Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

Sliwa, Jennifer Kern; Bossie, Cynthia A.; Fu, Dong-Jing; Turkoz, Ibrahim; Alphs, Larry

doi:10.2147/ndt.s32581

Cited by 15 publications

(13 citation statements)

References 54 publications

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“…In these patients, the tolerability of PP1M's initiation dosing was similar to oral risperidone (Gopal et al, 2011). During longer-term exposure, tolerability was similar to risperidone long-acting injection (Fu et al, 2014), with no unexpected findings compared with placebo or no treatment (Bossie et al, 2011; Sliwa et al, 2012). The current analysis did not show recent onset subjects were less tolerant of treatment, as reported by others (Alvarez-Jiménez et al, 2008; Francey et al, 2010; McEvoy et al, 2007).…”

Section: Discussionmentioning

confidence: 83%

“…Taken together, these results support the potential value of early intervention with PP1M and are consistent with previous reports (Heres et al, 2014; Kane et al, 2015; Llorca et al, 2013; Subotnik et al, 2015) that patients early in their psychiatric illness are often more responsive to treatment. Furthermore, they add to the growing body of evidence on the effects of PP1M in recently diagnosed schizophrenia patients (Bossie et al, 2011; Fu et al, 2014; Sliwa et al, 2012; Stevens et al, 2016; Zhang et al, 2015), including prospective parallel-group comparisons showing benefits with PP1M compared with daily oral antipsychotic treatment (Alphs et al, 2015; Schreiner et al, 2015). In these patients, the tolerability of PP1M's initiation dosing was similar to oral risperidone (Gopal et al, 2011).…”

Section: Discussionmentioning

confidence: 99%

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Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Bossie¹,

Turkoz²,

Alphs³

et al. 2017

J Nerv Ment Dis

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Data from a multiphase schizoaffective disorder study (NCT01193153) were used to examine the effects of paliperidone palmitate once-monthly (PP1M) by subjects' illness duration, defined as recent onset (≤5 years since first psychiatric diagnosis; n = 206) and chronic illness (>5 years; n = 461). Symptom and functioning scores, as measured during open-label PP1M acute and stabilization treatment phases, improved in both subpopulations, with greater improvements in recent onset than chronic illness subjects (p ≤ 0.022). Relapse rates, examined during the double-blind, placebo-controlled phase, were higher with placebo than PP1M: 30.0% vs. 10.2% (p = 0.014; hazard ratio [HR]: 2.8; 95% confidence interval [CI]: 1.11–7.12; p = 0.029) in the recent onset subpopulation and 35.5% vs. 18.1% (p = 0.001; HR: 2.38; 95% CI: 1.37–4.12; p = 0.002) in the chronic illness subpopulation. Growing evidence in the treatment of schizophrenia and schizoaffective disorder supports early intervention with long-acting antipsychotics.

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Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Bossie¹,

Turkoz²,

Alphs³

et al. 2017

J Nerv Ment Dis

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“…Long-term tolerability of PP was compared between recently diagnosed schizophrenia patients (≤5 years) and chronically ill patients as a post hoc analysis from an open-label multicenter trial. 31 Regarding main findings, nasopharyngitis was more common in chronically ill patients compared to recently diagnosed schizophrenia patients, and amenorrhea in recently diagnosed patients. Further, the authors found that prolactin levels were higher in women recently diagnosed when compared to chronically ill female schizophrenia patients.…”

Section: Resultsmentioning

confidence: 94%

“…From the 19 selected studies, we found several articles reporting outcomes by using different study designs, as follows: one randomized, cross-over trial; 17 six randomized, double-blind, placebo-controlled trials; 18 – 23 one open-label, noninferiority study comparing PP with risperidone long-acting injectable (RLAI); 24 five randomized, double-blind, noninferiority clinical trials, four of them comparing PP with RLAI 25 – 28 and one comparing PP with oral paliperidone extended release. 29 Further, six open-label prospective studies were detected: one long-term, 1-year prospective study; 30 one open-label, double-blind trial comparing PP in recently diagnosed patients versus chronically ill schizophrenia; 31 one flexible-dose, interventional, single-arm study with 6-month follow-up; 32 one open-label, 15-month, active-controlled trial; 33 one open-label, 6-month, prospective study; 34 and a 18-month, open-label, Phase IIIb study. 35 …”

Section: Resultsmentioning

confidence: 99%

Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

González-Rodríguez¹,

Catalán²,

Penadés³

et al. 2015

PPA

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Background and objectivesShort-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations.MethodElectronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available.ResultsNineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted.ConclusionSeveral studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release.

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“…The benefits of long-term maintenance 28 – 31 and recurrence prevention 32 in global patient populations with schizophrenia have also been shown across a flexible dose range of 50–150 mg eq. Two recently published long-term studies demonstrated the favorable efficacy and safety of PP1M in patients from the Asia-Pacific region (Chinese patients: n=100 in each study).…”

Section: Introductionmentioning

confidence: 96%

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

Zhao

Shi

et al. 2017

NDT

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RationaleLong-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.ObjectiveThe aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.MethodsIn this 25-week, open-label, Phase IV study, patients (18–65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60–120 (inclusive) were enrolled. All patients received injections of PP1M 150 mg eq. (day 1) and 100 mg eq. (day 8), followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq.).ResultsOf the 353 patients, 234 (66.3%) completed the study treatment (mean age, 31.1 years; 52.7% men). The PANSS total score (primary end point) improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, −27.2 [18.30]; P<0.0001). The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points) also improved significantly (P<0.0001). At 6 months, PP1M had a positive impact on medication satisfaction, adherence, and increased preference for LAIs. Treatment-emergent adverse events (TEAEs) were reported by 181 (51.3%) patients (TEAEs ≥5%: extrapyramidal disorder [15.3%], akathisia [10.5%], blood prolactin increase [8.8%], insomnia [5.4%]). A total of 8 deaths were reported, including 4 completed suicides.ConclusionLong-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies.

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Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

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Cited by 15 publications

References 54 publications

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

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Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

Abstract: Video abstract Video

Cited by 15 publications

References 54 publications

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Paliperidone Palmitate Once-Monthly Treatment in Recent Onset and Chronic Illness Patients With Schizoaffective Disorder

Profile of paliperidone palmitate once-monthly long-acting injectable in the management of&nbsp;schizophrenia: long-term safety, efficacy, and&nbsp;patient acceptability &ndash; a review

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

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Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review