Treatment with once-monthly Abilify Maintena® (aripiprazole) significantly reduces hospitalisation rates for patients with schizophrenia compared with daily oral antipsychotics

• Once-monthly Abilify Maintena® demonstrated a 10-fold reduction in hospitalisation rates when comparing the same patients with their previous standard of care with oral antipsychotics in a mirror-image study design (2.7 percent vs 27.1 percent respectively, p<0.0001)¹
• Once-monthly Abilify Maintena® was well tolerated with rates of treatment emergent adverse events similar to the favourable tolerability profile of oral Abilify® (aripiprazole)²
• Reducing the risk of recurring relapses and readmissions early in the course of the illness may help minimise their negative impact on a patient’s long-term prognosis and quality of life.^3,4

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka) today 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 who were switched from oral antipsychotics to Abilify Maintena once-monthly 400 mg – a prolonged-release suspension for intramuscular injection of aripiprazole.¹ These findings were presented as a late breaker poster at the 4th Biennial Schizophrenia International Research Society (SIRS) conference in Florence, Italy on April 5–9.

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.⁵ 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 three months versus prior oral antipsychotic [2.7 percent (n=9/336) vs 27.1 percent (n=91/336) respectively, p<0.0001].¹

Abilify Maintena once-monthly 400 mg also significantly reduced the rates of psychiatric hospitalisations at six months compared with prior oral antipsychotics (8.8 percent [n=9/336] vs 38.1 percent [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.2,6 The most common treatment emergent adverse events with greater than five percent incidence observed during the prospective treatment period with Abilify Maintena were insomnia (6.7 percent), and akathisia (6.5 percent).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, M.D., 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.^3,4

In previous studies, long-acting injectable (LAIs) antipsychotics have demonstrated significant reductions in the risk of hospitalisation compared with oral antipsychotics⁷ 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 percent compared with oral formulations.⁹

Reducing hospitalisation rates through improved medication adherence is a key 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.^1,5

*Including oral aripiprazole, asenapine, chlorpromazine, clozapine, fluphenazine, haloperidol, iloperidone, loxapine, lurasidone, olanzapine, paliperidone, perphenazine, pimozide, quetiapine, risperidone, thiothixene, and ziprasidone.

References

1. Kane J, Zhao C, Johnson B, Baker R, Eramo A, McQuade R, 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. Fleischhacker W, Sanchez R, Perry P, Jin N, Peters-Strickland T, Johnson B, 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.
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