ICEBERG study: an indirect adjusted comparison estimating the long-term benefit of esketamine nasal spray when compared with routine treatment of treatment resistant depression in general psychiatry

Autor: Albino J. Oliveira-Maia, Joachim Morrens, Benoit Rive, Yordan Godinov, Jedelyn Cabrieto, Nolen Perualila, Sebastien Barbreau, Siobhán Mulhern-Haughey
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Frontiers in Psychiatry, Vol 14 (2023)
Druh dokumentu: article
ISSN: 1664-0640
DOI: 10.3389/fpsyt.2023.1250980
Popis: BackgroundTreatment resistant depression (TRD) affects 10–30% of patients with major depressive disorder. In 4-week trials, esketamine nasal spray (NS) was efficacious vs. placebo when both were initiated in addition to a new selective serotonin or serotonin norepinephrine reuptake inhibitor. However, comparison with an extended range of real-world treatments (RWT) is lacking.MethodsICEBERG was an adjusted indirect treatment comparison using propensity score-based inverse probability weighting, performed on 6-month response and remission data from patients receiving esketamine NS plus oral antidepressant from the SUSTAIN-2 (NCT02497287; clinicaltrials.gov) study, compared with patients receiving other RWT from the European Observational TRD Cohort (EOTC; NCT03373253; clinicaltrials.gov) study. SUSTAIN-2 was a long-term open-label study of esketamine NS, while the EOTC was conducted at a time when esketamine NS was not available as RWT. Threshold and sensitivity analyses were conducted to assess how robust the primary analyses were.ResultsPatients receiving esketamine NS had a higher probability of 6-month response (49.7% [95% confidence interval (CI) 45.6–53.9]) and remission (33.6% [95% CI 29.7–37.6]) vs. patients receiving RWT (26.4% [95% CI 21.5–31.4] and 18.2% [95% CI 13.9–22.5], respectively), according to rescaled average treatment effect among treated estimates. Resulting adjusted odds ratios (OR) and relative risk (RR) favoured esketamine NS over RWT for 6-month response (OR 2.756 [95% CI 2.034–3.733], p
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