- The new safety data is from the ESCAPE-TRD Phase 3b study1
- Additional findings from this study showed esketamine NS demonstrated a significant increase in the proportion of patients achieving remission and response compared to quetiapine XR, based on the patient-reported Patient Health Questionnaire (PHQ-9)2
DUBLIN, Ireland, 31 October 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson have announced further findings for esketamine nasal spray [NS] from the ESCAPE-TRD study. Data on treatment-emergent adverse events (TEAEs) suggest a more favourable tolerability profile in adults with treatment-resistant major depressive disorder (TRD) receiving esketamine NS than quetiapine XR. Across all reported TEAEs experienced with esketamine NS, 92.1 percent were transient and resolved the same-day vs 12.1 percent of TEAEs experienced with quetiapine XR.1 The findings were presented at the 36th European College of Neuropsychopharmacology Congress (ECNP 2023) which took place from 7 October to 10 October in Barcelona, Spain.
While more TEAEs were observed with esketamine NS than with quetiapine XR, a greater proportion of esketamine NS-treated patients (82.6 percent) reported a TEAE that resolved same-day day vs quetiapine XR patients (15.5 percent)1 in TAES that occurred in ≤ 5% of patients. Fewer esketamine NS-treated patients (53.6 percent) reported a TEAE that persisted for more than one day vs quetiapine XR-treated patients (74.7 percent) and TEAEs leading to treatment discontinuation were more frequent with quetiapine XR (11.0 percent) than with esketamine NS (4.2 percent).1
Dr Lorcan Martin, Consultant in General Adult Psychiatry said, “When formulating the most effective treatment plans for a patient, the utmost priority remains ensuring patient safety. The findings from the ESCAPE-TRD study give confidence to healthcare professionals treating those living with TRD. By definition, TRD is challenging to treat, and it is critical to have treatment options with robust safety data that are less likely to lead to discontinuation for this patient population.”
While Major Depressive Disorder (MDD) affects nearly 40 million people in Europe3, Ireland has one of the highest rates of mental illness as it is estimated that approximately 150,000 people per year are living with severe depression (also known as Major Depressive Disorder or MDD) here. 4,5 Approximately one-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.6,7
Patients Report Superior Efficacy with Esketamine NS vs Quetiapine XR
In addition, patients enrolled in the ESCAPE-TRD study reported treatment effectiveness, using the nine-item patient health questionnaire (PHQ-9) scale. PHQ-9 is a widely used and effective tool for the detection of depression, and for monitoring its severity.8
Findings presented at ECNP 2023 showed that esketamine NS significantly increased the proportion of patients achieving, and shortened time to, PHQ-9 remission versus quetiapine XR, with patients being 1.21 times as likely to experience remission at Week 32.2 From the patients’ perspective of their own symptoms, esketamine NS showed superior short and long-term efficacy in TRD compared to quetiapine XR.2
Significantly more patients in the esketamine NS arm achieved PHQ-9 defined remission (56.8 percent versus 43.3 percent [p<0.001]) at Week 8, with numbers increasing by Week 32 (68.9 percent versus 57.2 percent [p<0.01], respectively) compared to patients in the quetiapine XR arm.2 These findings were consistent with results of the primary endpoint analysis, which showed a significantly higher remission rate measured using the clinician-rated Montgomery-Äsberg Depression Rating Scale (MADRS) in the esketamine NS arm versus the quetiapine XR arm.9
Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC, said: “Janssen has a longstanding commitment to address the unmet needs of people living with mental illness. In addition to the previously published clinician-rated efficacy data from the ESCAPE-TRD study, the patient rated PHQ-9 data further confirms the efficacy of esketamine NS compared to quetiapine XR. Incorporating patient-reported endpoints is essential to our collaborative strategies in research and development, driving improved clinical outcomes and patient experiences. Results like these show that choosing the right treatment really matters to people impacted by TRD, who often face treatment failure.”
The 2023 ECNP data announcement follows the recent New England Journal of Medicine publication of the primary manuscript of the ESCAPE-TRD Phase 3b study, demonstrating the superior efficacy of esketamine NS compared to quetiapine XR in achieving remission at Week 8, and remaining relapse-free through Week 32 for patients with TRD.9
