SAN ANTONIO, TX—Both paliperidone palmitate 1-month and 3-month long-acting injectables (LAI) decreased the severity of symptoms and increased Personal and Social Performance (PSP) scale scores in patients with schizophrenia, according to a study presented at the U.S. Psychiatric & Mental Health Congress.
“Guaranteed administration, transparency of adherence, lower relapse rates, delayed functional deterioration, and improved outcomes” are all advantages associated with LAI antipsychotics over oral medications in patients with schizophrenia, explained Brianne Brown, from Janssen Scientific Affairs, LLC, Titusville, NJ. Brown and coauthors presented findings from a post-hoc analysis of a Phase 3 randomized, multicenter, double-blind, parallel-group, non-inferiority trial (NCT01515423) that found the 3-month paliperidone palmitate injectable formulation was non-inferior to the 1-month paliperidone palmitate injectable formulation. For this analysis, researchers aimed to evaluate the effect of the 1-month and 3-month LAI therapy on symptom severity and functional remission in schizophrenia patients with varying duration of disease.
The study enrolled adults aged 18–70 years with a schizophrenia diagnosis according to the DSM-IV-VR for ≥1 year with worsening symptoms prior to screening. The Positive and Negative Syndrome Scale (PANSS) score evaluated symptom severity and the PSP scale evaluated functional status. The 1-month and 3-month paliperidone palmitate data were pooled and evaluated based on disease duration: ≤5, 6–10, and >10 years post-diagnosis.
“There were no statistically significant differences in the incidence of relapse or all-cause discontinuation in the ≤5 year, 6–10 year, and >10 year groups,” reported Brown. The ≤5 year group showed an 8% relapse and 26% discontinuation; the 6–10 year group showed a 7% relapse and 23% discontinuation; and the >10 year group showed a 10% relapse and 27% discontinuation.
The analysis found significant improvements in mean change from baseline in PANSS and PSP scores across all subgroups at the open-label phase endpoint (PANSS: P=0.005 and PSP: P=0.001); these improvements persisted until the double-blind phase endpoint (PANSS: P=0.009 and PSP: P=0.024). In addition, more patients in the ≤5 year and 6–10 year groups reached functional remission (PSP >70) compared to patients in the >10 year subgroup for both the open-label and double-blind phases. Specifically, a total of 107 patients (28.23%) in the ≤5 year group and 74 patients (31.48%) in the 6–10 year group achieved functional remission from Week 13 of the open-label phase and during the double-blind phase for ≥3 months compared to 71 patients (18.83%) in the >10 year group.
Generally, a greater improvement in symptom reduction and functional outcomes was seen in patients with a shorter disease duration vs. patients with longer disease duration; similarly, more patients in the ≤5 year and 6–10 year groups achieved functional remission. “These findings provide support for the earlier use of paliperidone 1-month and 3-month injectables in the treatment of schizophrenia to improve symptoms and functional outcomes,” concluded Brown.