ORLANDO, Fla. — Rexulti was safe and well tolerated in patients experiencing severe psychotic symptoms at baseline, according to poster data presented at Psych Congress.
Analysis revealed that Rexulti (brexpiprazole, Otsuka) 2 mg to 4 mg demonstrated clinically meaningful findings on the Positive and Negative Syndrome Scale total score.
“Unfortunately, schizophrenia is often challenging to treat, and the severity of a patient’s schizophrenia symptoms can be a key predictor of poor treatment outcomes,” Nicole Meade, PhD, from Otsuka Pharmaceutical Development and Commercialization Inc., told Healio Psychiatry. “We conducted this research to further understand the safety and efficacy of Rexulti in patients with schizophrenia experiencing severe psychotic symptoms during an acute episode.”
Meade presented post hoc analysis data from three short-term studies of Rexulti — Vector, Beacon and Lighthouse studies — that examined its efficacy in a group of patients with schizophrenia presenting with severe psychotic symptoms during an acute exacerbation.
Patients were randomized to receive oral placebo or brexpiprazole 0.25 mg, 2 mg or 4 mg once daily in Vector; to receive oral placebo or brexpiprazole 1 mg, 2 mg or 4 mg once daily in Beacon; and to receive oral placebo, or brexpiprazole 2 mg to 4 mg/day or quetiapine XR 400 mg to 800 mg/day in Lighthouse.
Because the three studies had similar designs, the researchers conducted pooled efficacy and functioning data analyses, which were grouped by baseline symptom severity. The investigators pooled analyses of patients randomized to fixed-dose brexpiprazole 2 mg or 4 mg, or to flexible-dose brexpiprazole 2 mg to 4 mg, as well as patients randomized to placebo. They assessed change on the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Severity scale (CGI-S) and responder rates.
In total, 681 patients had severe psychotic symptoms of schizophrenia and 724 patients were less severely ill at baseline. The results showed that mean PANSS Total score for patients receiving adjunctive brexpiprazole 2 mg to 4 mg was 105.8 for the severely ill group compared with 86.6 for those who were less severely ill, with similar scores found in the equivalent placebo groups.
Meade and colleagues found that severely ill patients treated with adjunctive brexpiprazole experienced a greater decrease in PANSS Total scores and CGI-S scores compared with patients who received placebo at 6 weeks of treatment. Patients who were less severally ill had similar results. Furthermore, patients with severe illness receiving adjunctive brexpiprazole showed clinically meaningful improvements in PANSS Total score, PANSS Positive, PANSS Negative subscale and CGI-S scores compared with placebo.
Patients with severe illness taking adjunctive brexpiprazole showed greater improvement than those receiving adjunctive placebo across all Marder factors and Profile of Emotional Competence (PEC) score, while those with less severe illness had shown improvement in most Marder factors and PEC score. In addition, the overall response rates were greater for severely ill patients receiving brexpiprazole after 6 weeks compared with those receiving placebo. The results were similar for patients with less severe illness as well.
The incidence of treatment-emergent adverse events among severely ill patients was similar across the placebo and adjunctive brexpiprazole treatment groups, the results showed. Some of these adverse events included insomnia, headache and agitation.
“The results from the study ... underscore the potential of Rexulti as an effective treatment option with a safety profile that can provide physicians the confidence to prescribe schizophrenia patients with varying degrees of the disease and symptoms, including those with more severe psychotic symptoms,” Meade told Healio Psychiatry. – by Savannah Demko
Meade N, et al. Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe psychotic symptoms during an acute exacerbation. Presented at: Psych Congress; Oct. 25-28, 2018; Orlando, Fla.
Disclosure: Meade is an employee of Otsuka Pharmaceutical Development and Commercialization Inc.