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

Abstract

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.

Oral and Palmitate Paliperidone Long-Acting Injectable Formulations’ Use in Schizophrenia Spectrum Disorders: A Retrospective Cohort Study from the First Episode Psychosis Intervention Program (CRUPEP)

“…Despite the lack of literature regarding the effectiveness of long-acting antipsychotic formulations in patients with an FEP, our results are in line with those reporting the effectiveness of PPLAI-1M and PPLAI-3M formulations on the treatment of patients with early-onset psychosis ( Emsley et al, 2008 , 2017 ; Zhang et al, 2015 ; Bossie et al, 2017 ; Petrić et al, 2019 ).…”

<p>Long-term efficacy and safety of paliperidone palmitate once-monthly in Chinese patients with recent-onset schizophrenia</p>

“…The institutionalizations reduced considerably in the 12-month period of therapy as compared with the retrospective period (37.0% vs 6.5%) in this study. Observations from the current study combined with data from other recent real-world observations in naturalistic clinical settings revealed very low rates of new hospitalization with 12-month PP1M therapy,34 suggesting that a lowered direct health care cost may be expected as a benefit of long-term PP1M therapy 35…”

Comparison of long-term efficacy and safety of blonanserin treatment in individuals with first-episode and relapsed schizophrenia: a 3-year retrospective study

“…Most of the subjects in the FE group received a dose decrease of blonanserin; however, each patient's highest dose was maintained in the non-FE group. This finding suggests that FE individuals require normal or lower doses of blonanserin [40].…”