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Summary
- INVEGA TRINZA has not been studied in patients with comorbid substance abuse (SA) in a pivotal clinical trial.1
- A history of substance dependence within 6 months before screening was an exclusion criterion.
- A long-term follow-up analysis of a retrospective, observational study evaluating INVEGA TRINZA monotherapy in patients with schizophrenia, including patients with a history of SA and comorbid SA diagnosis, reported that the risks of relapse and discontinuation of treatment were not associated with a history or diagnosis of SA.2
Clinical data
Clark et al (2024)2 reported the 36-month follow-up analysis of a retrospective, noninterventional, observational study conducted on 166 patients with schizophrenia initiated on INVEGA TRINZA monotherapy between November 2016 and September 2018 in London. The primary endpoints were rates related to the continuation of INVEGA TRINZA therapy or relapse by the end of the observational period.
- Ninety-seven patients (mean [standard deviation] age, 43.5 [11.1] years; male, 71.1%) were included in the follow-up analysis.
- Among these, 52.6% had a history of SA and 9.3% were diagnosed with comorbid SA per International Classification of Diseases, Tenth Revision (ICD-10), including cannabis-related disorder (n=5), mental and behavioral disorders due to multiple drug use and use of other psychoactive substances (n=3), and mental and behavioral disorders due to use of alcohol (n=1).
- Overall, 58% of the 97 patients continued INVEGA TRINZA monotherapy at 36 months; 5% relapsed, all within the first 18 months.
- 73% and 54% of patients who discontinued and continued treatment, respectively, had a history of SA or confirmed ICD-10 diagnosis.
- The risk of treatment discontinuation or relapse was not associated with a history or diagnosis of SA (risk of discontinuation: relative risk [RR]=1.35; 95% confidence interval [CI], 0.99-1.87 and risk of relapse: RR=1.31; 95% CI, 0.82-2.10).
LITERATURE SEARCH
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 17 March 2025.
1 | Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia - a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830-839. |
2 | Clark I, Wallman P, Gee S, et al. Clinical outcomes with paliperidone palmitate 3-monthly injection as monotherapy: observational 3-year follow-up of patients with schizophrenia. Eur Psychiatry. 2024;67(1):e15. |