95% CI, 6.3 to 18.4 months) to prevent one nonvertebral fracture per 100 treated women; this population-level estimate is not a drug-specific onset threshold and was not derived specifically from recent-fracture patients. Several injectable antiresorptive and bone-forming therapies show early fracture-risk reduction in pivotal trials, but treatment choice must remain safety qualified. In particular, romosozumab requires cardiovascular risk assessment because of the imbalance in serious cardiovascular events observed in ARCH and current labeling restrictions. Rare medication-related osteonecrosis of the jaw and denosumab-associated hypocalcemia in advanced chronic kidney disease are additional counseling and monitoring considerations. Treatment cessation is also time-sensitive, especially for denosumab because delayed dosing or discontinuation without follow-on therapy can lead to rebound bone turnover and vertebral fractures.</p><p><strong>Implications: </strong>Secondary fracture prevention may be improved by initiating appropriate therapy promptly after the index fracture, matching treatment characteristics to the period of highest risk, planning sequential therapy from the outset, and minimizing delivery delays. The framework is hypothesis-generating and should not override drug-specific contraindications, local labeling, or individualized benefit-risk assessment. Prospective studies should test whether explicitly time-matched care reduces early re-fracture compared with conventional risk-stratified treatment.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149223496","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":"First Oral Carbapenem Comes to the United States, a Mixed Blessing.","authors":"Stephanie Pisciella, Nicholas G Guerina","doi":"10.1016/j.clinthera.2026.09.012","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.012","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149206682","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":"Relapse After Dupilumab Discontinuation in Pediatric Moderate-to-Severe Atopic Dermatitis: A Single-Center Retrospective Study From China.","authors":"Lu Qin, Xin-Qin Feng, Jin-Ling Liu, Lei Wu, Xiang-Zhi Wang, Lan-Fang Tang","doi":"10.1016/j.clinthera.2026.09.009","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.09.009","url":null,"abstract":"<p><strong>Purpose: </strong>Dupilumab has been demonstrated to be an effective and safe treatment for atopic dermatitis (AD) in pediatric patients in clinical trials. However, data on postdiscontinuation relapse are scarce. This study aimed to describe relapse patterns and explore factors associated with relapse after dupilumab discontinuation in pediatric patients with moderate-to-severe AD.</p><p><strong>Methods: </strong>This retrospective study included 37 children treated with dupilumab for at least 16 weeks. Of these, 35 discontinued dupilumab and entered postdiscontinuation follow-up through May 2025. Relapse-free survival was evaluated using the Kaplan-Meier method. A prespecified exploratory Cox model including age at AD onset and baseline absolute eosinophil count was fitted using complete cases. An exploratory logistic regression analysis was reported separately as a supplementary analysis.</p><p><strong>Findings: </strong>Among the 35 patients who entered postdiscontinuation follow-up, 27 (77.1%) experienced relapse. The overall median relapse-free survival time was 150 days (95% CI, 120-240 days). No statistically significant difference was observed between dupilumab monotherapy and dupilumab plus subcutaneous immunotherapy (log-rank P = 0.709). In the prespecified two-variable Cox model, the estimated relapse hazards were lower with later age at AD onset (HR = 0.76; 95% CI, 0.54-1.07; P = 0.115) and higher baseline eosinophil count (HR = 0.39; 95% CI, 0.13-1.18; P = 0.094), but neither association reached statistical significance.</p><p><strong>Implications: </strong>Relapse was common after dupilumab discontinuation in this small retrospective cohort. The directions of the Cox estimates suggest that age at AD onset and baseline eosinophil count may warrant further investigation, but the current data do not establish either variable as a predictor of relapse. Larger prospective studies are required.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179883","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}