Off–label long acting injectable antipsychotics in real–world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study
Authors: D’Agostino Armando , Aguglia Andrea , Barbui Corrado , Bartoli Francesco , Carrà Giuseppe , Cavallotti Simone , Chirico Margherita , Ostinelli Edoardo G. , Zangani Caroline , Martinotti Giovanni , Ostuzzi Giovanni ,   STAR Network Depot Investigators, Barbui Corrado , Nosè Michela , Purgato Marianna , Turrini Giulia , Ostuzzi Giovanni , Mazzi Maria Angela , Papola Davide , Gastaldon Chiara , Terlizzi Samira , Bertolini Federico , Piccoli Alberto , Ruggeri Mirella , De Fazio Pasquale , Magliocco Fabio , Caroleo Mariarita , Raffaele Gaetano , D’Agostino Armando , Ostinelli Edoardo Giuseppe , Chirico Margherita , Cavallotti Simone , Bergamelli Emilio , Zangani Caroline , Lucii Claudio , Bolognesi Simone , Debolini Sara , Pierantozzi Elisa , Fargnoli Francesco , Del Zanna Maria , Giannini Alessandra , Luccarelli Livia , De Capua Alberto , Annese Pasqua Maria , Cerretini Massimiliano , Tozzi Fiorella , Magnani Nadia , Cardamone Giuseppe , Bardicchia Francesco , Facchi Edvige , Soscia Federica , Zotos Spyridon , Biancosino Bruno , Zonta Filippo , Pompei Francesco , Callegari Camilla , Zizolfi Daniele , Poloni Nicola , Ielmini Marta , Caselli Ivano , Giana Edoardo , Buzzi Aldo , Diurni Marcello , Milano Anna , Sani Emanuele , Calzolari Roberta , Bortolaso Paola , Piccinelli Marco , Cazzamalli Sara , Alberini Gabrio , Piantanida Silvia , Costantini Chiara , Paronelli Chiara , Di Caro Angela , Moretti Valentina , Gozzi Mauro , D’Ippolito Chiara , Barbanti Silva Veronica , Alessandro Papalini , Corbo Mariangela , Martinotti Giovanni , Campese Ornella , Fiori Federica , Lorusso Marco , Di Capro Lucia , Viceconte Daniela , Mancini Valerio , Suraniti Francesco , Signorelli Maria Salvina , Rossi Eugenio , Lupoli Pasqualino , Menchetti Marco , Terzi Laura , Boso Marianna , Risaro Paolo , De Paoli Giuseppe , Catania Cristina , Tarricone Ilaria , Caretto Valentina , Storbini Viviana , Emiliani Roberta , Balzarro Beatrice , Carrà Giuseppe , Bartoli Francesco , Tabacchi Tommaso , Nava Roberto , Bono Adele , Provenzi Milena , Brambilla Giulia , Aspesi Flora , Trotta Giulia , Tremolada Martina , Castagna Gloria , Bava Mattia , Verrengia Enrica , Lucchi Sara , Oriani Maria Ginevra , Barchiesi Michela , Pacetti Monica , Aguglia Andrea , Amerio Andrea , Amore Mario , Serafini Gianluca , Magni Laura Rosa , Rossi Giuseppe , Beneduce Rossella , Tura Giovanni Battista , Laffranchini Laura , Mastromo Daniele , Ferrato Farida , Restaino Francesco , Monzani Emiliano , Porcellana Matteo , Limosani Ivan , Ghio Lucio , Ferro Maurizio , Parise Vincenzo Fricchione , Balletta Giovanni , Addeo Lelio , De Vivo Elisa , Di Benedetto Rossella , Pinna Federica , Carpiniello Bernardo , Spano Mariangela , Giacomin Marzio , Pecile Damiano , Mattei Chiara , Fabrici Elisabetta Pascolo , Panarello Sofia , Peresson Giulia , Vitucci Claudio , Bonavigo Tommaso , Pacetti Monica , Perini Giovanni , Boschello Filippo , Strizzolo Stefania , Gardellin Francesco , di Giannantonio Massimo , Moretti Daniele , Fizzotti Carlo , Cossetta Edoardo , Di Gregorio Luana , Sozzi Francesca , Boncompagni Giancarlo , La Barbera Daniele , Colli Giuseppe , Laurenzi Sabrina , Calandra Carmela , Luca Maria 
Published: June 2022

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.