Journal of Clinical Immunology, Vol. 26, No. 1, January 2006 ( C  2006) DOI: 10.1007/s10875-006-8905-x Health-Related Quality of Life and Treatment Satisfaction in North American Patients with Primary Immunedeficiency Diseases Receiving Subcutaneous IgG Self-Infusions at Home UWE NICOLAY, 1,9 PETER KIESSLING, 2 MELVIN BERGER, 3 SUDHIR GUPTA, 4 LEMAN YEL, 4 CHAIM M. ROIFMAN, 5 ANN GARDULF, 1 FLORIAN EICHMANN, 6 STEFAN HAAG, 2 CORDULA MASSION, 7 and HANS D. OCHS 8 Received: June 20, 2005; accepted: October 3, 2005 The lifelong IgG replacement therapy for patients with primary immunedeficiencies (PIDD) may be provided by intravenous (IVIG) or by subcutaneous IgG (SCIG) infusions. We investi- gated the impact of weekly SCIG self-infusions at home on the health-related quality of life, treatment satisfaction, and pref- erences in patients treated with IVIG at the hospital/doctor’s office (Group A) or at home (Group B) before the study started. Forty-four adult North American PIDD patients were included in the study, 28 patients in Group A and 16 in Group B. Patients in Group A reported significantly less limitations with their work/daily activities, a significantly improved vitality, and better general health. Treatment satisfaction was significantly improved in Group A. The preference for the subcutaneous route and for home therapy was respectively 81% and 90% in Group A. In Group B, 69% preferred the subcutaneous route and 92% home therapy. KEY WORDS: Primary immunedeficiency disease; subcutaneous IgG therapy; intravenous IgG therapy; home-therapy; quality of life; treatment satisfaction. 1 Section of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm, Sweden. 2 Clinical Research, ZLB Behring GmbH, Marburg, Germany. 3 Division of Allergy, Immunology and Rheumatology, Rainbow Babies and Children’s Hospital, Cleveland, Ohio. 4 Division of Basic and Clinical Immunology, Department of Medicine, University of California, Irvine, California. 5 The Hospital for Sick Children, Toronto, Ontario, Canada. 6 Kendle International Inc., Munich, Germany. 7 Department of Biostatistics, Accovion GmbH, Marburg, Germany. 8 Department of Pediatrics, University of Washington, Seattle, Washington. 9 To whom correspondence should be addressed at M96, Section of Clinical Immunology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital, SE-14186 Stockholm, Sweden; e-mail: uwe.nicolay@labmed.ki.se. INTRODUCTION Primary immunedeficiency diseases (PIDD) are a hetero- geneous group of disorders (e.g., X-linked agammaglobu- linemia, common variable immunodeficiency) with a de- fective host defense leading to increased susceptibility to infections (1, 2). Lifelong replacement therapy with hu- man immunoglobulin (IgG) is the mainstay of treatment for patients with predominant antibody deficiencies (3–5). Since the introduction of intravenous IgG (IVIG), doses between 200 and 600 mg/kg body weight, generally given at 3–4-week intervals have been recommended to achieve serum IgG trough levels of 300 to 500 mg/dL above base- line (6). According to a recent survey in the US (7), 12% of the patients receive their IVIG therapy in a doctor’s office, 30% in a hospital, 11% in infusion suites, 40% at home, 1% reported multiple, and 5% other locations. In most of the cases (87%) the infusions are administered by health care providers, rarely by the patient or a family member. IVIG infusions may be associated with a range of side effects, and self/partner/parent infusions may not be suited for patients with poor venous access (8–14). Rapid subcutaneous IgG infusions (SCIG) can be eas- ily learned by adults and children/parents, are safe with very few systemic adverse reactions, result in high and consistent serum IgG levels, and were shown to facilitate self-infusions at home (15–28). However, data from pa- tients switching from IVIG therapy at the hospital/doctor’s office or at home to home-based SCIG self-infusions are limited (24). The preference for home-based IVIG replacement ther- apy over IVIG infusions from staff in a medical setting has been published (26). Most recently, Gardulf et al. presented data showing increased health-related quality of life (HRQL) and treatment satisfaction in patients 65 0271-9142/06/0100-0065/0 C  2006 Springer Science+Business Media, Inc.