Poster
171
(#171) Patient-reported symptom severity and functioning with brexpiprazole in combination with sertraline in adults with post-traumatic stress disorder
Psych Congress 2025
Abstract: Post-traumatic stress disorder (PTSD) is prevalent and associated with impaired functioning. This analysis evaluated patient-reported outcomes (PROs) for symptom severity and functioning from brexpiprazole+sertraline trials.
Data were analyzed from two flexible-dose, randomized, 12-week, US trials of brexpiprazole+sertraline versus sertraline+placebo in adults with PTSD (Trial 061 [ClinicalTrials.gov: NCT03033069]; Trial 071 [NCT04124614]). The primary efficacy measure was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The PTSD Checklist for DSM-5 (PCL-5) was also assessed - a PRO evaluating symptom-related functional impairment (total score 0-80). In Trial 071 only, the Brief Inventory of Psychosocial Function (B-IPF) was a key secondary endpoint - a PRO evaluating PTSD-specific psychosocial functioning (7 items scored 0-6; total score 0-100). Higher scores indicate greater impairment. In this analysis, change in PCL-5 Total (Trials 061+071 pooled), and change in B-IPF scores (Trial 071), were evaluated for brexpiprazole+sertraline versus sertraline+placebo (nominal P-values, not adjusted for multiplicity).
For Trials 061+071 pooled, LS mean change from randomization (Week 1) to Week 10 in PCL-5 Total score was -20.67 (brexpiprazole+sertraline) and -14.55 (sertraline+placebo) (P=0.0003). For Trial 071, B-IPF Total score changes were reported previously (Week 12: P=0.002). Across B-IPF items, LS mean changes from baseline (Day 0) to Week 12 ranged from -1.34 to -2.25 with brexpiprazole+sertraline, and -0.88 to -1.55 with sertraline+placebo (3 items P 0.01 ["trouble with family", "trouble at work", "trouble with friendship"]; others P>0.05).
In a pooled analysis of PRO data from two trials in adults, brexpiprazole+sertraline was associated with greater improvements in PTSD symptoms and functioning than sertraline+placebo.
Short Description: This is an analysis of patient-reported outcomes from two flexible-dose trials of brexpiprazole in combination with sertraline in PTSD. PTSD Checklist for DSM-5 (PCL-5) data were pooled from both trials, and Brief Inventory of Psychosocial Function (B-IPF) data were available for one trial. Based on PCL-5 Total score, B-IPF Total score, and B-IPF item scores from these trials, brexpiprazole+sertraline was associated with improvements in PTSD symptom severity and functioning compared with sertraline+placebo.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
Data were analyzed from two flexible-dose, randomized, 12-week, US trials of brexpiprazole+sertraline versus sertraline+placebo in adults with PTSD (Trial 061 [ClinicalTrials.gov: NCT03033069]; Trial 071 [NCT04124614]). The primary efficacy measure was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The PTSD Checklist for DSM-5 (PCL-5) was also assessed - a PRO evaluating symptom-related functional impairment (total score 0-80). In Trial 071 only, the Brief Inventory of Psychosocial Function (B-IPF) was a key secondary endpoint - a PRO evaluating PTSD-specific psychosocial functioning (7 items scored 0-6; total score 0-100). Higher scores indicate greater impairment. In this analysis, change in PCL-5 Total (Trials 061+071 pooled), and change in B-IPF scores (Trial 071), were evaluated for brexpiprazole+sertraline versus sertraline+placebo (nominal P-values, not adjusted for multiplicity).
For Trials 061+071 pooled, LS mean change from randomization (Week 1) to Week 10 in PCL-5 Total score was -20.67 (brexpiprazole+sertraline) and -14.55 (sertraline+placebo) (P=0.0003). For Trial 071, B-IPF Total score changes were reported previously (Week 12: P=0.002). Across B-IPF items, LS mean changes from baseline (Day 0) to Week 12 ranged from -1.34 to -2.25 with brexpiprazole+sertraline, and -0.88 to -1.55 with sertraline+placebo (3 items P 0.01 ["trouble with family", "trouble at work", "trouble with friendship"]; others P>0.05).
In a pooled analysis of PRO data from two trials in adults, brexpiprazole+sertraline was associated with greater improvements in PTSD symptoms and functioning than sertraline+placebo.
Short Description: This is an analysis of patient-reported outcomes from two flexible-dose trials of brexpiprazole in combination with sertraline in PTSD. PTSD Checklist for DSM-5 (PCL-5) data were pooled from both trials, and Brief Inventory of Psychosocial Function (B-IPF) data were available for one trial. Based on PCL-5 Total score, B-IPF Total score, and B-IPF item scores from these trials, brexpiprazole+sertraline was associated with improvements in PTSD symptom severity and functioning compared with sertraline+placebo.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
