Neuropsychiatric Disease and Treatment (Jan 2023)
Personal and Social Functioning and Health-Related Quality of Life in Patients with Schizophrenia Treated with the Long-Acting Injectable Antipsychotic Risperidone ISM
Abstract
Robert Litman,1,2 Dieter Naber,3 Lourdes Anta,4 Javier Martínez,4 Yuriy Filts,5 Christoph U Correll6– 8 1CBH Health LLC, Gaithersburg, MD, USA; 2Department of Psychiatry, Georgetown University Medical School, Washington, DC, USA; 3Department of Psychiatry and Psychotherapy, Hamburg-Eppendorf University, Hamburg, Germany; 4Medical Department, Laboratorios Farmacéuticos ROVI, S.A., Madrid, Spain; 5Communal Noncommercial Enterprise of Lviv Regional Council, Lviv Regional Clinical Psychiatric Hospital, Lviv, Ukraine; 6Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA; 7Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; 8Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, GermanyCorrespondence: Javier Martínez, Laboratorios Farmacéuticos ROVI, S.A., Calle Alfonso Gómez, 45A, Madrid, 28037, Spain, Tel +34 91 375 63 36, Fax +34 91 304 78 81, Email [email protected]: To analyze the effect of Risperidone ISM on social functioning and health-related quality of life (HR-QoL) in both short- and long-term treatment of patients with schizophrenia.Patients and Methods: This analysis was based on data from both phases of the PRISMA-3 study, including 433 relapsed patients from the double-blind (DB) phase of the PRISMA-3 trial who were treated for 12-weeks with once-monthly (every 28 days) intramuscular Risperidone ISM 75 mg or 100 mg (n = 288), or placebo (n = 145), as well as 174 patients transitioning from the DB to an open-label 52-week extension (OLE) phase, plus 41 de novo patients treated on a stable maintenance dose of oral risperidone. The clinician-administered Personal and Social Performance (PSP) scale and the patient-reported 20-item Subjective Well-being under Neuroleptics scale (SWN-20) were used to measure social functioning and HR-QoL outcomes, respectively.Results: Risperidone ISM significantly improved PSP total score from baseline to endpoint (Day 85) versus placebo in the DB phase with mean change total score (95% CI) of 10.7 (9; 12) compared to 4.8 (3; 7) for placebo (p < 0.0001). The statistically significant improvement was present from the first measurement time point (Day 29). SWN-20-measured HR-QoL increased on average in patients treated with Risperidone ISM in the DB phase. A significant improvement was also observed for PSP and SWN-20 scores from the OLE baseline to week 52 for patients transitioning from the DB phase. Stable de novo patients maintained similar PSP and SWN-20 scores during the whole OLE phase.Conclusion: Risperidone ISM provided a rapid and sustained improvement in personal and social functioning, and HR-QOL without need of oral risperidone supplementation or loading doses. These findings, along with a fast onset of efficacy, could contribute to reinforcing the therapeutic alliance and possibly an earlier discharge. Moreover, patient functioning continued improving or was maintained with long-term treatment.Keywords: risperidone, long-acting injectable, antipsychotics, schizophrenia, social functioning, quality of life
