Subcutaneous Immunoglobulin Replacement Therapy in Patients with Primary Immunodeficiency in Routine Clinical Practice: The VISPO Prospective Multicenter Study

Abstract

Background and ObjectivesSubcutaneous immunoglobulin (SCIG) therapy is becoming increasingly popular as self-administration is possible because intravenous access is unnecessary, and there is a lower frequency of systemic adverse events. The aim of this study was to evaluate the shifting from intravenous immunoglobulins (IVIGs) replacement therapy to SCIG in patients with primary immunodeficiency (PID) in a routine real-life situation.MethodsIn a multicenter prospective observational study, we enrolled 50 patients suffering from PID who were monitored for 24 months; 44 patients switched from IVIG and six from different SCIG preparations. The study preparation (human IgG 16 %, Vivaglobin®, CSL Behring GmbH, Germany) was subcutaneously infused weekly (maximum volume 15 mL/site; maximum infusion rate 22 mL/h). The study endpoints were: annual rate of severe bacterial infections (SBIs), local adverse reactions, quality of life, days off school/work, and days of hospitalization.ResultsThirty-three of 39 (84.6 %) patients who completed the study experienced an infection or signs thereof. Only five SBIs were observed, corresponding to an annual rate of 0.056 episodes per patient in 44 subjects [intention-to-treat (ITT) population]. A significant decrease in both days of hospitalization (1.93 ± 4.08 vs. 0.64 ± 2.94) and days off school/work (15.27 ± 23.17 vs. 2.26 ± 4.45) was recorded at 24 months. Local reactions were observed in 14/50 (28 %) patients, mainly consisting of skin manifestations at the injection site. Only three (6.8 %) patients discontinued due to infusion site reactions. In patients shifting from IVIG to SCIG, the total mean score of Life Quality Index (LQI) improved from 76.9 ± 16.8 to 90.7 ± 11.6 (P < 0.01) at 6 months; there was an improvement also in the overall patients’ evaluation.ConclusionsA total of 93.2 % patients tolerated the new route of administration and reported a significant improvement in their LQI. Our results from a routine clinical practice in a real-life population are consistent with those of phase III clinical studies.

A pilot study about subcutaneous administration of 10% immunoglobulin in patients with primary immune deficiencies: single center experience

“…Patients with similar problems have also been reported in the VISPO study (25). In VISPO study, the rate of patients suffered from diarrhea is 4,7% and their complaints did not improve in time, fortunately in our two patients with experienced recurrent non-infectious diarrhea was reduced during with SCIg therapy within 3 months.…”

Estimating the Cost of Immunoglobulin Replacement Therapy in Primary Immunodeficiency Patients

“…In order to switch from IVIg to SCIg, patients are trained to self-administer the procedure and are monitored weekly by local hospital care (12). Usually a 4 -6 session training course is required for home-based infusion preparation by the patients or their family.…”

“Experiences of the burden of treatment”—Patient reports of facilitated subcutaneous immunoglobulin treatment in adults with immunodeficiency

“…However, the exact prevalence of PID is not known, but it has been estimated that about 1 in 1,200 people in the United States are diagnosed with PID (Boyle & Buckley, ). Without treatment, patients suffering from PID have higher rates of four or more severe respiratory infections per year (Vultaggio et al., ). It is also known that patients with SID are at higher risk of developing severe infections.…”

“…Thus, the condition still impacts on HRQOL and patients’ desire to have a greater independence (Espanol et al., ). Previous research has concluded that SCIg could be preferable, as it reduces the incidence of systemic adverse events and is more flexible and easy to administer both at home or at the clinic (Jolles et al., ; Vultaggio et al., ). One problem with SCIg treatment is the administration of the small volume that can be infused in one site, resulting in several sites that need to be used simultaneously, which requires multiple needle sticks and an increased infusion frequency of 2–8 times each month.…”

“…Without treatment, patients suffering from PID have higher rates of four or more severe respiratory infections per year (Vultaggio et al, 2015). It is also known that patients with SID are at higher risk of developing severe infections.…”