A double-blind, randomized, active-controlled, parallel-group, noninferiority trial (NCT03345342) demonstrated that paliperidone palmitate once-every-6-months (PP6M) was noninferior to paliperidone palmitate once-every-3-months (PP3M) in preventing relapse in clinically stable adults with schizophrenia. This post hoc analysis assessed efficacy and safety following transition to PP6M from paliperidone once-monthly (PP1M) versus PP3M.

Adults with schizophrenia who were clinically stable on moderate/high doses of PP1M or PP3M were randomly assigned 1:2 to dorsogluteal PP3M or PP6M treatment for 12 months. The primary efficacy measure was time to relapse during the 12-month DB phase. Secondary endpoints included change from DB baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total and subscale scores, Clinical Global Impression-Severity (CGI-S) scale score, and Personal and Social Performance (PSP) scale score. Safety was assessed by treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory tests.

Of 702 patients in the study, 231 transitioned from PP1M to PP6M and 247 transitioned from PP3M to PP6M. Low relapse rates for PP6M were observed regardless of transition pathway (PP1M/PP6M: 7.8%; PP3M/PP6M: 7.3%). Changes from DB baseline to endpoint in PANSS total, PSP, and CGI-S scores were similar between transition groups. In the DB phase, ≥1 TEAE was observed in 61.0% and 63.2% of patients in the PP1M/PP6M and PP3M/PP6M, groups, respectively.

Adults with schizophrenia who transitioned to PP6M from either PP1M or PP3M experienced similarly low relapse rates. Additionally, symptom and functionality scores supported the primary analysis and, along with TEAE incidences, were comparable between transition groups.

Paliperidone palmitate 1-month (PP1M) is a Long-acting injectable antipsychotic formulation, approved for the treatment of schizophrenia and schizoaffective disorder. Recently, paliperidone palmitate 3-months (PP3M) formulation was introduced, which maintains stability while offering a longer dosing interval for the maintenance treatment in patients previously treated with PP1M. Despite of this, many patients are treated with PP1M without transition to PP3M.

To identify variables explaining maintenance of PP1M treatment instead of going to PP3M. We hypothesize that more severe patients are delayed in transition to PP3M because of expectation to complete stabilization.

A descriptive analysis of 123 patients, diagnosed with psychotic disorders, on treatment with paliperidone palmitate 1 month or 3 months, was performed. Age, sex, type of paliperidone treatment, hospitalizations after the initiaton of treatment, years since diagnosis, polytherapy and toxic habits were some of the variables measured and compared between both groups (PP1M and PP3M).

Most of patients (63,41%) were on PP3M. Both groups shared characteristics like male sex predominance, schizophrenia as the most common diagnosis, having a recent onset diagnosis, same frequency of polypharmacy and same pattern of drug consumption. There was a slight difference between both groups regarding severity. PP1M and PP3M showed respectively 33% and 16,7% of admissions after initiation.

No clear pattern determines less transition to PP3M from PP1M. No statistical difference was found except form the difference found in admission after change of treatment (to PP1M or PP3M), which could reflect influence of severity in treatment. Future research is needed in order to better elucidate this association.

No significant relationships.

Schizophrenia spectrum disorders may severely limit ability to achieve and maintain gainful employment of affected working-age individuals.

Assess the employment status in patients with schizophrenia spectrum disorders treated with long acting injectable paliperidone palmitate after the switch from oral antipsychotics.

A 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.

Mean 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.

The 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.

No significant relationships.

Schizophrenia is a chronic disease that deteriorates the functionality of patients, especially when forming a family and taking care of children. We are interested in analyzing the characteristics of mothers with schizophrenia and their degree of global activity when going from oral treatments to injectable treatments.

1 To assess the quality of life and functional level of mothers with schizophrenia receiving paliperidone treatment. 2. Compare quality of life and functional level when going from oral treatment to long-term injectables.

Sample: Mothers, 37-45 years old, diagnosed with schizophrenia in monotherapy with oral paliperidone who started treatment with Paliperidone Palmitate LD IM (200 - 300 mg / month). Retrospective data collection. QLS quality of life scale.

5 patients were included, caregivers of 1 child (80%), 2 children (20%) who met the inclusion criteria and completed the questionnaires. After its application and correction through non-parametric tests (N <30). During oral treatment, scores were observed in the QLS questionnaire of: mean intrapsychic functions 34.2, mean interpersonal relationships 19, mean instrumental role 8, mean daily activities 8. After 12 weeks of treatment with Paliperidone Palmitate IM, scores were obtained: functions Medium intrapsychic 36, medium interpersonal relationships 23, medium instrumental role 15, medium daily activities 11. A better functioning of the patients was observed in the instrumental and daily activities categories.

In our experience, injectable long-acting Paliperidone Palmitate is associated with the perception of better quality of life in mothers with schizophrenia and increases the ease of administration as well as planning in their daily life.

Around 30% of patients with schizophrenia are considered treatment resistant (TRS). Only around 40% of TRS patients respond to clozapine. Long acting injectable antipsychotics could be a useful augmentation strategy for nonresponders.

We conducted a multicenter, observational, naturalistic, retrospective, 6-month mirror-image study to evaluate the efficacy and tolerability of clozapine and paliperidone palmitate association in 50 patients with TRS and other psychotic disorders. Clinical outcomes and side effects were systematically assessed.

Six months after starting the combined treatment, participants showed a significant relief of symptoms, decreasing the Brief Psychiatric Rating Scale total score from 18.32 ± 7.71 to 7.84 ± 5.16 (p < 0.001). The number of hospitalizations, the length of hospital stays and the number of visits to emergency services also decreased, while an increase of the functionality was observed (Personal and Social Performance total score increased from 46.06 ± 118.7 to 60.86 ± 18.68, p < 0.001). There was also a significant decrease in the number and severity of side effects with the combination therapy, decreasing the Udvalg for Kliniske Undersogelser total score from 10.76 ± 8.04 to 8.82 ± 6.63 (p = 0.004).

This study provides the first evidence that combining clozapine with paliperidone palmitate in patients with TRS and other psychotic disorders could be effective and safe, suggesting further research with randomized controlled trials of augmentation strategies for clozapine nonresponder patients.

Patients with psychotic disorders such as schizophrenia show a variable response to antipsychotic treatments. Around 30% of patients are considered treatment resistant, indicated by insufficient symptom control to at least two different drugs. In these resistant cases, clozapine should be indicated, as it has shown to be superior to other options. However, only 40% of patients respond to clozapine, being necessary to establish which treatments could best potentiate clozapine action. Combining clozapine with long acting injectable antipsychotics, and particularly paliperidone palmitate, could be a useful strategy. We conducted a multicenter study of 50 patients with treatment-resistant schizophrenia and other psychotic disorders comparing the efficacy and tolerability in the 6 month-period prior and after starting the clozapine and paliperidone palmitate association. Our study suggests that this combination could be effective and safer, laying the groundwork for future clinical trials with this combination.

This analysis of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study (NCT01157351) compared outcomes after administration of once-monthly paliperidone palmitate (PP) vs conventional oral antipsychotics (COAs) or atypical oral antipsychotics (AOAs).

PRIDE was a 15-month study of 444 individuals with schizophrenia and a history of incarceration. They were randomly assigned to PP or to 1 of 7 commonly prescribed OAs. Primary endpoint was time to first treatment failure (TF). Event-free probabilities were estimated using the Kaplan–Meier method; treatment group differences (PP vs COAs, PP vs AOAs, and PP vs oral paliperidone/risperidone) were assessed using a log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models. No adjustment was made for multiplicity.

Compared with PP, risk for first TF was 34% higher with COAs (HR: 1.34; 95% CI: 0.80–2.25), 41% higher with AOAs (HR: 1.41; 95% CI: 1.06–1.88), and 39% higher with paliperidone/risperidone (HR: 1.39; 95% CI: 0.97–1.99). Incidences of extrapyramidal symptom–related adverse events (AEs) were 45.7%, 13.7%, and 10.6% in the COA, AOA, and oral paliperidone/risperidone groups vs 23.9% in the PP group. Incidences of prolactin-related AEs were 5.7%, 3.8%, and 3.5% vs 23.5%, and incidences of ≥7% weight increase were 11.4%, 14.9%, and 16.0% vs 32.4%.

Results suggest a lower risk of TF but a higher rate of some AEs after treatment with PP vs COAs, AOAs, and paliperidone/risperidone. Deselection of specific OAs and low patient-compliance rates with OAs likely biased the safety results.

Paliperidone palmitate long‐acting injection (PP‐LAI) has recently been approved for treatment of chronic schizophrenia. Its cost‐effectiveness has not been established. The objective was to compare direct costs and outcomes between PP‐LAI and olanzapine pamoate (OLZ‐LAI) in treating chronic schizophrenia in Norway from the perspective of the government payer.

We used a decision analytic model over a 1‐year time horizon. Clinical inputs were derived from the literature and an expert panel; costs were taken from standard lists, adjusted to 2010 Norwegian kroner (NOK). Discounting was not done. Main outcomes included average cost per patient treated, hospitalisations, emergency room (ER) visits and quality‐adjusted life years (QALYs). The pharmacoeconomic outcome was the incremental cost per QALY. Robustness was examined using one‐way sensitivity analyses on critical variables and a 5000‐iteration probabilistic Monte Carlo sensitivity analysis with all variables included.

PP‐LAI generated 0.845 QALY at a cost of 151 336 NOK of which 23% was due to drugs; 25% of patients were hospitalised and another 12% required ER visits. OLZ‐LAI cost 174 351 NOK (21% due to drugs); patient outcomes included 0.844 QALY, 27% hospitalisations and 14% ER visits. PP‐LAI dominated OLZ‐LAI in the base case. The analysis was reasonably robust against variations in drug cost but sensitive to small changes in adherence and hospitalisation rates. Overall, PP‐LAI was dominant over OLZ‐LAI in 54.5% of simulations. Replacing OLZ‐LAI with PP‐LAI would be cost saving for the Norwegian healthcare system.

PP‐LAI was cost‐effective compared with OLZ‐LAI in treating patients with chronic schizophrenia in Norway but sensitive to changes in adherence and hospitalisation rates.