Defining “Adequately Treated”: Characteristics of Patients With Schizophrenia Successfully Transitioned From Paliperidone Palmitate Once Monthly to Paliperidone Palmitate Once-Every-3-Months

Objective: To identify patient characteristics associated with successful transition to once-every-3-months paliperidone palmitate (PP3M).

Methods: This was a post hoc analysis of a double-blind, placebo-controlled, relapse prevention study (NCT01529515) of patients with schizophrenia. After 17 weeks of treatment with flexibly dosed once-monthly paliperidone palmitate (PP1M), patients who met stabilization criteria (including Positive and Negative Syndrome Scale [PANSS] total score < 70) received a single PP3M dose during the 12-week maintenance phase. At week 29, stabilized patients were randomly assigned to PP3M or placebo. Demographic and baseline characteristics were summarized using descriptive statistics and compared using analysis of variance or the chi-square test to identify potential differences between randomized and nonrandomized patients. Stepwise multiple logistic regression models identified patient characteristics associated with achieving randomization criteria.

Results: Of 506 patients who received PP1M, 379 received 1 dose of PP3M and 305 were randomized. At week 17, before patients transitioned to PP3M, the mean PANSS score in the nonrandomized group was 64.0 versus 56.9 for randomized patients. Mean Clinical Global Impression–Severity (CGI-S) scores at week 17 were 3.4 and 2.9, respectively. Multiple baseline factors that predicted achieving randomization criteria were identified in the stepwise logistical model. Patients who met randomization criteria had fewer prior hospitalizations, higher baseline Personal and Social Performance, lower CGI-S scores, and shorter duration of illness at baseline than nonrandomized patients.

Conclusion: Clinicians should transition patients to PP3M only if they respond well to PP1M. Confirming adequate stabilization with PP1M before transitioning to PP3M is critical in maximizing treatment response.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.