Efficacy and Safety of Paliperidone Palmitate 6-Month versus Paliperidone Palmitate 3-Month Long-Acting Injectable in European Patients with Schizophrenia: A Post Hoc Analysis of a Global Phase-3 Double-Blind Randomized Non-Inferiority Study

Cesar Gironâ€Hernandez,1 Joong Hee Han,2 Roberta Alberio,3 Arun Singh,2 Maria Paz García-Portilla,4 Maurizio Pompili,5 R Karl Knight,2 Ute Richarz,6 Srihari Gopal,2,7 José Antunes8 1EMEA Medical Affairs, Janssen-Cilag, Issy-les-Moulineaux, France; 2Janssen Research & Development, LLC, Titusville, NJ, USA; 3Medical Affairs, Janssen-Cilag, Milan, Italy; 4Department of Psychiatry, Universidad de Oviedo, Instituto Sanitario Del Principado de Asturias (ISPA) and CIBERSAM, Oviedo, Spain; 5Department of Neurosciences, Mental Health, and Sensory Organs, Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy; 6Janssen Global Services LLC, Cilag Int., Zug, Switzerland; 7Regeneron Pharmaceuticals, Tarrytown, NY, USA; 8EMEA Medical Affairs, Janssen-Cilag, Porto Salvo, PortugalCorrespondence: José Antunes, EMEA Medical Affairs, Janssen-Cilag, Porto Salvo, Portugal, Email jantune1@its.jnj.comPurpose: To examine efficacy and safety of paliperidone palmitate (PP) 6-month (PP6M) vs PP3-month (PP3M) long acting injectable (LAI) in patients with schizophrenia from European sites previously stabilized on PP3M or PP1-month (PP1M).Methods: This post-hoc subgroup analysis used data from a global phase-3 double-blind (DB) randomized non-inferiority study (NCT03345342). Patients were randomized (2:1, respectively) to receive dorsogluteal injections of PP6M (700 mg eq. or 1000 mg eq.) or PP3M (350 mg eq. or 525 mg eq.) in the 12-month DB phase. Primary endpoint was time-to-relapse during the DB phase, using a Kaplan–Meier cumulative survival estimate (non-inferiority margin 95% CI lower bound larger than prespecified as − 10%). Treatment emergent adverse events (TEAEs), physical examinations, and laboratory tests were also evaluated.Results: A total of 384 patients who entered the DB phase were included in European sites (PP6M, n = 260; PP3M, n = 124) with a mean age similar in both groups (mean age [SD] years: PP6M, 40.0 [11.39]; PP3M, 38.8 [10.41]). Baseline characteristics were similar across both groups. The ...