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
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

17562864211009100

Informations 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.

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Auteurs

Stefan Gingele (S)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Moritz Koch (M)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Anna Christina Saparilla (AC)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Gudrun M Körner (GM)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Jarle von Hörsten (J)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Marina Gingele (M)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Tabea Seeliger (T)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Franz Felix Konen (FF)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Martin W Hümmert (MW)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Alexandra Neyazi (A)

Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.

Martin Stangel (M)

Department of Neurology, Hannover Medical School, Hannover, Germany.

Thomas Skripuletz (T)

Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, Hannover 30625, Germany.

Classifications MeSH