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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

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Abstract

Humoral immunodeficiency diseases represent a heterogeneous group of disorders that require long-term therapies. Thus, the treatment provided must not only be effective but also safe and well tolerated. In this paper, we report our data on the efficacy, safety, and tolerability of recombinant human hyaluronidase-facilitated subcutaneous infusion of immunoglobulin (Ig) (fSCIG; HyQvia(®)) in immunodeficiency patients. We collected retrospective data from 30 patients with primary and secondary immunodeficiency diseases in therapy with fSCIG from September 2014 to December 2019. We evaluated the efficacy of the therapy, taking into account serum IgG values during follow-up and the number of annual infectious events and serious bacterial infections reported by patients. Safety was assessed on the basis of the number and intensity of adverse events (AEs) and local reactions reported. Our real-life data suggest that long-term repeated self-administration of recombinant human hyaluronidase-facilitated subcutaneous infusion of immunoglobulins results in a reduced rate of infectious events if compared to the pre-treatment rate. Both AEs and local reactions are mild to moderate and were never reasons for treatment discontinuation. Therapy with HyQvia shows prolonged efficacy and good tolerability; these aspects, together with the possibility of self-administration at home, minimize the impact the illness has on patients.

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Authors and Affiliations

  1. Clinical Immunology Unit, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy

    Francesca Angelotti, Riccardo Capecchi, Daiana Giannini, Ornella Mazzarella, Valeria Rocchi & Paola Migliorini

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  1. Francesca Angelotti
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  2. Riccardo Capecchi
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Correspondence to Paola Migliorini.

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The study was notified to the Ethics Committee of Area Vasta Nord Ovest (Pisa, Italy); due to the observational, retrospective nature of the study, formal approval was not required.

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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 20, 387–392 (2020). https://doi.org/10.1007/s10238-020-00633-4

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