Budesonide in previously untreated autoimmune hepatitis

Liver International

Volumn 25, Issue 5, 2005, Pages 927-934

  Wiegand, Johannes ^a   Schüler, Andreas ^a   Kanzler, Stephan ^b   Lohse, Ansgar ^b   Beuers, Ulrich ^c   Kreisel, Wolfgang ^d   Spengler, Ulrich ^e   Koletzko, Sibylle ^f   Jansen, Peter L M ^g   Hochhaus, Günther ^h   Möllmann, Helmut W ⁱ   Pröls, Markus ^j   Manns, Michael P ^a  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b JOHANNES GUTENBERG UNIVERSITY   (Germany)

^c UNIVERSITY OF MUNICH   (Germany)

^d UNIVERSITY OF FREIBURG   (Germany)

^e UNIVERSITY OF BONN   (Germany)

^f LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^g UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^h UNIVERSITY OF FLORIDA HEALTH   (United States)

ⁱ RUHR UNIVERSITY BOCHUM   (Germany)

^j Dr Falk Pharma GmbH   (Germany)

more..

Author keywords

Autoimmune hepatitis; Budesonide; Treatment options

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; AZATHIOPRINE; BUDENOFALK; BUDESONIDE; IMMUNOSUPPRESSIVE AGENT; PREDNISOLONE; PREDNISONE;

ABDOMINAL PAIN; ACNE; ADRENAL SUPPRESSION; ADULT; ARTICLE; AUTOIMMUNE HEPATITIS; CHRONIC LIVER DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; CUSHINGOID SYNDROME; DIABETES MELLITUS; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; EDEMA; FEMALE; FLU LIKE SYNDROME; HEARTBURN; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; INSULIN DEPENDENT DIABETES MELLITUS; LEUKOCYTOSIS; MALE; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; PHASE 2 CLINICAL TRIAL; RASH; REMISSION; SCHOOL CHILD; SIDE EFFECT; THROMBOCYTOSIS; TREATMENT OUTCOME; WEIGHT GAIN;

ADULT; AGED; ALANINE TRANSAMINASE; BUDESONIDE; FEMALE; HEPATITIS, AUTOIMMUNE; HUMANS; MALE; MIDDLE AGED;

EID: 26044432469     PISSN: 14783223     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1478-3231.2005.01122.x     Document Type: Article

References (31)

1. Donaldson P T, Doherty D G, Hayllar K M, McFarlane I G, Johnson P J, Williams R. Susceptibility to autoimmune chronic active hepatitis: human leukocyte antigens DR4 and A1-B8-DR3 are independent risk factors. Hepatology 1991; 13: 701-6.
2. Czaja A J, Carpenter H A, Santrach P J, Moore S B. Significance of HLA DR4 in type 1 autoimmune hepatitis. Gastroenterology 1993; 105: 1502-7.
3. Manns M P, Kruger M. Immunogenetics of chronic liver diseases. Gastroenterology 1994; 106: 1676-97.
4. Gregorio G V, Portmann B, Reid F, Donaldson P T, Doherty D G, McCartney M, Mowat A P, Vergani D, Mieli-Vergani G. Autoimmune hepatitis in childhood: a 20-year experience. Hepatology 1997; 25: 541-7.
5. Johnson P J, McFarlane I G, Eddleston A L. The natural course and heterogeneity of autoimmune-type chronic active hepatitis. Semin Liver Dis 1991; 11: 187-96.
6. Johnson P J, McFarlane I G. Meeting report: International Autoimmune Hepatitis Group. Hepatology 1993; 18: 998-1005.
7. Kirk A P, Jain S, Pocock S, Thomas H C, Sherlock S. Late results of the Royal Free Hospital prospective controlled trial of prednisolone therapy in hepatitis B surface antigen negative chronic active hepatitis. Gut 1980; 21: 78-83.
8. Cook G C, Mulligan R, Sherlock S. Controlled prospective trial of corticosteroid therapy in active chronic hepatitis. Q J Med 1971; 40: 159-85.
9. Soloway R D, Summerskill W H, Baggenstoss A H, Geall M G, Gitnick G L, Elveback I R, Schoenfield L J. Clinical, biochemical, and histological remission of severe chronic active liver disease: a controlled study of treatments and early prognosis. Gastroenterology 1972; 63: 820-33.
10. Geall M G, Schoenfield L J, Summerskill W H. Classification and treatment of chronic active liver disease. Gastroenterology 1968; 55: 724-9.
11. Czaja A J, Wolf A M, Baggenstoss A H. Laboratory assessment of severe chronic active liver disease during and after corticosteroid therapy: correlation of serum transaminase and gamma globulin levels with histologic features. Gastroenterology 1981; 80: 687-92.
12. Manns M P, Strassburg C P. Autoimmune hepatitis: clinical challenges. Gastroenterology 2001; 120: 1502-17.
13. Summerskill W H, Korman M G, Ammon H V, Baggenstoss A H. Prednisone for chronic active liver disease: dose titration, standard dose, and combination with azathioprine compared. Gut 1975; 16: 876-83.
14. Andus T T S. Glucocorticoids. In: Targan S, Shanahan F, eds, Inflammatory Bowel Disease: From Bench to Bedside. Baltimore: Williams & Wilkins, 1994; 487-502.
15. May B, Möllmann H W Glukokortikoidtherapie chronisch entzündlicher Darmerkrankungen. Von den Grundlagen zur rationalen Therapie. Freiburg: Falk Foundation e.V., 1996 (ISBN 3-929713-37-3).
16. Möllmann H W, Barth J, Hochhaus G, Mölmann A C, Derendorf H, Tromm A. Principles of topical versus systemic corticoid treatment in inflammatory bowel disease. In: Möllmann H W, May B, eds. Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease - From Basic Principles to Rational Therapy. Dordrecht: Kluwer Academic Publishers, 1996; 42-60.
17. Möllmann H W, Hochhaus G, Tromm A, Froehlich P, Möllmann A C, Krieg M, Weisser H, Derendorf H, Barth J. Pharmacokinetics and pharmacodynamics of Budesonide-pH-modified release capsules. In: Möllmann H W, May B, eds. Glucocorticoid Therapy in Chronic Inflammatory Bowel Disease - From Basic Principles to Rational Therapy. Dordrecht: Kluwer Academic Publishers, 1996; 107-20.
18. Clissold S P, Heel R C. Budesonide. A preliminary review of its pharmacodynamic properties and therapeutic efficacy in asthma and rhinitis. Drugs 1984; 28: 485-518.
19. Greenberg G R, Feagan B G, Martin F, Sutherland L R, Thomson A B, Williams C N, Nilsson L G, Persson T. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med 1994; 331: 836-41.
20. Rutgeerts P, Lofberg R, Malchow H, Lamers C, Olaison G, Jewell D, Danielsson A, Goebell H, Thomsen O O, Lorenz-Meyer H. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994; 331: 842-5.
21. Hamedani R, Feldman R D, Feagan B G. Review article: drug development in inflammatory bowel disease: budesonide-a model of targeted therapy. Aliment Pharmacol Ther 1997; 11(suppl. 3): 98-107.
22. Fleig W E. Topical steroids in chronic inflammatory bowel diseases. Internist (Berl) 1997; 38: 1154-9.
23. Bar-Meir S, Chowers Y, Lavy A, Abramovitch D, Sternberg A, Leichtmann G. Reshef R, Odes S, Moshkovitz M, Bruck R, Eliakim R, Maoz E, Mittmann U. Budesonide versus prednisone in the treatment of active Crohn's disease. The Israeli Budesonide Study Group. Gastroenterology 1998; 115: 835-40.
24. Danielsson A, Prytz H. Oral budesonide for treatment of autoimmune chronic active hepatitis. Aliment Pharmacol Ther 1994; 8: 585-90.
25. Schüler A, Möllmann H W, Manns M P. Treatment of autoimmune hepatitis with budesonide. Hepatology 1995; 22: 488A.
26. Czaja A J, Lindor K D. Failure of budesonide in a pilot study of treatment-dependent autoimmune hepatitis. Gastroenterology 2000; 119: 1312-6.
27. Strassburg C P, Manns M P. Autoantibodies and autoantigens in autoimmune hepatitis. Semin Liver Dis 2002; 22: 339-52.
28. Dimova H, Wang Y, Pommery S, Moellmann H, Hochhaus G. SPE/RIA vs. LC/MS for measurement of low levels of budesonide in plasma. Biomed Chromatogr 2003; 17: 14-20.
29. Czaja A J, Davis G L, Ludwig J, Taswell H F. Complete resolution of inflammatory activity following corticosteroid treatment of HBsAg-negative chronic active hepatitis. Hepatology 1984; 4: 622-7.
30. Möllmann H W, Schüler A, Böker K H W, Hochhaus G, Manns M P. Pharmacokinetics of budesonide in patients with autoimmune hepatitis. Falk Symposium 114, Basler Liver Week 1999.
31. Hempfling W, Grunhage F, Dilger K, Reichel C, Beuers U, Sauerbbuch T. Pharmacokinetics and pharmacodynamic action of budesonide in early- and late-stage primary biliary cirrhosis. Hepatology 2003; 38: 196-202.