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0.1% Tacrolimus Ointment in the Treatment of Discoid Lupus Erythematosus

0.1% Tacrolimus Ointment in the Treatment of Discoid Lupus Erythematosus Discoid lupus erythematosus (DLE), which is an autoimmune inflammatory disorder of the skin, often leads to scarring and alopecia. Current treatment options include topical and systemic glucocorticoids, antimalarial agents, and thalidomide. These treatments are often limited by a lack of efficacy or by adverse effects. We conducted an open-label pilot study using 0.1% tacrolimus (Protopic) ointment for the treatment of 5 subjects with biopsy-proved DLE. All subjects were receiving stable doses of systemic DLE-directed therapies for at least 4 weeks before study entry and had not applied topical steroids to the treatment area for 4 weeks. The subjects applied 0.1% tacrolimus ointment to 2 target lesions twice a day for 12 weeks. They were evaluated every 4 weeks. At each study visit, the target lesions were assessed using 4 criteria: diameter size, erythema, scarring, and thickness. These 4 criteria were graded using a 5-point scale (Table). At the final study visit, the investigator and subject assessed overall improvement. Table. View LargeDownload Scoring System for Assessing Lesions of Discoid Lupus Erythematosus Five subjects were enrolled in the study. Three subjects completed the study. One subject withdrew for personal reasons after near complete resolution of target lesions after 4 weeks of treatment. One subject did not return for the final visit and was unavailable for follow-up. Using the last observation carried forward, there was an overall improvement in erythema, scarring, thickness, and size of the target lesions. The mean percentage improvements in scores for erythema, scarring, thickness, and size were 32%, 53%, 56%, and 33%, respectively. The investigator and subject global assessments were obtained for the 3 subjects who completed the study. The investigator and subject global assessment scores were in agreement in all 3 cases. There was 1 case each of mild, moderate, and marked improvement. There were no reported application site reactions or other adverse events. Our positive findings agree with those of other case reports. One report described the beneficial effect of 0.3% tacrolimus in 0.05% clobetasol propionate ointment applied twice daily in 2 patients with DLE.1 A second case report described improvement in another patient with DLE who was treated with 0.1% tacrolimus ointment twice daily.2 Lampropoulos et al3 described 12 patients with cutaneous lupus who were treated with 0.1% tacrolimus ointment twice daily for 6 weeks. Of the 6 patients with DLE, 2 had definite improvement, 1 had minor improvement, 2 had no improvement, and 1 withdrew owing to application site reactions. Yoshimasu et al4 reported the use of 0.1% tacrolimus ointment once daily for 4 weeks in 11 patients with cutaneous lupus and dermatomyositis. Of the 4 patients with DLE, only 1 had a good response, suggesting that twice-daily application may be more effective than once-daily application. Limitations of the current study include the lack of a control group and the small sample size. The scoring system for assessing DLE lesion response has also not been validated. However, in our study, the relatively early and sustained improvement in the subjects with DLE who were treated with tacrolimus is promising. Large, controlled trials are warranted. Back to top Article Information Correspondence: Dr Heffernan, Dermatology Clinical Trials, Washington University, Suite 5B, 4921 Parkview Pl, St Louis, MO 63110 (mheffern@im.wustl.edu). Financial Disclosure: None. Funding/Support: This study was investigator initiated, and the study medication was provided by Fujisawa Healthcare, Inc, Deerfield, Ill. Additional Information: Drs Heffernan and Smith have participated in clinical trials with Fujisawa Healthcare, Inc. References 1. Walker SLKirby BChalmers RJ The effect of topical tacrolimus on severe recalcitrant chronic discoid lupus erythematosus Br J Dermatol 2002;147405- 406PubMedGoogle ScholarCrossref 2. de la Rosa Carrillo DChristensen OB Treatment of chronic discoid lupus erythematosus with topical tacrolimus Acta Derm Venereol 2004;84233- 234PubMedGoogle ScholarCrossref 3. Lampropoulos CESangle SHarrison PHughes GRD'Cruz DP Topical tacrolimus therapy of resistant cutaneous lesions in lupus erythematosus: a possible alternative Rheumatology (Oxford) 2004;431383- 1385PubMedGoogle ScholarCrossref 4. Yoshimasu TOhtani TSakamoto TOshima AFurukawa F Topical FK506 (tacrolimus) therapy for facial erythematous lesions of cutaneous lupus erythematosus and dermatomyositis Eur J Dermatol 2002;1250- 52PubMedGoogle Scholar http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Dermatology American Medical Association

0.1% Tacrolimus Ointment in the Treatment of Discoid Lupus Erythematosus

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Publisher
American Medical Association
Copyright
Copyright © 2005 American Medical Association. All Rights Reserved.
ISSN
0003-987X
eISSN
1538-3652
DOI
10.1001/archderm.141.9.1170
Publisher site
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Abstract

Discoid lupus erythematosus (DLE), which is an autoimmune inflammatory disorder of the skin, often leads to scarring and alopecia. Current treatment options include topical and systemic glucocorticoids, antimalarial agents, and thalidomide. These treatments are often limited by a lack of efficacy or by adverse effects. We conducted an open-label pilot study using 0.1% tacrolimus (Protopic) ointment for the treatment of 5 subjects with biopsy-proved DLE. All subjects were receiving stable doses of systemic DLE-directed therapies for at least 4 weeks before study entry and had not applied topical steroids to the treatment area for 4 weeks. The subjects applied 0.1% tacrolimus ointment to 2 target lesions twice a day for 12 weeks. They were evaluated every 4 weeks. At each study visit, the target lesions were assessed using 4 criteria: diameter size, erythema, scarring, and thickness. These 4 criteria were graded using a 5-point scale (Table). At the final study visit, the investigator and subject assessed overall improvement. Table. View LargeDownload Scoring System for Assessing Lesions of Discoid Lupus Erythematosus Five subjects were enrolled in the study. Three subjects completed the study. One subject withdrew for personal reasons after near complete resolution of target lesions after 4 weeks of treatment. One subject did not return for the final visit and was unavailable for follow-up. Using the last observation carried forward, there was an overall improvement in erythema, scarring, thickness, and size of the target lesions. The mean percentage improvements in scores for erythema, scarring, thickness, and size were 32%, 53%, 56%, and 33%, respectively. The investigator and subject global assessments were obtained for the 3 subjects who completed the study. The investigator and subject global assessment scores were in agreement in all 3 cases. There was 1 case each of mild, moderate, and marked improvement. There were no reported application site reactions or other adverse events. Our positive findings agree with those of other case reports. One report described the beneficial effect of 0.3% tacrolimus in 0.05% clobetasol propionate ointment applied twice daily in 2 patients with DLE.1 A second case report described improvement in another patient with DLE who was treated with 0.1% tacrolimus ointment twice daily.2 Lampropoulos et al3 described 12 patients with cutaneous lupus who were treated with 0.1% tacrolimus ointment twice daily for 6 weeks. Of the 6 patients with DLE, 2 had definite improvement, 1 had minor improvement, 2 had no improvement, and 1 withdrew owing to application site reactions. Yoshimasu et al4 reported the use of 0.1% tacrolimus ointment once daily for 4 weeks in 11 patients with cutaneous lupus and dermatomyositis. Of the 4 patients with DLE, only 1 had a good response, suggesting that twice-daily application may be more effective than once-daily application. Limitations of the current study include the lack of a control group and the small sample size. The scoring system for assessing DLE lesion response has also not been validated. However, in our study, the relatively early and sustained improvement in the subjects with DLE who were treated with tacrolimus is promising. Large, controlled trials are warranted. Back to top Article Information Correspondence: Dr Heffernan, Dermatology Clinical Trials, Washington University, Suite 5B, 4921 Parkview Pl, St Louis, MO 63110 (mheffern@im.wustl.edu). Financial Disclosure: None. Funding/Support: This study was investigator initiated, and the study medication was provided by Fujisawa Healthcare, Inc, Deerfield, Ill. Additional Information: Drs Heffernan and Smith have participated in clinical trials with Fujisawa Healthcare, Inc. References 1. Walker SLKirby BChalmers RJ The effect of topical tacrolimus on severe recalcitrant chronic discoid lupus erythematosus Br J Dermatol 2002;147405- 406PubMedGoogle ScholarCrossref 2. de la Rosa Carrillo DChristensen OB Treatment of chronic discoid lupus erythematosus with topical tacrolimus Acta Derm Venereol 2004;84233- 234PubMedGoogle ScholarCrossref 3. Lampropoulos CESangle SHarrison PHughes GRD'Cruz DP Topical tacrolimus therapy of resistant cutaneous lesions in lupus erythematosus: a possible alternative Rheumatology (Oxford) 2004;431383- 1385PubMedGoogle ScholarCrossref 4. Yoshimasu TOhtani TSakamoto TOshima AFurukawa F Topical FK506 (tacrolimus) therapy for facial erythematous lesions of cutaneous lupus erythematosus and dermatomyositis Eur J Dermatol 2002;1250- 52PubMedGoogle Scholar

Journal

Archives of DermatologyAmerican Medical Association

Published: Sep 1, 2005

Keywords: discoid lupus erythematosus,ointments,tacrolimus

References