Effect of Lurasidone on Life Engagement in Schizophrenia: Post-Hoc Analysis of the JEWEL Study

Hidenori Maruyama,1 Fumiya Sano,2 Reiko Sakaguchi,3 Keisuke Okamoto,4 Itaru Miura5 1Medical Science, Sumitomo Pharma Co., Ltd, Osaka, Japan; 2Department of Data Science, Drug Development Division, Sumitomo Pharma Co., Ltd, Tokyo, Japan; 3Department of Clinical Research, Drug Development Division, Sumitomo Pharma Co., Ltd, Tokyo, Japan; 4Department of Clinical Operation, Drug Development Division, Sumitomo Pharma Co., Ltd, Tokyo, Japan; 5Department of Neuropsychiatry, Fukushima Medical University, Fukushima, JapanCorrespondence: Hidenori Maruyama, Tel +81-80-4368-2576, Fax +81-6-6203-5733, Email hidenori.maruyama@sumitomo-pharma.co.jpPurpose: To evaluate the effect of lurasidone on a new, patient Life Engagement scale in schizophrenia.Patients and Methods: This post-hoc analysis included participants (ages 18 to 74) diagnosed with schizophrenia who were randomized to lurasidone (40 mg/day) or placebo in a 6-week double-blind efficacy study and those who continued in a subsequent 12-week open-label extension study during which patients received either 40 or 80/mg day lurasidone (flexibly dosed). Change in life engagement was measured using the Positive and Negative Syndrome Scale (PANSS) 11-item Life Engagement subscale score, and individual subscale items, at week 6 during the double-blind phase and extension phase week 12 during the open-label extension phase.Results: Analysis focused on 478 subjects randomized to lurasidone or placebo during the 6-week trial, and 146 who received lurasidone during the extension phase. During the 6-week trial, there was a significantly greater change on the PANSS11 Life Engagement subscale score from baseline to week 6 in the lurasidone group compared to the placebo group (mean changes of − 6.4 and − 4.8, respectively, p = 0.006; effect size = 0.27). Further improvement was evident during the extension phase for patients who received lurasidone in both phases, with a mean change from double-blind baseline to week 12 of the open-label treatment phase of − 10.1 on in PANSS11 Life Engagement subscale.Conclusion: This post-hoc analysis suggests that lurasidone may improve life engagement in patients with schizophrenia, a meaningful outcome from patients’ perspective. Further studies are needed to confirm this effect.Eudract Number: Trial registration: EudraCT Numbers: 2016-000060-42; 2016-000061-23.Keywords: lurasidone, schizophrenia, antipsychotic agents, life engagement, efficacy