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Poster
1569709
Real-World Safety Profile of Esketamine Nasal Spray During the First 12 Treatment Sessions: An Analysis at 46 Months After Approval in the United States
Psych Congress 2023
This work was sponsored by Janssen Scientific Affairs, LLC
Purpose: To examine real-world incidence of esketamine nasal spray (ESK) treatment-emergent adverse events (TEAEs) of interest (i.e., sedation, dissociation, increased blood pressure [BP]) and serious adverse events (SAEs) in the United States, and to determine if the rates of these events change between induction and maintenance periods.
Methods: ESK Risk Evaluation and Mitigation Strategy patient monitoring forms were evaluated to summarize key safety findings for the first 46 months (March 5, 2019, to January 5, 2023) after US product approval, with a focus on induction (weeks 1-4 of treatment with twice-weekly ESK dosing) and maintenance (weeks 5-8 of treatment with once-weekly ESK dosing) periods.
Results: A total of 34,110 patients had ≥1 ESK treatment session during the evaluation period. The cumulative percentage of patients who experienced ≥1 TEAEs of interest during sessions 1-8 and sessions 9-12 were 58.4% and 48.2% for sedation, 62.7% and 52.6% for dissociation, and 6.5% and 3.1% for increased BP, respectively. Hospitalizations occurred in 0.2% of patients (first session,
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