Long-term efficacy and safety of paliperidone palmitate once-monthly in Chinese patients with recent-onset schizophrenia
Authors Si T, Zhuo J, Feng Y, Lu H, Hong D, Zhang LL
Received 23 October 2018
Accepted for publication 2 April 2019
Published 27 June 2019 Volume 2019:15 Pages 1685—1694
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Andrew Yee
Peer reviewer comments 2
Editor who approved publication: Professor Jun Chen
Tianmei Si,1,2 Jianmin Zhuo,3 Yu Feng,4 Huafei Lu,5 Di Hong,5 Lili Zhang5
1National Clinical Research Center for Mental Disorders & The Key Laboratory of Mental Health, Ministry of Health (Peking University), Beijing, People’s Republic of China; 2Peking University Institute of Mental Health/The Sixth Hospital, Beijing, People’s Republic of China; 3Janssen (China) Research & Development Center, Johnson & Johnson (China) Investment Ltd., Shanghai, People’s Republic of China; 4Department of Neuroscience, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore; 5Medical Affairs, Xi’an Janssen Pharmaceuticals, Beijing, People’s Republic of China
Background: The subgroup analysis of a primary study (NCT01051531) evaluated the effect of long-term paliperidone palmitate once-monthly (PP1M) therapy in Chinese patients with recent-onset schizophrenia responding unsatisfactorily to previous oral antipsychotics.
Patients and methods: This 18-month, open-label study consisted of 3 phases – screening (7 days), treatment (18 months) and end-of-study/withdrawal visit. All enrolled patients (18–50 years) received PP1M: 150 mg eq. (day 1), 100 mg eq. (day 8) followed by a once-monthly flexible dose (50, 75, 100 or 150 mg eq.). Efficacy and safety were assessed.
Results: Among the 118 enrolled Chinese patients, 68 completed the treatment (mean age: 25.6 years; male: 54.7%). A clinically meaningful change from baseline to day 548 was observed in Positive and Negative Syndrome scale (primary endpoint, mean [SD]: −15.3 [20.76]), Personal and Social Performance scale (15.9 [19.65]), Clinician Global Impression-schizophrenia score (−1.2 [1.54]) and Medication Satisfaction Questionnaire score (0.9 [1.73]). Commonly reported treatment-emergent adverse events (TEAEs) included insomnia (13.9%), injection-site pain (13.9%), upper respiratory tract infection (13.0%), restlessness (13.0%) and akathisia (13.0%). Serious TEAEs were reported in 9.3% patients with schizophrenia being most common (6.5%) and one death (suicide) was observed.
Conclusion: Efficacy of PP1M corroborate findings from earlier studies and no new safety concerns emerged in this Chinese subgroup of patients with schizophrenia.
Keywords: Chinese patients, long-acting injectable, maintenance therapy, paliperidone palmitate once-monthly, schizophrenia
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