Table 1 Studies of manual administration of SCIG therapies other than Ig20Gly

Type of study, location

Phase 4, open-label multicentre study of high SCIG infusion rates in patients with PIDs in the USA

Retrospective chart review of paediatric patients with PIDs in North America

Retrospective chart review of patients with PIDs in the USA

Retrospective chart review of patients with PIDs in the USA

Retrospective chart review of patients with PIDs in the USA

Retrospective chart review of patients with PIDs enrolled in the SCIG manual administration program in Canada

Multicentre, open-label, randomized, non-inferiority trial in adults with PIDs in Australia, Germany, Italy, and the UK

Demographics

Adults and adolescents, n = 16

Paediatric patients, n = 88

Adults and paediatric patients, n = 104

Adults and paediatric patients, n = 173

Paediatric patients, n = 96

Adults, n = 62

Adults, n = 30

SCIG

SCIG 20% (IgPro20; Hizentra)

SCIG 20% (IgPro20; Hizentra)

SCIG 16% (Vivaglobin)

SCIG 16% (Vivaglobin) or SCIG 20% (IgPro20; Hizentra)

SCIG 16% (Vivaglobin) or SCIG 20% (IgPro20; Hizentra)

SCIG 16% (Vivaglobin), SCIG 20% (IgPro20; Hizentra) or SCIG 20% (Ig20Gly; Cuvitru)

SCIG 16.5% (Gammanorm)

Study objective

To evaluate the safety and tolerability of IgPro20 manual administration infusions at flow rates of 0.5–2.0 mL/min

To analyse the safety and efficacy of SCIG 20% in children aged < 5 years

To evaluate dosing and administration patterns, IgG trough levels, safety, and tolerability of manual administration compared with administration by infusion pump in patients who chose their SCIG administration method

To evaluate dosing and administration patterns, characterize serum IgG levels, and evaluate the safety and tolerability of the manual administration technique of patients receiving SCIG treatment

To analyse usage patterns, pharmacokinetic responses, and safety outcomes of paediatric patients using SCIG administered manually and by infusion pump

To determine the effectiveness of SCIG manual administration in adult patients with PIDs

To evaluate patient HRQoL and satisfaction with SCIG 16.5% when administered by infusion pump or manually

Inclusion criteria

Patients with PIDs receiving a stable dose of IgPro20 therapy at a flow rate of ~ 0.5 mL/min/site for ≥ 1 month prior to the first day of the study

Patients with PIDs who had received > 1 dose of SCIG 20% prior to 5 years of age, regardless of previous Ig replacement therapy

Patients who were either Ig-naive or were switched from IVIG to a 16% SCIG; patients who had received ≥ 1 course of SCIG therapy between 1 January 2006 and 1 April 2008 for PIDs

Patients of any age who had received ≥ 1 course of SCIG therapy for PIDs between 1 January 2006 and 1 November 2011

Patients of any age who received ≥ 1 course of SCIG therapy for PIDs between 1 January 2006 and 1 November 2011

Patients aged ≥ 18 years with PIDs who had received SCIG via manual administration for ≥ 12 consecutive months

Patients aged ≥ 18 years with PIDs who had received SCIG for ≥ 1 month

Key results

Subcutaneous IgPro20 manual administration infusions at flow rates up to 2.0 mL/min were well tolerated

Rates of treatment-related local TEAEs were 0.023, 0.082, and 0.025 per infusion for 0.5, 1.0, and 2.0 mL/min flow rates, respectively

Median volume administered was 55.0 mL and median dose was 127.3 mg/kg

Manual administration of SCIG 20% was tolerated without difficulty and permitted faster administration times in some patients than administration via infusion pump

Overall, 65/74 patients (88%) who initiated SCIG therapy using manual administration remained on manual administration and 13/29 (45%) who started on infusion pump switched to manual administration

Mean serum IgG levels were comparable between patients using manual administration (12.3 g/L) and infusion pump (11.5 g/L)

AEs were reported in 31% of patients. Local infusion site reactions occurred in 28% of patients using manual administration and 28% of patients using an infusion pump

Overall, AEs were reported once every 5–6 visits and were less frequent with manual administration than infusion pump

Approximately two-thirds of patients chose to initiate SCIG therapy with manual administration and most continued to use manual administration

Manual administration resulted in acceptable serum IgG levels and allowed for faster administration than infusion pump

Manual administration had a favourable safety profile and was a viable alternative to infusion pumps in children

Serum IgG levels were 17.8% higher with subcutaneous manual administration than with infusion pump

The frequency of AEs was generally lower among patients using manual administration than infusion pump (87% lower in patients aged < 2 years and 50% lower in patients aged 2 to < 10 years)

The majority of AEs for both infusion pump and manual administration were local and self-limiting

Manual administration allowed for faster infusion times (most completed in < 10 min) than infusion pump

Manual administration of SCIG was reported to result in adequate steady-state IgG levels

Only 8 patients discontinued SCIG following ≥ 12 months of treatment via manual administration

Compared with infusion pumps, for manual administration the number of infusions per site was > 2 times higher, total infusion rate was > 3 times higher, and total time expenditure for dosing was shorter

The 3-month rate of infection and residual serum Ig levels were comparable for infusion pump and manual administration

HRQoL did not significantly differ between patients using manual administration and those using administration via infusion pump

Direct treatment costs, excluding cost for SCIG 16.5%, were lower for manual administration than for infusion pump; indirect costs were similar for both modes of administration