Long-Term Safety and Symptom Trajectory With Aripiprazole Lauroxil in Female Patients With Schizophrenia: A Post Hoc Subgroup Analysis

Abstract: Background: Females are often underrepresented in clinical trials of antipsychotic treatment of schizophrenia. Symptom trajectory and safety outcomes in female patients who received aripiprazole lauroxil (AL) in successive long-term safety trials (EXT-1 and EXT-2) are reported. Methods: Adults with schizophrenia who completed a 12-week AL study or enrolled de novo were eligible to receive open-label AL (441 mg or 882 mg every 4 weeks ) for up to 52 weeks in EXT-1, with the option of continuing into EXT-2 for ≤128 additional weeks. Symptom trajectory was evaluated using Positive and Negative Syndrome Scale (PANSS) total scores; body mass index (BMI), prolactin-related adverse events (AEs), and injection site reactions (ISRs) were also assessed. Results: A total of 203/478 (42.5%) patients in EXT-1 were female (EXT-2, 135/291 [46.4%]). Mean (SD) overall PANSS total score at baseline was 61.5 (14.4). Mean PANSS total scores decreased over EXT-1 and remained stable through EXT-2. When assessed by age (≤40 vs >40 years) and illness severity (Clinical Global Impressions-Severity score ≤3 vs ≥4), patterns of change in females were similar to those in the overall population. Mean BMI was stable in EXT-1; variability increased with decreasing sample size during EXT-2. Rates of ISRs were comparable with those in the overall population. Few prolactin-related AEs were reported; all were mild or moderate in severity. Conclusions: Long-term treatment with AL was safe and effective in females with schizophrenia. Symptom trajectory and safety outcomes in females by age and illness severity were consistent with the overall study population results.Short Description: Because females are underrepresented in clinical trials, safety information specific to this subgroup is lacking. Analyses from 2 open-label extension studies (52 weeks and 128 weeks in duration) reveal that aripiprazole lauroxil (441 mg or 882 mg every 4 weeks) was safe and effective in female patients with schizophrenia during long-term treatment. Results among females analyzed by age and by illness severity were similar to those in the overall study population.Name of Sponsoring Organization(s): This study was funded by Alkermes, Inc. (Waltham, MA, USA). Medical writing and editorial support were provided by Peloton Advantage, LLC (Parsippany, NJ, USA), an OPEN Health company, and funded by Alkermes, Inc.