Budesonide Helpful in Pediatric Autoimmune Hepatitis

July 10, 2013

By David Douglas

NEW YORK (Reuters Health) Jul 10 - In children with autoimmune hepatitis (AIH), combining azathioprine with budesonide can help reduce the need for steroids, researchers suggest.

Their data, from a subgroup of participants in a randomized trial, "confirmed that budesonide in combination with azathioprine is able to induce and maintain remission in non-cirrhotic pediatric AIH patients with less steroid specific side effects," Dr. Marek Woynarowski told Reuters Health by email.

In a July 1 online paper in The Journal of Pediatrics, Dr. Woynarowski of Children's Health Memorial Institute, Warsaw, Poland, and colleagues report on 46 patients, ages nine to 17, who had taken part in an earlier large randomized trial comparing budesonide to prednisone, both given in combination with azathioprine.

Patients received either budesonide 3 mg two or three times daily, or prednisone 40 mg/day tapered to 10 mg/day, plus azathioprine 1-2 mg/kg/day. This was followed by a further six months of open-label budesonide therapy.

At six months, rates of the primary efficacy endpoint -- complete biochemical remission (normal serum alanine aminotransferase and aspartate aminotransferase levels) without predefined steroid-specific side effects - were similar, at 16% in the budesonide group and 15% in prednisone patients.

Biochemical remission rates were also similar (32% vs 33%), as were rates of freedom from steroid-specific side effects (53% vs 37%).

Patients in the budesonide group gained significantly less weight (1.2 vs 5.1kg).

In the 42 patients who received open-label budesonide, 46% achieved complete remission.

"The number of children treated in this study was too small to justify recommending budesonide as standard therapy in noncirrhotic children," the authors say. But, they add, for those with "severe steroid-related side effects, we believe that budesonide may be considered as maintenance therapy."

Dr. Woynarowski added, "Budesonide in combination with azathioprine is an alternative to induce and maintain remission in adolescent patients with AIH. Further studies have to evaluate potential long term benefits of budesonide on bone disease and growth."

Commenting on the findings by email, Dr. Joost P.H. Drenth, Professor of Molecular Gastroenterology & Hepatology at Radboud University Nijmegen Medical Center, The Netherlands, said, "Budesonide is an interesting alternative option for prednisone in the treatment of auto-immune hepatitis. The results from this sub-analysis suggest that it is safe, but (the) data do not allow making any firm statements about efficacy."

Dr. Drenth added, "I side with the authors who emphasize that drug trials in children are necessary and this is a cautious first move in that direction."

SOURCE: http://bit.ly/189dS1V

J Pediatr 2013.

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