Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency

Abstract

Background Subcutaneous immunoglobulin (SCIG) therapy is an alternative to intravenous immunoglobulin (IVIG) therapy. Methods We evaluated the efficacy and safety of the SCIG Vivaglobin ® (formerly known as Beriglobin ® SC) under real-life conditions in a post-marketing observational study in 82 patients with primary or secondary antibody deficiencies. Health-related quality of life (HRQoL) was evaluated in a subset of 30 patients previously treated with IVIG (including 11 children < 14 years) using the Short Form 36 (SF-36) for patients ≥ 14 years of age (adults) and the Child Health Questionnaire - Parental Form 50 (CHQ-PF50) for children < 14 years of age. Treatment preferences were assessed in adults. Results The mean serum immunoglobulin G (IgG) trough level during SCIG treatment (7.5 g/L) was higher than during previous IVIG treatment (6.6 g/L; p < 0.01). The investigators assessed the efficacy of SCIG therapy as "excellent" in 89% of patients. No systemic adverse drug reactions were observed. Improvements by ≥ 5 points were observed in 5 of 8 SF36 subscales and in 6 of 12 CHQ-PF50 subscales. Statistically significant improvements (p ≤ 0.05) were observed for the SF-36 subscales of bodily pain, general health perceptions, and vitality (adults), and for the CHQ-PF50 subscales of general health perceptions, parental impact - time, parental impact - emotional, and family activities (children). Patients preferred SCIG over IVIG therapy (92%) and home therapy over therapy at the clinic/physician (83%). Conclusion This study confirms that therapy with Vivaglobin ® at home is effective, safe, well tolerated, and improves quality of life in patients with antibody deficiency.

Fatigue and the wear-off effect in adult patients with common variable immunodeficiency

“…However, the frequency of infections reported overall was similar between patients receiving either treatment. This finding is compatible with previous studies that showed that IVIG and SCIG are equally effective in protecting against infections [21][22][23][24][25]. However, patients on IVIG reported higher infection rates towards the end of the infusion cycle, which was associated with the wear-off effect of IgGRT [26,27], and patients who switched from IVIG to SCIG reported less wear-off effect and less fatigue [28][29][30].…”

Subcutaneous immunoglobulin: rapid push vs. infusion pump in pediatrics

“…Furthermore, AUC is not a clinically established marker for evaluating Ig pharmacokinetics, and trough values may be more appropriate (13). Our clinic employs a general 1:1 dose conversion ratio when switching patients from IVIG to SCIG, and our findings corroborate other studies that have reported 1:1 dose conversion to be an appropriate strategy when switching patients from IVIG to SCIG (5,(14)(15)(16)(17). In this cohort of pediatric patients, monthly SCIG dosing was actually lower, on average, than prior IVIG dosing.…”

Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease

“…The usual practice of switching from IVIG to SCIG therapy in Europe has been to use the equivalent monthly IgG dose split into four equal weekly doses (1:1 dosing) [68,69]. Despite the recommendation of the US Food and Drug Administration to use a dose adjustment coefficient to achieve similar total exposure to IgG (non-inferior area under the curve of serum IgG concentration plotted versus time) [16], studies of clinical practice in the United States suggest that physicians are not necessarily heeding that recommendation, as there was no difference in the total monthly doses used by the intravenous and subcutaneous routes [70,71].…”

“…SCIG administration has been reported to be more compatible with an active lifestyle, including sports and schooling, and more convenient during business trips or holiday [13,21,24,[26][27][28]68,69]. Ninety per cent of patients receiving IVIG report having skipped a dose compared with 18% of those receiving SCIG therapy, and 45% of patients with SCIG self-administered doses with delay by 3 or more days at least once in the last 6 months [8,13].…”