Efficacy and Safety Outcomes When Transitioning to Paliperidone Palmitate 6-Month From Paliperidone Palmitate 1-Month Versus Paliperidone Palmitate 3-Month

This work was sponsored by Janssen Scientific Affairs, LLC Results from a double-blind (DB), randomized, active-controlled, parallel-group, non-inferiority study (NCT03345342) demonstrated that paliperidone palmitate 6-month (PP6M) was non-inferior to paliperidone palmitate 3-month (PP3M) in preventing relapse in clinically stable adult patients with schizophrenia (Kaplan-Meier estimate of the difference between treatment groups: −2.9% [95% confidence interval, −6.8% to 1.1%]; prespecified non-inferiority margin: −10%). Relapse rates were 7.5% (n=36/478) for PP6M and 4.9% for PP3M (n=11/224). This post hoc analysis was designed to assess efficacy and safety outcomes following transition to PP6M from paliperidone palmitate 1-month (PP1M) versus PP3M. After screening, open-label transition, and maintenance phases, patients receiving moderate or high doses of PP1M (156 and 234 mg, respectively) or PP3M (546 or 819 mg, respectively) were randomly assigned (2:1) to dorsogluteal PP6M or PP3M injections. The primary efficacy measure was time to relapse during the 12-month DB phase. Secondary endpoints included change from DB baseline to endpoint in PANSS total and subscale scores, CGI-S, and PSP scales. Safety was assessed by treatment-emergent adverse events (TEAEs), vital signs, and clinical laboratory tests. Of the 478 patients in the PP6M group (mean age, 41.2 years; male, 68.2%), 231 transitioned from PP1M and 247 transitioned from PP3M. Relapse rates were similar regardless of transition pathway (7.8%, PP1M/PP6M group; 7.3% PP3M/PP6M group; P=0.954). Changes from DB baseline to endpoint in PANSS total, PSP, and CGI-S scores were similar between groups. In the DB phase, ≥1 TEAE was observed in 61.0% and 63.2% of patients in the PP1M/PP6M and PP3M/PP6M, groups, respectively.