Off–label long acting injectable antipsychotics in real–world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

Abstract

Introduction Information on the off–label use of Long–Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on– vs off–label LAIs and predictors of off–label First– or Second–Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off– or on–label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off–label group. Results SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on– and off–label use. Approximately 1 in 4 patients received an off–label prescription. In the off–label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off–label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co–morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns.

Effect of long-acting injectable antipsychotics on hospitalizations and global functioning in schizophrenia: a naturalistic mirror-image study

“…A recent study performed by D’Agostino and colleagues 45 aimed to identify predictors of FGA-LAI or SGA-LAI choice in everyday clinical practice and found that FGA-LAIs were generally privileged in case of hostility, whereas SGA-LAIs are generally preferred in patients with more severe thought disturbances, but it confirmed that the rest of the literature on this topic is poor and sometimes conflicting.…”

“…43 A largest double-blind RCT (n = 290) found no significant differences at 24 months in psychiatric hospitalization for paliperidone palmitate (149 mg mean monthly dosage) compared to haloperidol decanoate (75 mg mean monthly dosage). 44 A recent study performed by D'Agostino and colleagues 45 aimed to identify predictors of FGA-LAI or SGA-LAI choice in everyday clinical practice and found that FGA-LAIs were generally privileged in case of hostility, whereas SGA-LAIs are generally preferred in patients with more severe thought disturbances, but it confirmed that the rest of the literature on this topic is poor and sometimes conflicting.…”

Long-acting injectable antipsychotics for the treatment of bipolar disorder: evidence from mirror-image studies

“… 13 – 15 Although LAIs represent a widely used off-label therapeutic option for BD, no LAI has been recommended by the EMA, while only risperidone microspheres (RM) and aripiprazole monohydrate (AM) are approved by the FDA for BD maintenance treatment. 16 …”