Oral to Injectable Tx Switch in Patients With Schizophrenia: An Analysis
SAN ANTONIO, TX—At the U.S. Psychiatric & Mental Health Congress, study authors presented that most outpatients who started on aripiprazole lauroxil 882mg every 4 weeks remained for the entire year with completion rates ranging between 73.2% (oral aripiprazole) to 52.6% (oral olanzapine).
Healthcare professionals treating schizophrenia "may be more familiar with switching between oral antipsychotics and less familiar with changing from an oral regimen to a long-acting formulation," explained Peter J. Weiden, MD, from Alkeremes, Inc., Waltham, MA. Dr. Weiden and coauthors evaluated the safety and efficacy of switching patients from current oral antipsychotics to 1 year of monthly aripiprazole lauroxil therapy. Aristada is an extended-release injectable antipsychotic approved for the treatment of schizophrenia. The team conducted a post hoc analysis on the subgroup of a 1-year open-label safety study (n=478) that initiated aripiprazole lauroxil as stable outpatients on oral antipsychotic therapy.
Study patients cross-overed from their oral drug to 882mg monthly injection in addition to 3 weeks of oral aripiprazole 15mg during the transition. The post hoc comparison groups based on previous antipsychotic used included: oral aripiprazole (n=56), oral risperidone/paliperidone (n=52), oral conventional (n=37), oral quetiapine (n=26), and oral olanzapine (n=19).
"Initial akathisia adverse events, as well as prolactin change, study retention, symptom trajectory measured by Positive and Negative Syndrome Scale (PANSS) total score over the 1-year period were analyzed," described Dr. Weiden. To clearly assess the relationship between early-onset adverse events and discontinuation, the treatment timeline was divided into 2 phases: AL Initiation Phase (Weeks 1-4) and AL Stabilization Phase (Weeks 5-12).
Of the de novo (n=242) patients, 190 were categorized into 1 of the oral pre-switch groups based on the oral antipsychotic that they were last prescribed. Over the 1-year study period, there were 9 reported events of akathisia with none being deemed as serious. Dr. Weiden added, "There were no akathisia adverse events among the subjects whose pre-switch antipsychotic was a high- or medium-potency conventional antipsychotic."
During the AL Initiation Phase, only 3.2% of patient dropped out and by Week 12 in the AL Stabilization Phase, the aggregate drop-out was 7.9%. The odds of discontinuing therapy did not differ much fro the oral aripiprazole pre-switch group vs. other groups, the authors noted. Regarding PANSS scores, study authors observed a significant improvement in PANSS scores for those switched from oral aripiprazole after 1 year of treatment. Across the other subgroups, the course of PANSS scores did not demonstrate diminishing efficacy.
Overall, the extension phase was consistent with a maintenance drug that was acceptable to most patients in terms of tolerability and efficacy regarding weight change and prolactin elevation. Patients in the oral aripiprazole group appeared to have a more consistent profile of symptom improvement over 12 months vs. the other pre-switch oral antipsychotic groups. "The overall course of symptoms show no evidence of diminishing efficacy over time," added Dr. Weiden.