Long-term safety and efficacy of esketamine nasal spray plus an oral antidepressant in patients with treatment-resistant depression – an Asian sub-group analysis from the SUSTAIN-2 study.

Hong Jin Jeon ^{1, 2, 3}, Po-Chung Ju ^{4, 5}, Ahmad Hatim Sulaiman ⁶, Salina Abdul Azis ⁷, Jong-Woo Paik ⁸, Wilson Tan ^9*, Daisy Bai ¹⁰, Cheng-Ta Li ^{11, 12}

¹Department of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, ²Korea Psychological Autopsy Center (KPAC), Seoul, Korea, ³Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Seoul, Korea, ⁴Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, ⁵Department of Psychiatry, Chung Shan Medical University Hospital, Taichung, Taiwan, ⁶Department of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia, ⁷Department of Psychiatry and Mental Health, Hospital Kuala Lumpur. Kuala Lumpur, Malaysia, ⁸Department of Psychiatry, Kyung Hee University College of Medicine, Seoul, Korea, Seoul, Korea, ⁹Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore, ¹⁰Statistics & Decision Sciences, Janssen Research & Development, LLC, Shanghai, China., ¹¹Division of Community & Rehabilitation Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ¹²Functional Neuroimaging and Brain Stimulation Lab, National Yang-Ming University, Taipei, Taiwan

Received: January 5, 2021; Revised: March 25, 2021; Accepted: March 26, 2021; Published online: March 26, 2021.

Abstract: Objective: To evaluate the long-term safety and efficacy of intranasal esketamine in patients with treatment-resistant depression from the Asian subgroup of the SUSTAIN-2 study.
Methods: SUSTAIN-2 was a phase 3, open-label, single-arm, multicenter study comprising a 4-week screening, 4-week induction, 48-week optimization/maintenance, and 4-week follow-up (upon esketamine discontinuation) phase. TRD patients received esketamine plus an oral antidepressant during the treatment period.
Results: The incidence of ≥1 serious treatment-emergent adverse events (TEAE) among the 78 subjects from the Asian subgroup (Taiwan: 33, Korea: 26, Malaysia: 19) was 11.5% (n=9); with no fatal TEAE. 13 Asian patients (16.7%) discontinued esketamine due to TEAEs. The most common TEAEs were dizziness (37.2%), nausea (29.5%), dissociation (28.2), and headache (21.8%). Most TEAEs were mild to moderate in severity, transient and resolved on the same day. Upon discontinuation of esketamine, no trend in withdrawal symptoms was observed to associate long-term use of esketamine with withdrawal syndrome. There were no reports of drug seeking, abuse, or overdose. Improvements in symptoms, functioning and quality of life, occurred during in the induction phase and were generally maintained through the optimization/maintenance phases of the study.
Conclusion: The safety and efficacy of esketamine in the Asian subgroup was generally consistent with the total SUSTAIN-2 population. There was no new safety signal and no indication of a high potential for abuse with the long-term (up to one year) use of esketamine in the Asian subgroup. Most of the benefits of esketamine occurred early during the induction phase.; Keywords: intranasal esketamine, sub-group analysis, Asia, treatment-resistant depression, long-term

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