Injectable Paliperidone Palmitate Research Articles

Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II).

Paliperidone palmitate 6-month (PP6M) intramuscular (IM) injection is the longest-acting treatment available for patients with schizophrenia. A population pharmacokinetic (popPK) modeling and simulation approach was deployed to inform dosing strategies for PP6M. The extensive analysis database included 15,932 paliperidone samples from 700 patients receiving gluteal paliperidone palmitate 3-month (PP3M) or PP6M injections in the double-blind phase of a phase-3 noninferiority study (NCT03345342). Exposure parameters for paliperidone appeared to increase dose-proportionally within each dosing schedule (PP3M/PP6M). The range of paliperidone exposures after IM administration of PP6M overlaps with that of corresponding doses of oral paliperidone extended release, PP 1-month (PP1M), and PP3M. Model-based simulations were performed to investigate paliperidone exposures in different PP6M dosing scenarios and relevant subpopulations. A dosing window of ≤ 2 weeks earlier and ≤ 3 weeks later than the target 6-month interval for maintenance treatment with PP6M dosing maintains paliperidone exposures at levels that are not expected to substantially impact its safety and efficacy. For missed-dose scenarios, tailored re-initiation regimens are proposed that should be applied before resuming PP6M maintenance dosing. Regarding subpopulations, PP6M 700 mg eq. is the highest dose recommended in mild renal-impairment patients; the paliperidone pharmacokinetics after PP6M administration is not affected by sex, body mass index, or age in a clinically meaningful way. Paliperidone concentration-time profiles after PP6M and PP3M dosing were adequately described by the popPK model. Model-based simulation results provide guidance for clinicians on initiating PP6M therapy, transitioning between paliperidone formulations, the dosing windows to use for maintenance dosing, and managing missed PP6M doses.

Safety and Efficacy of Paliperidone Palmitate in Pediatric Patients with Autism and Intellectual Disability.

This retrospective chart review examines the safety, tolerability and effectiveness of long acting injectable paliperidone palmitate (P-LAI) targeting irritability in twenty-six youth and transition-aged individuals with autism spectrum disorder (ASD) and/or intellectual disability (ID) over a 3-year window. Clinical response was evaluated via prospectively assigned Clinical Global Impressions Severity (CGI-S) and Improvement (CGI-I) scales as well as number of hospital presentations. P-LAI was well tolerated with only 3 patients stopping P-LAI due to side effects. The average duration of P-LAI treatment was 21.1months. Difficulty with medication compliance was the most common reason for initiating P-LAI. There was a statistically significant improvement in CGI-I, CGI-S and hospital visits and no change in BMI noted. Given the potential difficulty of medication administration in this population, this evidence of safety, tolerability as well as preliminary data supporting effectiveness is an important addition to the literature regarding psychopharmacologic management of irritability in youth with ASD and ID.

Postinjection Delirium/Sedation Syndrome After Paliperidone Palmitate Injection in a Bipolar Affective Disorder Patient: A Case Report.

Postinjection Delirium/Sedation Syndrome After Paliperidone Palmitate Injection in a Bipolar Affective Disorder Patient: A Case Report.

Projecting the Potential Budget Impact Analysis of Paliperidone Palmitate in Egyptian Adult Patients with Schizophrenia.

Background: Schizophrenia is a serious mental disorder that has greater negative consequences on role functioning than many other severe chronic diseases. Objective: We evaluated the economic impact of long-acting injections of paliperidone palmitate (PP) vs daily oral antipsychotics to treat chronic schizophrenia from a societal perspective over a 2-year period. Methods: A static budget impact model was developed to compare PP with daily oral antipsychotics (risperidone, olanzapine, and aripiprazole) in the treatment of patients with chronic schizophrenia. Our study included treatments used during relapse and hospitalization, validated by an expert panel. The clinical parameters were extracted from the PRIDE trial. Direct medical costs and indirect costs were measured. The unit cost of drug acquisition for all medications was extracted from the public sector. One-way sensitivity analyses were conducted. Results: The target population in our model was estimated to be 142 incident patients. In the first year, the total drug costs in Egyptian pounds (EGP) for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5.6 million, respectively. In the second year, the total drug costs for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5 million, respectively. The total costs for PP (£11.6 million) over 2 years were less than those of oral antipsychotics without PP (£12.7 million). PP produced an estimated budget savings of £1 046 561 (budget savings per patient per year, £3667). In addition, PP resulted in the avoidance of 18 hospitalizations per year compared with the without-PP arm. Sensitivity analyses showed that the percent of hospitalizations for both oral antipsychotics and PP had the greatest impact on the results. Conclusion: The lower hospitalization rates associated with PP offset the increase in drug costs. PP may potentially be cost-saving compared with the standard of care in chronic schizophrenia in Egyptian representative healthcare settings. Policy makers may consider this approach to improve patient outcomes and budget sustainability.

Lsisi G, Ezzat M, Ramadan M. Projecting the Potential Budget Impact Analysis of Paliperidone Palmitate in Egyptian Adult Patients with Schizophrenia

Background: Schizophrenia is a serious mental disorder that has greater negative consequences on role functioning than many other severe chronic diseases. Objective: We evaluated the economic impact of long-acting injections of paliperidone palmitate (PP) vs daily oral antipsychotics to treat chronic schizophrenia from a societal perspective over a 2-year period. Methods: A static budget impact model was developed to compare PP with daily oral antipsychotics (risperidone, olanzapine, and aripiprazole) in the treatment of patients with chronic schizophrenia. Our study included treatments used during relapse and hospitalization, validated by an expert panel. The clinical parameters were extracted from the PRIDE trial. Direct medical costs and indirect costs were measured. The unit cost of drug acquisition for all medications was extracted from the public sector. One-way sensitivity analyses were conducted. Results: The target population in our model was estimated to be 142 incident patients. In the first year, the total drug costs in Egyptian pounds (EGP) for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5.6 million, respectively. In the second year, the total drug costs for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5 million, respectively. The total costs for PP (£11.6 million) over 2 years were less than those of oral antipsychotics without PP (£12.7 million). PP produced an estimated budget savings of £1 046 561 (budget savings per patient per year, £3667). In addition, PP resulted in the avoidance of 18 hospitalizations per year compared with the without-PP arm. Sensitivity analyses showed that the percent of hospitalizations for both oral antipsychotics and PP had the greatest impact on the results. Conclusion: The lower hospitalization rates associated with PP offset the increase in drug costs. PP may potentially be cost-saving compared with the standard of care in chronic schizophrenia in Egyptian representative healthcare settings. Policy makers may consider this approach to improve patient outcomes and budget sustainability.

Prospective, randomized, multicenter clinical trial evaluating longitudinal changes in brain function and microstructure in first-episode schizophrenia patients treated with long-acting injectable paliperidone palmitate versus oral antipsychotics.

Widespread anatomical alterations and abnormal functional connectivity have shown strong association with symptom severity in first-episode schizophrenia (FES) patients. Second-generation antipsychotic treatment might slow disease progression and possibly modify the cerebral plasticity in FES patients. However, whether a long-acting injectable antipsychotic (paliperidone palmitate [PP]), available in monthly and every-3-months formulations, is more effective than oral antipsychotics (OAP) in improving cerebral organization has been unclear. Therefore, in the current longitudinal study, we evaluated the differences in functional and microstructural changes of 68 FES patients in a randomized clinical trial of PP vs OAP. When compared to OAP treatment, PP treatment was more effective in decreasing abnormally high fronto-temporal and thalamo-temporal connectivity, as well as increasing fronto-sensorimotor and thalamo-insular connectivity. Consistent with previous studies, multiple white matter pathways showed larger changes in fractional anisotropy (FA) and mean diffusivity (MD) in response to PP compared with OAP treatment. These findings suggest that PP treatment might reduce regional abnormalities and improve cerebral connectivity networks compared with OAP treatment, and identified changes that may serve as reliable imaging biomarkers associated with medication treatment efficacy.

Retrospective analysis of hospitalization rates in patients with schizophrenia 12 months before and 12 months after the switch on once-monthly long-acting injectable paliperidone palmitate

Background/Aim. There is no available published data about the use of long-acting injectable paliperidone palmitate (PP) in schizophrenia patients in the Republic of Serbia. The aim of this study was to assess hospitalization rates be-fore and after the switch to once-monthly long-acting injectable PP in schizophrenia patients, as well as their compliance with this drug. Methods. We conducted a retrospective cross-sectional study in which hospitalization rates were evaluated 12 months before and 12 months after the switch to once-monthly long-acting injectable PP in 113 schizophrenia patients. The age of the enrolled patients was between 18 and 66 years. Results. The average age of the enrolled patients was 38.36 ? 11.62 years. Among them, 77 (68.1%) were male, and 36 (31.9%) were female. Out of the total number of 113 patients treated with once-monthly injectable PP, 78 (69.03%) were on monotherapy, while 35 (30.97%) had one additional oral antipsychotic (risperidone, olanzapine, aripiprazole, or clozapine). Out of the total number of 113 patients, 68 (60.18%) were not hospitalized in the 12-month period before the switch to once-monthly long-acting injectable PP, while 45 (39.82%) were hospitalized in the same period. Given that 8 patients out of the total number of 113 were excluded from therapy due to an adverse event or their own decision in the period after the switch to PP, the analysis of the hospitalization rate after the switch to PP was performed for the remaining 105 patients, of which 9 (8.57%) were hospitalized in the period after the switch to PP, and 96 (91.43%) were not. Conclusion. Our results show high compliance in the treatment with once-monthly injectable PP and a positive impact of treatment with this drug on low hospitalization rate in a 12-month period in patients with schizophrenia. Considering the availability of this drug in the Republic of Serbia, these results encourage the use of once-monthly injectable PP as an important therapeutic option in schizophrenia patients.

Severe and persistent extrapyramidal symptoms after paliperidone palmitate injection in a patient with cavum septum pellusidum and the cavum vergae anomalies

Severe and persistent extrapyramidal symptoms after paliperidone palmitate injection in a patient with cavum septum pellusidum and the cavum vergae anomalies

Long-acting injectable paliperidone palmitate induced severe cutaneous allergic reaction in a patient with first episode delusional disorder tolerating oral paliperidone regimen: a case report

BackgroundPaliperidone is a second-generation antipsychotic agent that is effective in the treatment of schizophrenia and schizoaffective disorder as well as an adjunct to mood stabilizers and antidepressants for bipolar and depressive disorders. Paliperidone is available in both oral and injection forms. Here we report an unexpected case of cutaneous allergic reaction induced by paliperidone long-acting injection (LAI) following oral tolerance.Case presentationA 55-year-old man with first episode delusional disorder was treated with paliperidone tablets with tolerance. On day seven he received the paliperidone LAI and developed an allergic reaction in minutes including flushing of the face, widespread urticaria with mild airway constriction. The allergic symptoms were relived following the administration of antihistamine within several minutes.ConclusionThe allergic reaction that occurred post administration of the paliperidone LAI but not the oral tablets suggest it is likely due to the excipients in the formulation of the LAI rather than paliperidone itself. This case highlights the necessity of monitoring allergic reactions in psychiatric patients when converting from oral to LAI format of paliperidone.

Silent Neuroleptic Malignant Syndrome: A Case Report of Atypical Antipsychotic Induced Elevation of Creatinine Kinase and Altered Mental Status.

34-year-old African American male with a diagnosis of schizophrenia was placed on aripiprazole and risperidone for psychosis and mood stabilization. Two days after medication initiation, the patient's mentation was altered and he appeared confused with an elevated creatine kinase (CK) at 7101. Medications were held and CK normalized with IV fluids. Quetiapine was initiated after medical stabilization along with lithium and paliperidone palmitate injections. After the second dose of paliperidone palmitate, the patient's mentation was altered, and repeat CK was 4272. The patient received 4 liters of IV fluid and his mental status returned to baseline. There were two case studies noted that had marked increases in serum CK with risperidone use. The first was in an adolescent who was titrated to a dose of risperidone 3mg/ day but the only abnormality was an increase in his CK levels. The next case report was in a 40-year-old female who was on risperidone 2.5mg /day for one year. She had an intention tremor, minor muscle weakness of the lower extremities with a blood pressure of 140/100 and a pulse of 100. She manifested more clinical signs of possible Neuroleptic Malignant Syndrome (NMS). This case highlights the importance of laboratory investigations when there is a high suspicion of possible NMS. It also highlights that some cases of NMS may only present as altered mental status and increased CK in which quick treatment may lead to the prevention of full-blown clinical manifestations of NMS which could be life-threatening.

Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections.

PurposeThis retrospective cohort study evaluated real-world data on relapses in adult patients with schizophrenia who transitioned to long-acting injectable paliperidone palmitate once-every-3-months (PP3M) following treatment with once-monthly paliperidone palmitate (PP1M).Patients and MethodsData derived from the IBM® MarketScan® Multi-State Medicaid Database were analyzed. Adults aged ≥18 years with ≥1 schizophrenia diagnosis claim and ≥12 months of continuous medical and prescription enrollment before and/or at index date of PP3M were eligible for inclusion. Patients were matched on propensity score to 2 PP3M cohorts: (1) adequately treated (AT), defined as patients treated with PP1M for ≥4 months, with the last 2 doses the same and a PP3M initiation dose meeting the corresponding PP1M-to-PP3M dose conversion, or (2) not adequately treated (NAT), defined as patients who received ≤2 or no PP1M doses. Relapse rates and time to relapse distributions based on the first occurrence of a qualifying event during the 2-year follow-up period were compared between PP3M cohorts using Kaplan–Meier survival curves and log rank test statistics. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. Two sensitivity analyses using different matched populations were performed to assess the robustness of the primary findings.ResultsPropensity score matching yielded a sample of 1314 patients (657 per group). Most patients were male (68.9%) and aged 25–64 years (90.1%). The relapse rate was significantly lower in the AT (18.4%) versus NAT cohort (26.8%), P = 0.0002. Risk of relapse decreased by 35% for AT versus NAT (HR: 0.65 [95% CI: 0.51–0.81]). Relapse reductions favored the AT cohort in both sensitivity analyses (HR: 0.67 [95% CI: 0.54–0.83] and HR: 0.74 [95% CI: 0.56–0.97]).ConclusionIn this analysis of Medicaid claims data, patients adequately treated with PP1M before transitioning to PP3M demonstrated significantly lower relapse rates and delayed time to relapse.

Employment status of patients with schizophrenia spectrum disorder treated with long acting injectable paliperidone palmitate: Real world mirror image study

IntroductionSchizophrenia spectrum disorders may severely limit ability to achieve and maintain gainful employment of affected working-age individuals.ObjectivesAssess the employment status in patients with schizophrenia spectrum disorders treated with long acting injectable paliperidone palmitate after the switch from oral antipsychotics.MethodsA single centre mirror image design study of 115 patients with schizophrenia spectrum disorder was conducted in a tertiary level psychiatric hospital. Data were collected for period of 12 months prior toand 12 months after switching from oral antipsychotic to long acting injectable paliperidone.Employment status for 6 enrolled patients was missing.ResultsMean age of enrolled patients was 38,4±11,6 years. Of the 109 patients analyzed for employment status, 44,4% remained employed for 12 months after switching to long acting injectable paliperidone while 4,6% patients changed their employment status from unemployed to employed after the switch. No patient changed their employment status from employed to unemployed after the switch. 9,2% patients were already retired at the beginning of study period and 5,5% of patients maintained their student status. 36,7% patients remained unemployed for the whole study period. The correlation between employment status of employed and unemployed patients and duration of illness was borderline significant with p=0,049.ConclusionsThe data from this study suggest that use of long acting injectable paliperidone contributed to preservation of working ability of working-age patients suffering from schizophrenia spectrum disorders.DisclosureNo significant relationships.

Clinical Effectiveness of Second-Generation Injectable Antipsychotics


 The evidence in this report is limited because statistical information was not adequately reported in included studies.
 When comparing second-generation paliperidone palmitate injections and first-generation haloperidol decanoate injections, there is little-to-no difference in treatment success or adverse events.
 When comparing second-generation risperidone injections and first-generation haloperidol decanoate and fluphenazine decanoate injections given together, there is little-to-no difference in whether patients discontinue treatment.
 Hospitalization appears higher for patients who receive haloperidol decanoate injections compared to those who receive second-generation risperidone or aripiprazole injections, but there is little-to-no difference when comparing injections of risperidone to those of haloperidol decanoate and fluphenazine decanoate given together.
 There is little-to-no difference between patients who stop treatment when comparing risperidone injections to any oral second-generation antipsychotics, second-generation olanzapine injections compared to oral olanzapine, or aripiprazole injections compared to oral aripiprazole. There is little-to-no difference in adverse events between patients given aripiprazole injections compared to those given oral aripiprazole.
 Some studies showed a difference in relapse between second-generation injections compared to oral second-generation medication, while other studies showed little-to-no differences.
 Patients may experience fewer hospital days when given olanzapine injections compared to those receiving oral olanzapine.

Impact of 3-Monthly Long-Acting Injectable Paliperidone Palmitate in Schizophrenia: A Retrospective, Real-World Analysis of Population-Based Health Records in Spain.

BackgroundTreatment of schizophrenia requires long-term medication to prevent relapse. Treatment nonadherence may increase the risk of relapse, leading to increased hospitalizations and emergency room (ER) visits. Long-acting injectables (LAIs) such as paliperidone palmitate have improved treatment adherence and therefore symptoms. However, real-world studies comparing 3-monthly LAI formulations with other LAIs and oral antipsychotics (OAs) are scarce.ObjectiveThe objective of this study was to investigate and evaluate the clinical effectiveness of paliperidone palmitate LAI monthly (PP1M; Xeplion®) and 3-monthly (PP3M; Trevicta®) formulations compared with the monthly LAI aripiprazole (AM; Abilify Maintena®) and OAs in Spain.MethodsThis was a retrospective, observational study including 2275 adult patients with schizophrenia in a Spanish population. Data from hospital, primary care, and pharmacy dispensation electronic medical records were obtained between January 2017 and February 2018. The main outcomes included psychiatric hospitalizations and ER visit rates, days on treatment, and treatment persistence.ResultsPatients receiving PP3M had a significantly lower mean hospitalization rate (0.00046 ± standard deviation [SD] 0.00181; p < 0.0001) than other treatment groups. Kaplan–Meier curves revealed that 92.0 and 88.4% of patients receiving PP3M remained hospitalization free by 12 and 18 months, respectively. All treatment groups had at least a twofold significantly higher risk of psychiatric hospitalizations compared with those receiving PP3M or OAs, and the hospitalization risk among the PP3M group was significantly lower (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.31–0.67). The risk of ER visits was significantly lower with both PP3M and PP1M than with OAs, and lowest with PP3M (HR 0.462 [95% CI 0.29–0.62] and HR 0.833 [95% CI 0.59–0.97], respectively). Time until treatment switch with PP3M was high, with more than 86.5% of patients remaining on treatment at 18 months.ConclusionsPP3M was more effective than OAs and monthly LAIs in improving clinical outcomes for patients with schizophrenia in a real-world setting in Spain.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40263-022-00917-1.

A health economics study of long-acting injectable once-monthly paliperidone palmitate in schizophrenia: a one-year mirror-image study in China

Schizophrenia is ranked among the top 25 leading causes of disability worldwide in 2013 which resulting in social and economic burden. By observing patients with schizophrenia one year before and after switching from oral antipsychotics (OAPs) to once-monthly paliperidone palmitate (PP1M), we can better understand the change of total costs in schizophrenic patients, including direct costs and indirect costs, after switching treatment patterns.A total of 100 schizophrenic (ICD-10) patients from Shandong Mental Health Center were collected from December 2016 to June 2019. Treatment modalities, health care resource utilization and costs were compared before and after switching directly from oral antipsychotics to PP1M.Of the 82 patients included in the main analyses, treatment with PP1M resulted in an increase in direct costs of 31.92% (P < 0.01), an increase in medicine costs of approximately 142% (P < 0.01), and a reduction in hospital costs of 68.15% (P > 0.05). There was no significant increase in total costs (P = 0.25), while 31.92% increase in direct costs (P < 0.01), and 35.62% decrease in indirect costs (P < 0.01) after conversion to PP1M. Compared with before administration of PP1M, patients with ≥ 1 inpatient stay in 1 year Pre-PP1M treatment with OAPs (n = 32) had a 20.16% decrease in direct costs (P < 0.01), a 144% increase in medicine costs (P < 0.01), and a significant 72.02% decrease in hospital costs (P < 0.01). The observed reduction in the number of hospitalizations (t = 2.56, P ≤ 0.01) and inpatient stays (t = 1.73, P < 0.05) and after transition to PP1M resulted in a reduction in hospitalization costs (P < 0.01).Switching from OAPs to PP1M decreased the household workforce burden without increasing clinical healthcare costs. Direct costs were significantly reduced in patients with ≥ 1 inpatient stay in 1 year pre-PP1M treatment with OAPs after the switch, which decreased by improving adherence to therapy and reducing the number and length of hospital stays, suggesting that those patients may benefit after switching to PP1M.

Adolescents and dual pathology. Assessment of treatment with paliperidona palmitato long-term injectables

IntroductionToday cocaine use is very frequently associated with adolescents with maladaptive personality traits and impulse control disorder. It requires a multidisciplinary approach and individualized treatments to improve the clinic and achieve the abandonment of consumption.Objectives1. To assess the efficacy of monthly injectable paliperidone palmitate treatment in controlling impulsivity. 2. Determine the consumption of toxins after treatment.MethodsSample: Adolescents, 14-17 years old, with a diagnosis of Personality Limit T and cocaine consumption who start treatment with Paliperidone Palmitate LD IM (50-100mg / month) in monotherapy, with Diazepam 5mg if significant anxiety. Retrospective data collection. Plutchik impulsivity scale (IE) before starting treatment and at 3 months. Statistical analysis SPSS 20.0ResultsTwelve adolescents who met the inclusion criteria were included and 12 adolescents, 83% male, 16% female, completed the questionnaires. After its application and correction through non-parametric tests (N &lt;30), scores in the EI questionnaire of a mean of 37.42 points in the pretest were observed, corresponding to a severe level of impulsivity; and a mean of 26.28 points in the post-test, compatible with a mild-moderate degree of impulsive symptoms. A decrease in the consumption of toxins was observed in 65% of the cases.ConclusionsIn our experience, the management of toxic consumption in adolescent population with severe impulsivity symptoms has great limitations due to the scarce resources available. The Palpitate of Paliperidone long-term treatment has been useful in the approach of serious registered cases, being associated with symptomatic improvement and decrease in consumption.

Patients’ perspectives on three-monthly administration of antipsychotic treatment with paliperidone palmitate – a qualitative interview study

Introduction Three-monthly dosage of paliperidone palmitate entails longer time to relapse after discontinuation, is similarly tolerable and safe compared to monthly injections of paliperidone palmitate and is beneficial for the caregivers. However, few studies have so far explored in depth the patients’ experiences with paliperidone palmitate medication every three months, or with switching from monthly to three-monthly injections of paliperidone palmitate. Material and methods A qualitative study based on individual interviews with persons with schizophrenia who receive three-monthly paliperidone palmitate in Norway, Sweden and Denmark. Data was analysed according to qualitative content analysis. Results Twenty-four patients, 16 men and 8 women, took part in individual interviews. The patients’ mental health care professionals mainly recommended the switch to three-monthly paliperidone palmitate, and few or no disadvantages were described. According to the patients, three-monthly paliperidone palmitate had several advantages, such as less frequent injections, less administration and planning and less focus on the illness. In addition, the participants described feeling more stability, being more physically and socially active, and that improvement processes were supported. For some, the use involved practical and economic challenges, and some worried whether the medicine ‘wore off’ before the next injection. According to the patients, switching to three-monthly paliperidone palmitate did not influence the frequency or content of patients’ interaction with health care professionals. Conclusion Switching from monthly to three-monthly injections with paliperidone palmitate seems to be experienced as advantageous for patients with schizophrenia.

Impact of initiating long-acting injectable paliperidone palmitate on relapse and hospitalization in patients with bipolar I disorder: A mirror image retrospective study.

Literature assessing the use of long-acting injectable paliperidone palmitate in patients with bipolar I disorder is limited. The aim of this retrospective study was to determine the effectiveness of long-acting injectable paliperidone palmitate treatment on relapse and hospitalization in a real-world setting. Patients with bipolar I disorder aged 18-65 years, who were treated with paliperidone palmitate once-monthly (PP1M) for at least one year, were included. The rate of relapse, hospitalization, and length of hospital stay were collected. Safety outcomes included levels of prolactin, fasting blood sugar, total cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein. The data of 36 patients who met the study criteria were evaluated. Number and length of hospitalizations, number of manic and mixed episodes significantly decreased after PP1M addition. When we compared the prolactin, fasting blood sugar, total cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein levels as an indicator of the safety of treatment, there was no statistically significant change in these values before and after PP1M addition. Our findings suggested PP1M may be effective in reducing manic and mixed episodes. Limitations include a mirror image retrospective design and small sample size.

M197. SEASONAL ANTIPSYCHOTICS IN SCHIZOPHRENIA: OUTCOMES IN NATURALISTIC SETTINGS (SEASONS STUDY) OBSERVATIONAL RETROSPECTIVE MULTICENTRE CANADIAN STUDY ON 3MONTH-FORMULATION OF LONG-ACTING INJECTABLE PALIPERIDONE PALMITATE

BackgroundThe 3 month-formulation of long-acting injectable paliperidone palmitate (PP3M) is available in Canada since 2016. However, there are still limited data on its use in real life setting.MethodsThis ongoing study retrospectively reviews the use of this formulation in 6 centers across Canada (targeted n=250 patients). Data on PP3M use (dosage, duration of exposure, reasons for initiating PP3M and stopping it, if applicable) are recorded, as well as its clinical impact (hospitalizations, global severity of illness as measured by Clinical Global Impression Scales), the main outcome variable being discontinuation of PP3M.ResultsPreliminary data are available for the first 35 patients coming from 3 participating centers. 31/35 are men, on average 35 years old, Caucasian (25/35), exposed to antipsychotics for an average of 7 years (sd 2 yrs) with an average 2-year exposure to the 1-month formulation of long-acting injectable paliperidone palmitate (PP1M). 21/35 had also at least one concomitant disorder (some may be combined), such as substance use disorder, personality disorder or anxious disease, and 10/35 were under a court treatment order. Clinical Remission (as defined as a CGI S score equal or less to 3) was maintained in 27/35 subjects over an average of 14 months (sd 9 months) of PP3M. However, 8 patients stopped their treatment dues to compromise stability (2 patients), side effects (2 patients: somnolence, 1 patient: pain discomfort at site of injection) or loss to follow-up (3 patients).DiscussionIn this Canadian study, preliminary observations in real life settings suggest that PP3M may be an interesting option for patient previously stabilized on PP1M, although the number of treatment cessations might suggest that the clinical effectiveness of PP3M vs. PP1M may not be similar in all subjects.

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study.

Factors underlying the selection of antipsychotics for patients with schizophrenia are poorly understood. This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia. Adults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12months of continuous health plan enrollment prior to index date were included in the analysis. Multivariable logistic regression was performed to determine the factors associated with the initiation of LAI-PP versus LAI-AP. Of included patients, 5501 initiated LAI-PP and 1449 initiated LAI-AP. Patients more likely to initiate LAI-PP versus LAI-AP were older, male, or African American (all p < 0.01). Patients with obesity (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.71, 0.98), post-traumatic stress disorder (OR 0.76; 95% CI 0.63, 0.92), or prior oral antipsychotic use (OR 0.66; 95% CI 0.55, 0.79) were less likely to initiate LAI-PP; whereas, patients with nonorganic psychoses (OR 1.35; 95% CI 1.18, 1.55) or prior use of other injectable antipsychotics (OR 1.26; 95% CI 1.09, 1.47) were more likely to initiate LAI-PP versus LAI-AP. Patients with at least two all-cause hospitalizations were 1.37 times more likely to initiate LAI-PP vs LAI-AP (OR 1.37; 95% CI 1.18, 1.60). Factors associated with initiating LAI-PP and LAI-AP differed. Notably, patients who initiated LAI-PP had greater prior use of medical services than LAI-AP patients. Understanding prescribing practices may help optimize treatment strategies and improve disease management. Janssen Scientific Affairs, LLC.