Explore the vast range of titles available.

To examine reasons why rheumatoid arthritis patients discontinued subcutaneous (SQ) anti-tumor necrosis factor (anti-TNF) treatment in the past 12 months, so as to help inform successful, uninterrupted therapy. Data were collected in March and April 2011 using self-reported, internet-based questionnaires. Study inclusion criteria comprised: rheumatoid arthritis diagnosis; discontinuation of SQ anti-TNF medication (adalimumab, certolizumab, etanercept, or golimumab) within the past 12 months; aged ≥18 years; United States residency; and consent to participate. Patients reported primary and other reasons for discontinuation of their most recently discontinued anti-TNF. Questionnaires from 250 patients were analyzed; 72.8% were female, 80.8% were white, and median age was 51 years. Patients had discontinued etanercept (n=109), adalimumab (n=98), certolizumab (n=24), or golimumab (n=19) within the past 12 months. When prompted about their primary reason for discontinuation, lack of effectiveness (40.8%) was cited most often, followed by injection experience (18.4%). Combining prompted primary and other reasons for discontinuation, 60.8% of patients reported lack of effectiveness, while 40.8% reported injection experience, which included: pain/burning/discomfort after injection (14.4%); pain/burning/discomfort during injection (13.2%); injection reactions such as redness/swelling after injection (12.4%); dislike of self-injection (11.6%); dislike of frequency of injection (10.4%); and fear of injection/needles (6.8%). From the patient perspective, there are unmet needs with regard to the effectiveness and injection experience associated with SQ anti-TNF medications, which may lead to discontinuation. Treatment options with a better injection experience may address these needs. These results demonstrate the importance of including the patient perspective when making prescribing decisions or payer access and coverage decisions.

Purpose Reducing the dosing frequency of antipsychotics (APs) with long-acting injectables (LAIs) such as once-monthly paliperidone palmitate (PP1M) can improve adherence and clinical outcomes for schizophrenia patients. This US study compared physical and psychiatric comorbidity-related outcomes, AP adherence, healthcare resource utilization (HRU), and costs pre- and post-transition to PP1M among schizophrenia patients treated with oral risperidone/paliperidone pre-PP1M transition. Methods Health insurance claims from the IQVIA™ PharMetrics Plus database (01/01/2012–07/31/2018) were used to identify adults with ≥ 2 schizophrenia diagnoses, ≥ 1 claim for PP1M, and ≥ 30 days of treatment with oral risperidone/paliperidone in the 60 days before the first PP1M claim (i.e., the index date). Comorbidity-related outcomes, adherence to APs (measured via the proportion of days covered [PDC]), all-cause per-patient-per-month (PPPM) HRU, and all-cause PPPM medical, pharmacy, and total costs (i.e., sum of medical and pharmacy costs) during the 6-month periods pre- and post-transition to PP1M were compared using generalized estimating equation models adjusted for repeated measurements. Analyses were replicated in the subset of patients with ≥ 1 all-cause inpatient stay pre-PP1M transition. Findings Among 427 schizophrenia patients transitioning from oral risperidone/paliperidone to PP1M, the mean age was 41.1 years and 37.9% were female. Following the PP1M transition, patients were less likely to have claims with a diagnosis for psychoses (odds ratio [OR] 0.41; P  < 0.001), hypertension (OR 0.80; P  = 0.011), depression (OR 0.70; P  < 0.001), drug abuse (OR 0.60; P  < 0.001), substance-related and addictive disorders (OR 0.73; P  = 0.003), bipolar and related disorders (OR 0.59; P  < 0.001), sleep-wake disorders (OR 0.68; P  = 0.017), anxiety disorders (OR 0.78; P  = 0.034), and other conditions that may require a focus of clinical attention (OR 0.58; P  < 0.001). Mean PDC by APs was higher post-PP1M (mean = 0.81) versus pre-PP1M (mean = 0.68) transition. Post-PP1M, patients were less likely to have an all-cause emergency room visit (OR 0.51; P  < 0.001) or inpatient stay (OR 0.39; P  < 0.001) compared to pre-PP1M. All-cause total healthcare costs remained similar post- versus pre-transition to PP1M (mean monthly cost difference [MMCD] = $228; P  = 0.260). Pharmacy costs increased post-PP1M (MMCD = $960; P  < 0.001), but were offset by decreasing medical costs (MMCD = − $732; P  < 0.001), largely driven by lower costs related to inpatient stays (MMCD = − $695; P  < 0.001) and emergency room visits (MMCD = − $63; P  < 0.001). For patients with ≥ 1 all-cause inpatient stay pre-PP1M transition ( N  = 177), a more pronounced improvement in comorbidity-related outcomes, a more pronounced reduction in HRU, and a reduction in total healthcare costs (MMCD = − $1308; P  < 0.001) were observed post-transition to PP1M. Implications Among schizophrenia patients in the US, transitioning to PP1M following oral risperidone/paliperidone treatment was associated with improved comorbidity-related outcomes, higher adherence, and a reduction in HRU, while remaining cost neutral. Furthermore, patients with ≥ 1 all-cause inpatient stay pre-PP1M transition had significantly lower total healthcare costs post-PP1M transition.

Second-generation long-acting injectable therapies (SGA-LAIs) may reduce health care resource utilization (HRU) and health care costs compared with daily oral atypical antipsychotics (OAAs) in patients with schizophrenia due to reduced dosing frequency, delivery/monitoring by a health care provider, and improved adherence. The aim of the present study was to compare treatment patterns, HRU, and Medicaid spending in patients with schizophrenia initiated on SGA-LAIs (overall and according to agent) versus OAAs. Medicaid claims data (2010–2015) from 6 states were used to identify adult schizophrenia patients initiated on SGA-LAIs or OAAs. Treatment patterns (proportion of days covered [PDC] ≥80% and persistence [no gap ≥30, 60, or 90 days] to index treatment), HRU, and costs were evaluated over 12 months and compared by using multivariable logistic, Poisson, and ordinary least squares regression models, respectively. P values for HRU and cost outcomes were obtained from a nonparametric bootstrap procedure. Costs (2015 US dollars) reflect the Medicaid payer’s perspective before any rebate. Overall, 3307 and 21,355 patients initiated SGA-LAIs and OAAs, respectively (paliperidone palmitate LAI [PP-LAI; n = 2182], risperidone LAI [n = 968], aripiprazole LAI [n = 108], and olanzapine LAI [n = 49]). During follow-up and compared with OAA patients, SGA-LAI patients were more likely to reach PDC ≥80% (odds ratio [OR], 1.28; P < 0.001) and be persistent (eg, no gap ≥60 days; OR, 1.45; P < 0.001) to the index treatment. Relative to OAA patients, SGA-LAI patients had fewer long-term care days (incidence rate ratio [IRR], 0.75; P < 0.001) and home care visits (IRR, 0.75; P < 0.001) but more mental health institute (IRR, 1.16; P < 0.001) and 1-day mental health institute (IRR, 1.16; P < 0.001) admissions. Moreover, PP-LAI patients had fewer inpatient days (IRR, 0.78; P = 0.004) versus OAA patients. SGA-LAI patients had lower medical costs (mean monthly cost difference [MMCD], –$168; P < 0.001) than OAA patients, offsetting more than one half of the higher pharmacy costs (MMCD, $271; P < 0.001). Compared with OAAs, only PP-LAI was associated with significant medical cost savings (MMCD, –$225; P < 0.001). Medicaid beneficiaries with schizophrenia initiated on SGA-LAIs had better adherence and persistence to therapy over 12 months than patients initiated on OAAs. SGA-LAIs, particularly PP-LAI, were associated with lower medical costs that successfully offset more than one half of the higher pharmacy costs relative to OAA.

Background Studies suggest that RSV infection early in life is associated with the development of recurrent wheezing, yet, information on large population-based studies among US full-term healthy infants is incomplete. The objective of this study was to evaluate the risk of developing post-RSV recurrent wheezing/asthma during childhood among full-term infants in a US commercially insured population. Methods Retrospective, observational study used data from Truven MarketScan Commercial Claims and Encounters Database (January 1, 2000–December 31, 2016) to identify full-term infants with and without a RSV diagnosis in the first year of life (RSV and non-RSV cohorts respectively). Infants were excluded if they had any of the following: prematurity (<37 weeks’ gestation), low birth weight, small for gestational age, congenital heart or chronic lung disease, asthma or wheezing; or had received palivizumab. At least 2 years’ continuous follow-up post birth was required throughout the ≤5-year follow-up period. RSV/non-RSV infants were 1:1 matched for gender, region and health plan type. Cumulative incidence of recurrent wheezing or asthma was identified by ICD-9/10 codes, through 1, 2, 3 and 4 years (Y)’ post-index (1 year after birth) follow-up, and analyzed using conditional logistic regression. Results Matched RSV/non-RSV pairs totaled 38,494 (Y1), 25,603 (Y2), 17,429 (Y3), and 11,921 (Y4) for the years’ follow-up. Demographic characteristics, birth year and month were evenly represented between cohorts. Other infections during the perinatal period were more common in the RSV vs. the non-RSV cohort (5.4% vs. 3.2%; P < 0.0001), as were other respiratory conditions (5.8% vs. 2.6%; P < 0.0001), and antibiotic use (76.7% vs. 44.7%; P < 0.0001). Rates of influenza and pneumococcal vaccinations were comparable between cohorts. Cumulative incidence of recurrent wheezing or asthma in the RSV cohort was more than two-fold higher compared with the non-RSV cohort for each follow-up period (P < 0.001) (Figure 1). Conclusion Healthy, full-term, commercially insured children infected with RSV during the first year of life had from 2.2- to 3.6-fold increased risk of developing recurrent wheezing or asthma in the next 1–4 years. This reveals an important medical need for interventions targeting RSV infection in infants. Disclosures A. Mejias, Janssen: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Abbvie: CME talks, Speaker honorarium. B. Wu, Janssen Scientific Affairs, LLC: Employee and Shareholder, Salary. N. Tandon, Janssen Scientific Affairs: Employee and Shareholder, Salary and stocks. W. Chow, Janssen Scientific Affairs, LLC: Employee and Shareholder, Salary and stocks. N. Connolly, Janssen Scientific Affairs, LLC: Employee and Shareholder, Salary and Stocks. S. Lakhotia, Janssen Scientific Affairs, LLC: Research Contractor, Fee for service. E. Franco, Janssen Scientific Affairs, LLC: Employee and Shareholder, Salary and stocks. O. Ramilo, Janssen Scientific Affairs, LLC: Consultant, Consulting fee.

Objective The objective of this study was to compare persistence, costs, and healthcare resource utilization in patients with schizophrenia and cardiometabolic comorbidities treated with once-monthly paliperidone palmitate or an oral atypical antipsychotic. Methods Medicaid data from six states (07/2009–03/2015) were used to identify adults with schizophrenia and cardiometabolic comorbidities initiated on once-monthly paliperidone palmitate or an oral atypical antipsychotic (index date) on 01/2010 or after. Persistence to index medication at 12 months (no gap ≥ 90 days) was compared between patients taking once-monthly paliperidone palmitate and an oral atypical antipsychotic using Chi-squared tests. The 12-month post-index healthcare costs and healthcare resource utilization were compared using multivariate ordinary least squares and Poisson regression, respectively. Results Selected patients taking once-monthly paliperidone palmitate ( n  = 371) were younger (mean age: 45.0 vs. 47.5 years, standardized difference = 24%) than patients taking oral atypical antipsychotics ( n  = 8296). Persistence at 12 months was higher in patients taking once-monthly paliperidone palmitate (40 vs. 33%, p  = 0.006). Adjusted all-cause medical costs were lower in patients taking once-monthly paliperidone palmitate vs. patients taking oral atypical antipsychotics (mean monthly cost differences = US $ − 369, p  = 0.004) while all-cause pharmacy costs were higher (mean monthly cost differences = US $279, p  < 0.001), resulting in no significant difference in total costs (mean monthly cost differences = US $ − 90, p  = 0.357). No significant difference was observed in cardiometabolic comorbidity-related pharmacy or medical costs. Compared with patients taking oral atypical antipsychotics, patients taking once-monthly paliperidone palmitate had more schizophrenia-related outpatient visits (incidence rate ratio = 1.44, p  < 0.001) but fewer cardiometabolic comorbidity-related inpatient admissions (incidence rate ratio = 0.73, p  < 0.001) with shorter lengths of stay (incidence rate ratio = 0.72, p  = 0.020), and fewer cardiometabolic comorbidity-related long-term care admissions (incidence rate ratio = 0.56, p  = 0.016). Conclusions Medicaid beneficiaries with schizophrenia and cardiometabolic comorbidities who were initiated on once-monthly paliperidone palmitate had similar 12-month total healthcare costs compared with oral atypical antipsychotics. Cardiometabolic comorbidity-related utilization of inpatient and long-term care services was lower in patients taking once-monthly paliperidone palmitate.

Objectives The aim was to compare adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs before and after once-every-3-months paliperidone palmitate (PP3M) initiation in patients with schizophrenia. Methods Medicaid data (Iowa, Kansas, and Missouri; 1/2014–3/2017) were used to identify adults with at least one PP3M claim, ≥ 12 months of pre-index enrollment, and at least two schizophrenia diagnoses. Adequate treatment with once-monthly paliperidone palmitate (PP1M) was required pre-PP3M transition. Generalized estimating equations were used to assess linear trends in adherence to APs, HRU, and costs over the four quarters pre-PP3M transition, and to compare monthly HRU and costs 6 months pre- and 12 months post-PP3M transition as well as adherence to APs 12 months pre- and post-PP3M transition. Results Among 324 patients initiated on PP3M, the mean age was 41.4 years and 36.1% were females. Over the four quarters pre-PP3M transition, the monthly number of emergency room visits, medical costs, and inpatient costs decreased, while pharmacy costs and adherence to APs increased. For patients with ≥ 12 months of follow-up ( n  = 151), adherence to APs (66.2 vs. 70.2%, p  = 0.3758), total (US$3371 vs. US$3456; p  = 0.7000), pharmacy (US$1805 vs. US$1870; p  = 0.2960), and medical costs (US$1565 vs. US$1586; p  = 0.9040) remained similar pre- and post-PP3M transition, while mean monthly number of 1-day mental institute visits (1.71 vs. 1.51; p  < 0.01) and associated costs (US$260 vs. US$232, p  = 0.01) decreased. Conclusions Adherence to APs, HRU, and costs were similar pre- and post-PP3M transition, suggesting that PP3M has no impact on monthly costs for patients adequately treated with PP1M, with the added flexibility of once-every-3-months dosing.

BackgroundThe Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection.MethodsThe SONET study was a phase 4, prospective, observational, United States–based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments.ResultsOf 315 patients (intent-to-treat [ITT] population), 275 (87.3%) completed the study. Overall, 291 were treated with simeprevir + sofosbuvir, 17 with simeprevir + sofosbuvir + ribavirin, and 7 with simeprevir + peginterferon + ribavirin. The majority of patients were male (63.2%) and white (60.6%); median age was 58 years, 71.7% had genotype/subtype 1a, and 39.4% had cirrhosis. The SVR12 was achieved by 81.2% (255 of 314) of ITT patients (analysis excluded 1 patient who completed the study but was missing SVR12 data); 2 had viral breakthrough and 18 had viral relapse. The SVR12 was achieved by 92.4% (255 of 276) of patients in the modified ITT (mITT) population, which excluded patients who discontinued treatment for nonvirologic reasons before the SVR12 time point or were missing SVR12 assessment data. Among mITT patients, higher SVR12 rates were associated with factors including age ≥65 years, non-Hispanic/Latino ethnicity, and employment status, but not genotype/subtype nor presence of cirrhosis. Simeprevir-based treatment was well tolerated; no serious adverse events were considered related to simeprevir.ConclusionsIn the real-world setting, simeprevir + sofosbuvir treatment was common and 92% of mITT patients achieved SVR12. Simeprevir-based treatment was effective and well tolerated in this cohort, including patients with cirrhosis.