Elsevier

Clinical Immunology

Volume 126, Issue 1, January 2008, Pages 81-88
Clinical Immunology

Prognostic factors for health-related quality of life in adults and children with primary antibody deficiencies receiving SCIG home therapy

https://doi.org/10.1016/j.clim.2007.06.009Get rights and content

Abstract

The aims of the present study were to evaluate the health-related quality of life (HRQL) and treatment satisfaction (TS) of adults and children with primary antibody deficiencies (PAD) before and after the introduction of subcutaneous immunoglobulin G (SCIG) self-infusions at home and to identify prognostic factors (demographic/social, medical, patient/parent reported) for HRQL. 85 adults and 21 parents of children with PAD answered the SF-36 (adults), CHQ–PF50 (parents), and the LQI (adults and parents) at baseline and following 10 months of weekly self-administered SCIG infusions at home. The SCIG home therapy was associated with significant improvements in HRQL and TS, particularly in patients who had previously received IVIG therapy in hospital settings. Background factors that were found to be associated with HRQL changes in adults were age, serum IgG levels at month 10, concomitant joint/muscle/skeletal disorders, clinical study location and smoking status.

Introduction

Primary immunodeficiency disorders (PIDs) are a group of chronic diseases, with more than 120 genetically distinct subtypes identified [1]. PIDs that involve absence or low levels of antibodies (primary antibody deficiencies, PAD) result in an increased susceptibility to bacterial infections [2]. It was shown more than 50 years ago that regular replacement therapy with antibodies (immunoglobulin G, IgG) derived from human plasma decreases the risk and severity of infections [3].

IgG replacement therapy consists of either intravenous (IVIG) or subcutaneous (SCIG) IgG infusions. Both methods of administration have been shown to be safe and to effectively decrease the incidence and severity of infections in patients suffering from PAD [4], [5], [6], [7], [8], [9], [10], [11], [12], and both methods can be used as self-infusions at home [7], [8], [11], [12], [13], [14], [15], [16], [17]. Patients treated with IVIG infusions receive their therapy once every 2 to 5 weeks, while the SCIG therapy is typically given as weekly infusions [7], [8], [10], [11], [12], [18], [19]. Several previous investigations have demonstrated that following training and education, adults and children can easily and successfully self-administer SCIG therapy at home, with consistent serum IgG levels and few systemic adverse reactions [7], [8], [10], [11], [12], [17], [20], [21], [22], [23], [24], [25]. SCIG self-administered at home is highly appreciated by patients and families since it simplifies daily life [7], [17], [22], [23], [24], [25], [26], [27], [28], [29].

The introduction of SCIG self-infusions at home has improved the health-related quality of life (HRQL) and treatment satisfaction (TS) in both children and adults with PAD [17], [25], [27], [29]. Only one publication has so far shed some light on factors that are of importance for HRQL, coping, and hope in adults with PAD [30]. The identification of factors that are associated with self-reported HRQL in these patients may help to improve care by identifying vulnerable individuals and by tailoring support, treatment modalities, and training to suit patients' particular need. This study was conducted to evaluate the HRQL and TS of adults and children with PAD before and after the introduction of SCIG self-infusions at home with the main aim to identify prognostic background factors (demographic, social, medical, and patient/parent reported factors) related to HRQL.

Section snippets

Study designs

The current analyses were performed on the combined data from two prospective, multinational clinical studies evaluating the efficacy, safety, HRQL, and TS in children and adults [11], [12], [25], [27]. To summarize, in both studies, the participants or parents administered weekly subcutaneous infusions of a liquid, pasteurized, polyvalent, human 16% IgG preparation (Vivaglobin®, CSL Behring, Marburg, Germany). The patients/parents were trained on SCIG self-administration at their local

HRQL and TS in adults and children

Significant improvements in SF-36 scores from baseline to month 10 were found in four scales for adults previously on IVIG therapy at the hospital/doctor's office: “health transition” (HT, P < 0.01), role – physical” (RP, P < 0.05), “general health” (GH, P < 0.05), and “vitality” (VT, P < 0.01) (Table 2). For patients already receiving IVIG at home at study start and now only changing the mode of IgG administration route, the SF-36 scores significantly improved for the scale GH (P < 0.05) (Table 2). For

Discussion

By combining the results of two studies and thus increasing sample size, the current analyses were carried out both to investigate the effect of the introduction of SCIG self-infusions at home on PRO measures such as HRQL and TS, and to identify prognostic factors impacting HRQL changes in children and adults suffering from PAD.

Of the 125 patients, 19 did not present a final assessment because they had dropped out during the study. To exclude that the underlying process was informative we did a

Vivaglobin clinical study group

North American trialEuropean and Brazilian trial
USAAustria
Arthur H. Althaus, Louisville, KYAndreas Böck, Vienna
Pedro C. Avila, San Francisco, CABrazil
Melvin Berger, Cleveland, OHBeatriz Costa Carvalho, Sao Paolo
Sudhir Gupta, Irvine, CAGermany
Robert W. Hostoffer, South Euclid, OHMichael Borte, Leipzig
Lisa J. Kobrynski, Atlanta, GAHartmut Peter, Freiburg Sigune Schmidt, Freiburg
Robyn Levy, Atlanta, GAIlka Schulze, Berlin
Laurie Myers, Durham, NCTim Niehues, Dusseldorf
Hans D. Ochs, Seattle, WAPoland

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