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Background: This study aimed to describe the life impacts of intravesical therapies for non-muscle invasive bladder cancer (NMIBC) from a patient perspective. Methods: A cross-sectional online survey design was used. Adults with NMIBC (and no other cancer) treated intravesically in the prior 12 months were recruited from US patient online communities. Individuals participating in a clinical trial or treated with erdafitinib were excluded. Participants' treatment experiences were evaluated using a questionnaire comprising (a) custom questions reported on 11-point numerical rating scales and (b) validated patient reported outcome (PRO) measures for bladder symptom burden and work productivity. Results: Among 171 survey participants, most received bacillus Calmette-Guérin (BCG) (83%), intravesical gemcitabine (28%), or gemcitabine + docetaxel (13%) during the past year. Participants generally felt adequately informed about treatment, felt expectation of treatment matched actual experience, and expressed intent to complete the full treatment course and willingness to try different treatments if needed. Participants reported disease symptom burden of 42.6/72 on the NFBlSI-18 scale. Employed participants reported 51% work impairment and 59% overall work productivity loss due to NMIBC. Conclusions: Participants recently treated with intravesical therapies expressed intent to complete the full treatment course and willingness to try new therapies if needed. Participants reported high NMIBC symptom burden and work impairment negatively impacting their well-being, despite receiving intravesical treatment. [ABSTRACT FROM AUTHOR]

Aim: To describe overall survival, time to castration resistance and castration resistance-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) initiating apalutamide in a US oncology network. Patients & methods: Patients with mCSPC initiating apalutamide on or after 17 September 2019 from an electronic health record-derived deidentified database were included. Patients were followed from apalutamide initiation and were censored at the earlier of end of clinical activity or data availability (31 October 2022). Results: At 12 and 24 months, overall survival rates were 91.0 and 88.3%, rates of castration sensitivity were 85.7 and 72.1%, and castration resistance-free survival rates were 80.2 and 65.9%, respectively. Conclusion: Real-world clinical outcomes of patients with mCSPC treated with apalutamide were comparable to results from the phase III TITAN trial. Plain Language Summary Health outcomes among patients with prostate cancer receiving apalutamide: This study looked at health outcomes among 176 patients receiving a prostate cancer medication, apalutamide. The average age of patients was 72 years, and approximately two-thirds of patients were White. Two years after starting apalutamide, most patients remained alive and their cancer did not progress. Article highlights This real-world study supported the real-world effectiveness of apalutamide based on data from 176 patients with metastatic castration-sensitive prostate cancer treated with apalutamide from a US oncology network. Compared with the TITAN phase III trial, patients in this study were slightly older, Gleason scores were lower, and more patients had previous therapy for localized prostate cancer. Despite some differences in baseline characteristics, survival rates of patients treated with apalutamide were similar to those observed in TITAN; overall survival at 24 months was 88.3% in this study and 83.3% in TITAN. The impact of apalutamide in delaying time to castration resistance was similar between this study and TITAN; at 24 months, rates of castration sensitivity were 72.1% in this study and 67.7% in TITAN. When a composite outcome of castration resistance-free survival was considered (an outcome not reported in TITAN), 65.9% of patients were alive and had not developed castration resistance at 24 months after apalutamide initiation. [ABSTRACT FROM AUTHOR]

Introduction: Fistula is a common complication of Crohn's disease (CD). Treatment with biologics has been associated with fistula healing. Long-term persistence is an important factor for a chronic inflammatory process such as fistula. This study described 24-month persistence and time-to-surgery endpoints among bio-naïve patients with CD and intestinal fistula who were initiated on ustekinumab. Methods: Adults with CD and any enteric or perianal fistula initiated on ustekinumab (index date) between September 23, 2016, and March 2, 2022, were selected from the IQVIA PharMetrics® Plus database and followed up to 24 months. Persistence on ustekinumab (no gaps in days of supply of > 120 days) and composite endpoints of being persistent while on monotherapy and persistent while corticosteroid free were also assessed. The date of surgery was defined as the date of first claim for any CD-related surgeries. Persistence and time-to-surgery endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or other biologic use (event), corticosteroid use (event), date of surgery (event), 24-month follow-up or data end (censoring) using Kaplan-Meier analyses. Results: The sample included 445 patients (mean age: 42.8 years; 56.6% female). The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI] 55.8–71.4). Furthermore, 53.3% of patients were persistent while on monotherapy (95% CI 45.1–60.7), and 45.6% of patients were persistent while being corticosteroid free (95% CI 36.9–53.8). At 24 months, 22.8% (95% CI 17.0–30.3) of patients underwent any CD-related surgery. Conclusion: This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after initiation. Time-to-surgery estimate was comparable to existing evidence. These findings support ustekinumab as a treatment option for long-term management of CD with fistula. [ABSTRACT FROM AUTHOR]

Introduction: Persistence on advanced therapies in ulcerative colitis (UC) is a useful real-world treatment performance measure. This study compared real-world persistence during the maintenance phase among advanced therapy-naïve and -experienced patients with UC initiated on ustekinumab or adalimumab. Methods: Claims data from the IQVIA PharMetrics® Plus de-identified database (01/01/2015–06/30/2022) were used to select adult patients with UC treated with ustekinumab or adalimumab based on the agent first initiated (index date) after 10/21/2019. Inverse probability of treatment weighting was used to balance cohorts on baseline characteristics. Persistence on the index agent (no gaps in days of supply of > 120 days for ustekinumab or > 60 days for adalimumab), persistence while corticosteroid-free, while on monotherapy, and persistence on the US labeled dose were described and compared during the 12-month period post-index using Kaplan–Meier analysis and Cox proportional hazards models. Outcomes were analyzed separately among advanced therapy-naïve and advanced therapy-experienced patients. Results: At 12 months post-index, advanced therapy-naïve patients receiving ustekinumab (n = 371) had higher persistence on the index agent [83.8% vs. 57.6%, hazard ratio (95% confidence interval) = 3.09 (2.29–4.16); p < 0.001), persistence while corticosteroid-free [2.00 (1.63–2.45); p < 0.001], persistence while on monotherapy [2.67 (2.07–3.44); p < 0.001], and persistence on the labeled dose [4.21 (2.76–6.44); p < 0.001] versus those receiving adalimumab (n = 1726). At 12 months post-index, advanced therapy-experienced patients receiving ustekinumab (n = 693) had higher persistence on the index agent [78.1% vs. 59.2%, 2.44 (1.82–3.26); p < 0.001], persistence while corticosteroid-free [1.24 (1.01–1.54); p = 0.0447], persistence while on monotherapy [2.53 (2.00–3.21); p < 0.001], and persistence on the labeled dose [4.77 (3.09–7.35); p < 0.001] versus those receiving adalimumab (n = 254). Conclusion: This claims-based analysis demonstrated significantly higher treatment persistence, including persistence while corticosteroid-free, persistence while on monotherapy, and persistence on the labeled dose, among both advanced therapy-naïve and advanced therapy-experienced patients with UC initiated on ustekinumab compared to adalimumab. [ABSTRACT FROM AUTHOR]

Background: 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). Methods: 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® 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. Results: 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 < 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 < 0.001). Median time to discontinuation was not reached for the guselkumab cohort and was 8.9 months for the SC TNFi cohort. Conclusion: This real-world study employing US commercial health-plan claims data to assess on-label treatment persistence in PsA demonstrated that, at 12 months, guselkumab was associated with a 3 times greater likelihood of persistence compared with SC TNFi. [ABSTRACT FROM AUTHOR]

This study assessed direct-acting oral anticoagulant (DOAC) switching/discontinuation patterns in patients with non-valvular atrial fibrillation (NVAF) in 2019, by quarter (Q1–Q4), and associated socioeconomic risk factors. Adults with NVAF initiating stable DOAC treatment (July 2018–December 2018) were selected from Symphony Health Solutions' Patient Transactional Datasets (April 2017–January 2021). Switching/discontinuation rates were reported in 2019 Q1–Q4, separately. Non-medical switching/discontinuation (NMSD) was defined as the difference between switching/discontinuation rates in Q1 and mean rates across Q2–Q4. The associations of socioeconomic factors with switching/discontinuation were assessed. Of 46,793 patients (78.7% ≥ 65 years; 52.6% male; 7.7% Black), 18.0% switched/discontinued their initial DOAC in Q1 vs. 8.8% on average in Q2–Q4, corresponding to an NMSD of 9.2%. During the quarter following the switch/discontinuation, more patients who switched/discontinued in Q1 remained untreated (Q1: 77.0%; Q2: 74.3%; Q3: 71.2%) and fewer reinitiated initial DOAC (Q1: 17.6%; Q2: 20.8%; Q3: 24.0%). Factors associated with the risk of switching/discontinuation in Q1 were race, age, gender, insurance type, and household income (all p < 0.05). More patients with NVAF switched/discontinued DOACs in Q1 vs. Q2–Q4, and more of them tended to remain untreated relative to those who switched/discontinued later in the year, suggesting a potential long-term impact of NMSD. Findings on factors associated with switching/discontinuation highlight potential socioeconomic discrepancies in treatment continuity. [ABSTRACT FROM AUTHOR]

Objectives: To describe and compare healthcare resource utilization (HRU) among advanced therapy-naïve and advanced therapy-experienced patients with ulcerative colitis (UC) initiating ustekinumab or vedolizumab in the United States. Methods: Claims data from IQVIA PharMetrics Plus de-identified database (01/01/2015–06/30/2022) were used to identify adult patients with UC initiating ustekinumab or vedolizumab (index date) after 10/21/2019. Baseline characteristics were balanced using inverse probability of treatment weighting. All-cause and UC-related HRU (number of inpatient admissions, inpatient days, emergency department visits, and outpatient visits) were described during the post-index period, and Poisson regression models were used to evaluate associations between index therapy and HRU outcomes. Analyses were performed separately among advanced therapy-naïve or advanced therapy-experienced patients. Results: A total of 444 (ustekinumab) and 1,917 (vedolizumab) advanced therapy-naïve patients, and 647 (ustekinumab) and 1,152 (vedolizumab) advanced therapy-experienced patients were identified. In advanced therapy-naïve patients, higher rates of UC-related inpatient days (rate ratio [95% confidence interval] = 1.84 [1.15, 3.58]; p = 0.004), emergency department visits (1.39 [1.01, 2.17]; p = 0.044), and outpatient visits (1.81 [1.61, 2.04]; p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. In advanced therapy-experienced patients, higher rates of UC-related inpatient admissions (1.47 [1.06, 2.12]; p = 0.012), inpatient days (2.18 (1.44, 3.71); p < 0.001), and outpatient visits (1.50 (1.19, 1.82); p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. Results were similar when all-cause HRU was examined. Conclusions: Among patients with UC with and without advanced therapy experience, higher rates of all-cause and UC-related HRU were observed among those treated with vedolizumab relative to ustekinumab. [ABSTRACT FROM AUTHOR]

Purpose: Real-world data comparing long-term performance of interleukin (IL)-23 and IL-17 inhibitors in psoriasis are limited. This study compared treatment persistence and remission among patients initiating guselkumab versus IL-17 inhibitors. Methods: Adults with psoriasis initiating guselkumab, secukinumab, or ixekizumab treatment (index date) were identified from Merative™ MarketScan® Research Databases (01/01/2016–10/31/2021). Persistence was defined as no index biologic supply gaps of twice the labeled maintenance dosing interval. Remission was defined using an exploratory approach as index biologic discontinuation for ≥6 months without psoriasis-related inpatient admissions and treatments. Results: There were 3516 and 6066 patients in the guselkumab versus secukinumab comparison, and 3805 and 4674 patients in guselkumab versus ixekizumab comparison. At 18 months, the guselkumab cohort demonstrated about twice the persistence rate as secukinumab (hazard ratio [HR] = 2.15; p < 0.001) and ixekizumab cohorts (HR = 1.77; p < 0.001). At 6 months after index biologic discontinuation, the guselkumab cohort was 31% and 40% more likely to achieve remission than secukinumab (rate ratio [RR] = 1.31; p < 0.001) and ixekizumab cohorts (RR = 1.40; p < 0.001). Conclusions: Guselkumab was associated with greater persistence and likelihood of remission than IL-17 inhibitors, indicating greater disease control and modification potential. [ABSTRACT FROM AUTHOR]

Background: With the advent of the first targeted therapy for Rett Syndrome (RTT), a comprehensive assessment of the journey of RTT is needed to elucidate on present unmet needs in this population. This study characterized females with RTT in the United States and their disease journey with respect to longitudinal treatment patterns, RTT-related outcomes, and changes in disease severity. Methods: This retrospective cohort study used registry data of females with RTT from the 5211 RTT Natural History Study (RNHS) (November 2015–July 2021). Pharmacological and supportive therapy use, RTT-related outcomes, and RTT severity, as measured by the Clinical Severity Scale and Motor Behavioral Assessment scale, were evaluated following the first RNHS visit. Analyses were conducted overall and in subgroups by RTT type (classic and atypical RTT) and age at first visit (pediatric and adult). Results: A total of 455 females with RTT were included in the study, of whom 90.5% had classic RTT and 79.8% were pediatric individuals. Over a median follow-up of 4 years, use of pharmacological therapies, including prokinetic agents (42.7% vs. 28.3%), and supportive therapies, including physical therapy (87.3% vs. 40.2%) and speech-language therapy (86.8% vs. 23.9%), were more common in pediatric than adult individuals (all p < 0.05). Nearly half (44.6%) of all individuals had a hospital or emergency room visit, with a higher proportion of visits in individuals with classic RTT than atypical RTT and pediatric than adult individuals (both p = 0.001). An increasing trend in clinical severity was observed in pediatric individuals (mean change per year: 0.24; 95% confidence interval [CI]: 0.03, 0.44), while an increasing trend in motor-behavioral dysfunction was observed in pediatric individuals (mean change per year: 1.12; 95% CI: 0.63, 1.60) and those with classic RTT (mean change per year: 0.97; 95% CI: 0.53, 1.41). Conclusions: Findings from this study highlight the considerable burden of RTT across disease subtype and age. Despite reliance on supportive therapies and healthcare encounters, individuals with RTT experience increasing disease severity and motor-behavioral dysfunction in childhood and adolescence, underscoring the unmet needs of this population and the value of early intervention to manage RTT in the long-term. [ABSTRACT FROM AUTHOR]

Introduction: Obesity is a chronic disease that increases cardiovascular and metabolic morbidity and mortality, decreases quality of life, and increases health care costs. While the role of lifestyle behavioral factors in the development of obesity is well established, the role of traumatic life events, including violence, is unclear. The purpose of this study was to describe situations of traumatic life events reported by patients undergoing a bariatric surgery program, with a particular focus on sexual violence and its clinical correlates. Methods: In this cross-sectional study, patients with grade II or III obesity, admitted to our digestive surgery department for bariatric surgery from August 01, 2019, to December 31, 2020, underwent a structured interview by a trained psychologist to describe the history of traumatic life events self-reported by the patients. The primary endpoint was the presence of a history of sexual violence (SV). Multivariate logistic regressions were applied to identify independent risk factors for SV. Results: Of the 408 patients interviewed, 87.1% reported at least one traumatic life event and 33.1% reported having had an SV in the past. Female gender (aOR = 7.44, 95% confidence interval: 3.85–15.73; p < 0.001) and higher body mass index (1.05, 1.02–1.08; p = 0.002) were associated with an increased risk of SV. Male gender was associated with a higher risk of difficulties including sports cessation, depression, and work-related distress. Conclusion: In the context of obesity, psychosocial trauma is characterized by a high frequency and several gender specificities that must be taken into account in the management of these patients. [ABSTRACT FROM AUTHOR]

Purpose: To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic. Methods: This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan–Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies). Results: Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively. Conclusion: At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess health care resource utilization (HRU) and costs associated with delayed pulmonary arterial hypertension (PAH) diagnosis in the United States. Methods: Eligible adults with newly diagnosed PAH from Optum's de-identified Clinformatics® Data Mart Database (2016–2021) were assigned to mutually exclusive cohorts based on time between first PAH-related symptom and first PAH diagnosis (i.e., ≤12 months' delay, >12 to ≤24 months' delay, >24 months' delay). All-cause HRU and health care costs per patient per month (PPPM) were assessed during the first year following diagnosis and compared across cohorts using regression analysis adjusted for baseline covariates. Sensitivity analyses were conducted to assess outcomes during all available follow-up post-diagnosis. Results: Among 538 patients (mean age: 65.6 years; 60.6% female), 60.8% had ≤12 months' delay, 23.4% had a delay of >12 to ≤24 months, and 15.8% had >24 months' delay. Compared with ≤12 months, delays of >12 to ≤24 months and >24 months were associated with increased hospitalizations (incidence rate ratio [95% confidence interval]: 1.40 [1.11–1.71] vs 1.71 [1.29–2.12]) and outpatient visits (1.17 [1.06–1.30] vs 1.26 [1.08–1.41]). Longer delays were also associated with more intensive care unit (ICU) stays and 30-day readmissions. Diagnosis delays translated into excess costs PPPM of US$3986 [1439–6436] for >12 to ≤24 months and US$5366 [2107–8524] for >24 months compared with ≤12 months' delay; increased hospitalization costs (US$3248 [1108–5135] and US$4048 [1401–6342], respectively) being the driver. Sensitivity analyses yielded similar trends. Conclusions: Delayed PAH diagnosis is associated with significant incremental economic burden post-diagnosis, driven by hospitalizations including ICU stays and 30-day readmissions, highlighting the need for increased awareness and a potential benefit of earlier screening. [ABSTRACT FROM AUTHOR]

Aim: To investigate real-world time to next treatment in patients with chronic lymphocytic leukemia initiating first-line (1L) ibrutinib or acalabrutinib. Materials & methods: US specialty pharmacy electronic medical records (21/11/2018–30/4/2022) were used; patients initiated 1L on/after 21/11/2019 (acalabrutinib approval). Results: Among 710 patients receiving ibrutinib, 5.9% initiated next treatment (mean time to initiation = 9.2 months); among 373 patients receiving acalabrutinib, 7.5% initiated next treatment (mean time to initiation = 5.9 months). Adjusting for baseline characteristics, acalabrutinib-treated patients were 89% more likely to initiate next treatment (hazard ratio = 1.89; p = 0.016). Conclusion: This study addresses a need for real-world comparative effectiveness between 1L ibrutinib and acalabrutinib and shows that next treatment (a clinically meaningful measure for real-world progression) occurred less frequently with 1L ibrutinib. Ibrutinib and acalabrutinib are oral medications taken once-daily and twice-daily, respectively. They are recommended as initial treatment for chronic lymphocytic leukemia (CLL). The goal of this study was to compare the efficacy of these treatments as initial treatment for CLL. To meet this goal, real-world US specialty pharmacy electronic medical records between 11/21/2018–4/30/2022 were used. Patients treated with ibrutinib or acalabrutinib as initial treatment for CLL were studied. Treatment had to be started on or after the date of acalabrutinib approval for CLL (11/21/2019). Time to next treatment was used to estimate real-world disease progression. It was defined as the time from the initiation of initial treatment with ibrutinib or acalabrutinib to the initiation of a next treatment. Study results showed that patients were observed for a median of up to 1.5 years. Over this period, next treatment was more likely for acalabrutinib (7.5%) compared with ibrutinib (5.9%). After adjusting for differences in patient characteristics, next treatment was 89% more likely with acalabrutinib than ibrutinib. This study addresses a need to compare the effectiveness of initial treatment with ibrutinib and acalabrutinib in the real-world. It helps better contextualize results from clinical trial data and shows that next treatment occurred less frequently with ibrutinib. A real-world study using US specialty pharmacy electronic medical records found that first-line patients with chronic lymphocytic leukemia initiated on acalabrutinib were 89% more likely to initiate next treatment relative to those initiated on ibrutinib. [ABSTRACT FROM AUTHOR]

Biologics, Guselkumab, Persistence, Psoriasis, Remission, Treatment discontinuation Keywords: Biologics; Guselkumab; Persistence; Psoriasis; Remission; Treatment discontinuation EN Biologics Guselkumab Persistence Psoriasis Remission Treatment discontinuation 2917 2923 7 10/31/23 20231101 NES 231101 This reply refers to the comment available online at https://doi.org/10.1007/s13555-023-01015-w. Defining remission with claims data also has limitations, but identifying patients off all psoriasis treatment (while remaining insured) may be a reasonable proxy for full remission. [Extracted from the article]

Introduction: Connective tissue disorders (CTDs) are the most frequent diseases associated with pulmonary arterial hypertension (PAH). Despite advances in treatment, the prognosis of CTD-related PAH remains poor. To help identify areas for improvement in the management of CTD-related PAH, this study assessed real-world PAH treatment patterns in this population in the US. Methods: Eligible adult patients with PAH initiated on a PAH treatment (index date: 1st initiation date) were identified from Optum's de-identified Clinformatics® Data Mart Database (10/01/2015–09/30/2021) and categorized into mutually exclusive cohorts (CTD + PAH; PAH) based on the presence of CTD diagnosis claims. Treatment patterns were assessed from the index date to the earliest of death or end of continuous insurance eligibility, or data availability. Treatment persistence was assessed using Kaplan-Meier analysis. Results: A total of 4751 patients were included (CTD + PAH: n = 728, mean follow-up of 18.8 months; PAH: n = 4023, mean follow-up of 19.6 months). For both cohorts, the most common first treatment regimens were sildenafil (CTD + PAH: 38.7%; PAH: 51.5%), tadalafil (10.0%; 9.4%), and macitentan (8.1%; 5.4%) monotherapy; these were also the most frequent agents included in any of the first 3 treatment regimens. Combination therapy was more frequent in the CTD + PAH versus PAH cohort (any regimen: 40.9% vs. 27.2%; 1st treatment regimen: 26.9% vs. 18.5%; 2nd: 52.8% vs. 42.0%; 3rd: 55.2% vs. 48.5%). Treatment persistence was similar across cohorts and the first three treatment regimens, with persistence rates ranging from 42.6 to 49.7% at 12 months. Conclusions: Treatment patterns were generally similar between the CTD + PAH and PAH cohorts, although combination therapy was more frequent in the CTD + PAH cohort. Both cohorts may benefit from broader use of all available PAH treatment classes, including combination therapy. Considering the life-threatening nature of PAH, our findings also highlight the need to address the low persistence rates with PAH therapies regardless of etiology. [ABSTRACT FROM AUTHOR]

Bariatric surgery induces bone loss, but the exact mechanisms by which this process occurs are not fully known. The aims of this 2-year longitudinal study were to (i) investigate the changes in areal bone mineral density (aBMD) and bone turnover markers following sleeve gastrectomy (SG) and (ii) determine the parameters associated with the aBMD variations. Bone turnover markers, sclerostin, periostin and semaphorin 4D were assessed before and 1, 12 and 24 months after SG, and aBMD was determined by DXA at baseline and after 12 and 24 months in 83 patients with obesity. Bone turnover increased from 1 month, peaked at 12 months and remained elevated at 24 months. Periostin and sclerostin presented only modest increases at 1 month, whereas semaphorin 4D showed increases only at 12 and 24 months. A significant aBMD decrease was observed only at total hip regions at 12 and 24 months. This demineralisation was mainly related to body weight loss. In summary, reduced aBMD was observed after SG in the hip region (mechanical-loading bone sites) due to an increase in bone turnover in favour of bone resorption. Periostin, sclerostin and semaphorin 4D levels varied after SG, showing different time lags, but contrary to weight loss, these biological parameters did not seem to be directly implicated in the skeletal deterioration. [ABSTRACT FROM AUTHOR]

Introduction: This study aims to assess the risk of direct oral anticoagulant (DOAC) discontinuation among Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) who reach the Medicare coverage gap stratified by low-income subsidy (LIS) status and the impact of DOAC discontinuation on rates of stroke and systemic embolism (SE) among beneficiaries with increased out-of-pocket (OOP) costs due to not receiving LIS. Methods: In this retrospective cohort study, Medicare claims data (2015–2020) were used to identify beneficiaries with NVAF who initiated rivaroxaban or apixaban and entered the coverage gap during ≥ 1 year. DOAC discontinuation rates during the coverage gap were stratified by receipt of Medicare Part D Low-Income Subsidy (LIS), a proxy for not experiencing increased OOP costs. Among non-LIS beneficiaries, incidence rates of stroke and SE during the subsequent 12 months were compared between beneficiaries who did and did not discontinue DOAC in the coverage gap. Results: Among 303,695 beneficiaries, mean age was 77.3 years, and 28% received LIS. After adjusting for baseline differences, non-LIS beneficiaries (N = 218,838) had 78% higher risk of discontinuing DOAC during the coverage gap vs. LIS recipients (adjusted hazard ratio [aHR], 1.78; 95% CI [1.73, 1.82]). Among non-LIS beneficiaries, DOAC discontinuation during coverage gap (N = 91,397; 34%) was associated with 14% higher risk of experiencing stroke and SE during the subsequent 12 months (aHR, 1.14; 95% CI [1.08, 1.20]). Conclusion: Increased OOP costs during Medicare coverage gap were associated with higher risk of DOAC discontinuation, which in turn was associated with higher risk of stroke and SE among beneficiaries with NVAF. [ABSTRACT FROM AUTHOR]

Background: Patient affordability is an important nonclinical consideration for treatment access among patients with schizophrenia. Objective: This study evaluated and measured out-of-pocket (OOP) costs for antipsychotics (APs) among Medicaid beneficiaries with schizophrenia. Methods: Adults with a schizophrenia diagnosis, ≥ 1 AP claim, and continuous Medicaid eligibility were identified in the MarketScan® Medicaid Database (1 January 2018–31 December 2018). OOP AP pharmacy costs ($US 2019) were normalized for a 30-day supply. Results were descriptively reported by route of administration [ROA; orals (OAPs), long-acting injectables (LAIs)], generic/branded status within ROAs, and dosing schedule within LAIs. The proportion of total (pharmacy and medical) OOP costs AP-attributable was described. Results: In 2018, 48,656 Medicaid beneficiaries with schizophrenia were identified (mean age 46.7 years, 41.1% female, 43.4% Black). Mean annual total OOP costs were $59.97, $6.65 of which was AP attributable. Overall, 39.2%, 38.3%, and 42.3% of beneficiaries with a corresponding claim had OOP costs > $0 for any AP, OAP, and LAI, respectively. Mean OOP costs per patient per 30-day claim (PPPC) were $0.64 for OAPs and $0.86 for LAIs. By LAI dosing schedule, mean OOP costs PPPC were $0.95, $0.90, $0.57, and $0.39 for twice-monthly, monthly, once-every-2-months, and once-every-3-months LAIs, respectively. Across ROAs and generic/branded status, projected OOP AP costs per-patient-per-year for beneficiaries assumed fully adherent ranged from $4.52 to $13.70, representing < 25% of total OOP costs. Conclusion: OOP AP costs for Medicaid beneficiaries represented a small fraction of total OOP costs. LAIs with longer dosing schedules had numerically lower mean OOP costs, which were lowest for once-every-3-months LAIs among all APs. [ABSTRACT FROM AUTHOR]

To compare the risk of stroke and systemic embolism (SE) among patients with nonvalvular atrial fibrillation (NVAF) who abandoned their first direct oral anticoagulant (DOAC) fill ("abandoners") relative to patients who continued DOACs beyond the first fill ("continuers"). In this retrospective longitudinal study, adults with NVAF prescribed DOACs were selected from Symphony Health, an ICON plc Company, PatientSource, 1 April 2017 to 31 October 2020. A 90-day landmark period following the first DOAC fill was used to classify patients as abandoners or continuers. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Time to ischemic stroke/SE was described and compared between cohorts using weighted Kaplan-Meier and Cox proportional hazard models from the end of the landmark period until end of clinical activity or data. After weighting, 200,398 and 211,352 patients comprised the abandoner and continuer cohorts, respectively. The mean duration of follow-up was 14.9 and 15.7 months, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.34% in the abandoner cohort and 1.00% in the continuer cohort; the risk of ischemic stroke/SE was 35% higher in the abandoner versus continuer cohort (hazard ratio [95% confidence interval] = 1.35 [1.20, 1.51]; p < 0.0001). Patients with NVAF who abandoned the first DOAC fill had significantly higher risk of ischemic stroke/SE compared to patients who continued therapy beyond the first fill. There is an unmet need for better access to DOACs so that the long-term risk of poor outcomes may be minimized. [ABSTRACT FROM AUTHOR]

To evaluate the time to discontinuation (TTD) and baseline characteristics among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) treated with first-line (1L) venetoclax + obinutuzumab (VO) in the United States. A nationwide electronic health record-derived database was used to select adults with CLL/SLL initiating a 1L venetoclax-based regimen between April 11, 2016–July 31, 2020. Study measures included TTD (defined as >120-day treatment gap or switching therapy) and baseline characteristics by discontinuation status. A total of 113 patients receiving 1L VO on/before July 31, 2020 were eligible for analysis (mean age: 65.9 years; 31.9% women). During the first 60 days post-treatment initiation, 3.5% had tumor lysis syndrome (TLS). The proportion of patients using corticosteroids, anti-hyperuricemics, and anti-emetics was higher during the first 60 days post-treatment initiation (100.0%, 78.8%, and 52.2%, respectively) than the period from day 61 onward (67.0%, 45.5%, and 33.9%, respectively). Mean (median) duration of active treatment was 11.6 (12.1) months; 16.8% discontinued treatment before completing 12 cycles, 68.1% completed ≥12 cycles (among which 29.9% completed ≥15 cycles), and 15.0% who did not discontinue treatment were censored before completing 12 cycles. Kaplan-Meier analysis showed that median TTD was 13.8 months. Relative to those completing ≥12 cycles, patients discontinuing treatment before completing the prescribed 12 cycles were older (70.4 vs. 65.1 years) and had poorer renal function (36.8% vs. 13.0% with creatinine clearance <60 mL/min). A small proportion of CLL/SLL patients who were older and had poorer baseline renal function discontinued 1L VO prior to completing 12 treatment cycles. Additionally, treatment utilization, including medications related to TLS mitigation and management, was more intense during the initiation phase of VO. Further research with longer follow-up to assess long-term outcomes of VO treatment after early discontinuation is warranted. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) are the American Society of Hematology guideline-recommended treatment for venous thromboembolism (VTE) in the United States (US). Aim: To compare risk of VTE recurrence between patients who, following the first fill, discontinued ("one-and-done") versus those who continued ("continuers") DOACs. Method: Open source US insurance claims data (04/1/2017 to 10/31/2020) were used to select adult patients with VTE initiated on DOACs (index date). Patients with only one DOAC claim during the 45-day landmark period (starting on the index date) were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to reweight baseline characteristics between cohorts. VTE recurrence based on the first post-index deep vein thrombosis or pulmonary embolism event was compared using weighted Kaplan–Meier and Cox proportional hazard models from landmark period end to clinical activity or data end. Results: 27% of patients initiating DOACs were classified as one-and-done. After weighting, 117,186 and 116,587 patients were included in the one-and-done and continuer cohorts, respectively (mean age 60 years; 53% female; mean follow-up 15 months). After 12 months of follow-up, the probability of VTE recurrence was 3.99% and 3.36% in the one-and-done and continuer cohorts; the risk of recurrence was 19% higher in the one-and-done cohort (hazard ratio [95% confidence interval] = 1.19 [1.13, 1.25]). Conclusion: Substantial proportion of patients discontinued DOAC therapy after the first fill, which was associated with significantly higher risk of VTE recurrence. Early access to DOACs should be encouraged to reduce the risk of VTE recurrence. [ABSTRACT FROM AUTHOR]

Purpose: Increased dosing frequency adversely affects treatment adherence and outcomes in chronic diseases; however, such data related to treatment adherence is lacking in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This study compared adherence between patients treated with ibrutinib (once-daily) versus acalabrutinib (twice-daily) as first-line (1L) therapy for CLL/SLL.Patients and Methods: Specialty pharmacy electronic medical records were used to identify adults with CLL/SLL initiating 1L ibrutinib or acalabrutinib between 01/01/2018 and 11/30/2020. Adherence was measured by the proportion of days covered (PDC) and medication possession ratio (MPR) and was compared between cohorts using odds ratios (ORs) obtained from logistic regression models adjusted for baseline characteristics.Results: Between 01/01/2018 and 11/30/2020, 1374 and 140 patients initiated ibrutinib and acalabrutinib, respectively. Based on PDC/MPR ≥ 80%, patients treated with once-daily ibrutinib were more likely to be adherent than those treated with twice-daily acalabrutinib (OR ranges: PDC: 1.04– 1.76; MPR: 1.03– 1.58). At 6 months, patients on ibrutinib had a 58– 76% higher likelihood of staying adherent compared to patients on acalabrutinib (PDC: 75.9% for ibrutinib vs 63.6% for acalabrutinib, OR: 1.76, P= 0.008; MPR: 76.8% vs 66.9%, OR: 1.58, P= 0.036) with a similar trend noted for the entire line of treatment (LOT) (PDC: 53.0% vs 41.4%, OR: 1.53, P= 0.021; MPR: 58.7% vs 47.1%, OR: 1.50, P= 0.027).Conclusion: In this real-world analysis, CLL/SLL patients initiating 1L once-daily ibrutinib had > 50% higher treatment adherence than those initiating twice-daily acalabrutinib during their LOT. Given the importance of sustained adherence for disease control in CLL/SLL, dosing frequency may be an important consideration for patients and physicians. [ABSTRACT FROM AUTHOR]

To describe access and real-world use patterns of esketamine nasal spray among adults with treatment-resistant depression (TRD) with private or public insurance. Adults with ≥1 claim for esketamine nasal spray were selected from Clarivate's Real World Data product (January 2016–March 2021). Patients with evidence of TRD initiating esketamine (index date) after 05 March 2019 were included. Esketamine access, as measured by pharmacy claim approval rate for each treatment session, and use patterns were described post-index (follow-up period). Among 535 patients with pharmacy claims for esketamine nasal spray (mean age 49.1 years; 65.4% females), 534 had the first esketamine claim being a pharmacy claim, of which 34.6% were approved, 46.3% were rejected, and 19.1% were abandoned. Main reasons for rejection included "claim not covered by plan" (57.1%), "claim errors" (52.6%), and "prior authorization required" (22.7%). The approval rate increased to 85.2% by the second esketamine treatment session. A total of 273 patients initiated esketamine (mean age 49.3 years; 66.3% females). Patients had a mean ± standard deviation (SD) of 11.8 ± 13.3 esketamine sessions over a mean ± SD of 11.8 ± 6.4 months; 47.6% of patients completed ≥8 sessions (i.e. the number of sessions in induction phase) over a mean ± SD of 80.1 ± 71.9 days (per label, 28 days); 48 (17.6%) patients completed induction per label, and among them 93.8% continued treatment. Initial access to esketamine nasal spray may be hindered by prior authorization or claim filing errors. Among patients who initiated esketamine, treatment compliance generally deviates from label recommendations; yet, most of those who received induction per label successfully transition to maintenance with esketamine. Esketamine nasal spray is a novel therapy for treatment-resistant depression (TRD). In the United States, insurance plans often regulate access to esketamine. Additionally, for patients, it may be challenging to comply to the treatment schedule, because patients must receive esketamine in a certified treatment center, be monitored for 2 h for potential side effects, and they cannot drive until the next day. This real-world study used insurance claims data and found that patients with TRD had difficulties accessing esketamine. Among those with access, esketamine use patterns were suboptimal. [ABSTRACT FROM AUTHOR]

Maintaining continuity of care after schizophrenia-related hospitalization is challenging for patients and healthcare providers and systems. Prior evidence suggests that second-generation long-acting injectable antipsychotics (SGLAIs) may reduce the risk of treatment nonadherence and readmission versus oral atypical antipsychotics (OAAs). Therefore, quality measures were compared between patients initiated on SGLAIs and OAAs in the United States. Adults newly initiated on an SGLAI or OAA during a schizophrenia-related inpatient stay were identified in HealthVerity databases (01/2015–12/2020); the index date was the hospital discharge date. Patients had continuous health insurance coverage for pharmacy and medical services for 6 months pre-admission and post-discharge from the inpatient stay and ≥1 pharmacy or medical claim (i.e. treatment as indicated by the observed insurance claims) for an antipsychotic other than the index SGLAI or OAA in the 6 months pre-admission. Antipsychotic use and adherence, and schizophrenia-related readmissions and outpatient visits were compared during the 6-month period post-discharge. Characteristics between cohorts were balanced using inverse probability weights. Post-discharge, only 36.9% and 40.7% of weighted SGLAI (N = 466) and OAA (N = 517) patients had ≥1 pharmacy or medical claim for the antipsychotic initiated during the inpatient stay, among whom SGLAI patients were 4.4 times more likely to be adherent to that antipsychotic compared to OAA patients (p <.001). Additionally, SGLAI patients were 2.3 and 3.0 times more likely to have a pharmacy or medical claim for and be adherent to any antipsychotic relative to OAA patients (including index antipsychotic; all p <.001). Within 7 and 30 days post-discharge, 1.7% and 13.0% of SGLAI patients and 4.1% and 12.6% of OAA patients had a readmission. Further, SGLAI patients were 51% more likely to have an outpatient visit compared to OAA patients (p =.044). Less than half of patients initiated on antipsychotics during a schizophrenia-related inpatient stay continued the same treatment post-discharge. However, SGLAI patients were more likely to be adherent to the initiated antipsychotic and to have an outpatient visit, which may suggest improved continuity of care post-discharge relative to OAA patients. [ABSTRACT FROM AUTHOR]

Background: An estimated 10–15% of non-small cell lung cancer (NSCLC) cases present with epidermal growth factor receptor mutation (EGFRm). While EGFR tyrosine kinase inhibitors (EGFR-TKIs) such as osimertinib have become first-line (1L) standard of care for these patients, limited chemotherapy use still occurs in real-world practice. Studies of healthcare resource use (HRU) and cost of care provide a means by which the value of various treatment regimens, healthcare efficiency, and disease burden can be assessed. These studies are important for population health decision makers and health systems that prioritize value-based care to drive population health. Objective: The aim of this study was to descriptively assess HRU and costs among patients with EGFRm advanced NSCLC initiating 1L therapy in the United States. Methods: IBM MarketScan Research Databases (January 1, 2017 to April 30, 2020) were used to identify adult patients with advanced NSCLC, based on a diagnosis for lung cancer (LC) and initiation of 1L therapy or diagnosis of metastases within 30 days of the first LC diagnosis. All patients had ≥ 12 months of continuous insurance eligibility prior to the first LC diagnosis and initiated (in 2018 or after) an EGFR-TKI during any line of therapy to proxy EGFRm status. Per-patient-per-month all-cause HRU and costs were described during 1L for patients initiating 1L osimertinib or chemotherapy. Results: A total of 213 patients with advanced EGFRm NSCLC were identified (mean age at 1L initiation: 60.9 years; 69.0% female). In 1L, 66.2% initiated osimertinib, 21.1% chemotherapy, and 12.7% another regimen. Mean 1L therapy duration was 8.8 months (osimertinib) and 7.6 months (chemotherapy), respectively. Among osimertinib recipients, 28% had an inpatient admission, 40% an emergency room (ER) visit, and 99% an outpatient visit. Among chemotherapy recipients, these proportions were 22%, 31%, and 100%. Mean monthly all-cause healthcare costs among osimertinib and chemotherapy patients were US$27,174 and US$23,343, respectively. Among osimertinib recipients, drug-related costs (including pharmacy and outpatient antineoplastic drug and administration costs) made up 61% (US$16,673) of total costs, inpatient costs 20% (US$5462), and other outpatient costs 16% (US$4432). In chemotherapy recipients, 59% (US$13,883) of total costs were drug-related, 5% (US$1166) were inpatient costs, and 33% (US$7734) other outpatient costs. Conclusions: Higher mean total cost of care was observed among patients receiving 1L TKI (osimertinib) than 1L chemotherapy in EGFRm advanced NSCLC. However, descriptive differences in type of spending and HRU were identified: higher inpatient costs and inpatient days for osimertinib versus higher outpatient costs for chemotherapy. Findings suggest that significant unmet needs may remain for 1L treatment of EGFRm NSCLC, and despite significant advances in targeted care, further individualized therapies are needed to balance benefits, risks, and total cost of care. Furthermore, observed descriptive differences in inpatient admissions may have implications for quality of care and patient quality of life, for which additional research is warranted. [ABSTRACT FROM AUTHOR]

Introduction: Direct oral anticoagulants (DOACs) are essential in ischemic stroke/systemic embolism (SE) prevention among patients with nonvalvular atrial fibrillation (NVAF). This study compared the risk of ischemic stroke/SE among patients with NVAF who discontinued DOACs following the first fill ("one-and-done") relative to patients who continued DOACs beyond the first fill ("continuers"). Methods: De-identified data from Symphony Health, an ICON plc Company, PatientSource®, April 1, 2017 to October 31, 2020, were used to identify adults with NVAF initiated on DOACs (index date). Patients with only one DOAC claim during the 90-day landmark period starting on the index date were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to balance baseline characteristics in the cohorts. Time from the landmark period end to the first ischemic stroke/SE event or, among those without the event, to clinical activity or data end was compared between balanced cohorts using survival analysis. Results: Of patients initiating DOACs, 23.6% were classified as one-and-done users. After weighting was performed, 241,159 and 238,889 patients comprised the one-and-done and continuer cohorts, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.44% in the one-and-done cohort and 1.00% in the continuer cohort [hazard ratio (95% confidence interval) 1.44 (1.34–1.54); p < 0.0001]. Results at earlier and later time points and in a sensitivity analysis with a 75-day landmark period were similar. Conclusion: A substantial proportion of patients were one-and-done DOAC users, which was associated with significantly higher risk of ischemic stroke/SE events. There is an unmet need to improve access and encourage continuous use of DOACs among patients with NVAF so that severe and fatal complications may be mitigated. [ABSTRACT FROM AUTHOR]

Background Literature describing respiratory syncytial virus (RSV)–related complications in older adults in the United States is scarce. This study described risk factors of RSV-related complications and healthcare costs of Medicare-insured patients aged ≥60 years with medically attended RSV. Methods 100% Medicare Research Identifiable Files (1 January 2007–31 December 2019) were used to identify adults aged ≥60 years with RSV (index: first diagnosis date). Predictors of ≥1 RSV-related complication (ie, pneumonia, acute respiratory failure, congestive heart failure, hypoxia/dyspnea, non-RSV lower/upper respiratory tract infections, or chronic respiratory disease) during the up to 6-month post–RSV diagnosis period were identified. Patients with all aforementioned diagnoses during the 6 months pre-index could not be evaluated for a complication and were therefore ineligible for analyses. Differences between 6-month pre- and post-index total all-cause and respiratory/infection-related healthcare costs were assessed. Results Overall, 175 392 patients with RSV were identified. Post–RSV diagnosis, 47.9% had ≥1 RSV-related complication, with mean time-to-event of 1.0 month. The most common complications were pneumonia (24.0%), chronic respiratory disease (23.6%), and hypoxia or dyspnea (22.0%). Baseline predictors of ≥1 RSV-related complication included having previous diagnoses for complication/comorbidity listed in the Methods, hypoxemia, chemotherapy, chest radiograph, stem cell transplant, and anti-asthmatic and bronchodilator use. Total all-cause and respiratory/infection-related healthcare costs were $7797 and $8863 higher, respectively, post-index versus pre-index (both P <.001). Conclusions In this real-world study, almost half of patients with medically attended RSV experienced an RSV-related complication within 1 month post–RSV diagnosis, and costs significantly increased post-diagnosis. Having a complication/comorbidity pre-RSV predicted a higher risk of developing a different complication post–RSV infection. [ABSTRACT FROM AUTHOR]

Background: Rett syndrome (RTT) is a neurodevelopmental disorder that almost exclusively affects females and is associated with high clinical burden. However, literature characterizing the real-world journey of patients with RTT is limited. This study provided an overview of the epidemiology, patient characteristics, clinical manifestations, healthcare resource utilization (HRU), costs, and treatment patterns of patients with RTT in the US. Methods: IQVIA™ Medical Claims Data and Longitudinal Prescription Data (11/01/2016–10/31/2019) were used to identify female patients with RTT, with the first observed diagnosis defined as the index date. Annual incidence and prevalence of RTT were assessed over the entire study period; clinical manifestations, all-cause and RTT-related HRU and costs, and treatment patterns were evaluated during the observation period—from the index date to end of clinical activity or end of data availability, whichever occurred first. Results were further stratified into pediatric (< 18 years) and adult (≥ 18 years) subgroups. Results: In 2019, prevalence and incidence of RTT was 0.32 and 0.23 per 10,000 enrollees, respectively. Among 5,940 female patients (pediatric: 3,078; adult: 2,862) with mean observation period of 2.04 years, the most prevalent clinical manifestations were neurological disorders (72.8%), gastrointestinal/nutritional disorders (41.9%), and orthopedic disorders (34.6%). The incidence rate of all-cause HRU was 44.43 visits per-patient-per-year and RTT-related HRU comprised 47% of all-cause HRU. Mean all-cause healthcare costs were $40,326 per-patient-per-year, with medical costs driven by home/hospice care visits, therapeutic services, outpatient visits, and inpatient visits. RTT-related healthcare costs comprised 45% of all-cause healthcare costs. The most prevalent supportive therapy and pharmacologic agent were feeding assistance (37.9%) and antiepileptic drugs (54.8%), respectively. Trends were similar by subgroup; although, rates of HRU were generally higher among pediatric patients relative to adult patients (all-cause: 52.43 and 35.86, respectively), which translated into higher mean healthcare costs (all-cause: $45,718 and $34,548, respectively). Conclusions: Patients with RTT have substantial disease burden, including prevalent clinical manifestations, high rates of HRU and annual healthcare costs, and reliance on pharmacologic and supportive therapies. These findings underscore the unmet need for effective therapies to target the multifactorial manifestations of RTT. [ABSTRACT FROM AUTHOR]

Background: Biologics have revolutionized the management of psoriasis, but response to treatment varies. Loss of treatment efficacy may occur over time, requiring treatment switching or escalation. Claims data on persistence may be informative of real-world treatment outcome. This analysis described persistence and rates of remission of patients with psoriasis initiated on current biologics. Methods: Adults with psoriasis initiated (index date) on guselkumab, adalimumab, secukinumab, or ixekizumab between 07/13/2017 and 07/31/2020 were identified in the IBM MarketScan Databases. Discontinuation (or end of persistence) was defined as gaps in index biologic supply of more than twice the labelled dosing interval or mode days of supply (> 120 days for guselkumab and > 60 days for adalimumab, secukinumab, and ixekizumab). The proportion of patients reinitiating index therapy post-discontinuation and the proportion achieving remission (proxy definition: no claims for psoriasis-related treatment post-discontinuation among patients with ≥ 6 months of follow-up post-discontinuation) were assessed. Results: There were 3408 patients in the guselkumab (mean age: 47.9 years old; female: 47.1%), 8017 in the adalimumab (47.4 years old; 54.1%), 6123 in the secukinumab (49.4 years old; 54.2%), and 3728 in the ixekizumab cohorts (49.1 years old; 50.3%). The median time to discontinuation was 26.2 months in the guselkumab cohort and 9.9, 12.4, and 12.5 months in adalimumab, secukinumab, and ixekizumab cohorts, respectively. Among those who discontinued index therapy, 22.9% in the guselkumab cohort and 21.1%, 31.9%, and 32.0% in the adalimumab, secukinumab, and ixekizumab cohorts reinitiated it. Remission rates were 17.2% in the guselkumab cohort and 12.4%, 10.5%, and 9.0% in adalimumab, secukinumab, and ixekizumab cohorts, respectively. Conclusions: Patients on guselkumab showed trends toward better persistence and higher remission rates relative to other biologics. Finding patients who may be in remission suggests potential disease modification with current agents. [ABSTRACT FROM AUTHOR]

Pulmonary arterial hypertension (PAH) is commonly associated with connective tissue disorders (CTDs). This study provides a contemporary assessment of the economic burden of CTD + PAH and PAH in the United States. Eligible adult patients identified from Optum's deidentified Clinformatics ® Data Mart Database (10/01/2015-09/30/2021) were classified into mutually exclusive cohorts based on recorded diagnoses: (1) CTD + PAH, (2) PAH, (3) CTD, (4) control without CTD/PAH. The index date was a randomly selected diagnosis date for PAH (CTD + PAH, PAH cohorts) or CTD (CTD cohort), or a random date (control cohort). Entropy balancing was used to balance characteristics across cohorts. Healthcare costs and healthcare resource utilization (HRU) per patient per month (PPPM) were assessed for =12 months postindex and compared among balanced cohorts. A total of 552,900 patients were included (CTD + PAH: n = 1876; PAH: n = 8177; CTD: n = 209,156; control: n = 333,691). Average total all-cause costs were higher for CTD + PAH than PAH cohort ($16,854 vs. $15,686 PPPM; p = 0.02); both cohorts incurred higher costs than CTD and control cohorts ($4476 and $2170 PPPM; all p < 0.001). Average HRU PPPM was similar between CTD + PAH and PAH cohorts (inpatient stay: 0.15 vs. 0.15, outpatient visits: 4.23 vs. 4.11; all p > 0.05), while CTD and control cohorts incurred less HRU (inpatient stay: 0.07 and 0.03, outpatient visits: 2.67 and 1.69; all p < 0.001). CTD + PAH and PAH are associated with a substantial economic burden. The incremental burden attributable to PAH versus the general population and patients with CTD without PAH highlights significant unmet needs among PAH patients. [ABSTRACT FROM AUTHOR]

Introduction: Prior studies have found considerable disparities in prevalence and outcomes for patients with peripheral arterial disease (PAD). This study compared rates of diagnostic testing, treatment patterns, and outcomes after diagnosis of PAD among commercially insured Black and White patients in the United States. Methods: Optum's de-identified Clinformatics® Data Mart Database (1/2016–6/2021) were used to identify Black and White patients with PAD; first PAD diagnosis was deemed study index date. Baseline demographics, markers of disease severity, and healthcare costs were compared between cohorts. Patterns of medical management and rates of major adverse limb events (MALE; including acute or chronic limb ischemia, lower-limb amputation) and cardiovascular (CV) events (stroke, myocardial infarction) during the available follow-up period were described. Outcomes were compared between cohorts using multinomial logistic regression models, Kaplan–Meier survival analysis, and Cox proportional hazards models. Results: A total of 669,939 patients were identified, with 454,382 White patients and 96,162 Black patients. Black patients were younger on average (71.8 years vs. 74.2 years), but had higher comorbid burden, concomitant risk factors, and CV medication use at baseline. Prevalence of diagnostic testing, revascularization procedures, and medication use was numerically higher among Black patients. Black patients were also more likely than the White patients to receive medical therapy without a revascularization procedure [adjusted odds ratio with 95% confidence interval (CI) = 1.47 (1.44–1.49)]. However, Black patients with PAD had higher incidence of MALE and CV events than White patients [adjusted hazard ratio for composite event (95% CI) = 1.13, (1.11–1.15)]. Except myocardial infarction, the hazards of individual components of MALE and CV events were also significantly higher among Black patients with PAD. Conclusions: Results of this real-world study suggest that Black patients with PAD have higher disease severity at the time of diagnosis and are at increased risk of experiencing adverse outcomes following diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: Among patients with venous thromboembolism (VTE), direct oral anticoagulants (DOACs) are recommended for preventing thromboembolic recurrence, complications, and mortality. This study compared the risk of VTE recurrence among patients who abandoned their first DOAC fill ("abandoners") relative to patients who did not ("non-abandoners"). Methods: Adults with VTE who were prescribed DOACs were selected from Symphony Health, an ICON plc Company, PatientSource®, April 1, 2017 to October 31, 2020. Patients who abandoned their first (index) DOAC fill were classified as abandoners and patients with an approved index DOAC fill as non-abandoners. Baseline characteristics were balanced between cohorts using inverse probability of treatment weighting. VTE recurrence based on the first post-index VTE event (deep vein thrombosis or pulmonary embolism) was ascertained and compared between cohorts using weighted Kaplan–Meier and Cox proportional hazard models during the follow-up period (i.e., index DOAC fill date to end of clinical activity or data availability). Results: After weighting, 152,443 and 153,931 patients comprised the abandoner and non-abandoner cohorts, respectively (mean age 60 years; 53% female; mean follow-up duration 15 months). After 3 months of follow-up, the probability of VTE recurrence was 7.74% in the abandoner cohort and 4.65% in the non-abandoner cohort; the risk of recurrence was 72% higher in the abandoner versus non-abandoner cohort (hazard ratio [95% confidence interval] 1.72 [1.64, 1.82]; p < 0.0001). At 12 months, the probability of recurrence was 9.91% in the abandoner cohort and 6.89% in the non-abandoner cohort; the risk of recurrence was 53% higher in the abandoner versus non-abandoner cohort (1.53 [1.46, 1.61]; p < 0.0001). Conclusion: Patients abandoning the first DOAC fill had significantly higher risk of VTE recurrence compared to patients who did not abandon the first fill. Ensuring proper access and encouraging early and continuous use of DOACs may help prevent severe and fatal complications among patients with VTE. [ABSTRACT FROM AUTHOR]

To compare persistence and describe dose titration among bio-naïve patients with Crohn's disease (CD) initiated on ustekinumab or adalimumab. Bio-naïve adults with CD who initiated ustekinumab or adalimumab (index date) from 23 September 2016 (ustekinumab US approval for CD) to 1 August 2019 were selected from IQVIA PharMetrics Plus. Cohorts were balanced on baseline characteristics measured over 12 months pre-index using inverse probability of treatment weights. Persistence was defined as no gaps (ustekinumab: >120 days; adalimumab: >60 days) between days of supply. Dose escalation was defined as ≥2 consecutive sub-cutaneous claims 100% above the US label daily dose in the maintenance phase; de-escalation was a return to the daily dose for ≥2 consecutive claims. Outcomes were described using weighted Kaplan-Meier models; persistence outcomes were compared using Cox's proportional hazards models. At 12 months post-index, patients in the ustekinumab (n = 948) versus adalimumab (n = 4143) cohort had a significantly higher rate of persistence on index biologic (hazard ratio [HR] 1.50; 95% confidence interval [CI]: 1.29–1.74). A total of 830 (87.6%) patients in the ustekinumab cohort and 3713 (89.6%) in the adalimumab cohort began the maintenance phase; within 12 months, 11.2% and 16.9%, underwent a dose escalation, and 26.6% and 6.3%, respectively, subsequently de-escalated to the per US label daily exposure. Bio-naïve patients with CD initiated on ustekinumab were more persistent than patients initiated on adalimumab; moreover, these patients had numerically lower dose escalation and higher de-escalation rates than patients initiated on adalimumab. Findings support the use of ustekinumab as a first-line treatment for bio-naïve patients with CD. [ABSTRACT FROM AUTHOR]

Sleeve gastrectomy (SG) induces weight loss but its effects on body composition (BC) are less well known. The aims of this longitudinal study were to analyse the BC changes from the acute phase up to weight stabilization following SG. Variations in the biological parameters related to glucose, lipids, inflammation, and resting energy expenditure (REE) were concomitantly analysed. Fat mass (FM), lean tissue mass (LTM), and visceral adipose tissue (VAT) were determined by dual-energy X-ray absorptiometry in 83 obese patients (75.9% women) before SG and 1, 12 and 24 months later. After 1 month, LTM and FM losses were comparable, whereas at 12 months the loss of FM exceeded that of LTM. Over this period, VAT also decreased significantly, biological parameters became normalized, and REE was reduced. For most of the BC, biological and metabolic parameters, no substantial variation was demonstrated beyond 12 months. In summary, SG induced a modification in BC changes during the first 12 months following SG. Although the significant LTM loss was not associated with an increase in sarcopenia prevalence, the preservation of LTM might have limited the reduction in REE, which is a longer-term weight-regain criterion. [ABSTRACT FROM AUTHOR]

Introduction: The healthcare resource utilization (HRU) and costs of oral anticoagulant-naïve patients with non-valvular atrial fibrillation (NVAF) and diabetes initiated on rivaroxaban or warfarin in the United States (US) has not been previously evaluated. Methods: This retrospective study used data from the Optum's de-identified Clinformatics® Data Mart Database (1 January, 2012 to 30 September, 2021) to evaluate the HRU and costs of adult patients with NVAF and diabetes newly initiated on rivaroxaban or warfarin (on or after January 2013). Inverse probability of treatment weighting (IPTW) was used to adjust for confounding between cohorts. HRU and costs (USD 2021) were assessed per patient-year (PPY) post-treatment initiation. Weighted cohorts were compared using rate ratios (RR) from Poisson regression models, odds ratios (OR) from logistic regression models, and cost differences; 95% confidence intervals (CI) and p values were generated using non-parametric bootstrap procedures. Results: After IPTW, 17,881 and 19,274 patients initiated on rivaroxaban and warfarin were included, respectively (mean age: 73 years; 40% female). During 12 months of follow-up, the rivaroxaban cohort had lower all-cause HRU PPY across all components, including lower rates of inpatient stays (RR: 0.84, 95% CI 0.81, 0.88), outpatient visits (RR: 0.67, 95% CI 0.66, 0.68), and 30 day hospital readmission (OR: 0.75, 95% CI 0.66, 0.83; all p < 0.001) compared to the warfarin cohort. Moreover, rivaroxaban was associated with medical cost savings PPY (mean cost difference: − $9306, 95% CI − $11,769, − $6607), which compensated for higher pharmacy costs relative to warfarin (mean cost difference: $5518, 95% CI $5193, $5839), resulting in significantly lower all-cause total healthcare costs for rivaroxaban versus warfarin (mean cost difference: − $3788, 95% CI − $6258, − $1035; all p < 0.001). Conclusion: Among NVAF patients with diabetes in a real-world US setting, rivaroxaban was associated with lower healthcare costs compared to warfarin. [ABSTRACT FROM AUTHOR]

This study assessed the total costs of testing, including the estimated costs of delaying care, associated with next-generation sequencing (NGS) versus single-gene testing strategies among patients with newly diagnosed metastatic non-small cell lung cancer (mNSCLC) from a Canadian public payer perspective. A decision tree model considered testing for genomic alterations using tissue biopsy NGS or single-gene strategies following Canadian guideline recommendations. Inputs included prevalence of mNSCLC, the proportion that tested positive for each genomic alteration, rebiopsy rates, time to test results, testing/medical costs, and costs of delaying care based on literature, public data, and expert opinion. Among 1,000,000 hypothetical publicly insured adult Canadians (382 with mNSCLC), the proportion of patients that tested positive for a genomic alteration with an approved targeted therapy was 38.0% for NGS and 26.1% for single-gene strategies. The estimated mean time to appropriate targeted therapy initiation was 5.1 weeks for NGS and 9.2 weeks for single-gene strategies. Based on literature, each week of delayed care cost CAD 406, translating to total mean per-patient costs of CAD 3480 for NGS and CAD 5632 for single-gene strategies. NGS testing with mNSCLC in current Canadian practice resulted in more patients with an identified mutation, shorter time to appropriate targeted therapy initiation, and lower total testing costs compared to single-gene strategies. [ABSTRACT FROM AUTHOR]

Objective: To compare health care resource utilization (HRU) and costs among commercially insured patients with nasal polyposis (NP) with and without recurrence after endoscopic sinus surgery (ESS). Study Design: Retrospective matched cohort study. Setting: Adults with initial ESS or an NP excision after a new NP diagnosis were identified in Optum's Clinformatics Data Mart Database (October 1, 2014–December 31, 2019). Methods: The index date was the date of NP recurrence, identified with a claims‐based algorithm for the recurrent cohort, or a random date for the nonrecurrent cohort. Patients in both cohorts were matched 1:1 on baseline characteristics (12 months preindex) via propensity scores and exact matching factors. Annual HRU and costs (2019 US$) were compared between the matched cohorts at 12 months postindex. Results: NP recurrence was identified among 3343 of 16,693 patients with initial ESS; after matching, each cohort comprised 1574 patients (median age, 54 years; 40% female) with similar baseline health care costs (recurrent, $34,420; nonrecurrent, $33,737). At 12 months postindex, the recurrent cohort had higher HRU, including 36% and 51% more outpatient and emergency department visits, respectively (all P <.01). Mean health care costs were $9676 higher in the recurrent cohort ($24,039) relative to the nonrecurrent cohort ($14,363, P <.01). The mean cost difference between cohorts was driven by $8211 in additional outpatient costs, as well as $6062 in additional NP‐related outpatient costs, in the recurrent cohort (all P <.01). Conclusion: NP recurrence is associated with a substantial economic burden, which appears to be driven by outpatient services. [ABSTRACT FROM AUTHOR]

Rett syndrome (RTT) is a severe neurodevelopmental disorder. Management strategies are heterogeneous with no clear definition of success. This study describes physician decision-making regarding diagnosis, therapeutic goals, and management strategies to better understand RTT clinical management in the US. This study was conducted among practicing physicians, specifically neurologists and pediatricians in the US with experience treating ≥2 individuals with RTT, including ≥1 individuals within the past two years. In-depth interviews with five physicians informed survey development. A cross-sectional survey was then conducted among 100 physicians. Neurologists had treated more individuals with RTT (median: 12 vs. 5, p < 0.001) than pediatricians throughout their career and were more likely to report being "very comfortable" managing RTT (31 vs. 4%, p < 0.001). Among physicians with experience diagnosing RTT (93%), most evaluated symptoms (91%) or used genetic testing (86%) for RTT diagnoses; neurologists used the 2010 consensus diagnostic criteria more than pediatricians (54 vs. 29%; p = 0.012). Improving the quality of life (QOL) of individuals with RTT was the most important therapeutic goal among physicians, followed by improving caregivers' QOL. Most physicians used clinical practice guidelines to monitor the progress of individuals with RTT, although neurologists relied more on clinical scales than pediatricians. Among all physicians, the most commonly treated symptoms included behavioral issues, epilepsy/seizures, and feeding issues. Management strategies varied by symptom, with referral to appropriate specialists being common across symptoms. A large proportion of physicians (37%) identified the lack of novel therapies and reliance on symptom-specific management as an unmet need. Although most physicians had experience and were comfortable diagnosing and treating individuals with RTT, better education and support among pediatricians is warranted. Additionally, novel treatments that target multiple symptoms associated with RTT could reduce the burden and improve the QOL of individuals with RTT and their caregivers. [ABSTRACT FROM AUTHOR]

Background: Historical vaccination coverage in economically disadvantaged, ethnic minority, non-affluent white and agricultural populations in the US has lagged coverage in more affluent urban and suburban white populations due to a variety of social and economic factors. In the current COVID-19 pandemic, sociocultural and economic challenges continue to present significant obstacles to achieving equitable uptake of COVID-19 vaccines. The goal of this study was to qualitatively assess perceptions of key US healthcare stakeholders of the most significant barriers to COVID-19 vaccine access and equity to better characterize their expected impact on US communities.Methods: After conducting a targeted literature review (TLR), we hypothesized 20 high-impact barriers which included structural and logistical barriers, capturing systemic challenges to vaccine accessibility, and attitudinal and informational barriers, affecting patient willingness to pursue vaccination. We developed a qualitative discussion guide, which included both open-ended and closed-ended questions, and interview stimulus material to conduct one-on-one in-depth interviews to assess the expected prevalence, severity, and persistence of these 20 high-impact barriers, which were hypothesized based on TLR. As a part of this qualitative study, we conducted one-on-one in-depth interviews with a diverse set of 15 US healthcare stakeholders who were involved in the COVID-19 vaccine rollout in states with relatively disparate vaccination rates by ethnicity. These stakeholders were selected to reflect an array of roles in the COVID-19 vaccine rollout, including infectious disease specialists, pharmacists, community advocacy representatives, and partners of local governments involved in the COVID-19 vaccine rollout and community education.Results: Respondents identified limited vaccination sites in rural settings and technology-related barriers as the most prevalent and severe structural and logistical barriers in US communities. Respondents assessed COVID-19 vaccine safety concerns and politically motivated skepticism to be the most prevalent and severe attitudinal and informational barriers. Respondents cited proliferation of mobile vaccination clinics and local community messaging to endorse vaccines as the most effective solutions to these top structural and attitudinal barriers. Respondents expected politically motivated skepticism to be the most significant and persistent barrier to broader vaccine uptake in the US.Conclusions: Our study suggests that attitudinal barriers, particularly politically motivated skepticism, are likely to remain the most persistent challenges to widespread vaccination against COVID-19 in the US. [ABSTRACT FROM AUTHOR]

Analysis of real-world treatment patterns in a matched rheumatology population that continued innovator infliximab therapy or switched to biosimilar infliximab. Impact of switching to infliximab biosimilars on treatment patterns among US veterans receiving innovator infliximab. SAT0172 economic outcomes, treatment patterns, and adverse events and reactions for patients prescribed infliximab or ct-p13 in the Turkish population. The approach used also allowed patients to contribute to both the switcher and continuer cohorts, thus allowing us to focus on switches driven by the physician or patient rather than non-medical switches (the latter being used to define our cohorts instead). [Extracted from the article]

Evaluate systemic therapy utilization patterns and outcomes by line of therapy among patients with advanced/recurrent endometrial cancer (EC) treated in the United States. This retrospective observational study used the Optum Clinformatics Extended Data Mart Date of Death database (1 January 2004–31 December 2019) and included de-identified data from adult patients with advanced/recurrent EC who were treated with first-line (1L) platinum-based chemotherapy and initiated second-line (2L) anti-neoplastic therapy. The index date was the date of 1L therapy initiation. The number and sequence of treatments received and the proportion of patients who received each type of treatment for each line of therapy were evaluated. To account for new drug approvals, patients first treated in 2018 or 2019 were also assessed separately. Among the 1317 patients who met all eligibility criteria, 520 (39.5%) and 235 (17.8%) patients received 3 or 4+ lines of treatment, respectively, during a median total follow-up time of 25.2 months (range, 2.5–173.3 months) following the index date. Chemotherapy, including platinum- and non-platinum-based regimens, was the most common treatment across all lines of therapy: 2L, 80.0%; 3L, 66.2%; 4L+, 80.4%. Overall, 2.5%, 2.3%, and 8.9% of 2L, 3L, and 4L + patients, respectively, received anti-program death 1 (anti-PD-1) immunotherapies. In patients first treated in 2018 and 2019 (n = 163), 9.8% of patients received anti-PD-1 immunotherapy in the 2L. In the overall population, median time to next treatment (TTNT) was 19.3, 10.5, and 8.1 months for patients undergoing 2L, 3L, and 4L treatment, respectively. Among patients with advanced/recurrent EC treated with 1L platinum-based therapy in clinical practice, chemotherapy was the most common treatment choice across all lines of therapy. Immunotherapy use was low overall but increased in patients who started treatment in 2018 or 2019. Overall, median TTNT decreased as lines of therapy increased. [ABSTRACT FROM AUTHOR]

Aim: To assess reduction in prostate-specific antigen (PSA) levels among Black and non-Black patients treated with apalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC). Patients & methods: Patients were identified from electronic medical data. PSA reduction (≥50%, ≥90% or below 0.2 ng/ml) after apalutamide initiation was assessed. Results: A total of 313 patients with nmCRPC and 260 patients with mCSPC were identified. The majority of patients treated with apalutamide achieved a 90% reduction in PSA regardless of indication or race. The proportion of patients achieving a PSA reduction at any level was similar among Black and non-Black patients and was consistent with apalutamide phase III trials. Conclusion: In routine clinical practice, apalutamide consistently produced reduction in PSA levels in Black and non-Black men with nmCRPC or mCSPC. This study looked at prostate health following treatment with a prostate cancer medication, apalutamide. Most patients had better prostate health after the medication. This improvement was achieved after 2 months of treatment in most patients. The observations were similar in Black and non-Black patients. Prostate cancers in Black and non-Black men respond similarly to apalutamide and the outcomes for the real-world population are broadly similar to those of the published trials. [ABSTRACT FROM AUTHOR]

The prevalence of sarcopenia in patients with obesity varies according to the definition used. The purpose of our study was to: (i) determine the prevalence of sarcopenia in terms of lean tissue mass in older women with obesity using the current cut-offs, (ii) redefine a specific cut-off for low lean tissue mass (LLTM), and (iii) re-determine the prevalence of LLTM using this new cut-off. Appendicular lean mass (ALM) and the ALM index [ALM/height2: ALMI(h2)] and ALMI/body mass index [ALMI(BMI)] were determined in 791 women with or without obesity. LLMM prevalence was calculated using the current cut-offs: EWGSOP2: ALM < 15 kg and ALMI(h2) < 5.5 kg/m2; FNIH: ALM < 15.02 kg and ALMI(BMI) < 0.51; and IWGS: ALMI(h2) < 5.67 kg/m2 and cut-offs newly determined from data provided from young women with obesity. ALM, ALMI(h2) and ALMI(BMI) were lower in older compared to young obese women. Using the current cut-offs, a wide distribution of LLTM prevalence (0 to 29.2%) was observed. When the newly determined cut-offs were applied – i.e., ALM < 18.51 kg; ALMI(h2) < 7.15 kg/m2, ALMI(BMI) < 0.483, and T-score: [(ALMI(h2) measured)-(2.08 + 0.183*BMI)]/0.72] − the LLTM mass prevalence was 17.37%; 8.47, 14.8 and 12.71%. respectively. This study showed that the current cut-offs for LLTM as criteria for sarcopenia diagnosis are not adapted to the obese population. Although the new "static" cut-offs appeared to be more adapted, a "dynamic" cut-off for ALMI(h2) that took into account the BMI and thus the obesity severity appeared even more relevant. [ABSTRACT FROM AUTHOR]

Prior observational studies suggest rivaroxaban is safe and effective among patients with morbid obesity who suffered a venous thromboembolism (VTE) event, but existing data are more limited in the broader population of VTE patients with obesity. This study assessed VTE recurrence, major bleeding, healthcare resource utilization, and healthcare costs among VTE patients with obesity who received rivaroxaban versus warfarin. VTE patients with obesity who initiated rivaroxaban or warfarin after a first VTE (index date) were identified from the IQVIA PharMetrics® Plus database (01/02/2011–09/30/2019). The follow-up period spanned from the index date until health plan disenrollment, end of data availability, cancer diagnosis/treatment, end of the 12 month post-index period, or (for the analysis of major bleeding) anticoagulant discontinuation or switch. Patient characteristics were balanced using inverse probability of treatment weighting. The weighted rivaroxaban (N = 8666) and warfarin cohorts (N = 5946) were well balanced (mean age = 51 years, females = 52%). Over a 9.6 months mean observation period, rivaroxaban users had a significantly lower risk of VTE recurrence [7.0% vs. 8.2%, HR(95% CI) = 0.85(0.75;0.97)] and a similar risk of major bleeding [4.1% vs. 3.6%, HR(95% CI) = 1.11(0.89;1.37)] relative to warfarin users at 12 months. Relative to warfarin users, rivaroxaban users had significantly fewer all-cause outpatient visits [RR(95% CI) = 0.71(0.70;0.74)]. The higher pharmacy costs incurred by rivaroxaban recipients (cost difference = $1252) were offset by lower medical costs (cost difference = − $2515, all p < 0.05) compared with warfarin recipients. Our findings suggest that rivaroxaban is safe and effective versus warfarin, and associated with lower medical costs among VTE patients with obesity. [ABSTRACT FROM AUTHOR]

Purpose: To describe changes due to the COVID-19 pandemic in the prescribing of long-acting antipsychotics (LAI) for schizophrenia, patient outcomes, and patient and healthcare provider (HCP) attitudes regarding COVID-19 vaccination in the United States (US). Methods: An anonymous online survey was administered to US-based LAI prescribers with a psychiatry specialty in May 2021. Information on prescriber and clinical practice characteristics, LAI prescribing, patient outcomes, and attitudes toward COVID-19 vaccination was collected and described. Results: Of the 401 LAI prescribers meeting survey criteria, 64.6% reported that LAI prescribing remained unchanged (increase: 19.2%, decrease: 14.0%). The majority did not switch patients from LAIs to oral antipsychotics (OAP; 63.3%) or to LAI formulations with lower frequency of administration (68.1%); most prescribers switched the same number of patients from OAPs to LAIs during the pandemic as in previous practice (65.1%). Half of LAI prescribers (50.1%) reported antipsychotic adherence as unchanged among most patients; 44.6% reported symptom control/relapse frequency as unchanged. Most prescribers believed their patients with schizophrenia should be prioritized for COVID-19 vaccination (74.1%) and encouraged all patients to obtain a COVID-19 vaccine (84.0%). However, 64.1% of prescribers reported hesitancy among some patients about vaccines' safety; 51.4% reported that some patients were willing to be vaccinated despite the hesitancy, 48.6% indicated that some patients perceived COVID-19 vaccines as safe, effective, and important. Conclusion: LAI prescribing and prescriber-reported antipsychotic adherence in patients with schizophrenia remained largely unchanged approximately one year after the start of COVID-19. Focused efforts to overcome patients' COVID-19 vaccine hesitancy are warranted. [ABSTRACT FROM AUTHOR]