START Study: Steroids Not Effective For Biliary Atresia (After Kasai)

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A recent multicenter study has shown that steroids are not helpful after hepatoportoenterostomy for Bilairy Atresia (BA) (Bezerra JA et al. Hepatoportoenterostomy for Bile Drainage in Infants With Biliary Atresia. JAMA. 2014 May 7;311(17):1750).  Thanks to Saul Karpen for the reference.  I want to congratulate all of the authors, but particularly Jorge Bezerra, Saul Karpen, and Rene Romero for collaborating on this important study.

The randomized, double-blind, placebo-controlled START trial from the NIH-supported ChiLDren study enrolled 140 patients (257 were screened) from 2005-2011.  High-dose steroids, starting with methylprednisolone 4 mg/kg/day for 2 weeks and then tapered was compared with placebo.  No statistically significant improvement was noted.  Ultimately, the steroid intervention did not affect transplant-free survival which was 58.7% in the steroid group and 59.4% in the placebo group at 24 months of age.  Figure 2 (see below -from @JAMA twitter feed) shows Kaplan-Meier analysis plots with regard to transplant-free survival and bile drainage; the latter was slightly better in steroid group, but not statistically significant. In addition, steroids were associated with an earlier onset of first serious adverse events, 37% in steroid group compared with 19% in the placebo group within 30 days of Kasai.

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With regard to safety, the authors note that both groups were “found to have a high incidence of adverse events, indicating that they were most likely the direct consequences of the severe liver disease typical of biliary atresia. However, steroid therapy was associated with…complications at the sites of surgical anastomoses and intestinal perforation.”

Take-home message: Avoid steroids after Kasai procedure.

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