Real-world Change in Depressive Symptoms Among Patients with Treatment-Resistant Depression Initiated on Esketamine Nasal Spray

Abstract: BACKGROUND: Real-world evidence of clinical benefits of esketamine nasal spray for treatment-resistant depression (TRD) is limited. This study used health insurance claims data augmented with Patient Health Questionnaire (PHQ-9) scores to address this gap in knowledge. METHODS: Adults with TRD initiated on esketamine (index date) with ≥12 months of continuous insurance eligibility preceding index date (baseline) were identified using Komodo Research Database closed claims (01/2016-06/2023). Follow-up period spanned the index date to end of continuous insurance eligibility or data. Change in depression severity from the most recent PHQ-9 score during baseline to the most recent score during follow-up while on treatment was estimated with generalized estimating equations. Probability of achieving substantial clinical improvement in PHQ-9 score (≥ 6 points) while on treatment was estimated using Kaplan-Meier analysis. RESULTS: 103 patients were identified (mean age: 41.5 years, 65.0% female, 68.9% commercial insurance, 20.4% Medicaid and 7.8% Medicare Advantage). Mean PHQ-9 score decreased, indicating lower depression severity, by 3.93 points (95% confidence interval [CI]: 2.72-5.11) and odds of reporting moderately severe or severe depression (PHQ-9 score ≥ 15) decreased by 65% (odds ratio: 0.35; 95% CI: 0.24-0.51) from baseline to follow-up. The probability of achieving substantial clinical improvement in PHQ-9 score 12 months post-index was 71.0% (95% CI: 58.7-82.3). CONCLUSIONS: This real-world study demonstrated that initiation of esketamine was associated with significant clinical benefits among patients with TRD, which is consistent with evidence from clinical trials. These findings highlight the suitability of esketamine for alleviating depression symptoms in this population.Short Description: This real-world study utilized insurance claims data and Patient Health Questionnaire (PHQ-9) scores to analyze change in depression severity among patients with treatment-resistant depression initiating esketamine nasal spray. A statistically significant reduction in depression severity and odds of reporting moderately severe or severe depression (PHQ-9 score ≥ 15) were observed after esketamine initiation. The probability of achieving substantial clinical improvement in PHQ-9 score (≥ 6 points) was 71.0% 12 months post-esketamine initiation.Name of Sponsoring Organization(s): Johnson & Johnson Innovative Medicine