Patient-reported outcomes in schizophrenia patients treated with once-monthly extendedrelease risperidone in a long-term clinical study

Purpose: RBP-7000 (PERSERIS[TM]) is a once-monthly subcutaneous extended-release risperidone formulation approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. The objective of this study was to describe the long-term impact of RBP-7000 on health-rel...

Full description

Saved in:
Bibliographic Details
Published in:Patient preference and adherence 2019-07, p.1037
Main Authors: Dhanda, Rahul, Varghese, Della, Nadipelli, Vijay R, Fava, Maurizio, Joshi, Namita, Solem, Caitlyn T, Graham, James A, Learned, Susan M, Heidbreder, Christian
Format: Article
Language:English
Subjects:
Antipsychotic agents
Care and treatment
Clinical trials
Drug approval
Patient compliance
Patient outcomes
Pharmaceutical industry
Recurrence (Disease)
Schizophrenia
Surveys
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Purpose: RBP-7000 (PERSERIS[TM]) is a once-monthly subcutaneous extended-release risperidone formulation approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. The objective of this study was to describe the long-term impact of RBP-7000 on health-related quality of life (HRQoL), subjective well-being, treatment satisfaction and medication preference in patients with schizophrenia. Patients and methods: HRQoL was derived from a 52-week multicentre Phase III singlearm open-label outpatient study that assessed the safety and efficacy of RBP-7000 (120 mg) in patients with schizophrenia. HRQoL was measured using the EuroQol EQ-5D-5L and Short-Form Survey SF-36 version 2; well-being using the Subjective Well-being Under Neuroleptic Treatment - Short Version (SWN-S); satisfaction using the Medication Satisfaction Questionnaire and medication preference using the Preference of Medication questionnaire. Results: Of 482 participants at baseline, 234 remained through the end of study (EOS; week 52). Mean HRQoL and well-being scores remained stable between baseline (EQ-5D-5L index: 0.83; SF-36v2 Physical Component Score: 50; SF-36v2 Mental Component Score: 46; total SWN-S score: 89) and EOS (EQ-5D-5L index: 0.86; SF-36v2 Physical Component Score: 49; SF-36v2 Mental Component Score: 47; total SWN-S score: 90). The proportion of participants reporting satisfaction increased between week 4 (66%) and EOS (81%), with a similar trend for the preference of RBP-7000 over previous treatment (week 4: 66%; EOS: 72%). Sensitivity analyses suggested a minor effect of dropout on characterization of change over time in patient-reported outcomes (PRO) measures. Conclusion: Study participants attained mean HRQoL scores near that of the general US population. Over two-thirds reported high satisfaction with and preference for RBP-7000 across the study period. Additional research is needed to confirm whether these PRO translate into improved outcomes such as adherence and ultimately fewer relapses in patients with schizophrenia. Keywords: antipsychotics, quality of life, medication satisfaction, medication preference, clinical trial
ISSN:1177-889X
1177-889X
DOI:10.2147/PPA.S202173