Overview:
A new study recently published in Therapeutic Advances in Psychopharmacology leveraged the NeuroBlu Database to create an external comparator arm (ECA) using EHR-derived data for patients with schizophrenia. Johnson & Johnson Innovative Medicine conducted the study, in collaboration with Holmusk, which examined the effectiveness of different formulations of paliperidone palmitate (PP), a long-acting injectable (LAI), comparing an ECA to a open label extension (OLE) clinical trial arm. The design of this study underscores the utility of using real-world evidence to assess outcomes among patients in routine clinical settings to supplement clinical trials.
Impact:
Patients with schizophrenia, especially patients who are non-adherent to antipsychotic treatment, experience recurrent relapses that inhibit long-term cognitive and social functioning. Non-adherence and inconsistent medication use in the real-world limits the applicability of treatment benefits demonstrated in clinical trials. Patients in the real world typically experience higher illness severity and a high number of comorbidities and thus are often excluded from clinical trials due to stringent inclusion and exclusion criteria. Studies that incorporate real-world data are more inclusive of a broader range of patients, not just patients who meet clinical trial criteria and participate in studies.
The atypical antipsychotic paliperidone palmitate (PP) is a long-acting injectable (LAI) indicated for monotherapy and adjunctive treatment of adult patients with schizophrenia. In this study, data from patients receiving PP1M or PP3M for the treatment of schizophrenia in routine clinical practice were used in an ECA to evaluate the comparative effectiveness of PP6M in an OLE study. The ECA was derived from the NeuroBlu database, which provided a contemporaneous patient pool closely mimicking that of the PP6M OLE study. This type of study design makes it possible to compare patient outcomes in highly controlled trial settings to outcomes in real-world clinical settings.
To read the full manuscript and study findings, visit the journal online.
Turkoz I, Wong J, Chee B, et al. Comparative effectiveness study of paliperidone palmitate 6-month with a real-world external comparator arm of paliperidone palmitate 1-month or 3-month in patients with schizophrenia. Therapeutic Advances in Psychopharmacology. 2023;13. doi:10.1177/20451253231200258
