Long-term safety and effectiveness of high-dose dimethylfumarate in the treatment of moderate to severe psoriasis: A prospective single-blinded follow-up study

Journal of Dermatological Treatment

Volumn 27, Issue 1, 2016, Pages 31-36

  Lijnen, Raphaël ^a   Otters, Elsemieke ^b   Balak, Deepak ^c   Thio, Bing ^c  

^a LAURENTIUS HOSPITAL   (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Dimethylfumurate; high dose; monotherapy; prospective study; psoriasis

Indexed keywords

ACENOCOUMAROL; ADALIMUMAB; ALANINE AMINOTRANSFERASE; CHOLESTEROL; FUMARIC ACID DIMETHYL ESTER; GAMMA GLUTAMYLTRANSFERASE; METHOTREXATE; TRIACYLGLYCEROL; DERMATOLOGICAL AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGINA PECTORIS; APPETITE DISORDER; ARTICLE; ATRIAL FIBRILLATION; BASAL CELL CARCINOMA; BREAST CANCER; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; ECZEMA; EOSINOPHIL; FATIGUE; FEMALE; FLUSHING; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GIANT CELL GRANULOMA; HEADACHE; HEART INFARCTION; HEART PALPITATION; HEART VALVE REPLACEMENT; HERPES ZOSTER; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; INCIDENCE; LEG PAIN; LEUKOCYTE COUNT; LONG TERM CARE; LYMPHOCYTE; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MONOTHERAPY; NEUTROPHIL; OLIGODENDROGLIOMA; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTATE CANCER; PRURITUS; PSORIASIS; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; ROSACEA; SIDE EFFECT; SINGLE BLIND PROCEDURE; SYSTEMIC THERAPY; TREATMENT DURATION; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL; WEIGHT REDUCTION; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; DERMATOLOGIC AGENTS; DIMETHYL FUMARATE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PSORIASIS; SINGLE-BLIND METHOD;

EID: 84961369897     PISSN: 09546634     EISSN: 14711753     Source Type: Journal    
DOI: 10.3109/09546634.2015.1050980     Document Type: Article

References (36)

1. Schweckendiek W. Treatment of psoriasis vulgaris. Med Monatsschr. 1959; 13: 103-4
2. Altmeyer PJ, Matthes U, Pawlak F, et al. Antipsoriatic effect of fumaric acid derivatives. Results of a multicenter double-blind study in 100 patients. J Am Acad Dermatol. 1994; 30: 977-81
3. Nugteren-Huying WM, van der Schroeff JG, Hermans J, et al. Fumaric acid therapy for psoriasis: a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 1990; 22: 311-12
4. 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
5. Reich K, Thaci D, Mrowietz U, et al. Efficacy and safety of fumaric acid esters in the long-Term treatment of psoriasis: a retrospective study (FUTURE). J Dtsch Dermatol Ges. 2009; 7: 603-11
6. Mrowietz U, Rostami-Yazdi M, Neureither M, et al. 15 Years of fumaderm: fumaric acid esters for the systemic treatment of moderately severe and severe psoriasis vulgaris. J Dtsch Dermatol Ges. 2009; 7 Suppl 2: S3-16
7. Hoefnagel JJ, Thio HB, Willemze R, et al. Long-Term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. Br J Dermatol. 2003; 149: 363-9
8. Wain EM, Darling MI, Pleass RD, et al. Treatment of severe, recalcitrant, chronic plaque psoriasis with fumaric acid esters: a prospective study. Br J Dermatol. 2010; 162: 427-34
9. Kokelj F, Plozzer C, Avian A, et al. Fumaric acid and its derivatives in the treatment of psoriasis vulgaris: our experience in forty-one patients. Acta Dermatovenerol Croat. 2009; 17: 170-5
10. Fallah Arani S, Neumann H, Hop WC, et al. FAE vs. methotrexate in moderate to severe chronic plaque psoriasis: a multicentre prospective randomized controlled clinical trial. Br J Dermatol. 2011; 164: 855-61
11. de Jong R, Bezemer AC, Zomerdijk TP, et al. Selective stimulation of T helper 2 cytokine responses by the anti-psoriasis agent monomethylfumarate. Eur J Immunol. 1996; 26: 2067-74
12. Litjens NH, Nibbering PH, Barrois AJ, et al. Beneficial effects of fumarate therapy in psoriasis vulgaris patients coincide with downregulation of type 1 cytokines. Br J Dermatol. 2003; 148: 444-51
13. Litjens NH, Rademaker M, Ravensbergen B, et al. Effects of monomethylfumarate on dendritic cell differentiation. Br J Dermatol. 2006; 154: 211-17
14. Zhu K, Mrowietz U. Inhibition of dendritic cell differentiation by fumaric acid esters. J Invest Dermatol. 2001; 116: 203-8
15. Treumer F, Zhu K, Glaser R, et al. Dimethylfumarate is a potent inducer of apoptosis in human T cells. J Invest Dermatol. 2003; 121: 1383-8
16. Ockenfels HM, Schultewolter T, Ockenfels G, et al. The antipsoriatic agent dimethylfumarate immunomodulates T-cell cytokine secretion and inhibits cytokines of the psoriatic cytokine network. Br J Dermatol. 1998; 139: 390-5
17. Lehmann JC, Listopad JJ, Rentzsch CU, et al. Dimethylfumarate induces immunosuppression via glutathione depletion and subsequent induction of heme oxygenase 1. J Invest Dermatol. 2007; 127: 835-45
18. Rubant SA, Ludwig RJ, Diehl S, et al. Dimethylfumarate reduces leukocyte rolling in vivo through modulation of adhesion molecule expression. J Invest Dermatol. 2008; 128: 326-31
19. Harries MJ, Chalmers RJ, Griffiths CE. Fumaric acid esters for severe psoriasis: a retrospective review of 58 cases. Br J Dermatol. 2005; 153: 549-51
20. Mrowietz U, Asadullah K. Dimethylfumarate for psoriasis: more than a dietary curiosity. Trends Mol Med. 2005; 11: 43-8
21. Nieboer C, de Hoop D, van Loenen AC, et al. Systemic therapy with fumaric acid derivates: new possibilities in the treatment of psoriasis. J Am Acad Dermatol. 1989; 20: 601-8
22. Nieboer C, de Hoop D, Langendijk PN, et al. Fumaric acid therapy in psoriasis: a double-blind comparison between fumaric acid compound therapy and monotherapy with dimethylfumaric acid ester. Dermatologica. 1990; 181: 33-7
23. Kolbach DN, Nieboer C. Fumaric acid therapy in psoriasis: results and side effects of 2 years of treatment. J Am Acad Dermatol. 1992; 27: 769-71
24. Papp KA, Fonjallaz P, Casset-Semanaz F, et al. Analytical approaches to reporting long-Term clinical trial data. Curr Med Res Opin. 2008; 24: 2001-8
25. Mrowietz U, Christophers E, Altmeyer P. Treatment of severe psoriasis with fumarates: scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester Consensus Conference. Br J Dermatol. 1999; 141: 424-9
26. Litjens N, Burggraaf J, van Strijen E, et al. Pharmacokinetics of oral fumarates in healthy subjects. Br J Clin Pharmacol. 2004; 58: 429-32
27. Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012; 66: 369-75
28. Farhi D, Falissard B, Dupuy A. Global assessment of psoriasis severity and change from photographs: a valid and consistent method. J Invest Dermatol. 2008; 128: 2198-203
29. Langham S, Langham J, Goertz HP, et al. Large-scale, prospective, observational studies in patients with psoriasis and psoriatic arthritis: a systematic and critical review. BMC Med Res Methodol. 2011; 11: 32
30. Thio HB, Van Der Schroeff JG, Nugteren-Huying WM, et al. Long-Term systemic therapy with dimethylfumarate and monoethylfumarate (Fumaderm) in psoriasis. J Eur Acad Dermatol Venereol. 1995; 4: 35-40
31. Fliegner L, Spiegel P. Osteomalacia as an apparently rare side effect of oral fumaric acid therapy. Secondary DeToni-Debre Fanconi syndrome in the adult. Hautarzt. 1992; 43: 554-60
32. Warzecha J, Runck A, Priepke E, et al. Multiple pathological fractures within the scope of DeToni-Debre-Fanconi syndrome after fumarate therapy in psoriasis. Unfallchirurg. 2001; 104: 448-51
33. Roodnat JI, Christiaans MH, Nugteren-Huying WM, et al. Acute kidney insufficiency in patients treated with fumaric acid esters for psoriasis. Ned Tijdschr Geneeskd. 1989; 133: 2623-6
34. Ogilvie S, Lewis Jones S, Dawe R, et al. Proteinuria with fumaric acid ester treatment for psoriasis. Clin Exp Dermatol. 2011; 36: 632-4
35. van Oosten B, Killestein J, Barkhof F, et al. PML in a patient treated with dimethyl fumarate from a compounding pharmacy. N Engl J Med. 2013; 368: 1658-9
36. Ermis U, Weis J, Schulz JB. PML in a patient treated with fumaric acid. N Engl J Med. 2013; 368: 1657-8