2023 PROMs Case Study

Case Study- Successful transition to ASCENIV therapy with improved PROMs

Author: Barbara Prosser, RPh; Christine Miller, PharmD – Soleo Health

Objective

The purpose of this case study review was to demonstrate the use of patient reported outcome measures (PROMs) to evaluate the effectiveness of therapy success and outcomes in a patient with primary immunodeficiency.

Background

A 74-year-old Caucasian woman receives IVIg for the treatment of selective deficiency of immunoglobulin G [IgG] subclasses, ICD-10 D80.3. Past medical history included chronic obstructive lung disease and hypothyroidism. After 4 months of receiving IVIg therapy in the home, the patient was transitioned to another IVIg product, ASCENIV, for the continued treatment of her condition. A retrospective review of her medical records was performed by a multidisciplinary team from the start of care to current status. The review included customized clinical assessments specific to primary immunodeficiency, wellness, and fatigue that were performed by the specialty infusion pharmacy, as reported through the proprietary clinical outcomes program SoleMetrics^®. The review also included progress notes, nursing assessments, and hospital and physician office visit notes.

Methods

The patient assessment and completion of select PROMs were completed prior to each dispense of the medication or at the time of a home infusion nursing visit. Wellness was assessed using the Soleo Health Wellness scale and an immunology disease-specific assessment. The Modified Rasch-built Fatigue Severity Scale (mFSS) was used to track fatigue and lifestyle changes related to the disease state.

Summary

The purpose of this case study is to highlight the successful transition from a previous prescribed IVIg to ASCENIV therapy. Wellness was based on 5 questions related to overall wellness, mood, energy, sleep patterns and stress. Other factors used were a subjective statement by the patient, “How are you feeling today,” emergency department and hospitalization records, reported infections, and medication changes. While on the previous IVIg regimen, the patient reported an average wellness score of 16.6 compared to an average of 13 while on ASCENIV. Additionally, while on ASCENIV the patient reported zero infections, zero emergency or hospital visits, and improvement in the ability to exercise and participate in family and social activities. The unique source plasma for ASCENIV, which specifically contains neutralizing antibodies to respiratory syncytial virus, has the potential to improve outcomes in patients with poor response to other IVIg therapies.