Skip to main content
Erschienen in: Rheumatology International 6/2011

01.06.2011 | Original Article

Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus

verfasst von: Katsuya Suzuki, Hideto Kameda, Koichi Amano, Hayato Nagasawa, Hirofumi Takei, Eiko Nishi, Ayumi Okuyama, Kensei Tsuzaka, Tsutomu Takeuchi

Erschienen in: Rheumatology International | Ausgabe 6/2011

Einloggen, um Zugang zu erhalten

Abstract

The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus (TAC) in various manifestations of systemic lupus erythematosus (SLE) patients in daily clinical practice. Each of the 21 TAC-treated patients with SLE in our care over 2 years was enrolled in this open-label trial. Patients were administered TAC at a dosage of 1–6 mg once daily, followed up for 24 weeks. Efficacy and safety were evaluated utilizing clinical and laboratory findings. As treatment targets, TAC was preferentially used with oral corticosteroid administration for mild active manifestations such as arthritis, skin eruptions, or asymptomatic nephritis. In efficacy, the mean value of the SLE disease activity index was significantly reduced to 4.1, 2.7, 1.8, and 1.2 (N = 21, 20, 16 and 13) at 0, 4, 12, and 24 weeks, respectively. In eight cases, treatment was discontinued within 24 weeks due to insufficient effects (6 cases) and side effects (2 cases). Non-serious side effects were observed in only five cases (23.8%) over 24 weeks. TAC can be considered both effective and safe for the treatment of various manifestations of SLE.
Literatur
1.
Zurück zum Zitat D’Cruz DP, Khamashta MA, Hughes GR (2007) Systemic lupus erythematosus. Lancet 369:587–596PubMedCrossRef D’Cruz DP, Khamashta MA, Hughes GR (2007) Systemic lupus erythematosus. Lancet 369:587–596PubMedCrossRef
2.
3.
Zurück zum Zitat Takeuchi T, Tsuzaka K, Abe T et al (2005) T cell abnormalities in systemic lupus erythematosus. Autoimmunity 38:339–346PubMedCrossRef Takeuchi T, Tsuzaka K, Abe T et al (2005) T cell abnormalities in systemic lupus erythematosus. Autoimmunity 38:339–346PubMedCrossRef
4.
Zurück zum Zitat Bertsias G, Ioannidis JP, Boletis J et al (2008) Task force of the EULAR standing committee for international clinical studies including therapeutics. EULAR recommendations for the management of systemic lupus erythematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis 67:195–205PubMedCrossRef Bertsias G, Ioannidis JP, Boletis J et al (2008) Task force of the EULAR standing committee for international clinical studies including therapeutics. EULAR recommendations for the management of systemic lupus erythematosus. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis 67:195–205PubMedCrossRef
5.
Zurück zum Zitat Siekierka JJ, Sigal NH (1992) FK-506 and cyclosporin A: immunosuppressive mechanism of action and beyond. Curr Opin Immunol 4:548–552PubMedCrossRef Siekierka JJ, Sigal NH (1992) FK-506 and cyclosporin A: immunosuppressive mechanism of action and beyond. Curr Opin Immunol 4:548–552PubMedCrossRef
6.
Zurück zum Zitat Sakuma S, Kato Y, Nishigaki F et al (2000) FK506 potently inhibits T cell activation induced TNF-alpha and IL-1beta production in vitro by human peripheral blood mononuclear cells. Br J Pharmacol 130:1655–1663PubMedCrossRef Sakuma S, Kato Y, Nishigaki F et al (2000) FK506 potently inhibits T cell activation induced TNF-alpha and IL-1beta production in vitro by human peripheral blood mononuclear cells. Br J Pharmacol 130:1655–1663PubMedCrossRef
7.
Zurück zum Zitat Sakuma S, Kato Y, Nishigaki F et al (2001) Effects of FK506 and other immunosuppressive anti-rheumatic agents on T cell activation mediated IL-6 and IgM production in vitro. Int Immunopharmacol 1:749–757PubMedCrossRef Sakuma S, Kato Y, Nishigaki F et al (2001) Effects of FK506 and other immunosuppressive anti-rheumatic agents on T cell activation mediated IL-6 and IgM production in vitro. Int Immunopharmacol 1:749–757PubMedCrossRef
8.
Zurück zum Zitat European FK506 Multicentre Liver Study Group (1994) Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. Lancet 344:423–428CrossRef European FK506 Multicentre Liver Study Group (1994) Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. Lancet 344:423–428CrossRef
9.
Zurück zum Zitat The U.S. Multicenter FK506 Liver Study Group (1994) A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med 331:1110–1115CrossRef The U.S. Multicenter FK506 Liver Study Group (1994) A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med 331:1110–1115CrossRef
10.
Zurück zum Zitat Schleibner S, Krauss M, Wagner K et al (1995) FK 506 versus cyclosporin in the prevention of renal allograft rejection—European pilot study: six-week results. Transpl Int 8:86–90PubMed Schleibner S, Krauss M, Wagner K et al (1995) FK 506 versus cyclosporin in the prevention of renal allograft rejection—European pilot study: six-week results. Transpl Int 8:86–90PubMed
11.
Zurück zum Zitat Laskow DA, Vincenti F, Neylan JF, Mendez R, Matas AJ (1996) An open-label, concentration-ranging trial of FK506 in primary kidney transplantation: a report of the United States Multicenter FK506 Kidney Transplant Group. Transplantation 62:900–905PubMedCrossRef Laskow DA, Vincenti F, Neylan JF, Mendez R, Matas AJ (1996) An open-label, concentration-ranging trial of FK506 in primary kidney transplantation: a report of the United States Multicenter FK506 Kidney Transplant Group. Transplantation 62:900–905PubMedCrossRef
12.
Zurück zum Zitat Konishi T, Yoshiyama Y, Takamori M, Yagi K, Mukai E, Saida T (2003) Japanese FK506 MG Study Group. Clinical study of FK506 in patients with myasthenia gravis. Muscle Nerve 28:570–574PubMedCrossRef Konishi T, Yoshiyama Y, Takamori M, Yagi K, Mukai E, Saida T (2003) Japanese FK506 MG Study Group. Clinical study of FK506 in patients with myasthenia gravis. Muscle Nerve 28:570–574PubMedCrossRef
13.
Zurück zum Zitat Gremillion RB, Posever JO, Manek N, West JP, van Volen-Hoven RF (1999) Tacrolimus (FK506) in the treatment of severe, refractory rheumatoid arthritis: initial experience in 12 patients. J Rheumatol 26:2332–2336PubMed Gremillion RB, Posever JO, Manek N, West JP, van Volen-Hoven RF (1999) Tacrolimus (FK506) in the treatment of severe, refractory rheumatoid arthritis: initial experience in 12 patients. J Rheumatol 26:2332–2336PubMed
14.
Zurück zum Zitat Furst DE, Saag K, Fleischmann MR, Sherrer Y, Block JA, Schnitzer T et al (2002) Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study. Arthritis Rheum 46:2020–2028PubMedCrossRef Furst DE, Saag K, Fleischmann MR, Sherrer Y, Block JA, Schnitzer T et al (2002) Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study. Arthritis Rheum 46:2020–2028PubMedCrossRef
15.
Zurück zum Zitat Kondo H, Abe T, Hashimoto H et al (2004) Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study. J Rheumatol 31:243–251PubMed Kondo H, Abe T, Hashimoto H et al (2004) Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study. J Rheumatol 31:243–251PubMed
16.
Zurück zum Zitat Suzuki K, Kameda H, Amano K et al (2009) Single center prospective study of tacrolimus efficacy and safety in treatment of rheumatoid arthritis. Rheumatol Int 29:431–436PubMedCrossRef Suzuki K, Kameda H, Amano K et al (2009) Single center prospective study of tacrolimus efficacy and safety in treatment of rheumatoid arthritis. Rheumatol Int 29:431–436PubMedCrossRef
17.
Zurück zum Zitat Hochberg MC (1997) Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 40(9):1725PubMedCrossRef Hochberg MC (1997) Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 40(9):1725PubMedCrossRef
18.
Zurück zum Zitat Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH (1992) Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 35:630–640PubMedCrossRef Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH (1992) Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 35:630–640PubMedCrossRef
19.
Zurück zum Zitat Duddridge M, Powell RJ (1997) Treatment of severe and difficult cases of systemic lupus erythematosus with tacrolimus. A report of three cases. Ann Rheum Dis 56(11):690–692PubMedCrossRef Duddridge M, Powell RJ (1997) Treatment of severe and difficult cases of systemic lupus erythematosus with tacrolimus. A report of three cases. Ann Rheum Dis 56(11):690–692PubMedCrossRef
20.
Zurück zum Zitat Yoon KH (2004) Successful usage of tacrolimus (FK506) in resistant/relapsed rheumatic diseases. APLAR J Rheumatol 7:44–48CrossRef Yoon KH (2004) Successful usage of tacrolimus (FK506) in resistant/relapsed rheumatic diseases. APLAR J Rheumatol 7:44–48CrossRef
21.
Zurück zum Zitat Politt D, Heintz B, Floege J, Mertens PR (2004) Tacrolimus- (FK506) based immunosuppression in severe systemic lupus erythematosus. Clin Nephrol 62:49–53PubMed Politt D, Heintz B, Floege J, Mertens PR (2004) Tacrolimus- (FK506) based immunosuppression in severe systemic lupus erythematosus. Clin Nephrol 62:49–53PubMed
22.
Zurück zum Zitat Mok CC, Tong KH, To CH, Siu YP, Au TC (2005) Tacrolimus for induction therapy of diffuse proliferative lupus nephritis: an open-labeled pilot study. Kidney Int 68:813–817PubMedCrossRef Mok CC, Tong KH, To CH, Siu YP, Au TC (2005) Tacrolimus for induction therapy of diffuse proliferative lupus nephritis: an open-labeled pilot study. Kidney Int 68:813–817PubMedCrossRef
23.
Zurück zum Zitat Mok CC (2006) Therapeutic options for resistant lupus nephritis. Semin Arthritis Rheum 36:71–81PubMedCrossRef Mok CC (2006) Therapeutic options for resistant lupus nephritis. Semin Arthritis Rheum 36:71–81PubMedCrossRef
24.
Zurück zum Zitat Tse KC, Lam MF, Tang SC, Tang CS, Chan TM (2007) A pilot study on tacrolimus treatment in membranous or quiescent lupus nephritis with proteinuria resistant to angiotensin inhibition or blockade. Lupus 16:46–51PubMedCrossRef Tse KC, Lam MF, Tang SC, Tang CS, Chan TM (2007) A pilot study on tacrolimus treatment in membranous or quiescent lupus nephritis with proteinuria resistant to angiotensin inhibition or blockade. Lupus 16:46–51PubMedCrossRef
25.
Zurück zum Zitat Oki E, Tsugawa K, Suzuki K, Tanaka H (2007) Effective treatment of a refractory case of systemic lupus erythematosus with low-dose tacrolimus. Nippon Jinzo Gakkai Shi 49:1020–1024PubMed Oki E, Tsugawa K, Suzuki K, Tanaka H (2007) Effective treatment of a refractory case of systemic lupus erythematosus with low-dose tacrolimus. Nippon Jinzo Gakkai Shi 49:1020–1024PubMed
26.
Zurück zum Zitat Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS (2008) Successful treatment of class V + IV lupus nephritis with multitarget therapy. J Am Soc Nephrol 19:2001–2010PubMedCrossRef Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS (2008) Successful treatment of class V + IV lupus nephritis with multitarget therapy. J Am Soc Nephrol 19:2001–2010PubMedCrossRef
27.
Zurück zum Zitat Szeto CC, Kwan BC, Lai FM et al (2008) Tacrolimus for the treatment of systemic lupus erythematosus with pure class V nephritis. Rheumatology (Oxford) 47:1678–1681CrossRef Szeto CC, Kwan BC, Lai FM et al (2008) Tacrolimus for the treatment of systemic lupus erythematosus with pure class V nephritis. Rheumatology (Oxford) 47:1678–1681CrossRef
28.
Zurück zum Zitat Dong G, Panaro F, Bogetti D et al (2005) Standard chronic immunosuppression after kidney transplantation for systemic lupus erythematosus eliminates recurrence of disease. Clin Transplant 19:56–60PubMedCrossRef Dong G, Panaro F, Bogetti D et al (2005) Standard chronic immunosuppression after kidney transplantation for systemic lupus erythematosus eliminates recurrence of disease. Clin Transplant 19:56–60PubMedCrossRef
29.
Zurück zum Zitat Tang H, Chelamcharla M, Baird BC, Shihab FS, Koford JK, Goldfarb-Rumyantzev AS (2008) Factors affecting kidney-transplant outcome in recipients with lupus nephritis. Clin Transplant 22:263–272PubMedCrossRef Tang H, Chelamcharla M, Baird BC, Shihab FS, Koford JK, Goldfarb-Rumyantzev AS (2008) Factors affecting kidney-transplant outcome in recipients with lupus nephritis. Clin Transplant 22:263–272PubMedCrossRef
30.
Zurück zum Zitat Tanaka H, Oki E, Tsugawa K, Nonaka K, Suzuki K, Ito E (2007) Effective treatment of young patients with pediatric-onset, long-standing lupus nephritis with tacrolimus given as a single daily dose: an open-label pilot study. Lupus 16:896–900PubMedCrossRef Tanaka H, Oki E, Tsugawa K, Nonaka K, Suzuki K, Ito E (2007) Effective treatment of young patients with pediatric-onset, long-standing lupus nephritis with tacrolimus given as a single daily dose: an open-label pilot study. Lupus 16:896–900PubMedCrossRef
31.
Zurück zum Zitat Maruoka H, Honda S, Takeo M, Koga T, Fukuda T, Aizawa H (2006) Tacrolimus treatment for refractory lupus cystitis. Mod Rheumatol 16:264–266PubMedCrossRef Maruoka H, Honda S, Takeo M, Koga T, Fukuda T, Aizawa H (2006) Tacrolimus treatment for refractory lupus cystitis. Mod Rheumatol 16:264–266PubMedCrossRef
32.
Zurück zum Zitat Mok CC, To CH, Mak A, Poon WL (2008) Immunoablative cyclophosphamide for refractory lupus-related neuromyelitis optica. J Rheumatol 35:172–174PubMed Mok CC, To CH, Mak A, Poon WL (2008) Immunoablative cyclophosphamide for refractory lupus-related neuromyelitis optica. J Rheumatol 35:172–174PubMed
33.
Zurück zum Zitat Yoshimasu T, Ohtani T, Sakamoto T, Oshima A, Furukawa F (2002) Topical FK506 (tacrolimus) therapy for facial erythematous lesions of cutaneous lupus erythematosus, dermatomyositis. Eur J Dermatol 12:50–52PubMed Yoshimasu T, Ohtani T, Sakamoto T, Oshima A, Furukawa F (2002) Topical FK506 (tacrolimus) therapy for facial erythematous lesions of cutaneous lupus erythematosus, dermatomyositis. Eur J Dermatol 12:50–52PubMed
34.
Zurück zum Zitat Walker SL, Kirby B, Chalmers RJ (2002) The effect of topical tacrolimus on severe recalcitrant chronic discoid lupus erythematosus. Br J Dermatol 147:405–406PubMedCrossRef Walker SL, Kirby B, Chalmers RJ (2002) The effect of topical tacrolimus on severe recalcitrant chronic discoid lupus erythematosus. Br J Dermatol 147:405–406PubMedCrossRef
35.
Zurück zum Zitat Kanekura T, Yoshii N, Terasaki K, Miyoshi H, Kanzaki T (2003) Efficacy of topical tacrolimus for treating the malar rash of systemic lupus erythematosus. Br J Dermatol 148:353–356PubMedCrossRef Kanekura T, Yoshii N, Terasaki K, Miyoshi H, Kanzaki T (2003) Efficacy of topical tacrolimus for treating the malar rash of systemic lupus erythematosus. Br J Dermatol 148:353–356PubMedCrossRef
36.
Zurück zum Zitat Lampropoulos CE, Sangle S, Harrison P, Hughes GR, D’Cruz DP (2004) Topical tacrolimus therapy of resistant cutaneous lesions in lupus erythematosus: a possible alternative. Rheumatology (Oxford) 43:1383–1385CrossRef Lampropoulos CE, Sangle S, Harrison P, Hughes GR, D’Cruz DP (2004) Topical tacrolimus therapy of resistant cutaneous lesions in lupus erythematosus: a possible alternative. Rheumatology (Oxford) 43:1383–1385CrossRef
37.
Zurück zum Zitat Morton SJ, Powell RJ (2000) Cyclosporin and tacrolimus: their use in a routine clinical setting for scleroderma. Rheumatology (Oxford) 39:865–869CrossRef Morton SJ, Powell RJ (2000) Cyclosporin and tacrolimus: their use in a routine clinical setting for scleroderma. Rheumatology (Oxford) 39:865–869CrossRef
38.
Zurück zum Zitat Oddis CV, Sciurba FC, Elmagd KA, Starzl TE (1999) Tacrolimus in refractory polymyositis with interstitial lung disease. Lancet 353:1762–1763PubMedCrossRef Oddis CV, Sciurba FC, Elmagd KA, Starzl TE (1999) Tacrolimus in refractory polymyositis with interstitial lung disease. Lancet 353:1762–1763PubMedCrossRef
39.
Zurück zum Zitat Ochi S, Nanki T, Takada K et al (2005) Favorable outcomes with tacrolimus in two patients with refractory interstitial lung disease associated with polymyositis/dermatomyositis. Clin Exp Rheumatol 23:707–710PubMed Ochi S, Nanki T, Takada K et al (2005) Favorable outcomes with tacrolimus in two patients with refractory interstitial lung disease associated with polymyositis/dermatomyositis. Clin Exp Rheumatol 23:707–710PubMed
40.
Zurück zum Zitat Nalda AM, Caballero CM, Guimeral CA, Rom MB, García PB (2006) Efficacy of tacrolimus (FK-506) in the treatment of recalcitrant juvenile dermatomyositis: study of 6 cases. Med Clin (Barc) 127:697–701CrossRef Nalda AM, Caballero CM, Guimeral CA, Rom MB, García PB (2006) Efficacy of tacrolimus (FK-506) in the treatment of recalcitrant juvenile dermatomyositis: study of 6 cases. Med Clin (Barc) 127:697–701CrossRef
41.
Zurück zum Zitat Kitahara K, Kawai S (2007) Cyclosporine and tacrolimus for the treatment of rheumatoid arthritis. Curr Opin Rhumatol 19(3):238–245CrossRef Kitahara K, Kawai S (2007) Cyclosporine and tacrolimus for the treatment of rheumatoid arthritis. Curr Opin Rhumatol 19(3):238–245CrossRef
Metadaten
Titel
Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus
verfasst von
Katsuya Suzuki
Hideto Kameda
Koichi Amano
Hayato Nagasawa
Hirofumi Takei
Eiko Nishi
Ayumi Okuyama
Kensei Tsuzaka
Tsutomu Takeuchi
Publikationsdatum
01.06.2011
Verlag
Springer-Verlag
Erschienen in
Rheumatology International / Ausgabe 6/2011
Print ISSN: 0172-8172
Elektronische ISSN: 1437-160X
DOI
https://doi.org/10.1007/s00296-010-1366-9

Weitere Artikel der Ausgabe 6/2011

Rheumatology International 6/2011 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Echinokokkose medikamentös behandeln oder operieren?

06.05.2024 DCK 2024 Kongressbericht

Die Therapie von Echinokokkosen sollte immer in spezialisierten Zentren erfolgen. Eine symptomlose Echinokokkose kann – egal ob von Hunde- oder Fuchsbandwurm ausgelöst – konservativ erfolgen. Wenn eine Op. nötig ist, kann es sinnvoll sein, vorher Zysten zu leeren und zu desinfizieren. 

Aquatherapie bei Fibromyalgie wirksamer als Trockenübungen

03.05.2024 Fibromyalgiesyndrom Nachrichten

Bewegungs-, Dehnungs- und Entspannungsübungen im Wasser lindern die Beschwerden von Patientinnen mit Fibromyalgie besser als das Üben auf trockenem Land. Das geht aus einer spanisch-brasilianischen Vergleichsstudie hervor.

Wo hapert es noch bei der Umsetzung der POMGAT-Leitlinie?

03.05.2024 DCK 2024 Kongressbericht

Seit November 2023 gibt es evidenzbasierte Empfehlungen zum perioperativen Management bei gastrointestinalen Tumoren (POMGAT) auf S3-Niveau. Vieles wird schon entsprechend der Empfehlungen durchgeführt. Wo es im Alltag noch hapert, zeigt eine Umfrage in einem Klinikverbund.

Das Risiko für Vorhofflimmern in der Bevölkerung steigt

02.05.2024 Vorhofflimmern Nachrichten

Das Risiko, im Lauf des Lebens an Vorhofflimmern zu erkranken, ist in den vergangenen 20 Jahren gestiegen: Laut dänischen Zahlen wird es drei von zehn Personen treffen. Das hat Folgen weit über die Schlaganfallgefährdung hinaus.

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.