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

Rahul Dhanda; Della Varghese; Vijay R Nadipelli; Maurizio Fava; Namita Joshi; Caitlyn T Solem; James A Graham; Susan M Learned; Christian Heidbreder

doi:10.2147/PPA.S202173

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

Patient Prefer Adherence. 2019 Jul 2:13:1037-1050. doi: 10.2147/PPA.S202173. eCollection 2019.

Authors

Rahul Dhanda¹, Della Varghese², Vijay R Nadipelli¹, Maurizio Fava³, Namita Joshi², Caitlyn T Solem², James A Graham⁴, Susan M Learned⁴, Christian Heidbreder⁵

Affiliations

¹ Global Health Economics and Outcomes Research, Indivior Inc, Richmond, VA 23235, USA.
² Real-World Evidence and Data Analytics, Pharmerit International, Bethesda, MD 20814, USA.
³ Clinical Trials Network Institute (CTNI), Massachusetts General Hospital (MGH) and Harvard Medical School, Boston, MA 02114, USA.
⁴ Global Medicines Development, Indivior Inc, Richmond, VA 23235, USA.
⁵ Global Research and Development, Indivior Inc, Richmond, VA 23235, USA.

Abstract

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; clinical trial; medication preference; medication satisfaction; quality of life.