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
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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