Fig. 5: Relationship between change in immune parameters and primary metabolic outcome.

a, OR (with 95% CI) of having a stable or increasing C-peptide level between weeks 28 and 52. Above the horizontal dashed line is the whole-study group comparing placebo and ustekinumab treated. Below the dashed line it compares those on ustekinumab stratified based on the change in immune subsets (from baseline to week 52) as indicated. The vertical dotted line denotes an OR of 1 (no effect). The square represents the OR points estimate and the lines represent the 95% CI. b–d, Box plots of the change in immune population (expressed as the ratio of the frequency at week 52 relative to baseline) stratified by the stability of C-peptide between weeks 28 and 52. The line represents the median, the box the IQR and the whiskers all data points within 1.5× the IQR of the nearer quartile; outliers are excluded. A value of <1 indicates a reduction in the immune population in response to treatment (b) change in T_H17.1 cells at week 52 versus baseline (P = 0.03), change in IL-17A⁺IFNγ⁺GM-CSF⁺ and/or IL-2⁺ at week 52 versus baseline (P = 0.02) (c) and change in IL-17A⁺IFNγ⁺GM-CSF⁻IL-2⁻ at week 52 versus baseline (d). ^*P < 0.05 for odds of having a lower ratio. From the ustekinumab group, 41 participants and, from the placebo group, 21 participants were included in the analysis presented in a. Analysis presented in b–d included 34 ustekinumab-treated partcipants. Statistical significance was determined by using logistic regression for the odds of having a stable C-peptide at week 52 adjusted for age. gender, baseline C-peptide and week 28 C-peptide in the analysis presented in b–d.