Budesonide in previously untreated autoimmune hepatitis

Wiegand, Johannes; Schüler, Andreas; Kanzler, Stephan; Lohse, Ansgar W.; Beuers, Ulrich; Kreisel, Wolfgang; Spengler, Ulrich; Koletzko, Sibylle; Jansen, Petér L. M.; Hochhaus, Günther; Möllmann, H; Pröls, Markus; Manns, Michael P.

doi:10.1111/j.1478-3231.2005.01122.x

Cited by 91 publications

(44 citation statements)

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“…Preliminary studies in patients with mild disease have suggested that it is useful in selected patients as a frontline treatment, [111][112][113] and these small reports have justified the performance of a randomised clinical trial. The European trial compared the combination regimen of budesonide (3 mg thrice daily) and azathioprine (1-2 mg/kg daily) with that of prednisone (40 mg daily, tapered to 10 mg daily) and azathioprine (1-2 mg/kg daily) in 203 treatment-naïve patients with autoimmune hepatitis.…”

Section: -110mentioning

confidence: 99%

Systematic review: managing suboptimal treatment responses in autoimmune hepatitis with conventional and nonstandard drugs

Selvarajah

Montano‐Loza

Czaja

2012

Aliment Pharmacol Ther

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Section: -110mentioning

confidence: 99%

Systematic review: managing suboptimal treatment responses in autoimmune hepatitis with conventional and nonstandard drugs

Selvarajah

Montano‐Loza

Czaja

2012

Aliment Pharmacol Ther

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“…A potential advantage over prednisolone is the theoretical ability to achieve high local tissue levels without systemic adverse effects. Budesonide is effective in both inducing and maintaining remission [114], although there is currently no good evidence that budesonide provides a benefit over prednisolone and care must be taken when using it in patients with cirrhosis in whom shunting may reduce hepatic first pass metabolism [115,116].…”

Section: Treatment Failure and Alternative Therapies For Aihmentioning

confidence: 99%

Autoimmune hepatitis: new paradigms in the pathogenesis, diagnosis, and management

2010

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Autoimmune hepatitis (AIH), primary biliary cirrhosis, and primary sclerosing cholangitis are the three major autoimmune diseases affecting the liver, and of these three, AIH is the most typical autoimmune disease being characterized by a T-cell-rich infiltrate, raised circulating c-globulins, autoantibodies, HLA associations, and links with other autoimmune diseases. It is the only one, of the three diseases, that responds well to immunosuppressive therapy. AIH is caused by dysregulation of immunoregulatory networks and the consequent emergence of autoreactive T cells that orchestrate a progressive destruction of hepatocytes leading untreated to liver failure. T cells play a major role in the immunopathogenesis, and both CD4? and CD8? T cells are involved together with effector responses mediated by NK cells, cd T cells, and macrophages. A number of triggering factors have been proposed including viruses, xenobiotics, and drugs, but none have been conclusively shown to be involved in pathogenesis.

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“…However, it cannot be expected that budesonide treatment will overcome treatment failure following conventional combination therapy with prednisone and azathioprine. The main advantage of a topical steroid such as budesonide might be the replacement of conventional steroids in long-term maintenance therapy in order to reduce systemic steroid-specific side effects [7,15]. However, such a benefit should only be observed in noncirrhotic patients in the absence of portosystemic shunting.…”

Section: Alternative Treatment Strategiesmentioning

confidence: 99%

Therapeutic Strategies for Autoimmune Hepatitis

Manns

Strassburg²

2011

Dig Dis

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Autoimmune hepatitis (AIH) is a disease of unknown etiology. However, a loss of tolerance against the patient’s own liver is regarded as the main pathogenetic mechanism. Immunosuppressive therapy prolongs survival in patients with severe AIH. Two phases of therapy have to be distinguished. In newly diagnosed AIH, induction of remission is the main goal. Here predniso(lo)ne alone or in combination with azathioprine has been shown to induce remission in the majority of patients. In the past, reduction of aminotransferase levels below two times the upper limit of normal was the aim of therapy. Nowadays, normalization of aminotransferase levels should be achieved. The majority of patients usually respond to therapy within 6–12 months. A significant reduction in aminotransferase levels is achieved within a few weeks of therapy. Improvement in clinical symptoms is followed by improvement in biochemical parameters of disease activity and then by significant improvement in histological disease activity. Around 20–40% of patients do not achieve remission. In these patients, alternative therapies should be evaluated for the individual patient. Prospective controlled trials with a larger number of patients are missing in this population. At the moment, mycophenolate mofetil at a dose of 2 × 1 g daily, either given alone or in combination with predniso(lo)ne, is able to achieve remission in a significant proportion of patients. Based on recent retrospective observations, mycophenolate mofetil is beneficial in patients who were previously azathioprine intolerant rather than azathioprine failure patients. Again, prospective trials are missing. Alternative drugs include cyclophosphamide, cyclosporin A, tacrolimus and others. Women in particular suffer from steroid-specific side effects, including weight gain, moon face, diabetes, glaucoma and bone disease. Recently, a topical steroid, budesonide, was shown to induce disease remission in combination with azathioprine. The second phase of therapy is maintenance of remission with the lowest possible dose in order to maintain remission while preventing significant side effects. Careful evaluation of the individual patients should lead to the decision whether predniso(lo)ne, budesonide, azathioprine or a combination of one of the steroids with azathioprine is to be used to maintain remission. Recently, a study has shown that after 6 months of induction therapy with prednisone plus azathioprine, a switch to budesonide in combination with azathioprine reduced steroid-specific side effects while maintaining remission of liver disease. Therefore, the application of the topical steroids may be helpful in maintaining remission while reducing steroid-specific side effects. Patients with liver cirrhosis should not be treated with budesonide since the benefit of budesonide with its 90% pass effect in the liver is lost if the patient has already developed portal hypertension with significant portosystemic shunting. Furthermore, there are safety concerns regarding budesonide use in cirrhotic p...

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Budesonide in previously untreated autoimmune hepatitis

Abstract: Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment naïve patients with AIH. It should be further evaluated in prospective controlled trials and should be compared to predniso(lo)ne both in monotherapy and in combination with azathioprine.

Cited by 91 publications

References 25 publications

Systematic review: managing suboptimal treatment responses in autoimmune hepatitis with conventional and nonstandard drugs

Systematic review: managing suboptimal treatment responses in autoimmune hepatitis with conventional and nonstandard drugs

Autoimmune hepatitis: new paradigms in the pathogenesis, diagnosis, and management

Therapeutic Strategies for Autoimmune Hepatitis

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