Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial

Immunotherapies aimed at preserving residual beta cell function in type 1 diabetes have been successful, although the effect has been limited, or raised safety concerns. Transient effects often observed may necessitate redosing to prolong the effect, although this is not always feasible or safe. Tre...

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Vydáno v:International journal of molecular sciences Ročník 26; číslo 1; s. 374
Hlavní autoři: Casas, Rosaura, Tompa, Andrea, Åkesson, Karin, Teixeira, Pedro F., Lindqvist, Anton, Ludvigsson, Johnny
Médium: Journal Article
Jazyk:angličtina
Vydáno: Switzerland MDPI AG 01.01.2025
MDPI
Témata:
Adolescent
Adult
Alum Compounds - administration & dosage
Alum Compounds - therapeutic use
Antigens
autoantigen
C-Peptide - blood
Clinical trials
Cytokines
Diabetes
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - immunology
Disease management
Drug dosages
Enzymes
Female
GAD-alum
Glutamate Decarboxylase - administration & dosage
Glutamate Decarboxylase - therapeutic use
Haplotypes
Humans
Hypoglycemia
Immune system
immunotherapy
Insulin
Insulin-Secreting Cells - drug effects
Insulin-Secreting Cells - metabolism
intralymphatic
lymph node
Lymphatic system
Male
Peptides
Pilot Projects
redosing
type 1 diabetes
Vitamin D
Young Adult
type 1 diabetes
lymph node
immunotherapy
autoantigen
intralymphatic
GAD-alum
redosing
ISSN:1422-0067, 1661-6596, 1422-0067
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Shrnutí:Immunotherapies aimed at preserving residual beta cell function in type 1 diabetes have been successful, although the effect has been limited, or raised safety concerns. Transient effects often observed may necessitate redosing to prolong the effect, although this is not always feasible or safe. Treatment with intralymphatic GAD-alum has been shown to be tolerable and safe in persons with type 1 diabetes and has shown significant efficacy to preserve C-peptide with associated clinical benefit in individuals with the human leukocyte antigen DR3DQ2 haplotype. To further explore the feasibility and advantages of redosing with intralymphatic GAD-alum, six participants who had previously received active treatment with intralymphatic GAD-alum and carried HLA DR3-DQ2 received one additional intralymphatic dose of 4 μg GAD-alum in the pilot trial DIAGNODE-B. The participants also received 2000 U/day vitamin D (Calciferol) supplementation for two months, starting one month prior to the GAD-alum injection. During the 12-month follow-up, residual beta cell function was estimated with Mixed-Meal Tolerance Tests, and clinical and immune responses were observed. C-peptide decreased minimally, and most patients showed stable HbA1c and IDAA1c. The mean % TIR increased while the mean daily insulin dose decreased at month 12 compared to the baseline. Redosing with GAD-alum seems to be safe and tolerable, and may prolong the disease modification elicited by the original GAD-alum treatment.
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ISSN:1422-0067
1661-6596
1422-0067
DOI:10.3390/ijms26010374