Estimating the Benefit of Esketamine Nasal Spray Versus Real-World Treatment on Patient-Reported Functional Remission: Results From the Iceberg Study
Author(s)
Oliveira-Maia A1, Rive B2, Morrens J3, Godinov Y4, Mulhern-Haughey S5
1Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisbon, Portugal, and NOVA Medical School, NMS, Universidade Nova de Lisboa, Lisbon, Portugal, Lisbon, Portugal, 2Janssen EMEA, Paris, France, 3Janssen EMEA, Beerse, Belgium, 4Janssen EMEA, Sofia, Bulgaria, 5Janssen EMEA, Dublin , Ireland
Presentation Documents
OBJECTIVES: Treatment resistant depression (TRD) affects 10–30% of patients with major depressive disorder; most patients do not respond to real‑world treatments (RWT).1 Esketamine nasal spray (NS), in combination with a selective serotonin or serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), was recently approved for treatment of TRD. Esketamine NS has demonstrated significant benefit on response and remission versus RWT strategies;2 benefit on daily function remains to be established.
METHODS: An indirect treatment comparison (ITC) study (ICEBERG) was performed using data from two studies of patients with TRD: SUSTAIN-2 (an open-label study of esketamine NS plus SSRI/SNRI) and the European Observational TRD cohort (EOTC; a prospective, non-interventional study in real-world practice). Both studies defined TRD as failure of ≥2 treatments in the current depressive episode. Functional remission was defined as a total Sheehan Disability Scale (SDS) score ≤6, at Month 6. Analyses were conducted using propensity score re‑weighting based on 17 covariates.
RESULTS: Baseline characteristics were similar across studies, including mean (standard deviation) SDS: 22.5 (5.0) for patients receiving esketamine NS (n=512) and 22.0 (5.5) for RWT (n=226). At Month 6, the probability of functional remission was 25.6% (95% confidence interval [CI] 21.8–29.4) in patients receiving esketamine NS and the adjusted probability for RWT was 12.0% (95% CI 7.3–16.6). The risk difference favoured esketamine NS over RWT for 6-month functional remission (0.136 [95% CI 0.076–0.196], p<0.0001); the number needed to treat was 8 (95% CI 6–14). Results were similar across sensitivity analyses and using alternative re-weighting comparisons.
CONCLUSIONS: This ITC suggests esketamine NS has a significant functional benefit over 6 months versus RWT for patients with TRD. Following adjustment for multiple covariates, consistent results demonstrate robustness of the comparison.
ACKNOWLEDGEMENTS: Editorial services (Costello Medical) and study funded by Janssen.
REFERENCES: 1Heerlein, K (2021). JAD; 290:334–44. 2Morrens, J (2021). Eur Neuropsychopharmacol; 53(S1):S162–3.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
CO151
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas