Topical tacrolimus for the treatment of inflammatory skin diseases

Bibliography

• HERD RM, TIDMAN MJ, PRESCOTT RJ, HUNTER JA: The cost for atopic eczema. Br j Dermatal (1996) 135:20–23.
   PubMed Web of Science ®Google Scholar
• PETER RU, RUZICKA T: [Cyclosporin A in the therapy of inflammatory dermatosed Cyclosporin A in der Therapie entzilndlicher Dermatosen. Hautarzt (1992) 43:687–694.
   PubMedGoogle Scholar
• SCHREIBER SL, CRABTREE GR: The mechanism of action of cyclosporine A and FK506. Immune]. Today (1992) 13:136–142.
   PubMedGoogle Scholar
• ••Excellent review on the mechanism ofaction of tacrolimus.
   Google Scholar
• SURBER C, ITIN, P, BOCHNER S: Clinical controversy on the effect of topical ciclosporin: What is the target site? Dermatology (1992) 9:805–817.
   Google Scholar
• MROWIETZ U: The enigma of cyclosporin A treatment for psoriasis: Systemic efficacy versus topical nonresponsiveness. Acta Derm. Venereal (Stockh) (1992) 72:321–326.
   PubMedGoogle Scholar
• SAWADA S, SUZUKI G, KAWASE Y, TAKAKU F: Novel immunosuppressive agent, FK506; In vitro effects on cloned T cell activation. j Immune]. (1987) 139:1797–1803.
   PubMed Web of Science ®Google Scholar
• •Early data on the mechanisms of action of tacrolimus in vitro.
   Google Scholar
• MEINGASSNER JG, STOTZ A: Immunosuppressive macrolides of the type FK506: a novel class of topical agents for the treatment of skin diseases. j Invest. Dermatal. (1992) 98:851–855.
   PubMed Web of Science ®Google Scholar
• ••Tacrolimus is topically effective in contrastto cyclosporin A.
   Google Scholar
• KINO T, HATANAKA H, MIYATA S et al.: FK-506, a novel immunosuppressant isolated from a Streptomyces. II. Immunosuppressive effect of FK-506 in vitro. J Aritibiat. Tokyo (1987) 40:1256–1265.
   Google Scholar
• GOTO T, KINO T, HATANAKA H et al: FK 506: Historical Perspectives. Transplant. Proc. (1991) 23:2713–2717.
   PubMed Web of Science ®Google Scholar
• THOMSON AW: FK506 enters the clinic. Immune]. Today (1990) 11:35–36.
   PubMedGoogle Scholar
• STARZL TE, TODO S, FUNG J, DEMETRIS AJ, VENKATARAMMAN R, JAIN A: FK506 for liver, kidney and pancreas transplantation. Lancet (1989) 8670:1000–1004.
   Google Scholar
• TODO S, FUNG JJ, STARZL TE et al: Liver, kidney, and thoracic organ transplantation under FK506. Ann. Surg. (1990) 212:295–307.
   PubMed Web of Science ®Google Scholar
• NAKAGAWA H, ETOH T, ISHIBASHI Y et al.: Tacrolimus ointment for atopic eczema. Lancet (1994) 344:883.
   PubMed Web of Science ®Google Scholar
• ••First publication on tacrolimus ointmentfor atopic eczema.
   Google Scholar
• AOYAMA H, TABATA N, TANAKA M, UESUGI Y, TAGAMI H: Successful treatment of resistant facial lesions of atopic eczema with 0.1% FK506 ointment. Br Dermatal. (1995) 133:494–496.
   PubMed Web of Science ®Google Scholar
• RUZICKA T, BIEBER T, SCHOPF E et al.: A short-term trial of tacrolimus ointment for atopic eczema. N Engl. Med. (1997) 337:816–821.
   PubMed Web of Science ®Google Scholar
• ••First and largest multi-centre short-termtrial for tacrolimus ointment for atopic eczema.
   Google Scholar
• BOGUNIEWICZ M, FIEDLER VC, RAIMER S, LAWRENCE ID, LEUNG DY, HANIFIN JM: A randomised, vehicle-controlled trial of tacrolimus ointment for treatment of atopic eczema in children. Pediatric Tacrolimus Study Group. Allergy CM]. Immurial. (1998) 102:637–644.
   Google Scholar
• ••Safety of tacrolimus ointment for childrenwith atopic eczema.
   Google Scholar
• SIEKIRKA JJ, HUNG SHY, POEM, LIN CS, SIGAL NH: A cytosolic protein for the immunosuppressant FK506 has peptidyl- prolyl isomerase activity but is distinct from cyclophilin. Nature (1989) 341:755–757.
   PubMedGoogle Scholar
• HARDING MW, GALAT A, UEHLING DE, SCHREIBER SL: A receptor for the immunosuppressant FK506 is a cis-mans peptidyl-prolyl isomerase. Nature (1989) 341:758–760.
   PubMed Web of Science ®Google Scholar
• TOCCI MJ, MATKOVICH DA, COLLIER KA et al.: The immunosuppressive agent, FK506: in vitro effects on the cloned T cell activation. Immune]. (1989) 139:718–726.
   Google Scholar
• SIGAL NH, DUMONT FJ: Cyclosporine A, FK506 and rapamycin: pharmacological probes of lymphocyte signal transduction. Ann. Rev Immune]. (1992) 10:519–560.
   PubMed Web of Science ®Google Scholar
• CLIPSTONE NA, CRABTREE GR: Identification of calcineurin as a key signalling enzyme in T-lymphocyte activation. Nature (1992) 357:695–697.
   PubMed Web of Science ®Google Scholar
• •Mechanisms of lymphocyte activation.
   Google Scholar
• RAO A: NF-ATp: a transcription factor required for the co-ordinate induction of several cytokine genes. Immurial. Today (1994) 15:274–281.
   PubMedGoogle Scholar
• HANIFIN JM: Assembling the puzzle pieces in atopic inflammation. Arch. Dermatal. (1996) 132:1230–1232.
   PubMedGoogle Scholar
• MARONE G, GIUGLIANO R, LEMBO G, AYALA F: Human basophil releasability. II. Changes in basophil releasability in patients with atopic dermatitis. j Invest. Dermatal. (1986) 87:19–23.
   Google Scholar
• DE PAULIS A, STELLATO C, CIRILLO R, CICCARELLI A, ORIENTE A, MARONE G: Anti-inflammatory effect of FK-506 on human skin mast cells. j Invest. Dermatal. (1992) 99:723–728.
   PubMed Web of Science ®Google Scholar
• EBERLEIN-KONIG B, RUZICKA T, MICHEL G, PRZYBILLA B: Modulation of histamine release in vitro by FK506 and interleukin-3 is determined by sequence of incubation. Arch. Dermatal Res. (1997) 289:606–608.
   PubMedGoogle Scholar
• •Mechanisms of tacrolimus in mast cells and basophils.
   Google Scholar
• HOMEY B, ASSMANN T, VOHR HW et al.: Topical FK506 suppresses cytokine and costimulatory molecule expression in epidermal and local draining lymph node cells. j Immurial (1998) 160:5331–5340.
   Google Scholar
• •Effects of topical tacrolimus on the cutaneous cytokine network in hypersensitivity.
   Google Scholar
• PANHANS- GROSSA, NOVAK N, KRAFT S, BIEBER T: Human epidermal Langerhans' cells are targets for the immunosuppressive macrolide tacrolimus (FK506). j Allergy Clin. Immune]. (2001) 107:345–352.
   PubMedGoogle Scholar
• WOLLENBERG A, SHARMA S, VON BUBNOFF D, GEIGER E, HABERSTOK J, BIEBER T: Topical tacrolimus (FK506) leads to profound phenotypic and functional alterations of epidermal antigen-presenting dendritic cells in atopic dermatitis.j Allergy Clin. Immurial. (2001) 107:445–448.
   PubMedGoogle Scholar
• REMITZ A, KYLLONEN H, GRANLUND H, REITAMO S: Tacrolimus ointment reduces staphylococcal colonization of atopic dermatitis lesions.j Allergy OM. Immune]. (2001) 107:196–197.
   PubMed Web of Science ®Google Scholar
• SCHULZ BS, MICHEL G, WAGNER S et al.: Increased expression of epidermal IL-8 receptor in psoriasis. Down-regulation by FK-506 in vitro. j Immune]. (1993) 151:4399–4406.
   Google Scholar
• LEMSTER BH, CARROLL PB, RILO HR, JOHNSON N, NIKAEIN A, THOMSON AW: IL-8/IL-8 receptor expression in psoriasis and the response to systemic tacrolimus (FK506) therapy. Clin. Exp. Immune]. (1995) 99:148–154.
   PubMed Web of Science ®Google Scholar
• NISHIO H, MATSUI K, TSUJI H, TAMURA A, SUZUKI K: Immunolocalization of calcineurin and FKBP-12, the FK506-binding protein, in Hasse11's corpuscles of human thymus and epidermis. Histochem. Cell Biol. (2000) 114:9–14.
   PubMedGoogle Scholar
• MICHEL G, AUER H, KEMENY L, BOCKING A, RUZICKA T: Antioncogene P53 and mitogenic cytokine interleukin-8 aberrantly expressed in psoriatic skin are inversely regulated by the antipsoriatic drug tacrolimus. Biochem. Pharmacal. (1996) 51:1315–1320.
   PubMedGoogle Scholar
• MEKKI O, LEE C, CARRRIER S et al: The effect of food on oral bioavailability of tacrolimus (FK506) in liver transplant patients. Clin. Pharmacal. Ther. (1993) 53:229.
   Google Scholar
• Prograf Product Information, Fujisawa, 1995
   Google Scholar
• PETERS DH, FITTON A, PLOSKER GL et al.: Tacrolimus: a review of its pharmacology, and therapeutic potential in hepatic and renal transplantation. Drugs (1993) 46:746–794.
   PubMed Web of Science ®Google Scholar
• VENKATARAMANAN R, JAIN A, WARTY VS: Pharmacokinetics of FK506 in transplant patients. Transplant. Proc. (1991) 23:2736–2740.
   PubMed Web of Science ®Google Scholar
• SATTLER M, GUENGERICH FP, YUN CH, CHRISTIANS U, SEWING KF: Cytochrome P-450 3A enzymes are responsible for biotransformation of FK506 and rapamycin in man and rat. Drug Metab. Dispos. (1992) 20:753–761.
   PubMed Web of Science ®Google Scholar
• SHIRAGA T, MATSUDA H, NAGASE K et al.: Metabolism of FK506, a potent immunosuppressive agent, by cytochrome P450 3A enzymes in rat, dog and human liver microsomes. Biochem. Pharmacal (1994) 47:727–735.
   PubMed Web of Science ®Google Scholar
• BEKERSKY I, FITZSIMMONS W, TANASE A, MAHER, RIVI, HOD OSH E, LAWRENCE I: Nonclinical and early clinical development of tacrolimus ointment for the treatment of atopic dermatitis.j Am. Acad. Dermatal. (2001) 44:S17–27.
   PubMedGoogle Scholar
• REITAMO S, WOLLENBERG A, SCHOPF E et al: Safety and efficacy of 1 year tacrolimus ointment monotherapy in adults with atopic dermatitis. Arch. Dermatal. 136:999–1006.
   Google Scholar
• ••Large European Phase III study on thelong-term safety and efficacy of tacrolimus ointment in atopic eczema.
   Google Scholar
• ABU ELMAGD K, JEGASOTHY BV, ACKERMAN CD et al.: Efficacy of FK506 in the treatment of recalcitrant pyoderma gangrenosum. Transplant. Proc. (1991) 23:3328–3329.
   PubMedGoogle Scholar
• SAKANE T, MOCHIZUKI M, INABA G, MASUDA K: A Phase II study of FK506 (tacrolimus) on refractory uveitis associated with Behcet's disease and allied conditions. Ryumachi (1995) 35:802–813.
   PubMedGoogle Scholar
• KOGA T, YANO T, ICHIKAWA Y, OIZUMI K, MOCHIZUKI M: Pulmonary infiltrates recovered by FK506 in a patient with Behcet's disease. Chest (1993) 104:309–311.
   PubMed Web of Science ®Google Scholar
• JEGASOTHY BV, ACKERMAN CD, TODO S, FUNG JJ, ABU ELMAGD K, STARZL TE: Tacrolimus (FK 506)--a new therapeutic agent for severe recalcitrant psoriasis. Arch. Dermatal. (1992) 128:781–785.
   PubMed Web of Science ®Google Scholar
• THE EUROPEAN FK506 MULTICENTER PSORIASIS STUDY GROUP: Systemic tacrolimus (FK506) is effective for the treatment of psoriasis in a double-blind, placebo-controlled study. Arch. Dermatal (1996) 132:419–423.
   PubMed Web of Science ®Google Scholar
• PLATZ KP MUELLER AR, BLUMHARDT G et al: Nephrotoxicity following orthotopic liver transplantation. A comparison between cyclosporine and FK506. Transplantation (1994) 58:170–178.
   Google Scholar
• KATARI SR, MAGNONE M, SHAPIRO R et al.: Clinical features of acute reversible tacrolimus (FK506) nephrotoxicity in kidney transplant recipients. Clin. Transplant. (1997) 11:237–242.
   PubMed Web of Science ®Google Scholar
• WIJDICKS EF, WIESNER RH, DAHLKE LJ, KROM RA: FK506-induced neurotoxicity in liver transplantation. Ann. Neural (1994) 35:498–501.
   PubMed Web of Science ®Google Scholar
• STEINMULLER TM, GRAF KJ, SCHLEICHER J et al.: The effect of FK506 versus cyclosporine on glucose and lipid metabolism - a randomized trial. Transplantation (1994) 58:669–674.
   PubMedGoogle Scholar
• ZONNEVELD IM, RUBINS A, JABLONSKA S et al.: Topical tacrolimus is not effective in chronic plaque type psoriasis. A pilot study. Arch. Dermatal. (1998) 134:1101–1102.
   PubMed Web of Science ®Google Scholar
• REMITZ A, REITAMO S, ERKKO P, GRANLUND H, LAUERMA Al: Tacrolimus ointment improves psoriasis in a microplaque assay. Br j Dermatal. (1999) 141:103–107.
   PubMed Web of Science ®Google Scholar
• SCHUPPE HC, HOMEY B, ASSMANN T, MARTENS R, RUZICKA T: Topical tacrolimus for pyoderma gangrenosum. Lancet (1998) 351:832.
   PubMed Web of Science ®Google Scholar
• RICHTER-HINTZ D, SCHUPPE HC, HOMEY B, LEHMANN P, RUZICKA T: Topical tacrolimus (FK506) is effective in the treatment of pyoderma gangrenosum. j. Am. Acad. Dermatal. (2000) 42:304–305.
   PubMedGoogle Scholar
• VENTE C, REICH K, RUPPRECHT R, NEUMANN C: Erosive mucosal lichen planus: response to topical treatment with tacrolimus. Br. j Dermatal. (1999) 140:338–342.
   PubMed Web of Science ®Google Scholar
• SCHUPPE HC, RICHTER-HINTZ D, STIERLE HE, HOMEY B, RUZICKA T, LEHMANN P: Topical tacrolimus for recalcitrant leg ulcer in rheumatoid arthritis. Rheumatology (Oxford) (2000) 39:105–106.
   PubMed Web of Science ®Google Scholar
• HANIFIN JM, RAJKA G: Diagnostic features of atopic dermatitis. Acta Derm. Venereal Suppl. (Stockh) (1980) 92:44–47.
   Google Scholar
• •Clinical characteristics of atopic eczema.
   Google Scholar
• DIEPGEN TL, FARTASCH M: Recent epidemiological and genetic studies in atopic dermatitis. Acta Berm. Venereal Suppl. (Stockh ) (1992) 176:13–18.
   PubMedGoogle Scholar
• SCHULTZ-LARSEN F, DIEPGEN T, SVENSSON A: The occurrence of atopic dermatitis in north Europe: an international questionnaire study. I Am. Acad. Derail-dal (1996) 34:760–764.
   PubMedGoogle Scholar
• SUGIURA H, UMEMOTO N, DEGUCHI H et al.: Prevalence of childhood and adolescent atopic dermatitis in a Japanese population: comparison with the disease frequency examined 20 years ago. Acta Derm. Venereal (1998) 78:293–294.
   PubMed Web of Science ®Google Scholar
• LAUGHTER D, ISTVAN J, TOFTE S, HANIFIN JM: The prevalence of atopic dermatitis in Oregon schoolchildren. j Am. Acad. Dermatal. (2000) 43:649–655.
   PubMed Web of Science ®Google Scholar
• LEUNG DYM, SOTER NA: Cellular and immunologic mechanisms in atopic dermtitis. j Am. Acad. Dermatal (2001) 44:S1–12.
   PubMedGoogle Scholar
• ••Excellent summary and up-date on theimmunopathogenesis in atopic eczema.
   Google Scholar
• GORDON K, GUITART J, VICTOR T et al.: Topical triamcinolone and tacrolimus differ in their in vivo effects on Langerhans cells during the treatment of atopic dermatitis. j Invest. Dermatol . (1999) 112:654. Abstract.
   Google Scholar
• REITAMO S, RISSANEN J, REMITZ A et al.: Tacrolimus ointment does not affect collagen synthesis: results of a single-center randomized trial. ..J. Invest. Dermatal (1998) 111:396–398.
   PubMed Web of Science ®Google Scholar
• ••Important data on the interaction oftacrolimus ointment with collagen synthesis.
   Google Scholar
• ALAITI S, KANG S, FIEDLER VC et al: Tacrolimus (FK506) ointment for atopic dermatitis: a Phase I study in adults and children. J. Am. Acad. Dermatal (1998) 38:69–76.
   PubMed Web of Science ®Google Scholar
• HANIFIN JM AND THE TACROLIMUSOINTMENT STUDY GROUP: Use of tacrolimus ointment in 3–6 year-olds with severe atopic dermatitis: a dose escalation study. J. Invest. Dermatal (1998) 110:681. Abstract.
   Google Scholar
• KANG S and THE TACROLIMUS OINTMENT STUDY GROUP: Tacrolimus for adults with moderate to severe atopic dermatitis. j Invest. Dermatal (1998) 110:681. Abstract.
   Google Scholar
• ISHIBASHI Y, NAKAGAWA H, ETOH T et al: Early Phase II study of FK506 ointment in atopic dermatitis [Japanese]. Ther. Med. (1998) 14:2293–2311.
   Google Scholar
• FK506 OINTMENT STUDY GROUP: A late Phase II study to determine the concentration of FK506 (tacrolimus) ointment in atopic dermatitis (Part I): revised version [Japanese]. Nishinihon Dermatal (1998) 60:685–698.
   Google Scholar
• FK506 OINTMENT STUDY GROUP: A late Phase II study to determine the concentration of FK506 (tacrolimus) ointment in atopic dermatitis (Part 2) [Japanese]. Nishinihon Dermatal (1997) 59:427–435.
   Google Scholar
• FK506 OINTMENT STUDY GROUP: Phase III comparative study of FK506 (tacrolimus) ointment vs. betamethasone valerate ointment in atopic dermatitis (trunkJextremities) [in Japanese]. Nishinihon Dermatal (1997) 59:870–879.
   Google Scholar
• FK506 OINTMENT STUDY GROUP: Phase III comparative study of FK506 (tacrolimus) ointment vs. alcolmethasone dipropionate ointment in atopic dermatitis (face and neck lesions) [in Japanese]. Acta Dermatol (Kyoto) (1997) 92:277–288.
   Google Scholar
• KANG S, LUCKY AW, PARISER D, LAWRENCE I, HANIFIN JM and THE TACROLIMUS OINTMENT STUDY GROUP: Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. j Am. Acad. Dermatal. (2001) 44:S58–64.
   PubMed Web of Science ®Google Scholar
• ••Large Phase III study for tacrolimusointment in children with atopic eczema.
   Google Scholar
• Product Information Protopic, Ointment, Fujisawa Healthcare, Inc., USA
   Google Scholar
• DRAKE L, PRENDERGAST M, MAHER R et al.: The impact of tacrolimus ointment on health-related quality of life of adults and pediatric patients with atopic dermatitis. j Am. Acad. Dermatal. (2001) 44:S65–72.
   PubMed Web of Science ®Google Scholar
• HAAPASAARI KM, RISTELI J, KARVONEN J et al.: Effect of hydrocortisone, methylprednisolone aceponate and mometasone furoate on collagen synthesis in human skin in vivo. Skin Pharmacal (1997) 10:261–264.
   PubMedGoogle Scholar
• WILKINSON SM, BECK MH: Fluticasone propionate and mometason furoate have a low risk of contact sensitisation. Contact Dermatitis (1996) 34:365–366.
   PubMedGoogle Scholar
• CORAZZA M, VIRGILI A: Allergic contact dermatitis from a-methylprednisolone aceponate and budenoside. Contact Dermatitis (1998) 38:356–357.
   PubMedGoogle Scholar
• RUZICKA T: Atopic eczema between rationality and irrationality. Arch. Dermatal (1998) 134:1462–1469.
   PubMedGoogle Scholar
• MEINGASSNER JG, STUTZ A: Anti-inflammatory effects of macrophilin-interacting drugs in animal models of irritant and allergic contact dermatitis. _kir Arch. Allergy Immunal (1992) 92:486–489.
   Google Scholar
• DUNCAN JI: Differential inhibition of cutaneous T-cell-mediated reactions and epidermal cell proliferation by ciclosporin A, FK-506 and rapamycin. j Invest. Dermatal (1994) 102:84–88.
   PubMedGoogle Scholar
• BORNHOVD EC, SCHULLER E, BIEBER T, WOLLENBERG A: Immunsuppressive Makrolide und ihr Einsatz in der Dermatologie [The use of immunosuppressive macrolides in clinical dermatology]. Hautarzt (2000) 51:646–654.
   PubMedGoogle Scholar
• VAN LEENT EJ, GRABER M, THURSTON M, WAGENAAR A, SPULS PI, BOS JD: Effectiveness of the ascomycin macrolactam SDZ ASM 981 in the topical treatment of atopic dermatitis. Arch. Dermatal (1998) 134:805–809.
   PubMed Web of Science ®Google Scholar
• MEINGASSNER JG, GRASSBERGER M,FAHRNGRUBER H, MOORE HD, SCHUURMAN H, STUTZ A: A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology. Br Dermatal (1997) 137:568–576.
   PubMed Web of Science ®Google Scholar