What are the adverse effects of Abilify Maintena in adult patients with schizophrenia over a 12-month treatment period?

The primary adverse effects of 12-month Abilify Maintena treatment included mild-to-moderate symptoms (insomnia, headache, anxiety), weight gain in up to 25.7% of patients, neurological effects in 7.2-14.3%, and serious adverse events in 14.6% of cases.

Abstract

This systematic review examined the adverse effects of Abilify Maintena (aripiprazole once-monthly) in adult patients with schizophrenia over a 12-month treatment period. The review included 40 studies of various designs, including randomized controlled trials, observational studies, and systematic reviews, with sample sizes ranging from 15 to over 3,000 participants and study durations from 12 weeks to 6 years.

The most commonly reported adverse events were insomnia, headache, anxiety, akathisia, weight changes, and injection site pain. The frequency of these events varied across studies, with most being reported as mild to moderate in severity. Serious adverse events were relatively rare, with one study reporting serious adverse drug reactions in 14.6% of patients.

Metabolic effects, particularly weight changes and alterations in lipid profiles, were observed but generally less pronounced compared to some other antipsychotics. Clinically significant weight gain (≥7% increase) was reported in 11.2% to 25.7% of patients across different studies. Neurological effects, including akathisia and extrapyramidal symptoms, were reported at rates ranging from 7.2% to 14.3%.

Treatment discontinuation rates varied across studies, ranging from 14.28% to 41%, but were generally lower than those reported for oral antipsychotics. Common reasons for discontinuation included lack of efficacy, patient/caregiver choice, and adverse events. Notably, several studies reported good long-term persistence with Abilify Maintena, with one study finding that 69.6% of patients continued treatment over a four-year follow-up period.

Overall, the evidence suggests that Abilify Maintena has a generally favorable safety and tolerability profile in adult patients with schizophrenia over a 12-month treatment period. However, clinicians should monitor patients for a range of potential side effects, particularly weight changes, metabolic parameters, and neurological effects. The variability in study designs, populations, and reporting methods highlights the need for further long-term, head-to-head comparisons with other antipsychotics to fully elucidate the safety profile of Abilify Maintena.

Methods

We analyzed 40 sources from an initial pool of 490, using 7 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question.

Papers identified with Elicit search

• n = 490

Papers screened using: Population Age and Diagnosis, Intervention, Study Duration, Outcomes, Study Design, Sample Size, Study Type

• n = 490

Papers screened out

• n = 444

Papers included for extraction

• n = 46

Data extraction

We asked a large language model to extract each data column below from each paper. We gave the model the extraction instructions shown below for each column.

• Study Design:
  • Describe the specific type of study design used:
  • Specify if it is a randomized controlled trial, prospective cohort, observational study, etc.
  • Note any key design features (e.g., double-blind, open-label, naturalistic)
  • If multiple phases are present, describe each phase briefly.
• Sample Size and Patient Population:
  • Record:
    • Total number of participants enrolled
    • Number of participants who completed the study
    • Diagnostic criteria for schizophrenia (if specified)
    • Key demographic characteristics (age range, gender distribution)
• Intervention Details:
  • Specify:
    • Exact medication (Abilify Maintena/aripiprazole once-monthly)
    • Dosage
    • Administration method (injectable)
    • Duration of treatment
• Adverse Effects:
  • Systematically extract:
    • Types of adverse effects reported
    • Frequency of each adverse effect
• Outcome Measurements:
  • List all outcome measures used to assess patient response and adverse effects.

Results

Characteristics of Included Studies

• Study Design: Randomized-controlled trials, observational and mirror-image studies.
• Population Size: Range from 15 to 3,000 participants.
• Duration: Varied from 12 weeks to 6 years.
• Primary Outcomes: Adverse effects and safety outcomes.

Treatment-Emergent Adverse Events

• Most Commonly Reported Adverse Events:
  • Weight gain (up to 25.7%)
  • Insomnia (up to 22%)
  • Akathisia (up to 11%)
  • Headache (up to 7.6%)

Serious Adverse Events

• Frequency ranged from 8% to 20% across studies that reported this information.

Metabolic Effects

• Clinically significant weight gain (≥7%) in 11.2-25.7% of patients.

Neurological Effects

• Akathisia in 7-11%, Parkinsonism in 10.5%, and tardive dyskinesia at a low rate (1.8%).

Treatment Discontinuation Patterns

• Discontinuation rates ranged from 14.28% to 41% for Abilify Maintena.
• Common reasons included lack of efficacy and adverse events.