Long-term Efficacy, Safety, and Tolerability of Normal Human IgG with Facilitated Absorption in Patients with Humoral Immunodeficiency
The treatment of patients with humoral immunodeficiency is long-term and therefore needs to be not only effective but also safe and well-tolerated. Below, we present the outcomes from an Italian real-world clinical practice study evaluating the efficacy, safety, and tolerability of human immunoglobulin for facilitated subcutaneous administration and patient satisfaction with this therapy.
Methodology and Study Process, Evaluated Population
A total of 30 adult patients (17 women and 13 men; average age 40 years) with primary humoral immunodeficiency (n = 25; most commonly common variable immunodeficiency [CVID] or IgG subclass deficiency) or secondary symptomatic humoral immunodeficiency, specifically hypogammaglobulinemia, (3 patients with hematologic malignancy and 2 with solid tumors) were included in the retrospective monocentric study. These patients underwent subcutaneous substitution therapy with normal human immunoglobulin with recombinant hyaluronidase facilitating absorption from the subcutaneous tissue (fSCIG) between September 2014 and December 2019. The average duration from diagnosis to study entry was 40.5 months (6.8–89.8). Serum IgG levels were determined at the start of the study, after 3 months of therapy, and subsequently every 6–12 months.
A total of 23 patients received the preparation every 4 weeks, 5 patients every 3 weeks, and 2 patients every 2 weeks (average administration interval of 3.7 ± 0.6 weeks). The average weekly dose was 7.5 g (6.3–7.7 g), respectively, 98.0 mg/kg body weight (86.3-113.6 mg/kg). The average monthly dose was thus 25 g.
Therapy efficacy (primarily the frequency of bacterial infections), safety (occurrence of adverse events), and tolerability (reaction at the injection site) were assessed, along with patient satisfaction with the treatment (according to a completed questionnaire).
Results
A total of 23 patients (88%) experienced at least one infectious disease during the 12 months of therapy (19 patients with primary and 4 with secondary immunodeficiency). The most common infections were nasopharyngitis (11/year), bronchitis (8/year), sinusitis (5/year), urogenital infection (4/year), diarrhea (3/year), rhinitis (3/year), otitis (1/year), and mucocutaneous infection (1/year). The average serum IgG level before the start of substitution was 4.17 g/l. The achieved target level remained stable throughout the substitution period.
A total of 6 patients (20%) reported an adverse event (AE) related to therapy – in 5 cases, these were moderately severe (fever and headache) and in 1 case mild (fatigue). Three patients (10%) reported a local reaction at the injection site (erythema, pruritus, induration, pain). However, none of the patients discontinued therapy due to adverse events or local reactions.
Patient satisfaction regarding efficacy was reported by 88.8% of patients, for the minimum of adverse events by 73.5%. The application of the fSCIG preparation was considered comfortable by 85.0% of patients. Overall, 92.9% of patients were satisfied with the therapy.
Conclusion
The fSCIG preparation demonstrates long-term efficacy (reduction in the frequency of infectious diseases) and good tolerability (mild to moderately severe adverse events and local reactions at the injection site) in patients with primary and secondary immunodeficiency. Its advantage also lies in the possibility of home administration, which reduces the impact of the disease on the patient's daily life.
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Source: Angelotti F., Capecchi R., Giannini D. et al. Long-term efficacy, safety, and tolerability of recombinant human hyaluronidase-facilitated subcutaneous infusion of immunoglobulin (Ig) (fSCIG; HyQvia) in immunodeficiency diseases: real-life data from a monocentric experience. Clin Exp Med 2020; 20 (3): 387–392, doi: 10.1007/s10238-020-00633-4.
VV-MEDMAT-79250; preparation date 12/2022
Abbreviated information about the HyQvia product HERE.
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