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

Abstract

Objective: A post hoc analysis of the Disease Recovery Evaluation and Modification (DREaM) study was conducted to evaluate time to first major treatment failure (ie, arrest/incarceration or psychiatric hospitalization) in participants with recent-onset schizophrenia or schizophreniform disorder treated with paliperidone palmitate (PP) versus oral antipsychotics (OAPs).

Methods: DREaM was an open-label, delayed-start, randomized, multipart trial consisting of: Part I, 2-month oral run-in; Part II, 9-month disease progression phase (PP or OAP); and Part III, 9 months of additional treatment (PP/PP; OAP re-randomized: OAP/OAP or OAP/PP). PP/PP and OAP/OAP comprised the 18-month extended disease progression (EDP) analysis.

Results: In Part II (PP, n = 78; OAP, n = 157), similar proportions of participants experienced a major treatment failure across groups (PP: 12.8 %; OAP: 13.4 %); no difference in time to first major treatment failure was identified (P = 0.918). Significant differences favoring PP emerged after 9 months; in Part III, no participants in the PP/PP group, 3.5 % of participants in the OAP/PP group, and 15.9 % in the OAP/OAP group experienced a major treatment failure (P = 0.002). In the EDP analysis, 10.2 % (PP/PP) and 25.4 % (OAP/OAP) of participants experienced a major treatment failure (P = 0.045; number needed to treat = 6). Safety results were similar between groups and consistent with the known safety profile of PP in adults with schizophrenia.

Conclusions: Initiation of PP during the early stages of schizophrenia spectrum disorders significantly delayed time to hospitalization and arrest/incarceration, outcomes with important personal and economic consequences, compared with OAP during this 18-month study.

Clinicaltrials: gov identifier: NCT02431702.

Keywords: Hospitalization; Incarceration; Oral antipsychotics; Paliperidone palmitate; Randomized clinical trial; Recent-onset schizophrenia; Study design; Treatment failure.

Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Alphs is a former employee of Janssen Scientific Affairs, LLC, and holds stock in Johnson & Johnson. Dr. Alphs is currently a consultant for Newron Pharmaceuticals, LLC. Dr. Baker and Dr. Brown are employees of Janssen Scientific Affairs, LLC, and hold stock in Johnson & Johnson. Dr. Fu and Dr. Turkoz are employees of Janssen Research and Development, LLC, and hold stock in Johnson & Johnson. Dr. Nuechterlein has received research grant support from Janssen Scientific Affairs, LLC, and Alkermes, Inc., and has served as a consultant to Astellas, Genentech, Janssen, MedinCell, Otsuka, Recognify Life Sciences, Takeda, and Teva.

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