Tacrolimus Ointment in the Treatment of Chronic Cutaneous Graft-vs-Host Disease: A Case Series of 18 Patients | Allergy and Clinical Immunology | JAMA Dermatology | JAMA Network
[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
September 2001

Tacrolimus Ointment in the Treatment of Chronic Cutaneous Graft-vs-Host Disease: A Case Series of 18 Patients

Author Affiliations

From the Department of Dermatology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Harvard Medical School, Boston, Mass (Drs Choi and Nghiem); and the Department of Chemistry and Chemical Biology, Harvard University, Cambridge, Mass (Dr Nghiem). The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.

Arch Dermatol. 2001;137(9):1202-1206. doi:10.1001/archderm.137.9.1202

Background  Tacrolimus (formerly FK 506) is an immunosuppressive drug that works by inhibiting calcineurin, a calcium-dependent protein phosphatase required for immune function. Tacrolimus has been shown to be effective topically in atopic dermatitis and systemically in psoriasis and graft-vs-host disease (GVHD). However, its efficacy in treating cutaneous GVHD when applied topically has not been reported.

Objective  To assess the therapeutic efficacy of 0.1% tacrolimus ointment on chronic cutaneous GVHD in patients with symptoms refractory to systemic corticosteroid therapy.

Results  Tacrolimus ointment effectively treated pruritus and/or erythema in 13 (72%) of 18 patients with chronic GVHD. Responding patients had a rapid effect within several hours to days. Effectiveness was measured by means of patient report, results of physical examination, side-by-side comparisons of tacrolimus vs a vehicle control, and temporal flares of the cutaneous symptoms of the disease in the context of stopping tacrolimus ointment therapy. Because of the progression of GVHD and in 2 cases, loss of drug efficacy, all patients eventually went on to receive more aggressive treatment, including increases in steroid dosage, psoralen–UV-A therapy, and extracorporeal photopheresis.

Conclusions  This case series suggests that tacrolimus ointment has efficacy in treating the erythema and pruritus of steroid-refractory, chronic cutaneous GVHD in most patients. The rapid response of tacrolimus ointment may provide a useful therapeutic bridge to systemic therapies that have slower onset, such as psoralen–UV-A therapy or extracorporeal photopheresis.