Variables Associated with Remission in Patients Treated with Esketamine Nasal Spray or Quetiapine Extended Release: A Post Hoc Subgroup Analysis of the ESCAPE-TRD Study

Abstract: Objective: To examine baseline and disease characteristics of patients with treatment-resistant depression (TRD) who achieved remission at week 8 with quetiapine extended release (QXR) or esketamine nasal spray (ESK) (both with an oral antidepressant) in ESCAPE-TRD (NCT04338321) to identify potential variables associated with treatment benefit. Methods: In this exploratory post hoc subgroup analysis of patients treated with ESK or QXR, consistent with USPI, univariate and stepwise logistic regression models were used to identify potential baseline and disease characteristics associated with remission (defined as Montgomery-Åsberg Depression Rating Scale [MADRS] total score ≤12 at week 8). Remission rate differences between ESK and QXR (observed cases) were evaluated at week 8 using odds ratios (ORs) and corresponding CIs. Results: Remission at week 8 was achieved by 74/249 patients (29.7%) receiving QXR and 120/282 patients (42.6%) receiving ESK. Patients receiving ESK had a 78% increase in odds of achieving remission at week 8 (OR 1.78; 95% CI, 1.23-2.55; P=0.002) compared to QXR. Among remitters, treatment discontinuation rates were higher with QXR than ESK (18.9% vs 10.0%). With ESK, potential variables associated with predicting remission included baseline body mass index, duration of current episode, and baseline MADRS total score. MADRS total score, screening CGI-S score, employment status, prior number of treatment failures, and family history of psychiatric disorders were predictive in the QXR group. Conclusions: Variables associated with achieving remission varied between both treatment groups. Regardless, patients treated with ESK were more likely to achieve remission at week 8 compared with those treated with QXR.Short Description: This exploratory post hoc analysis of ESCAPE-TRD (NCT04338321) examined potential baseline and disease characteristics associated with the likelihood of achieving remission of treatment-resistant depression at week 8. Results indicated that patients treated with esketamine nasal spray are more likely to achieve remission than those treated with quetiapine extended release when both are taken in combination with an oral antidepressant.Name of Sponsoring Organization(s): Janssen Scientific Affairs, LLC, a Johnson & Johnson company