Long-Acting Injectables Yield Similar Benefit in Schizophrenia

Megan Brooks

April 11, 2019

Topline results of the ALPINE study show the value of two long-acting injectable antipsychotics — aripiprazole lauroxil (Aristada, Alkermes) and paliperidone palmitate (Invega Sustenna, Janssen) — when initiated in hospitalized patients suffering an acute exacerbation of schizophrenia, with continued treatment in the outpatient setting.

Patients receiving aripiprazole lauroxil once every 2 months experienced  similar improvements in schizophrenia symptoms as those receiving paliperidone palmitate once per month, and the efficacy was similar for both medications throughout the 6-month study.

"This research provides evidence that these two long-acting medicines, each with their own distinct safety and tolerability profile, may be clinically useful in helping to bridge the critical transition between inpatient and outpatient settings of care," Craig Hopkinson, MD, Alkermes chief medical officer, said in a news release announcing the results.

The ALPINE study was a multicenter, randomized, double-blind, phase 3b study testing the efficacy, safety, and tolerability of aripiprazole lauroxil and paliperidone palmitate in 200 patients experiencing an acute exacerbation of schizophrenia. The study had a 2-week inpatient phase, during which all patients were started on either drug, followed by an outpatient phase for a total of 6 months.

Patients randomly assigned to the aripiprazole lauroxil group were started using the Aristada Initio regimen — comprised of aripiprazole lauroxil (675 mg) plus a single 30-mg oral dose of aripiprazole — on day 1, followed by aripiprazole lauroxil (1064 mg) on day 8 and every 2 months thereafter. 

Patients randomly assigned to the paliperidone palmitate arm received an initiation dose of the drug (234 mg) on day 1, followed by a dose of 156 mg on day 8 and every month thereafter.

The study met its prespecified primary endpoint, demonstrating statistically significant (P < .001) and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores with both antipsychotics at week 4, with further significant (P < .001) reductions at week 9 and week 25 (secondary endpoints).

Table. Change (Reduction) in PANSS Total Score

 

Aripiprazole lauroxil

Paliperidone palmitate

Week 4

-17.4

-20.1

Week 9

-19.8

-22.5

Week 25

-23.3

-21.7

 

Improvements in PANSS total scores from baseline were similar and not statistically different between treatment groups at any assessment time point during the study, the company said.

The most common adverse events reported in both treatment groups were were injection site pain (17.2% with aripiprazole lauroxil; 24.8% with paliperidone), increase in weight (9.1% and 16.8%, respectively) and akathisia (9.1% and 10.9%, respectively). Overall, 56.6% of patients in the aripiprazole lauroxil group and 42.6% of those in the paliperidone palmitate group completed the 6-month study.

"People living with schizophrenia face a complex treatment system and countless challenges that can disrupt continuity of care and make them vulnerable to relapse and re-hospitalization," Jelena Kunovac, MD, founder and president of Altea Research and one of the ALPINE study investigators, said in the news release.

"The results from ALPINE validate the role that long-acting atypical antipsychotics can play in rapidly and effectively stabilizing patients in the hospital and supporting their continuity of care after discharge. The ability to start and stay on effective medication is essential to helping patients and caregivers achieve long-term treatment goals," added Kunovac.

Alkermes plans to submit results from the ALPINE study to peer-reviewed journals for publication and present full study results — including efficacy, safety, tolerability, and exploratory analyses — at upcoming scientific meetings.

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