New Frontiers in Subcutaneous Immunoglobulin Treatment

Abstract

Subcutaneous immunoglobulin (SCIG) treatment provides stable serum immunoglobulin G (IgG) levels, is associated with fewer systemic adverse events than intravenous immunoglobulin (IVIG) treatment, and offers the convenience of home therapy. In clinical practice, IVIG is still used preferentially for initiation of treatment in newly diagnosed patients with primary immunodeficiency (PI) and for immunomodulatory therapy, such as treatment of peripheral neuropathies, when high doses are believed to be necessary. The authors discuss recent experience in using SCIG in place of IVIG in these settings. SCIG has been successfully used for initiation of therapy in previously untreated PI patients. Seventeen of 18 PI patients achieved serum IgG levels ≥5 g/L after the loading phase. Daily treatment was well tolerated and provided opportunities for patient/parent training in self-infusion. SCIG has been used for maintenance therapy in multifocal motor neuropathy (MMN) in three recent clinical trials, with good efficacy and tolerability results. Seven of eight MMN patients maintained serum IgG levels of 14–22 g/L with a mean dose of 272 mg/kg/week, had stable muscle strength, and felt comfortable with self-administration. Four patients with polymyositis or dermatomyositis achieved improvement in serum creatine kinase levels and muscle strength with SCIG therapy. Recent experience with SCIG suggests that traditional concepts of immunoglobulin therapy may be challenged to increase available therapy options. SCIG can be used to achieve high IgG levels within several days in untreated PI patients and to maintain high serum levels, as shown in patients with MMN.

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

“…In contrast, recent pooled analyses showed that the incidence of infection increases as the IgG level falls towards the end of each 3‐ or 4‐week IVIG dosing cycle . It is not possible to achieve the near steady‐state IgG levels with weekly SCIG using IVIG.…”

“…In contrast, recent pooled analyses showed that the incidence of infection increases as the IgG level falls towards the end of each 3-or 4-week IVIG dosing cycle [45]. It is not possible to achieve the near steady-state IgG levels with weekly SCIG [46][47][48] using IVIG. The reduced incidence of systemic AEs and the comparative ease of the subcutaneous infusion facilitate home-based self-or family-administered SCIG regimens.…”

“…Weekly SCIG raises the IgG more gradually, reaching levels >5 g/l after 3-4 weeks [65], with steady-state levels reached after 6 months. In the US registration trials and in patients in whom serum IgG levels must be raised rapidly, IVIG is given first, followed by a switch to SCIG therapy for maintenance [48].…”

The history and evolution of immunoglobulin products and their clinical indications

“…A retrospective study of 12 children with prolonged hypogammaglobulinemia after hematopoietic stem cell transplantation found that they experienced fewer side-effects and no more infections that children who received IVIG (Lingman-Framme and Fasth 2013). SCIG has also been used instead of IVIG in maintenance therapy of patients with MMN and CDIP (Jolles et al 2011). SCIG therapy has also been studied as the first immunoglobulin treatment of patients with polymyositis or dermatomyositis (Jolles et al 2011).…”

“…SCIG has also been used instead of IVIG in maintenance therapy of patients with MMN and CDIP (Jolles et al 2011). SCIG therapy has also been studied as the first immunoglobulin treatment of patients with polymyositis or dermatomyositis (Jolles et al 2011).…”