Discussion
T1D
DISEASE, TYPE 1 DIABETES, OTHER AUTOIMMUNE DISEASE
The DIAGNODE-2 study constituted the first placebo-controlled trial in which an autoantigen was administrated into the lymph nodes of patients with Type 1 diabetes, and immunological changes observed in GAD-alum treated patients with respect to placebo have not been previously described. Modifications following therapy included an increment of GADA, GADA subclasses, and GADAlthough no significant treatment effect was seen in the whole study cohort during the clinical trial, a statistically significant preservation of beta cell function was found in the prespecified subgroup of GAD-alum patients with DR3DQ2 haplotype (The increasing consensus on the heterogenicity of T1D, that can reflect diverse immunological pathways to disease, brings focus to the matter that, as in many other autoimmune diseases, many of the patients participating in T1D clinical trials benefit from the treatments, while others do not (In an attempt to find biomarkers for clinical response, GAD-alum treated individuals were classified according to their preservation of C-peptide. Comparison of the immunological response revealed that patients displaying a better beta cell preservation had a more pronounced GADIn a previous study we have shown that administration of GAD-alum subcutaneously induced an early Th2-skewed immune response associated to clinical benefit (Although better preservation of C-peptide and an improvement in several clinical parameters was observed in GAD-alum treated patients with DR3DQ2 haplotype (In conclusion, here we show that patients with DR3DQ2 haplotype had an early immune response to GAD-alum injections into the lymph node, and predominant GAD