5 results
Characterization and Treatment Goals of Patients on Long-Acting Injectable vs Oral Antipsychotics: Results from a Patient/Caregiver/Psychiatrist Survey
- Heather M. Fitzgerald, Jason Shepherd, Hollie Bailey, Mia Berry, Jack Wright, Maxine Chen
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- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, p. 154
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Background
Patient preferences in schizophrenia (SCZ), including identification of key goals and outcomes for treatment and relative importance of certain treatment goals to patients, have been assessed by several studies. However, there continues to be a lack of sufficient evidence on US patient attitudes and perceptions towards treatment goals and pharmacotherapy options in SCZ, especially taking into context long-acting injectable antipsychotics (LAIs) in this disease area. This lack of evidence is further pronounced in caregivers of individuals with SCZ. The objective of this analysis was to characterize patients with SCZ on LAIs vs patients on oral antipsychotics (OAPs) and evaluate the treatment goals of patients in each group.
MethodsThis was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old with a diagnosis of SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology, which has been previously published. Psychiatrists (n=120) completed detailed record forms for next 8 consecutive outpatients and 2 inpatients matching inclusion criteria, including non-interventional clinical and subjective assessments. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.
ResultsOf 1135 patients on treatment where the physician provided survey data; 251 were on an LAI, and 884 were on an OAP. Mean (SD) time to SCZ diagnosis for those on an LAI was 10.3 (12.0) years vs 7.8 (10.5) years for those on OAPs. More patients in the LAI vs OAP group were being treated as an inpatient (27.1% vs 15.7%, respectively; p<0.0001). Patients on an LAI reported being on their current medication regimen for less time (mean 1.7 years) vs those on OAPs (mean 2.5 years) (p=0.0093). More patients on LAIs were unemployed due to disability vs those on OAPs (56.1% vs 39.5%, respectively), and less patients on LAIs were able to work part-time or full-time (21.1% or 4.1%) vs those on OAPs (23.2% or 11.4%). More patients on an LAI had a caregiver vs those on OAPs (37.3% vs 26.1%, respectively; p=0.0011). Regarding the most important treatment goals reported by patients, both groups reported similar preferences for decrease in disease symptoms (62% on LAI vs 65% on OAPs) and thinking more clearly (53% on LAI vs 46% on OAPs); however, a numerically higher proportion of LAI patients reported that the current medication helped decrease hospitalizations due to relapse vs those on OAPs (38% vs 32%, respectively).
DiscussionGiven the characteristics of patients participating in this real-world survey, those on LAIs exhibited qualities which indicate a higher severity of illness vs those on OAPs. Results suggest that treatment with LAIs is still mainly being provided to patients later in the disease course and/or who have adherence problems, despite a growing body of evidence of utility in younger patients earlier in the course of illness.
FundingOtsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck LLC
Analysis of Treatment Goals for Patients with Schizophrenia: A US Survey of Psychiatrists, Patients with SCZ and Caregivers
- Maxine Chen, Jason Shepherd, Hollie Bailey, Jack Wright, Heather M. Fitzgerald
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- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, p. 158
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Objectives
Objectives for this survey are to determine similarities or differences in treatment goals reported by psychiatrists, patients with schizophrenia (SCZ) and caregivers in the US, as well as whether goals differed by patients currently on an oral antipsychotic (OAP) or long-acting injectable (LAI), and whether goals differed by age.
MethodsThis was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old diagnosed with SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology. Psychiatrists (n=120) completed detailed record forms for next 8 outpatients and 2 inpatients matching inclusion criteria. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.
ResultsResponses on treatment goals were collected from psychiatrists for all patients included in the analysis (n=1161), patients (n= 542) and caregivers (n=130). Among 3 top goals, psychiatrists, patients and caregivers concurred that “decrease in disease symptoms” is most important (63%, 64%, 68% respectively). For psychiatrists and caregivers, second was “decrease in hospitalization for relapse” (41%, and 38% respectively), whereas for patients, it was “thinking clearly” (47%). Of the 3 least important goals, psychiatrists, patients and caregivers agreed with “sexual problems” (59%, 43%, 44%, respectively) and “weight gain” (38%, 44%, 38%, respectively).
When asked which goals were met by current medication, patients responded “decrease in disease symptoms” (68%) and “thinking clearly” (39%). However, caregivers responded “thinking clearly” (30%) was not met by current medication. Caregivers most important goals, “decrease in disease symptom” (70%) and “decrease in hospitalization for relapse” (41%), were met. Additional analyses of patients on OAPs and LAIs, did not show differences in goals. However, “decrease in disease symptoms” was numerically more important for patients on LAIs vs OAPs according to psychiatrists (68% vs 62%) and caregivers (77% vs 70% respectively). Caregivers responded “decrease in hospitalization for relapse” was met for 63% patients currently on an LAI and 35% OAP. No major differences in treatment goals were observed by patient age (18–35 vs 36–65 vs >65 years).
DiscussionThere is consensus among US psychiatrists, patients and caregivers on the most important treatment goal “decrease in disease symptoms”, regardless of patients’ current medication or age. For patients, “thinking more clearly” was second, compared with “decrease in hospitalization due to relapse”, for psychiatrists and caregivers. All agreed that least important treatment goals, related to AEs, were “weight gain” and “sexual problems”. More caregivers agreed “decrease in hospitalization for relapse” was met by patients on LAIs vs OAPs. These findings may help with discussions between psychiatrists, patients and caregivers.
FundingLundbeck LLC and Otsuka Pharmaceutical Development & Commercialization, Inc.
155 Symptom Stability in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study
- Jessica J Madera, Pedro Such, Maxine Chen, Ross A Baker
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, p. 299
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Introduction:
Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).
Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.
Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.
Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.
Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.
Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.
154 Functioning in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study
- Jessica J Madera, Pedro Such, Maxine Chen, Ross A Baker
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, pp. 298-299
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Introduction:
Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).
Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.
Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.
Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.
Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.
Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.
47 Sustained Functional Recovery and Symptom Remission After Maintenance Treatment with Aripiprazole Once-Monthly for Patients with Bipolar I Disorder
- Eduard Vieta, Ross A. Baker, Jessica J. Madera, Peter Zhang, Pedro Such, Maxine Chen, Joseph Calabrese
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 201-202
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Study Objectives
To report functional recovery, symptomatic remission, and sustained symptomatic remission rates after treatment with aripiprazole once-monthly 400mg (AOM 400) administered every 4weeks for up to 52weeks as maintenance treatment in a mixed cohort of AOM 400 naïve (de novo) and experienced adults (rollover) with bipolar I disorder (BP-I).
MethodThis open-label study (NCT01710709) enrolled de novo patients with a diagnosis of BP-I and ≥1 previous manic or mixed episode and rollover patients who completed a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of AOM 400 (NCT01567527). Efficacy was assessed by mean changes from baseline in Young-Mania Rating Scale (YMRS), Montgomery-Asberg Depressive Rating Scale (MADRS), and Clinical Global Impression- Bipolar Version-Severity of Illness (CGI-BP-S) scores. Sustained functional recovery was defined as a total score of ≤11 on the Functioning Assessment Short Test (FAST) for ≥8 consecutive weeks. Remission was defined as YMRS and MADRS total scores ≤12, and sustained remission was defined as meeting criteria for remission for 8 consecutive weeks. The study included a screening phase (6weeks) for de novo patients, an oral aripiprazole conversion phase (4–6weeks), an oral stabilization phase (4–12weeks), and an AOM 400 maintenance phase (up to 52weeks). Rollover patients entered directly into the AOM 400 maintenance phase.
ResultsA total of 464 subjects entered the maintenance phase and 63% (291/464) completed the trial. Of patients entering the maintenance phase, 379 (82%) were de novo and 85 (18%) were rollover. The most frequent reasons for discontinuation were withdrawal of consent (11%) and adverse events (AEs) (10%). Weight increase (1.5%, 7/464) and BP-I (0.9%, 4/464) were the most common reasons for discontinuation due to AEs. Improvements in mean YMRS, MADRS, CGI-BP-S, and FAST scores achieved in previous phases were maintained over 52weeks. Treatment-emergent AEs experienced by >10% of the patients were akathisia (14.7%), weight increased (13.4%), nasopharyngitis (12.1%), and insomnia (11.0%). A high proportion of de novo patients met the criteria for symptomatic remission (87.2%, 328/376) and sustained remission (77%, 292/379) by last visit. Rollover patients’ remission rate remained stable (98.8%, 84/85) by last visit. Of the rollover patients, 35/85 (43%) and 35/116 (36%) of de novo subjects met the criteria for sustained functional recovery after study completion.
ConclusionsPatients treated with AOM 400 maintained symptomatic and functional stability for up to 52weeks. Importantly, more than one-third of patients achieved sustained functional recovery using a strict criterion. Overall, AOM 400 was safe and well tolerated in patients with BP-I. Results support AOM 400 as a viable once-monthlyoption for maintenance treatment of BP-I.
These data were previously presented at the 31st ECNP Congress, 2018, Barcelona,Spain.
Funding Acknowledgements: The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.