Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections

Ibrahim Turkoz; Mehmet Daskiran; H Lynn Starr; Dean Najarian; Oliver Lopena; Camilo Obando; Alexander Keenan; Carmela Benson; Srihari Gopal

doi:10.2147/NDT.S373725

Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections

Neuropsychiatr Dis Treat. 2022 Aug 30:18:1927-1937. doi: 10.2147/NDT.S373725. eCollection 2022.

Authors

Ibrahim Turkoz¹, Mehmet Daskiran¹, H Lynn Starr², Dean Najarian², Oliver Lopena², Camilo Obando², Alexander Keenan³, Carmela Benson³, Srihari Gopal⁴

Affiliations

¹ Statistics & Decision Sciences, Janssen Research and Development, LLC, Titusville, NJ, USA.
² Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
³ Real World Value & Evidence, Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
⁴ Schizophrenia/Neuroscience Therapeutic Area, Janssen Research and Development, LLC, Titusville, NJ, USA.

Abstract

Purpose: This retrospective cohort study evaluated real-world data on relapses in adult patients with schizophrenia who transitioned to long-acting injectable paliperidone palmitate once-every-3-months (PP3M) following treatment with once-monthly paliperidone palmitate (PP1M).

Patients and methods: Data derived from the IBM^® MarketScan^® Multi-State Medicaid Database were analyzed. Adults aged ≥18 years with ≥1 schizophrenia diagnosis claim and ≥12 months of continuous medical and prescription enrollment before and/or at index date of PP3M were eligible for inclusion. Patients were matched on propensity score to 2 PP3M cohorts: (1) adequately treated (AT), defined as patients treated with PP1M for ≥4 months, with the last 2 doses the same and a PP3M initiation dose meeting the corresponding PP1M-to-PP3M dose conversion, or (2) not adequately treated (NAT), defined as patients who received ≤2 or no PP1M doses. Relapse rates and time to relapse distributions based on the first occurrence of a qualifying event during the 2-year follow-up period were compared between PP3M cohorts using Kaplan-Meier survival curves and log rank test statistics. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. Two sensitivity analyses using different matched populations were performed to assess the robustness of the primary findings.

Results: Propensity score matching yielded a sample of 1314 patients (657 per group). Most patients were male (68.9%) and aged 25-64 years (90.1%). The relapse rate was significantly lower in the AT (18.4%) versus NAT cohort (26.8%), P = 0.0002. Risk of relapse decreased by 35% for AT versus NAT (HR: 0.65 [95% CI: 0.51-0.81]). Relapse reductions favored the AT cohort in both sensitivity analyses (HR: 0.67 [95% CI: 0.54-0.83] and HR: 0.74 [95% CI: 0.56-0.97]).

Conclusion: In this analysis of Medicaid claims data, patients adequately treated with PP1M before transitioning to PP3M demonstrated significantly lower relapse rates and delayed time to relapse.

Keywords: long-acting injectable antipsychotic; paliperidone palmitate; real-world; relapse; schizophrenia.

Grants and funding

This study was supported by Janssen Scientific Affairs, LLC. The study sponsor was involved in the design and conduct of the study and the collection, management, analysis, and interpretation of data. All authors made significant contributions to the development of the manuscript in accordance with ICMJE authorship criteria. Authors provided direction and comments on the manuscript, reviewed, and approved the final version prior to submission, made the final decision about where to publish these data, and approved submission to this journal. All authors had full access to the study data and take responsibility for data integrity and the accuracy of the analyses.