Once-monthly Paliperidone Palmitate Research Articles

Effectiveness of 2-year treatment with aripiprazole long-acting injectable and comparison with paliperidone palmitate.

Background:The pragmatic management of psychotic disorders is more complex than that delivered in a controlled trial environment. Therefore, this study aims to evaluate the real-world effectiveness of aripiprazole long-acting injectable (ALAI) and compare it with another commonly used long-acting anti-psychotic, once-monthly paliperidone palmitate (PP1M).Methods:This naturalistic, independent 4-year mirror image study compared the mean number and length of hospital admissions 2 years before and 2 years after treatment initiation with ALAI. Retention rates, discontinuation reasons and level of adherence were also recorded. Furthermore, indirect comparisons were made between treatment outcomes on ALAI and PP1M.Results:A total of 109 eligible patients with a severe mental illness (65% with schizophrenia and 35% with other diagnosis) commenced on ALAI and 173 patients (69% with schizophrenia and 31% with other diagnoses) initiated on PP1M were included. Of these, 37% on ALAI and 34% on PP1M stopped treatment at 2 years; retention rates were most favourable for the schizophrenia group on PP1M. Patients were more likely to discontinue due to lack of effectiveness on ALAI and due to tolerability issues on PP1M. Those who continued for 2 years on ALAI (n = 69), demonstrated an overall decrease of 84% in the mean number and 88% in the mean length of hospital admissions compared with the 2 years before initiation. Although patients on ALAI appeared to have a significantly higher bed occupancy the 2-year period before initiation than patients on PP1M, the reductions in hospitalizations were comparable across both cohorts after 2 years of treatment.Conclusions:The introduction of ALAI had a substantial impact on long-term clinical outcomes in this naturalistic cohort; more than half of patients continued treatment and had no admission during 2 years of follow up. There were no significant differences in hospitalisation rates between patients on ALAI and PP1M at 2 years.

Defining "Adequately Treated": A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate.

PurposePaliperidone palmitate once every 3 months (PP3M) is indicated in adults with schizophrenia adequately treated with once-monthly paliperidone palmitate (PP1M) for at least 4 months, in whom the last two consecutive doses are the same. The decision of when to transition to PP3M is based on the patient’s symptom status while receiving PP1M.Patients and MethodsIn a double-blind relapse–prevention study (NCT01529515), patients who met Positive and Negative Syndrome Scale (PANSS) score stabilization criteria after 4 months of PP1M were eligible for transition to PP3M; those who continued to meet stabilization criteria after 12 weeks following an open-label PP3M dose were randomized to receive PP3M or placebo. We compared (post hoc) PANSS, Clinical Global Impression–Severity (CGI-S), and Personal and Social Performance (PSP) scores during the pre-randomization, open-label phase in patients in randomized versus non-randomized groups using analysis of variance or chi-square tests.ResultsOf 506 patients enrolled, 305 were randomized. After 4 months’ PP1M treatment, PANSS and CGI-S scores were significantly lower and PSP scores significantly higher in randomized patients versus non-randomized patients (least squares means [95% CI]: 57.1 [55.7, 58.6] vs 62.2 [60.0, 64.3], 2.9 [2.8, 3.1] vs 3.3 [3.1, 3.4], and 67.0 [65.7, 68.3] vs 64.5 [62.6, 66.4], respectively); changes from baseline between groups differed significantly (all P ≤0.009).ConclusionConfirming adequate stabilization with PP1M prior to transitioning to PP3M is critical in maximizing treatment response; clinicians should consider transitioning patients to PP3M only if patients respond well to PP1M for at least 4 months and their last two consecutive doses are the same.

T211. COMPARISON OF REHOSPITALIZATION RATE IN INDIVIDUALS WITH SCHIZOPHRENIA CHANGED FROM PALIPERIDONE PALMITATE TO ORAL ANTIPSYCHOTICS

BackgroundLong-acting antipsychotic therapy (LAT) may help effectively manage individuals with schizophrenia by optimizing adherence, improving treatment response, reducing the risk of relapse, and improving long-term outcomes. LAT has an established role in the maintenance treatment of chronic, poorly adherent, and/or severely ill patients in later stages of schizophrenia.It is not yet known whether the positive effects of these LATs are merely on the control of symptoms and preventing relapse or on changes in insights and attitudes to medications, resulting in changes in disease course.MethodsThis retrospective, single-center study was conducted within the Department of Psychiatry at Inje University Haeundae Paik Hospital. To investigate the efficacy of LAT on the disease course, we compared re-hospitalization rate, drug attitude inventory (DAI), and The Positive and Negative Syndrome Scale (PANSS) in individuals with schizophrenia who had treated with once-monthly paliperidone palmitate and then switched to oral antipsychotics.ResultsA total of 105 patients changed from oral drugs to LAI. Of these, 31 patients were later changed to oral medication.Of the total LAI patients, 32 patients received less than 5 months a week. Thirteen patients were hospitalized for 6 months before LAI change and 3 patients were re-hospitalized during the maintenance period after LAI change. Three patients who did not have hospitalized for 6 months after the change of oral medication but did not have hospitalized during LAI maintenance period were re-hospitalized after changing to oral medication.Of the 72 patients who maintained the LAI for more than 5 months, 28 patients experienced re-hospitalization during oral medication before LAI, 9 of whom were re-hospitalized during the LAI. All of them kept on LAI. Seven patients who changed to oral medication during maintenance were not hospitalized during the maintenance period, but three patients were hospitalized after changing to oral medication. Of the 92 patients who had never been hospitalized within 6 months before the change of LAI, 14 had re-hospitalized after changing to LAI. However, none of the 92 patients who had never been hospitalized changed to oral medication. Regardless of the length of time, 5 (about 16%) were re-hospitalized in 31 patients who changed from LAI to the oral medication again. Interestingly, the patients were not hospitalized during the LAI period.There were 27 dropouts. Twenty patients (19%) after LAI change and 7 patients (6%) after oral change. There was no statistical difference in DAI and PANSS scores after the change from LAI to oral medication.DiscussionAs previously known, the inhibition effect of relapse was evident during the LAI period.There was no change in adherence to medication, attitudes toward treatment, and degree of illness within 6 months. There were 27 dropouts. Twenty patients (19%) after LAI change and seven patients (6%) after oral change. It has been a long time since the onset, and 7 patients have moved to the hospital. Most of these seven patients were considered to be the case of compliance problems. Immediately after the change of oral medication, dropout occurred in 4 patients, and the duration of LAI in these patients was 2–5 months.The lack of statistical difference between DAI and PANSS after changing to oral drug in LAI can be attributed to the short interval of 6 months.

Healthcare Resource Utilization and Costs Among Patients With Schizophrenia Switching From Oral Risperidone/Paliperidone to Once-Monthly Paliperidone Palmitate: A Veterans Health Administration Claims Analysis

BackgroundSchizophrenia is associated with high health care resource utilization and treatment costs. ObjectiveThis study compared treatment patterns, health care resource utilization, and medical costs before and after a switch from oral antipsychotic drug (risperidone or paliperidone [RIS/PALI]) therapy to the long-acting injectable once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia. MethodsData for adult patients (aged ≥18 years) with at least 1 diagnosis of schizophrenia who initiated treatment with oral RIS/PALI ≥6 months before switching and had continuous health plan enrollment during the study period before and after the switch were extracted from the Veterans Health Administration database. Treatment patterns, health care resource utilization, and costs were compared between the period 6 or 12 months before and after switching directly from oral RIS/PALI to PP1M. ResultsThe analysis included 676 and 493 patients in the 6-month and 12-month cohorts, respectively. Adherence to oral RIS/PALI during the 12 months preswitch was 11.0% and 22.1% as measured by proportion of days covered and medication possession ratio ≥80%, respectively. During the 12 months postswitch, adherence to PP1M was 27.0% and 35.9%, respectively. Among patients treated with oral RIS/PALI, from 12 months pre- to 12 months post-PP1M switch, fewer all-cause inpatient stays (2.2 vs 1.1, respectively; P < 0.05) and a shorter mean length of inpatient stay (28.1 and 14.0 days, respectively; P < 0.05) were observed. This pattern was similar for both the number of mental health– and schizophrenia-related inpatient stays and length of stay. Compared with 12 months pre-PP1M switch, significantly higher mean numbers of all-cause outpatient visits and pharmacy visits were observed at 12 months postswitch. In line with health care resource utilization findings, at 12 months pre- versus 12 months post-PP1M switch we observed decreases in all-cause inpatient stay costs ($41,886 vs $20,489; P < 0.05) and increases in outpatient visit costs ($22,005 vs $29,069; P < 0.05). Findings for the 6-month cohort followed a similar pattern. ConclusionsPost-PP1M switch, a decrease in total medical costs fully offset an increase in pharmacy costs, resulting in similar total costs. The findings suggest potential economic benefits of switching patients with schizophrenia from oral RIS/PALI to PP1M in the Veterans Health Administration.

Real-World Analysis of Switching Patients with Schizophrenia from Oral Risperidone or Oral Paliperidone to Once-Monthly Paliperidone Palmitate.

PurposeReducing 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.MethodsHealth 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.FindingsAmong 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.ImplicationsAmong 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.

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization

Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.Methods: VHA patients with schizophrenia (aged ≥18 years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015–March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12 months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar’s test, as appropriate.Results: The study included 319 patients (mean [SD] age = 51.6 [4.2] years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered [PDC] ≥ 80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p < .0001) and shorter inpatient length of stay (43.4 vs 18.3 days, p < .0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p < .0001), total medical costs ($87,917 vs $56,947, p < .0001), and total costs ($91,181 vs $69,106, p < .0001). A similar trend was observed for mental health and schizophrenia-related costs.Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.

A post hoc analysis on hospitalization risk in Asian patients with schizophrenia switching to once-monthly paliperidone palmitate from oral antipsychotics

ABSTRACTBackground: In this post hoc analysis in patients recently diagnosed (≤5 years) with schizophrenia, the effect on hospitalization risk after switching from oral antipsychotic to once-monthly paliperidone palmitate (PP1M) was evaluated.Research design and methods: Change in hospitalization risk following PP1M initiation among patients switching from oral antipsychotics was assessed using prescription sequence symmetry analysis. Hospitalization risk was expressed as an adjusted sequence ratio (ASR) of the number of patients hospitalized prior to PP1M initiation/post PP1M initiation. Cumulative distribution of the time to hospitalization was estimated by the Kaplan-Meier method and symmetry of distribution was assessed using log-rank test. Hazard ratio and 95% CI were calculated using the Cox proportional hazard model.Results: The number of patients hospitalized after switching to PP1M: no change, 203/300 (67.7%); increase, 18/300 (6.0%); and decrease, 79/300 (26.3%). Following PP1M initiation, ASR (95% CI) was 3.56 (2.67, 5.33) suggesting asymmetry and a significant decline in hospitalization risk. Asymmetry in distribution of hospitalization events with significant (p ≤ 0.001) delay in time to hospitalization was also observed.Conclusion: Switching to PP1M treatment from oral antipsychotics is likely to be associated with a significant reduction in hospitalization risk along with a delay in time to hospitalization and rehospitalization.

Real-world outcomes post-transition to once-every-3-months paliperidone palmitate in patients with schizophrenia within US commercial plans

Objectives: To compare comorbidity-related outcomes, adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-3-months paliperidone palmitate (PP3M) in commercially-insured patients with schizophrenia.Methods: Adults with ≥1 claim for PP3M, ≥2 schizophrenia diagnoses, and adequate treatment with once-monthly paliperidone palmitate (PP1M; i.e. no gap of >45 days in PP1M coverage for ≥4 months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014–February 2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to APs, HRU, and costs during the 6-month period pre- vs post-transition to PP3M.Results: Of 152 included patients, the mean age was 41.0 years and 36.2% were females. Post-PP3M transition, patients were less likely to have a claim with a diagnosis for substance-related and addictive disorders (odds ratio [OR] = 0.57), psychoses (OR = 0.57), diabetes without chronic complication (OR = 0.72), and drug abuse (OR = 0.64; all p < .05). Patients were more likely to be adherent to APs (OR = 2.01, p = .007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- vs post-transition. All-cause total (mean monthly cost difference [MMCD] = $242), pre-rebate pharmacy (MMCD = $65), and medical costs (MMCD = $176) remained similar pre- vs post-transition (all p > .05).Conclusions: Transitioning to PP3M was associated with an improvement in adherence and in comorbidity-related outcomes related to substance-related and addictive disorders, psychoses, diabetes without chronic complication, and drug abuse. These findings suggest PP3M may enhance comorbidity-related outcomes and adherence while remaining cost neutral.

Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate.

ObjectiveThe aim of this study was to evaluate the safety of 3-monthly paliperidone palmitate (PP3M) vs once-monthly paliperidone palmitate (PP1M) treatment with regard to extrapyramidal symptom (EPS)-related treatment-emergent adverse events (TEAEs) in patients with schizophrenia, previously stabilized on PP1M treatment.Patients and methodsData on overall incidence, time to onset (TTO), and time to resolution (TTR) of EPS-related TEAEs (overall, subclasses such as dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor) from a randomized double-blind (DB) non-inferiority study were compared between PP3M and PP1M. Subgroup analysis was performed by age (18–25, 26–50, and 50+ years) and final open-label (OL) dose (50/75, 100, and 150 mg eq.).ResultsOverall incidence of spontaneously reported EPS-related TEAEs decreased from 12.6% (PP1M) in OL phase to 8.3% (PP3M) and 7.4% (PP1M) in the DB phase; overall median TTO and TTR values were comparable between both groups. Among patients with reported EPS-related TEAEs, the median TTO for all EPS-related TEAEs was 17 days (PP1M) in OL phase and 115 days (PP3M) and 98.5 days (PP1M) in DB phase; median TTR was 36.5 days (PP1M) in OL phase and 91 days (PP3M) and 85.5 days (PP1M) in DB phase. No clear dose- or age-related differences in TTO and TTR of EPS-related TEAEs were noted.ConclusionDespite differences in apparent half-life and pharmacokinetic profiles (peak plasma exposure of PP3M formulation is 70% higher than that of PP1M formulation), both PP3M and PP1M formulations exhibited comparable incidence of EPS-related TEAEs, TTO, and TTR in patients with schizophrenia.

Short-term rehospitalizations in young adults with schizophrenia treated with once-monthly paliperidone palmitate or oral atypical antipsychotics: a retrospective analysis

Objective: To compare rehospitalizations in patients with schizophrenia treated with paliperidone palmitate (PP1M) vs oral atypical antipsychotics (OAAs), with a focus on young adults (18–35 years).Methods: The Premier Healthcare database (January 2009–December 2016) was used to identify hospitalizations of adults (≥18 years) with schizophrenia treated with PP1M or OAA between September 2009 and October 2016 (index hospitalizations). Rehospitalizations were assessed at 30, 60, and 90 days after each index hospitalization in young adults and in all patients. Proportions of index hospitalizations resulting in rehospitalization were reported and compared between groups using odds ratios (ORs) and 95% confidence intervals (CIs).Results: A total of 8578 PP1M and 306,252 OAA index hospitalizations were included. Hospitalized young adults treated with PP1M (n = 3791) were more likely to be seen by a psychiatrist (94.0% vs 90.0%), and had a longer length of stay (12.5 vs 8.6 days) compared to hospitalized young adults treated with OAA (n = 96,502). Following their discharge, young adults receiving PP1M during an index hospitalization had a 25–27% lower odds of rehospitalization within 30, 60, and 90 days compared to young adults receiving OAAs (all p < .001). Similarly, when observing all patients, those receiving PP1M during an index hospitalization had 19–22% lower odds of rehospitalization within 30, 60, and 90 days compared to those receiving OAAs (all p < .001).Conclusions: Following a hospitalization for schizophrenia, PP1M treatment was associated with fewer 90-day rehospitalizations among young adults (18–35 years) relative to OAA treatment. This finding was also observed in other hospitalized adults with schizophrenia.

Adherence, Healthcare Resource Utilization, and Costs in Medicaid Beneficiaries with Schizophrenia Transitioning from Once-Monthly to Once-Every-3-Months Paliperidone Palmitate.

ObjectivesThe 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.MethodsMedicaid 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.ResultsAmong 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.ConclusionsAdherence 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.

PMH4 - Treatment Patterns and Medicaid Spending in Comorbid Schizophrenia Populations: Once-Monthly Paliperidone Palmitate Vs Oral Atypical Antipsychotics

This study compared treatment patterns and Medicaid spending between schizophrenia patients with cardiovascular disease (CVD), diabetes, hypertension (HTN), or obesity initiated on once-monthly paliperidone palmitate (PP1M) or an oral atypical antipsychotic (OAA). Medicaid data from five states (09/2008-03/2015) identified adults with schizophrenia initiated on PP1M or an OAA (index date). Patients were grouped based on ≥1 diagnosis for CVD, diabetes, HTN, or obesity during the 12 months pre-index. Outcomes (assessed during the 12 months post-index) were compared using inverse probability of treatment weighting. Treatment patterns (AP polypharmacy as well as adherence [proportion of days covered {PDC}≥80%] and persistence [no gap≥60 days] to the index AP) were compared using chi-squared tests. Medical and pre-rebate pharmacy costs were compared using linear regression with a non-parametric bootstrap procedure to compute p-values. The following groups were identified: CVD (N[PP1M]=230; N[OAA]=4,071), diabetes (N[PP1M]=420; N[OAA]=5,349), HTN (N[PP1M]=655; N[OAA]=8,974), and obesity (N[PP1M]=194; N[OAA]=2,319). PP1M patients were less likely to have AP polypharmacy (eg CVD: 21% vs 28%; p<0.001) versus OAA patients. Relative to OAA patients, adherence was more likely in PP1M patients with CVD or obesity (eg CVD: 29% vs 22%; p<0.001), similar for HTN patients, and less likely for diabetes patients (22% vs 24%; p=0.031). Across all comorbidities, PP1M patients were more likely to be persistent (eg CVD: 50% vs 27%; p<0.001). There was no significant difference in total costs between PP1M and OAA patients for any comorbidity. PP1M patients with diabetes, HTN, or obesity had higher pre-rebate pharmacy costs which were offset by lower medical costs (all p<0.05). Within comorbid populations (CVD, diabetes, HTN, obesity) with schizophrenia, PP1M was associated with less AP polypharmacy and more persistence to therapy compared to OAA. Total healthcare costs were not significantly different between PP1M and OAA, as medical cost savings offset higher pharmacy costs.

Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study.

PurposeTo evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate.Patients and methodsPREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18–65 years) diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis.ResultsSignificant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (P≤0.01), PANSS subscales (positive and general psychopathology; all P≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P≤0.01), Personal and Social Performance scale scores (P≤0.05) and Clinical Global Impression-Severity categorical summary (P≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup (P≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups.ConclusionEarly initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization.

Treatment patterns and Medicaid spending in comorbid schizophrenia populations: once-monthly paliperidone palmitate versus oral atypical antipsychotics

Objective: To compare treatment patterns and Medicaid spending between schizophrenia patients initiating once-monthly paliperidone palmitate (PP1M) and oral atypical antipsychotics (OAAs) within four comorbid populations: cardiovascular disease (CVD), diabetes, hypertension and obesity.Methods: Five-state Medicaid data identified comorbid adults with schizophrenia initiating PP1M or OAAs (index) from September 2009 balanced with inverse probability of treatment weighting. Chi-squared and t-tests compared index antipsychotic (AP) exposure (no gap >90 days) duration, AP polypharmacy, and index AP adherence (proportion of days covered ≥80%) and persistence (no gap ≥60 days) at 12 months post-index. Linear models with a non-parametric bootstrap procedure compared costs.Results: PP1M patients consistently had longer index AP exposure (e.g. CVD: 244 vs. 189 days; p < .001) and less AP polypharmacy (e.g. CVD: 21.1% vs. 28.1%; p < .001) versus OAA patients. Relative to OAA patients, adherence was more likely in PP1M patients with CVD or obesity (e.g. CVD: 28.6% vs. 22.1%; p < .001) and less likely for patients with diabetes (22.0% vs. 24.4%; p = .031). Persistence was consistently more likely for PP1M versus OAA patients (e.g. CVD: 49.9% vs. 27.4%; p < .001). Total costs were not significantly different between PP1M and OAA patients for any comorbidity. PP1M patients with diabetes, hypertension or obesity had higher pharmacy and lower medical costs (all p < .05).Conclusions: Treatment with PP1M versus OAAs may reduce AP polypharmacy and increase AP persistence in comorbid patients with schizophrenia, without increasing total healthcare costs. Comorbidities are a highly prevalent driver of excess mortality in this vulnerable population; thus, future studies should specifically address the real-world effectiveness of therapies, including long acting injectable therapies (LAIs), for these patients.

Economic Impact in Medicaid Beneficiaries with Schizophrenia and Cardiometabolic Comorbidities Treated with Once-Monthly Paliperidone Palmitate vs. Oral Atypical Antipsychotics.

ObjectiveThe 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.MethodsMedicaid 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.ResultsSelected 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).ConclusionsMedicaid 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.Electronic supplementary materialThe online version of this article (10.1007/s40801-018-0130-4) contains supplementary material, which is available to authorized users.

An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Objectives: To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M).Methods: This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks.Results: Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression–Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (p < .0001); the change was clinically and statistically significant both in patients treated with PP1M in monotherapy and in combination with other antipsychotics. Clear improvements in functioning and high patient satisfaction with the treatment were observed. Time from admission to PP1M therapy initiation correlated with the length of hospital stay (p < .0001); earlier start of PP1M treatment was associated with shorter hospital stay. Adverse events were reported in 7.1% of patients (all non-serious).Conclusions: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

P.3.d.023 - Effect of time to treatment initiation with once-monthly paliperidone palmitate in hospitalised Asian patients with acute exacerbated schizophrenia

P.3.d.023 - Effect of time to treatment initiation with once-monthly paliperidone palmitate in hospitalised Asian patients with acute exacerbated schizophrenia

P.3.d.020 - Impact of once-monthly paliperidone palmitate treatment on hospitalisation risk in patients with schizophrenia switching from oral antipsychotics

Data on transplantation survival is widely available for developed countries where cadaveric transplantation is the dominant transplantation type. We aimed to assess patient and graft survival and to determine the possible factors affecting graft survival in a developing country where kidney transplantations were mainly performed from living donors.We retrospectively analyzed data from 427 adult kidney transplantations performed at our center from January 1990 to November 2010. We collected data from patient files, including characteristics of the recipients and donors, transplantation-related factors, post-transplantation features, causes of graft loss, and patient death. The Kaplan-Meier method was used to analyze survival, and Cox regression analysis was used to evaluate the effects of multiple factors on graft survival.Most of the recipients (82.6%) received their organs from living donors. One-year and 5-year graft survival rates were 87.5% and 78.3%, respectively, where the 5-year graft survival rates were 87.1% for living donors and 74.8% for cadaveric donors. The 1-year and 5-year patient survival rates were 90.9% and 88.9%, respectively. Univariate analysis showed that predictors for better graft survival were serum creatinine levels <1.5 mg/dL at 1 month after transplantation, proteinuria <500 mg/d at 1 year after transplantation, use of tacrolimus and mycophenolic acid derivative–based immunosuppression at baseline, living-donor transplantation, and transplantations performed in the years 2000–2010.We report data on kidney transplantation in an emerging country where living-donor transplantation constitutes a large proportion of kidney transplant activities. Modern immunosuppressive medications help to achieve a better survival. Our 5-year results are similar to those of developed countries.

Once-monthly paliperidone palmitate in early stage schizophrenia - a retrospective, non-interventional 1-year study of patients with newly diagnosed schizophrenia.

BackgroundLong-acting antipsychotic therapy may be best suited for patients in the early stage of schizophrenia, when the most can be done before disease progression associated with poor adherence occurs. We explored the patterns of use of once-monthly paliperidone palmitate (PP1M), concomitant medication use, hospitalization, and clinical outcomes of adult, newly diagnosed patients with schizophrenia receiving continuous treatment with PP1M for at least 12 months.MethodsThis was an international, multicenter, exploratory, retrospective chart review of medical records of adult patients who were newly diagnosed (not more than 1 year before initiation of PP1M treatment) with schizophrenia and who had received continuous treatment with PP1M for ≥12 months in naturalistic clinical settings.ResultsA total of 84 (93.3%) patients were included in the analysis. All but one patient (98.8%, n=83) had received oral antipsychotic medication at least during the last month before the first PP1M administration. Three patients (3.6%) were newly hospitalized during the 12-month documentation period. The reason for hospitalization for all three was management of episode/relapse. A total of 79.2% of patients had a ≥20% improvement and 47.2% had a ≥50% improvement in Positive and Negative Syndrome Scale total score from baseline to endpoint. Half of patients (53.3%) showed a significant improvement, as reflected by an increase in Personal and Social Performance (PSP) total score of at least 7 points from baseline to endpoint (mean [SD] 11.9 [15.0] points; P<0.001). One quarter of patients (24.4%, n=11) moved from a PSP score of 31–70 (ie, moderate to marked functional impairment) at baseline to a PSP score of mild to no functional impairment (PSP score ≥71) at endpoint. Most adverse drug reactions were mild or moderate in severity.ConclusionContinuous treatment with PP1M over 12 months was associated with statistically significant and clinically meaningful improvements in psychotic symptoms, disease severity, and functional outcomes in patients with schizophrenia.

Treatment response and tolerability with once-monthly paliperidone palmitate initiated shortly after hospital admission in patients with schizophrenia

Objectives: Partial or non-adherence in patients with schizophrenia is common and increases the risk of relapse. This study explored safety, tolerability and treatment outcomes in patients hospitalised for an exacerbation of schizophrenia initiated on maintenance treatment of once-monthly paliperidone palmitate (PP1M).Methods: A 6-week, observational cohort study of patients initiated on PP1M within 3 weeks after hospital admission.Results: Overall, 367 patients were documented, 85.8% with paranoid schizophrenia subtype. Mean time from hospital admission to PP1M initiation was 9.4 ± 7.7 days. Treatment-emergent adverse events were reported by 22.9% of patients. From baseline to endpoint, significant improvements were observed in psychotic symptoms (Brief Psychiatric Rating Scale total score mean change –19.3 ± 12.6, P < .0001) and functioning (Personal and Social Performance scale total score mean change 14.3 ± 12.4, P < .0001). Overall, 6.0% of patients were very or extremely satisfied with their prior antipsychotic medication at baseline compared with 47.2% very or extremely satisfied with PP1M treatment at endpoint.Conclusions: Initiating PP1M in patients with exacerbated schizophrenia shortly after hospital admission was well tolerated and resulted in statistically significant and clinically relevant improvements in symptoms and patient functioning, suggesting that patients may benefit from early initiation of PP1M during their hospital stay.