Drugs - Real World Outcomes最新文献

{"title":"Residual Depressive Symptoms in Treatment-Resistant Bipolar Depression Following Short-Term Ketamine Administration.","authors":"Michał Pastuszak, Wiesław Jerzy Cubała, Aleksander Kwaśny","doi":"10.1007/s40801-024-00453-y","DOIUrl":"https://doi.org/10.1007/s40801-024-00453-y","url":null,"abstract":"<p><strong>Background: </strong>Residual symptoms are frequently observed in a significant number of patients with depression, indicating an unmet need for effective management strategies to achieve functional recovery.</p><p><strong>Objective: </strong>This observational study aimed to evaluate the impact of ketamine infusions on depressive symptoms in patients with bipolar disorder who continued their baseline psychotropic and chronic somatic treatments.</p><p><strong>Methods: </strong>Datasets of the two consecutive real-world registries (NCT04226963 for 2019-2022; NCT05565352 from 2023 onward) for the tertiary reference center for psychiatry at the Medical University of Gdańsk (Poland) for the safety and tolerability of ketamine use in mood and anxiety disorders were retrospectively analyzed. Depressive symptoms were assessed using the Inventory of Depressive Symptomatology Self-Report 30 (IDS-SR30). Residual symptoms were identified in patients who achieved a treatment response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to the seventh infusion.</p><p><strong>Results: </strong>Overall, 14 out of 22 patients met the criteria for response. The most commonly persistent depressive symptoms included sad mood (85.7%), view of my future (78.6%), difficulty falling asleep, and leaden paralysis/physical energy (both 71.4%), with the most severe being difficulty falling asleep (64.3%) and sad mood (42.9%).</p><p><strong>Conclusions: </strong>This observational post hoc analysis indicates that the most frequently observed residual depressive symptoms were low mood, altered view of future, sleep disturbances, and low energy levels. This study should be treated with caution as causality does not apply, however, it reports on a real-world population of subjects with treatment-resistant bipolar depression. Establishing standardized definitions for residual symptoms could enhance the quality and comparability of future research in this area.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282012","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 Evidence of User Experience with Microenemas for Relief of Constipation.","authors":"Stefanie Rasche, Christer Spegel, Katarina Lundh","doi":"10.1007/s40801-024-00444-z","DOIUrl":"https://doi.org/10.1007/s40801-024-00444-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Constipation is a commonly reported gastrointestinal complaint. Research on this widespread condition focuses mainly on clinical trials for chronic constipation with less emphasis on patient experience and nonchronic situations. Sufferers report that constipation interferes with daily activities and quality of life. It is likely that this is common among all sufferers of constipation, regardless of how often the condition is experienced.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This work explored attitudes and perceptions of people who experience occasional constipation and self-treat with over the counter products, particularly Microlax&lt;sup&gt;®&lt;/sup&gt; microenemas.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this retrospective study, real-world data were collected from 1635 respondents from France and Russia who experienced occasional constipation. Participants completed a questionnaire about their experiences with occasional (not chronic) constipation and perceptions of over the counter treatments of oral laxatives, suppositories, and Microlax microenemas. Questions focused on comfort, quality of life, ease of use, and reliability of these treatments. Participants had used the microenema for treatment of occasional constipation within 3 months of study participation. Occasional constipation was based on the Rome IV diagnostic criteria for adults and babies. Data were analyzed across the total population of all groups, then by subgroup. Success criteria were defined as of at least 70% agreement with the statements scoring ≥ 7 on the scale of 0-10. The proportion of respondents agreeing with the individual statements was calculated using the denominator for the total sample within each group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study shows that experiencing even occasional bouts of constipation negatively affect quality of life and well-being. Participants (women aged 25-54 years, older men, and women aged 60-80 years) reported that it severely limited daily life and activities and caused negative emotions and embarrassment. Pregnant women and mothers with babies showed great concern that constipation indicated a serious and painful condition and was bad for their babies. Participants agreed that using Microlax microenema provided greater ease of use, comfort, reliability, and safety than oral laxatives and rectal suppositories.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Sufferers of occasional constipation report that these bouts interfere with their daily lives and reduce quality of life, similar to what is reported for those with chronic constipation based on existing literature. The microenema, Microlax, showed benefits in the relief of occasional constipation compared with oral laxatives and rectal suppositories. Trepidation about using the microenema, experienced before using it, was greatly reduced after the first and subsequent uses. Microlax microenema enabled users to regain the feeling of control and provided positive impacts on ","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153432","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":"Prescription Patterns of Inducers and Inhibitors of Cytochrome P450 and Their Potential Drug Interactions in the Real World: A Cross-Sectional Study.","authors":"Luis Fernando Valladales-Restrepo, Juan Alberto Ospina-Cano, Brayan Stiven Aristizábal-Carmona, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-024-00450-1","DOIUrl":"https://doi.org/10.1007/s40801-024-00450-1","url":null,"abstract":"<p><strong>Introduction: </strong>Both the induction and inhibition of cytochrome P450 are associated with multiple pharmacological interactions, which can lead to loss of efficacy or increase the risk of adverse drug reactions.</p><p><strong>Objective: </strong>The aim was to determine the prescription patterns of cytochrome P450-inducing and -inhibiting drugs and their contraindicated and major pharmacological interactions in a group of patients from Colombia.</p><p><strong>Methods: </strong>This cross-sectional observational study included patients who received drugs that induce or inhibit metabolism and examined their contraindicated and major pharmacological interactions. The patients were identified from a population-based database of drug dispensing. Patients were included between December 1 and December 31, 2021. Inhibitors and inducers of cytochrome P450 were classified based on FDA (Food and Drug Administration) guidelines. Drug interactions were identified using the Micromedex® database. Descriptive, bivariate and multivariable analysis was performed.</p><p><strong>Results: </strong>A total of 63,433 patients were analyzed. Antiseizure medications (35.9%) and antifungals (27.6%) were the most used inducers and inhibitors. A total of 30.1% of patients had potential contraindicated or greater interactions. The following factors were associated with a higher probability of presenting a potential pharmacological interaction: being male (OR 1.14; 95% CI 1.10-1.19), aged 18-39 years (OR 1.77; 95% CI 1.67-1.89) or 40-64 years (OR 1.64; 95% CI 1.56-1.72), having neurological diseases (OR 1.28; 95% CI 1.21-1.35), having psychiatric diseases (OR 3.84; 95% CI 3.58-4.13), having rheumatologic diseases (OR 1.32; 95% CI 1.23-1.41), receiving comedications with statins (OR 1.14; 95% CI 1.08-1.19), receiving comedications with analgesics (OR 1.33; 95% CI 1.27-1.38), receiving comedications with antiparasitics (OR 2.88; 95% CI 2.66-3.11) and an increase in the number of medications (OR 1.24; 95% CI 1.23-1.25).</p><p><strong>Conclusion: </strong>Among the users of cytochrome P450 inhibitors and inducers, potential contraindications and greater interactions are very common, especially in men under 65 years of age with comorbidities and polypharmacy.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145386","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":"Prescribing Cascades of Loop Diuretics and Anti-vertigo Drugs Following Treatment with Gabapentinoids and Benzodiazepines: Prescription Sequence Symmetry Analysis of a Large-Scale Claims Database Including Japanese Older Adults.","authors":"Rina Omata, Akane Asami, Azusa Hara, Hisashi Urushihara","doi":"10.1007/s40801-024-00446-x","DOIUrl":"10.1007/s40801-024-00446-x","url":null,"abstract":"<p><strong>Background: </strong>Gabapentinoids (GBP) and benzodiazepines (BZ) are commonly prescribed in older adults and their package inserts list edema and vertigo as adverse drug reactions. These adverse drug reactions may be treated with symptomatic drug therapies without discontinuing the culprit drugs or decreasing their dose, thereby initiating a prescribing cascade and often resulting in polypharmacy. Whether prescribing cascades occur in the treatment of edema and dizziness among Japanese patients treated with GBP and BZ has not been investigated, including treatment with mirogabalin, a class drug of GBP marketed in Japan.</p><p><strong>Objective: </strong>We aimed to investigate prescribing cascades with GBP-induced and BZ-induced edema and dizziness treated with loop diuretics (LD) and anti-vertigo drugs (AVD), respectively, among older adults.</p><p><strong>Methods: </strong>A prescription sequence symmetry analysis design was used to detect signals of prescribing cascades associated with edema and dizziness induced by GBP and BZ (exposure drugs). Loop diuretics and AVD were the outcome drugs used to identify prescribing cascades following the initiation of exposure drugs. The study population consisted of enrollees of a large-scale health claims database provided by DeSC Healthcare, Inc., between April 2014 and March 2021. Subjects eligible for a prescription sequence symmetry analysis were patients aged ≥ 65 years prescribed an outcome drug within 90 days before and after exposure drug initiation. A signal of a prescribing cascade was detected if secular trend-adjusted sequence ratios were statistically significant on comparison of the frequencies of outcome drug initiation before and after exposure drug initiation.</p><p><strong>Results: </strong>We identified 2671 patients with prescriptions of a GBP-LD combination, 4009 with a GBP-AVD combination, 8675 with a BZ-LD combination, and 9462 with a BZ-AVD combination. The adjusted sequence ratios for GBP-LD and BZ-LD cascades were significantly larger than one (adjusted sequence ratio [95% confidence interval], 1.69 [1.56-1.83]; 1.35 [1.29-1.41], respectively), indicating positive signals of prescribing cascades. No signal was detected for the GBP-AVD or BZ-AVD cascade (0.89 [0.83-0.94]; 0.90 [0.87-0.94], respectively). The adjusted sequence ratio for the mirogabalin cascade was higher than that for pregabalin (2.23 [1.84-2.71] vs 1.59 [1.46-1.73]).</p><p><strong>Conclusions: </strong>Our study provides good evidence that LD-prescribing cascades associated with edema would be a class effect of GBP and BZ. Edema emerging around 1 month after GBP initiation should be carefully differentiated from pathological edema, and undue LD prescription as a prescribing cascade should be avoided.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Falls and Fractures among Nursing Home Residents Treated with Pimavanserin versus Other Atypical Antipsychotics: Analysis of Medicare Beneficiaries with Parkinson's Disease Psychosis.","authors":"Krithika Rajagopalan, Nazia Rashid, Daksha Gopal, Dilesh Doshi","doi":"10.1007/s40801-024-00433-2","DOIUrl":"10.1007/s40801-024-00433-2","url":null,"abstract":"<p><strong>Background: </strong>Reducing falls and fractures remains an important clinical goal in managing older residents with Parkinson's disease psychosis (PDP) in long-term care/nursing home (LTC/NH) settings.</p><p><strong>Objectives: </strong>This analysis examined risk of all-cause falls or fractures among PDP residents on continuous monotherapy with pimavanserin (PIM) versus (i) other atypical antipsychotics (AAPs) [quetiapine (QUE), risperidone (RIS), olanzapine (OLA), aripiprazole (ARI)] and (ii) QUE.</p><p><strong>Methods: </strong>A retrospective analysis of parts A, B, and D claims from a 100% Medicare sample (2013-2019) in LTC/NH settings was conducted. LTC/NH residents in the USA initiating continuous monotherapy (PIM versus other AAPs; PIM versus QUE) for ≥ 6 months between 01 January 2014 and 31 December 2018 were 1:1 propensity score matched (PSM) on 31 variables (age, sex, race, region, and 27 Elixhauser comorbidities). Outcomes included three measures: risks of falls only, fractures only, and falls/fractures during 6-months follow-up. Demographic characteristics were described using chi-square and t-tests. Generalized linear models were used to assess difference in risks of falls/fractures.</p><p><strong>Results: </strong>Of 7187 residents, 47.59% (n = 3420) were female and mean age was 78.8 (± 7.75) years. In total, 14% (n = 1005) were on PIM and 86% (n = 6182) were on other AAPs. After PSM, falls only among PIM residents (n = 1005) was 4.58% (n = 46) versus 7.66% (n = 77) for other AAPs (n = 1005) [relative risk (RR) = 0.63 (0.46, 0.86), p < 0.05] and 8.26% (n = 83) for QUE (n = 1005) residents (p < 0.05). Fractures only among PIM residents was 1.39% (n = 14) compared with 2.09% (n = 21) for other AAPs (p = 0.31) and 1.89% (n = 19) for QUE (p = 0.49), respectively. Taken together, falls/fractures among PIM residents were 5.67% (n = 57) versus 9.05% (n = 91) for other AAPs [RR = 0.63 (0.46, 0.86), p < 0.05] and 9.55% (n = 96) for QUE (p < 0.05), respectively.</p><p><strong>Conclusions: </strong>In this analysis of LTC/NH residents with PDP, PIM had a 37% and 41% lower risk of all-cause falls/fractures versus other AAPs and versus QUE, respectively.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations Previously Treated with Platinum-Based Chemotherapy and Immunotherapy.","authors":"Jerome H Goldschmidt, Wan-Yu Tseng, Yunfei Wang, Janet Espirito, Anupama Vasudevan, Michelle Silver, Jackie Kwong, Ruchit Shah, Elizabeth Marrett","doi":"10.1007/s40801-024-00440-3","DOIUrl":"10.1007/s40801-024-00440-3","url":null,"abstract":"<p><strong>Background: </strong>For patients with metastatic non-small cell lung cancer, timely molecular testing is essential to determine the appropriate course of therapy. Initial treatment with platinum chemotherapy and/or an immune checkpoint inhibitor (ICI) is the standard of care for patients without actionable genomic alterations.</p><p><strong>Objective: </strong>We aimed to assess treatment patterns and clinical outcomes among patients with metastatic non-small cell lung cancer, no actionable genomic alterations, and with prior ICI and platinum-based chemotherapy in a community oncology setting.</p><p><strong>Methods: </strong>This retrospective observational study examined electronic health records from adult patients with an initial metastatic non-small cell lung cancer diagnosis without actionable genomic alterations from 2017 to 2019. Patients had received a subsequent line of therapy (LOT) [index] after discontinuing platinum-based chemotherapy plus an ICI in the previous one or two LOTs. Patient demographics and clinical characteristics were analyzed descriptively. Clinical outcomes were evaluated using Kaplan-Meier analyses.</p><p><strong>Results: </strong>Among the study population (n = 961), the most common index LOT regimens were non-platinum-based chemotherapies (57.3%), platinum-based chemotherapies (12.9%), ICI-based chemotherapies (12.7%), platinum + ICI-based chemotherapies (9.4%), and other (7.7%). The most common post-index LOT regimens were non-platinum based (61.2%), ICI based (15.3%), platinum based (10.7%), platinum + ICI based (3.2%), and other (2.5%). Median time to treatment discontinuation, time to next treatment, and overall survival were numerically longest with index LOT ICI-based regimens (6.5, 9.9, and 18.9 months, respectively) and shortest with platinum-based regimens (2.8, 5.3, and 8.0 months, respectively) and non-platinum-based regimens (2.6, 5.0, and 7.8 months, respectively).</p><p><strong>Conclusions: </strong>Among patients with metastatic non-small cell lung cancer without actionable genomic alterations previously treated with platinum + ICIs, non-platinum chemotherapy agents were most commonly prescribed in the index LOT. Clinical outcomes including time to treatment discontinuation, time to next treatment, and overall survival were short, highlighting the unmet need for more effective later-line treatments.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365910/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Outcomes in Chronic Fibrotic Interstitial Lung Disease Through Aggressive Management of Nintedanib-Induced Adverse Drug Reactions: A Retrospective Analysis.","authors":"Yu-Wen Chang, Meng-Yun Tsai, Yu-Ping Chang, Chien-Chang Liao, Yu-Ting Lin, Chien-Hao Lai, Meng-Chih Lin, Kuo-Tung Huang","doi":"10.1007/s40801-024-00443-0","DOIUrl":"10.1007/s40801-024-00443-0","url":null,"abstract":"<p><strong>Background and objectives: </strong>Nintedanib, a tyrosine kinase inhibitor, is integral in slowing pulmonary fibrosis progression in chronic fibrotic interstitial lung disease (ILD). However, the occurrence of adverse drug reactions (ADRs) often limits its use, leading to treatment discontinuation, typically within 3-12 months. Discontinuation adversely affects patient outcomes. The study investigated whether aggressive ADR management can prolong nintedanib therapy and improve patient outcomes.</p><p><strong>Methods: </strong>This retrospective, single-center study enrolled Taiwanese patients with chronic fibrotic ILD who were treated with nintedanib from January 2016 to December 2022 in Kaohsiung Chang Gung Memorial Hospital. Patients were categorized into those who discontinued treatment within 180 days and those continuing beyond. Management of ADRs was identified through concurrent prescriptions for symptoms such as nausea, vomiting, diarrhea, or hepatic dysfunction. Baseline demographics, comorbidities, pulmonary function tests, and instances of acute exacerbation were analyzed.</p><p><strong>Results: </strong>The study enrolled 94 patients, with 71 (75.5%) experiencing ADRs. Among these, 41 (43.6%) discontinued nintedanib within 180 days. The administration of medications for managing nausea/vomiting [17 (41.5%) versus 36 (67.9%), p = 0.0103] and diarrhea [12 (29.3%) versus 33 (62.3%), p = 0.0015] was less frequent in the discontinued group compared with the continued group. Additionally, a higher incidence of acute exacerbation was observed in the discontinued group (34.1% versus 20.8%, p = 0.016).</p><p><strong>Conclusion: </strong>Aggressive management of ADRs may enhance patient tolerance to nintedanib, potentially prolonging treatment duration and improving outcomes in chronic fibrotic ILD.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Real-World On-Label Treatment Persistence in Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Tumor Necrosis Factor Inhibitors.","authors":"Jessica A Walsh, Iris Lin, Ruizhi Zhao, Natalie J Shiff, Laura Morrison, Bruno Emond, Louise H Yu, Samuel Schwartzbein, Patrick Lefebvre, Dominic Pilon, Soumya D Chakravarty, Philip Mease","doi":"10.1007/s40801-024-00428-z","DOIUrl":"10.1007/s40801-024-00428-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Treatment persistence among patients with psoriatic arthritis (PsA) is essential for achieving optimal treatment outcomes. Guselkumab, a fully human interleukin-23p19-subunit inhibitor, was approved by the United States (US) Food and Drug Administration for the treatment of active PsA in July 2020, with a dosing regimen of 100 mg at week 0, week 4, then every 8 weeks. In the Phase 3 DISCOVER-1 and DISCOVER-2 studies of patients with active PsA, 94% of guselkumab-randomized patients completed treatment through 1 year and 90% did so through 2 years (DISCOVER-2). Real-world evidence is needed to compare treatment persistence while following US prescribing guidelines (i.e., on-label persistence) for guselkumab versus subcutaneous (SC) tumor necrosis factor inhibitors (TNFis).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Adults with PsA receiving guselkumab or their first SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, or golimumab) between 14 July 2020 and 31 March 2022 were identified in the IQVIA PharMetrics&lt;sup&gt;®&lt;/sup&gt; Plus database (first claim defined the treatment start date [index date]). Baseline characteristics and biologic use (biologic-naïve/biologic-experienced) were assessed during the 12-month period preceding the index date. Baseline characteristics were balanced between cohorts using propensity-score weighting based on the standardized mortality ratio approach. The follow-up period spanned from the index date until the earlier of the end of continuous insurance eligibility or end of data availability. On-label persistence, defined as the absence of treatment discontinuation (based on a gap of 112 days for guselkumab or 56 days for SC TNFi) or any dose escalation/reduction during follow-up, was assessed in the weighted treatment cohorts using Kaplan-Meier (KM) curves. A Cox proportional hazards model, further adjusted for baseline biologic use, was used to compare on-label persistence between the weighted cohorts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The guselkumab cohort included 526 patients (mean age 49.8 years; 61.2% female) and the SC TNFi cohort included 1953 patients (mean age: 48.5 years; 60.2% female). After weighting, baseline characteristics were well balanced with a mean follow-up of 12.3-12.4 months across cohorts; 51.5% of patients in the guselkumab cohort and 16.7% in the SC TNFi cohort received biologics in the 12-month baseline period. Respective rates of treatment persistence at 3, 6, 9, and 12 months were 91.2%, 84.1%, 75.9%, and 71.5% for the guselkumab cohort versus 77.3%, 61.6%, 50.0%, and 43.7% for the SC TNFi cohort (all log-rank p &lt; 0.001). At 12 months, patients in the guselkumab cohort were 3.0 times more likely than patients in the SC TNFi cohort to remain persistent on treatment (p &lt; 0.001). Median time to discontinuation was not reached for the guselkumab cohort and was 8.9 months for the SC TNFi cohort.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This real-world study employing US commerci","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence of Liver and Non-liver Cancers After Hepatitis C Virus Eradication: A Population-Based Cohort Study.","authors":"José Ríos, Víctor Sapena, Zoe Mariño, Jordi Bruix, Xavier Forns, Rosa Morros, María Reig, Ferran Torres, Caridad Pontes","doi":"10.1007/s40801-024-00437-y","DOIUrl":"10.1007/s40801-024-00437-y","url":null,"abstract":"<p><strong>Background and objectives: </strong>Direct-acting antivirals (DAAs) offer a high rate of hepatitis C virus (HCV) eradication. However, concerns on the risk of cancer after HCV eradication remain. Our study aimed at quantifying the incidence of cancer in patients treated with anti-HCV therapies in Catalonia (Spain) and their matched controls.</p><p><strong>Methods: </strong>This was a population-based study using real-world data from the public healthcare system of Catalonia between 2012 and 2016. Propensity score matching was performed in patients with HCV infection treated with interferon-based therapy (IFN), sequential IFN and DAA (IFN+DAA), and DAA only (DAA) with concurrent controls. We estimated the annual incidence of overall cancer, hepatocellular carcinoma, and non-liver cancer of HCV-treated patients and their corresponding rate ratios.</p><p><strong>Results: </strong>The study included 11,656 HCV-treated patients and 49,545 controls. We found statistically significant increases in the rate of overall cancer for IFN+DAA-treated (rate ratio [RR] 1.77, 95% confidence interval [CI] 1.27-2.46) and DAA-treated patients (RR 1.90, 95% CI 1.66-2.19) and in the rate of HCC for IFN-treated (RR 1.50, 95% CI 1.02-2.22), IFN+DAA-treated (RR 3.89, 95% CI 2.26-6.69), and DAA-treated patients (RR 6.45, 95% CI 4.90-8.49) compared with their corresponding controls. Moreover, DAA-treated patients with cirrhosis showed an increased rate of overall cancer versus those without cirrhosis (RR 1.92, 95% CI 1.51-2.44).</p><p><strong>Conclusions: </strong>Results showed that overall cancer and hepatocellular carcinoma incidence in Catalonia was significantly higher among HCV-treated patients compared with matched non-HCV-infected controls, and risks were higher in patients with cirrhosis. An increased awareness of the potential occurrence of uncommon malignant events and monitoring after HCV eradication therapy may benefit patients.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141317032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterizing Utilization and Outcomes of Digoxin Immune Fab for Digoxin Toxicity.","authors":"Sophia Sheikh, Taylor Munson, Gerard Garvan, Claire Layton, Dawn Sollee, Colleen Cowdery, Alexa Peterson, Lindsay Schaack Rothstein, Morgan Henson, Hayley Gartner, Michael Ujhelyi","doi":"10.1007/s40801-024-00435-0","DOIUrl":"10.1007/s40801-024-00435-0","url":null,"abstract":"<p><strong>Background: </strong>Digoxin is a widely prescribed drug for congestive heart failure and atrial fibrillation. Digoxin has a narrow therapeutic index and toxicity can develop quite easily. Digoxin immune fab (DIF) is an effective treatment for toxicity, however there are limited studies characterizing its impact on clinical outcomes in real-world clinical practice.</p><p><strong>Objectives: </strong>The aim of this study was to identify factors and healthcare outcomes associated with digoxin immune fab (DIF) treatment in patients with confirmed/suspected digoxin toxicity.</p><p><strong>Methods: </strong>An IRB-approved retrospective chart review of digoxin toxic patients (2011-2020) presenting at an academic healthcare system was conducted. Demographic and clinical data were collected. Patients were stratified by DIF treatment versus non-DIF treatment. DIF utilization patterns (appropriate, use when not indicated, or underutilized) were determined using pre-defined criteria. Severe digoxin toxicity was defined as having one or more of the following: mental status disturbances, antiarrhythmic therapy, acute renal impairment or dehydration, serum digoxin concentration (SDC) > 4 ng/mL, or serum K+ > 5 mEq/mL. Logistic multivariable regression analysis evaluated factors associated with DIF use. All statistical analyses were performed in R version 4.1.</p><p><strong>Results: </strong>Data from 96 patients (non-DIF treated group = 49; DIF treated group = 47) were analyzed. DIF was used appropriately in 70 patients (73%), underutilized in 19 (20%), and administered to 7 (7%) patients when it was not indicated. Several clinical parameters differentiated the DIF from the non-DIF group (p < 0.05) including higher mean SDC (3.41 ± 1.63 vs 2.87 ± 1.17), higher mean potassium (5.33 ± 1.48 vs 4.55 ± 0.87), more toxicity severity (85% vs 49%), and more likely to require cardiac pacing (26% vs 4%). Digoxin toxicity resolved sooner in the DIF group (coefficient - 0.702, 95% CI - 1.137 to - 0.267) (p < 0.01) and they had shorter intensive care unit lengths of stay (12.4 ± 20.3 vs 24.4 ± 28.7 days; p = 0.018). The all-cause mortality rate in patients appropriately managed with DIF therapy versus those patients where DIF was underutilized was 11% and 21%, respectively.</p><p><strong>Conclusions: </strong>Based on our study population, DIF therapy appears to be beneficial in limiting duration of toxicity and intensive care unit lengths of stay in digoxin toxic patients. Although DIF was appropriately utilized in most cases, there was a relatively high proportion of cases in which DIF treatment was either underutilized or not indicated.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}