Study results for schizophrenia treatment Abilify Maintena show long-term benefit to younger adults

Otsuka Pharmaceuticals Ltd and Lundbeck UK have announced the publication of the pivotal QUALIFY study in the October edition of Schizophrenia Research. QUALIFY is the first head-to-head study of long-acting injectable medications (LAI) comparing the effectiveness of two once-monthly treatments for schizophrenia - Abilify Maintena (aripiprazole once-monthly 400 mg (AOM)) and a widely prescribed atypical LAI, paliperidone palmitate once-monthly (PP)² - in a close-to-real life setting.¹

For the first time, results show that AOM brings significant improvements in functioning and health-related quality of life (HRQoL) in addition to effectively treating the clinical symptoms of schizophrenia versus PP,¹ the UK's most widely prescribed atypical LAI.² AOM also showed particular advantages in the treatment of younger adult schizophrenia patients (<35 years), in whom HRQoL and functioning as well as clinical symptoms were significantly improved (vs PP).¹

Prof David Taylor, professor of psychopharmacology at Kings College London, commented: "Head-to-head trials rarely show important differences between antipsychotic treatments. This trial is unusual in that it demonstrates clinically important superiority for aripiprazole once-monthly long-acting injectable, over another widely used atypical long-acting injectable. The relative benefits of aripiprazole once-monthly for younger patients is particularly striking."

AOM is the first and only LAI antipsychotic that exerts partial agonist activity at the D2 dopamine receptor. It is licensed for the treatment of schizophrenia in adult patients stabilised with oral aripiprazole.⁴ In the QUALIFY study, the primary endpoint results showed a statistically significant difference in improvement from baseline between the two arms to Week 28 on health-related quality of life outcomes QLS score (as assessed by the Heinrichs-Carpenter Quality of Life Scale (QLS)).¹ The respective changes from baseline to Week 28 were 7.5 ±1.53 for AOM and 2.8 ±1.62 for PP, with higher scores indicating better quality of life.¹ The differences between the two treatment arms at week 28 were statistically significantly different in favour of AOM, with a difference of 4.67 (p=0.036).1 In younger patients, this difference increased to 10.7.1 Changes above 5.0 on the scale can be described as clinically meaningful, meaning that doctors are able to notice improvements in patients in clinical practice.⁵ In the study, both treatments were generally well-tolerated.¹

Schizophrenia is a complex, debilitating and progressive condition that usually develops in late adolescence or early adulthood and carries a significant clinical, quality of life and economic burden for the individuals affected, their families and society in general.^6,7,8 Two-thirds of people living with schizophrenia are unable to fulfil basic social roles as spouse, parent or worker, even when psychotic symptoms are in remission.² Preventing relapse and preserving functional status and quality of life are fundamental long-term, patient-centred goals in the management of schizophrenia. Early, effective therapy could improve the opportunity for normal life participation, reduce the risk for relapse and subsequent neurological and functional decline over time and consequently help to reduce associated healthcare costs.^9,10,11

However, despite advances in treatment of the clinical symptoms of schizophrenia, many patients report ongoing problems with functioning and quality of life including emotional stability, interpersonal relationships, functioning at work and ability to fully participate in day-to-day life.^3,12

Healthcare professionals can assess functional status and HRQoL in addition to clinical symptoms, as an integral component of a regular patient consultation, in order to take a long-term, holistic view of each patient's needs. They can use simple but effective, validated tools to monitor these important indicators of schizophrenia impact.

There is currently a typically low adherence to schizophrenia oral medication, which leaves patients dangerously exposed to the risk of relapse and further functional decline.^11,13,14 LAI treatment is administered less often and consistently associated with better adherence and prevention of relapse.¹⁵ LAIs have also been shown to offer better treatment outcomes, with fewer relapses and hospitalisations than oral antipsychotics.^16,17