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Use and experience of Italian healthcare professionals with aripiprazole once-monthly 400mg two-injection start initiation regimen in adult patients with schizophrenia

Published online by Cambridge University Press:  26 August 2025

C. Beckham*
Affiliation:
Otsuka Pharmaceutical Europe Ltd., Berkshire, United Kingdom
M. Yildirim
Affiliation:
H. Lundbeck A/S, Valby, Denmark
S. Pappa
Affiliation:
Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, United Kingdom
K. Leopold
Affiliation:
Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Hospital am Urban and Vivantes Hospital im Friedrichshain, Charite, Universitätsmedizin, Berlin Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany
W. J. Cottam
Affiliation:
Real-World Evidence, OPEN Health, London, United Kingdom
J. Hickey
Affiliation:
Real-World Evidence, OPEN Health, London, United Kingdom
O. Rogerson
Affiliation:
Real-World Evidence, OPEN Health, London, United Kingdom
A. Fagiolini
Affiliation:
Università Di Siena, Siena, Italy
*
*Corresponding author.

Abstract

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Introduction

Aripiprazole once monthly 400mg (AOM400) is a long-acting injectable (LAI) available as a two-injection start initiation regimen (AOM400-TIS) for the maintenance treatment of adult patients with schizophrenia stabilised with oral aripiprazole.

Objectives

This survey sought to explore HCPs’ perspectives and attitudes towards prescribing and/or administering AOM400-TIS according to the European label in clinical practice (including reasons for its use, potential benefits, and common barriers and/or concerns) across Europe.

Methods

HCPs who had prescribed and/or administered the AOM400-TIS regimen to ≥3 patients with schizophrenia were invited to participate in an online survey. The survey was launched in two waves across the target countries (wave 1: Italy, Germany, United Kingdom; wave 2: Denmark, Italy, Sweden). Analysis was descriptive; data was collected between February 1–March 21, 2024 (wave 1) and September 16-October 28 (wave 2). Data from Italian HCPs are presented.

Results

31 HCPs from the 1st wave and 64 from the 2nd wave completed the survey including psychiatrists (69%), psychiatric nurses (23%), community nurses (4%) and general practitioners/primary care practitioners (1%). HCPs estimated 30.0% (median; IQR: 20.0–50.0) of patients in their caseload were diagnosed with schizophrenia, and of these, 45.0% were treated with LAIs (median; IQR: 25.0–62.5). 47% of HCPs were primarily responsible for prescribing AOM400-TIS, 24% for administering it, and 28% were responsible for both. HCPs estimated that 44% of patients typically spent up to 14 days on oral aripiprazole prior to AOM400-TIS, with HCPs rating the severity of symptoms of patients initiated with AOM400-TIS as mild (22% of HCPs), moderate (68% of HCPs) and severe (40% of HCPs). The most common reasons for initiating AOM400-TIS after transitioning from oral aripiprazole were poor adherence (80%) and patient preference (49%), and the most reported goals for prescribing AOM400-TIS were to improve adherence (75%) and prevent relapses (69%). Common barriers to the use of AOM400-TIS were patient reluctance to receive two injections (39%), concerns about tolerability (24%), safety of administering a high dose in a single day (23%). Prior treatment adherence (54%) and efficacy (46%) were the most cited factors influencing prescribing of AOM400-TIS. Overall, HCPs “agreed”, or “strongly agreed”, that AOM400-TIS was easy to administer (81%) and that it had a similar safety/tolerability profile to the single injection start regimen (69%), while the majority were satisfied with patient outcomes with AOM400-TIS (83%).

Conclusions

Overall, Italian HCPs with experience of using AOM400-TIS reported that it is easy to administer, well tolerated and improves treatment outcomes, while barriers to its use include patient reluctance and perceived safety concerns.

Disclosure of Interest

C. Beckham Employee of: Clodagh Beckham is a full-time employee of Otsuka Pharmaceutical Europe Ltd., Berkshire, UK., M. Yildirim Employee of: Murat Yildirim is a full-time employee of H.Lundbeck A/S, Valby, Copenhagen., S. Pappa Grant / Research support from: Recordati, Janssen, Consultant of: Lundbeck, Janssen, Otsuka, Recordati, Rovi, Gedeon Richter, Sunovion., Speakers bureau of: Lundbeck, Janssen, Otsuka, Recordati, Rovi, Gedeon Richter, Sunovion., K. Leopold Grant / Research support from: Janssen, Otsuka, Consultant of: Boehringer Ingelheim, Lundbeck, Janssen, Otsuka Recordati, ROVI, Speakers bureau of: Boehringer Ingelheim, Lundbeck, Janssen, Otsuka Recordati, ROVI, W. Cottam Employee of: Will Cottam is a full-time employee of OPEN Health (London)., J. Hickey Employee of: Joe Hickey is a full-time employee of OPEN Health (London)., O. Rogerson Employee of: Olivia Rogerson is a full-time employee of OPEN Health (London)., A. Fagiolini Grant / Research support from: Angelini, Boehringer Ingelheim, Lundbeck, Janssen, Otsuka, Pfizer, Recordati, Viatris, Consultant of: Angelini, Boehringer Ingelheim, Idorsia, Italfarmaco, Lundbeck, Janssen, Medicamenta, Mylan, Otsuka, Pfizer, Recordati, Rovi, Sunovion, Teva, Viatris

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Abstract
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Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of European Psychiatric Association
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