Gardulf A, Nicolay U, Math D, et al. J Allergy Clin Immunol. 2004;114:936–942
Purpose of the Study.
To determine the impact of a change from in-hospital infusion of intravenous immunoglobulin (IVIG) to in-home infusion of subcutaneous immunoglobulin (SCIG) on health-related quality of life (HRQOL) and treatment satisfaction.
Fifty-eight patients between the ages of 2 and 75 years (17 patients <14 years old [“children” for the purposes of this study]; 41 patients ≥14 years old [“adults”]) with primary antibody deficiency. Thirty-seven patients were receiving IVIG, and 10 were receiving SCIG (a control group to compare for effects specifically related to the switch from IVIG to SCIG); prior therapy for 1 patient was not stated.
Patients received weekly SCIG infusions at home over a period of 10 months (43 infusions). Questionnaires were administered at baseline and at 6 and 10 months. For assessment of HRQOL in children, parents completed the Child Health Questionnaire-Parental Form 50; adults used the Short Form 36. For assessment of treatment satisfaction, the authors adapted a Life Quality Index instrument previously developed in a study of antibody-deficient patients receiving IVIG.
On the Child Health Questionnaire-Parental Form 50, the children demonstrated significant improvement in 6 of 14 concepts analyzed: “role/social-emotional, behavioral,” “general health perceptions,” “parental impact-emotional,” “parental impact-time,” “family activities,” and “global health.” On the Short Form 36, adults had improvements in vitality, mental health, and social functioning. These differences were found only in those adults who switched from IVIG to SCIG, not in those who were already receiving SCIG, suggesting that the improvement resulted from the change in therapy. Both children and adults had significant improvements in Life Quality Index. Again, in the adults, no change was seen in the group that was already receiving SCIG at enrollment. At study end, all children/parents, the 10 adults on SCIG at enrollment, and 73% of the adults who switched preferred to continue SCIG at home. Two expressed a preference for SCIG regardless of setting, 1 expressed a preference for home regardless of method, 1 expressed no preference for anything, and only 1 expressed a preference for IVIG in the hospital.
Home therapy with SCIG in children and adults with antibody deficiency is generally self-perceived as superior to in-hospital therapy with IVIG with respect to several validated measures of HRQOL.
IVIG has been a major mode of therapy for immunodeficiency for 30 years. Many primary care providers have 1 or a few patients who receive this therapy. Less widely recognized, SCIG has also been used with safety and efficacy equivalent to IVIG and has been the major mode of immunoglobulin delivery in some countries (although this is an off-label use in the United States). For a variety of reasons, SCIG is gaining in popularity and may replace IVIG for many patients with immunodeficiency diseases.