Skip to main content
Psych Congress  

Paliperidone Palmitate Treatment Response in Early and Chronic Illness Schizoaffective Disorder Patients

Cynthia Bossie, PhD
Ibrahim Turkoz, PhD
Larry Alphs, MD
Lucy Mahalchick, PhD
Dong-Jing Fu, MD, PhD
Janssen Scientific Affairs, LLC

Introduction: Schizoaffective disorder (SCA) presents with mixed symptoms of psychosis, depression, and mania, and is associated with significant functional impairment. Once-monthly monotherapy or adjunctive paliperidone palmitate (PP) significantly reduced relapse risk in the first placebo (PBO)-controlled, relapse-prevention SCA study (NCT01193153). Exploratory analysis examined whether patients early in their illness were more responsive to treatment than those with a longer duration of SCA.

Method: Subjects who stabilized (via psychotic and mood symptom scores) in a 25-week open-label (OL)-phase could enter the 15-month double-blind (DB) relapse-prevention phase. Exploratory analyses compared early- (diagnosis <5 years) and chronic-illness (≥5 years) subgroups for OL changes in PANSS, HAMD, YMRS, and PSP (t-test); adverse events; percent meeting OL-stabilization criteria and entering DB-phase (Chi-square test); and DB time-to-relapse and relapse rates (Kaplan-Meier estimates, Hazard Ratios [HR] from Cox proportional hazards models).

Results: 667 (206 early; 461 chronic) subjects enrolled in the OL PP treatment phase. Mean symptom and functioning scores improved more in early- versus chronic-illness groups: PANSS, HAMD, YMRS, and PSP, all P<0.05. Most common adverse events: weight increased (8.7%), insomnia (6.9%), injection site pain (6.5%), parkinsonism (6.5%), akathisia (5.2%). A higher percentage of early- than chronic-illness patients met OL-stabilization criteria (70.4%[143/203] versus 60.0%[270/450], respectively; P=0.010) and entered DB randomization (57.8%[119/206] versus 46.6%[215/461]; P=0.008). DB-relapse rates: Early-illness, PP=10.2% versus PBO=30.0% (P=0.014), HR=2.8 (95%CI=1.11, 7.12; P=0.029); Chronic-illness, PP=18.1% versus PBO=35.5% (P=0.001), HR=2.38 (95%CI=1.37, 4.12; P=0.002).

Conclusion: Exploratory data-analyses suggest that early versus later treatment with PP in SCA results in greater symptom improvement and lower relapse rates.

Back to Top