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. 2024 Oct 9:20:1901-1917.
doi: 10.2147/NDT.S459104. eCollection 2024.

TV-46000, A Long-Acting Subcutaneous Antipsychotic Agent, Demonstrated Improved Patient-Centered Outcomes in Patients with Schizophrenia

Leslie Citrome  1 , Mark Suett  2 , Kelli R Franzenburg  3 , Roy Eshet  4 , Anna Elgart  4 , Glen L Davis Rd  5 , Eran Harary  4 , Orna Tohami  4 , Marko A Mychaskiw  6 , John M Kane  7   8   9
Affiliations

TV-46000, A Long-Acting Subcutaneous Antipsychotic Agent, Demonstrated Improved Patient-Centered Outcomes in Patients with Schizophrenia

Leslie Citrome et al. Neuropsychiatr Dis Treat. .

Abstract

Background: TV46000 is a long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone approved for the treatment of schizophrenia in adults.

Methods: The RISE study (NCT03503318) compared TV-46000 once monthly (q1m) and once every 2 months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. The SHINE study (NCT03893825) evaluated the long-term safety, tolerability, and effectiveness of TV-46000 in patients who completed RISE without relapse (rollover; placebo rollover randomized [1:1] to q1m or q2m; TV-46000 rollover continued assigned treatment) or who were newly recruited (de novo; randomized [1:1] to q1m or q2m after oral stabilization). Patient-centered outcomes included the Schizophrenia Quality of Life Scale (SQLS), the 5-Level EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L), the Personal and Social Performance Scale (PSP), and the Drug Attitudes Inventory 10-item version (DAI-10).

Results: In RISE, SQLS least-squares mean changes (SE) improved to last assessment (LA) for TV-46000 q1m (-4.15 [1.03]) and q2m (-3.28 [1.06]) but worsened for placebo (1.75 [1.07]; P<0.001 for both). PSP, EQ5D-5L, and DAI-10 showed similar trends. In SHINE, SQLS decreased (improved) at LA for both TV-46000 q1m (-0.43 [0.98]) and q2m (-2.16 [0.98]); reductions were observed in the de novo (q2m only) and placebo rollover (q1m and q2m) cohorts, but not for the TV46000 rollover cohort. Results for PSP, EQ5D-5L, and DAI-10 were consistent with those reported in the RISE study.

Conclusion: Improvements in patient-centered outcomes were observed across cohorts, with the largest improvements observed for patients who began TV-46000 during SHINE (ie, de novo and placebo rollover cohorts), while gains made during RISE were minimally improved or maintained in the TV-46000 rollover cohort, indicating the benefit of uninterrupted TV-46000 treatment. These data support the effectiveness of TV-46000 to improve patient-centered outcomes in patients with schizophrenia.

Keywords: long-acting injectable; patient-centered outcomes; risperidone; schizophrenia.

Plain language summary

RISE and SHINE were clinical studies where patients with schizophrenia received TV-46000. TV-46000 is injected under the skin once monthly or once every 2 months to treat schizophrenia in adults. In RISE, patients took pills for the first 3 months, and then received injections under the skin. Some patients received inactive (placebo) injections. Comparing results among groups showed the effectiveness and side effects of TV-46000. Patients who completed RISE could continue into SHINE. SHINE included patients who had not been part of RISE as well. All patients received TV-46000 in SHINE to see if results were the same long term. This report summarizes the results of patient-centered outcomes. These included measures of quality of life and attitudes toward the medicine. In RISE, quality of life and attitudes toward the medicine improved with TV-46000, but worsened with placebo. In SHINE, the patient-centered outcomes also improved. The largest improvements were for patients who began taking TV-46000 during SHINE. This analysis showed that there is a benefit in taking TV-46000 for longer times without breaks. It also showed that TV-46000 improves quality of life and attitudes toward the medicine.

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Conflict of interest statement

Dr Citrome has been a consultant for AbbVie/Allergan, Acadia, Adamas, Alkermes, Angelini, Astellas, Avanir, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cadent Therapeutics, Cerevel, Clinilabs, COMPASS, Delpor, Eisai, Enteris BioPharma, HLS Therapeutics, Idorsia, INmune Bio, Impel, Intra-Cellular Therapies, Janssen, Karuna, Lundbeck, Luye, Lyndra, MapLight, Marvin, Medavante-ProPhase, Merck, Mitsubishi-Tanabe Pharma, Neumora, Neurocrine, Neurelis, Noema, Novartis, Noven, Otsuka, Ovid, Praxis, Recordati, Relmada, Reviva, Sage, Sumitomo/Sunovion, Supernus, Teva, University of Arizona, Vanda, Wells Fargo, and one-off ad hoc consulting for individuals/entities conducting marketing, commercial, or scientific scoping research; he has been a speaker for AbbVie/Allergan, Acadia, Alkermes, Angelini, Axsome, BioXcel, Eisai, Idorsia, Intra-Cellular Therapies, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Recordati, Sage, Sunovion, Takeda, Teva, and CME activities organized by medical education companies such as Medscape, NACCME, NEI, Vindico, and Universities and Professional Organizations/Societies; he owns a small number of shares of common stock in Bristol-Myers Squibb, Eli Lilly, J & J, Merck, and Pfizer purchased (>10 years ago) and has stock options in Reviva; and he receives royalties/publishing Income from Taylor & Francis (Editor-in-Chief, Current Medical Research and Opinion, 2022 to the present), Wiley (Editor-in-Chief, International Journal of Clinical Practice, through end of 2019), UpToDate (reviewer), Springer Healthcare (book), Elsevier (topic editor for psychiatry for the journal Clinical Therapeutics). Dr Suett is an employee and/or shareholder of Teva UK Limited. Dr Franzenburg is an employee and/or shareholder of Teva Branded Pharmaceutical Products R&D, Inc. Dr Eshet is an employee and/or shareholder of Teva Pharmaceutical Industries Ltd. Dr Elgart is an employee and/or shareholder of Teva Pharmaceutical Industries Ltd. Mr Davis 3rd is an employee and/or shareholder of Teva Branded Pharmaceutical Products R&D, Inc. Dr Harary is an employee and/or shareholder of Teva Pharmaceutical Industries Ltd. Ms Tohami is an employee and/or shareholder of Teva Pharmaceutical Industries Ltd. Dr Mychaskiw is an employee and/or shareholder of Teva Pharmaceutical Industries Ltd. Dr Kane has been a consultant for or received honoraria from Alkermes, Allergan, Boehringer-Ingelheim, Cerevel, Click Therapeutics, Dainippon Sumitomo, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest (Allergan), Genentech, HealthRhythms, HLS Therapeutics, Indivior, Intra-Cellular Therapies, Janssen, Johnson & Johnson, Karuna Therapeutics, LB Pharmaceuticals, Lundbeck, Lyndra Therapeutics, Merck, Minerva, Neurocrine Biosciences, Newron, Novartis, NW PharmaTech, Otsuka, Pierre Fabre, Reviva Pharmaceuticals, Roche, Saladax Biomedical, Sunovion, Takeda, and Teva Pharmaceuticals; has received grant support from Otsuka, Lundbeck, and Janssen; and is a shareholder of North Shore Therapeutics, LB Pharmaceuticals and Vanguard Research Group; has received royalties from UpToDate. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study design (RISE and SHINE).
Figure 2
Figure 2
RISE study: PSP, SQLS, EQ-5D-5L VAS, and DAI-10 scores at EoT and LA.
Figure 3
Figure 3
SHINE study: Overall, De novo, Placebo rollover, and TV-46000 rollover PSP, SQLS, EQ-5D-5L VAS, and DAI-10 LSM change scores at EoT.
Figure 4
Figure 4
SHINE study: Overall, De novo, Placebo rollover, and TV-46000 rollover PSP, SQLS, EQ-5D-5L VAS, and DAI-10 LSM change scores at LA.
See this image and copyright information in PMC

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