Paliperidone LAI and Aripiprazole LAI Plasma Level Monitoring in the Prophylaxis of Bipolar Disorder Type I with Manic Predominance

Abstract

Introduction The objective of this study was the evaluation of utility of plasma level monitoring in the clinical stabilizing efficacy and tolerability of paliperidone palmitate (PP) vs. aripiprazole monohydrate (AM) in bipolar disorder I (BD I) with manic predominance.

Methods Fifty-six outpatients of both sexes, age ranging from 18 to 65 years, affected by BD I with manic predominance, orally treated and stabilized after acute episode for at least 2 weeks with paliperidone or aripiprazole (n=31, paliperidone; n=25, aripiprazole) underwent a prospective observational study of switching to the corresponding long-acting injection (LAI) on the basis of clinical evaluation. The efficacy and tolerability of the 2 treatments were assessed by BPRS, PANSS, HAMD21, and MRS rating scales and a check list every month for 12 months. Drug plasma levels determinations (PLs) were performed at the same times.

Results A good clinical stability and tolerability of both drugs were reported. Lower mean PLs of PP showed a positive effect on depressive symptoms. AM PLs variability was associated with greater instability of manic symptoms whereas intermediate PLs seem to have more influence on depressive symptomatology.

Discussion PLs drug monitoring has been proven to be useful, and further investigations to identify optimal therapeutic ranges for LAI formulations are needed.

Key words

bipolar disorder - antipsychotics - therapeutic drug monitoring

• References

• 1 Merikangas KR, Jin R, He JP. et al. Prevalence and correlates of bipolar spectrum disorder in the World Mental Health Survey Initiative. Arch Gen Psychiatry 2011; 68: 241-251
• 2 APA) American Psychiatric Association. DSM. 5. 2013
• 3 Altamura AC, Serati M, Albano A. et al. An epidemiologic and clinical overview of medical and psychopathological comorbidities in major psychoses. Eur Arch Psychiatry Clin Neurosci 2011; 261: 489-508
• 4 Konstantakopoulos G, Ioannidi N, Typaldou M. et al. Clinical and cognitive factors affecting psychosocial functioning in remitted patients with bipolar disorder. Psychiatriki 2016; 27: 182-191
• 5 MacQueen GM, Memedovich KA. Cognitive dysfunction in major depression and bipolar disorder: assessment and treatment options. Psychiatry Clin Neurosci 2017; 71: 18-27
• 6 Kessler RC, McGonagle KA, Zhao S. et al. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States: results from the National Comorbidity Survey. Arch Gen Psychiatry 1994; 51: 8-19
• 7 Large M, Ryan C, Nielssen O. The validity and utility of risk assessment for inpatient suicide. Australas Psychiatry 2011; 19: 507-512
• 8 Beyer JL, Weisler RH. Suicide behaviors in bipolar disorder: a review and update for the clinician. Psychiatr Clin North Am 2016; 39: 111-123
• 9 Pompili M, Shrivastava A, Serafini G. et al. Bereavement after the suicide of a significant other. Indian J Psychiatry 2013; 55: 256-263
• 10 Altamura AC, Buoli M, Serati M. Duration of illness and duration of untreated illness in relation to drug response in psychiatric disorders. Neuropsychiatry (London) 2011; 1: 81-90
• 11 Dell’Osso B, Glick ID, Baldwin DS. et al. Can long-term outcomes be improved by shortening the duration of untreated illness in psychiatric disorders? A conceptual framework. Psychopathology 2012; 46: 14-21
• 12 Colom F, Vieta E, Suppes T. Predominant polarity in bipolar disorders: refining or redefining diagnosis?. Acta Psychiatr Scand 2015; 132: 324-326
• 13 Colom F, Vieta E, Daban C. et al. Clinical and therapeutic implications of predominant polarity in bipolar disorder. J Affect Disord 2006; 93: 13-17
• 14 Baldessarini RJ, Undurraga J, Vázquez GH. et al. Predominant recurrence polarity among 928 adult international bipolar I disorder patients. Acta Psychiatr Scand 2012; 125: 293-302
• 15 Carvalho AF, Quevedo J, McIntyre RS. et al. Treatment implications of predominant polarity and the polarity index: a comprehensive review. Int J Neuropsychopharmacol 2015; 18: 1-11
• 16 Calabrese JR, Sanchez R, Jin N. et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder. J Clin Psychiatry 2017; 78: 324-331
• 17 Bortolato B, Miskowiak KW, Köhler CA. et al. Cognitive dysfunction in bipolar disorder and schizophrenia: a systematic review of meta-analyses. Neuropsychiatr Dis Treat 2015; 11: 3111-3125
• 18 López-Jaramillo C, Lopera-Vásquez J, Gallo A. et al. Effects of recurrence on the cognitive performance of patients with bipolar I disorder: implications for relapse prevention and treatment adherence. Bipolar Disord 2010; 12: 557-567
• 19 Fagiolini A, Kupfer DJ, Masalehdan A. et al. Functional impairment in the remission phase of bipolar disorder. Bipolar Disord 2005; 7: 281-285
• 20 Rosa AR, Reinares M, Franco C. et al. Clinical predictors of functional outcome of bipolar patients in remission. Bipolar Disord 2009; 11: 401-409
• 21 Hirschfeld RMA, Bowden CL, Gitlin M. et al. Practice guideline for the treatment of patients with bipolar disorder, second edition. APA Pract Guidel 2002; 159: 1-82
• 22 Lage MJ, Hassan MK. The relationship between antipsychotic medication adherence and patient outcomes among individuals diagnosed with bipolar disorder: a retrospective study. Ann Gen Psychiatry 2009; 8: 7
• 23 Martinez-Aran A, Scott J, Colom F. et al. Treatment nonadherence and neurocognitive impairment in bipolar disorder. J Clin Psychiatry 2009; 70: 1017-1023
• 24 Perlis RH, Ostacher MJ, Miklowitz DJ. et al. Clinical features associated with poor pharmacologic adherence in bipolar disorder. J Clin Psychiatry 2010; 71: 296-303
• 25 Velligan DI, Weiden PJ, Sajatovic M. et al. The expert consensus guideline series: adherence problems in patients with serious and persistent mental illness. J Clin Psychiatry 2009; 70 (Suppl. 04) 1-46
• 26 Hiemke C, Bergemann N, Clement HW. et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017. Pharmacopsychiatry 2018; 51: 9-62
• 27 Tiihonen J, Mittendorfer-Rutz E, Majak M. et al. Real-world effectiveness of antipsychotic treatments in a nationwide cohort of 29,823 patients with schizophrenia. JAMA Psychiatry 2017; 74: 686-693
• 28 Tiihonen J, Haukka J, Taylor M. et al. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. Am J Psychiatry 2011; 168: 603-609
• 29 Subotnik KL, Casaus LR, Ventura J. et al. Long-acting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia a randomized clinical trial. JAMA Psychiatry 2015; 72: 822-829
• 30 Citrome L. Long-acting injectable antipsychotics update: lengthening the dosing interval and expanding the diagnostic indications. Expert Rev Neurother 2017; 17: 1029-1043
• 31 Derry S, Moore RA. Atypical antipsychotics in bipolar disorder: systematic review of randomised trials. BMC Psychiatry 2007; 7: 40
• 32 Gigante AD, Lafer B, Yatham LN. Long-acting injectable antipsychotics for the maintenance treatment of bipolar disorder. CNS Drugs 2012; 26: 403-420
• 33 Correll CU Haddad PM, Lauriello J, Olfson M. et al. The use of long-acting injectable antipsychotics in Schizophrenia: evaluating the evidence. J Clin Psychiatry 2016; 77: 3
• 34 Kane JM, Sanchez R, Zhao J. et al. Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia. J Med Econ 2013; 16: 917-925
• 35 Otsuka Pharmaceutical Co Ltd Abilify Maintena (aripiprazole) extended-release injectable suspension (Product label)July. 2017
• 36 Janssen Pharmaceuticals Inc Invega Sustenna (paliperidone palmitate) extended- release injectable suspension (product label) June. 2017
• 37 Janssen Pharmaceuticals Inc Risperdal Consta (risperidone) long acting injection (product label) February. 2017
• 38 Greenberg WM, Citrome L. Paliperidone palmitate for schizoaffective disorder: A review of the clinical evidence. Neurol Ther 2015; 4: 81-91
• 39 Parabiaghi A, Tettamanti M, D’Avanzo B. et al. Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol. Acta Psychiatr Scand 2016; 133: 63-75
• 40 Citrome L. New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia. Expert Rev Neurother 2013; 13: 767-783
• 41 Citrome L. Paliperidone palmitate – review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Int J Clin Pract 2010; 64: 216-239
• 42 Janssen Pharmaceuticals Inc Invega Trinza (paliperidone palmitate) extended- release injectable suspension (Product label). February. 2017
• 43 De Fazio P, Girardi P, Maina G. et al. Aripiprazole in acute mania and long-term treatment of bipolar disorder. Clin Drug Investig 2010; 30: 827-841
• 44 First MB, Williams JBW, Karg RSSRL. SCID-5-CV. Intervista Clinica Strutturata per i Disturbi Del DSM-5. Versione per Il Clinico; (Editore. RC, ed.) Milano: 2017
• 45 Overall JE, Gorham DR. The Brief Psychiatric Rating Scale. 1962. Psychol Rep 1962; 10: 799-812
• 46 Kay S, Fiszbein A, Opler L. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261-276
• 47 Hamilton MC. 5.2. Hamilton Depression Scale (HDS) with Melancholia Scale (MES). Acta Psychiatr Scand 1986; 73: 23-28
• 48 Young RC, Biggs JT, Ziegler VE. et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-435
• 49 Mauri MC, Paletta S, Di Pace C. et al. Paliperidone long-acting plasma level monitoring and a new method of evaluation of clinical stability. Pharmacopsychiatry 2017; 50: 145-151
• 50 Torres-Llenza V, Lakshmin P, Lieberman DZ. Spotlight on once-monthly long-acting injectable aripiprazole and its potential as maintenance treatment for bipolar I disorder in adult patients. Neuropsychiatr Dis Treat 2018; 14: 285-292
• 51 Calabrese JR, Sanchez R, Jin N. et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar i disorder: A double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry 2017; 78: 324-331
• 52 Pandina G, Lane R, Gopal S. et al. A double-blind study of paliperidone palmitate and risperidon long-acting injectable in adults with schizonphrenia. Prog Neuro-Psychopharmacology. Biol Psychiatry 2010; 35: 1002-1008
• 53 Fleischhacker WW, Gopal S, Lane R. et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol 2012; 15: 107-118
• 54 Naber D, Hansen K, Forray C. et al. Qualify: A randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res 2015; 168: 498-504
• 55 Majer IM, Gaughran F, Sapin C. et al. Efficacy, tolerability, and safety of aripiprazole once-monthly vs. other long-acting injectable antipsychotic therapies in the maintenance treatment of schizophrenia: a mixed treatment comparison of double-blind randomized clinical trials. J Mark Access Heal Policy 2015; 3: 27208
• 56 Mauri MC, Reggiori A, Paletta S. et al. Paliperidone for the treatment of schizophrenia and schizoaffective disorders – a drug safety evaluation. Expert Opin Drug Saf 2017; 16: 365-379
• 57 Hough D, Gopal S, Vijapurkar U. et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled study. Schizophr Res 2010; 116: 107-117
• 58 Pandina GJ, Lindenmayer JP, Lull J. et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol 2010; 30: 235-244
• 59 Kramer M, Litman R, Hough D. et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol 2010; 13: 635-647
• 60 Coppola D, Liu Y, Gopal S. et al. A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia. BMC Psychiatry 2012; 12: 12-26
• 61 Zhang F, Si T, Chiou C-F. et al. Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia. Neuropsychiatr Dis Treat 2015; 11: 657-68
• 62 Mauri MC, Paletta S, Maffini M. et al. Clinical pharmacology of atypical antipsychotics: an update. Excli J 2014; 13: 1163-1191
• 63 Potkin SG, Raoufinia A, Mallikaarjun S. et al. Safety and tolerability of once monthly aripiprazole treatment initiation in adults with schizophrenia stabilized on selected atypical oral antipsychotics other than aripiprazole. Curr Med Res Opin 2013; 29: 1241-1251
• 64 Mauri MC, Paletta S, Di Pace C. et al. Clinical pharmacokinetics of atypical antipsychotics: an Update. Clin Pharmacokinet 2018; 57: 1493-1528
• 65 Baumann P, Hiemke C, Ulrich S. et al. The AGNP-TDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 2004; 37: 243-265
• 66 Urban A, Cubała W. Therapeutic drug monitoring of atypical antipsychotics. Psychiatr Pol 2017; 51: 1059-1077
• 67 Salzman PM, Raoufinia A, Legacy S. et al. Plasma concentrations and dosing of 2 long-acting injectable formulations of aripiprazole. Neuropsychiatr Dis Treat 2017; 13: 1125-1129
• 68 Baldelli S, Mauri MC, Di Pace C. et al. Intraindividual and interindividual variability of olanzapine trough concentrations in patients treated with the long-acting injectable formulation. J Clin Psychopharmacol 2018; 38: 365-369