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HomeProductsClinically provenEfficacy and Safety of Paliperidone Tablets (Parnido®) in Clinical Practice in Patients with Schizophrenia or Schizoaffective Disorder

Anica Gorjanc Vitez, Breda Barbič-Žagar, Marina Vrzel, Tjaša Cepič

Key words

schizophrenia, schizoaffective disorder, paliperidone, efficacy, functioning, safety

Abstract

Background: Schizophrenia and schizoaffective disorder are psychotic disorders that are classified as two separate diagnoses. Owing to their similarities, it is difficult to distinguish between them, particularly at an early stage. This makes it difficult to give a correct diagnosis and also affects the choice of treatment. Paliperidone prolonged-release tablets are the only atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorder that is available in the market. The purpose of the non-interventional study was to monitor the clinical efficacy and safety of paliperidone tablets in regular clinical practice in patients with schizophrenia and schizoaffective disorder.

Methods: The non-interventional study included 153 patients. Each patient was followed for two months and was scheduled for three visits, which is in line with clinical practice. Most of the patients (83.0%) were treated with some other antipsychotic before inclusion in the study. Paliperidone (Parnido®) tablets were initiated at a dose of 3 mg in almost a half (49.3%) of the monitored patients. At Visit 2, as many as 72.5% of the patients were treated with a therapeutic dose of 6 mg or higher. Investigators assessed the efficacy of treatment based on the Clinical Global Impression Rating Scale for Severity (CGI-S) at all visits, the Clinical Global Impression Scale for Improvement (CGI-I) at Visits 2 and 3; based on the 7-point scales, they also evaluated the social and occupational functioning at all visits and the improvement of social and occupational functioning at Visits 2 and 3. Adverse events were monitored from the start of the patient inclusion in the study.

Results: The results of the non-interventional study confirmed the efficacy of paliperidone tablets as all four parameters used by the investigators for assessing the efficacy of treatment (CGI-S score, CGI-I score, scores for patients’ social and occupational functioning and scores for improvement in patients’ social and occupational functioning) were statistically significantly improved. After two months of monitoring, a statistically significant reduction, by 32%, was observed in the severity of the disease. The percentage of the patients who were not at all ill anymore or were borderline or mildly ill increased to 57.6%. The clinical condition improved in 87.8% of patients. Statistically significant improvement, by 29%, was observed in social and occupational functioning. At the end of the observation period, functioning was improved in 87.6% of the patients. The efficacy of paliperidone tablets was further confirmed in the group of patients who were previously treated with risperidone. After two months, the severity of the disease in these patients was relatively reduced by 33%. In addition, the clinical condition improved in 93.1% of the patients and the social and occupational functioning in 92.9%. The treatment with paliperidone tablets was well tolerated as in 84.3% of the patients no adverse events were recorded. Causally related adverse events occurred in 14.4% of the patients, most frequently in the first month of the treatment. Owing to the causally related adverse events, the medicine was discontinued in 3.3% of the patients.

Conclusions: The non-interventional study confirmed the safety and efficacy of paliperidone tablets used in regular clinical practice in the patients with schizophrenia and schizoaffective disorder regardless of the fact that most of them had been previously treated with an antipsychotic. The initiation of tablets containing paliperidone may improve the clinical outcome of the treatment also in patients who had been previously treated with risperidone.

Introduction

Schizophrenia and schizoaffective disorder share certain similarities. Both are characterised by psychotic and affective symptoms (symptoms of depression and/or mania), though these are even more frequent and more pronounced in schizoaffective disorder.(1) For a long time researchers didn’t know whether we were dealing with one or two disorders.(2) Today they are recognised as two separate disorders with clear diagnostic criteria.(3, 4, 5)

Schizophrenia affects around 1% of the population and is well identified.(6) Patients get mostly identified and also treated, but achieving functional remission (defined as symptomatic remission without functioning problems) remains low (12% of patients).(7, 8)

Compared to schizophrenia, schizoaffective disorder is less common (it occurs in 0.2–1.1% of the population). Due to the wide range of symptoms and similarities with other psychotic disorders, patients with schizoaffective disorder are more difficult to identify. In the initial stages, they are often misdiagnosed with schizophrenia or some other mental disorder. It usually takes several years for a correct diagnosis to be put forth. Schizoaffective disorder is also a very unstable diagnosis to make. In clinical practice, it is often an intermediate diagnosis, which in later stages turns into a diagnosis of schizophrenia or bipolar disorder.(1, 9, 10)

Treatment of both disorders is long-term. The basis of treatment for schizophrenia are antipsychotics, both in the acute phase to control the symptoms and in maintenance treatment to prevent relapse.(11, 12) There are no guidelines with recommendations for the treatment of schizoaffective disorder; in clinical practice, these patients are usually treated with an antipsychotic in monotherapy or in a combination with an antidepressant or a mood stabilizer.(9, 10, 13)

One of the long-term goals of treatment is to restore the patients’ functioning to the level it was before the disease. However, improving symptoms does not necessarily lead to an improvement in patients’ daily functioning. Since cognitive and negative symptoms often persist despite treatment, patients’ functioning in their daily lives is worse.(11, 14)

Paliperidone is the active metabolite of risperidone. Despite similarities in structure, antipsychotics differ in their pharmacological properties, which may lead to different treatment outcomes.(15)

Paliperidone prolonged-release tablets are the only atypical antipsychotic approved in Europe for the treatment of schizophrenia and schizoaffective disorder.(16) It is indicated for the treatment of schizophrenia in adults and adolescents 15 years of age and older, and for the treatment of schizoaffective disorder in adults.(17)

The non-interventional safety and efficacy study of paliperidone tablets was intended to demonstrate the clinical efficacy and safety of the drug in patients with schizophrenia or schizoaffective disorder in regular clinical practice.(18)

Methods

From October 2019 to September 2020, a non-interventional study was conducted in Slovenia to monitor the safety and efficacy of paliperidone prolonged-release tablets (Parnido®) in regular clinical practice in patients with schizophrenia or schizoaffective disorder. It was carried out in compliance with the Declaration of Helsinki, national legislation, study protocol and the Slovenian Code of Medical Ethics. The study was approved by the Committee for Medical Ethics of the Republic of Slovenia and was notified to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.

The non-interventional study included male and female patients with over 18 years of age with a diagnosis of schizophrenia or schizoaffective disorder, who required treatment with paliperidone tablets in accordance with the indications from the Summary of Product Characteristics for Parnido®. The study involved both newly diagnosed patients and those who received antipsychotics in the past with ineffective treatment results or poor tolerability. Each patient was followed for two months. Three visits were planned during this period, which is in line with regular clinical practice: Visit 1 at the inclusion in the study, Visit 2 after one month, and Visit 3 two months after inclusion in the study.

Efficacy monitoring

Physicians monitored treatment efficacy based on various clinical indicators.

Based on the Clinical Global Impression Rating Scale – Severity, (CGI-S), the patients’ disease severity was assessed at all three visits. The Clinical Global Impression Rating Scale – Severity (CGI-S) is a 7-point rating scale (1 – not at all ill, 7 – among the most extremely ill patients).

Based on the Clinical Global Impression Rating Scale – Improvement (CGI-I), the improvement of patient’s clinical condition was assessed at Visit 2 and Visit 3. CGI-I is also a 7-point scale (1 – very much improved, 7 – very much worse).

At all three visits, the patient’s social and occupational functioning was assessed on a 7-point scale (1 – very good functioning in various activities, 7 – inability to maintain minimum personal hygiene and social functioning). They also assessed improvement in functioning at Visits 2 and 3 (1 – very much improved, 7 – very much worse).

A sub-analysis was made for the group of patients previously treated with risperidone.

Efficacy parameters were considered as random ordinal variables. Due to the reasonably large sample, an asymptotic z-test was used to establish the statistical significance of the difference in the means of two measurements within the same population, whereas the asymptotic 95% confidence interval (CI) was used for interval assessments of the means. Due to rounding, the sum of the shares in the graphs may not necessarily be 100%.

Safety monitoring

The safety of treatment was evaluated by monitoring all adverse events throughout the noninterventional study period. Type, occurrence, seriousness, severity, measure taken, frequency and outcome were determined for each adverse event.

Results

Patients

The non-interventional study included 153 patients, more than half of which were men (55.6%). The mean age of the included patients was 43.1 ± 13.5 years. Paliperidone was most commonly initiated for schizophrenia (47.7%), schizoaffective disorder (20.3%), or other psychotic disorder (19.0%). The majority of the included patients (83.0%) had previously been treated with antipsychotics. Most of them were treated with olanzapine (43.3%), risperidone (27.6%), aripiprazole (21.3%), quetiapine (18.1%) and paliperidone (14.2%). Patients could take one or more antipsychotics concomitantly.(18)

Reasons for initiating paliperidone tablets

Physicians cited one or more reasons for initiating paliperidone tablets in this study. The most common reasons were expected good efficacy of the medicine (89.4%), poorer social and occupational functioning of the patient (53.0%) and once-daily dosage regimen (51.0%) (Figure 1).(18)

Figure 1: Reasons for initiating paliperidone tablets

Figure 1: Reasons for initiating paliperidone tablets

Dosage

Paliperidone tablets were administered at a dose of 3 mg in almost half of the patients (49.3%). At Visits 2 and 3, the largest number of patients (43.0% of patients at Visit 2 and 44.2% at Visit 3) were treated with 6 mg (Figure 2). No dose data were recorded for five patients at Visit 1, one patient at Visit 2 and 15 patients at Visit 3. The mean daily dose at Visit 1 was 5.1 mg and it increased during treatment; at Visit 2 it was 6.3 mg and 6.7 mg at Visit 3.(19)

Figure 2: Proportion of patients treated with a single dose of paliperidone tablets by visits

Figure 2: Proportion of patients treated with a single dose of paliperidone tablets by visits

Efficacy

After two months of treatment with paliperidone tablets, a statistically significant reduction in the severity of the disease assessed according to CGI-S score was observed (p < 0.0001), i.e. from 4.64 ± 0.95 at Visit 1 to 3.88 ± 1.12 at Visit 2 and 3.12 ± 1.35 at Visit 3. After two months it was relatively reduced by 32%. The CGI-S score was not recorded in three patients at Visit 2 and 14 patients at Visit 3. At Visit 1 more than half of the patients (59.5%) were markedly, severely or among the most extremely ill (Figure 3). After 2-month treatment the percentage of such patients was reduced to 16.6%, whereas the percentage of patients that were not at all ill or were borderline to mildly ill increased from 9.2% to 57.6%.(18)

Figure 3: Distribution of patients according to disease severity assessment (CGI-S) by visits

Figure 3: Distribution of patients according to disease severity assessment (CGI-S) by visits

During the 2-month treatment, statistically significant improvement in the clinical condition of patients assessed according to the CGI-I scale was observed (p < 0.0001). The mean CGI-I score at Visit 2 was 2.81 ± 1.08; at Visit 3 the score was 2.18 ± 1.08. The CGI-S score was not recorded in three patients at Visit 2 and 14 patients at Visit 3. After one month of treatment, improvement of clinical condition was observed in 73.3% of patients, and after two months in 87.8% of patients (Figure 4).(18)

Figure 4: Distribution of patients according to the assessment of improvement of clinical condition (CGI-I) at Visit 2 and Visit 3

Figure 4: Distribution of patients according to the assessment of improvement of clinical condition (CGI-I) at Visit 2 and Visit 3

The patient’s social and occupational functioning (assessed on a 7-point scale) improved statistically significantly during treatment with paliperidone tablets (p < 0.0001). The average assessment of social and occupational functioning was 4.44 ± 0.99 at Visit 1, 3.81 ± 1.10 at Visit 2 and 3.07 ± 1.24 at Visit 3. Assessment of functioning was not recorded for one patient at Visit 1, three patients at Visit 2, and 15 patients at Visit 3. After one month of treatment, the score relatively decreased by 12% and after two by 29%. The proportion of patients who had severely reduced functioning in several areas or were unable to function in almost all areas (a score of 5 and 6) decreased from 52.6% to 13.8% after two months of treatment. The proportion of patients with good to very good functioning (a score of 1 and 2) increased from 3.9% to 34.8% (Figure 5). After one month of treatment, improvement of functioning was achieved by 74.7% of patients and after two months by 87.6% (Figure 6). An assessment of improvement in social and occupational functioning was not recorded in three patients at Visit 2 and 16 patients at Visit 3.(18)

Figure 5: Distribution of patients into groups according to the assessment of social and occupational functioning by visits

Figure 5: Distribution of patients into groups according to the assessment of social and occupational functioning by visits

Figure 6: Distribution of patients into groups according to the assessment of improvement of social and occupational functioning by visits

Figure 6: Distribution of patients into groups according to the assessment of improvement of social and occupational functioning by visits

Subanalysis of the group of patients previously treated with risperidone

The sub-analysis included 35 patients previously treated with risperidone at an average daily dose of 4.4 mg. Upon inclusion in the study, they were given paliperidone tablets at an average daily dose of 5.6 mg. After one month, 82.8% of patients in this group were treated with paliperidone 6 mg or more. No dose data were available for two patients at Visit 1 and eight patients at Visit 3.(18, 19)

After discontinuing risperidone and initiating treatment with paliperidone tablets, the severity of the disease (assessed according to CGI-S) decreased statistically significantly (p < 0.0001) from 4.74 ± 0.85 at Visit 1 to 3.81 ± 1.06 at Visit 2 and 3.03 ± 1.38 at Visit 3. After two months, the severity of the disease was relatively reduced by 33%. A CGI-S score was not recorded in three patients at Visit 2 and six patients at Visit 3. At Visit 1, 60.0% of patients were markedly or severely ill, and only 13.8% after two months of treatment. The proportion of patients who were not at all ill or were borderline to mildly ill increased from 5.7% to 62.1% (Figure 7).(18)

Figure 7: Distribution of patients previously treated with risperidone according to disease severity assessment (CGI-S) by visits

Figure 7: Distribution of patients previously treated with risperidone according to disease severity assessment (CGI-S) by visits

During two months of treatment, the clinical condition of patients in this group, assessed according to the CGI-I scale, improved statistically significantly (p < 0.0001). The mean CGI-I score was 2.75 ± 1.48 at Visit 2 and 2.00 ± 0.93 at Visit 3. A CGI-I score was not recorded in three patients at Visit 2 and six patients at Visit 3. After two months of treatment, the clinical condition improved in 93.1% of patients, of whom as many as 72.4% reported much to very much improved clinical condition (Figure 8).(18)

Figure 8: Distribution of patients previously treated with risperidone according to the assessment of improvement of clinical condition (CGI-I) at Visit 2 and Visit 3

Figure 8: Distribution of patients previously treated with risperidone according to the assessment of improvement of clinical condition (CGI-I) at Visit 2 and Visit 3

In this group of patients, also social and occupational functioning improved statistically significantly (p < 0.0001) (estimated on a 7-point scale). The mean score at Visit 1 was 4.60 ± 0.91, at Visit 2 it was 3.88 ± 1.21 and at Visit 3 it was 2.93 ± 1.16. No assessment was recorded in three patients at Visit 2 and six patients at Visit 3. After two months of treatment, the assessment of patient’s functioning was relatively reduced by 33%. The proportion of patients with severely reduced functioning in several areas or inability to function in almost all areas (scores of 5 and 6) decreased from 54.3% to 6.9% after two months of treatment (Figure 9). After one month of treatment, 81.3% of patients achieved improvement of functioning and 92.9% after two months (Figure 10). No score was recorded in three patients at Visit 2 and seven patients at Visit 3.(18)

Figure 9: Distribution of patients previously treated with risperidone into groups according to assessment of social and occupational functioning by visits

Figure 9: Distribution of patients previously treated with risperidone into groups according to assessment of social and occupational functioning by visits

Figure 10: Distribution of patients previously treated with risperidone according to the assessment of improvement of social and occupational functioning at Visit 2 and Visit 3

Figure 10: Distribution of patients previously treated with risperidone according to the assessment of improvement of social and occupational functioning at Visit 2 and Visit 3

Safety

No adverse events were reported in 84.3% of patients during the 2-month follow-up period. Adverse events causally related to paliperidone tablets occurred in 14.4% of patients and 1.3% had casually unrelated adverse events. The majority of causally related adverse events occurred between Visits 1 and 2 (12.4% of patients), with 4.6% of patients reporting them at Visit 3. The most common causally related adverse events were sedation (7.2% of patients), somnolence (7.2% of patients), headache (3.3% of patients) and dizziness (3.3% of patients). Other causally related adverse events, such as insomnia, anxiety, parkinsonism, agitation, hyperprolactinaemia, amenorrhea and weight gain occurred in two or one patient. The most common adverse events were the same as those listed in the Summary of Product Characteristics for Parnido®.(18)

The reported causally related adverse events were mild to moderate in most patients. No severe causally related adverse events were reported in the study. One patient developed a serious causally related adverse event (hyperprolactinaemia and amenorrhea). Patients with causally related adverse events were most likely to have their dose reduced (4.6%) or no action was required (3.9%), and 3.3% of patients had their treatment discontinued.(18)

Discussion

This non-interventional study demonstrated the efficacy of paliperidone tablets (Parnido®) in regular clinical practice in the treatment of patients with schizophrenia or schizoaffective disorder, since all four parameters used by the researchers to evaluate the efficacy of treatment (CGI-S score, CGI-I score, assessment of social and occupational functioning of patients, assessment of improvement of social and occupational functioning of patients) improved in a statistically significant manner. It was shown that the efficacy parameters are proportionally dependent. Already after the first month, most patients were treated with the recommended daily dose of 6 mg.(17, 18, 19)

Global clinical disease indicators (CGI-S, CGI-I) are the most appropriate methods for clinically evaluating significant changes in patients.(20, 21) After two months of follow-up, the severity of the disease (assessed by CGI-S) relatively decreased by 32%. The proportion of patients who were markedly to among the most extremely ill decreased from 59.5% at Visit 1 to 16.6% at Visit 3. At the end of the study, 57.6% of patients were not at all ill anymore or were borderline to mildly ill. The clinical condition (assessed by CGI-I) improved in 87.8% of patients. The results are comparable to similar studies that evaluated the efficacy of paliperidone tablets in treating schizophrenia or schizoaffective disorder.(18, 22, 24) In a study in which patients with acute schizophrenia were treated with paliperidone tablets with a flexible dosing regimen at doses of 3 to 12 mg, the percentage of patients who were markedly to most extremely ill after 6 weeks of treatment decreased from 74.1% at the start of the study to 20.0% at the end of the study. At the end of the study, 48.3% of patients were not at all ill or were borderline to mildly ill.(22) In studies performed in patients with schizoaffective disorder, the severity of the disease decreased by 21.7% to 32.6% after six weeks of treatment with paliperidone tablets.(24)

This non-interventional study demonstrated a statistically significant improvement in patients’ social and occupational functioning. On average, after two months of paliperidone treatment, it improved by one third (29%), with 87.6% of patients reporting about such improvement. Similar to the results related to overall efficacy, these results are comparable to other studies.(22, 23) In a study conducted under naturalistic conditions, the functioning of patients with schizophrenia was assessed according to the Personal and Social Performance Scale (PSP). After 6 weeks of treatment, the patients’ functioning improved by 27.2%.(22) According to data from another study involving patients previously treated with another antipsychotic, functioning improved by 35.2% after 24 weeks of treatment with paliperidone tablets.(23) According to literature, paliperidone tablets at a dose of 3 to 15 mg (flexible dosing regimen) maintained improved functioning for 52 weeks, i.e. the duration of the study.(25)

Patients tolerated the treatment well, with 84.3% reporting no adverse events during the 2-month follow-up period. Causally related adverse events occurred in 14.4% of patients, most commonly within the first month of treatment. The most common were somnolence, sedation, headache and dizziness, which is in line with the Summary of Product Characteristics for Parnido®. Safety monitoring results were better than in similar clinical studies. In a study in which the safety of paliperidone tablets was monitored for six weeks in patients with acute schizophrenia, treatmentrelated adverse events occurred in 66-77% of patients. The most common adverse events occurring in ≥ 5% of patients were headache, anxiety and insomnia. This study included patients who needed treatment with paliperidone tablets regardless of the phase of their disease, which could be the reason for the differences in results.(17,18,26)

Paliperidone is the active metabolite of risperidone. This non-interventional study also demonstrated its efficacy in patients previously treated with risperidone. Switching the treatment is simple; in this study it was performed on the basis of equivalent doses of risperidone and paliperidone. In these patients, the severity of the disease and the assessment of their social and occupational functioning improved by 33% after two months, which is comparable to the results of the treatment of all patients involved.(18, 27) Other clinical studies examining the efficacy of paliperidone tablets after risperidone treatment have reported slightly lower improvement in patients’ clinical condition and functioning.(18, 26, 28, 29) In one of the studies, after six weeks of treatment with paliperidone tablets at a dose of 3 to 12 mg (flexible dosing regimen), there was a significant reduction in disease severity (CGI-S) by 15.2% and an improvement in personal and social functioning assessed according to PSP by 14.5%.(28)

The production of paliperidone tablets (Parnido®) is based on the technology of the osmotic controlled release oral delivery system (OROS), which provides a constant release of the active substance over 24-hours, allowing for treatment to be initiated at a therapeutic dose, rapid onset of action and a patient-friendly dosing regimen.(17,26,30)

Due to the reduced fluctuations in the plasma concentrations of paliperidone prolonged-release tablets, the risk of some adverse events may also be reduced compared to risperidone. In post hoc analysis based on the results of two six-week studies with risperidone (2-6 mg/day) or paliperidone tablets (3-12 mg/day) in patients with acute schizophrenia, the tolerability of both drugs was compared. They found that treatment with paliperidone tablets resulted in lower levels of akathisia, restlessness, anxiety, insomnia, somnolence, dizziness, and gastrointestinal problems. Weight gain was also slightly higher in risperidone-treated patients (1.3 ± 3.7 kg) than in paliperidonetreated patients (0.7 ± 2.7 kg).(26) A six-month clinical study monitoring patients with non-acute schizophrenia showed a clinically relevant improvement in extrapyramidal symptoms, sleep quality and daytime sleepiness after switching risperidone with paliperidone tablets.(33)

Treatment with paliperidone tablets had a favourable safety profile and led to a significant improvement in all monitored efficacy parameters. Although the majority of enrolled patients (83.0%) had previously been treated with another antipsychotic, most commonly olanzapine (43.3%) or risperidone (27.6%), which are among the most effective antipsychotics in clinical practice, the study demonstrated that paliperidone tablets are an effective and safe treatment option even for patients whose treatment with another antipsychotic had failed.(18, 34)

Conclusions

This non-interventional study demonstrated the clinical efficacy and safety of paliperidone tablets (Parnido®) in patients with schizophrenia and schizoaffective disorder. Treatment statistically significantly reduced the severity of the disease and improved the clinical condition of patients and their social and occupational functioning. Due to its different pharmacological properties, paliperidone, as the active metabolite of risperidone, allows the patient to have an easy once-daily dosing regimen, which may improve patient adherence compared to risperidone. Additional subanalysis confirmed that paliperidone tablets were also effective in patients previously treated with risperidone, as all efficacy parameters were statistically significantly improved in this group as well.

Paliperidone tablets were well tolerated by the patients included in this study. No adverse events were reported in 84.3% of patients. The results therefore confirm that Parnido® is an effective and safe antipsychotic that can improve the clinical outcome of treatment.

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Authors

Anica Gorjanc Vitez, MD
Idrija Psychiatric Hospital, Slovenia

Breda Barbič-Žagar, MD
Krka, d. d., Novo mesto, Slovenia

Marina Vrzel, MPharm
Krka, d. d., Novo mesto, Slovenia

Tjaša Cepič, MPharm
Krka, d. d., Novo mesto, Slovenia

Krka’s medicines are marketed in different countries under different brand names.

Some products may not be available in all countries due to still valid patent protection.

For complete information on the products please refer to the Summary of Product Characteristics. You can obtain it from Krka’s medical representatives.

We have compiled a collection of scientific papers in which we present the rich experience obtained from the clinical studies with Krka’s medicines.

Published: December, 2021