Abstract
Background: The QUALIFY (QUAlity of LIfe with AbiliFY Maintena) study compared the effectiveness of aripiprazole once-monthly 400 mg (AOM 400) to paliperidone palmitate once-monthly (PP) using Heinrichs-Carpenter Quality-of-Life Scale (QLS) [1,2]. The Readiness for Work Questionnaire (WoRQ) was an additional functional endpoint [3]. This post-hoc analysis investigates the relationship between QLS/WoRQ following treatment.
Methods: QUALIFY was a 28-week, randomized, open-label, rater-blinded, head-to-head study (NCT01795547) of 2 atypical long-acting injectable anti-psychotics in patients (18–60 years) with schizophrenia. The primary endpoint was change from baseline to week 28 in QLS total score [1]. WoRQ-derived work readiness (Yes/No) was assessed at baseline and week 28. Irrespective of treatment, patients were categorized by work readiness at baseline and week 28 (No-to-Yes, Yes-to-Yes, or No at week 28), and changes from baseline to week 28 in QLS total, domain, and items scores were assessed with a mixed model for repeated measures.
Results: QLS total score showed superior improvement with AOM 400 vs PP and more patients changed from No-to-Yes in work readiness with AOM 400 vs PP treatment (39.2% vs 17.4%) with greater odds of work readiness at week 28. Patients in the No-to-Yes group (n=41) showed least squares mean (LSM) changes in QLS total score of 14.3 ± 2.2, significantly greater than No at week 28 group (n=118; LSM change: 2.7 ± 1.4; LSM difference: 11.6 ± 2.6, 95%CI:[6.5;16.7], p<0.0001). QLS instrumental role domain scores were significantly improved in the No-to-Yes group vs No at week 28 group, with LSM improvements of ~1 point on each item.
Conclusion: These results show a strong association between shifts in work readiness and improvements on QLS, particularly in QLS categories related to work functioning. The association between functional improvements in health-related quality of life and work readiness suggest that increasing patients’ capacity to work is a realistic goal in the treatment of schizophrenia.
References
[1] Naber D, Hansen K, Forray C, et al. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res. 2015; 168: 498–504.
[2] Heinrichs DW, Hanlon TE, Carpenter WT, Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10:388–398
[3] Potkin SG, Bugarski-Kirola D, Edgar CJ, Soliman S, Le Scouiller S, Kunovac J, Miguel Velasco E, Garibaldi GM: Psychometric evaluation of the Work Readiness Questionnaire in schizophrenia. CNS Spectr 2014:1–8