Higher Persistence Rates Research Articles

Treatment of OSA beyond adenotonsillectomy.

Pediatric obstructive sleep apnea (OSA) is a common syndrome in children. While an adenotonsillectomy is effective for most, it may not be the treatment of choice for all, and possible alternative treatment options are briefly discussed herein. In obese children, in whom OSA is more prevalent, and has high rates of persistence after surgery, weight loss interventions may be recommended. Anti-inflammatory therapies, such as nasal steroids and montelukast, reduce the size of the adenoids and tonsils and are considered part of the stepwise treatment approach. Functional orthodontic therapies may improve OSA as well as orthopedic interventions in children in whom orthodontic indications exist. Positive airway pressure and high flow nasal cannula, stent the airway open and alleviate the obstruction, but adherence may be challenging. Tongue surgery, as well as several additional interventions are further discussed. In conclusion, multiple therapeutic options are available for pediatric OSA. Further studies are required to better identify the children most likely to benefit from these therapies.

Analysis of Longitudinal Patterns and Predictors of Medicine Use in Residential Aged Care Using Group-Based Trajectory Modeling: The "MEDTRAC-Cardiovascular" Longitudinal Cohort Study.

Cardiovascular diseases are the leading cause of death globally. Ensuring ongoing use of medicines-medication persistence-is crucial, yet no prior studies have examined this in residential aged care facilities (RACFs). We aimed to identify long-term trajectories of persistence with cardiovascular medicines and determine predictors of persistence trajectories. A longitudinal cohort study of 2837 newly admitted permanent residents from 30 RACFs in New South Wales, Australia. We monitored weekly exposure to six cardiovascular medicine classes-lipid modifiers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARBs), beta-blockers, diuretics, calcium channel blockers (CCB), and cardiac therapy-over 3 years. Group-based trajectory modeling was employed to determine persistence trajectories for each class. At baseline, 76.6% (n = 2172) received at least one cardiovascular medicine with 41.2% receiving lipid modifiers, 31.4% ACEI/ARBs, 30.2% beta-blockers, 24.4% diuretics, 18.7% CCBs, and 14.8% cardiac therapy. The model identified two persistence trajectories for CCBs and three trajectories for all other classes. Sustained high persistence rates ranged from 68.4% (ACEI/ARBs) to 79.8% (beta-blockers) while early decline in persistence and subsequent discontinuation rates ranged from 7.6% (cardiac therapy) to 25.3% (CCBs). Logistic regressions identified 11 predictors of a declining persistence across the six medicine classes. Our study revealed varied patterns of cardiovascular medicine use in RACFs, with 2-3 distinctive medicine use trajectories across different classes, each exhibiting a unique clinical profile, and up to a quarter of residents discontinuing a medicine class. Future studies should explore the underlying reasons and appropriateness of nonpersistence to aid in identifying areas for improvement.

Comparative effects of different treatments based on the levonorgestrel intrauterine system in endometrial carcinoma and endometrial hyperplasia patients: a network meta-analysis.

Levonorgestrel intrauterine system (LNG-IUS) has been widely used in patients with endometrial carcinoma (EC), endometrial hyperplasia without atypical (EH), and atypical endometrial hyperplasia (AEH). The purpose of our Network meta-analysis (NMA) is to evaluate the efficacy of the treatments based on the LNG-IUS in patients with EC and EH with or without atypical. We examined PubMed, EMBASE, Web of Science and the Cochrane Library up to 22 April 2024 to determine studies reporting treatment outcomes in EC and EH patients receiving LNG-IUS therapy, LNG-IUS + metformin (MET), oral progestins (OP), etc. We used EndNote 9 to select studies, Jadad scale and NOS scale to assess quality, stata(16.0) and R (4.3.1) to analysis the data. Overall, 28 studies involving 3752 patients were included in our NMA. As for EH patients, LNG-IUS (RR 1.21; 95% CrI [1.11, 1.34]) and LNG-IUS + MET (RR 323.57; 95% CrI [1.61, 214,223,188.1])] significantly increased CR rate in comparison with OP. Based on SUCRA, LNG-IUS + OP was the best treatment to improve CR(SUCRA = 67.2%) in patients with EC, whereas LNG-IUS + MET was superior in increasing CR (SUCRA = 99.8%) than any other treatments for EH patients. Besides, the ranking based on SUCRA illustrated that LNG-IUS alone was the best choice to raise CR rates (SUCRA = 76.7%) for AEH patients. In head-to-head meta-analysis, OP has a higher progression rate (RR 4, 95% CI 1.89-8.46, p = 0.062; I2 = 71.3%), a higher nausea rate (RR 1.93, 95% CI 1.24-3.01, p = 0.187; I2 = 40.4%) than LNG-IUS in patients with EH. In contrast, LNG-IUS had a irregular vaginal bleeding rates (RR 0.76, 95% CI 0.64-0.90, p = 0.034; I2 = 77.7%) than OP in EH patients. In addition, as for AEH patients, OP has a higher persistence rate (RR 4.31, 95% CI 1.43-13.00, p = 0.93; I2 = 0.0%) than LNG-IUS. According to the NMA, LNG-IUS related studies are feasible for conservative therapy in patients with EC and EH with or without atypical. Therefore, concerning the curative effect, we recommend LNG-IUS-based treatments as the best conservative therapy for EC and EH patients. However, future studies require large sample sizes and more outcomes to further evaluate the differences of treatment selections based on LNG-IUS.

Temporal Development of Microhabitats on Living Habitat Trees in Temperate European Forests

AbstractTree-related microhabitats (TreMs) have been promoted as indicators of forest biodiversity and to guide conservation practices. Ensuring the provision of diverse TreMs in the long term is crucial for the survival of many forest-dwelling species. Yet, this task is challenging in the absence of information regarding TreM dynamics. We analysed the temporal development of TreMs on 11,569 living trees in temperate European forests. To identify drivers of change in TreM abundance and richness over a period of 3–12 years, we estimated the rates of TreM persistence and loss events at the tree-level using survival analysis methods: persistence was characterised by consistency and increment events (when TreM numbers were maintained or increased) and loss was defined as a reduction in TreM numbers or their disappearance. Stratified Cox proportional hazards models were fitted for different TreM groups. Our study revealed a highly dynamic TreM development on living habitat trees, particularly on large trees. While specific TreMs are prone to disappearing, irrespective of tree species or TreM groups, total TreM richness persists over a 12-year period. TreMs such as crown deadwood, epiphytes or woodpecker cavities are prone to decrease in the long term. However, large trees were more likely to maintain a certain degree of TreM richness. Increasing diameters resulted in high persistence rates in seven TreM groups and concomitantly low loss rates in four of them (exposed sap- and heartwood, concavities). Selecting habitat trees based on TreMs should consider the likelihood of TreMs being lost over time, to ensure the long-term provision of microhabitats for associated species. Graphical Abstract

Persistence of STEM Majors in Higher Education

Students in STEM programs often face difficult or ‘weed out’ courses in their first year of declaring their major and are frequently confronted with academic threats such as lack of understanding complex concepts, or receiving poor grades. The U.S. is estimated to need at least 1 million more STEM majors to meet the growing job market in STEM fields, and nearly 60% of students who declare a STEM major eventually switch to a non-STEM major or leave without any degree (Turetsky et al., 2020). Drawing on self-affirmation theory, this quantitative study explores the role that academic confidence and a sense of belonging play in STEM major persistence through a lens of self-affirmations. Fifty-four undergraduate students participated in a pre-test/post-test survey with a double-blind affirmation intervention in an introductory chemistry I course. Findings revealed a remarkably high STEM major persistence rate of 102%, but no statistically significant findings, challenging the notion of standalone affirmation interventions as a quick solution for retention. While the intervention did not yield statistically significant results, post-test belonging scores suggest a more significant influence on persistence than academic confidence. The study underscores the complexity of promoting STEM major persistence. Future research could explore longitudinal impacts, additional institutions, and mechanisms underlying student belonging to develop more effective retention strategies.

Review of Evolocumab for the Reduction of LDL Cholesterol and Secondary Prevention of Atherosclerotic Cardiovascular Disease.

Elevated low-density lipoprotein cholesterol (LDL-C) is a major causal factor for atherosclerotic cardiovascular disease (ASCVD), the leading cause of mortality worldwide. Statins are the recommended first-line lipid-lowering therapy (LLT) for patients with primary hypercholesterolemia and established ASCVD, with LLT intensification recommended in the substantial proportion of patients who do not achieve levels below guideline-recommended LDL-C thresholds with statin treatment alone. The proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibody evolocumab has demonstrated significant LDL-C reductions of 60% in the clinical trial and open-label extension settings, with LDL-C reductions observed early post-evolocumab initiation and maintained long term, during up to 8.4 years of follow-up. Evolocumab therapy, when added to a statin, also conferred a significant reduction in major cardiovascular (CV) events, including a 20% reduction in the composite of CV death, myocardial infarction (MI), or stroke. The absolute benefits were enhanced among various patient types at high and very high risk for secondary ASCVD (e.g., with recent MI, multiple events or peripheral artery disease). Importantly, evolocumab treatment resulted in incremental CV risk reductions during the extended follow-up, including a 23% reduction in CV mortality and no apparent LDL-C level below which there is no further CV risk reduction. Hence, the evolocumab clinical data support the need for early and significant LDL-C lowering, especially in vulnerable ASCVD patients, in order to derive the greatest benefit in the long term. Importantly, evolocumab had no impact on any treatment emergent adverse events apart from a small increase in local injection site reactions. A growing body of real-world evidence (RWE) for evolocumab in heterogeneous populations is consistent with the trial data, including robust LDL-C reductions below guideline-recommended thresholds, a favourable safety profile even at the lowest levels of LDL-C achieved, and a high treatment persistence rate of 90%. Altogether, this review highlights findings from 50 clinical trials and RWE studies in 51,000 patients treated with evolocumab, to demonstrate the potential of evolocumab to address the healthcare gap in LDL-C reduction and secondary prevention of ASCVD in a variety of high- and very high-risk patients.

Association Between Mode of Delivery and Postpartum Assessment of High-Grade Cervical Dysplasia Diagnosed in Pregnancy [ID 2683564

INTRODUCTION: Approximately 5% of pregnancies are complicated by cervical dysplasia. It is hypothesized that cervical remodeling during vaginal delivery may confer higher rates of postpartum regression when compared to cesarean. We sought to evaluate the relationship between mode of delivery and postpartum dysplasia outcomes. METHODS: This is a retrospective cohort study of patients with biopsy-proven high-grade dysplasia diagnosed during pregnancy from January 2013 to December 2022. Demographics, obstetric outcomes, and antepartum and postpartum cervical pathology were collected and IRB approval obtained. Only immunocompetent patients with postpartum pathology obtained within 1 year of delivery were included. Definitions based on postpartum pathology were as follows: regression as low-grade or resolved dysplasia, persistence as high-grade dysplasia, and progression as cervical cancer. Rates were stratified by mode of delivery and data analyzed using the chi-squared test. RESULTS: Among our cohort (N=286), 101 (35%) were diagnosed with CIN2, 181 (63%) with CIN3/CIS, and 4 (1%) with HSIL (not otherwise specified) on antepartum cervical biopsy. 228 (80%) delivered via vaginal delivery and 58 (20%) delivered via cesarean. Rate of postpartum regression was similar in both delivery groups (37% versus 38%; P=.927), as was persistence (62% versus 60%; P=.786). Rate of apparent progression to invasive cancer was low in both groups (<1% versus 2%; P=.365). CONCLUSION: High rates of persistence and low rates of apparent progression were observed subsequent to both vaginal and cesarean deliveries. Our data indicate that the natural history of high-grade dysplasia diagnosed during pregnancy is not affected by route of delivery in a way that should influence postpartum management.

Perception and Impact of COVID-19 Pandemic in Psoriasis Patients: Data from the German PsoBest and the CoronaBest Registries.

Limited data are available characterizing the impact of the SARS-CoV-2 pandemic on psoriasis care for patients in Germany. To analyze patient perception and impact of the pandemic on well-being and psoriasis management of German patients with moderate-to-severe psoriasis or psoriasis arthritis under systemic therapies. The CoronaBest registry captures events of SARS-CoV-2 infections and analyzes the impact of the pandemic on patients with psoriasis or psoriasis arthritis. In June 2020, and independently in February 2022, patients with psoriasis or psoriasis arthritis received a standardized questionnaire for current treatment, protective measures, well-being, and individual risks for COVID-19, among others. Included were 4,194 patients in 2020 (mean age of 47.7 years and 41.8% women) and 4,818 patients in 2022 (mean age of 56.4 and 42.9% women). Treatment discontinuations were observed in 2.7% and 1.7% of patients in 2020 and 2022, respectively. In the vast majority of the cases (>92%), no additional measures were taken concerning the management of psoriasis treatments in either 2020 or 2022. Those patients with changes reported most frequently: telephone calls instead of face-to-face visits (80.2%, in 2020 vs 40.5% in 2022) or more frequent controls (27.1%, 2020 vs 22.0%, 2022). A majority (66.7%, 2020, and 70.6%, 2022) did not perceive the virus as a considerable threat. The proportion of patients feeling well informed about COVID-19 by physicians increased from 42.6% in 2020 to 51.8% in 2022. About 81.1% of patients in 2020 and 67.5% in 2022 stated that their overall personal condition was not affected due to the pandemic. Physicians attributed no special risk of contracting SARS-CoV-2 in most of the patients. A high rate of systemic treatment persistence and awareness of risks and protective measures indicate that health care for psoriasis largely followed current national and international recommendations during the COVID-19 pandemic.

Effect of soft tissue tension around the knee joint on medio-lateral patellar position

Patellofemoral pain (PFP) is one of the most common sports injuries of the knee joint and has a high persistence and recurrence rate. Medio-lateral patellar position in the knee extension position during contraction is associated with PFP. However, soft tissue tension that most influences the medio-lateral patellar position in the knee extension position during contraction in vivo is unclear. We aimed to clarify the relationship between medio-lateral patellar position and soft tissue tension around the knee joint. Twelve patients with PFP and 20 healthy participants were included. Medio-lateral patellar position and tension of the rectus femoris, vastus lateralis (VL), vastus medialis, iliotibial band (ITB), lateral patellofemoral ligament, and medial patellofemoral ligament were measured during contraction and rest. The tensions of the VL and ITB during contraction and the medio-lateral patellar position at rest were significantly associated with medio-lateral patellar position during contraction (β = 0.449, 0.354, and 0.393, respectively). In addition, the tension of ITB was significantly associated with the medio-lateral patellar position at rest (β = 0.646). These relationships were not affected by the presence of PFP. These findings suggest that the patellar position during contraction became more lateral as the tension in the VL and ITB increased, regardless of the presence of PFP. These results may facilitate the prevention and treatment of PFP.

Persistence to statin treatment: A cohort study in Lithuania.

Cardiovascular diseases are the main causes of death, and statins can reduce the risk of major vascular events. Lithuania is among the European countries with the highest cardiovascular mortality despite a rapidly increasing use of statins. Previous reviews have shown the problem of poor patient adherence, but there are limited studies from Eastern European countries. The aim of this study was to evaluate treatment persistence in new users of statins in Lithuania and to investigate factors associated with persistence. Dispensed prescriptions from patients aged >18 years old initiated on statins in 2018-2019 were included, and data were obtained from a national health insurance fund. Persistence was assessed by the proportion of patients who still had statins dispensed 1year after the first dispensing. Factors associated with persistence were assessed using logistic regression. A total of 104 726 patients (41.3% men) were initiated on statin treatment. Only 41% of them continued statin use 1year after initiation. Factors associated with higher persistence rate were older age, higher dose of statin, use of other medicines and use of statins as secondary prevention. Low persistence to statin therapy needs to be recognized by healthcare workers, pharmacists and policy makers to address this problem.

Real-World Outcomes of Patients Starting Intravenous and Transitioning to Subcutaneous Vedolizumab in Inflammatory Bowel Disease

BackgroundReal-world data on starting intravenous (IV) vedolizumab (VDZ) and transitioning to subcutaneous (SC) treatment in inflammatory bowel disease (IBD) are scarce.AimsTo assess treatment outcomes of patients with IBD starting IV VDZ and switching to SC VDZ in routine clinical care.MethodsAdult patients with IBD switching from IV to SC VDZ treatment between 1 March 2020 and 31 December 2021 were identified from the Swedish IBD quality register. The primary outcome was SC VDZ persistence. Secondary outcomes included clinical remission, changes in quality of life (QoL) according to EuroQual 5-Dimensions 5-Levels (EQ-5D-5L) and the Short-Health Scale (SHS) and inflammatory markers, including faecal Calprotectin (FCP).ResultsAltogether, 406 patients with IBD (Crohn's disease, n = 181; ulcerative colitis, n = 225) were identified. After a median follow-up of 30 months from starting IV VDZ treatment, the persistence rates were 98%(178/181) in Crohn's disease and 94% (211/225) in ulcerative colitis. Most patients (84%) transitioned during maintenance therapy, and the median follow-up from switch to SC VDZ was 10 months. Compared to baseline, statistically significant improvements were observed in all domains of the SHS, EQ-5D index value and visual analogue scale. Median (interquartile range) FCP concentrations (μg/g) decreased from 459 (185–1001) to 65 (26–227) in Crohn's disease (n = 45; p < 0.001) and from 646 (152–1450) to 49 (20–275) in ulcerative colitis (n = 58; p < 0.001).ConclusionInitiating IV VDZ and switching to SC treatment was associated with high persistence rates and improvements in measures of QoL and FCP. These findings are reassuring for patients who start IV VDZ and switch to SC VDZ.Graphical

Dynamic Analysis of Loneliness at Older Ages in Europe by Gender

In this article, we analyse loneliness trajectories for older people aged 50 or more in selected European countries by gender. We also focus on the relationship between disability and loneliness trajectories. We use three waves of the longitudinal SHARE database. Loneliness trajectories are non-linear, increasing with age for both genders, and have the same shape irrespective of disability status but with different levels of loneliness. Loneliness persistence increases with disability and disability severity, especially for women. Worsening (improving) disability increases (decreases) the risk of loneliness persistence. We build rankings of the country's effects on loneliness persistence by gender. Mediterranean and Eastern European countries have the highest persistence rates, while the lowest rates are in Northern countries.

Predictors of non-persistence in women with overactive bladder syndrome

Persistence is important for the success in the treatment of women with overactive bladder syndrome (OAB). We aimed to identify the predictors of non-persistence in women with OAB after first-line medical treatment. All consecutive women with OAB (n = 608), who underwent urodynamic studies and received first-line medical treatment (5 mg of solifenacin or 25 mg of mirabegron per day) in a referral medical center, were reviewed. Mirabegron (hazard ratio [HR] = 0.711) was associated with a higher persistence rate, compared to solifenacin. Mirabegron treatment (HR = 0.269) was less likely to switch medication; however, a high Urogenital Distress Inventory score (HR = 1.082) was more likely to switch medication. Furthermore, old age (HR = 1.050, especially for ≥ 75 years) and high voided volume (dL, HR = 1.420, especially for voided volume ≥ 250 ml) were associated with added medication at follow-up. Additionally, women with low parity (HR = 0.653, especially for parity ≤ 3) and a low Incontinence Impact Questionnaire (IIQ-7) score (HR = 0.828, especially for IIQ-7 score ≤ 7) were associated with improvement without medication. In conclusion, mirabegron can be considered as the first frontline treatment to increase the persistence rate and decrease the rate of switched medications, compared to solifenacin. In addition, combination therapy or higher-dose monotherapy could be used as the first front-line treatment for women ≥ 75 years of age or with ≥ 250 ml of voided volume.

Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial

BackgroundThe objective of this analysis was to gain new insights into the patient characteristics and other factors associated with lasmiditan usage and clinical outcomes under conditions resembling the real-world setting.MethodsThis was a post hoc analysis of data from the 12-month, open-label extension (OLE) of the phase 3, double-blind, randomized, controlled CENTURION trial, which examined the efficacy and safety of lasmiditan as acute treatment across four migraine attacks. Patients completing the main study who treated ≥ 3 attacks could continue in the OLE. The initial lasmiditan dose was 100 mg, with dose adjustments to 50 mg or 200 mg allowed at the investigator’s discretion. Patient and clinical characteristics were summarized by dosing pattern and completion status. Safety was assessed based on adverse event (AE) frequency by number of doses.ResultsIn total, 445 patients treated ≥ 1 migraine attacks with lasmiditan during the OLE, 321 of whom (72.1%) completed the study. Forty-seven percent of patients remained on the 100-mg initial dose during the OLE whereas 20.2% used both 100 mg and 50 mg, 30.6% used both 100 mg and 200 mg, and 6 (1.3%) used multiple dose levels. All dosing patterns were associated with clinical and patient-reported improvement; however, the 100-mg group had the highest proportion of patients reporting improvement in the Patient Global Impression of Change – Migraine Headache Condition (56.5% vs 33.4%–52.2%). In comparison, all three groups that made dose adjustments had higher rates of completion compared to the 100-mg group (72.1%–83.3% vs 68.9%). The frequency of AEs decreased with continued use of lasmiditan. Concomitant triptans and lasmiditan use did not increase AE frequency.ConclusionsBased on high persistence and patient satisfaction rates, the 100-mg dose appears optimal for most patients. For those who adjusted dose levels, dose adjustments appeared beneficial to improve efficacy or tolerability, retaining patients on treatment. Collectively, the data suggest that patients who experienced efficacy continued to use lasmiditan regardless of the occurrence or frequency of AEs, and continued use appeared associated with fewer AEs.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials Database (EudraCT): 2018–001661-17; ClinicalTrials.gov: NCT03670810; registration date: September 12, 2018.Graphical

High persistence and low treatment rates of metabolic syndrome in patients with mood and anxiety disorders: A naturalistic follow-up study

BackgroundPatients with affective and anxiety disorders are at risk of metabolic syndrome (MetS) and, consequently, cardiovascular disease and premature death. In this study, the course and treatment of MetS was investigated using longitudinal data from a naturalistic sample of affective- and anxiety-disordered outpatients (Monitoring Outcome of psychiatric PHARmacotherapy [MOPHAR]). MethodsDemographics, clinical characteristics, medication use, and MetS components were obtained for n = 2098 patients at baseline and, in a FU-subsample of n = 507 patients, after a median follow-up (FU) of 11 months. Furthermore, pharmacological treatment rates of MetS were investigated at baseline and FU. Finally, demographic and clinical determinants of change in MetS (component) scores were investigated. ResultsAt baseline, 34.6 % of n = 2098 patients had MetS, 41.4 % of whom received treatment. Of patients with persisting MetS, 46.1 % received treatment for one (or more) MetS component(s) at baseline, and 56.6 % received treatment at FU. Treatment rates of solely elevated blood pressure and reduced HDL-cholesterol did significantly, but modestly, improve. Higher age, male sex, smoking behavior, low education, diabetes, and depressive versus anxiety disorder were predictors of worse outcome at FU on at least one MetS component. LimitationsWe did not have data on lifestyle interventions as a form of treatment, which might partly have explained the observed low pharmacotherapeutic treatment rates. ConclusionMetS (components) show high persistence rates in affective- and anxiety-disordered patients, and are, despite adequate monitoring, undertreated over time. This indicates that adherence and implementation of monitoring protocols should be crucially improved in psychiatric outpatients in secondary care.

Real-world Impact of Fremanezumab on Migraine-Related Health Care Resource Utilization in Patients with Comorbidities, Acute Medication Overuse, and/or Unsatisfactory Prior Migraine Preventive Response.

Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed. Data for this US, retrospective claims analysis were obtained from the Merative® MarketScan® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had≥ 12months of continuous enrollment prior to initiation (preindex period) and ≥ 6months of data following initiation (postindex period; variable follow-up after 6months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex. In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P < 0.001) and 0.94 (0.74) to 0.81 (0.75) (P < 0.001). Migraine-related outpatient and neurologist office visits, emergency department visits, and other outpatient services PPPM decreased pre- versus postindex (P < 0.001 for all), resulting in a reduction in mean (SD) total health care costs PPPM from US$541 (US$858) to US$490 (US$974) (P = 0.003). Patients showed high adherence and persistence rates, with mean (SD) proportion of days covered of 0.71 (0.29), medication possession ratio of 0.74 (0.31), and persistence duration of 160.3 (33.2) days 6months postindex. Patients with certain migraine comorbidities, potential AMO, and/or UPMPR in a real-world setting had reduced migraine-related medication use, HCRU, and costs following initiation of fremanezumab. Graphical abstract available for this article.

Persistence on subcutaneous tocilizumab as monotherapy or in combination with synthetic disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients in Greece (EMBRACE study): a multicenter, post-marketing, non-interventional, observational trial

IntroductionRheumatoid arthritis (RA) is a systemic, inflammatory disease affecting multiple organs and causing physical disability over time.ObjectiveThe primary objective was to evaluate treatment persistence to subcutaneous tocilizumab (TCZ-SC). Additionally, treatment effects on persistence and their associations with clinical and patient-reported outcomes were assessed.MethodWe performed a multicenter, non-interventional, 52-week observational study on 222 patients with moderate or severe RA. Clinical outcomes were evaluated by using disease activity score for 28 joints (DAS28) and European League Against Rheumatism (EULAR) response, and patients’ perceptions were evaluated by using Health Assessment Questionnaire (HAQ), Visual Analog Scale (VAS) for pain, and patient global assessment (PtGA) of disease activity. Safety was assessed throughout the study.ResultsThe mean age of the overall cohort was 62.2 ± 12.3 years, and 83.8% were females. Persistence to TCZ-SC was 89.6% at week 24 and 85.1% at week 52 in the overall cohort with slightly increased persistence in the combination group. At week 52, changes from the baseline were − 2.68 in DAS28, − 0.76 in HAQ, − 43.21 in VAS pain, and − 41.66 in PtGA (p < 0.0001 for all). Moderate and good EULAR response was achieved in 83.2% of patients. Non-serious and serious adverse events occurred in 18.5% and 3.2% of the participants, respectively.ConclusionsThe current study confirms the favorable safety and effectiveness of TCZ-SC as well as its acceptability by RA patients in Greece, with sustained high persistence rates up to 52 weeks. TCZ-SC offers a sustainable treatment response in RA.Key Points• Based upon clinical and patient-reported outcomes, TCZ-SC is a highly effective and safe treatment modality in patients with moderate-to-severe RA.• Persistence to TCZ-SC was high throughout the study, both as monotherapy and in combination with csDMARDs.• TCZ-SC is effective both as monotherapy and when used in combination with other csDMARDs regardless of the line of treatment.

Adalimumab Biosimilar in Pediatric Inflammatory Bowel Disease: A Retrospective Study from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

Background: The utilization of anti-tumor necrosis factor-α (anti-TNF-α) biosimilars in inflammatory bowel disease (IBD) is constantly increasing. However, pediatric data are limited. This study aimed to assess the effectiveness and safety of adalimumab biosimilar (ADL-BioS) in pediatric IBD patients. Methods: All consecutive pediatric IBD patients from the Sicilian Network for Inflammatory Bowel Disease cohort treated with ADL-BioS from 2019 to 2021 were recruited. Remission at weeks 14 and 52, treatment persistence, and adverse events were the endpoints of this study. Factors associated with clinical remission and treatment persistence were examined. Results: There were 41 patients in total. Nine (22%) patients were switched from the reference product to ADL-BioS. Two patients had multiple switches. Eleven months was the median follow-up period. Clinical remission was attained by 70.7% and 72.0% of patients on weeks 14 and 52, respectively. Four (9.8%) adverse events occurred (10.1/100 person-year). Treatment persistence was 85.4% at 1 and 2 years. Patients with a longer duration of disease had a higher probability of stopping their treatment (p = 0.036). Conclusions: This is the first real-world study that particularly addresses the use of ADL-BioS in pediatric IBD. With high rates of treatment persistence and a low frequency of non-serious side effects, ADL-BioS seems to be effective.

Outcomes of robot-assisted laparoscopic extended pelvic lymph node dissection for prostate Cancer

IntroductionExtended pelvic lymph node dissection (ePLND) in men undergoing robot-assisted laparoscopic radical prostatectomy (RARP) is a widely used procedure. However, little is known about anatomical site-specific yields and subsequent metastatic patterns in these patients.Patients and methodsData on a consecutive series of 1107 patients undergoing RARP at our centre between 2004 and 2018 were analysed. In men undergoing LN dissection, the internal, external and obturator nodes were removed and sent in separately. We performed an analysis of LN yields in total and for each anatomical zone, patterns of LN metastases and complications. Oncological outcome in pN+ disease was assessed including postoperative PSA persistence and survival.ResultsA total of 823 ePLNDs were performed in the investigated cohort resulting in 98 men being diagnosed as pN+ (8.9%). The median (IQR) LN yield was 19 (14–25), 10 (7–13) on the right and 9 (6–12) on the left side (P < 0.001). A median of six (4–8) LNs were retrieved from the external, three (1–6) from the internal iliac artery, and eight (6–12) from the obturator fossa. More men had metastatic LNs on the right side compared to the left (41 vs. 19). Symptomatic lymphoceles occurred exclusively in the ePLND group (2.3% vs. 0%, p = 0.04). Postoperatively, 47 (47.9%) of men with pN+ reached a PSA of < 0.1μg/ml. There was no association between a certain pN+ region and postoperative PSA persistence or BCRFS. The estimated cancer specific survival rate at 5 years was 98.5% for pN+ disease.ConclusionRobot-assisted laparoscopic ePLND with a high LN yield and low complication rate is feasible. However, we observed an imbalance in more removed and positive LNs on the right side compared to the left. A high rate of postoperative PSA persistence and early recurrence in pN+ patients might indicate a possibly limited therapeutical value of the procedure in already spread disease. Yet, these men demonstrated an excellent survival.

Are Biodegradable Calcium Sulfate Antibiotic Beads Effective and Safe Adjuvants for Diabetic Foot Osteomyelitis?

Diabetic foot osteomyelitis (DFO) is a highly morbid condition that commonly affects diabetic patients. Biodegradable calcium-sulfate antibiotic beads (CaSO4) are theoretical adjuvant agents to reduce morbidity in DFO. However, there is a paucity of research on the safety and effectiveness of CaSO4 beads in DFO.Therefore, the purpose of this study was to assess the safety and effectiveness of CaSO4 beads in different DFO locations. We conducted a retrospective cohort study between January 1, 2015 and January 1, 2022 of patients with DFO who underwent surgical intervention and adjuvant CaSO4 beads placement.The location of DFO was determined based on the forefoot, midfoot, or hindfoot locations.Outcomes measured were ulcer-free time points of three and six months as well as recurrence of DFO at 12 months.Safety was also evaluated with incidences of acute kidney injury, wound drainage, and hypercalcemia. Forty-five cases were included. Of these, only 9/45 (20%) and 13/45 (29%) were ulcer-free at three months and six months, respectively.DFO recurred in 19/45 (42%) patients.Safety outcomes were significant for wound drainage (62%) and acute kidney injury (9%).Stratifying according to the location of DFO showed no statistically significant difference in outcomes. In this cohort study, adjuvant CaSO4 beads showed high rates of ulcer persistence and DFO recurrence. Given the limited benefits seen here and the potential for high rates of wound drainage, the use of adjuvant CaSO4 beads should be used cautiously until a multicenter randomized clinical trial is conducted to definitely evaluate the safety and effectiveness of CaSO4 beads in DFO.