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Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Indivior Inc.

Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices

Release Date: September 28, 2018
Expiration Date: September 28, 2019
Media: Internet - based

Activity Overview

Schizophrenia affects an estimated 21 million people worldwide, and BPD is the sixth leading cause of disability. These are chronic psychiatric illnesses that require long-term care, and place significant health and economic burdens on patients and their families. In recent decades, the distinct separation of these 2 illnesses has weakened, and the medical literature now recognizes a partial genetic overlap between schizophrenia and BPD. Unfortunately, both schizophrenia and BPD are difficult to treat and are associated with substantial morbidity and mortality, particularly when suboptimally treated. Lack of consistent adherence to treatment is also a significant issue; however, new formulations and medications that may improve adherence have been recently approved or are under development.

During this Medical Crossfire®, a panel of expert faculty will review the burdens of illness associated with BPD and schizophrenia, along with the roles of the primary care physician in screening and management of these disorders. Additional discussions will include strategies to help improve adherence and recent data on new and emerging agents for people with BPD or schizophrenia.

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Indivior Inc.

Target Audience

This educational program is directed toward nurses interested in the management of patients with cancer. Other healthcare professionals interested in the management of patients with cancer are also invited to attend.

Educational Objectives

At the conclusion of this activity, you should be better prepared to:

  1. Discuss the burden associated with schizophrenia.
  2. Explain the burden associated with BPD.
  3. Describe strategies to improve poor adherence associated with schizophrenia and BPD.
  4. Identify new and emerging agents seeking to improve outcomes in patients with schizophrenia or BPD.

Faculty, Staff, and Planners' Disclosures

Faculty

Joseph R. Calabrese, MD
Director, Mood Disorders Program
Bipolar Disorders Research Chair
Department of Psychiatry
University Hospitals Cleveland Medical Center
Professor, Department of Psychiatry
Case Western Reserve University School of Medicine
Cleveland, Ohio

Disclosure: Grant/Research Support: Janssen Research & Development, LLC.; Consultant: Alkermes, Inc., Janssen Research & Development, LLC., Lundbeck, Otsuka; Pharmaceutical Development & Commercialization, Inc.

Christoph U. Correll, MD
Professor of Psychiatry and Molecular Medicine
The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Hempstead, New York

Disclosure: No relevant financial information to disclose

Paul P. Doghramji, MD, FAAFP
Family Physician, Collegeville Family Practice
Medical Director, Health Services; Ursinus College
Collegeville, Pennsylvania

Disclosure: No relevant financial information to disclose

Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP
Director, Psychiatric Mental Health Nurse Practitioner (Lifespan) Specialty
Vanderbilt University School of Nursing
Nashville, Tennessee

Disclosure: No relevant financial information to disclose

The staff of Physicians' Education Resource®, LLC, (PER®) have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse™ Recaps

1 of 3
Insight from Christoph U. Correll, MD – PER Pulse™ Recap:
Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices

The online continuing medical education activity Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices, features a round table discussion of the management of patients with bipolar disorder (BPD) or schizophrenia. Expert faculty Joseph R. Calabrese, MD; Christoph U. Correll, MD; Paul P. Doghramji, MD, FAAFP; and Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP, provide perspectives on associated burdens, adherence issues, and new and emerging medications for these disorders. You will discover how the expert faculty members approach treatment decision points, as well as some of the key challenges and questions that community physicians face when treating patients with BPD or schizophrenia.

This first of 3 PER Pulse Recaps for the activity will focus the use of long-acting injectables in patients with schizophrenia. Below are some highlights from the activity featuring Dr. Correll:

Aristada Initio (aripiprazole lauroxil)

Aristada Initio received US Food and Drug Administration (FDA) approval in October 2015 for the treatment of schizophrenia in adults. Tolerability with the oral formulation of aripiprazole must be established before Aristada Initio is administered via intramuscular (IM) injection into the deltoid or gluteal muscle by a health care professional. Doses are administered monthly (441, 662, or 882 mg), every 6 weeks (882 mg), or every 2 months (1064 mg).1

The efficacy of Aristada Initio was evaluated in a 12-week, phase III study involving patients with schizophrenia and a Positive and Negative Syndrome Scale (PANSS) score of 70 to 120, with a score of ≥4 for at least 2 of the selected Positive Scale items, in addition to a score of >4 on the Clinical Global Impression Improvement Scale. After establishing tolerability with the oral formulation of aripiprazole over a 3-week period, patients were randomized to receive IM injections of 441 mg, 882 mg, or placebo on days 1, 29, and 57. The primary efficacy endpoint was change in PANSS total score from baseline to day 85. Both doses of Aristada Initio were statistically significant for superiority to placebo, as shown in Table 1.1

Table 1. Primary Efficacy Results of Aristada

Treatment Group N Primary Efficacy Measure: PANSS Total Score
Mean Baseline Score (SD) LS Mean Change From Baseline (SE) Placebo-subtracted Differencea (95% CI)
Aristada 441 mgb 207 92.6 (10.2) –20.9 (1.4) –10.9 (–14.5, –7.3)
Aristada 882 mgb 208 92.0 (10.8) –21.8 (1.4) –11.9 (–15.4, –8.3)
Placebo 207 93.9 (11.3) –9.8 (1.4)
PANSS indicated Positive and Negative Syndrome Scale.
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval, not adjusted for
multiple comparisons.
aDifference (drug minus placebo) in least-squares mean change from baseline.
bDoses that are demonstrated to be effective.

The most common reaction occurring in more than 5% of patients was akathisia.1

Invega Trinza (paliperidone palmitate)

Invega Trinza is a 3-month injectable that received FDA approval in May 2015 for adults with schizophrenia who have been treated with Invega Sustenna (monthly injection of paliperidone palmitate) for at least 4 months. Invega Trinza is administered via IM injection into the deltoid or gluteal muscles by a health care professional. Dosages should be converted based on Invega Sustenna dose and include 273, 410, 546, and 819 mg.2

The efficacy and safety of Invega Trinza were evaluated in a long-term trial designed to evaluate time to relapse, which was defined as emergence of 1 or more of the following: psychiatric hospitalization; ≥25% or a 10-point increase in total PANSS score if baseline score was >40 or ≤40, respectively, on 2 consecutive assessments; deliberate self-injury; violent behavior; suicidal/homicidal ideation; or specific PANSS item scores of ≥5 or ≥6 if the maximum baseline score was ≤3 or 4, respectively, on 2 consecutive assessments. By end of study, 23% of patients receiving placebo and 7.4% receiving Invega Trinza experienced a relapse event, which was a statistically significant difference.2

Adverse events that occurred in more than 5% of patients were injection-site reaction, increased weight, headache, upper respiratory tract infection, akathisia, and parkinsonism.2

Perseris (risperidone)

Perseris received FDA approval in July 2018 for the treatment of schizophrenia in adults. After establishing tolerability with the oral formulation of risperidone, Perseris is administered monthly by a health care professional via an abdominal subcutaneous injection, with dosage options of 90 or 120 mg.3

In a phase III study, patients with schizophrenia and a PANSS total score of 80 to 120 at the screening visit were given 2 doses of 0.25 risperidone 24 hours apart to establish tolerability; those without an improvement of ≥20% between the screening visit (3-8 days prior to double-blind treatment) and first dosing day were randomized to receive 2 doses of 90 mg, 120 mg, or placebo on days 1 and 29. The primary efficacy endpoint was a change in PANSS total score from baseline to the end of the study, which occurred at day 57. Both doses of Perseris demonstrated statistically significant superiority to placebo in the primary endpoint, as shown in Table 2.3

Table 2. Primary Efficacy Results of Perseris

Treatment Group N (# ITT subjects) Primary Efficacy Measure: PANSS Total Score
Mean Baseline Score (SD) LS Mean Change From Baseline (SE) Placebo-subtracted Differencea (95% CI)
Perseris 90 mg 111 95.5 (9.23) –19.86 (1.56) –6.50 (–10.87, –2.13)c
Perseris 120 mg 114 94.9 (8.09) –23.61 (1.58) –10.24 (–14.64, –5.85)c
Placebo 112 94.1 (8.89) –13.37 (1.58)
ITT indicates intent-to-treat, PANSS indicated Positive and Negative Syndrome Scale; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI unadjusted confidence interval
ªDifference (drug minus placebo) in least-squares mean change from baseline.
cDoses that are statistically significantly superior to placebo

Adverse reactions occurring in more than 5% of patients included increased weight (13%), constipation (8%), sedation/somnolence (8%), pain in extremity (8%), back pain (7%), akathisia (7%), anxiety (7%), and musculoskeletal pain (5%).3

“The medication is only as good as it’s taken. There is only one single way of knowing the month, the week, the day, the hour when a patient becomes nonadherent and that is when they don’t return for their injection. These agents have better efficacy because they have better adherence.”
— Christoph U. Correll, MD

References

  1. Aristada [prescribing information]. Waltham, MA: Alkermes; 2018.
  2. Invega Trinza [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2018.
  3. Perseris [prescribing information]. Richmond, VA: Indivior; 2018.

2 of 3
PER Pulse™ Recap:
Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices

The online continuing medical education activity Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices, features a round table discussion of the management of patients with bipolar disorder (BPD) or schizophrenia. Expert faculty Joseph R. Calabrese, MD; Christoph U. Correll, MD; Paul P. Doghramji, MD, FAAFP; and Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP, provide perspectives on associated burdens, adherence issues, and new and emerging medications for these disorders. You will discover how the expert faculty members approach treatment decision points, as well as some of the key challenges and questions that community physicians face when treating patients with BPD or schizophrenia.

This second of 3 PER Pulse Recaps for the activity will focus on red flags for BPD and schizophrenia. Below are some clinical pearls from the Medical Crossfire® expert discussion panel:

  • Adolescents with BPD or schizophrenia do not present with the same symptoms as adults, and symptoms are often difficult to differentiate from other mental health disorders.
  • Clinicians should meet with the family alongside the patient, and family history should be discussed and considered in any diagnosis, because heritability is a factor. It’s also important to consider what may be going on at home, because children of a parent with depression are at greater risk and may not respond well to treatment. Trauma impacts mental health and should always be considered in the evaluation of a child or adolescent with symptoms of a disorder.
  • Red flags that should raise suspicion of mental health issues include the following:
    • Social withdrawal
    • Substance abuse1-2 (regardless of age, this usually suggests an undiagnosed, untreated illness)
    • Lack of functioning at school or work
    • Unusual behaviors or sadness
    • Schizophrenia-specific red flags include negative symptoms (eg, not talking as much, not enjoying things, etc), positive symptoms (eg, hallucinations, hearing noises), and cognitive symptoms (eg, delusions, disorganized thinking, etc.)
  • These red flags may be first seen by the primary care provider when children/adolescents come in for regular checkups, so maintaining awareness and investigating any unordinary issues are critical to early detection.
  • Children and adolescents with schizophrenia may be misdiagnosed with attention-deficit/hyperactivity disorder (ADHD), but these patients will not respond to typical ADHD medications. Stimulants may even make symptoms worse, which should raise suspicion of schizophrenia.
  • Screening tests for BPD and schizophrenia are useful, but clinicians must keep in mind that these do not replace the relationship with the provider. Specific, individualized questions are an important component of any evaluation.

“It would be most important to have a general screening, like, ‘How have you been doing? Any change from the usual? Are you functioning well?’ Because symptoms do not make a disorder. It’s either distress or dysfunction. Then you might be more specific. ‘Well, what about your mood? What about anything strange going on?’ In general, ask about functioning.”
— Christoph U. Correll, MD

References

  1. Messer T, Lammers G, Müller-Siecheneder F, Schmidt RF, Latifi S. Substance abuse in patients with bipolar disorder: A systematic review and meta-analysis. Psychiatry Res. 2017;253:338-350. doi: 10.1016/j.psychres.2017.02.067.
  2. Nielsen SM, Toftdahl NG, Nordentoft M, Hjorthøj C. Association between alcohol, cannabis, and other illicit substance abuse and risk of developing schizophrenia: a nationwide population based register study. Psychol Med. 2017;47(9):1668-1677. doi: 10.1017/S0033291717000162.

3 of 3
PER Pulse™ Recap:
Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices

The online continuing medical education activity Medical Crossfire®: Schizophrenia and Bipolar Disorder: Barriers to Care, Therapeutic Updates, and Best Practices, features a round table discussion of the management of patients with bipolar disorder (BPD) or schizophrenia. Expert faculty Joseph R. Calabrese, MD; Christoph U. Correll, MD; Paul P. Doghramji, MD, FAAFP; and Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP, provide perspectives on associated burdens, adherence issues, and new and emerging medications for these disorders. You will discover how the expert faculty members approach treatment decision points, as well as some of the key challenges and questions that community physicians face when treating patients with BPD or schizophrenia.

Lack of consistent adherence to treatment is a significant issue in mental health. In patients with BD, nonadherence rates range from 20% to 60%.1 Among patients with schizophrenia beginning treatment with oral atypical antipsychotics, only 33% have been found to be adherent, with 25% immediately discontinuing treatment.2 Nonadherence occurs for many reasons, including poor insight into the need for medication and concern about adverse events (AEs).1 In patients with BD, risk factors for poor adherence include younger age, substance misuse, homelessness, non-Caucasian ethnicity, being unmarried, and living alone.1 Among patients with schizophrenia, lack of insight, medication beliefs, and substance abuse have been associated with nonadherence.3

This third of 3 PER Pulse Recaps for the activity will focus on adherence issues in BD and schizophrenia. Below are some clinical pearls from the Medical Crossfire® expert discussion panel:

  • It’s important to keep in mind that adherence can be intentional or unintentional.
  • For many newer medications, blood work is unable to monitor adherence, so determining who is adherent can be very difficult. If a patient responded well to a medication initially, then stops responding as well, this may indicate an adherence issue.
  • Providers should strive to minimize the medication burden in order to optimize adherence. Aim for once-daily dosing of oral medications and those with low risk of AEs.
  • Long-acting injectables (LAIs) are a great option to combat adherence issues. Because patients must come into the provider’s office for regular injections, adherence is more easily monitored. Depending on the agent, LAIs can be administered every 2 weeks, month, 6 weeks, 8 weeks, or 3 months. Types of injections range from deep intramuscular to subcutaneous.
    • For patients with schizophrenia, options include aripiprazole, risperidone, and paliperidone.
    • For patients with BD, options include aripiprazole and risperidone.
  • Substance use is associated with poor adherence, so providers must be prepared to assess and address this issue with patients.
  • Clear communication and consistent follow-up are critical to ensuring adherence. Patients may not be aware that an ongoing AE is related to their medication or they may misunderstand timing of doses or other administration-related instructions. Many patients become nonadherent after an emergency department visit or being discharged from the hospital. Follow-up and communication are important roles for primary care providers to address many of these contributing issues.

“I think the main problem is, we don’t help patients learn enough about their illness, so they don’t have a good understanding of their illness. The more we can teach patients about their symptoms, the better they’ll be.”
— Joseph R. Calabrese, MD

“I think this could be a really important role for primary care. Sometimes, in certain regions of the country, you’re looking at 3 months out for specialty care, so by de facto, primary care has more availability to see these patients, engage them, and begin the conversation. ‘How are you tolerating your medicine? Are you taking your medicine?’ Ask about suicidal symptoms. Ask about psychosocial support. Make sure they have their medicine.”
— Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP

References

  1. Torres-Llenza V, Lakshmin P, Lieberman DZ. Spotlight on once-monthly long-acting injectable aripiprazole and its potential as maintenance treatment for bipolar I disorder in adult patients. Neuropsychiatr Dis Treat. 2018;14:285-292. doi:10.2147/NDT.S129559.
  2. MacEwan JP, Forma FM, Shafrin J, Hatch A, Lakdawalla DN, Lindenmayer J-P. Patterns of Adherence to Oral Atypical Antipsychotics Among Patients Diagnosed with Schizophrenia. J Manag Care Spec Pharm. 2016;22(11):1349-1361. doi:10.18553/jmcp.2016.22.11.1349.
  3. Higashi K, Medic G, Littlewood KJ, Diez T, Granström O, De Hert M. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systematic literature review. Ther Adv Psychopharmacol. 2013;3(4):200-218. doi:10.1177/2045125312474019.

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