ORLANDO, Fla.—Brexpiprazole demonstrated “robust efficacy” in the treatment of patients with schizophrenia who have severe psychotic symptoms, researchers reported at Psych Congress 2018.
A post hoc analysis of 3 short-term studies was conducted for patients with a baseline Positive and Negative Syndrome Scale (PANSS) Total score above 95, the median score of the overall patient population in the studies.
Lead researcher Nicole Meade, PhD, Senior Medical Science Liaison, Otsuka Pharmaceutical Co., Ltd., said the analysis was conducted because “oftentimes, the severity of symptoms is a key predictor of poor treatment outcomes” in patients with schizophrenia.
There were 681 patients who had severe schizophrenia at baseline, with an average baseline PANSS Total score of 106. Of those, 427 were assigned to 2-4 mg of brexpiprazole, an atypical antipsychotic, while 254 received a placebo.
The treatment group had a mean improvement in PANSS Total score of 24.03, vs 17.27 for patients receiving placebo. Efficacy was also demonstrated by a number of other measures, Dr. Meade said, with effect sizes of greater than 0.2.
The response rate was 46.9% for patients taking brexpiprazole, compared with a 27.3% response rate in the placebo group. Similar results were seen in patients with less severe symptoms, according to Otsuka, and the adverse events in each group were similar.
“Brexpiprazole is displaying efficacy in both populations,” Dr. Meade said.
The poster was sponsored by Otsuka, which markets brexpiprazole as Rexulti.
Data demonstrate safety and efficacy of brexpiprazole in patients with schizophrenia experiencing severe psychotic symptoms [press release]. Orlando, FL: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S; October 27, 2018.
Meade N, Shi L, Meehan S, Weiss C. Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe psychotic symptoms during an acute exacerbation. Poster presented at Psych Congress 2018: October 25-28, 2018; Orlando, FL. Poster 124.