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Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Paliperidone Palmitate Improves and Maintains Functioning in Asia-Pacific Patients with Schizophrenia.
Advances in Therapy 2017 November
INTRODUCTION: Post hoc analyses (two single-arm studies) were conducted to determine the impact of once-monthly injection of paliperidone palmitate on functioning in adult patients with schizophrenia in the Asia-Pacific region.
METHODS: Study 1 enrolled hospitalized patients with acute exacerbation of schizophrenia, and study 2 enrolled patients with recently diagnosed schizophrenia unsatisfactorily treated with oral antipsychotics. Patients received paliperidone palmitate, 150 mg eq. on day 1, 100 mg eq. on day 8, then once monthly (50-150 mg eq.) (study 1, days 36 and 64; study 2, 18 months). Functional status was evaluated by Personal and Social Performance score in both studies and employment only in study 2.
RESULTS: In study 1, 54 of 184 patients (29.4%) with an unfavorable level of functioning at the baseline improved to a favorable level (Personal and Social Performance score greater than 70) at day 92. This improvement was significantly greater among patients with recently diagnosed schizophrenia (5 years or less) compared with patients with chronic schizophrenia (more than 5 years): 40% versus 22% (p < 0.0001). Improvements were observed in all four domains (socially useful activities, personal and social relationships, self-care, disturbing/aggressive behavior). In study 2, significant (p < 0.0001) improvement in functioning was observed at all visits, beginning at week 5. Almost half (48.7%, 247/507) of patients showed clinically meaningful improvement in functioning (i.e., 10 point or greater increase in Personal and Social Performance score) at month 18. The proportion of patients fully/partially employed was greater at all postbaseline visits (134 of 280, 47.9%, at month 18) as compared with the baseline.
CONCLUSION: Functioning, including employment, was improved after short-term, once-monthly paliperidone palmitate injection, and was sustained to 18 months in Asia-Pacific patients with schizophrenia.
FUNDING: Janssen-Cilag Asia-Pacific Medical Affairs.
METHODS: Study 1 enrolled hospitalized patients with acute exacerbation of schizophrenia, and study 2 enrolled patients with recently diagnosed schizophrenia unsatisfactorily treated with oral antipsychotics. Patients received paliperidone palmitate, 150 mg eq. on day 1, 100 mg eq. on day 8, then once monthly (50-150 mg eq.) (study 1, days 36 and 64; study 2, 18 months). Functional status was evaluated by Personal and Social Performance score in both studies and employment only in study 2.
RESULTS: In study 1, 54 of 184 patients (29.4%) with an unfavorable level of functioning at the baseline improved to a favorable level (Personal and Social Performance score greater than 70) at day 92. This improvement was significantly greater among patients with recently diagnosed schizophrenia (5 years or less) compared with patients with chronic schizophrenia (more than 5 years): 40% versus 22% (p < 0.0001). Improvements were observed in all four domains (socially useful activities, personal and social relationships, self-care, disturbing/aggressive behavior). In study 2, significant (p < 0.0001) improvement in functioning was observed at all visits, beginning at week 5. Almost half (48.7%, 247/507) of patients showed clinically meaningful improvement in functioning (i.e., 10 point or greater increase in Personal and Social Performance score) at month 18. The proportion of patients fully/partially employed was greater at all postbaseline visits (134 of 280, 47.9%, at month 18) as compared with the baseline.
CONCLUSION: Functioning, including employment, was improved after short-term, once-monthly paliperidone palmitate injection, and was sustained to 18 months in Asia-Pacific patients with schizophrenia.
FUNDING: Janssen-Cilag Asia-Pacific Medical Affairs.
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