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Study shows long-term efficacy of Aristada for schizophrenia
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Efficacy of Aristada continued for 1 year among individuals successfully treated for an acute episode of schizophrenia, according to recent findings.
“Studies associated with seeking FDA approval of a drug tend to be shorter-term studies that are either open-label, not blinded or allow for flexible dosing,” Joseph P. McEvoy, MD, study researcher with Augusta University, Georgia, told Healio.com/Psychiatry. “This study asked a rigidly structured question about two doses of Aristada, 441 mg and 882 mg, and randomized individuals to those doses, blinded, without clinician-adjustment through a year-long extension.”
To assess durability of therapeutic effect of long-term Aristada (aripiprazole lauroxil, Alkermes) among patients with schizophrenia successfully treated for an acute psychotic episode, researchers conducted post-hoc analysis among participants who completed a 52-week extension study after a 12-week placebo-controlled randomized clinical trial.
Durability of effect was determined by the proportion of participants who completed a 1-year course of aripiprazole lauroxil, the trajectories of the Positive and Negative Syndrome Scale (PANSS) total and the Clinical Global Impression-Severity (CGI-S) item scores beyond the first 12 weeks, and remission likelihood at any follow-up point, according to study methodology.
Overall, 73% of participants who received 441-mg aripiprazole lauroxil and 66% of those who received 882-mg aripiprazole lauroxil completed all 13 aripiprazole treatments every 4 weeks for 1 year.
Both dosage groups continued to exhibit positive symptom improvements, as shown by PANSS total and CGI-S scores (P < .001 for both).
Overall, 74% of participants who received 441-mg aripiprazole lauroxil and 68% of those who received the 882-mg dose achieved remission during follow-up.
“For clinicians, these findings indicate that if they have started a patient on 441 mg or 882 mg of Aristada, and the patient had a good outcome, they can expect that to continue, regardless of dose,” McEvoy said. “If a patient is receiving 882 mg, clinicians may want to use the option to stretch the dosing out to every 6 weeks instead of every 4 weeks. There is evidence this will hold patients in remission with good, well-tolerated outcomes.”
Further, aripiprazole lauroxil is “as effective as the very best frontline antipsychotics” and can be given at a higher dose than necessary without additional risk for side effects, according to McEvoy. – by Amanda Oldt
Disclosures: McEvoy reports receiving consulting fees, honoraria and/or grants from Alkermes, Avanir, Boehringer Ingelheim, Neurocrine, Otsuka and Teva. Please see the study for all other authors’ relevant financial disclosures.