New Assessment Scale to Measure Adherence to Oral Anticoagulants Based on Impact of Patient Relevant Bleeding in Atrial Fibrillation Presented at ISPOR 2023

CAMBRIDGE, Mass., May 9, 2023 – 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.”