Paliperidone palmitate may reduce schizophrenia treatment failure in Black patients

Paliperidone palmitate appeared to benefit Black patients with recent-onset schizophrenia or schizophreniform disorder, according to study results presented at NEI Congress.

“In this poster, we present the results of a post-hoc analysis evaluating the effectiveness and safety of paliperidone palmitate compared with oral antipsychotics in the Black/African American subset of patients in the [Disease Recovery Evaluation and Modification (DREaM)] study,” H. Lynn Starr, MD, group medical director and schizophrenia area lead at Janssen Scientific Affairs, said during a virtual presentation. “The DREAM study was a prospective, match-controlled, double randomized, open label, flexible dose multicenter study.”

Starr and colleagues noted that Black participants have been underrepresented in clinical trials, and that racial disparities affect schizophrenia diagnosis and treatment. The DREAM study consisted of part one, which included a 2-month oral run-in; part two, which included a 9-month disease progression phase; and part three, which included 9 months of additional treatment.

The study also featured an 18-month extended disease phase. Starr and colleagues focused on this phase during their analysis. They used the Kaplan-Meier method to estimate cumulative distribution functions of time to first treatment failure. They analyzed data of 42 Black participants (men, 69%; mean age, 23 years), of whom 17 received paliperidone palmitate and 25 oral antipsychotics.

Results showed fewer treatment failures among the paliperidone palmitate group (25.3%) compared with the oral antipsychotic group (44%), with a 55% reduction in the former vs. the latter group (HR = 0.45; 95% CI, 0.14-1.42); however, this reduction was not statistically significant because of the small sample size. Discontinuation of treatment because of safety or tolerability represented the common reason for first treatment failure in the paliperidone palmitate group (11.8%), whereas psychiatric hospitalization (16%) and deliberate self-injury or suicidal/homicidal ideation (16%) were the most common among the oral antipsychotic group.

Treatment emergent adverse events occurred among 88.2% and 92% of participants in the paliperidone palmitate and oral antipsychotic groups, respectively, with weight increase the most common among both groups.

“These findings highlight the potential benefit of treatment with paliperidone palmitate in Black/African American patients with recent onset schizophrenia or schizophreniform disorder,” Starr said.