Long-term quality of life of adults with schizophrenia treated with subcutaneous long-acting injectable olanzapine (TV-44749): SOLARIS phase 3 results

Background

Use of long-acting injectable antipsychotics (LAIs) for schizophrenia can improve adherence and clinical outcomes versus oral antipsychotics. Olanzapine is available in oral and intramuscular (IM) formulations; however, IM LAI olanzapine pamoate is limited by post-injection syndrome risk and post-injection monitoring requirements. TV-44749 is an investigational subcutaneous LAI olanzapine using copolymer delivery technology to provide sustained efficacy over monthly dosing and avoid post-injection syndrome risk. SOLARIS (NCT05693935), a Phase 3 trial assessing efficacy, safety, and tolerability of TV-44749 in adults with schizophrenia, met its primary and key secondary endpoints with no new safety signals. This analysis assessed long-term quality of life (QoL) of SOLARIS participants.

Methods

SOLARIS comprised an 8-week, randomized, double-blind, placebo-controlled period (P1) followed by an open-label safety period of ≤48 weeks (P2). Adult participants with acute schizophrenia exacerbation (≤8 weeks prior to screening) were randomised 1:1:1:1 to once-monthly TV-44749 (318 mg, 425 mg, or 531 mg) or placebo in P1. In P2, participants receiving TV-44749 continued their assigned dose, and participants previously receiving placebo were re-randomised 1:1:1 to once-monthly TV-44749 318 mg, 425 mg, or 531 mg. Exploratory P2 endpoints included change from baseline to end of treatment (EoT) in the schizophrenia QoL scale (SQLS; total score; psychosocial feelings subscale score; cognition and vitality subscale score), 3-Level EuroQol 5-Dimension Questionnaire (EQ-5D-3L; a descriptive instrument measuring self-rated health status across mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and EuroQol Visual Analog Scale (EQ-VAS). Analyses included participants completing P2 at any time, and those receiving ≥10 TV-44749 injections with an EoT visit.

Results

There were 423 participants in P2 (318 mg, n=140; 425 mg, n=142; 531 mg, n=141); 72% were male and the mean age was 44.8 years. Participants previously receiving placebo had higher P2 baseline symptom severity. The TV-44749 total group showed a mean (SD) reduction in SQLS total score from P2 baseline to EoT of −3.6 (15.8). Similar improvements were noted in psychosocial feelings (−3.9 [17.7]) and cognition and vitality (−3.2 [15.5]) subscales. Improvements in EQ-5D-3L domains, particularly self-care and usual activities, were observed, with reductions of 8% and 21%, respectively. Improvements in EQ-VAS from P2 baseline to EoT were observed for the TV-44749 total group, with a mean (SD) change of 1.6 (16.9). Mean change in SQLS total and EQ-5D-3L VAS scores from P2 baseline to EoT were similar for EoT at any time and EoT among participants who received ≥10 TV-44749 injections in P2 and completed an EoT visit. Greater improvements in SQLS and EQ-VAS from P2 baseline were observed in participants previously receiving placebo than in those who had received TV-44749 in P1, likely due to higher P2 baseline symptom severity. Over time, all participants achieved comparable absolute scores across scales, regardless of P1 treatment assignment.

Conclusions

Continuous improvements in QoL measures from SOLARIS P2 baseline were maintained over time following treatment with TV-44749; this included self-rated health status measures that are relevant to individuals with schizophrenia. These exploratory findings support the potential value of TV-44749 for the long-term treatment of schizophrenia in adults.

References

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