Researchers have found that in a real-world setting, patients with schizophrenia who were transitioned from once-monthly paliperidone palmitate (PP1M) to once-every-three-months paliperidone palmitate (PP3M) showed the following characteristics in the months leading up to PP3M initiation: decreased healthcare resource utilization (HRU), increased adherence to treatment closer to PP3M initiation, and persistence in their PP3M treatment. The findings were published in Current Medical Research and Opinion.1
The US Food and Drug Administration (FDA) recently approved a PP3M formulation of paliperidone palmitate for treating adults with schizophrenia who were adequately treated with PP1M for at least 4 months. While safety and efficacy were demonstrated in 2 double-blind randomized clinical trials,2,3 the researchers noted that “there is a need to better understand the characteristics and treatment patterns of patients initiating PP3M in a real-world setting.”
Neeta Tandon, PhD, from Janssen Scientific Affairs, LLC, in Titusville, New Jersey, and colleagues examined medical claims in the Symphony Health Solutions (SHS) database from May 2014 through September 2016 for adults with schizophrenia who were initiated on PP3M. Two cohorts were included: all patients initiated on PP3M and patients transitioned from PP1M based on prescribing guidelines and an adaptation of the strict clinical trial protocol for transitioning from PP1M to PP3M.
The researchers assessed baseline characteristics during the 12-month baseline period, and for each baseline quarter evaluated PP1M treatment patterns, the percentage of days covered (PDC) by mental health-related medications, and healthcare resource utilization (HRU) patterns. They assessed PP3M treatment patterns post-index.
Out of the 1545 patients initiated on PP3M (the first cohort), 68.8% of them transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition (forming the second cohort).
The researchers found that in both cohorts, the percentage of patients with a PDC of ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased. They also found that the percentage of patients with ≥1 emergency room, inpatient, and outpatient visits decreased in baseline quarters closer to PP3M initiation. In patients with follow-up for 4 or more months after the first dose, 85% to 88% had a second dose, and in patients with follow-up for 4 or more months after the second dose, 87% to 90% received a third dose.
“This retrospective observational study found that PP3M was generally administered to schizophrenia patients following the prescribing guidelines. The most common first PP3M dose strength was 819 mg (the highest dosage available) and most patients had a consistent dose for their first three PP3M claims,” the researchers wrote. “The average number of days between subsequent PP3M claims was also consistent with the recommendations.”
Many of the patients (68.8%) transitioned from PP1M to PP3M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition.2 The main reason patients were not transitioned to PP3M was because of gaps >45 days in PP1M coverage in the 4 months prior to PP3M initiation.
Summary & Clinical Applicability
“A high proportion of patients were persistent and adherent to their PP3M treatment, with more than 80% of the population having a PDC at 6 months of ≥0.80 and most of the patients having subsequent PP3M claims within 4 months of interval,” the researchers concluded.
“The results also suggest optimal adherence and persistence with PP3M, the only 3-month antipsychotic therapy option for patients suffering with schizophrenia. Further research with longer follow-up is needed to confirm treatment patterns and adherence of PP3M findings.”
Limitations & Disclosures
- The SHS database does not capture services that patients received from a provider that is outside of the SHS network
- As with all real world data sources, these data were subject to billing inaccuracies and missing data
- PDC and medication possession ratio (MPR) do not account for whether the drugs dispensed were actually taken as prescribed, which may overestimate patient adherence, especially for oral medication
- Given the limited sample with sufficient follow-up after index date, the researchers could not assess any trend on healthcare resource utilization and associated costs after PP3M initiation
This research was funded by Janssen Scientific Affairs.
KJ, BB, and NT are employees of Janssen Scientific Affairs, LLC and Johnson & Johnson. MHL, WW, BE, and PL are employees of Analysis Group, Inc., a consulting company that has received research funds from Janssen Scientific Affairs, LLC. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.
- Joshi K, Lafeuille M-H, Brown B, et al. Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once every-three-month paliperidone palmitate in the real-world setting. Curr Med Res Opin. 2017;1473-4877. doi:10.1080/03007995.2017.1359516
- 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. JAMA Psychiatry. 2015;8560:1-10.doi:10.1001/jamapsychiatry.2015.0241
- Savitz AJ, Xu H, Gopal S, et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: a randomized, multicenter, double-blind, noninferiority study. Int J Neuropsychopharmacol. 2016:1-14. doi:10.1093/ijnp/pyw018