Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence

Abstract

Background:Limited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics.Aim:To investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia.Methods:This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75–150 mg eq.) or switching to another antipsychotic(s).Results:There were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2–88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48–5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02–1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, ‘no use’ (hazard ratio=13.13, 95% confidence interval=1.33–129.96, p=0.03) and ‘interrupted use’ (hazard ratio=11.04, 95% confidence interval=1.03–118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified.Conclusion:Continued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

Results from PSIPROSPER: A multicenter retrospective study to analyze the impact of treatment with paliperidone palmitate 1-month on clinical outcomes and hospital resource utilization in adult patients with schizophrenia in Portugal

“…The most frequent reason to start OAP was the first antipsychotic treatment, while PP1M was initiated in the case of lack of adherence, lack of efficacy of previous treatments, or concomitant lack of adherence and efficacy, which is to be expected due to the therapeutic indication of PP1M. Again, the current results corroborate previous research ( 20 ).…”

“…Other studies have shown that PP1M provides good outcomes in relapse prevention and hospitalizations. This is even more significant in patients with prior history of non-adherence to treatment, which is also highlighted by the reduction in bed use in fully compliant patients under PP1M (20,21). LAIs have shown better outcomes in a real-world setting-namely in hospitalizations and relapse risk-compared to OAPs (22), with lower rates of treatment failure.…”

Persistence With and Adherence to Paliperidone Palmitate Once-Monthly Injection for Schizophrenia Treatment in China and Japan

“…[14][15][16][17][18][19] Poor adherence to antipsychotic treatment is a significant risk factor for relapse in Chinese patients. 20 However, to date, these data were obtained in clinical trial participants, and to our knowledge, no real-world database studies have compared treatment patterns between PP1M and oral SGAs among Chinese or Japanese patients with schizophrenia. Therefore, we conducted a large, retrospective real-world cohort study in patients with schizophrenia in China and Japan to compare persistence and adherence between PP1M and oral SGAs.…”

Projecting the Long-Term Economic Impact of Once-Monthly Paliperidone Palmitate Versus Oral Atypical Antipsychotics in Medicaid Patients with Schizophrenia

“…4,12 This target population may also derive the greatest incremental benefit from a treatment switch to PP1M. 4,12,39,41 17,19,42 Probability of adherence was consistent across all cycles unless a patient switched from PP1M to an OAA or from an OAA to a different OAA, and probability of relapse was consistent across all cycles and treatment unless a patient's adherence status changed. At each cycle, patients were subject to nonadherence or adherence, regardless of their adherence status in the previous cycle.…”