Thymosin alpha 1 fails to reduce infected pancreatic necrosis in severe acute necrotising pancreatitis patients

Infected pancreatic necrosis (IPN) is a severe and highly morbid complication of acute necrotising pancreatitis (ANP), a condition characterized by significant inflammation and tissue damage. Patients with ANP often experience early-onset immunosuppression, which contributes to the high incidence of secondary infections like IPN. Current standard-of-care primarily focuses on supportive measures and managing complications, but there's a clear need for therapies that can mitigate the underlying immune dysfunction. Immune enhancement strategies, such as those involving Thymosin alpha 1 (Tα1), have been explored as a potential therapeutic option to bolster the immune response and prevent infectious complications in this vulnerable patient population.

This multicentre, double-blind, randomised, placebo-controlled trial enrolled 508 ANP patients with predicted severe disease (APACHE II score ≥8 and CT severity score ≥5), admitted within 7 days of symptom onset. Participants were randomly assigned to receive either Thymosin alpha 1 (Tα1) 1.6 mg via subcutaneous (SC) injection every 12 hours for the first 7 days, followed by 1.6 mg once daily for the subsequent 7 days, or a matching placebo (normal saline). The primary outcome measured was the development of IPN during the index hospital admission, with secondary outcomes including other major complications.

Of the 508 patients randomised, 254 received Tα1 and 254 received placebo, with 94.3% (479/508) requiring ICU admission. The study found no significant difference in the incidence of IPN between the groups. During the index admission, 40/254 (15.7%) patients in the Tα1 group developed IPN, compared to 46/254 (18.1%) in the placebo group. This represented a difference of -2.4% (95% CI -7.4 to 5.1%), which was not statistically significant (p=0.48). Similar results were observed across four predefined subgroups. Furthermore, there were no significant differences in other major complications, including new-onset organ failure (10.6% in Tα1 vs. 15% in placebo), bleeding (6.3% vs. 3.5%), or gastrointestinal fistula (2% vs. 2.4%).