Patient-reported outcomes in schizophrenia patients treated with once-monthly extended-release risperidone in a long-term clinical study
Received 19 January 2019
Accepted for publication 4 June 2019
Published 2 July 2019 Volume 2019:13 Pages 1037—1050
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Rahul Dhanda,1 Della Varghese,2 Vijay R Nadipelli,1 Maurizio Fava,3 Namita Joshi,2 Caitlyn T Solem,2 James A Graham,4 Susan M Learned,4 Christian Heidbreder5
1Global Health Economics and Outcomes Research, Indivior Inc, Richmond, VA 23235, USA; 2Real-World Evidence and Data Analytics, Pharmerit International, Bethesda, MD 20814, USA; 3Clinical Trials Network Institute (CTNI), Massachusetts General Hospital (MGH) and Harvard Medical School, Boston, MA 02114, USA; 4Global Medicines Development, Indivior Inc, Richmond, VA 23235, USA; 5Global Research and Development, Indivior Inc, Richmond, VA 23235, USA
Purpose: RBP-7000 (PERSERIS™) 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 single-arm 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
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