Brexpiprazole in Combination With Sertraline in Patients With Post-Traumatic Stress Disorder: A Pooled Post hoc Analysis of key Clinical Efficacy Data

Additional pharmacotherapies are needed for post-traumatic stress disorder (PTSD). This pooled post-hoc analysis evaluated key clinical efficacy data for brexpiprazole in combination with sertraline in PTSD.
Trials 061 (NCT03033069), 071 (NCT04124614) and 072 (NCT04174170) enrolled outpatients aged 18–65 with PTSD. All trials included an 11-week double-blind treatment period, and included brexpiprazole + sertraline and sertraline + placebo treatment arms. In this post-hoc analysis, three pools were analyzed: All trials (071, 061, 072); Flexible-dose (071, 061); Phase 3 (071, 072). Least squares (LS) mean change from randomization (Week 1) to Week 10 in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total score (primary efficacy endpoint) and Clinical Global Impression – Severity of illness (CGI-S) score were compared between brexpiprazole + sertraline and sertraline + placebo.
The ‘All trials’ pool comprised 481 (brexpiprazole + sertraline) and 339 (sertraline + placebo) patients; Flexible-dose pool, n=225/209; Phase 3 pool, n=404/264. Across the pools, LS mean change from randomization (Week 1) to Week 10 in CAPS-5 Total score ranged from -17.82 to -18.30 with brexpiprazole + sertraline, and -12.68 to -15.57 with sertraline + placebo (LS mean difference [LSMD]: All, -3.49 [p=0.0004]; Flexible-dose, -5.27 [p < 0.0001]; Phase 3, -2.73 [p=0.0101]). Change in CGI-S score ranged from -1.40 to -1.45 with brexpiprazole + sertraline, and -0.99 to -1.18 with sertraline + placebo (LSMD: All, -0.30 [p=0.0006]; Flexible-dose, -0.46 [p=0.0001]; Phase 3, -0.23 [p=0.0150]).
In conclusion, brexpiprazole in combination with sertraline is associated with greater improvement in key clinical measures of PTSD symptoms than sertraline + placebo.