Switch from intravenous to subcutaneous immunoglobulin IgPro20 in CIDP patients: a prospective observational study under real-world conditions.
Chronic inflammatory demyelinating polyneuropathy
intravenous immunoglobulin
subcutaneous immunoglobulin
Journal
Therapeutic advances in neurological disorders
ISSN: 1756-2856
Titre abrégé: Ther Adv Neurol Disord
Pays: England
ID NLM: 101480242
Informations de publication
Date de publication:
2021
2021
Historique:
received:
15
03
2021
accepted:
18
03
2021
entrez:
5
5
2021
pubmed:
6
5
2021
medline:
6
5
2021
Statut:
epublish
Résumé
IgPro20 is the first approved subcutaneous immunoglobulin (SCIg) preparation for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Two different doses of the SCIg preparation were investigated in the pivotal PATH study. Real-world data, and particularly the efficacy of an equivalent dose switch from intravenous immunoglobulin (IVIg) to SCIg, are still not available. In this prospective observational study, 41 patients with CIDP treated with intravenous immunoglobulin (IVIg) were changed to an equivalent (1:1) dose of IgPro20 1 week after last IVIg treatment. Patients were examined at the time of switch from IVIg to SCIg, after 3 and after 6 months and efficacy, treatment preferences and systemic and local reactions were assessed. Various clinical outcome parameters demonstrated overall stability regarding disability, general activity and social participation, grip and muscle strength, as well as gait impairment. Treatment satisfaction remained unchanged between IVIg and SCIg therapy. However, 88% of patients favoured treatment with subcutaneous IgPro20 over IVIg 6 months after switch to IgPro20. Results demonstrate that the switch of IVIg to an equivalent dose of SCIg represents an effective and preferred treatment option for CIDP patients.
Sections du résumé
BACKGROUND
BACKGROUND
IgPro20 is the first approved subcutaneous immunoglobulin (SCIg) preparation for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Two different doses of the SCIg preparation were investigated in the pivotal PATH study. Real-world data, and particularly the efficacy of an equivalent dose switch from intravenous immunoglobulin (IVIg) to SCIg, are still not available.
METHODS
METHODS
In this prospective observational study, 41 patients with CIDP treated with intravenous immunoglobulin (IVIg) were changed to an equivalent (1:1) dose of IgPro20 1 week after last IVIg treatment. Patients were examined at the time of switch from IVIg to SCIg, after 3 and after 6 months and efficacy, treatment preferences and systemic and local reactions were assessed.
RESULTS
RESULTS
Various clinical outcome parameters demonstrated overall stability regarding disability, general activity and social participation, grip and muscle strength, as well as gait impairment. Treatment satisfaction remained unchanged between IVIg and SCIg therapy. However, 88% of patients favoured treatment with subcutaneous IgPro20 over IVIg 6 months after switch to IgPro20.
CONCLUSION
CONCLUSIONS
Results demonstrate that the switch of IVIg to an equivalent dose of SCIg represents an effective and preferred treatment option for CIDP patients.
Identifiants
pubmed: 33948119
doi: 10.1177/17562864211009100
pii: 10.1177_17562864211009100
pmc: PMC8053839
doi:
Types de publication
Journal Article
Langues
eng
Pagination
17562864211009100Informations de copyright
© The Author(s), 2021.
Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declare no conflict of interest. Outside the submitted work, the authors received honoraria for lectures, travel grants, or research grants. Stefan Gingele reports research support from Else Kröner Fresenius Stiftung and honoraria for lectures from Merck and Alnylam. Moritz Koch, Anna Christina Saparilla, Gudrun Körner, Jarle von Hörsten, Marina Gingele, Tabea Seeliger, Franz Felix Konen and Martin Hümmert declare that they have no conflict of interest. Alexandra Neyazi reports research support from Internal Funding of the MHH (HiLF) and honoria for lectures from Novartis and Merck. Martin Stangel has received honoraria for scientific lectures or consultancy from Alexion, Bayer Healthcare, Biogen, Celgene, CSL Behring, Grifols, Janssen, Merck-Serono, NeuroTransData, Novartis, Roche, Sanofi Aventis, Takeda, and Teva. His institution received research support from Sanofi Aventis, Novartis and Merck-Serono. Thomas Skripuletz reports research support from Bristol-Myers Squibb, Claudia von Schilling Foundation, Else Kröner Fresenius Stiftung, Hannover Biomedical Research School (HBRS), Sanofi Aventis and honoraria for lectures and travel grants from Alexion, Alnylam, Bayer Vital, Biogen, Celgene, Centogene, CSL Behring, Euroimmun, Merck, Novartis, Roche, Sanofi Aventis, Siemens.
Références
Lancet Neurol. 2018 Jan;17(1):35-46
pubmed: 29122523
Eur J Neurol. 2013 May;20(5):836-42
pubmed: 23294032
Eur J Neurol. 2013 May;20(5):748-55
pubmed: 22891893
Neurorehabil Neural Repair. 2011 Sep;25(7):672-9
pubmed: 21436388
J Neurol. 2014 Nov;261(11):2159-64
pubmed: 25149866
JAMA Neurol. 2020 Sep 1;77(9):1159-1166
pubmed: 32338716
Neurol Neuroimmunol Neuroinflamm. 2019 Jul 03;6(5):e590
pubmed: 31355323
Neurology. 2011 Jan 25;76(4):337-45
pubmed: 21263135
Eur J Neurol. 2010 Mar;17(3):356-63
pubmed: 20456730
J Peripher Nerv Syst. 2011 Jun;16(2):150-2
pubmed: 21692916
J Neurol Neurosurg Psychiatry. 2019 Sep;90(9):981-987
pubmed: 30992333
Muscle Nerve. 1991 Nov;14(11):1103-9
pubmed: 1745285