Home > Psychiatry > ECNP 2021 > Mood Disorders > Esketamine outperforms real-world management for treatment-resistant depression: preliminary results

Esketamine outperforms real-world management for treatment-resistant depression: preliminary results

Presented by
Mr Joachim Morrens , Janssen EMEA, Belgium
ECNP 2021
Phase 3, SUSTAIN-2; EOTC

Esketamine nasal spray is more beneficial than real-world management for treatment-resistant depression (TRD) in general psychiatry, according to preliminary findings of an indirect comparison of these 2 approaches. Adjustment for multiple covariates and several sensitivity analyses did not substantially alter the results [1].

Esketamine nasal spray was recently approved by the EMA in combination with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for the treatment of treatment-resistant depression [2]. To evaluate the relative effectiveness of esketamine versus real-world treatment strategies for TRD, Mr Joachim Morrens (Janssen EMEA, Belgium) and colleagues performed an indirect treatment comparison of data from 2 studies. The first study was SUSTAIN-2 (NCT02497287), a long-term, open-label study of the safety and efficacy of esketamine nasal spray in combination with a newly initiated antidepressant. The SUSTAIN-2 results were compared with those of the European Observational Treatment-resistant Depression cohort (EOTC; NCT03373253), a prospective, non-interventional, multicentre study of patients starting a new, routine treatment-resistant depression treatment. The 2 studies shared the same definition of treatment-resistant depression (i.e. failure of ≥2 previous treatments) and had similar recruitment conditions and follow-up time. Treatment response and remission after 6 months were compared.

Mr Morrens presented the preliminary results. Patients receiving esketamine had an adjusted odds ratio (OR) for treatment response of 4.38 (95% CI 3.16–6.09; P<0.0001) versus real-world treatment, with a relative risk (RR) of 2.80 (2.32–3.29) and a risk difference (RD) of 0.30 (0.22–0.38). The adjusted OR for remission was 3.34 (2.31–4.83; P<0.0001), with a RR of 2.64 (2.01–3.38), and an RD of 0.18 (0.11–0.27).

The estimated probability of response was 0.47 (0.43–0.51) for esketamine and 0.17 (0.13–0.21) for real-world treatment. The estimated probability of remission was 0.32 (0.28–0.35) and 0.12 (0.09–0.16), respectively. Applying 27 different sensitivity analyses consistently yielded similar results. The results must be interpreted with caution, due to limitations of pooling data from different sources.

  1. Morrens J, et al. Indirect comparison estimating the benefit of esketamine compared to real-world treatment of treatment-resistant depression in general psychiatry: preliminary analysis. P.0225, ECNP 2021 Congress, 2–5 October.
  2. European Medicines Agency 2021. Spravato EPAR Product Characteristics.

Copyright ©2021 Medicom Medical Publishers

Posted on