Earlier initiation of paliperidone palmitate (PP) was associated with fewer events of treatment failure due to hospitalization, arrest, or incarceration compared with oral antipsychotics (OAPs) among patients with schizophrenia. These findings were published in Schizophrenia Research.
This study was a post hoc analysis of data from the Disease Recovery Evaluation and Modification (DREaM) study, which was a prospective, matched-control, double-blind, randomized, open-label, flexible-dose, multipart, multicenter study. Patients had a 2-month run-in period, followed by randomization to receive PP (n=78) or OAP (n=157) for 9 months, and 9-month re-randomization to PP or OAP (PP/PP, n=49; OAP/PP, n=57; OAP/OAP, n=63). Patients who were randomized to receive PP/PP (n=49) or OAP/OAP (n=63) had an 18-month extension on treatment. This study evaluated time to treatment failure and safety.
Most study participants were men (>74%) with a mean age of 23.0-24.1 years; 75%-84% had schizophrenia, and the mean time since first psychotic episode was 0.9-1.0 years.
During the first randomization, 5.1% of PP recipients had treatment failure due to psychiatric hospitalization and 2.6% due to arrest or incarceration compared with 7.0% and 2.5% among OAP recipients, respectively. During the second randomization period, the rates of treatment failure due to hospitalization or arrest or incarceration were 0% and 0% for PP/PP, 3.5% and 0% for OAP/PP, and 12.7% and 3.2% for OAP/OAP, respectively.
During the treatment extension, 4.1% of the PP/PP group were hospitalized, 12.7% of the OAP/OAP group were hospitalized, and 4.8% of the OAP/OAP group were arrested or incarcerated.
There was no significant difference in the risk for treatment failure between cohorts during the first randomization period (hazard ratio [HR], 1.04; 95% CI, 0.47-2.16; P =.918). In the second randomization period, among patients who received OAP during the first randomization, switching to PP was associated with decreased risk for treatment failure compared with patients who remained on OAP (HR, 0.20; 95% CI, 0.03-0.92; P =.002).
In the final extension, PP/PP was associated with decreased risk for treatment failure compared with OAP/OAP (HR, 0.37; 95% CI, 0.12-0.95; P =.045).
This study may have been limited as a large study effect was observed at 2 months.
Study authors concluded, “Our results suggest that treatment with PP may delay time to first major treatment failure (hospitalization or arrest/incarceration), which could have profound personal, societal, and economic impact. The findings of this post hoc analysis add to the body of literature demonstrating the safety and efficacy of long-acting injectable antipsychotics and support the rationale for earlier implementation of long-acting injectable antipsychotics in the disease course of schizophrenia spectrum disorders.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Alphs L, Baker P, Brown B, Fu D-J, Turkoz I, Nuechterlein KH. Evaluation of major treatment failure in patients with recent-onset schizophrenia or schizophreniform disorder: a post hoc analysis from the Disease Recovery Evaluation and Modification (DREaM) study. Schizophr Res. 2022;248:58-63. doi:10.1016/j.schres.2022.07.015