M. Tocco, United States Minor Outlying Islands
Sunovion Pharmaceuticals Inc. Medical AffairsPresenter of 2 Presentations
O268 - Lurasidone in Adolescents with Schizophrenia: Sustained Remission and Recovery During 2 Years of Open-label Treatment
ABSTRACT
Introduction
Compared with adult onset, early onset schizophrenia is typically characterized by greater illness severity and less favorable prognosis.
Objectives
To evaluate the proportion of adolescent patients with schizophrenia who achieved sustained remission and recovery during 2 years of treatment with lurasidone.
Methods
Patients aged 13-17 years with a DSM-IV-TR diagnosis of schizophrenia, and a Positive and Negative Symptom Scale (PANSS) total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB), fixed-dose treatment with lurasidone (37 or 74 mg/d) or placebo. Patients who completed 6 weeks of DB treatment were eligible to enroll in a 2-year, open-label (OL), flexible dose extension study of lurasidone (18.5-74 mg/d). Criteria for sustained remission, were the 6-month consensus criteria summarized by Andreasen (Am J Psych 2005;162:441-9). Criteria for sustained recovery consisted of meeting sustained remission criteria with a Children’s Global Assessment Scale (CGAS) score ≥70 for at least 6-months indicating no clinically significant functional impairment.
Results
A total of 271 patients completed the 6-week DB study and entered the extension study, and 186 (68.6%) and 156 (57.6%) completed 52 weeks and 104 weeks of treatment, respectively. During OL treatment with lurasidone, 52.8% met sustained remission criteria, with a Kaplan-Meier (KM) estimate of 64.1 weeks for median time to sustained remission; and 28.8% met sustained recovery criteria, KM estimate of 104.6 weeks for median time to sustained recovery.
Conclusions
For adolescents with schizophrenia, treatment with lurasidone was associated with high rates of sustained remission and sustained recovery over a two-year period.
O269 - Efficacy and Safety of Lurasidone in Adolescents and Young Adults with Schizophrenia: Pooled Analysis of Double-blind, Placebo-controlled 6-Week Studies
ABSTRACT
Introduction
Onset of schizophrenia commonly occurs during late adolescence or early adulthood and is often characterized by greater symptom severity and impairment.
Objectives
To evaluate the efficacy and safety of lurasidone in the treatment of acute schizophrenia in adolescents and young adults.
Methods
The 4 studies in this pooled analysis used similar study designs. Patients (ages 13-25 years) were randomized to 6 weeks of double-blind, placebo-controlled treatment with once-daily lurasidone (37 mg, 74 mg, 111 mg, 148 mg). The primary outcome was endpoint change in the Positive and Negative Syndrome Scale (PANSS) total score; secondary measures included the Clinical Global Impression, Severity scale (CGI-S).
Results
The safety population consisted of 537 patients; 79.1% completed the studies. Treatment with lurasidone was significant (P<0.001) at Week 6 endpoint for change in the PANSS total score, with higher effect sizes (ES) at higher doses (37 mg, 0.53; 74 mg, 0.57; 111 mg, 0.67; 148 mg, 1.35); significance was also observed for change in the CGI-S (37 mg, 0.51; 74 mg, 0.49; 111 mg, 0.57; 148 mg, 1.75). For lurasidone (combined doses), 3 adverse events occurred with a frequency ≥5% (nausea, 13.5%; somnolence, 12.1%; akathisia, 10.1%); 4.8% of patients discontinued due to an adverse event. At LOCF-endpoint, 3.6% of patients had weight gain ≥7%, and 1.5% had weight loss ≥7%. Minimal median changes were observed at endpoint in metabolic lab values.
Conclusions
In adolescents and young adults with schizophrenia, treatment with lurasidone in doses of 37-148 mg/d was a safe, well-tolerated, and effective treatment.