Study confirms efficacy of initiating Tx in hospital


SAN DIEGO— In a cohort analysis of long-acting injectable atypical antipsychotics, Aristada (aripiprazole lauroxil) initiated with a single oral loading dose of aripiprazole 30 mg was as effective as paliperidone palmitate (PP) for treatment of acutely ill schizophrenia patients. 

Moreover, initiating Aristada with the 1 day dose of oral aripiprazole was as effective as Aristada initiated with 21 days of oral aripiprazole, researchers reported here at Psych Congress 2019

This new analysis compared matched cohorts–one treated with Aristada initiated with a single loading dose, to a cohort of PP treated patients, and finally to patients treated with Aristada initiated with 21 days of oral aripiprazole.

When the FDA first approved Aristada, it required the 21-day oral supplementation schedule with the first intramuscular dose. 

Patients were adults age 18-65 who were hospitalized for acute exacerbations of schizophrenia. Entry criteria included a baseline Positive and Negative Syndrome Scale (PANSS) score of “80 to 120 with a score of 4 or higher for 2 or more of the Positive Scale items: 1 (delusions), 2 (conceptual disorganization), 3 (hallucinatory behavior) or 6 (auspiciousness/persecution),” the researchers wrote.

Sergey Yadoda, MD, PhD, associate medical director at Alkermes, told BreakingMED that the main objective of the study was to confirm the efficacy of the 1-day dosing alternative. The study was not powered to demonstrate either superiority or non-inferiority to PP, but there were some interesting findings from the head-to-head study. 

For example, in the Aristada group, 13 of 97 patients experienced a weight gain of 7% of baseline weight (13.4%) versus 31 of 101 patients in the PP arm (30.7%). Weight loss, as expected, was rare in either arm but did occur more frequently among patients treated with Aristada: six of 97 patients (6.2%) versus two of 101 patients (2.0%). 

In the Aristada group, patients received a single dose of Aristada and single oral aripiprazole on day 1 and then their first IM 1,064 mg Aristada injection on day 8 — but placebo gluteal injections (to match PP) were administered on day 1 and day 8. Aristada was continued at 1,064 mg every 8 weeks, with placebo injections added every 4 weeks (again to match the every 4-week dosing of PP). 

Patients in the PP arm received a 234 mg injection on day 1 followed by 156 mg on day 8. “Gluteal IM placebo injections were administered on days 1 and 8 to maintain the blind. The PP regimen was continued with 156 mg gluteal IM injections on an every-4-weeks schedule (weeks 5, 9, 13, 17, and 21),” the authors wrote. 

In both arms, no oral antipsychotics were permitted after day 1 and all patients were discharged after 2 weeks.

Among the findings:

  • In both treatment arms, patients had significant reductions in PANSS score by week 4.
  • Within group reductions in PANSS total score were also significant at weeks 9 and 25 in both treatment groups.
  • Both regimens were well-tolerated.

The take home message, Yadoda said, was that “both regimens can be used effectively to initiate treatment among hospitalized patients— treatment that can continue on an outpatient basis.”

 

Written by Peggy Peck, Editor-in-Chief, BreakingMED, is a service of @Point of Care, LLC, which provides daily medical news reports curated to serve the unique needs of busy physicians and other healthcare professionals.