THE EFFECT OF LURASIDONE ON FUNCTIONAL REMISSION AMONG PATIENTS WITH BIPOLAR DEPRESSION
Author(s)
Hassan M1, Dansie E2, Rajagopalan K1, Wyrwich K2, Loebel A3, Pikalov A1
1Sunovion Pharmaceuticals, Inc., Marlborough, MA, USA, 2Evidera, Bethesda, MD, USA, 3Sunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA
OBJECTIVES: Bipolar depression is characterized by depressive symptoms and impairment in many areas of functioning, including work, family, and social life. There is continuing need for treatment options that provide remission in symptoms and functioning. The efficacy of lurasidone on symptom remission of bipolar depression has been demonstrated previously. The objective of this study was to assess the effect of lurasidone on functional remission. METHODS: Post-hoc analysis of a 6-week, randomized, double-blind, placebo-controlled clinical trial of lurasidone (20–60 mg or 80-120 mg) versus placebo was conducted. Functioning was measured using the Sheehan Disability Scale (SDS), a validated patient-reported outcome measure assessing functioning in terms of work/school, family, and social life (higher scores indicate lower functioning). Functional remission (defined as SDS total score ≤6) was compared between lurasidone and placebo groups using logistic regressions. RESULTS: In this 6-week trial (N=485), few participants were in functional remission at baseline (1.7%). The mean change in SDS total score from baseline to study endpoint was -10.4 (SD = 7.49) in the lurasidone group and -7.1 (SD = 8.27) in the placebo group. A greater percentage of participants on lurasidone achieved functional remission in comparison to placebo (40.9% vs. 25.5%, p=0.01) at week 6; the functional remission rate was similar for participants receiving lurasidone 20-60 mg and lurasidone 80-120 mg group (41.1% and 40.6%, respectively). Controlling for baseline SDS total score and study center, the adjusted odds ratio for functional remission among participants receiving lurasidone versus placebo was 3.96 (p<0.01, 95% CI [1.72, 9.13]) in the 20-60 mg lurasidone group and 2.46 (p=0.52, 95% CI [1.12 - 5.43]) in the 80-120 mg lurasidone group. CONCLUSIONS: This post-hoc analysis of a lurasidone pivotal trial showed statistically significant improvement in functional remission within 6-week study duration among patients with bipolar depression treated with lurasidone compared to placebo.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PMH9
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Mental Health