Response Rates of Esketamine Nasal Spray Plus an Oral Antidepressant Among Patients Not Meeting Study Criteria for Early Response to Treatment
Objective: Esketamine nasal spray (ESK) plus a newly initiated antidepressant (AD) reduces depression symptoms in patients with treatment-resistant depression (TRD), in a subset meeting study-defined response criterion (≥50% improvement in total Montgomery-Åsberg Depression Rating Scale score) within 24 hours. This analysis helps inform clinicians regarding how long to continue ESK treatment in patients without an early response.
Methods: This was a post hoc analysis of pooled data from two 4-week phase 3 ESK trials (TRANSFORM-1, NCT02417064; TRANSFORM-2, NCT02418585). Response rates at day 28 were determined among those without a response at day 2 and for those without a response at both day 2 and day 8 and were compared between ESK+AD and AD+placebo (AD+PBO) treatment groups. Probabilities for both treatment groups at day 28 were estimated; odds ratios (ORs) and corresponding 95% CI were computed.
Results: Among those without a response at day 2, 54.9% (130/237) and 44.3% (77/174) of patients in the ESK+AD and AD+PBO groups, respectively, were responders at day 28 (OR, 1.67; 95% CI, 1.08-2.57). Among those without a response at day 2 and day 8, 52.1% (113/217) and 42.4% (70/165) of patients in the ESK+AD and AD+PBO groups, respectively, were responders at day 28 (OR, 1.74; 95% CI, 1.10-2.73).
Conclusion: Among patients without evidence of early response, those receiving ESK+AD have a significantly higher likelihood of attaining response at day 28 compared with patients receiving AD+PBO, supporting the benefit of continuing ESK+AD treatment for the full 4 weeks of induction.
This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.
