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Introduction <p>TV-46000 [once monthly (q1m) or once every 2 months (q2m)] is a subcutaneously administered long-acting injectable antipsychotic (LAI) formulation of risperidone for the treatment of schizophrenia in adults. As second-generation LAIs become available, understanding comparative efficacy and safety is needed.</p> Methods <p>We undertook a systematic literature review (SLR; January 1, 2020 to May 11, 2023) and network meta-analyses (NMAs) of randomized controlled clinical trials to compare the efficacy and safety of TV-46000 q1m and q2m with second-generation LAIs approved in Canada and used for treatment of schizophrenia [intramuscular aripiprazole monohydrate q1m, paliperidone palmitate q1m (PP1M), and paliperidone palmitate once every 3 months (PP3M)]. The primary efficacy outcome was relapse rate at 6 months, while safety outcomes were adverse event (AE)-related discontinuation, significant weight gain (≥&#xa0;7%), treatment-related AEs, and injection-site pain.</p> Results <p>Sixty-one records from 24 studies were included in the SLR, and 6 were included in the NMAs. For the relapse rate at 6 months, all treatments were significantly better than placebo, with relative risks (RRs) ranging from 0.23 for TV-46000 q1m to 0.46 for PP1M 50–150 mg eq and no significant differences among LAIs. There were no significant differences between TV-46000 and either placebo or PP1M 25–100 mg eq for AE-related discontinuation. TV-46000 q1m, PP1M 25–100 mg eq, and TV-46000 q2m were significantly less likely to cause weight gain&#xa0;≥&#xa0;7% than PP3M (RR: 0.09, 0.09, and 0.06, respectively) or PP1M 50–150 mg eq&#xa0;(0.08, 0.08, and 0.06, respectively). Treatment-related AEs were significantly less likely with PP1M 25–100 mg eq, TV-46000 q1m, and placebo than PP3M (RR: 0.48, 0.62, and 0.66, respectively). There were no significant differences in injection-site pain between groups.</p> Conclusion <p>TV-46000 q1m and q2m demonstrated comparable efficacy and safety to second-generation LAIs approved in Canada and used for maintenance treatment of schizophrenia.</p>

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Efficacy and Safety of TV-46000 and Second-Generation Long-Acting Injectable Antipsychotics for Schizophrenia: A Systematic Literature Review and Network Meta-Analysis of Randomized Controlled Trials

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  • 发表日期：

    2025年7月16日

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  • Kelli R. Franzenburg,
  • Rolf Hansen,
  • Mark Suett,
  • Stephen F. Thompson,
  • Martin Sergerie,
  • David Garcia,
  • Howard C. Margolese

摘要

Introduction

TV-46000 [once monthly (q1m) or once every 2 months (q2m)] is a subcutaneously administered long-acting injectable antipsychotic (LAI) formulation of risperidone for the treatment of schizophrenia in adults. As second-generation LAIs become available, understanding comparative efficacy and safety is needed.

Methods

We undertook a systematic literature review (SLR; January 1, 2020 to May 11, 2023) and network meta-analyses (NMAs) of randomized controlled clinical trials to compare the efficacy and safety of TV-46000 q1m and q2m with second-generation LAIs approved in Canada and used for treatment of schizophrenia [intramuscular aripiprazole monohydrate q1m, paliperidone palmitate q1m (PP1M), and paliperidone palmitate once every 3 months (PP3M)]. The primary efficacy outcome was relapse rate at 6 months, while safety outcomes were adverse event (AE)-related discontinuation, significant weight gain (≥ 7%), treatment-related AEs, and injection-site pain.

Results

Sixty-one records from 24 studies were included in the SLR, and 6 were included in the NMAs. For the relapse rate at 6 months, all treatments were significantly better than placebo, with relative risks (RRs) ranging from 0.23 for TV-46000 q1m to 0.46 for PP1M 50–150 mg eq and no significant differences among LAIs. There were no significant differences between TV-46000 and either placebo or PP1M 25–100 mg eq for AE-related discontinuation. TV-46000 q1m, PP1M 25–100 mg eq, and TV-46000 q2m were significantly less likely to cause weight gain ≥ 7% than PP3M (RR: 0.09, 0.09, and 0.06, respectively) or PP1M 50–150 mg eq (0.08, 0.08, and 0.06, respectively). Treatment-related AEs were significantly less likely with PP1M 25–100 mg eq, TV-46000 q1m, and placebo than PP3M (RR: 0.48, 0.62, and 0.66, respectively). There were no significant differences in injection-site pain between groups.

Conclusion

TV-46000 q1m and q2m demonstrated comparable efficacy and safety to second-generation LAIs approved in Canada and used for maintenance treatment of schizophrenia.