End-stage methotrexate-related liver disease is rare and associated with features of the metabolic syndrome

Alimentary Pharmacology and Therapeutics

Volumn 40, Issue 8, 2014, Pages 938-948

  Dawwas, M F ^a,b   Aithal, G P ^a  

^a NIHR NOTTINGHAM BIOMEDICAL RESEARCH CENTRE   (United Kingdom)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGE; ALCOHOL LIVER DISEASE; ARTICLE; BODY MASS; CAUCASIAN; CLINICAL FEATURE; CONTROLLED STUDY; DIABETES MELLITUS; DISEASE ASSOCIATION; DRUG INDUCED DISEASE; END STAGE LIVER DISEASE; END STAGE METHOTREXATE RELATED LIVER DISEASE; ETHNIC DIFFERENCE; FEMALE; HUMAN; LIVER TOXICITY; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; METABOLIC SYNDROME X; NONALCOHOLIC FATTY LIVER; RISK ASSESSMENT; RISK FACTOR; SCLEROSING CHOLANGITIS; SEX DIFFERENCE; AGED; CHEMICALLY INDUCED; CHOLANGITIS, SCLEROSING; EPIDEMIOLOGY; LIVER DISEASES, ALCOHOLIC; MIDDLE AGED; NON-ALCOHOLIC FATTY LIVER DISEASE; RISK; STATISTICAL MODEL; UNITED STATES;

AGED; BODY MASS INDEX; CHOLANGITIS, SCLEROSING; DIABETES MELLITUS; END STAGE LIVER DISEASE; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER DISEASES, ALCOHOLIC; LIVER TRANSPLANTATION; LOGISTIC MODELS; MALE; METABOLIC SYNDROME X; METHOTREXATE; MIDDLE AGED; NON-ALCOHOLIC FATTY LIVER DISEASE; ODDS RATIO; RISK FACTORS; UNITED STATES;

EID: 84907891023     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12912     Document Type: Article

References (86)

1. Kremer JM,. Toward a better understanding of methotrexate. Arthritis Rheum 2004; 50: 1370-82.
2. Boffa MJ,. Methotrexate for psoriasis: current European practice. A postal survey. J Eur Acad Dermatol Venereol 2005; 19: 196-202.
3. Menter A, Korman NJ, Elmets CA, et al,. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol 2009; 61: 451-85.
4. Sokka T,. Increases in use of methotrexate since the 1980s. Clin Exp Rheumatol 2010; 28 (5 Suppl. 61): S13-20.
5. Kuhn A, Ruland V, Patsinakidis N, Luger TA,. Use of methotrexate in patients with psoriasis. Clin Exp Rheumatol 2010; 28 (5 Suppl. 61): S138-44.
6. ®: National 2010. Available at: http://drugtopics.modernmedicine.com/drugtopics/data/articlestandard//drugtopics/252011/727243/article.pdf (accessed 13 A.D. July 3).
7. Saag KG, Teng GG, Patkar NM, et al,. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008; 59: 762-84.
8. Kalb RE, Strober B, Weinstein G, Lebwohl M,. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol 2009; 60: 824-37.
9. Yazici Y,. Long-term safety of methotrexate in the treatment of rheumatoid arthritis. Clin Exp Rheumatol 2010; 28 (5 Suppl. 61): S65-7.
10. Choi HK, Hernan MA, Seeger JD, Robins JM, Wolfe F,. Methotrexate and mortality in patients with rheumatoid arthritis: a prospective study. Lancet 2002; 359: 1173-7.
11. Gelfand JM, Troxel AB, Lewis JD, et al,. The risk of mortality in patients with psoriasis: results from a population-based study. Arch Dermatol 2007; 143: 1493-9.
12. Pathirana D, Ormerod AD, Saiag P, et al,. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol 2009; 23 (Suppl. 2): 1-70.
13. Ash Z, Gaujoux-Viala C, Gossec L, et al,. A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2012; 71: 319-26.
14. Dahl MG, Gregory MM, Scheuer PJ,. Liver damage due to methotrexate in patients with psoriasis. Br Med J 1971; 1: 625-30.
15. Nyfors A,. Liver biopsies from psoriatics related to methotrexate therapy. 3. Findings in post-methotrexate liver biopsies from 160 psoriatics. Acta Pathol Microbiol Scand A 1977; 85: 511-8.
16. Zachariae H, Kragballe K, Sogaard H,. Methotrexate induced liver cirrhosis. Studies including serial liver biopsies during continued treatment. Br J Dermatol 1980; 102: 407-12.
17. Roenigk HH Jr, Maibach HI, Weinstein GD,. Use of methotrexate in psoriasis. Arch Dermatol 1972; 105: 363-5.
18. Roenigk HH Jr, Maibach HI, Weinstein GP,. Methotrexate therapy for psoriasis. Guideline revisions. Arch Dermatol 1973; 108: 35.
19. Roenigk HH Jr, Auerbach R, Maibach HI, Weinstein GD,. Methotrexate guidelines-revised. J Am Acad Dermatol 1982; 6: 145-55.
20. Roenigk HH Jr, Auerbach R, Maibach HI, Weinstein GD,. Methotrexate in psoriasis: revised guidelines. J Am Acad Dermatol 1988; 19: 145-56.
21. Lewis JH, Schiff E,. Methotrexate-induced chronic liver injury: guidelines for detection and prevention. The ACG Committee on FDA-related matters. American College of Gastroenterology. Am J Gastroenterol 1988; 83: 1337-45.
22. Methotrexate in rheumatoid arthritis. Health and Public Policy Committee, American College of Physicians. Ann Intern Med 1987; 107: 418-9.
23. Roenigk HH Jr, Auerbach R, Maibach H, Weinstein G, Lebwohl M,. Methotrexate in psoriasis: consensus conference. J Am Acad Dermatol 1998; 38: 478-85.
24. Kremer JM, Alarcon GS, Lightfoot RW Jr, et al,. Methotrexate for rheumatoid arthritis. Suggested guidelines for monitoring liver toxicity. American College of Rheumatology. Arthritis Rheum 1994; 37: 316-28.
25. Guidelines for monitoring drug therapy in rheumatoid arthritis. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Arthritis Rheum 1996; 39: 723-31.
26. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum 2002; 46: 328-46.
27. Pavy S, Constantin A, Pham T, et al,. Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines based on published evidence and expert opinion. Joint Bone Spine 2006; 73: 388-95.
28. Smith CH, Barker JN,. Psoriasis and its management. BMJ 2006; 333: 380-4.
29. Yeung H, Wan J, Van Voorhees AS, et al,. Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis. J Am Acad Dermatol 2013; 68: 64-72
30. Nast A, Mrowietz U, Kragballe K, de Jong EM, Puig L, Reich K, Warren RB, Werner R, Kopkow C, Schmitt J,. Barriers to the prescription of systemic therapies for moderate-to-severe psoriasis-a multinational cross-sectional study. Arch Dermatol Res. 2013; 305: 899-907.
31. Pincus T, Furer V, Sokka T,. Underestimation of the efficacy, effectiveness, tolerability, and safety of weekly low-dose methotrexate in information presented to physicians and patients. Clin Exp Rheumatol 2010; 28 (5 Suppl. 61): S68-79.
32. Price S, James C, Deighton C,. Methotrexate use and alcohol. Clin Exp Rheumatol 2010; 28 (5 Suppl. 61): S114-6.
33. Barker J, Horn EJ, Lebwohl M, et al,. Assessment and management of methotrexate hepatotoxicity in psoriasis patients: report from a consensus conference to evaluate current practice and identify key questions toward optimizing methotrexate use in the clinic. J Eur Acad Dermatol Venereol 2011; 25: 758-64.
34. Collin B, Srinathan SK, Finch TM,. Methotrexate: prescribing and monitoring practices among the consultant membership of the British Association of Dermatologists. Br J Dermatol 2008; 158: 793-800.
35. Methotrexate prescribing information. Hospira Healthcare Corporation, Canada, 2012. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM294829.pdf (cited 2012 Nov 8)
36. Maurice PD, Maddox AJ, Green CA, Tatnall F, Schofield JK, Stott DJ,. Monitoring patients on methotrexate: hepatic fibrosis not seen in patients with normal serum assays of aminoterminal peptide of type III procollagen. Br J Dermatol 2005; 152: 451-8.
37. Gottlieb AB, Dann F,. Comorbidities in patients with psoriasis. Am J Med 2009; 122: 1150-9.
38. Kim N, Thrash B, Menter A,. Comorbidities in psoriasis patients. Semin Cutan Med Surg 2010; 29: 10-5.
39. Salliot C, van der Heijde D,. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis 2009; 68: 1100-4.
40. Spuls PI, Tuut MK, van Everdingen JJ, de Rie MA,. The practice guideline 'Photo(chemo)therapy and systemic therapy in severe chronic plaque-psoriasis'. Ned Tijdschr Geneeskd 2004; 148: 2121-5.
41. UK: The Summary of Product Characteristics, Methotrexate 2.5 mg (updated 19/09/2012). Electronic Medicines Compendium (internet), 2012. Available at: http://www.medicines.org.uk/emc/medicine/22954/SPC (accessed Nov 8 2012).
42. Kremer JM, Lee RG, Tolman KG,. Liver histology in rheumatoid arthritis patients receiving long-term methotrexate therapy. A prospective study with baseline and sequential biopsy samples. Arthritis Rheum 1989; 32: 121-7.
43. Whiting-O'Keefe QE, Fye KH, Sack KD,. Methotrexate and histologic hepatic abnormalities: a meta-analysis. Am J Med 1991; 90: 711-6.
44. Walker AM, Funch D, Dreyer NA, et al,. Determinants of serious liver disease among patients receiving low-dose methotrexate for rheumatoid arthritis. Arthritis Rheum 1993; 36: 329-35.
45. West SG,. Methotrexate hepatotoxicity. Rheum Dis Clin North Am 1997; 23: 883-915.
46. Visser K, van der Heijde DM,. Risk and management of liver toxicity during methotrexate treatment in rheumatoid and psoriatic arthritis: a systematic review of the literature. Clin Exp Rheumatol 2009; 27: 1017-25.
47. Langman G, Hall PM, Todd G,. Role of non-alcoholic steatohepatitis in methotrexate-induced liver injury. J Gastroenterol Hepatol 2001; 16: 1395-401.
48. Aithal GP, Haugk B, Das S, Card T, Burt AD, Record CO,. Monitoring methotrexate-induced hepatic fibrosis in patients with psoriasis: are serial liver biopsies justified? Aliment Pharmacol Ther 2004; 19: 391-9.
49. Rosenberg P, Urwitz H, Johannesson A, et al,. Psoriasis patients with diabetes type 2 are at high risk of developing liver fibrosis during methotrexate treatment. J Hepatol 2007; 46: 1111-8.
50. Aithal GP,. Dangerous liaisons: drug, host and the environment. J Hepatol 2007; 46: 995-8.
51. Zachariae H,. Have methotrexate-induced liver fibrosis and cirrhosis become rare? A matter for reappraisal of routine liver biopsies. Dermatology 2005; 211: 307-8.
52. Laharie D, Seneschal J, Schaeverbeke T, et al,. Assessment of liver fibrosis with transient elastography and FibroTest in patients treated with methotrexate for chronic inflammatory diseases: a case-control study. J Hepatol 2010; 53: 1035-40.
53. Dickinson DM, Bryant PC, Williams MC, et al,. Transplant data: sources, collection, and caveats. Am J Transplant 2004; 4 (Suppl. 9): 13-26.
54. Daily OP, Kauffman HM,. Quality control of the OPTN/UNOS Transplant Registry. Transplantation 2004; 77: 1309-10.
55. van Buuren S, Boshuizen HC, Knook DL,. Multiple imputation of missing blood pressure covariates in survival analysis. Stat Med 1999; 18: 681-94.
56. White IR, Royston P,. Imputing missing covariate values for the Cox model. Stat Med 2009; 28: 1982-98.
57. Royston P, Willi S,. Multivariable Model-Building: A Pragmatic Approach to Regression Anaylsis Based on Fractional Polynomials for Modelling Continuous Variables (Wiley Series in Probability and Statistics). Chichester, UK; Hoboken, NJ: Wiley, 2008.
58. Kaplan MM,. Methotrexate hepatotoxicity and the premature reporting of Mark Twain's death: both greatly exaggerated. Hepatology 1990; 12: 784-6.
59. Zachariae H, Sogaard H,. Methotrexate-induced liver cirrhosis. A follow-up. Dermatologica 1987; 175: 178-82.
60. Kremer JM, Furst DE, Weinblatt ME, Blotner SD,. Significant changes in serum AST across hepatic histological biopsy grades: prospective analysis of 3 cohorts receiving methotrexate therapy for rheumatoid arthritis. J Rheumatol 1996; 23: 459-61.
61. Lindsay K, Fraser AD, Layton A, Goodfield M, Gruss H, Gough A,. Liver fibrosis in patients with psoriasis and psoriatic arthritis on long-term, high cumulative dose methotrexate therapy. Rheumatology (Oxford) 2009; 48: 569-72.
62. Visser K, Katchamart W, Loza E, et al,. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Ann Rheum Dis 2009; 68: 1086-93.
63. Paul C, Gallini A, Maza A, et al,. Evidence-based recommendations on conventional systemic treatments in psoriasis: systematic review and expert opinion of a panel of dermatologists. J Eur Acad Dermatol Venereol 2011; 25 (Suppl. 2): 2-11.
64. Kremer JM,. Not yet time to change the guidelines for monitoring methotrexate liver toxicity: they have served us well. J Rheumatol 2002; 29: 1590-2.
65. Zachariae H, Sogaard H, Heickendorff L,. Methotrexate-induced liver cirrhosis. Clinical, histological and serological studies-a further 10-year follow-up. Dermatology 1996; 192: 343-6.
66. Neuman MG, Cameron RG, Haber JA, Katz GG, Malkiewicz IM, Shear NH,. Inducers of cytochrome P450 2E1 enhance methotrexate-induced hepatocytoxicity. Clin Biochem 1999; 32: 519-36.
67. Jahovic N, Cevik H, Sehirli AO, Yegen BC, Sener G,. Melatonin prevents methotrexate-induced hepatorenal oxidative injury in rats. J Pineal Res 2003; 34: 282-7.
68. Cetiner M, Sener G, Sehirli AO, et al,. Taurine protects against methotrexate-induced toxicity and inhibits leukocyte death. Toxicol Appl Pharmacol 2005; 209: 39-50.
69. Malhi H, Kaufman RJ,. Endoplasmic reticulum stress in liver disease. J Hepatol 2011; 54: 795-809.
70. Dara L, Ji C, Kaplowitz N,. The contribution of endoplasmic reticulum stress to liver diseases. Hepatology 2011; 53: 1752-63.
71. Farrell GC,. Drugs and steatohepatitis. Semin Liver Dis 2002; 22: 185-94.
72. Miele L, Vallone S, Cefalo C, et al,. Prevalence, characteristics and severity of non-alcoholic fatty liver disease in patients with chronic plaque psoriasis. J Hepatol 2009; 51: 778-86.
73. Davidovici BB, Sattar N, Prinz JC, et al,. Psoriasis and systemic inflammatory diseases: potential mechanistic links between skin disease and co-morbid conditions. J Invest Dermatol 2010; 130: 1785-96.
74. Gisondi P, Targher G, Zoppini G, Girolomoni G,. Non-alcoholic fatty liver disease in patients with chronic plaque psoriasis. J Hepatol 2009; 51: 758-64.
75. Amur S, Parekh A, Mummaneni P,. Sex differences and genomics in autoimmune diseases. J Autoimmun 2012; 38: J254-65.
76. Gelfand JM, Stern RS, Nijsten T, et al,. The prevalence of psoriasis in African Americans: results from a population-based study. J Am Acad Dermatol 2005; 52: 23-6.
77. Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD,. Liver biopsy. Hepatology 2009; 49: 1017-44.
78. Thomas JA, Aithal GP,. Monitoring liver function during methotrexate therapy for psoriasis: are routine biopsies really necessary? Am J Clin Dermatol 2005; 6: 357-63.
79. Henning JS, Gruson LM, Strober BE,. Reconsidering liver biopsies during methotrexate therapy. J Am Acad Dermatol 2007; 56: 893-4.
80. Yazici Y, Erkan D, Paget SA,. Monitoring methotrexate hepatic toxicity in rheumatoid arthritis: is it time to update the guidelines? J Rheumatol 2002; 29: 1586-9.
81. Yazici Y, Erkan D, Paget SA,. Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events. Arthritis Rheum 2003; 48: 2769-72.
82. Peckham PE, Weinstein GD, McCullough JL,. The treatment of severe psoriasis. A national survey. Arch Dermatol 1987; 123: 1303-7.
83. Petrazzuoli M, Rothe MJ, Grin-Jorgensen C, Ramsey WH, Grant-Kels JM,. Monitoring patients taking methotrexate for hepatotoxicity. Does the standard of care match published guidelines? J Am Acad Dermatol 1994; 31: 969-77.
84. Lee J, Belanger A, Doucette JT, Stanca C, Friedman S, Bach N,. Transplantation trends in primary biliary cirrhosis. Clin Gastroenterol Hepatol 2007; 5: 1313-5.
85. Kim WR, Terrault NA, Pedersen RA, et al,. Trends in waiting list registration for liver transplantation for viral hepatitis in the United States. Gastroenterology 2009; 137: 1680-6.
86. Charlton MR, Burns JM, Pedersen RA, Watt KD, Heimbach JK, Dierkhising RA,. Frequency and outcomes of liver transplantation for nonalcoholic steatohepatitis in the United States. Gastroenterology 2011; 141: 1249-53.