Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies.

Authors:
Adam J Savitz
Adam J Savitz
Weill Cornell Medical Center
Haiyan Xu
Haiyan Xu
Key Laboratory of Dairy Biotechnology and Engineering
China
Srihari Gopal
Srihari Gopal
University of Cincinnati College of Medicine
United States
Isaac Nuamah
Isaac Nuamah
Janssen Research & Development
Maju Mathews
Maju Mathews
Drexel University College of Medicine
United States
Bernardo Soares
Bernardo Soares
Shanghai Jiaotong University School of Medicine
China

Braz J Psychiatry 2019 Apr 15. Epub 2019 Apr 15.

Janssen-Cilag UK, Buckinghamshire, UK.

Objective: To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW).

Methods: We analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on PP1M/PP3M (open-label [OL] phase). Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B).

Results: In study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups.

Conclusion: PP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings.

Clinical Trial Registration: NCT01515423, NCT01529515.

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http://dx.doi.org/10.1590/1516-4446-2018-0153DOI Listing
April 2019
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References

(Supplied by CrossRef)
Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study
Li H et al.
Neuropsychiatr Dis Treat 2016

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