Lundbeck's schizophrenia drug wallops competition in novel head-to-head trial
- The recently completed QUALIFY trial comparing injectable once-monthly aripiprazole (from Otsuka/Lundbeck) and injectable once-monthly paliperidone palmitate (from Janssen) is the first head-to-head study comparing atypical antipsychotics in a close to real-world setting. In the study, aripiprazole had significantly better outcomes on the Heinrichs-Carpenter Quality of Life Scale (QLS).
- QUALIFY is a 28-week, randomized, open-label, head-to-head comparison trial that included a total of 295 patients in North America and Europe .
- In addition to testing QLS outcomes, other measures that were compared include the Clinical Global Impressions (CGI) scale and the Investigator's Assessment Questionnaire (IAQ), which is designed to evaluate response to antipsychotics.
One of the most important issues facing drug developers is whether or not clinical trial results can be reproduced in the real world. And this is especially important in the context of psychotropic medications.
This study is an important first, because it looks at the comparative efficacy of two once-monthly injectable atypical antipsychotics in patients with schizophrenia. The validated tools used to track outcomes reflect many different factors related to mental health and the ability to function in the world, including interpersonal relationships, having a sense of purpose, work functioning, and other activities related to daily living.
The results clearly showed superior outcomes for patients treated with aripiprazole. Discontinuation rates due to adverse events for aripiprazole and paliperidone palmitate were 10.8% and 18.4%, respectively.