Anticoagulant Bleeding Burden Adherence Confidence Assessment Scale [ABBA-CAS] Created to Better Address an Important Treatment Gap in the Management of Atrial Fibrillation (AF) and Bring Patient Issues to the Forefront
Developed with Reference to FDA Guidance for the Development of Clinical Outcomes Assessments
CAMBRIDGE, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today presented details of the development of a novel patient-reported outcome (PRO) assessment scale to measure the patient relevant burden of oral anticoagulant treatment at ISPOR—The Professional Society for Health Economics and Outcomes Research’s annual meeting, held in Boston, May 7-10, 2023.
Patients who use direct oral anticoagulants (DOACs) commonly report experiencing bleeding events, including any types of bleeding or bruising that are concerning to patients, but do not require medical intervention. In contrast to “clinically relevant bleeding events,” which may be life-threatening, patients who experience these types of “patient relevant bleeding events,” such as nose bleeds, easy bruising, and heavy menstrual cycles, have reported impacts on their appearance, emotional distress and an overall decrease in their quality of life, and has been associated with medication adherence issues.
Currently, there is no validated patient-reported outcome measure to assess the burden of DOACs on patient health-related quality of life (HRQoL) and its effect on adherence. The development of the Anticoagulant Bleeding Burden Adherence Confidence Assessment Scale (ABBA-CAS) was specifically designed to help fill that treatment gap.
“Doctors are often so focused on balancing the risks of strokes and major bleeds in patients that they can miss the significant impact of other types of bleeding that are often very important to patients and can – and does – have a negative effect on their daily lives,” said Leslie Lake, Volunteer President, National Blood Clot Alliance. “Sometimes the bleeding or bruising experienced by patients on DOACs is burdensome enough that they discontinue much needed treatment, putting some patients at a higher risk of stroke. We think the Anticoagulant Bleeding Burden Confidence Adherence Assessment Scale has the potential to help clinicians and their patients better understand and circumvent dangerous underutilization of anticoagulants.”
The ABBA-CAS is an 18-item questionnaire intended to assess patients in three categories: emotional/psychological, physical, and lifestyle/activities of daily living; the frequency of bleeding and bruising related to oral anticoagulants; and the severity and frequency of their associated impacts on quality of life and adherence to therapy. It was developed in adherence to the FDA’s Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, and will be available as a non-proprietary scale for all researchers.
“As physicians, we are hypervigilant about managing major bleeding events but are sometimes less attentive to what we historically refer to as ‘nuisance bleeding,’ often leaving patients to manage on their own,” said Dan Bloomfield, M.D., Chief Medical Officer at Anthos. “We set out to find a way to give patient relevant bleeding the attention it deserves and provide the basis for a better physician-patient dialogue about their care. Anthos intends to field a revised version of ABBA-CAS in an observational study to evaluate scoring and psychometrics. We hope other study investigators will also utilize it in their AF research as well.”
About Anthos Therapeutics
Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic (CVM) diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company. Anthos Therapeutics was launched by Blackstone Life Sciences and Novartis in 2019 and has obtained the global rights to develop, manufacture, and commercialize abelacimab (MAA868) under a license agreement with Novartis. For more information, visit the company’s website and follow on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the initiation, and timing, of future clinical trials and its research and development. All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become”, “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
Media Contact
Caren Begun
TellMed Strategies
201-396-8551
caren.begun@tmstrat.com
