We performed a systematic review and meta-analysis to assess the efficacy and safety of
antigen-based
immunotherapies in
tertiary prevention of
autoimmune diabetes. We searched for randomised controlled trials testing
antigen-based
immunotherapies in patients with recent-onset
type 1 diabetes or
latent autoimmune diabetes of adults in MEDLINE, COCHRANE and EMBASE databases, trial registries, conference proceedings and reference lists of pertinent records. Primary outcomes were fasting and stimulated
C-peptide (after
glucagon or mixed meal stimulation). Change in glycosylated haemoglobin (HbA1c), daily
insulin needs and incidence of any or severe hypoglycaemic events or severe adverse events were secondary outcomes. Fifteen studies were included in the meta-analysis. Overall, there was no difference in fasting [weighted mean difference (WMD) 0.01 nmol/L; 95 % confidence interval (CI) -0.09, 0.11; I 2 = 73 %] or mixed meal stimulated
C-peptide (WMD 0.02 nmol/L/min; 95 % CI -0.08, 0.12; I 2 = 50 %) compared with placebo.
Glucagon stimulated
C-peptide was maintained higher (WMD 0.13 nmol/L/min; 95 % CI 0.05, 0.21; I 2 = 0 %) in patients treated with Diapep277. Moreover, there was no change in daily
insulin needs (WMD 0.02 IU/kg; 95 % CI -0.04, 0.09; I 2 = 51 %) or HbA1c (WMD -0.06 %; 95 % CI -0.35, 0.23; I 2 = 42 %) vs. placebo. Finally, there was no effect on the incidence of severe hypoglycaemic events or overall serious adverse events [risk ratio 0.94, 95 % CI 0.62, 1.41; I 2 = 0 % and 0.87; 95 % CI 0.53, 1.44; I 2 = 0 %, respectively).
Antigen-based
immunotherapies are not effective in preventing the progression of
autoimmune diabetes in newly diagnosed patients.