H Lundbeck and Otsuka Pharmaceutical Europe Ltd announced results from the final analysis of a mirror-image study showing statistically significant reductions (p<0.0001) in total psychiatric hospitalisation rates in patients diagnosed with schizophrenia.
The patients were switched from oral antipsychotics to Abilify Maintena® once-monthly 400 mg – a prolonged-release suspension for intramuscular injection of aripiprazole.(1)
In this multi-centre, open-label, North American mirror-image study, patients with schizophrenia who had been treated with oral antipsychotics as standard of care,* were switched to Abilify Maintena once-monthly 400 mg and followed for 6 months in a naturalistic community setting.(2) The results from the Abilify Maintena treatment period were compared retrospectively with the treatment period on oral antipsychotics prior to the switch in the same patients and setting. The study primary endpoint showed that Abilify Maintena once-monthly 400 mg significantly reduced the rates of psychiatric hospitalisation by 10-fold during the last 3 months versus prior oral antipsychotic (2.7% [n=9/336] versus 27.1% [n=91/336], respectively; p<0.0001).(1)
Abilify Maintena once-monthly 400 mg also significantly reduced the rates of psychiatric hospitalisations at 6 months compared with prior oral antipsychotics (8.8% [n=9/336] versus 38.1% [n=91/336], respectively, p<0.0001). The study found Abilify Maintena once-monthly 400 mg to be well tolerated, consistent with previously reported treatment-emergent adverse events with oral Abilify.(3,4) The most common treatment emergent adverse events with greater than 5% incidence observed during the prospective treatment period with Abilify Maintena were insomnia (6.7%) and akathisia (6.5%).1
“Our ability to reduce the risk of relapse and rehospitalisation is critical in facilitating improvement in psychosocial and vocational functioning. With each relapse patients can lose hard won gains and find it more and more difficult to progress towards recovery,” said study investigator John M Kane, MD, Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System.
Hospitalisations in schizophrenia are most commonly a result of relapses, and protecting patients from relapse and hospital readmissions is a major goal in patient management. Minimising the risk of relapse early in the course of the illness may help to reduce the negative impact that recurring relapses and readmissions have on a patient’s long-term prognosis and quality of life.(5,6)
In previous studies, long-acting injectable (LAIs) antipsychotics have demonstrated significant reductions in the risk of hospitalisation compared with oral antipsychotics(7) and may be particularly beneficial for patients with first-episode psychosis.(8) In patients hospitalised for the first time, the use of LAIs was shown to reduce the risk of readmission by 64% compared with oral formulations.(9)
Reducing hospitalisation rates through improved medication adherence is a major focus for improving functional outcomes in patients with schizophrenia and would also reduce associated healthcare costs,(10,11) as hospitalisation represents a significant portion of the overall economic burden of treating patients with schizophrenia.(12) The significant reduction of hospital rates observed in the mirror study data suggest that once-monthly Abilify Maintena may provide cost savings for healthcare services.(1,2)
These findings were presented as a late breaker poster at the 4th Biennial Schizophrenia International Research Society (SIRS) conference in Florence, Italy on 5–9 April 2014.
*Including oral aripiprazole, asenapine, chlorpromazine, clozapine, fluphenazine, haloperidol, iloperidone, loxapine, lurasidone, olanzapine, paliperidone, perphenazine, pimozide, quetiapine, risperidone, thiothixene and ziprasidone.
REFERENCES
1. Kane J et al. (editors). Hospitalization rates in patients switched from oral antipsychotics to aripiprazole once-monthly: a mirror study. Poster presented at the Schizophrenia International Research Society (SIRS) Congress; 5–9 April 2014, Florence, Italy.
2.Kane JM et al. Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia. J Med Econ 2013;16:917–25.
3. Fleischhacker W et al. (editors). Poster: Aripiprazole once-monthly for the treatment of schizophrenia: a double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of the American Psychiatric Association, 18–22 May 2013.
4. Kane JM et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73:617–24.
5. Lieberman JA et al. The early stages of schizophrenia: speculations on pathogenesis, pathophysiology, and therapeutic approaches. Biol Psychiatry 2001;50:884–97.
6. Boyer L et al. Quality of life is predictive of relapse in schizophrenia. BMC Psychiatry 2013;13:15.
7. Kishimoto T et al. Long-acting injectable versus oral antipsychotics in schizophrenia: a systematic review and meta-analysis of mirror-image studies. J Clin Psychiatry 2013;74:957–65.
8. Zhornitsky S, Stip E. Oral versus long-acting injectable antipsychotics in the treatment of schizophrenia and special populations at risk for treatment nonadherence: a systematic review. Schizophr Res Treatment 2012;2012:407171.
9. Tiihonen J et al. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. Am J Psychiatry 2011;168:603–9.
10. Marcus SC, Olfson M. Outpatient antipsychotic treatment and inpatient costs of schizophrenia. Schizophr Bull 2008;34:173–80.
11. Keith S. Advances in psychotropic formulations. Prog Neuropsychopharmacol Biol Psychiatry 2006;30:996–1008.
12. Gilmer TP et al. Adherence to treatment with antipsychotic medication and health care costs among Medicaid beneficiaries with schizophrenia. Am J Psychiatry 2004;161:692–9.
