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Weight changes in esketamine nasal spray and quetiapine extended-release treated patients with treatment resistant depression: Results from ESCAPE-TRD study

Published online by Cambridge University Press:  27 August 2024

A. Reif*
Affiliation:
1Goethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt 2Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany
A. Fagiolini
Affiliation:
3Department of Molecular Medicine, University of Siena School of Medicine, Siena, Italy
E. Buntinx
Affiliation:
4Medical Center Anima, Alken, Belgium
H. Ruggeri
Affiliation:
5CEN (Centro especializado en Neurociencias), Córdoba, Argentina
Y. Godinov
Affiliation:
6Janssen EMEA, Sofia, Bulgaria
J. Buyze
Affiliation:
7Janssen Pharmaceutica NV, Beerse, Belgium
S. Mulhern-Haughey
Affiliation:
8Janssen EMEA, Dublin, Ireland
I. Bitter
Affiliation:
9Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary
*
*Corresponding author.

Abstract

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Introduction

In ESCAPE-TRD, esketamine nasal spray (ESK-NS) significantly increased the probability of remission at Week (Wk)8 and being relapse‑free through Wk32 after remission at Wk8 versus (vs) quetiapine extended-release (QTP-XR), in patients (pts) with treatment resistant depression (TRD). Safety data were consistent with established profiles of each treatment, with no new safety signals identified (Reif et al. DGPPN 2022; P-01-04).

Objectives

To explore weight changes and their impact on treatment discontinuation in ESCAPE-TRD.

Methods

ESCAPE‑TRD (NCT04338321) was a randomised, open-label, rater-blinded, phase IIIb trial comparing efficacy and safety of ESK-NS vs QTP-XR in pts with TRD. Safety analyses were conducted on pts who received ≥1 dose of study treatment. Treatment-emergent adverse events (TEAEs) were defined as occurring at or after the first dose of study treatment and within 14 days/30 days (non-serious/serious) of the last dose. A ≥7% increase/decrease in weight from screening was considered for evaluation as a TEAE. Weights were measured and are reported as observed, with no missing data imputation.

Results

336 and 340 pts were randomised to ESK-NS and QTP-XR; 334 and 336 were included in the safety population. Over the 32-week study, a TEAE of weight increase was reported in fewer pts treated with ESK-NS than QTP-XR (9 [2.7%] vs 42 [12.5%]), leading to treatment discontinuation in 0 vs 6 (1.8%) pts, respectively. Incidences of weight increase TEAEs were balanced across pts categorised as normal, overweight or obsese by baseline body mass index (BMI; Figure). A weight decrease TEAE was reported in 7 pts (2.1%) in the ESK-NS arm vs 0 pts in the QTP-XR arm. Mean (standard deviation [SD]) weight at baseline was 76.4 (16.2) kg (ESK-NS; n=334) vs 79.1 (16.9) kg (QTP-XR; n=336). At Wk32, mean weight was maintained (76.5 [16.3] kg) in ESK-NS treated pts (n=249; mean [SD] change from baseline: 0.1 [4.0] kg) and increased (80.7 [15.6] kg) in QTP-XR treated pts (n=203; mean [SD] change from baseline: 2.5 [5.1] kg).

Image:

Conclusions

Increase in weight was uncommon with ESK-NS; weight increases were more common with QTP-XR and resulted in more treatment discontinuations. Weight increase was independent from baseline BMI.

Acknowledgements

We thank the patients who participated. Funding: Janssen, medical writing: Costello Medical, UK

Disclosure of Interest

None Declared

Type
Abstract
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2024. Published by Cambridge University Press on behalf of European Psychiatric Association
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