Haematology CE/CME ACCREDITED Watch Time: 25 mins

touchEXPERT OPINIONS Getting personal: Individualizing therapy for cold agglutinin disease

Watch two experts give their perspectives on the recommended workup for a timely and accurate diagnosis, as well as the evolving treatment landscape, and the importance of individualizing therapy for patients with cold agglutinin disease.

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Dr Catherine M Broome
MedStar Georgetown University Hospital, Washington DC, USA
Optimizing the diagnostic workup for CAD: Clinical presentations and differential diagnoses

Dr Catherine M Broome considers when to suspect CAD, and the steps needed to confirm a diagnosis, the impact of poor sample handling and delays to diagnosis, as well as the importance of real-world data in informing ongoing management of CAD.

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In this interview, Dr Catherine M Broome answers the following questions:

  • What signs and symptoms should increase your clinical suspicion of cold agglutinin disease?
  • What tests, and in what order, are recommended to diagnose primary cold agglutinin disease?
  • How important is timing of tests and proper sample handling in obtaining accurate results?
  • How do diagnostic delays impact treatment decisions and outcomes?
  • Will longitudinal real-world data help to inform our understanding of the natural history of cold agglutinin disease?

Catherine M Broome, MD, is board certified in internal medicine, haematology and medical oncology. She has been on the staff at the MedStar Georgetown University Hospital’s Lombardi Comprehensive Cancer Center for 13 years. read more

A fascination with the science of haematology, and the opportunity to develop a strong relationship with patients and their families led Dr Broome to specialize in haematology and medical oncology. Dr Broome focuses on developing a partnership with her patients, providing them the most up-to-­date information and treatment options. They work together to develop a treatment plan that fits medically, while also taking into account all aspects of the patient’s life.

In addition to patient care, Dr Broome is an associate professor in the Lombardi Cancer Center’s Department of Medicine. She also serves on the hospital’s safety committee.

Dr Catherine M Broome discloses Advisory board/panel fees from Alexion, Annexon Biosciences, Argenx, Incyte and Sanofi. Consultancy fees from Star Therapeutics.

 
Dr Ilene Ceil Weitz
Keck-USC School of Medicine, Los Angeles, USA
Current and emerging treatment options for CAD: Importance of individualizing therapy

Dr Ilene Weitz outlines the role of complement inhibitors as an alternative treatment option in the evolving treatment landscape of CAD, and how to use specific markers to tailor treatment for individual patients.

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In this interview, Dr Ilene Ceil Weitz answers the following questions:

  • How are complement inhibitors changing the current treatment paradigm for cold agglutinin disease?
  • In terms of the evolving treatment landscape for cold agglutinin disease, when should clinicians consider the use of rituximab or sutimlimab?
  • Are there any biomarkers or other factors to help tailor treatment to the individual patient?
  • What indicators can be used to measure treatment response, and how can we measure the impact of cold agglutinin disease from a patient perspective?

Dr Weitz, MD, is a professor of clinical medicine in the Division of Hematology at Keck-USC School of Medicine. read more

Dr Weitz attended the Medical College of Pennsylvania, and did her internal medicine training at Cedars Sinai Medical Center in Los Angeles. She completed her haematology fellowship at Scripps Clinic and Research Foundation.  

Dr Weitz’s research and clinical interests include: haemostasis thrombosis, complement disorders (including paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome and cold agglutinin disease), aplastic anaemia, iron metabolism, haemoglobinopathies (sickle cell and thalassaemia), mega platelet syndromes, and immune-mediated blood disorders.   

She has published multiple original articles, reviews and chapters. Dr Weitz received the faculty teaching award from the University of Southern California, as well as Cedars Sinai Medical Center in the USA. She was honoured with the Morris Press Humanism award from Cedars Sinai Medical Center.

Dr Ilene Ceil Weitz discloses Advisory board/panel fees from Alexion, Apellis, Novartis and Sanofi. Speaker’s bureau fees from Alexion.

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Overview & Learning Objectives
Overview

In this activity, US-based experts discuss best practice for diagnosing cold agglutinin disease (CAD) and how real-world data can inform our understanding of the natural history of the disease, as well as the current and emerging treatment options, and how we can use specific markers to tailor therapy and measure outcomes in patients with CAD.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of haematologists and haematologist-oncologists involved in the management of patients with cold agglutinin disease.

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant financial relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty 

Dr Catherine M Broome discloses: Advisory board/panel fees from Alexion, Annexon Biosciences, Argenx, Incyte and Sanofi. Consultancy fees from Star Therapeutics.

Dr Ilene Ceil Weitz discloses: Advisory board/panel fees from Alexion, Apellis, Novartis and Sanofi. Speaker’s bureau fees from Alexion.

Content reviewer

Caitlin Papa, APRN has no relevant financial relationships to disclose.

Touch Medical Directors

Kathy Day and Sadaf Kazi have no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu.

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 10 October 2022. Date credits expire: 10 October 2023.

If you have any questions regarding credit please contact cpdsupport@usf.edu.

Learning Objectives

After watching this activity, participants should be better able to:

  • Outline strategies for the accurate diagnosis of cold agglutinin disease
  • Evaluate the current and emerging treatment options for patients with cold agglutinin disease using the latest data
  • Assess potential strategies for individualizing the treatment for patients with cold agglutinin disease
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This Activity Is Funded By:

An independent medical education grant from Alexion AstraZeneca Rare Disease and is jointly provided by USF Health and touchIME.

The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits /contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

This content is intended for healthcare professionals.

Date of original release: 10 October 2022. Date credits expire: 10 October 2023.

This content is intended for healthcare professionals only. Please confirm that you are a healthcare professional.

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Question 1/5
What tests and in what order would you recommend to your colleagues to confirm a suspected case of CAD?

CAD, cold agglutinin disease; DAT, direct antiglobulin test; LDH, lactate dehydrogenase.
 Correct

For a patient suspected of having CAD, the first step is to check for signs of haemolysis, such as increased LDH and bilirubin levels, and assess for increased reticulocytes, although in some cases reticulocytes may appear normal or low. If haemolysis is present, an autoimmune aetiology can be confirmed with a DAT. A monospecific DAT positive for C3d, and a cold agglutinin titre ≥64 suggests either CAD or CAS. If there is no other underlying pathology, then a diagnosis of CAD can be made.

Abbreviations

C, serum complement protein; CAD, cold agglutinin disease; CAS, cold agglutinin syndrome; DAT, direct antiglobulin test; LDH, lactate dehydrogenase.

Reference

Berentsen S, Barcellini W. N Engl J Med. 2021;385:1407–19.

Question 2/5
A 68-year-old woman has presented with severe anaemia and cold-induced circulatory symptoms resulting in lesions on two fingers. After deciding she is in need of prompt treatment to quickly improve her condition, what treatment would you recommend?
 Correct

Rituximab, with or without chemotherapy, can support patients with CAD; however, average time to response can be approximately 2 months.1 Sutimlimab has been shown in phase III clinical trials to give rapid improvements in haemoglobin and bilirubin levels within 1–3 weeks, and improved fatigue over the longer term.2,3 Corticosteroids are not considered effective in CAD, and eculizumab is recommended as an acute treatment, possibly as a bridge to more long-term treatment.1

Abbreviation

CAD, cold agglutinin disease.

References

  1. Jäger U, et al. Blood Rev. 2020;41:100648.
  2. Röth A, et al. Blood. 2022;140:980–91.
  3. Röth A, et al. N Engl J Med. 2021;384:1323–34.
Question 3/5
What does retrospective data tell us about the risks associated with CAD and the use of conventional treatment approaches?

CAD, cold agglutinin disease.
 Correct

Even after diagnosis and treatment, patients continue to experience symptoms and complications. Retrospective data over a 10-year period showed that patients with CAD have a 1.9 times higher risk of thromboembolic events compared to patients without CAD.1 Another large scale retrospective trial found that 72% of patients with CAD experienced severe anaemia within 1-year of follow-up.2 

Abbreviation

CAD, cold agglutinin disease.

References

  1. Broome C, et al. Res Pract Thromb Haemost. 2020;4:628–35.
  2. Mullins M, et al. Blood Adv. 2017;1:839–48.
Question 4/5
What indicators should you use to monitor your patient with CAD to reliably assess their response to treatment?

CAD, cold agglutinin disease; LDH, lactate dehydrogenase.
 Correct

Monitoring for signs of haemolysis is central to assessing the response to treatment in patients with CAD. Haemoglobin is the most direct marker of disease severity and is reduced in moderate and severe forms of haemolytic anaemia. Reticulocytes are usually increased in haemolysis; however, reticulocytopenia may also be seen in some cases. LDH and bilirubin both rise with haemolysis. A complete response to therapy can be defined as haemoglobin levels >12 g/dL and other haemolytic marker normalization. A partial response is classed as haemoglobin levels >10g/dL or a 2 g/dL increase and reduction of haemolytic markers with no transfusion need. 

Abbreviations

CAD, cold agglutinin disease; LDH, lactate dehydrogenase.

References

Barcellini W, Fattizzo B. Dis Markers. 2015;2015:635670.

Question 5/5
Your patient is experiencing disabling cold-induced circulatory symptoms and has asked to be considered for sutimlimab therapy. What would you advise this patient about the effect of sutimlimab on cold-induced circulatory symptoms?
 Correct

Cold-induced circulatory symptoms are seen in up to 90% of patients.1 These symptoms, such as Raynaud’s phenomenon or acrocyanosis, are due to red blood cell agglutination following cold agglutinin binding prior to complement activation.2 Sutimlimab, as a C1s inhibitor, acts downstream of the cold agglutinin binding,1 and has not been demonstrated to improve cold-induced circulatory symptoms in clinical trials.3 

Abbreviations

C1s, complement component 1s; CAD, cold agglutinin disease.

References

  1. Berentsen S, et al. J Blood Med. 2019;10:93–103.
  2. Berentsen S. Front Immunol. 2020;11:590.
  3. Röth A, et al. Blood. 2022;140:980–91.
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