Study Supports Long-Term Efficacy of Esketamine Nasal Spray in Patients with ESRD

CONFERENCE REPORTER

Results from a recent study showed that flexible-dosing esketamine nasal spray demonstrated sustained improvements in depressive symptoms in adults with treatment-resistant depression (TRD) for up to 6.5 years. Study investigators shared these results in a poster presentation at Psych Congress 2023.

The poster presentation, titled Long-Term Efficacy of Esketamine Nasal Spray Dosed According to US Prescribing Information in Adults With Treatment-Resistant Depression: A Subgroup Analysis of the SUSTAIN-3 Study Up to 6.5 Years, described some of the results of the SUSTAIN -3 clinical trial titled A Long-Term Safety Study of Esketamine Nasal Spray in Treatment-Resistant Depression (SUSTAIN-3), a Phase 3, Open-Label, Long-Term Extension Study.^1.2

The purpose of the SUSTAIN-3 study is to evaluate the overall tolerability and safety of esketamine nasal spray in subjects with TRD over 2 phases: a 4-week induction phase and an optimization and maintenance phase of varying duration.^1.2

For the subgroup analysis discussed in this poster presentation, researchers specifically focused on the long-term efficacy of esketamine nasal spray in adults with ESRD who were dosed according to US prescribing information, extracting efficacy data from the SUSTAIN-3 study. To explore this, researchers recruited 1,021 adults ages 18 to 64 with TRD who had already participated in 1 of 5 parental esketamine nasal spray studies before entering the SUSTAIN-3 study. These patients had also been receiving esketamine nasal spray treatment for an average of 46.9 months.¹

For the current subgroup analysis, patients received esketamine nasal spray 56 mg or 84 mg twice weekly during the induction phase and flexible-dosing esketamine nasal spray during the optimization and maintenance phase, in addition to an oral antidepressant. Investigators assessed physician- and patient-reported severity of illness using the Montgomery-sberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire 9-Item (PHQ-9).¹

The mean baseline MADRS and PHQ-9 scores at the beginning of the induction phase were 29.1 and 15.4, respectively, which, the investigators noted, were both consistent with moderate to severe disease. After reassessment at the end of the 4-week induction phase, MADRS and PHQ-9 scores changed to -12.9 (9.67) and -5.9 (5.77), respectively. The researchers also noted that these improvements were maintained throughout the optimization and maintenance phase.¹

The percentage of patients achieving MADRS and PHQ-9 remission, respectively, defined as < 12 and < 5 at the time of the last evaluation in the optimization and maintenance phase was 49.6% and 33.6%, respectively.¹

This subgroup analysis demonstrates that in adults with TRD, improvements in depressive symptoms with flexible doses [esketamine nasal spray] appear to be maintained with long-term treatment (up to 6.5 years), the researchers concluded.

The research described in this poster presentation was contributed by John Zajecka, MD, of Rush University Medical Center in Chicago, Illinois, and colleagues at Janssen Research & Development, LLC, and Janssen Scientific Affairs, LLC.

Learn about research and important issues in psychiatry at the 2023 Psychiatric Times World CME Annual Conference, which will feature expert presentations and panel discussions on best practices for managing a wide range of psychiatric diagnoses, including schizophrenia, major depressive disorder, substance use disorders, and more. This year’s conference takes place October 19-21, 2023. Register for the conference here.

References

1. Zajecka J, Zaki N, Fu D, et al. Long-term efficacy of esketamine nasal spray dosed according to US prescribing information in adults with treatment-resistant depression: a subgroup analysis of the SUSTAIN-3 study up to 6.5 years. Poster Presentation. Presented at Psych Congress 2023. Accessed September 8, 2023. https://www.national.psychcongress.com/

2. A Long-Term Safety Study of Esketamine Nasal Spray in Treatment-Resistant Depression (SUSTAIN-3). ClinicalTrials.gov. Accessed September 8, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT02782104