Findings presented at the 31st European Congress of Psychiatry (EPA 2023) confirm the importance of SPRAVATO® as a long-term therapeutic option for adults with treatment-resistant major depressive disorder
BEERSE, BELGIUM, 27 March 2023 –The Janssen Pharmaceutical Companies of Johnson & Johnson today announced further findings for SPRAVATO® (esketamine nasal spray [NS]) from the ESCAPE-TRD study. Data show that adults with treatment-resistant major depressive disorder (TRD) treated with esketamine NS achieved significantly* higher remission rates from Week 6 and response rates as early as Day 15 in the study, and at every subsequent time-point through Week 32, compared to adults treated with quetiapine extended-release (XR), when both were dosed as per their respective labels and used in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).1 The findings were presented at the 31st European Congress of Psychiatry (EPA 2023) taking place from March 25 to March 28 in Paris, France, following earlier top line data from the study presented at the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) Congress last year.2
*Tested at a two-sided 0.05 significance level without adjustment for multiple testing.1
Major depressive disorder (MDD) affects around 40 million people in the EU.3 Approximately a third of people who experience MDD do not respond to treatment and are considered to have TRD – a term for people living with MDD who have cycled through two or more antidepressant treatments within the current depressive episode without experiencing symptomatic relief.4,5
“TRD is a major burden to the millions of people3 impacted by the condition, as well as to their caregivers and healthcare systems,” said Professor Andreas Reif, Principal Investigator for the ESCAPE-TRD study and Head of the Department of Psychiatry, Psychosomatic Medicine and Psychotherapy at University Hospital Frankfurt, Germany†.“The ESCAPE-TRD study findings show us that using esketamine NS over the long-term provides clinically important improvements in remission rates in people with TRD, with treatment response increasing over time.1 These data give those affected by TRD and their healthcare professionals reassurance and confidence that esketamine NS could have a meaningful impact in helping reduce the effect TRD has on their lives, and eventually enabling them to take a more active role in society.”
ESCAPE-TRD is a long-term, comparative, randomised, open-label, rater-blinded phase 3b clinical study designed to evaluate the short- and long-term efficacy, safety and tolerability of flexibly-dosed esketamine NS compared with quetiapine XR, both in combination with a continuing SSRI or SNRI, in adults with TRD.1,2,6 The study evaluated 676 adults aged 18-74 years with TRD, randomised to receive either esketamine NS (n=336) or quetiapine XR (n=340), both in combination with a continuing SSRI/SNRI.1,6 TRD was defined as non-response to at least two consecutive adequately dosed treatments (including the ongoing treatment) during the current depressive episode.1
Findings presented at EPA 2023 showed that a significantly* higher proportion of participants in the esketamine NS arm achieved remission‡ from Week 6 and at every subsequent time-point through Week 32 compared to the quetiapine XR arm.1At Week 32, 55 percent of patients in the esketamine NS arm achieved remission compared to 37 percent in the quetiapine XR arm.1
†Professor Andreas Reif has been a paid consultant to Janssen; he has
not been paid for contributing to this press release *Tested at a
two-sided 0.05 significance level without adjustment for multiple
testing.1 ‡ Remission was defined as Montgomery-Åsberg Depression Rating
Scale [MADRS] total score ≤10. MADRS is a clinician‐rated measure of
depression severity1
In addition, a significantly* greater proportion of participants in the esketamine NS arm versus the quetiapine XR arm experienced response§ from Day 15 and at every subsequent time-point through Week 32.1 Notably, the absolute response rate at Week 8 in the esketamine NS arm was 55.4 percent vs 39.1 percent for quetiapine XR, rising to 75.5 percent vs 55.5 percent respectively at Week 32.1
Participants in the esketamine NS study arm also experienced a significantly* improved reduction of depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) vs quetiapine XR from Day 8, with an average difference over time in the least squares (LS) means total MADRS score change from baseline of −2.4.1 MADRS is a clinician‐rated measure of depression severity.1
“Today marks another major milestone in the treatment of TRD. With a third of people with MDD not responding to treatment and considered to be treatment-resistant4, the data being presented today at EPA 2023 demonstrate that esketamine nasal spray may help a greater proportion of people living with TRD achieve response and remission over the long-term, compared to quetiapine extended-release.1 We are hopeful that this news will be welcomed by people living with TRD, their caregivers and their healthcare providers,” said Dr. Tamara Werner-Kiechle, EMEA Therapeutic Area Lead, Neuroscience and Pulmonary Hypertension, Janssen-Cilag GmbH, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. “We are committed to bringing to life therapies to prevent and treat what can be a devastating disease and are confident that today’s ESCAPE-TRD results, on top of those presented last year, show the potential of esketamine nasal spray in ending repeated treatments failures in a population that is often difficult to treat and providing positive outcomes for people impacted by TRD.”
Safety findings demonstrated that the rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs) were lower in the esketamine NS arm (4.2 percent versus the quetiapine XR arm (11.0 percent).1 The most common TEAEs leading to treatment discontinuation in the esketamine NS arm were dizziness (0.6 percent vs 1.2 percent for quetiapine XR), dissociation (0.6 percent vs 0 percent for quetiapine XR) and vomiting (0.6 percent vs 0 percent for quetiapine XR).1 In the quetiapine XR arm the most common TEAEs leading to treatment discontinuation were sedation (2.1 percent vs 0 percent for esketamine NS), weight increase (1.8 percent vs 0 percent for esketamine NS) and somnolence (1.5 percent vs 0 percent for esketamine NS).1
*Tested at a two-sided 0.05 significance level without adjustment for
multiple testing.1
§ Response was defined as ≥50% improvement in MADRS
total score from baseline or MADRS ≤101
1 Reif A. et al., Esketamine nasal spray shows higher remission and response rates over 32 weeks of treatment compared with quetiapine extended-release in patients with treatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trial. Presented at EPA 2023, March 25-28. Poster PO0067
2 Reif A. et al., Esketamine nasal spray improves short‐ and long‐term outcomes compared with quetiapine extended release in patients with treatment resistant depression: First results from ESCAPE‐TRD, a randomised, multi‐centre phase IIIb clinical trial. Presented at DGPPN 2022, November 23-26. Poster P-01-04.
3 World Health Organization (WHO). Raising awareness of depression. Available at: https://www.who.int/europe/activities/supporting-country-work-around-mental-health/raising-awareness-of-depression Last accessed: March 2023.
4 Ionescu DF, et al. Dialogues Clin Neurosci 2015;17(2):111–126. European Medicines Agency, 2013. Guideline on clinical investigation of medicinal products in the treatment of depression. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-depression_en.pdf Last accessed: March 2023.
5 European Medicines Agency, 2013. Guideline on clinical investigation of medicinal products in the treatment of depression. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-depression_en.pdf Last accessed: March 2023.
6 Clinicaltrials.gov. A long-term comparison of esketamine nasal spray versus quetiapine extended release, both in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor, in participants with treatment resistant major depressive disorder (ESCAPE-TRD). NCT 04338321.Available at: https://clinicaltrials.gov/ct2/show/NCT04338321?term=escape-trd&draw=2&rank=1. Last accessed: March 2023.
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