Contributions
Abstract: EP1340
Type: E-Poster Presentation
Session title: Transfusion medicine
Background
Secondary immunodeficiency diseases (SID) commonly affect patients with hematological malignancies such as chronic lymphocytic leukemia (CLL) and lymphoma. Immunoglobulin replacement therapy (IGRT) is an important therapeutic option for preventing severe, recurrent, or persistent infections in patients with hematologic malignancies and SID. Facilitated subcutaneous immunoglobulin (fSCIG) is a dual-vial unit of immunoglobulin G (IgG) 10% and recombinant human hyaluronidase (rHuPH20) approved in the European Union as an IGRT for patients with SID. rHuPH20 depolymerizes hyaluronan in the extracellular matrix to transiently increase local subcutaneous tissue permeability, allowing for fSCIG infusion at rates, volumes, and frequencies comparable to intravenous immunoglobulin (IVIG) with better systemic tolerability.
Aims
To assess fSCIG usage and tolerability over time in patients with SID treated in routine clinical practice.
Methods
FIGARO (NCT03054181) is a European multicenter, prospective, observational study. Patients were eligible if they received ≥1 fSCIG infusion for primary immunodeficiency diseases or SID and provided informed consent. Patients are being followed for up to 3 years. An interim analysis (data cut-off date: February 2, 2021) was conducted to evaluate fSCIG usage and tolerability over the first 2 years of follow up in the subgroup of patients with SID.
Results
Of the 156 patients enrolled, 31 (mean [range] age: 61 [3–88] y) had SID and are included in the baseline (inclusion visit) analysis. At interim analysis, 1- and 2-year follow-up data were available for 23 and 12 patients, respectively. Indications for IGRT were CLL (n=20), non-Hodgkin lymphoma (n=6), SID due to immunosuppressive therapy (n=3), and Hodgkin lymphoma (n=2). At the inclusion visit, fSCIG (median total monthly dose: 30.0 g) was most recently infused at home (61%) or at a hospital (36%) by the patient (58%) or a nurse (42%). Most patients received fSCIG every 4 weeks (68%), infused into a single site. The median maximum infusion rate was consistent over the 2-year follow up: 290 mL/h at inclusion, 268 mL/h at 1 year, and 300 mL/h at 2 years. The median infusion volume was 300 mL across all visits to 2 years, with all patients receiving the full dose as planned. Two patients each reported 1 adverse drug reaction (ADR; erythema and headache) at the inclusion visit, with no ADRs reported at any of the follow-up visits. One patient changed to IVIG by 12 months.
Conclusion
In patients with SID primarily due to hematologic malignancies, fSCIG was tolerated over 2-years’ follow up in routine clinical practice and offered the flexibility of administration at home or in a hospital setting, either by the patient or a nurse. Infusion parameters remained consistent over time.
Keyword(s): Immunodeficiency, Immunoglobulin, Long-term follow-up, Subcutaneous
Abstract: EP1340
Type: E-Poster Presentation
Session title: Transfusion medicine
Background
Secondary immunodeficiency diseases (SID) commonly affect patients with hematological malignancies such as chronic lymphocytic leukemia (CLL) and lymphoma. Immunoglobulin replacement therapy (IGRT) is an important therapeutic option for preventing severe, recurrent, or persistent infections in patients with hematologic malignancies and SID. Facilitated subcutaneous immunoglobulin (fSCIG) is a dual-vial unit of immunoglobulin G (IgG) 10% and recombinant human hyaluronidase (rHuPH20) approved in the European Union as an IGRT for patients with SID. rHuPH20 depolymerizes hyaluronan in the extracellular matrix to transiently increase local subcutaneous tissue permeability, allowing for fSCIG infusion at rates, volumes, and frequencies comparable to intravenous immunoglobulin (IVIG) with better systemic tolerability.
Aims
To assess fSCIG usage and tolerability over time in patients with SID treated in routine clinical practice.
Methods
FIGARO (NCT03054181) is a European multicenter, prospective, observational study. Patients were eligible if they received ≥1 fSCIG infusion for primary immunodeficiency diseases or SID and provided informed consent. Patients are being followed for up to 3 years. An interim analysis (data cut-off date: February 2, 2021) was conducted to evaluate fSCIG usage and tolerability over the first 2 years of follow up in the subgroup of patients with SID.
Results
Of the 156 patients enrolled, 31 (mean [range] age: 61 [3–88] y) had SID and are included in the baseline (inclusion visit) analysis. At interim analysis, 1- and 2-year follow-up data were available for 23 and 12 patients, respectively. Indications for IGRT were CLL (n=20), non-Hodgkin lymphoma (n=6), SID due to immunosuppressive therapy (n=3), and Hodgkin lymphoma (n=2). At the inclusion visit, fSCIG (median total monthly dose: 30.0 g) was most recently infused at home (61%) or at a hospital (36%) by the patient (58%) or a nurse (42%). Most patients received fSCIG every 4 weeks (68%), infused into a single site. The median maximum infusion rate was consistent over the 2-year follow up: 290 mL/h at inclusion, 268 mL/h at 1 year, and 300 mL/h at 2 years. The median infusion volume was 300 mL across all visits to 2 years, with all patients receiving the full dose as planned. Two patients each reported 1 adverse drug reaction (ADR; erythema and headache) at the inclusion visit, with no ADRs reported at any of the follow-up visits. One patient changed to IVIG by 12 months.
Conclusion
In patients with SID primarily due to hematologic malignancies, fSCIG was tolerated over 2-years’ follow up in routine clinical practice and offered the flexibility of administration at home or in a hospital setting, either by the patient or a nurse. Infusion parameters remained consistent over time.
Keyword(s): Immunodeficiency, Immunoglobulin, Long-term follow-up, Subcutaneous