The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies
Authors Peters-Strickland T, Baker RA, Such P, Zhang P, Madera JJ
Received 14 December 2018
Accepted for publication 16 May 2019
Published 24 June 2019 Volume 2019:15 Pages 1659—1669
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Dr Roger Pinder
Timothy Peters-Strickland,1 Ross A Baker,2 Pedro Such,3 Peter Zhang,4 Jessica J Madera2
1Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 3Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 4Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Objective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®,) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.
Methods: Post hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).
Results: In Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; P=0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; P=0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7–10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.
Conclusion: AOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.
Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophrenia, patient function, psychosocial function
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