Thymosin α1 administration not associated with improved mortality in septic patients

1. The use of thymosin α1 in adult patients with sepsis was not associated with a reduction in all cause 28 day mortality. 

Evidence Rating Level: 1 (Excellent)

Thymosin α1 is an immodulatory therapy which has been approved for the management of melanoma, chronic hepatitis and other diseases. Previous studies have demonstrated a reduction in mortality in patients with sepsis who received thymosin α1, but such studies have been limited by small sample sizes. This multicentre, randomised controlled trial therefore sought to evaluate the efficacy and safety of thymosin α1 in the treatment of sepsis. 1106 adult patients (median age[IQR], 65[52-73] years) with a diagnosis of sepsis from 22 centres across China were included in the study and randomised to receive either thymosin α1 or a matched placebo. The primary outcome was 28-day all-cause mortality following randomisation. The 28-day all-cause mortality was not statistically different between the thymosin α1 and placebo groups (23.4% and 24.1% respectively, hazard ratio 0.99, 95% CI 0.77 to 1.27, P=0.93). Similarly, the 90-day all-cause mortality was not statistically different between the thymosin α1 and placebo groups (31.0% and 32.4% respectively, hazard ratio 0.94, 0.76 to 1.16, P=0.54). Based on subgroup analysis, patients with diabetes in the thymosin α1 group had a lower 28 day mortality than those with diabetes in the placebo group (0.58, 0.35 to 0.99, P for interaction=0.04). There was no statistical significance in the rate of adverse events between the thymosin α1 group and the placebo group (66.4% and 67.6% respectively; group difference −1.2%, 95% CI −6.8% to 4.4%, P=0.70). Overall, this study found that the use of thymosin α1 in adult patients with sepsis was not associated with a reduction in all cause 28 day mortality, but may have a benefit in patients with chronic conditions like diabetes.

Click to read the study in BMJ

Image: PD

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