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Steroid use did not improve biliary atresia in infants after hepatoportoenterostomy

Infants with biliary atresia who received corticosteroids after hepatoportoenterostomy did not show improved bile drainage and experienced serious adverse events sooner compared with controls, according to data from a study funded by the National Institutes of Health.

Averell H. Sherker, MD, FRCP(C), of the National Institute of Diabetes and Digestive and Kidney Diseases, and colleagues analyzed 140 infants (mean age, 10 weeks) with biliary atresia in the Steroids in Biliary Atresia Randomized Trial (START). The trial, conducted at 14 clinical sites, was held between September 2005 and February 2011 and designed to determine if corticosteroid injections after hepatoportoenterostomy improved bile flow and preserved the liver.

Averell H. Sherker

Infants in the steroid group (n=70) received intravenous methylprednisolone (4 mg/kg daily for 2 weeks) and oral prednisolone (2 mg/kg per day for 2 weeks), followed by a tapering protocol for 9 additional weeks. The other 70 patients were assigned placebo for 13 weeks. Corticosteroids and placebo were initiated within 72 hours of surgery, and follow-up was through January 2013.

“We know that the surgery restores the flow of bile, relieves pain and delays the need for liver transplants in many infants, but we did not have the data to prove that adding steroids significantly improved bile drainage in infants who had their own livers,” Sherker said in a press release.

Researchers said there was not a large difference between improvement in bile drainage among the steroid (58.6%) and placebo groups (48.6%) at 6 months (adjusted RR=1.14; 95% CI, 0.83-1.57). Transplant-free survival when patients were aged 2 years was 58.7% in the steroid group vs. 59.4% in the placebo group (aHR=1; 95% CI, 0.6-1.8).

Serious adverse events were similar between the treated and placebo groups (81.4% vs. 80%, respectively; P>.99), but their onset occurred earlier in corticosteroid patients at 30 days post-surgery (37.2%; 95% CI, 26.9%-50% vs. 19%; 95% CI, 11.5%-30.4%).

“The results confirm that steroids did not benefit the infants and, in fact, might harm them by increasing their risk for complications,” Sherker said in the release.

Disclosure: See the study for a full list of relevant financial disclosures.