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 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Novartis Pharmaceuticals Corporation.

Advances In™ the Management of Chronic Immune Thrombocytopenia


Release Date: December 30, 2018
Expiration Date: December 30, 2019
Media: Internet - based

Activity Overview

This activity, Advances in™ the Management of Chronic Immune Thrombocytopenia, developed in Physicians’ Education Resource®, LLC established Advances in™ legacy format, will provide an overview of recent data on emerging options for the treatment of chronic immune thrombocytopenia (ITP), including FcRn inhibitors, spleen tyrosine kinase inhibition, and a novel thrombopoietin receptor agonist. You will hear expert discussion of long-term follow-up data for available therapeutic options. Topics will also include considerations for making treatment choices, including meeting the needs of the patient for optimizing therapeutic outcomes. You will benefit from expert opinion on how and when to incorporate new options into your treatment strategy for your patients. Benefits of Participating

By participating in this activity, you will learn about:

  • How expert opinion can inform therapy-sequencing choices in ITP treatment
  • Emerging data on novel agents and the biological rationale for new options in treating ITP
  • Considerations in long-term outcomes with systemic therapies for IT

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Novartis Pharmaceuticals Corporation.

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 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 certificate upon completion of these steps.


Target Audience

This educational activity is directed toward medical oncologists, hematologists, pathologists, and nurses who treat patients with ITP. Nurse practitioners, physician assistants, pharmacists, and other healthcare professionals interested in the treatment of ITP are also invited to participate.

Learning Objectives

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

  • Describe the pathogenesis of chronic ITP and strategies to facilitate its early diagnosis
  • Differentiate between first and second-line treatment strategies for chronic ITP to optimize outcomes in adult patients
  • Examine potential treatment-associated adverse events and strategies to mitigate their impact on outcomes in the management of patients with ITP
  • Evaluate recent clinical trial evidence, including efficacy and safety profiles of current and novel therapeutic strategies for treatment of ITP

Faculty, Staff, and Planners' Disclosures

Faculty

James B. Bussel, MD
Weill Cornell Medical College
NewYork-Presbyterian Hospital/
Weill Cornell Medical Center
New York, NY
 

Disclosures: Grant/ Research Support: Novartis, Amgen, Rigel, Protalex; Consultant: Momenta, UCB, Argenx, Dova, Amgen, Novartis, Rigel

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 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

The online activity Advances in™ the Management of Chronic Immune Thrombocytopenia, developed in the Advances In™ legacy format established by Physicians’ Education Resource®, LLC (PER), is intended to update physicians and other healthcare providers on the latest developments in the management of chronic immune thrombocytopenia (ITP). James B. Bussel, MD, provides his expert perspective on the diagnosis of ITP and current and emerging strategies for optimal treatment of these patients. This first of 3 PER Pulse™ Recaps focuses on diagnosis and the current treatment landscape for patients with ITP.

ITP is a rare hematologic disorder caused by autoimmune-mediated platelet destruction and inhibited platelet production. ITP can manifest in both children and adults as primary ITP in approximately 80% of cases or as secondary ITP caused by a range of viral, bacterial, or other systemic disorders. The diagnosis is mainly one of exclusion, with no existing gold standard test for confirming ITP. Guidelines for confirming a diagnosis include the presence of isolated thrombocytopenia in the absence of other known causes, peripheral blood film examination with no evidence of dysplasia, and 3 or more of the following laboratory findings with at least 1 being No. 4, 5, or 61:

  1. Absence of anemia
  2. Normal leukocyte count
  3. Increased anti–glycoprotein (Gp) llb/llla antibody-producing B-cell frequency
  4. Increased platelet-associated anti-GPllb/llla antibody level
  5. Elevated percentage of reticulated platelets
  6. Normal or slightly increased plasma thrombopoietin (TPO) level (<300 pg/mL)

Although children frequently experience only an isolated incidence of ITP followed by remission without recurrence, adults almost always experience chronic ITP. Treatment regimens have a goal of adequate hemostasis, and there are limited clinical data to determine the optimal plan of treatment. Dr Bussel points out that if a line of treatment is undertaken and a patient experiences intolerable adverse events (AEs), switching to an alternative line of therapy is acceptable. Corticosteroids are often the first choice of treatment for many patients, and intravenous immunoglobulin (IVIG) is also a common choice for first-line therapy. IVIG is also a preferred treatment option for patients intolerant or refractory to steroid treatment.

Second-line treatment options have historically been limited, although recent advances have expanded the choices available. Rituximab is frequently used, although it is also associated with grade 3 and 4 AEs.2 The advent of TPO receptor agonists, including eltrombopag and romiplostim, provided a second-line options for patients 1 year of age and older.3,4 The spleen tyrosine kinase inhibitor fostamatinib is now also indicated for the treatment of ITP in adult patients after insufficient response to prior therapy.5

References

  1. Nomura S. Advances in diagnosis and treatments for immune thrombocytopenia. Clin Med Insights Blood Disord. 2016;9:15-22. doi: 10.4137/CMBD.S39643.
  2. Neunert C, Lim W, Crowther M, et al; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;17(16):4190-4207. doi: 10.1182/blood-2010-08-302984.
  3. Vishnu P, Aboulafia DM. Long-term safety and efficacy of romiplostim for treatment of immune thrombocytopenia. J Blood Med. 2016;7:99-106. doi: 10.2147/JBM.S80646.
  4. Cheng G. Eltrombopag, a thrombopoietin- receptor agonist in the treatment of adult chronic immune thrombocytopenia: a review of the efficacy and safety profile. Ther Adv Hematol. 2012;3(3):155-164. doi: 10.1177/2040620712442525.
  5. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930. doi: 10.1002/ajh.25125.

2 of 3

The online activity Advances in™ the Management of Chronic Immune Thrombocytopenia, developed in the Advances In™ legacy format established by Physicians’ Education Resource®, LLC (PER), is intended to update physicians and other healthcare providers on the latest developments in the management of chronic immune thrombocytopenia (ITP). James B. Bussel, MD, provides his expert perspective on the diagnosis of ITP and current and emerging strategies for optimal treatment of these patients. This second of 3 PER Pulse™ Recaps focuses on long-term outcomes associated with treatment options for patients with ITP.

Many patients with ITP will not have a curative treatment option. Splenectomy can be curative in a subset of patients and may be appropriate for those who are experiencing severe symptoms or have not responded to other treatments. However, splenectomy is associated with other long-term complications, including susceptibility to infection and vascular problems.1 The thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag have been available for clinical use since 2008, and long-term follow-up studies have been conducted.2,3 TPO-RA use reported in these studies for as long as 5 years did not reveal any new adverse events or long-term consequences of these treatment options. Dr Bussel noted that prior concerns about bone marrow fibrosis occurring with long-term TPO-RA treatment are unlikely to be a significant consequence based on the available follow-up data.

References

  1. Mikhael J, Northridge K, Lindquist K, Kessler C, Deuson R, Danese M. Short-term and long-term failure of laparoscopic splenectomy in adult immune thrombocytopenic purpura patients: a systematic review. Am J Hematol. 2009;84(11):743-748. doi: 10.1002/ajh.21501.
  2. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. doi: 10.1111/bjh.12260.
  3. Wong RSM, Saleh MN, Khelif A, et al. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707.

3 of 3

The online activity Advances in™ the Management of Chronic Immune Thrombocytopenia, developed in the Advances In™ legacy format established by Physicians’ Education Resource®, LLC (PER), is intended to update physicians and other healthcare providers on the latest developments in the management of chronic immune thrombocytopenia (ITP). James B. Bussel, MD, provides his expert perspective on the diagnosis of ITP and current and emerging strategies for optimal treatment of these patients. This third of 3 PER Pulse™ Recaps focuses on emerging options for the treatment of patients with ITP.

Ongoing clinical trials testing new options for the treatment of ITP include a novel thrombopoietin receptor agonist (TPO-RA), as well as 2 agents that target the neonatal Fc receptor (FcRn) for IgG, in addition to the recently approved spleen tyrosine kinase (Syk) inhibitor. Results from a phase III trial of avatrombopag, a synthetic TPO-RA, demonstrated a platelet response in 65.6% of 49 patients at day 8 and a median platelet response time of 12.4 weeks.1 Adverse events (AEs) in the phase III report remained consistent with a phase II trial reported earlier, in which 16% of patients withdrew due to AEs.2 There are 2 agents in development that block the activity of FcRn and were developed with a goal of reducing the half-life of IgG. An interim analysis of a phase II trial of rozanolixizumab, a monoclonal antibody against FcRn, demonstrated clinically relevant platelet responses and reported mild to moderate AEs in 15 patients.3 An engineered antagonist of FcRn, efgartigimod, is also in a phase II trial for which interim results were announced in a press release; a platelet response was reported in 46% of 38 patients, and the majority of observed AEs were mild.4 Fostamatinib was approved based on the results of 2 phase III trials, which reported stable platelet response in 18% of patients, with 10% of patients withdrawing from treatment due to AEs.5

References

  1. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490. doi: 10.1111/bjh.15573.
  2. Bussel JB, Kuter DJ, Aledort LM, et al. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014;123(25):3887-3894. doi: 10.1182/blood-2013-07-514398.
  3. Robak T, Jarque I, Musteata V, et al. Phase II, multiple-dose study of anti-FcRn antibody, rozanolixizumab (UCB7665), in patients with primary immune thrombocytopenia: interim analysis. Presented at the 2017 American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract PF666. bloodjournal.org/content/130/Suppl_1/15?sso-checked=true.
  4. Argenx reports positive topline results from phase 2 proof-of-concept trial of efgartigimod in primary immune thrombocytopenia [press release]. argenx.com/en-GB/news-internal/argenx-reports-positive-topline-results-from-phase-2-proof-of-concept-trial-of-efgartigimod-in-primary-immune-thrombocytopenia/30200/. Breda, The Netherlands: Argenx; September 17, 2018. Accessed December 23, 2018.
  5. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930. doi: 10.1002/ajh.25125.

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