Clinical Summary: Safety and Efficacy of Aripiprazole 2-Month Ready-to-Use 960 mg: Secondary Analysis of Outcomes in Adult Patients With Schizophrenia in a Randomized, Open-label, Parallel-Arm, Pivotal Study
For adults with schizophrenia who struggle with long-term adherence, a 2-month long-acting injectable can reduce dosing frequency only if it maintains stability without adding tolerability problems. This analysis focuses on clinically stable patients with schizophrenia and addresses whether aripiprazole 2-month ready-to-use 960 mg performs comparably to aripiprazole once-monthly 400 mg over maintenance treatment.
Key Findings
- Study completion rate was 79.3% (73/92 patients) in the Ari 2MRTU 960 group and 67.7% (63/93 patients) in the AOM 400 group (P = .0954).
- Overall, 64.9% of patients with schizophrenia (120/185) experienced treatment-emergent AEs, including 66.3% (61/92) in the Ari 2MRTU 960 group and 63.4% (59/93) in the AOM 400 group; serious TEAEs occurred in 5 patients in each treatment group.
- Potentially clinically significant weight gain of ≥ 7% at the end of the study was reported in 39.7% of patients in the Ari 2MRTU 960 group (29 of the 73 patients for whom post-baseline weight assessment data were available) and in 38.1% of patients in the AOM 400 group (24 of the 63 patients for whom post-baseline weight assessment data were available; P = .8619).
- Injection site pain was experienced by 15.2% of patients (14/92) in the Ari 2MRTU 960 group and 9.7% of patients (9/93) in the AOM 400 group (P = .2740); mean (SD) VAS scores were 3.9 (9.96) following the first injection and 1.5 (4.58) following the last injection with Ari 2MRTU 960 versus 2.9 (5.40) and 1.3 (2.79) with AOM 400, with no significant between-group difference after the first injection (P = .3859) or last injection (P = .7427).
- Motoric TEAEs were reported in 15.2% of patients (14/92) in the Ari 2MRTU 960 group and in 11.8% of patients (11/93) in the AOM 400 group (P = .5265); akathisia was the most frequently observed motoric adverse event, reported in 8.7% of patients (8/92) and 7.5% of patients (7/93), respectively.
For clinically stable adults with schizophrenia, Ari 2MRTU 960 maintained symptomatic stability over 32 weeks with safety and tolerability comparable to AOM 400. The every-2-month formulation offers a lower-frequency maintenance option without a signal of worse injection tolerability, extrapyramidal burden, or overall adverse events in this study.
Practice Implications
- Consider Ari 2MRTU 960 as a maintenance option for clinically stable patients with schizophrenia who want fewer injections, noting that efficacy measures showed minimal change from baseline through week 32 in both groups.
- Monitor weight closely with either aripiprazole LAI, because potentially clinically significant weight gain of ≥ 7% occurred in 39.7% of Ari 2MRTU 960-treated patients and 38.1% of AOM 400-treated patients.
- Counsel patients that injection site pain was uncommon and generally low in intensity, with all events occurring within 2 days of injection and mean VAS pain scores remaining low after both the first and last injections.
- When initiating from oral antipsychotic treatment, follow the overlap approach used in the trial: 7 days after the first administration of Ari 2MRTU 960 and 14 days after the first administration of AOM 400; there was no oral overlap for participants stabilized on AOM 400.
