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hange in mean PANSS total score from baseline to LOCF endpoint* of a 6-month study5

header-Trevicta-Invega Sustenna Efficacy
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Invega Sustenna is indicated as:3
- a maintenance treatment for the symptoms of schizophrenia in adult patients stabilised on palpiridone or,
- in patients with mild to moderate symptoms who showed responsiveness to palperidone or risperidone in the past.
Adapted from Schreiner A et al. 2014.
* Month 6 or early discontinuation. Study endpoint.5
** p<0.0001 vs. baseline, Error bars represent 95% CI.5
† The main reasons for switching to INVEGA SUSTENNA® were patient’s wish (n=259 [43.7%]), lack of efficacy (n=144 [24.3%]), lack of compliance (n=138 [23.3%]), and lack of tolerability (n=52 [8.8%]) with the previous oral antipsychotic medication.5
BL, baseline; LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome scale.
i. For guidance on switching patients with schizophrenia to INVEGA SUSTENNA® please refer to the Ministry of Health approved leaflet.
ii. Following INVEGA SUSTENNA® 150 mg equivalent dose on Day 1.5 the primary objective for the studied group was to explore the tolerability, safety, and treatment response of flexible doses of once- monthly paliperidone palmitate (PP) in non-acute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents.5
This study was a prospective, interventional, single- arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. A total of 160 sites in 21 countries took part in the study. The study consisted of a 7-day screening and a 6-month prospective study period.5
Eligible participants were male and female patients aged ≥18 years with a diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV])
who were switched to PP from an unsuccessful treatment with a previous oral antipsychotic agent. Patients were required to be in stable condition but symptomatic. Patients were
categorized according to the main reason for switching, either due to lack of efficacy or due to other reasons. The efficacy intent-to-treat population consisted of 589 patients.5
PP was initiated at 150 milligram equivalents (mg eq) on day1 and 100 mg eq on day8(± 2 days)
intra- muscularly, both given in the deltoid muscle. Previous oral anti psychotics included:
amisulpride, aripiprazole, haloperidol, olanzapine, paliperidone ER, quetiapine, quetiapine fumarate, risperidone, sertindole, and ziprasidone.6
The primary efficacy outcome for patients switched due to lack of efficacy was the percentage of patients achieving treatment response, defined as ≥20% improvement in PANSS total score from baseline(day1) to last-observation-carried-forward(LOCF)endpoint (at 6 months or early discontinuation).5
ER, extended release.

References
1. INVEGA® Ministry of Health approved leaflet, 18/3/2019.
2. Risperdal® Ministry of Health approved leaflet, 16/12/2019.
3. INVEGA SUSTENNA® Ministry of Health approved leaflet, 18/3/2019.
4. TREVICTA® Ministry of Health approved leaflet.19/5/2019.
5. Schreiner A, Bergmans P, Cherubin P, et al. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014;36(10):1372-88.e1.
6. Schreiner A, Aadamsoo K, Altamura AC, et al. Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schizophr Res.2015;169(1-3):393-399.

CP-253609

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