This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Background: Paliperidone palmitate 3-month (PP3M) is a long-acting injectable formulation of paliperidone that is administered every three months for the treatment of adults with schizophrenia. The manufacturer recommends that patients be adequately treated for at least four months with paliperidone palmitate 1-month (PP1M) prior to transitioning to PP3M. To further clarify the term "adequately treated", we used data from a double-blind randomized clinical trial to identify characteristics of patients who achieved symptomatic remission after transition to PP3M.
Methods: We conducted a post hoc analysis of the Janssen R&D Phase 3 noninferiority trial of PP1M versus PP3M, R092670PSY3011. Using the Remission in Schizophrenia Working Group definition, we compared demographic characteristics and open-label symptom assessments (CGI-S, PANSS, PSP) in subjects who achieved remission during the double-blind phase with those who did not.
Results: 260/411 (63.3%) patients achieved remission on PP3M during the double-blind period. We found significantly greater improvements CGI, PANSS, and PSP during the open-label phase in subjects who achieved remission compared to those who did not. Those who exhibited larger improvements in CGI and PANSS scores sustained from the first PP1M maintenance dose through month 4 were more likely to achieve remission during the double-blind phase. Lower scores on CGI and PANSS and higher PSP scores at the time of randomization were also all significantly correlated with achieving remission.
Conclusions: Subjects who demonstrate early clinically meaningful symptom improvement after initiation of PP1M are more likely to achieve remission after transition to PP3M.