Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial.

The a priori defined primary pharmacodynamic outcome of an increase in the frequency of Tregs as a percentage of CD4 + T-lymphocytes at D8 was dose-dependent (JT-J test, p < 0.0001) and highly significant for both treated arms (MW-U test, p < 0·0001; 2 MIU: mean [SD]: +6·2% [2·2]; 1 MIU: mean [SD]: +3·9% [1·2]) as compared to placebo (mean [SD]: −0·5% [1·3]) (see Table 3 , Fig. 2 a and b).

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This improvement in Treg function is highly significant in the 1 MIU arm, with all individuals showing an increase in function, while in the 2 MIU group only a trend toward significance was observed, due to increased variation in response between individuals.

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