Recovery-Oriented Outcomes Associated with Long-Acting Injectable Antipsychotics in an Urban Safety-Net Population

Yoshimatsu, K; Elser, Andrea; Thomas, Melanie; Dilley, James; Barnes, Deborah E.; Ballinger, Alexandra; Wozniak, Steven; Mangurian, Christina

doi:10.1007/s10597-019-00412-w

Cited by 8 publications

(6 citation statements)

References 13 publications

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“…Although improvements are often measured through traditional methods, such as changes in PSP, PANSS, and CGI-S scale scores, recovery may also be assessed through other psychosocial outcome measures. For example, the San Francisco Adult Strengths and Needs Assessment score has tracked reductions in criminal behavior and improvements in spirituality among patients who switched from an oral antipsychotic medication to an LAI antipsychotic . Regardless of approach, psychosocial interventions paired with LAI antipsychotic treatment are associated with improved functioning .…”

Section: Discussionmentioning

confidence: 99%

Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia

Correll,

Johnston,

Turkoz

et al. 2024

JAMA Netw Open

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ImportanceLong-acting injectable (LAI) antipsychotics have the potential to improve adherence and symptom control in patients with schizophrenia, promoting long-term recovery. Paliperidone palmitate (PP) once every 6 months is the first and currently only LAI antipsychotic with an extended dosing interval of 6 months.ObjectiveTo assess long-term outcomes of PP received once every 6 months in adults with schizophrenia.Design, Setting, and ParticipantsIn a 2-year open-label extension (OLE) study of a 1-year randomized clinical trial (RCT), eligible adults with schizophrenia could choose to continue PP every 6 months if they had not experienced relapse after receiving PP once every 3 or 6 months in the 1-year, international, multicenter, double-blind, randomized noninferiority trial. The present analysis focused on patients receiving PP every 6 months in the double-blind trial through the OLE study (November 20, 2017, to May 3, 2022).InterventionPatients received a dorsogluteal injection of PP on day 1 and once every 6 months up to month 30.Main Outcomes and MeasuresEnd points included assessment of relapse and change from the double-blind trial baseline to the OLE end point in Positive and Negative Syndrome Scale (PANSS) total and subscale, Clinical Global Impression–Severity (CGI-S) Scale, and Personal Social Performance (PSP) Scale scores. Treatment-emergent adverse events (TEAEs), injection site evaluations, and laboratory tests were also assessed.ResultsAmong 121 patients (83 [68.6%] male), mean (SD) age at baseline was 38.6 (11.24) years and mean (SD) duration of illness was 11.0 (9.45) years. At screening of the double-blind study, 101 patients (83.5%) were taking an oral antipsychotic and 20 (16.5%) were taking an LAI antipsychotic. Altogether, 5 of 121 patients (4.1%) experienced relapse during the 3-year follow-up; reasons for relapse were psychiatric hospitalization (2 [1.7%]), suicidal or homicidal ideation (2 [1.7%]), and deliberate self-injury (1 [0.8%]). Patients treated with PP every 6 months were clinically and functionally stable, and outcomes were well maintained, evidenced by stable scores on the PANSS (mean [SD] change, −2.6 [9.96] points), CGI-S (mean [SD] change, −0.2 [0.57] points), and PSP (mean [SD] change, 3.1 [9.14] points) scales over the 3-year period. In total, 101 patients (83.5%) completed the 2-year OLE. At least 1 TEAE was reported in 97 of 121 patients (80.2%) overall; no new safety or tolerability concerns were identified.Conclusions and RelevanceIn a 2-year OLE study of a 1-year RCT, results supported favorable long-term outcomes of PP once every 6 months for up to 3 years in adults with schizophrenia.

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Section: Discussionmentioning

confidence: 99%

Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia

Correll,

Johnston,

Turkoz

et al. 2024

JAMA Netw Open

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“…17 Longer intervals of medication may also be desirable for patients who are socially isolated or less connected to the healthcare system. [18][19][20][21][22] It also can be advantageous during a health emergency such as the COVID-19 pandemic. 23,24 PP6M can reduce the need for patients with schizophrenia to attend the clinic every month or 3-months for injections, thus allowing more time for a physician to intervene and focus on other aspects of treatment to further improve quality of life.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Paliperidone Palmitate 6-Month versus Paliperidone Palmitate 3-Month Long-Acting Injectable in European Patients with Schizophrenia: A Post Hoc Analysis of a Global Phase-3 Double-Blind Randomized Non-Inferiority Study

Giron‐Hernandez¹,

Han²,

Alberio³

et al. 2023

NDT

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Purpose To examine efficacy and safety of paliperidone palmitate (PP) 6-month (PP6M) vs PP3-month (PP3M) long acting injectable (LAI) in patients with schizophrenia from European sites previously stabilized on PP3M or PP1-month (PP1M). Methods This post-hoc subgroup analysis used data from a global phase-3 double-blind (DB) randomized non-inferiority study (NCT03345342). Patients were randomized (2:1, respectively) to receive dorsogluteal injections of PP6M (700 mg eq. or 1000 mg eq.) or PP3M (350 mg eq. or 525 mg eq.) in the 12-month DB phase. Primary endpoint was time-to-relapse during the DB phase, using a Kaplan–Meier cumulative survival estimate (non-inferiority margin 95% CI lower bound larger than prespecified as −10%). Treatment emergent adverse events (TEAEs), physical examinations, and laboratory tests were also evaluated. Results A total of 384 patients who entered the DB phase were included in European sites (PP6M, n = 260; PP3M, n = 124) with a mean age similar in both groups (mean age [SD] years: PP6M, 40.0 [11.39]; PP3M, 38.8 [10.41]). Baseline characteristics were similar across both groups. The number of patients who experienced a relapse during DB phase were PP6M: 18 (6.9%) vs PP3M: 3 (2.4%) with percentage relapse-free difference of −4.9% (95% CI: −9.2%, −0.5%), thus achieving non-inferiority criteria. Secondary efficacy endpoints indicated comparable improvements. Incidence of TEAEs was similar between PP6M (58.8%) and PP3M (54.8%) groups. Nasopharyngitis, headache, increased weight, and injection-site pain were the most common TEAEs. Conclusion The efficacy of PP6M was non-inferior to that of PP3M in preventing relapse in the European subgroup previously treated with PP1M or PP3M, which was consistent with the global study. No new safety signals were identified.

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“…86 Furthermore, transitioning from oral antipsychotics to LAIs was also associated with improvements in criminal behavior, medication adherence, spirituality, and housing stability in a safety-net population of individuals experiencing trauma, homelessness, incarceration, and poverty. 87…”

Section: Effect Of Longer Acting Formulations On Other Specific Sub-p...mentioning

confidence: 99%

The Effect of Longer Dosing Intervals for Long-Acting Injectable Antipsychotics on Outcomes in Schizophrenia

Milz¹,

Benson²,

Knight³

et al. 2023

NDT

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Medication nonadherence in schizophrenia can have serious implications including relapses and hospitalization. Longacting injectable (LAI) antipsychotics require fewer administrations, while ensuring sustained medication coverage. In this review, we summarize the expected real-world benefits of longer dosing intervals in the management of schizophrenia. LAIs are associated with improved clinical outcomes of less frequent relapses and reduced functional impairment, encouraging patients to regain control of their lives. Aripiprazole lauroxil and paliperidone palmitate three-monthly (PP3M) LAIs have longer dosing intervals of 2-3 months and provide improved outcomes in patients with schizophrenia. Paliperidone palmitate six-monthly (PP6M) LAI provides the longest dosing interval, twice-yearly dosing, among existing LAIs. Decreasing the frequency of LAI administrations has the potential to reduce occurrence of serious outcomes associated with poor medication adherence. By eliminating the need for daily oral antipsychotic dosing, LAIs could increase the likelihood of patient acceptance, decrease stigma, and promote self-esteem. Longer intervals of medication coverage may be desirable for patients with higher risk of relapse including adults with recent-onset schizophrenia, those living in circumstances that may deprive them of regular access (eg, homeless), those that are in transitions between care settings or to reduce interpersonal contact during public health emergencies (eg, COVID-19 pandemic).

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Recovery-Oriented Outcomes Associated with Long-Acting Injectable Antipsychotics in an Urban Safety-Net Population

Cited by 8 publications

References 13 publications

Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia

Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia

Efficacy and Safety of Paliperidone Palmitate 6-Month versus Paliperidone Palmitate 3-Month Long-Acting Injectable in European Patients with Schizophrenia: A Post Hoc Analysis of a Global Phase-3 Double-Blind Randomized Non-Inferiority Study

The Effect of Longer Dosing Intervals for Long-Acting Injectable Antipsychotics on Outcomes in Schizophrenia

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