Key Takeaways
Extended Takeaways
- For stable outpatients with schizophrenia, the less frequent schedule did not lead to more dropouts in this 32-week trial; study completion was 79.3% (73/92 patients) with Ari 2MRTU 960 versus 67.7% (63/93 patients) with AOM 400 (P = .0954).
- Injection tolerability was favorable despite the larger 3.2 mL gluteal injection volume for Ari 2MRTU 960 versus 2.0 mL for AOM 400: injection site pain occurred in 15.2% of patients (14/92) versus 9.7% of patients (9/93) (P = .2740), all within 2 days, and mean (SD) VAS pain scores fell from 3.9 (9.96) after the first injection to 1.5 (4.58) after the last injection.
- Weight gain was common with both aripiprazole LAIs, so metabolic monitoring remains important even in clinically stable patients; potentially clinically significant weight gain of ≥ 7% was reported in 39.7% of patients in the Ari 2MRTU 960 group and in 38.1% of patients in the AOM 400 group (P = .8619).
- Extrapyramidal burden was similar across formulations, with motoric TEAEs in 15.2% of patients (14/92) on Ari 2MRTU 960 and in 11.8% of patients (11/93) on AOM 400 (P = .5265); akathisia was the most frequent event at 8.7% of patients (8/92) and 7.5% of patients (7/93), respectively.
- This study supports Ari 2MRTU 960 as a maintenance option rather than an acute-stabilization strategy: participants were already clinically stable, and PANSS, CGI-S, SWN-S, and CGI-I showed minimal change over 32 weeks rather than symptomatic improvement.
- When transitioning from oral antipsychotics, clinicians should note the different oral overlap requirements used in the trial: 7 days after the first administration of Ari 2MRTU 960 versus 14 days after the first administration of AOM 400, with no oral overlap for participants stabilized on AOM 400.
