Accreditation/Credit Designation

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 2.0 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 2.0 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Incyte Corporation, Mallinkrodt LLC, and Takeda Oncology.

Community Practice Connections™: Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds


Release Date: January 31, 2019
Expiration Date: January 31, 2020
Media: Internet - based

Activity Overview

In this interactive online activity, you will engage with Drs. Corey Cutler, MD, MPH, FRCP(C); John F. DiPersio, MD, PhD; David Miklos, MD, PhD; and Shernan Holtan, MD, to discover their approaches for diagnosing, treating, and monitoring patients with acute or chronic graft-versus-host disease (GvHD). Video interviews will bring key clinical trial evidence into focus, and you will gain insight into incorporating an emerging and dynamic evidence base into your daily clinical practice. The content and interviews are based on presentations delivered at Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds, a satellite symposium held November 30, 2018, adjunct to the 2018 American Society of Hematology (ASH) Annual Meeting, a major hematology conference in San Diego, CA. As you work through the program, you can evaluate your approaches in relation to those of the physician faculty and review the evidence base supporting their clinical decisions.

As a busy oncologist engaged in the care of patients with GvHD, you will have the opportunity to gain clinically relevant information that can significantly enhance the care of your patients.

Below are some clinical pearls and highlights from the activity:

  • Dr. Cutler presented a global view of GvHD, starting with an approach to the diagnosis and staging of both acute and chronic GvHD. He discussed novel approaches to diagnosis, including useful biomarkers, and evolving and emerging therapies for both acute and chronic GvHD.
  • Dr. DiPersio recommended that patients with steroid-refractory GvHD should be considered for a clinical trial. He said that there are emerging therapies that look encouraging, but there is no definitive approach for these patients, and clinical trials should be one of the primary options. He also noted that there has been substantial improvement in prophylaxis for GvHD with the use of high-dose cyclophosphamide and the emergent use of JAK inhibitors. Another exciting new approach to prophylaxis is the use of abatacept.
  • Dr. Miklos pointed out that ibrutinib was recently approved by the FDA, which brings the number of approved drugs to 4. It has been used in patients with previously treated GvHD, which is an exciting development to improve patient care. Dr. Miklos highlighted the importance of using clinical trials in the development of these novel therapies. Enrollment is especially important when we are uncertain about what is better than the standard treatment with steroids. A series of randomized controlled trials have shown that antithymoglobulin therapies are beneficial for in vivo T-cell depletion. He mentioned the importance of treating acute GvHD before it progressed to chronic GvHD, and discussed some key ongoing clinical trials.
  • Dr. Holtan emphasized that there are multiple novel and interesting biomarkers being investigated for both acute and chronic GvHD. All of these biomarkers need to be validated in prospective clinical trials before they are implemented in routine clinical use.

Acknowledgement of Commercial Support

This activity is supported by educational grants from Incyte Corporation, Mallinkrodt LLC, and Takeda Oncology.

Instructions for This Activity and Receiving Credit

  • You will need to log in to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review audio files/content until you finish the presentation.
  • At the end of the activity, educational content/audio files will be available for your reference.
  • In order to receive a CME/CE certificate, you must complete the activity.
  • Complete the Posttest and pass with a score of 70% or higher, complete the Evaluation, and then click on “Request for Credit.” You may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This educational activity is directed toward hematologists, medical oncologists, nurse practitioners, nurses, and fellows who treat patients with GvHD. Physician assistants, pharmacists, researchers, and other healthcare professionals interested in the treatment of GvHD are also invited to participate.

Learning Objectives

Upon successful completion of this activity, you should be better prepared to:

  1. Assess the pathogenesis of acute and chronic GvHD and the guidelines to assess, stage, and manage patients with these conditions
  2. Outline preventive strategies to deter the development of acute and chronic GvHD in patients undergoing hematopoietic stem cell transplantation
  3. Evaluate the clinical benefits and safety of novel and emerging agents and regimens to decrease risk, as well as to treat acute and chronic GvHD
  4. Discuss novel biomarkers that can facilitate the identification of acute and chronic GvHD and the probability of treatment response

Faculty, Staff, and Planners' Disclosures

Faculty

Corey Cutler
Corey Cutler, MD, MPH, FRCP(C)
Associate Professor of Medicine
Harvard Medical School
Division of Hematologic Oncology
Dana-Farber Cancer Institute
Boston, MA

Disclosures: Consultant: Kadmon, Pharmacyclics, Fate Therapeutics, Incyte

John F. DiPersio
John F. DiPersio, MD, PhD
Virginia E. and Samuel J. Golman Professor
Chief, Division of Oncology
Deputy Director, Siteman Cancer Center
Washington University School of Medicine
St. Louis, MO

Disclosures: Grant/Research Support: Amphivena Therapeutics, Novimmune; Consultant: Amphivena Therapeutics, Celgene, Cellworks Group, Inc., Incyte, Karyopharm Therapeutics, RiverVest Venture Partners, Tioma Therapeutics (formerly Vasculox, Inc); Shareholder: Magenta Therapeutics, WUGEN

Shernan Holtan
Shernan Holtan, MD
Assistant Professor of Medicine
Division of Hematology, Oncology and Transplantation
University of Minnesota
Minneapolis, MN

Disclosures: Consultant: Incyte, Bristol-Myers Squibb

David Miklos
David Miklos, MD, PhD
Associate Professor of Medicine
Clinical Director, Cancer Cell Therapy Program
Division of Blood and Marrow Transplantation
Stanford University
Stanford, CA

Disclosures: Grant/Research Support: Pharmacyclics, Abbott, Janssen, Novartis, Genentech; Consultant: Pharmacyclics, Janssen, Novartis, Genentech

The staff of 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/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE 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/CE 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/CE 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 Corey Cutler, MD, MPH, FRCP(C)—PER Pulse™ Recap


This first of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making. This presentation focuses on a global view of both aGvHD and cGvHD, including diagnosis and staging of GvHD, useful biomarkers in this process, and novel and emerging treatments for both aGvHD and cGvHD. Below are some highlights from the activity featuring Dr Cutler:

  • Dr Cutler presented a global view of GvHD, starting with an approach to the diagnosis and staging of both aGvHD and cGvHD. He discussed novel approaches to diagnosis, including useful biomarkers, and evolving and emerging therapies for both aGvHD and cGvHD .
  • Acute and chronic GvHD are multisystem diseases that have many clinical symptoms affecting the skin, eyes, mucocutaneous surfaces, gut, and lungs, particularly in its chronic form.1
  • Several biomarkers offer promise in aiding the diagnosis and prognosis of aGvHD and cGvHD.2 Biomarkers for aGvHD are better characterized due to the broader variety of manifestations for cGvHD. These biomarkers are still being evaluated in clinical trials and are not yet ready for routine clinical use.
  • Corticosteroids have long been the backbone of treatment of both aGvHD and cGvHD.They are potent and effective immunosuppressants. However, there are toxicity limitations with steroid therapy.

References

  1. Socié G, Ritz J. Current issues in chronic graft-versus-host disease. Blood. 2014;124(3):374-384. doi: 10.1182/blood-2014-01-514752.
  2. Wolff D, Greinix H, Lee SJ, et al. Biomarkers in chronic graft-versus-host disease: quo vadis? Bone Marrow Transplant. 2018;53(7):832-837. doi: 10.1038/s41409-018-0092-x.
  3. Salmasian H, Rohanizadegan M, Banihosseini S, et al. Corticosteroid regimens for treatment of acute and chronic graft versus host disease (GvHD) after allogenic stem cell transplantation. Cochrane Database Syst Rev. 2010;Jan 20;(1):CD005565. doi: 10.1002/14651858.CD005565.pub2.


2 of 3
Insight from John DiPersio, MD, PhD—PER Pulse™ Recap


Community Practice Connections™: Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds is a continuing medical education (CME)–certified program. In this interactive online activity, you will engage with Drs Corey Cutler, MD, MPH, FRCP(C); John F. DiPersio, MD, PhD; David Miklos, MD, PhD; and Shernan Holtan, MD, to discover their approaches for diagnosing graft-vs-host disease (GvHD) and treating and monitoring these patients. Video interviews will bring key clinical trial evidence into focus, and you will gain insight into incorporating an emerging and dynamic evidence base into your daily clinical practice. The content and interviews are based on presentations delivered at Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds, a satellite symposium held November 30, 2018, adjunct to the 2018 American Society of Hematology Annual Meeting, a major hematology conference in San Diego, California. This program will arm you with the most up-to-date information for personalizing care for your patients at risk of developing acute GvHD (aGvHD) or chronic GvHD (cGvHD).

This second of 3 PER Pulse™ Recaps summarizing the online activity focuses on the management of acute GvHD featuring Dr DiPersio:

  • Dr DiPersio recommended that patients with steroid-refractory GvHD be considered for a clinical trial. He said that there are emerging therapies that look encouraging, but there is no definitive approach for these patients, and clinical trials should be 1 of the primary options. He also noted that there has been substantial improvement in prophylaxis for GvHD with the use of high-dose cyclophosphamide and the emergent use of JAK inhibitors. Another exciting new approach to prophylaxis is the use of abatacept.
  • Corticosteroids have been used for years to manage patients with GvHD, but they are associated with several adverse events (AEs).1 These include poor control of blood glucose and diabetes, loss of muscle mass, inactivity, muscle weakness, and—most importantly—osteopenia and bone mineral loss. The AEs affecting the bone may lead to multiple fractures and disability and overall failure to thrive. These conditions can be devastating, especially in patients who have been on steroids for a number of years. Steroids also put people at risk of bacterial, fungal, and viral infections.

  • Dr DiPersio describes an interesting case of a 52-year-old woman who received a diagnosis of acute myeloid leukemia and underwent an allogeneic hematopoietic stem cell transplant with an unrelated 8/8 HLA matched donor. Four weeks later, she developed grade 3 GvHD (skin and gastrointestinal involvement) and was treated with methylprednisolone/a calcineurin inhibitor/mycophenolate mofetil 2 mg/kg for 1 week, with no improvement. Dr DiPersio then discusses the treatment options available for this patient.

Reference

  1. Ericson-Neilsen W, Kaye AD. Steroids: pharmacology, complications, and practice delivery issues. Ochsner J. 2014;14(2):203-207.


3 of 3
Insight from David Miklos, MD, PhD—PER Pulse™ Recap


Community Practice Connections™: Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds is a continuing medical education (CME)–certified program. In this interactive online activity, you will engage with Drs Corey Cutler, MD, MPH, FRCP(C); John F. DiPersio, MD, PhD; David Miklos, MD, PhD; and Shernan Holtan, MD, to discover their approaches for diagnosing graft-vs-host disease (GvHD) and treating and monitoring these patients. Video interviews will bring key clinical trial evidence into focus, and you will gain insight into incorporating an emerging and dynamic evidence base into your daily clinical practice. The content and interviews are based on presentations delivered at Advancing Care for Patients With GvHD: Making Sense of Recent Approvals and Late-Stage Compounds, a satellite symposium held November 30, 2018, adjunct to the 2018 American Society of Hematology Annual Meeting, a major hematology conference in San Diego, California. This program will arm you with the most up-to-date information for personalizing care for your patients at risk of developing acute GvHD (aGvHD) or chronic GvHD (cGvHD).

This third of 3 PER Pulse™ Recaps summarizing the online activity focuses on best practices to manage GvHD, featuring Dr Miklos:

  • Dr Miklos pointed out that ibrutinib was recently approved by the FDA, which brings the number of approved drugs to 4.1 It has been used in patients with previously treated GvHD, which is an exciting development to improve patient care. Dr Miklos highlighted the importance of using clinical trials in the development of these novel therapies. Enrollment is especially important when there is uncertainty about what is better than the standard treatment with steroids. A series of randomized controlled trials have shown that antithymoglobulin therapies are beneficial for in vivo T-cell depletion. He mentioned the importance of treating aGvHD before it progressed to cGvHD and discussed some key ongoing clinical trials.
  • The International National Institutes of Health Chronic GVHD Diagnosis and Staging Working Group published new proposed criteria for diagnosing and scoring the severity of cGvHD in 2015.2 The working group presented a scoring system for the following organs and sites to diagnose and grade cGvHD:
    1. Skin
    2. Mouth
    3. Eyes
    4. Gastrointestinal tract
    5. Liver
    6. Lungs
    7. Joints and fascia
    8. Genital tract
  • Each organ or site is scored on a 4-point scale (0 [no involvement] to 3 [severe impairment]). Additionally, performance status is captured on a 0-to-3 scale.2
  • Development of aGvHD is one of the greatest risk factors for developing cGvHD. Only about 30% of cGvHD cases are de novo, without any preceding aGvHD.3
  • Both aGvHD and cGvHD negatively affect the quality of life of the patient.4
  • Dr Miklos discusses the most problematic chronic GvHD treatment-related toxicities.


References

  1. Jaglowski SM, Blazar BR. How ibrutinib, a B-cell malignancy drug, became an FDA-approved second-line therapy for steroid-resistant chronic GVHD. Blood Adv. 2018;2(15):2012-2019. doi: 10.1182/bloodadvances.20188013060.
  2. Jagasia MH, Greinix HT, Arora M, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. the 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001.
  3. Lee SJ. Classification systems for chronic graft-versus-host disease. Blood. 2017;129(1):30-37. doi: 10.1182/blood-2016-07-686642.
  4. Lee SJ, Kim HT, Ho VT, et al. Quality of life associated with acute and chronic graft-versus-host disease. Bone Marrow Transplant. 2006;38(4):305-310. doi: 10.1038/sj.bmt.1705434.
  5.  

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