Lumateperone in the Treatment of Schizophrenia: Efficacy in Demographic and Clinical Subgroups

Introduction: Patients with schizophrenia are a heterogenous population and understanding which factors may influence antipsychotic efficacy is important in improving outcomes. Lumateperone (ITI-007) is a novel-acting antipsychotic in development for schizophrenia, bipolar depression, and other neuropsychiatric disorders. In 2 randomized, placebo-controlled studies in patients with schizophrenia, lumateperone 42mg significantly reduced Positive and Negative Syndrome Scale (PANSS) score vs placebo. A pooled analysis evaluated the antipsychotic efficacy of lumateperone in demographic and clinical subgroups.

Methods: Data were pooled from the 2 positive studies. The primary efficacy assessment was change from baseline in PANSS score conducted in subgroups stratified by demographics (age, sex, and race) and clinical characteristics (PANSS score, depression symptoms [measured via Calgary Depression Scale for Schizophrenia, CDSS]).

Results: The efficacy of lumateperone 42mg treatment extended across all subgroups, with lumateperone 42mg improvement exceeding that of placebo. No subgroup appeared to drive the overall efficacy of lumateperone. Benefits in PANSS Total score improvement were seen in women (LSMD vs placebo=−6.99) and men (LSMD=−3.95), in patients ≤40 (LSMD=−3.82) and >40 (LSMD=−5.49) years of age, and in black (LSMD=−4.19) and white (LSMD=−5.15) patients. Treatment effects were observed in patients with baseline PANSS Total score < 88 (LSMD=−5.15) and ≥88 (LSMD=−4.48). In patients with CDSS score ≥6 at baseline, lumateperone showed marked improvement on PANSS Total score (LSMD=−8.75).

Conclusions: Lumateperone 42mg improved schizophrenia symptoms across various demographic and clinical subgroups. Improvement in PANSS score was pronounced in patients with moderate-to-severe depression at baseline suggesting potential benefits of lumateperone in treating this dimension of schizophrenia.

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