Effect of Paliperidone Palmitate 3-Month Formulation on Goal Attainment and Disability After 52 Weeks’ Treatment in Patients with Clinically Stable Schizophrenia

Martin Lambert,1 Pedro Sanchez,2,3 Paul Bergmans,4 Srihari Gopal,5 Maju Mathews,6 Annette Wooller,7 Katalin Pungor8 1Centre for Psychosis and Integrated Care, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 2Treatment Resistant Psychosis Unit, Hospital Psiquiatrico De Álava, Osakidetza, Vitoria, Spain; 3School of Medicine, University of Deusto, Bilbao, Spain; 4Janssen-Cilag B.V., Biostatistics, Breda, Netherlands; 5Janssen R&D LLC, Titusville, NJ, USA; 6Janssen Pharma, Global Medical Affairs, New York City, NY, USA; 7Janssen, Medical Affairs EMEA, High Wycombe, UK; 8Janssen Medical Affairs EMEA, Janssen-Cilag GmbH. Johnson and Johnson Platz 1, 41470 Neuss, GermanyCorrespondence: Katalin Pungor Tel +491724463940Email kpungor@its.jnj.comPurpose: This pragmatic clinical study aimed to assess goal attainment among patients with schizophrenia treated with paliperidone palmitate 3-monthly (PP3M) and its relation to their level of disability, and whether patients achieved symptomatic remission at the study endpoint.Patients and Methods: Goal attainment was assessed as a secondary endpoint using Goal Attainment Scaling (GAS) within a 52-week, prospective, single-arm, non-randomized, open-label, international, multicenter study evaluating the impact of transitioning stable patients with schizophrenia from paliperidone palmitate 1-monthly (PP1M) to PP3M. Additional exploratory analyses were performed to investigate the relationship between disability and functioning as measured by the World Health Organization Disability Assessment Schedule (WHODAS), Version 2.0, symptomatic remission, and goal attainment.Results: Overall, 305 patients were enrolled, of whom 281 (92.1%) provided GAS data at baseline. Of these, 160 achieved symptomatic remission at the last observation carried forward (LOCF) endpoint. The most common category of goals was “self” related, of which work-related was most frequent. Two-thirds of patients (67.7%) achieved at least one goal at the LOCF endpoint. Goal achievement was positively associated with lower baseline symptoms and symptomatic remission at LOCF endpoint, and with lower WHODAS scores at baseline and LOCF endpoint and greater WHODAS score improvements from baseline. Age, duration of disease, and duration of PP1M treatment before the switch did not impact goal setting and goal attainment. The proportion of patients with remunerated work status increased by 11.3% at LOCF endpoint.Conclusion: The results of this secondary endpoint analysis indicate that continued treatment of patients with schizophrenia with PP3M following stabilization with PP1M may facilitate attainment of patients’ personal goals and reduce disability, especially, but not exclusively, in patients with symptomatic remission achieved at LOCF.Keywords: GAS, goal attainment, paliperidone palmitate 1-monthly formulation, paliperidone palmitate 3-monthly formulation, schizophrenia, WHODAS