Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan

Abstract

Introduction The use of the blonanserin patch (BLO-P) for schizophrenia treatment was approved in Japan in 2019. This systematic review of trials in Japan assessed the efficacy and safety profile of BLO-P compared with other antipsychotics.

Methods The systematic review included 6-week, double-blind, randomized, placebo-controlled, phase 3 trials in Japan that included patients with acute schizophrenia. Pooled data for patients receiving BLO-P 40 and 80 mg/day (BLO-P40+80) were compared with pooled data for patients receiving asenapine 10 and 20 mg/day (ASE10+20) and data for those receiving brexpiprazole 2 mg/day (BRE2) and paliperidone extended-release 6 mg/day (PAL-ER6).

Results All the investigated treatments were superior to placebo in reducing the Positive and Negative Syndrome Scale (PANSS) total score; the Hedges’ g values (95% confidence interval) for BLO-P40+80, ASE10+20, BRE2, and PAL-ER6 were−0.40 (−0.58,−0.22),−0.61 (−0.79,−0.42),−0.33 (−0.60,−0.07), and−0.69 (−0.93,−0.45), respectively. There were differences among the antipsychotics in the incidence of various individual adverse events.

Discussion BLO-P40+80 may have a good efficacy/safety/tolerability profile for the treatment of patients with acute schizophrenia.

Keywords

asenapine - blonanserin patch - brexpiprzole - paliperidone extended-release - acute schizophrenia

• References

• 1 Leucht S, Leucht C, Huhn M. et al. Sixty years of placebo-controlled antipsychotic drug trials in acute schizophrenia: systematic review, Bayesian meta-analysis, and meta-regression of efficacy predictors. Am J Psychiatry 2017; 174: 927-942
• 2 Leucht S, Tardy M, Komossa K. et al. Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: a systematic review and meta-analysis. Lancet 2012; 379: 2063-2071
• 3 Kishi T, Ikuta T, Matsui Y. et al. Effect of discontinuation v. maintenance of antipsychotic medication on relapse rates in patients with remitted/stable first-episode psychosis: a meta-analysis. Psychol Med 2019; 49: 772-779
• 4 Hasan A, Falkai P, Wobrock T. et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance. World J Biol Psychiatry 2012; 13: 318-378
• 5 Hasan A, Falkai P, Wobrock T. et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. World J Biol Psychiatry 2013; 14: 2-44
• 6 NICE Psychosis and schizophrenia in adults: treatment and management: Updated Edition. 2014. London: 2014
• 7 Acosta FJ, Ramallo-Farina Y, Bosch E. et al. Antipsychotic treatment dosing profile in patients with schizophrenia evaluated with electronic monitoring (MEMS(R)). Schizophr Res 2013; 146: 196-200
• 8 Brain C, Sameby B, Allerby K. et al. Stigma, discrimination and medication adherence in schizophrenia: results from the Swedish COAST study. Psychiatry Res 2014; 220: 811-817
• 9 Czobor P, Van Dorn RA, Citrome L. et al. Treatment adherence in schizophrenia: a patient-level meta-analysis of combined CATIE and EUFEST studies. Eur Neuropsychopharmacol 2015; 25: 1158-1166
• 10 Velligan DI, Sajatovic M, Hatch A. et al. Why do psychiatric patients stop antipsychotic medication? A systematic review of reasons for nonadherence to medication in patients with serious mental illness. Patient Prefer Adherence 2017; 11: 449-468
• 11 Das AK, Malik A, Haddad PM. A qualitative study of the attitudes of patients in an early intervention service towards antipsychotic long-acting injections. Ther Adv Psychopharmacol 2014; 4: 179-185
• 12 Spanarello S, La Ferla T. The pharmacokinetics of long-acting antipsychotic medications. Curr Clin Pharmacol 2014; 9: 310-317
• 13 Priebe S, Yeeles K, Bremner S. et al. Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial. BMJ 2013; 347: f5847
• 14 Iwata N, Ishigooka J, Kim WH. et al. Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study. Schizophr Res 2019;
• 15 Isaac M, Holvey C. Transdermal patches: the emerging mode of drug delivery system in psychiatry. Ther Adv Psychopharmacol 2012; 2: 255-263
• 16 Citrome L, Zeni CM, Correll CU. Patches: established and emerging transdermal treatments in psychiatry. J Clin Psychiatry. 2019; 80 (04)
• 17 Kinoshita T, Bai YM, Kim JH. et al. Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology (Berl) 2016; 233: 2663-2674
• 18 Ishigooka J, Iwashita S, Tadori Y. Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia in Japan: A 6-week, randomized, double-blind, placebo-controlled study. Psychiatry Clin Neurosci 2018; 72: 692-700
• 19 Hirayasu Y, Tomioka M, Iizumi M. et al. A double-blind, placebo-controlled, comparative study of paliperidone extended-release (ER) tablets in patients with schizophrenia. Jpn J Clin Psychopharmacol 2010; 13: 2077-2103
• 20 Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261-276
• 21 Leucht S, Chaimani A, Mavridis D. et al. Disconnection of drug-response and placebo-response in acute-phase antipsychotic drug trials on schizophrenia? Meta-regression analysis. Neuropsychopharmacology 2019;
• 22 Moteshafi H, Zhornitsky S, Brunelle S. et al. Comparing tolerability of olanzapine in schizophrenia and affective disorders: a meta-analysis. Drug Saf 2012; 35: 819-836
• 23 Huhn M, Nikolakopoulou A, Schneider-Thoma J. et al. Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. Lancet 2019;
• 24 Bozzatello P, Rocca P, Uscinska M. et al. Efficacy and tolerability of asenapine compared with olanzapine in borderline personality disorder: an open-label randomized controlled trial. CNS Drugs 2017; 31: 809-819