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ORLANDO, FL — Brexpiprazole demonstrated efficacy and safety in patients with severe psychotic symptoms, similar to results found in patients who were less severely ill, according to research presented at US Psych Congress 2018, October 25 to 28 in Orlando, Florida.
For this poster presentation, researchers reported a post hoc analysis from 3 short-term studies of brexpiprazole: VECTOR (NCT01396421), BEACON (NCT01393613), and LIGHTHOUSE (NCT01810380). In this pooled analysis, the efficacy of brexpiprazole was evaluated in patients with schizophrenia and severe psychotic symptoms during an acute exacerbation.
In the VECTOR study, patients were randomly assigned to either oral placebo or brexpiprazole 0.25 mg, 2 mg, or 4 mg once daily (2:1:2:2). In the BEACON study, participants received oral placebo or brexpiprazole 1 mg, 2 mg, or 4 mg once daily (3:2:3:3). Those in the LIGHTHOUSE study were given oral placebo or brexpiprazole 2 to 4 mg/day or quetiapine XR 400 to 800 mg/day (1:1:1). Patients with symptoms of severe psychosis were defined as those with baseline Positive and Negative Symptom Scale (PANSS) total score >95 (the median score at baseline), which corresponds with a Clinical Global Impression-Severity (CGI-S) score of markedly ill.
The 3 studies had similar designs, therefore, pooled efficacy and functioning data analyses were conducted and grouped according to baseline symptom severity. Low-dose brexpiprazole (0.25 mg and 1 mg) and quetiapine XR treatment groups were not included in this analysis. Data were analyzed using a mixed model repeated measures (MMRM) with treatment, visit, treatment visit interaction, protocol, trial center within protocol, baseline value, and baseline visit interaction as covariates. A Cochran-Mantel-Haenszel (CMH) test was used in statistical analysis for responder rates, controlling for protocol (last observation carried forward; LOCF).
A total of 681 patients had severe psychotic symptoms of schizophrenia at baseline (PANSS total >95), and 724 patients were less severely ill at baseline (PANSS total ≤95). The average total score of severely ill patients receiving adjunctive brexpiprazole 2 to 4 mg was 105.8 for the severely ill group and 86.6 for the less severely ill group.
At 6 weeks of treatment, the researchers found that severely ill patients treated with adjunctive brexpiprazole had a greater reduction in PANSS total scores (mean change from baseline: -24.03) and CGI-S scores (mean change from baseline: -1.23) compared with patients treated with placebo (mean change from baseline PANSS placebo group: -17.27; mean change from baseline CGI-S placebo group: -0.9). Similar results were found in patients who were less severely ill.
Brexpiprazole demonstrated safety in this population, with similar incidences of treatment-emergent adverse events in patients receiving brexpiprazole and placebo. The average dose of brexpiprazole in severely and less severely ill patients was 2.7 mg/day.
“Brexpiprazole demonstrated robust efficacy in the treatment of the subgroup of patients experiencing severe psychotic symptoms at baseline. Clinically meaningful findings with brexpiprazole 2-4 mg were demonstrated for the PANSS Total, PANSS Marder factors, the PANSS Positive and PANSS Negative subscales, [Personal and Social Performance] scores, the CGI-S, and responder rates,” the researchers concluded. “This analysis showed that brexpiprazole was safe and well tolerated in patients with severe psychotic symptoms.”
Nicole Meade, PhD, senior medical science liaison for Otsuka, spoke to Psychiatry Advisor regarding the importance of this post hoc, pooled analysis of patients with schizophrenia treated with brexpiprazole who experience psychotic symptoms during an acute episode.
“Schizophrenia is a lifelong chronic heterogeneous disease and oftentimes a key predictor to poor clinical outcomes or the severity of symptoms at baseline.” She added that this information is important to note when choosing a treatment option for patients with schizophrenia who have severe psychotic symptoms during an acute episode at baseline. Efficacy was observed across a variety of measures in patients treated with brexpiprazole, including PANSS scores and CGI-I scores, and the safety profile was consistent with previous data. This information “provides healthcare professionals empirical data to help their decision making when treating patients with a similar profile.”
Disclosures: Nicole Meade, Lily Shi and Catherine Weiss are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA. Stine R. Meehan is a full-time employee of H. Lundbeck A/S, Valby, Denmark.
Funding/support: Supported by funding from Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA and H. Lundbeck A/S, Valby, Denmark.
Meade N, Shi L, Meehan SR, Weiss C. Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe psychotic symptoms during an acute exacerbation. Presented at: US Psych Congress 2018; October 25-28, 2018; Orlando, FL. Poster 124.