Clinical therapeutics最新文献

{"title":"Impact of Changes to In-hospital Drug Formularies on Out-of-hospital Prescription Rates and Cost: A Systematic Review","authors":"Eduardo Carracedo-Martínez PhD ,&nbsp;Nuria Choren-Alvarez MSc ,&nbsp;Raquel Vázquez-Mourelle PhD ,&nbsp;Adolfo Figueiras PhD","doi":"10.1016/j.clinthera.2024.12.005","DOIUrl":"10.1016/j.clinthera.2024.12.005","url":null,"abstract":"<div><h3>Purpose</h3><div>One of the main goals of an in-hospital drug formulary (in-HDF) is to modulate hospitalized patients’ drug utilization. Theoretically, however, in-HDFs could also have an impact on out-of-hospital prescriptions in several ways, including discharged patients taking chronic medications that were initiated during hospitalization, hospital physicians prescribing to outpatients as if in-HDFs were equally applicable to the latter (“spillover effect”), and primary care physicians subsequently not changing such prescriptions (“induced prescription”). The aim of this study was thus to conduct a systematic review of papers that studied the impact of changes to in-HDF on out-of-hospital prescriptions.</div></div><div><h3>Methods</h3><div>We conducted a search of the PubMed and Embase databases. To be eligible for inclusion, studies had to be reported in English, Spanish, French, or Portuguese; as their designated aim, studies had to seek to evaluate the impact of a change in at least 1 active ingredient in the in-HDF on out-of-hospital prescriptions; and studies had to have at least 1 control period before the in-HDF change or a control group without any such change.</div></div><div><h3>Findings</h3><div>A total of 8 studies met the inclusion criteria: in 7 of these, out-of-hospital drug-utilization rates changed in line with the changes made to in-HDFs, with a decrease if the drug had been removed or restricted and an increase if the drug had been included and/or the opposite for competitor me-too medicines. Only 4 papers analyzed the impact on costs, half of which reported no statistically significant result.</div></div><div><h3>Implications</h3><div>Changes to in-HDFs have an impact on out-of-hospital prescription rates. Further studies are needed to examine the cost aspect since a research gap has been identified.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 219-225"},"PeriodicalIF":3.2,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913836","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 Persistence Among Anti-Tumor Necrosis Factor–experienced Patients With Ulcerative Colitis Switching to a Biologic With a Different Mode of Action or Cycling to Another Anti–Tumor Necrosis Factor Agent","authors":"Maryia Zhdanava MA ,&nbsp;Sabree Burbage PharmD, MPH ,&nbsp;Porpong Boonmak MD, MPHS, PhD ,&nbsp;Sumesh Kachroo PhD ,&nbsp;Aditi Shah MA ,&nbsp;Bridget Godwin MD ,&nbsp;Dominic Pilon MA","doi":"10.1016/j.clinthera.2024.12.002","DOIUrl":"10.1016/j.clinthera.2024.12.002","url":null,"abstract":"<div><h3>Purpose</h3><div>In ulcerative colitis (UC), anti–tumor necrosis factor (TNF) agents often are first-line biologic therapy. Switching to a biologic with a different mode of action (ustekinumab and vedolizumab) or cycling to another anti–TNF agent (adalimumab, infliximab, and golimumab) is necessary if an initial anti–TNF fails. This study compared real-world persistence in patients with UC who switched to a biologic with a different mode of action or cycled with another anti–TNF after nonresponse to an anti–TNF.</div></div><div><h3>Methods</h3><div>Adults with UC treated with an anti–TNF, who switched or cycled (index date) between October 21, 2019, and March 02, 2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti–TNF without UC-indicated biologics or advanced therapies. During the 12 months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti–TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on the index biologic was defined as no therapy exposure gaps &gt;120 days (ustekinumab, vedolizumab, and infliximab) or &gt;60 days (adalimumab and golimumab) between days of supply. Composite end points were persistence while corticosteroid-free (&lt;14 consecutive days of corticosteroid supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics/advanced therapies). End points were assessed with weighted Kaplan-Meier and Cox proportional hazards models 12 months after the maintenance phase started.</div></div><div><h3>Findings</h3><div>The switch cohort included 488 patients (mean age: 41.4 years; 44.9% female), and the cycle cohort included 129 patients (mean age: 40.7 years; 43.8% female). At 12 months after the maintenance phase started, the proportions of persistent patients (switch cohort: 79.6%; cycle cohort: 64.9%) and persistent patients on monotherapy (switch cohort: 74.6%; cycle cohort: 48.0%) were significantly higher in the switch versus cycle cohort; the proportions of persistent patients while corticosteroid-free was also higher in the switch (60.1%) versus cycle cohort (49.3%) but was not significant. In the switch cohort, the rate of persistence was 1.92 times higher (hazard ratio [HR] = 1.92; 95% CI, 1.31−2.82), the rate of persistence while on monotherapy was 2.56 times higher (HR = 2.56; 95% CI, 1.86−3.53), and the rate of persistence and being corticosteroid-free was 1.31 times higher (HR = 1.31; 95% CI, 0.98−1.77) than in the cycle cohort.</div></div><div><h3>Implications</h3><div>Patients with UC who switched from an anti–TNF agent to a biologic with a different mode of action were more persistent on treatment than patients who cycled to another anti–TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti–TNF agent.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 204-211"},"PeriodicalIF":3.2,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913839","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":"Amoxicillin Blood Concentration in High-Dose Intravenous Discontinuous Amoxicillin: Look Beyond Numbers. Max-Amox Study","authors":"Mélissa Clément MD ,&nbsp;Florence Anglade MD ,&nbsp;Lucie Gibold MD ,&nbsp;Delphine Martineau MSc ,&nbsp;Claude Dubray PhD ,&nbsp;Marc Ruivard PdD ,&nbsp;Marc André PhD ,&nbsp;Anne Tournadre PhD ,&nbsp;Guillaume Clerfond MD ,&nbsp;Etienne Geoffroy MD ,&nbsp;Xavier Moisset PhD ,&nbsp;Claire Dupuis MD ,&nbsp;Bruno Pereira MSc ,&nbsp;Damien Richard MD ,&nbsp;Magali Vidal MD","doi":"10.1016/j.clinthera.2024.12.003","DOIUrl":"10.1016/j.clinthera.2024.12.003","url":null,"abstract":"<div><h3>Purpose</h3><div>High doses of amoxicillin are recommended to treat severe infections such as endocarditis. Amoxicillin causes dose-dependent toxicities, in particular crystal nephropathy. Toxicity could be avoided by monitoring of amoxicillin trough plasma concentrations (ATPC). However, the relevance of ATPC testing in routine medical practice remains poorly studied.</div></div><div><h3>Methods</h3><div>We conducted a prospective clinical trial in adults treated with high doses of discontinuous intravenous amoxicillin in a French university hospital. The primary outcome was the distribution of ATPCs over three days during the first week of treatment. Urine tests for amoxicillin crystalluria (AC), pH, and density were also performed.</div></div><div><h3>Findings</h3><div>Seventy patients were included. Overall intra-class correlation (ICC) was 0.35 IC95% [0.21; 0.53] with the following pairwise concordances: D1-D4 (n= 55) 0.23 IC95% [-0.02; 0.47], D1-D7 (n= 47) 0.41 IC95% [0.19; 0.63], and D4-D7 (n= 50) 0.17 IC95% [-0.10; 0.43]. Inter-individual variability was also significant, with coefficients of variation being 0.87 at D1, 1.20 at D4, and 1.35 at D7. AC occurred in 32 patients (47.8%). Risk of AC increased when pH was below or equal to 6 (<em>P</em> = 0.002). ATPCs were higher in patients with AC and/or acute kidney injury.</div></div><div><h3>Implications</h3><div>Variability in ATPC was high and ATPC cannot be considered as the only monitoring tool to adjust amoxicillin dosage. High ATPC, low urinary pH, and presence of AC can alert physicians to a potential iatrogenic effect and lead to the decision to hydrate the patient, alkalinize urine and decrease the dosage of amoxicillin.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 212-218"},"PeriodicalIF":3.2,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142902622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polyneuropathy in Parkinson's Disease is Highly Prevalent and Not Related to Treatment","authors":"Valeria Sajin MD ,&nbsp;Uwe Jahnke MD ,&nbsp;Uazman Alam MPHe, FRCP(UK), PhD ,&nbsp;Antonella Macerollo MD, PhD, FRCP (London), FEBN","doi":"10.1016/j.clinthera.2024.12.004","DOIUrl":"10.1016/j.clinthera.2024.12.004","url":null,"abstract":"<div><h3>Purpose</h3><div>An increased prevalence of peripheral polyneuropathy (PN) in Parkinson's disease (PD) associated with greater functional impairment has previously been reported. A possible cause has been suggested as levodopa therapy. The aim of this real-world study was to assess the prevalence and the characteristics of PN in PD and to investigate the putative association between PN and oral levodopa.</div></div><div><h3>Methods</h3><div>A cohort of 692 consecutive patients with idiopathic PD had routine clinical, laboratory, and lower limb clinical neurophysiology assessment when attending the certified tertiary Parkinson center, Schön Klinik Neustadt, Neustadt in Holstein, Germany, between 2016 and 2019. Patients were sent by general neurologists for the medication adjustment, physiotherapy, ergotherapy, and logopaedic treatment. A retrospective cross-sectional review of the data was performed.</div></div><div><h3>Findings</h3><div>The mean age of the cohort was 72.6 (8.44) years (range, 44–90 years) and 60% were male. The age of the first PD manifestation was 65.22 (10.09) years (range, 31–88 years). Of 692 patients with PD, 507 (73.27%) had clinical signs of neuropathy and PN was first diagnosed 6.3 (5.7) years after the PD onset. Of these 507 patients, 446 (87.96%) underwent the electrophysiological investigations with PN confirmed in 396 patients (88.79% out of 446 electrophysiologically investigated patients with PD). Peripheral polyneuropathy was ruled out in 50 patients (11.21% of 446 electrophysiologically investigated patients with PD). The half of patients had moderate and severe sensory axonal PN (201 patients or 53.03% of all 396 with confirmed PN). The mean motor examination part of the Movement Disorders Society's Unified PD Rating Scale score in patients with PN was significantly higher (off, 30.48 [11.60] points; on, 19.92 [10.27] points), than in patients without PN (off, 27.17 [14.57] points; on, 17.14 [11.98] points), with <em>P</em> &lt; 0.01 in the both off and on states.</div><div>The mean levodopa daily dosage was similar in patients with PN and without PN (565 mg vs 556 mg, <em>P</em> = nonsignificant). No difference between other dopaminergic medication in PN and non-PN group was found.</div></div><div><h3>Implications</h3><div>PN is highly prevalent in patients with PD. There was no association between oral levodopa or other dopaminergic medication and PN. More awareness of PN in PD clinics and further understanding of the pathophysiology, which leads to the development of an axonal polyneuropathy in PD, are required.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages e13-e21"},"PeriodicalIF":3.2,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892674","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":"Comment on “Pancreatitis and Pancreatic Cancer Risk Among Patients With Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials”","authors":"Yuki Nakano PhD ,&nbsp;Kazuki Adachi B. Pharm ,&nbsp;Kazumasa Kotake B. Pharm","doi":"10.1016/j.clinthera.2024.08.021","DOIUrl":"10.1016/j.clinthera.2024.08.021","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Page 1086"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343082","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":"Toxic Epidermal Necrolysis Observed in a Patient With the HLA-B*1502 Treated With Levofloxacin","authors":"Xiufang Wang ,&nbsp;Gangying Cheng ,&nbsp;Xiaofang Liang ,&nbsp;Junhui Yang ,&nbsp;Aiping Deng ,&nbsp;Dan Chen ,&nbsp;Chao Liu ,&nbsp;Ying Gao ,&nbsp;Juyi Li","doi":"10.1016/j.clinthera.2024.09.014","DOIUrl":"10.1016/j.clinthera.2024.09.014","url":null,"abstract":"<div><h3>Purpose</h3><div>To determine the relationship between HLA-B gene mutations and levofloxacin-induced toxic epidermal necrolysis (TEN).</div></div><div><h3>Methods</h3><div>A 71-year-old Chinese woman developed TEN after oral administration of solifenacin (5 mg) and levofloxacin (0.5 g) for cystitis. HLA-B*5801 and HLA-B*1502 alleles were detected using real-time PCR.</div></div><div><h3>Findings</h3><div>After supportive therapy (antiallergic treatments, plasma exchange, etc) and withdrawal of the culprit medication levofloxacin, the patient was discharged with re-epithelialization of the exfoliated skin. The patient was HLA-B*1502 allele positive and HLA-B*5801 allele negative.</div></div><div><h3>Implications</h3><div>This is the first report of levofloxacin-induced TEN suspected to be caused by mutations in the HLA-B*1502 allele.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1082-1085"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364682","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":"Sex Differences in Testing for Pulmonary Embolism Among Emergency Department Patients Aged 18–49 by Chief Complaint","authors":"Angela F Jarman MD, MPH ,&nbsp;Brandon C Maughan MD, MSPS ,&nbsp;Richard White MD ,&nbsp;Sandra L Taylor PhD ,&nbsp;Zainab Akinjobi MS ,&nbsp;Bryn E Mumma MD, MAS","doi":"10.1016/j.clinthera.2024.10.008","DOIUrl":"10.1016/j.clinthera.2024.10.008","url":null,"abstract":"<div><h3>Background</h3><div>Women undergo diagnostic testing for pulmonary embolism (PE) in greater numbers than men, despite the disease incidence being higher in men overall. It is unknown if testing for PE varies based on patient chief complaint.</div></div><div><h3>Methods</h3><div>This retrospective cohort study was conducted at two academic tertiary care hospitals. Nonpregnant adult patients (aged 18–49 years) were included if they presented to the ED between 1/1/2016 and 12/31/2018 with nontraumatic mechanisms and any of the following chief complaints: chest pain, shortness of breath, hemoptysis, or syncope AND had objective testing for PE. Data were obtained from the electronic medical record and analyzed descriptively. Four outcome variables were assessed: receipt of D-dimer testing, D-dimer positivity, receipt of pulmonary vascular imaging, and diagnosis of PE.</div></div><div><h3>Results</h3><div>We studied 1,991 unique patient encounters, most of whom (63%; 1,256/1,991) were female. Overall, female patients had higher odds of receiving D-dimer testing than male patients (OR 1.30, CI 1.06–1.59, <em>P</em> = 0.015), while they had lower odds of being diagnosed with PE (OR 0.57, CI 0.36–0.90, <em>P</em> = 0.019). However, this trend varied by chief complaint. Among patients with chest pain, females had higher odds of having a D-dimer performed (OR 1.35, CI 1.01–1.80, <em>P</em> = 0.049) and lower odds of being diagnosed with PE (OR 0.36, CI 0.18–0.70, <em>P</em> = 0.003) than males.</div></div><div><h3>Conclusions</h3><div>Both patient sex and chief complaint were associated with trends in diagnostic testing for PE. Among patients with chest pain, females are significantly more likely to be tested with a D-dimer and less likely to be diagnosed with PE.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 995-1000"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616379","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 Evolving Roles of Sex and Gender in Acute Care Medicine","authors":"Angela F. Jarman MD, MPH ,&nbsp;Sarah M. Perman MD, MSCE","doi":"10.1016/j.clinthera.2024.11.001","DOIUrl":"10.1016/j.clinthera.2024.11.001","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 943-944"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750283","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":"Impact of Preliminary Bronchodilator Dose in Chronic Obstructive Pulmonary Disease Patients With Suboptimal Peak Inspiratory Flow","authors":"Mohamed Ismail Hassan ,&nbsp;Nabila Ibrahim Laz PhD ,&nbsp;Yasmin M. Madney PhD ,&nbsp;Mohamed E.A. Abdelrahim PhD ,&nbsp;Hadeer S. Harb PhD","doi":"10.1016/j.clinthera.2024.09.016","DOIUrl":"10.1016/j.clinthera.2024.09.016","url":null,"abstract":"<div><h3>Purpose</h3><div>Suboptimal peak inspiratory flow rate (PIFR) is highly prevalent in patients with chronic obstructive pulmonary disease (COPD) owing to the mismatch of their PIFR with the corresponding inhaler-device resistance. This study aimed to investigate the impact of a preliminary dose of pressurized metered dose inhalers (pMDIs) on patients with COPD with suboptimal PIFR using Diskus dry powder inhalers (DPIs).</div></div><div><h3>Methods</h3><div>A prospective, randomized, case–control study included 24 patients with COPD. PIFR was measured using the In-Check Dial G16 with low-to-medium resistance. Spirodoc was used to measure baseline spirometric data and compare it before and 30 minutes after the administration of Diskus DPI. On a different day, the study dose was given to each suboptimal patient by the same aerosol generator with preceded 2 puffs of salbutamol pMDI and re-evaluated for spirometric parameters 30 minutes after the study dose.</div></div><div><h3>Findings</h3><div>There was a significant difference between the optimal and suboptimal groups in peak expiratory flow (2.38 ± 1.20 vs 1.49 ± 1.06 L/s, <em>P</em> = 0.050). PIFR showed a statistically significant difference between the optimal and suboptimal groups (71.66 ± 6.15 vs 41.25 ± 9.79 L/min, <em>P</em> &lt; 0.0001). There was a significant difference in forced vital capacity (ΔFVC) between optimal and suboptimal groups without a preliminary dose (0.42 ± 0.21 vs 0.16 ± 0.11 L, <em>P</em> = 0.002), forced expiratory volume in 6 seconds (ΔFEV₆) (0.53 ± 0.49 vs 0.17 ± 0.11 L, <em>P</em> = 0.022), forced expiratory volume in 3 seconds (ΔFEV₃) (0.41 ± 0.38 vs 0.1 ± 0.16 L, <em>P</em> = 0.013), forced expiratory volume in 1 second (ΔFEV₁)/FVC (−2.38 ± 8.41 vs 2.96% ± 2.95%, <em>P</em> = 0.033), and ΔFEV₁/FEV₆ (−4.32 ± 11.23 vs 2.91% ± 4.35%, <em>P</em> = 0.015). There was a significant difference in ΔFVC between optimal and suboptimal groups with a preliminary dose (0.42 ± 0.21 vs 0.23 ± 0.18 L, <em>P</em> = 0.046), ΔFEV₁/FVC (−2.38 ± 8.41 vs 5.67% ± 6.53%, <em>P</em> = 0.009), ΔFEV₁/FEV₆ (−4.32 ± 11.23 vs 5.16% ± 4.99%, <em>P</em> = 0.008), and forced expiratory time (ΔFET) (0.28 ± 0.45 vs −0.31 ± 0.70 seconds, <em>P</em> = 0.022). The only parameter that showed a significant difference between suboptimal groups without and with a preliminary dose is Δ peak expiratory flow (0.24 ± 0.59 vs 0.65 ± 0.68 L/s, <em>P</em> = 0.004).</div></div><div><h3>Implications</h3><div>Administering a preliminary dose of pMDI can minimally enhance the effectiveness of DPIs in patients with COPD with suboptimal PIFR and health outcomes.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages e16-e24"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364679","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 Use of Mogamulizumab Among Patients With Mycosis Fungoides and Sézary Syndrome Before and During COVID-19 in the United States","authors":"Chunlan Chang PhD ,&nbsp;Robert Ristuccia PhD ,&nbsp;Zhishui Zheng MS ,&nbsp;Takeshi Takahashi PhD ,&nbsp;Takanobu Nomura PhD ,&nbsp;Eslie Dennis MD","doi":"10.1016/j.clinthera.2024.09.011","DOIUrl":"10.1016/j.clinthera.2024.09.011","url":null,"abstract":"<div><h3>Purpose</h3><div>During the coronavirus disease 2019 (COVID-19) pandemic, professional organizations suggested extending dosing intervals for systemic cancer therapies to limit in-person visits. Mogamulizumab, indicated for adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after ≥1 prior systemic therapy, should be administered every 7 days of the first 28-day cycle (loading) and every 14 days of each subsequent cycle (maintenance) according to the approved prescribing information in the United States (US). This study examined the real-world use of mogamulizumab before and during the COVID-19 pandemic in the US.</div></div><div><h3>Methods</h3><div>Using Symphony Health's Integrated Dataverse (IDV) database, adults with ≥1 diagnosis of MF or SS and ≥1 mogamulizumab claim between October 1, 2018 and December 22-, 2022 were identified. Patients in MF and SS cohorts were divided into 3 subgroups based on the date they initiated mogamulizumab treatment: pre-COVID-19 (October 1, 2018–March 31, 2020), COVID-19 Phase 1 (April 1, 2020–July 31, 2021), and COVID- 19 Phase 2 (August 1, 2021–December 22, 2022).</div></div><div><h3>Findings</h3><div>During the study, 270 patients with MF and 337 patients with SS initiated mogamulizumab. The pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups included 95, 81, and 94 patients with MF and 124, 119, and 94 patients with SS, respectively. In the MF cohort, mean loading dosing intervals were 13, 12, and 9 days for the pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups, respectively, and mean maintenance dosing intervals were 16, 16, and 16 days, respectively. In the SS cohort, mean loading dosing intervals were 16, 11, and 11 days, and mean maintenance dosing intervals were 19, 18, and 16 days, respectively. For both cohorts, more patients in the COVID-19 Phase 1 and Phase 2 subgroups than in the pre-COVID-19 subgroup had gaps of ≤10 days between loading doses and ≤21 days between maintenance doses.</div></div><div><h3>Implications</h3><div>In patients with MF and SS, loading dosing intervals in the pre-COVID-19 period were longer than the loading schedule per the approved prescribing information, but there was a trend towards closer concordance in the COVID-19 periods. Maintenance dosing intervals in patients with MF were consistently similar to the approved schedule across treatment periods, and in patients with SS became more closely aligned over time. Thus, dosing intervals for mogamulizumab in both loading and maintenance cycles do not appear to have been extended during the COVID-19 Phase 1 and Phase 2 periods compared with the pre-COVID-19 period, despite recommendations to extend dosing intervals for systemic cancer therapies during COVID-19.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 1024-1033"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}