Effects of Aripiprazole Once-Monthly and Paliperidone Palmitate Once Monthly in Patients With Schizophrenia and Concomitant Substance Use: A Post-hoc Analysis of QUALIFY, a Head-to-Head Study

Background: Post-hoc analyses of the QUALIFY study (1), comparing effects of aripiprazole once-monthly (AOM 400) and paliperidone palmitate once-monthly (PP1M) treatment in patients with a positive urine drug screen during the study.

Methods: QUALIFY was a 28-week, randomized, open-label, head-to-head study (NCT01795547) of 2 atypical long-acting injectable antipsychotics, AOM 400 and PP1M in patients with schizophrenia. Urine drug screens were conducted at screening, baseline and completion/withdrawal visits. Primary endpoint was change from baseline to week 28 on rater-blinded Heinrichs-Carpenter Quality-of-Life Scale total score (QLS). Secondary endpoints included change from baseline on Clinical Global Impression–Severity (CGI-S) scale and Work Readiness Questionnaire total score (WoRQ). A mixed model for repeated measures was used to analyze changes on the above.

Results: Changes from baseline to week 28 in QLS were 7.5±1.5 (AOM 400, (n=136) and 2.8±1.6 (PP1M, n=132); treatment difference was 4.7 (95% CI: [0.3;9.0], p=0.036). Patients with a positive urine drug screen during study included 26/136 (19.1%) receiving AOM 400 and 29/132 (22.0%) receiving PP1M. In subgroups, LSM changes from baseline on QLS were 6.4±5.9 (AOM 400) and -4.7±5.4 (PP1M), while CGI-S and WoRQ scores were numerically better with AOM 400 vs PP1M.

Conclusion: In the subgroup with positive urine drug screen, patients receiving AOM400 showed numerical improvements in QLS, while patients receiving PP1M worsened. Limitations include that data are post-hoc and sample size is small. These results suggest effectiveness of AOM 400 on quality of life and functioning is not compromised by concomitant substance use.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.