Abstracts
3427191
(#18) Rapid and Sustained Remission With Esketamine Nasal Spray in Adult Patients With Treatment-Resistant Depression: Overview of Remission Rates From Six Clinical Trials
Abstract: Introduction: Attaining remission in patients with treatment-resistant depression (TRD) reduces risk for relapse, improves functioning, and reduces morbidity and mortality. Esketamine nasal spray (ESK) is approved for the treatment of adults with TRD as monotherapy or in combination with an oral antidepressant (OAD). Here, we provide an overview of remission data from ESK TRD clinical trials.
Methods: Data were analyzed from two placebo nasal spray (PBO)-controlled ESK trials (TRD4005 [NCT04599855]; TRANSFORM-2 [NCT02418585]), one active-controlled trial (ESCAPE-TRD [NCT04338321]), and three open-label trials (ESCAPE-LTE [NCT04829318]; SUSTAIN-2 [NCT02497287]; SUSTAIN-3 [NCT02782104]). Remission was defined as Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤12.
Results: In TRD4005, remission rates at week 4 were 7.7%, 15.3%, and 22.8%, with PBO, ESK 56 mg, and ESK 84 mg respectively. In TRANSFORM-2, remission rates were 31.0% (PBO+OAD) versus 52.5% (ESK+OAD) at week 4. In the ESCAPE-TRD trial, remission rates were 24.4% (quetiapine XR+OAD) versus 40.4% (ESK+OAD) at week 8 and 46.3% versus 65.1%, respectively, at week 32. In the long-term extension of ESCAPE-TRD, 86.8% of patients receiving ESK+OAD attained remission at week 136. Remission rates with ESK+OAD in open-label trials were 56.5% at OP/MA endpoint (week 48: SUSTAIN-2) and 49.4% at OP/MA endpoint (year 6: SUSTAIN-3). Remission rates based on MADRS total score ≤10 will also be presented.
Conclusion: Rapid and sustained remission was observed as early as the post-baseline assessment across six TRD studies with ESK, administered as monotherapy or in combination with an OAD, supporting remission as an attainable treatment goal for patients with TRD.
Short Description: Esketamine nasal spray, as monotherapy or in combination with an oral antidepressant, resulted in rapid and sustained remission (MADRS total score ≤12) in patients with treatment-resistant depression in two placebo-controlled trials (15.3% to 52.5% [week 4]), one active-controlled trial (40.4% and 65.1% at weeks 8 and 32, respectively) and three open-label trials (56.5%, 86.8%, and 49.4% at weeks 48, 136, and year 6, respectively), supporting remission as an attainable treatment goal.
Name of Sponsoring Organization(s): Johnson & Johnson
Methods: Data were analyzed from two placebo nasal spray (PBO)-controlled ESK trials (TRD4005 [NCT04599855]; TRANSFORM-2 [NCT02418585]), one active-controlled trial (ESCAPE-TRD [NCT04338321]), and three open-label trials (ESCAPE-LTE [NCT04829318]; SUSTAIN-2 [NCT02497287]; SUSTAIN-3 [NCT02782104]). Remission was defined as Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤12.
Results: In TRD4005, remission rates at week 4 were 7.7%, 15.3%, and 22.8%, with PBO, ESK 56 mg, and ESK 84 mg respectively. In TRANSFORM-2, remission rates were 31.0% (PBO+OAD) versus 52.5% (ESK+OAD) at week 4. In the ESCAPE-TRD trial, remission rates were 24.4% (quetiapine XR+OAD) versus 40.4% (ESK+OAD) at week 8 and 46.3% versus 65.1%, respectively, at week 32. In the long-term extension of ESCAPE-TRD, 86.8% of patients receiving ESK+OAD attained remission at week 136. Remission rates with ESK+OAD in open-label trials were 56.5% at OP/MA endpoint (week 48: SUSTAIN-2) and 49.4% at OP/MA endpoint (year 6: SUSTAIN-3). Remission rates based on MADRS total score ≤10 will also be presented.
Conclusion: Rapid and sustained remission was observed as early as the post-baseline assessment across six TRD studies with ESK, administered as monotherapy or in combination with an OAD, supporting remission as an attainable treatment goal for patients with TRD.
Short Description: Esketamine nasal spray, as monotherapy or in combination with an oral antidepressant, resulted in rapid and sustained remission (MADRS total score ≤12) in patients with treatment-resistant depression in two placebo-controlled trials (15.3% to 52.5% [week 4]), one active-controlled trial (40.4% and 65.1% at weeks 8 and 32, respectively) and three open-label trials (56.5%, 86.8%, and 49.4% at weeks 48, 136, and year 6, respectively), supporting remission as an attainable treatment goal.
Name of Sponsoring Organization(s): Johnson & Johnson
