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

Abstract

Ibrahim Turkoz,1 Mehmet Daskiran,1 H Lynn Starr,2 Dean Najarian,2 Oliver Lopena,2 Camilo Obando,2 Alexander Keenan,3 Carmela Benson,3 Srihari Gopal4 1Statistics & Decision Sciences, Janssen Research and Development, LLC, Titusville, NJ, USA; 2Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Real World Value & Evidence, Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 4Schizophrenia/Neuroscience Therapeutic Area, Janssen Research and Development, LLC, Titusville, NJ, USACorrespondence: Ibrahim Turkoz, Statistics & Decision Sciences, Janssen Research & Development, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA, Tel [phone], Fax [phone], Email [email protected]: 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: paliperidone palmitate, schizophrenia, real-world, relapse, long-acting injectable antipsychotic

Keywords

• paliperidone palmitate
• schizophrenia
• real-world
• relapse
• long-acting injectable antipsychotic