2024 IVIG 10% Case Study

Case Study: IgG deficient patient receiving immune globulin intravenous, human-slra 10% demonstrates improvement in quality of life

Authors: Christine Miller, PharmD; Barbara Prosser, RPh; Derek Blake, RN, BSN, IgCN; Drew Doyle, RPh – Soleo Health

Rationale

Immunoglobulin replacement therapy (IgRT) is proven to be effective in preventing the occurrence of serious bacterial infections in patients with immunodeficiencies, but quality of life is not frequently studied in IgRT clinical trials. This case study highlights the effect of IgRT on quality of life. A 68 year-old female was referred to this complex specialty pharmacy to initiate IgRT infusions in the home for selective IgG deficiency, selective deficiency of immunoglobulin A, pemphigus, and mild asthma. She was prescribed immune globulin intravenous, human-slra 10%, an Ig product that is manufactured using plasma from donors that possess high antibody titers against RSV and other common pathogens including influenza, parainfluenza, metapneumovirus, and seasonal coronaviruses.^1,2

Methods

A retrospective analysis of the patient’s medical records was performed. The review consisted of data contained within a customized clinical assessment created by this complex specialty pharmacy, including the Primary Antibody Immune Deficiency Quality of Life (PADQOL-16), a validated quality of life measure specific to primary immunodeficiency.3 Additional items collected and analyzed from the customized clinical assessment included drug tolerability, side effect management, infection history, and anti-infective us

Results

After 148 days of therapy, the patient experienced an 11-point improvement in the PADQOL-16 (Table 1). The most significant improvement in the PADQOL-16 total score was obtained at day 58 of therapy (score = 2), which was then sustained through the remainder of the available clinical documentation at day 148. The patient did not experience any infections while on therapy, and reported side effects were chills/rigors with one infusion. Differences in the PADQOL-16 scores around the same infusion were observed depending on the interviewer – a pharmacy team member via telephonic outreach versus a registered nurse during IgRT administration. A therapy satisfaction questionnaire was conducted with the patient in January 2024 (Table 2). No issues related to immune globulin intravenous, human-slra 10% or barriers to care were reported.

Conclusion

Immune globulin human-slra 10% is well-tolerated and effective in preventing infections in IgG deficient patients, and this case study demonstrates the added quality of life benefit this IgRT provides. The addition of a validated, disease-specific quality of life measure, such as the PADQOL-16, in routine clinical assessments allows the opportunity for this national complex specialty pharmacy to collect and analyze real-world data for IgRT beyond single case reports in future studies.