Safety and Tolerability of bi-monthly Aripiprazole: findings from a real-world descriptive study
T. Prodi, R. Leuzzi, M. C. Angeletti, K. La Monica, R. Anniverno, B. Dell’Osso, M. OlivolaIntroduction
Non-adherence remains one of the major challenges in the treatment of severe and persistent mental disorders. Long-acting injectable (LAI) formulations of antipsychotics may improve adherence and reduce relapse rates. Aripiprazole LAI 960 mg every two months (Q2M) is a novel treatment option designed to simplify management and support continuity of care.
Objectives
Through the present study, we aimed to evaluate the efficacy, safety, and tolerability of bi-monthly aripiprazole in a sample of outpatients with a history of low compliance.
Methods
We conducted a descriptive analysis of a naturalistic sample of 12 patients who switched from oral or monthly LAI aripiprazole to the 960 mg Q2M formulation at ASST FBF Sacco (Milan, Italy). Sociodemographic, clinical, and treatment-related variables were collected, including diagnosis, comorbidities, substance use, hospitalizations, and tolerability.
Results
The sample was evenly distributed by sex (50% female), with a mean age of 29.8 years and a mean duration of untreated psychosis (DUP) of 8.8 years. Half of the patients were diagnosed with schizophrenia spectrum disorders, while 25% had bipolar disorder and 25% personality disorders. Psychiatric comorbidities were present in 50%, and medical comorbidities in 33%. A high prevalence of family psychiatric history (67%) and previous hospitalizations (100%) was observed, with 75% having experienced compulsory admissions (TSO). Most patients (83%) had a history of poor adherence. All had prior exposure to oral and monthly LAI aripiprazole (mainly 400 mg). At baseline with 960 mg Q2M, 66.7% had already received two injections. No adverse events were reported after switching to the bimestral formulation.
Conclusions
This preliminary real-world evidence suggests that switching to aripiprazole LAI 960 mg Q2M is feasible and well-tolerated in a highly complex and non-adherent clinical population. The absence of reported adverse effects, combined with the potential to improve adherence in patients with a severe course of illness, supports further investigation of this treatment option. Larger samples and prospective designs, including clinical scales, are warranted to confirm these encouraging results.
Disclosure of Interest
None Declared