Summary

• An exploratory analysis was performed to evaluate the efficacy and tolerability of INVEGA SUSTENNA vs placebo in recently diagnosed (<5 yrs) vs chronically ill schizoaffective disorder patients. Time to relapse was significantly longer in INVEGA SUSTENNA vs placebo (PBO)-treated patients for both recent (P=0.014) and chronic (P=0.001) subgroups.¹

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available dosage strengths in the United States. The conversion factor from mg eq to mg is 1.56.

• INVEGA SUSTENNA doses expressed as 39, 78, 117, 156, and 234 mg of paliperidone palmitate are equal to 25, 50, 75, 100, and 150 mg eq of paliperidone, respectively.

Post Hoc Analyses

Bossie et al (2017)¹ conducted an exploratory analysis of an international, long-term, double-blind (DB), PBO-controlled, randomized-withdrawal study of INVEGA SUSTENNA in patients with schizoaffective disorder² focusing on patients recently diagnosed (<5 years) vs chronically ill (≥5 years).

Study Design/Methods

• Screening period (1-7 days) during which patients received oral tolerability testing if necessary.
• 13-week, open-label (OL), lead-in period, during which patients received INVEGA SUSTENNA (234 mg on day 1 and 156 mg on day 8 in the deltoid muscle, followed by flexible doses of 117-234 mg on day 36 and 78-234 mg on days 64 and 92), as monotherapy or as an adjunct to, stable doses of their adjunctive mood stabilizer or antidepressant medications.
• 12-week, OL, fixed-dose phase, during which patients who met predefined stabilization criteria (Positive and Negative Syndrome Scale Score [PANSS] total scores ≤70; Young Mania Rating Scale [YMRS] and Hamilton Depression Rating Scale [HDRS]-21 scores ≤12) received INVEGA SUSTENNA once every 4 weeks, at the final dose received during the lead-in period.
• 15-month, DB phase, during which patients who maintained stability based on predefined criteria were randomized to PBO or a fixed dose of INVEGA SUSTENNA.²

Results

• OL Phase: A total of 667 patients enrolled in the OL treatment phase (recent: n=206; mean age: 33.8 years; chronic: n=461; mean age: 42.1 years).
• From OL baseline to endpoint mean PANSS total scores significantly improved for recent and chronic subgroups with significant between group differences (-27.3 vs -22.2; P=0.001).
• DB Phase: Significantly more recently diagnosed (57.8%; 119/206) vs chronically ill (46.6%; 215/461) patients entered the DB randomization phase (P=0.008).
• Time to relapse was significantly longer in INVEGA SUSTENNA vs PBO-treated patients for both recent (P=0.014) and chronic (P=0.001) subgroups.
• Significantly fewer recently diagnosed patients treated with INVEGA SUSTENNA vs PBO experienced a relapse event (10.2% [6/59] vs 30.0% [18/60], respectively; HR: 2.81-fold higher for PBO vs INVEGA SUSTENNA, P=0.029).
• In addition, significantly fewer chronically ill patients treated with INVEGA SUSTENNA vs PBO experienced a relapse event (18.1% [19/105] vs 35.5% [39/110], respectively; HR: 2.38-fold higher for PBO vs INVEGA SUSTENNA, P=0.002).
• Adverse events reported by >5% of patients in any subgroup included: headache, hyperprolactinemia, insomnia, nasopharyngitis, pyrexia, schizoaffective disorder, upper respiratory tract infection and weight increased.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 20 May 2024.