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

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.

An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients

“…Also, previous studies have shown that switching from oral risperidone to LAI risperidone improves health-related quality of life (HRQoL) in patients with schizophrenia [ 10 , 11 ]. In the 52-week multicenter Phase 3 trial of 120 mg RBP-7000, over two-thirds of patients reported high satisfaction with RBP-7000 throughout the study, with HRQoL scores close to the general population [ 18 ].…”

“…Clinical efficacy, safety, and tolerability of RBP-7000 injections for the treatment of acute schizophrenia have been demonstrated in Phase 3 trials consisting of an 8-week, double-blind, placebo-controlled, randomized study [ 13 – 15 ] and a 52-week, open-label, long-term safety study [ 16 ]. In both studies, participants reported high satisfaction with and preference for RBP-7000 as compared with their most recent pre-study antipsychotic medication [ 17 , 18 ]. Also, participants’ overall well-being and health-related quality of life were significantly greater after treatment with RBP-7000 compared with placebo [ 17 ] and were stable over time with long-term treatment [ 18 ].…”

“…In both studies, participants reported high satisfaction with and preference for RBP-7000 as compared with their most recent pre-study antipsychotic medication [ 17 , 18 ]. Also, participants’ overall well-being and health-related quality of life were significantly greater after treatment with RBP-7000 compared with placebo [ 17 ] and were stable over time with long-term treatment [ 18 ].…”

Conventional and retrospective change in health-related quality of life of trauma patients: an explorative observational follow-up study

“…Measurement of change in HRQL, individual or aggregate, has been used to evaluate health interventions in a wide range of conditions and populations (e.g. [3][4][5][6][7]). Inaccurate measurement of change in HRQL may therefore affect clinical practice and health care, and ultimately the quality of care and HRQOL of patients.…”