Treatment Response by Age Group in a Phase 3 study of Aripiprazole Lauroxil for Acute Exacerbation of Schizophrenia

January 6, 2017

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Background We conducted an age analysis of treatment outcome in a 12-week study evaluating 441 mg and 882 mg doses of aripiprazole lauroxil (AL; ARISTADA®, Alkermes, Inc.), a long-acting injectable antipsychotic, versus placebo.

Methods Evaluations in the age groups: 18-29 (n=128), 30-39 (n=170), 40-49 (n=165), and 50-69 (n=133) years included mean change in total positive and negative syndrome scale (PANSS) scores (using ANCOVA) and response (defined as ≥30% improvement of total PANSS from baseline).

Results PANSS scores decreased in AL-treated age groups over all study time-points. By ascending age group, the least squares mean difference (standard error) in PANSS score changes from baseline for the placebo, 441 mg and 882 mg arms, respectively, were -9.2 (2.60), -20.3 (3.13) and -19.1 (2.76); -10.0 (2.81), -19.8 (2.46) and -19.2 (2.60); -8.1 (2.48), -20.4 (2.19) and -21.0 (2.23); and -4.9 (2.82), -14.9 (3.21) and -20.1 (3.00). Response for the placebo, 441 mg and 882 mg arms was achieved by 20%, 35% and 41% in the 18-29 year group; 18%, 39% and 28% in the 30-39 year group; 19%, 35% and 33% in the 40-49 year group; and 16%, 32% and 40% in the 50-69 year group. Akathisia was the most common adverse event (frequency ≥5%) that occurred 11.6%, 11.5% and 4.3%, in the 441 mg, 882 mg and placebo arms, respectively.

Conclusion While limited by its post hoc nature, this analysis supports the efficacy of both doses of AL across all 4 adult age groups.

Authors: 
Steven Targum, MD
Robert Risinger, MD
Yangchun Du, PhD
Hassan Jamal, MSc
Bernard Silverman, MD
Sponsoring Organization: 
Alkermes, Inc
Presented By: 
Robert Risinger, MD, Sr. Medical Director, Alkermes, Inc, Waltham, MA
Year: 
2016
Tracks: 
Schizophrenia
Psychotic Disorders