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Intra-lymphatic adm...
Intra-lymphatic administration of GAD-alum in type 1 diabetes : long-term follow-up and effect of a late booster dose (the DIAGNODE Extension trial)
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- Casas, Rosaura, 1954- (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Dietrich, Fabricia (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Puente Marin, Sara (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Barcenilla, Hugo (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Tavira Iglesias, Beatriz (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten
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- Wahlberg, Jeanette, 1969- (författare)
- Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
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- Achenbach, Peter (författare)
- Institute of Diabetes Research, School of Medicine, Forschergruppe Diabetes, Helmholtz Zentrum München, Technical University of Munich, Munich, Germany,Tech Univ Munich, Germany
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- Ludvigsson, Johnny, 1943- (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
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(creator_code:org_t)
- 2022-01-31
- 2022
- Engelska.
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Ingår i: Acta Diabetologica. - : Springer. - 0940-5429 .- 1432-5233. ; 59:5, s. 687-696
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Abstract
Ämnesord
Stäng
- Aim: To evaluate the long-term effect of intra-lymphatic administration of GAD-alum and a booster dose 2.5 years after the first intervention (DIAGNODE Extension study) in patients with recent-onset type 1 diabetes.Methods: DIAGNODE-1: Samples were collected from 12 patients after 30 months who had received 3 injections of 4 μg GAD-alum into a lymph node with one-month interval. DIAGNODE Extension study: First in human, a fourth booster dose of autoantigen (GAD-alum) was given to 3 patients at 31.5 months, who were followed for another 12 months. C-peptide was measured during mixed meal tolerance tests (MMTTs). GADA, IA-2A, GADA subclasses, GAD65-induced cytokines, PBMCs proliferation and T cells markers were analyzed.Results: After 30-month treatment, efficacy was still seen in 8/12 patients (good responders, GR). Partial remission (IDAA1c < 9) had decreased compared to 15 months, but did not differ from baseline, and HbA1c remained stable. GAD65-specific immune responses induced by the treatment started to wane after 30 months, and most changes observed at 15 months were undetectable. GADA subclasses IgG2, IgG3 and IgG4 were predominant in the GR along with IgG1. A fourth intra-lymphatic GAD-alum dose to three patients after 31.5 months gave no adverse events. In all three patients, C-peptide seemed to increase the first 6 months, and thereafter, C-peptide, HbA1c, insulin requirement and IDAA1c remained stable.Conclusion: The effect of intra-lymphatic injections of GAD-alum had decreased after 30 months. Good responders showed a specific immune response. Administration of a fourth booster dose after 31.5 months was safe, and there was no decline in C-peptide observed during the 12-month follow-up.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Autoantigen
- Booster dose
- GAD-alum
- Immunotherapy
- Intra-lymphatic
- Type 1 diabetes
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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