Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data.
2020
BACKGROUND: Esketamine nasal spray was recently approved for treatment-resistant depression (TRD). The current analysis evaluated the impact of symptom-based treatment frequency changes during esketamine treatment on clinical outcomes. METHODS: This is a post-hoc analysis of an open-label, long-term (up to 1 year) study of esketamine in patients with TRD (SUSTAIN 2). During a 4-week Induction phase, 778 patients self-administered esketamine twice-weekly plus a new oral antidepressant daily. In responders (>/=50% reduction in Montgomery-Asberg Depression Rating Scale [MADRS] total score from baseline), esketamine treatment frequency was thereafter decreased during an Optimization/Maintenance phase, to weekly for 4 weeks and then adjusted to the lowest frequency (weekly or every-other-week) that maintained remission (MADRS =12) based on a study-defined algorithm. The relationship between treatment frequency and symptom response, based on clinically meaningful change in Clinical Global Impression-Severity (CGI-S) score, was subsequently evaluated 4 weeks after treatment frequency adjustments in the Optimization/Maintenance phase. RESULTS: Among 580 responders treated with weekly esketamine for the first 4 weeks in the Optimization/Maintenance phase (per protocol), 26% continued to improve, 50% maintained clinical benefit, and 24% worsened. Thereafter, when treatment frequency could be reduced from weekly to every-other-week, 19% further improved, 49% maintained benefit, and 32% worsened. For patients no longer in remission after treatment frequency reduction, an increase (every-other-week to weekly) resulted in: 47% improved, 43% remained unchanged, and 10% worsened. CONCLUSIONS: These findings support individualization of esketamine nasal spray treatment frequency to optimize treatment response in real-world clinical practice.
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