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Long-term safety, efficacy, treatment satisfaction, and impact on healthcare service use of paliperidone palmitate one-month intramuscular formulation in patients with recent-onset schizophrenia in taiwan: A subgroup analysis of an asia-pacific, 18-month, phase 3b study
Tze-Chun Tang M.D., Ph.D 1, Ming-Hong Hsieh M.D., Ph.D 2, Chen-Chung Liu M.D., Ph.D 3, Nan-Ying Chiu M.D 4, Fong-Lin Jang M.D 5, Chih-Lin Chiang M.D., M.P.H 6, Tung-Ping Su M.D 7
1 Dr. Tang's Psychiatric Clinic, Kaohsiung, Taiwan
2 Department of Psychiatry, Chung Shan Medical University Hospital; Department of Psychiatry, School of Medicine, Chung Shan Medical University, Taichung, Taiwan
3 Department of Psychiatry, National Taiwan University Hospital; Department of Psychiatry, College of Medicine, National Taiwan University, Taipei, Taiwan
4 Department of Psychiatry, Changhua Christian Hospital, Changhua, Taiwan
5 Department of Psychiatry, Chi-Mei Medical Center, Tainan, Taiwan
6 Medical Affairs, Janssen Pharmaceuticals of Johnson and Johnson, Cheng Hsin General Hospital, Taipei, Taiwan
7 Department of Psychiatry, Cheng Hsin General Hospital; Department of Psychiatry, Taipei Veterans General Hospital; Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan
Correspondence Address:
Tung-Ping Su
No. 45, Cheng Hsin Street, Taipei 112
Taiwan
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/TPSY.TPSY_39_19
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Objectives: In this study, the authors intended to evaluate the efficacy and safety of paliperidone palmitate 1-month injection (PP1M) in patients with recent-onset schizophrenia (SCH). Methods: A subgroup analysis was done for patients enrolled in Taiwan in an Asia-Pacific, Phase 3b study (ClinicalTrials.gov identifier NCT01051531). Patients were switched from oral antipsychotics to intramuscular PP1M. Results: We included 61 patients (age: 31.2 ± 8.8 years). The Positive and Negative Syndrome Scale scores were significantly decreased, with the largest effect size observed in positive, disorganized, and depressive factors (Cohen's d = 0.52, 0.52, and 0.79, respectively). Most symptoms stabilized within six months, whereas stabilization of functional improvement required 1–1.5 years of PP1M treatment, especially for employment/academic status. PP1M treatment was well-tolerated, with over 70% of treatment satisfaction rate, and significantly reduced the average days of hospitalization (43.3–7.1/person-years). Conclusion: Switching to PP1M improved treatment outcome and satisfaction as well as reduced healthcare service use in patients with recent-onset SCH.
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