PMID- 32385734
OWN - NLM
STAT- MEDLINE
DCOM- 20210526
LR  - 20210526
IS  - 1591-9528 (Electronic)
IS  - 1591-8890 (Linking)
VI  - 20
IP  - 3
DP  - 2020 Aug
TI  - Long-term efficacy, safety, and tolerability of recombinant human 
      hyaluronidase-facilitated subcutaneous infusion of immunoglobulin (Ig) (fSCIG; 
      HyQvia(((R)))) in immunodeficiency diseases: real-life data from a monocentric 
      experience.
PG  - 387-392
LID - 10.1007/s10238-020-00633-4 [doi]
AB  - 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(((R)))) 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.
FAU - Angelotti, Francesca
AU  - Angelotti F
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy.
FAU - Capecchi, Riccardo
AU  - Capecchi R
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy.
FAU - Giannini, Daiana
AU  - Giannini D
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy.
FAU - Mazzarella, Ornella
AU  - Mazzarella O
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy.
FAU - Rocchi, Valeria
AU  - Rocchi V
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy.
FAU - Migliorini, Paola
AU  - Migliorini P
AUID- ORCID: 0000-0001-6433-4964
AD  - Clinical Immunology Unit, Department of Clinical and Experimental Medicine, 
      University of Pisa and Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 
      56126, Pisa, Italy. paola.migliorini@med.unipi.it.
LA  - eng
PT  - Journal Article
DEP - 20200508
PL  - Italy
TA  - Clin Exp Med
JT  - Clinical and experimental medicine
JID - 100973405
RN  - 0 (Antigens, Neoplasm)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Immunologic Factors)
RN  - 0 (Recombinant Proteins)
RN  - EC 2.3.1.48 (Histone Acetyltransferases)
RN  - EC 3.2.1.169 (OGA protein, human)
RN  - EC 3.2.1.35 (Hyaluronoglucosaminidase)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antigens, Neoplasm/*chemistry
MH  - Drug Administration Schedule
MH  - Female
MH  - Histone Acetyltransferases/*chemistry
MH  - Humans
MH  - Hyaluronoglucosaminidase/*chemistry
MH  - Immunoglobulins, Intravenous/*administration & dosage/adverse effects/chemistry
MH  - Immunologic Factors/*administration & dosage/adverse effects/chemistry
MH  - Infusions, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Primary Immunodeficiency Diseases/*drug therapy
MH  - Recombinant Proteins/chemistry
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Hyaluronidase
OT  - Immunodeficiency diseases
OT  - Subcutaneous immunoglobulins
EDAT- 2020/05/10 06:00
MHDA- 2021/05/27 06:00
CRDT- 2020/05/10 06:00
PHST- 2019/09/10 00:00 [received]
PHST- 2020/05/01 00:00 [accepted]
PHST- 2020/05/10 06:00 [pubmed]
PHST- 2021/05/27 06:00 [medline]
PHST- 2020/05/10 06:00 [entrez]
AID - 10.1007/s10238-020-00633-4 [pii]
AID - 10.1007/s10238-020-00633-4 [doi]
PST - ppublish
SO  - Clin Exp Med. 2020 Aug;20(3):387-392. doi: 10.1007/s10238-020-00633-4. Epub 2020 
      May 8.