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Rate of Major Treatment Failure Over Long Term Lower With Paliperidone Palmitate

September 11, 2020

In patients with recent-onset schizophrenia, the rate of major treatment failure with longer treatment was lower with paliperidone palmitate than with oral antipsychotics, according to a poster presented at Psych Congress 2020. 

“Major treatment failures, such as psychiatric hospitalization and arrest/incarceration, are associated with substantial economic and societal burden, especially for persons with recent-onset schizophrenia,” researchers wrote.

The post hoc analysis of the open-label Disease Recovery Evaluation and Modification (DREaM) study examined differences in time to first major treatment failure in participants with recent-onset schizophrenia randomized to treatment with paliperidone palmitate or oral antipsychotics.

The study consisted of 3 phases: part 1 was a 2-month oral run-in; part 2 was a 9-month disease progression phase with oral antipsychotics or paliperidone palmitate; and part 3 was 9 months of additional treatment with paliperidone palmitate or, in patients who started with oral antipsychotics, rerandomization to paliperidone palmitate or continued oral antipsychotics.

During the 9-month disease progression phase, rates of major treatment failure were 12.8% in the paliperidone palmitate group and 13.4% in the oral antipsychotics group, according to the poster.

During an 18-month extended disease progression phase that focused on patients who received only paliperidone palmitate compared with those who received only oral antipsychotics during the study, rates of major treatment failure were 10.2% in the paliperidone palmitate group and 25.4% in the oral antipsychotic group.

During the final 9 months of the study, rates of major treatment failure were 0% in the group that continued paliperidone palmitate, 3.5% in the group that switched from oral antipsychotics to paliperidone palmitate, and 15.9% in the group that continued with oral antipsychotics.

There was no statistically significant difference in time to first major treatment failure with paliperidone palmitate or oral antipsychotics in the first 9 months.

A large study effect due to inherent biases associated with study participation was observed in part 1 that persisted for the trial’s duration,” researchers wrote. “Nevertheless, with longer treatment, the differences between groups became significant for time to first major treatment failure in favor of paliperidone palmitate, suggesting greater effectiveness of paliperidone palmitate compared with oral antipsychotics as measured by key public health treatment events.” 

Janssen Scientific Affairs LLC sponsored the study.

—Jolynn Tumolo

Reference

Baker P, Brown B, O'Donnell A, Turkoz I, Alphs L. Evaluation of major treatment failures in patients with recent-onset schizophrenia: a post hoc analysis from the Disease Recovery Evaluation and Modification (DREaM) study. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.

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