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Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies

Authors Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ

Received 28 June 2019

Accepted for publication 17 December 2019

Published 19 June 2020 Volume 2020:16 Pages 1533—1542


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Roger Pinder

Maju Mathews,1 Srihari Gopal,2 Arun Singh,3 Isaac Nuamah,4 Katalin Pungor,5 Wilson Tan,6 Bernardo Soares,7 Edward Kim,8 Adam J Savitz2

1Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA; 3Department of Neuroscience, Janssen Research & Development, LLC, Pennington, PA, USA; 4Clinical Biostatistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Medical Affairs, Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany; 6Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore; 7Medical Affairs, Jan-Cil, High Wycombe, Buckinghamshire, UK; 8Janssen Scientific Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ, USA

Correspondence: Maju Mathews
Global Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, USA
Tel +1 609 433-9257

Background: Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.
Objective: To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).
Methods: Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.
Results: In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M PP1M (172 days [134– 222 days])> paliperidone ER (58 days [42– 114 days]) and was “not-estimable” in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P< 0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P< 0.001]).
Conclusion: The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence.
Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).

Keywords: relapse prevention, schizophrenia, oral paliperidone extended release, paliperidone palmitate once monthly, paliperidone palmitate three monthly

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