音声学と聴覚学ジャーナル
オープンアクセス

概要

Observational Study of Intravenous Immunoglobulin 5% for Alleviating Adverse Drug Reactions in Primary Immunodeficiency Disorders

Isaac Melamed, Melinda Heffron, Ruth Dana, Alessandro Testori and Nazia Rashid

Background: Intravenous immunoglobulin (IVIG) preparations are used to treat individuals with primary immunodeficiency disorders (PIDD) by increasing low immunoglobulin levels. This observational study was designed to assess the change in adverse drug reactions (ADRs) in subjects switching from IVIG 10% to IVIG 5% and explore potential underlying mechanisms.

Methods: The primary endpoint was the change in ADRs between IVIG 10% (various products) and IVIG 5% (Octagam 5%) as assessed by a severity rating scale (1=none, 2=mild, 3=moderate, 4=severe). The recruitment goal was 15 subjects receiving IVIG 10% who had experienced ADRs up to 72 hours post-infusion. Subjects were then switched to IVIG 5% at the next scheduled infusion and continued on this regimen for a total of 6 infusions. Secondary endpoints included changes in C1 esterase inhibitor (C1-INH), SF-36 Quality of Life (QOL) assessments, and measurement of inflammatory biomarkers.

Results: Fifteen subjects were enrolled in the study with a mean age of 51 years. While on IVIG 10%, 15 subjects reported headache, fatigue, generalized pain, and 13 reported joint pain with average severity scores of 3.13, 3.20, 2.87, and 2.20, respectively. After switching to IVIG 5%, the average severity scores for these ADRs significantly decreased: 1.33 (P<0.0001), 1.33 (P<0.0001), 2.00 (P=0.0037), 1.80 (P=0.2141). C1-INH decreased significantly and all SF-36 domain scores improved on IVIG 5%.

Conclusion: IVIG 5% may be an alternative to subcutaneous immunoglobulin for subjects who develop ADRs on IVIG 10% preparations. Having multiple therapeutic options for patients with PIDD may improve compliance and continuity of therapy. In our study, there was a lower incidence of ADRs and improvement in QOL with use of IVIG 5%. C1-INH may play a role in the mechanism of ADRs, indicating a potential subset of patients more susceptible to C1-INH down regulation via IVIG 10% who may benefit from switching to IVIG 5%.