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Efficacy and safety of tacrolimus ointment in pediatric Patients with moderate to severe atopic dermatitis.
J Med Assoc Thai. 2006 Nov; 89(11):1915-22.JM

Abstract

BACKGROUND

Atopic dermatitis (AD) is an immunological skin disease. It is common in pediatric populations and often requires topical steroid treatment. Moderate to severe AD may not respond to topical steroids. They often require systemic steroids, which may result in growth retardation. Protopic, a non-steroid, tacrolimus based ointment which is a calcinurin inhibitor has been proved to be effective in caucacian with AD.

OBJECTIVE

To evaluate safety and efficacy of 0.03% tacrolimus ointment (Protopic&) in moderate to severe AD in pediatric patients age 2-12 years.

MATERIAL AND METHOD

This was a one month multicenter open-label clinical trial using tacrolimus ointment twice daily in 61 subjects with moderate to severe AD from September to December 2004. Efficacy assessments were measured by Physician's Global Evaluation of Clinical Response (PhGECR), Eczema area and Severity Index (EASI), Patient's Global Evaluation of Clinical Response (PaGECR), and Quality of Life (QOL). Safety assessment was measured by incidence rate of adverse events.

RESULTS

Fifty-eight patients completed the studies. Twenty-two patients were male; thirty-nine patients were female. Twenty-nine patients had moderate AD. Thirty-two patients had severe AD. Three cases had discontinued treatment at the third week due to increase in severity. Over all PhGECR were significantly increased, 94% showed moderate improvement in PhGECR at week 4 or end of treatment (EOT)and 83% had better improvement in PaGECR at EOT Within 7 days, tacrolimus demonstrated rapid onset in reduction of EASI score and itch in patients. Mean QOL were significantly decreased at the end of the present study. Incidence of adverse events included application site burning (21%), itching (17%), pruritus (9%), infections(3%), and erythema and folliculitis (2%). Burning sensation, erythema, pruritus and itching were resolved after the first week.

CONCLUSION

Topical tacrolimus ointment is effective and safe in moderate to severe AD. It significantly improved PhGECR, EASI, PaGECR, and QOL in pediatric patients after the first week of treatment and continued through the end of the study. The major adverse events were burning, itching, and pruritus, which were resolved within the first week of therapy.

Authors+Show Affiliations

Dermatology Unit, Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

17205874

Citation

Singalavanija, Srisuphaluk, et al. "Efficacy and Safety of Tacrolimus Ointment in Pediatric Patients With Moderate to Severe Atopic Dermatitis." Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, vol. 89, no. 11, 2006, pp. 1915-22.
Singalavanija S, Noppakun N, Limpongsanuruk W, et al. Efficacy and safety of tacrolimus ointment in pediatric Patients with moderate to severe atopic dermatitis. J Med Assoc Thai. 2006;89(11):1915-22.
Singalavanija, S., Noppakun, N., Limpongsanuruk, W., Wisuthsarewong, W., Aunhachoke, K., Chunharas, A., Wananukul, S., & Akaraphanth, R. (2006). Efficacy and safety of tacrolimus ointment in pediatric Patients with moderate to severe atopic dermatitis. Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, 89(11), 1915-22.
Singalavanija S, et al. Efficacy and Safety of Tacrolimus Ointment in Pediatric Patients With Moderate to Severe Atopic Dermatitis. J Med Assoc Thai. 2006;89(11):1915-22. PubMed PMID: 17205874.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tacrolimus ointment in pediatric Patients with moderate to severe atopic dermatitis. AU - Singalavanija,Srisuphaluk, AU - Noppakun,Noppadon, AU - Limpongsanuruk,Wanida, AU - Wisuthsarewong,Wanee, AU - Aunhachoke,Kobkul, AU - Chunharas,Amornsri, AU - Wananukul,Siriwan, AU - Akaraphanth,Rutsanee, PY - 2007/1/9/pubmed PY - 2007/2/17/medline PY - 2007/1/9/entrez SP - 1915 EP - 22 JF - Journal of the Medical Association of Thailand = Chotmaihet thangphaet JO - J Med Assoc Thai VL - 89 IS - 11 N2 - BACKGROUND: Atopic dermatitis (AD) is an immunological skin disease. It is common in pediatric populations and often requires topical steroid treatment. Moderate to severe AD may not respond to topical steroids. They often require systemic steroids, which may result in growth retardation. Protopic, a non-steroid, tacrolimus based ointment which is a calcinurin inhibitor has been proved to be effective in caucacian with AD. OBJECTIVE: To evaluate safety and efficacy of 0.03% tacrolimus ointment (Protopic&) in moderate to severe AD in pediatric patients age 2-12 years. MATERIAL AND METHOD: This was a one month multicenter open-label clinical trial using tacrolimus ointment twice daily in 61 subjects with moderate to severe AD from September to December 2004. Efficacy assessments were measured by Physician's Global Evaluation of Clinical Response (PhGECR), Eczema area and Severity Index (EASI), Patient's Global Evaluation of Clinical Response (PaGECR), and Quality of Life (QOL). Safety assessment was measured by incidence rate of adverse events. RESULTS: Fifty-eight patients completed the studies. Twenty-two patients were male; thirty-nine patients were female. Twenty-nine patients had moderate AD. Thirty-two patients had severe AD. Three cases had discontinued treatment at the third week due to increase in severity. Over all PhGECR were significantly increased, 94% showed moderate improvement in PhGECR at week 4 or end of treatment (EOT)and 83% had better improvement in PaGECR at EOT Within 7 days, tacrolimus demonstrated rapid onset in reduction of EASI score and itch in patients. Mean QOL were significantly decreased at the end of the present study. Incidence of adverse events included application site burning (21%), itching (17%), pruritus (9%), infections(3%), and erythema and folliculitis (2%). Burning sensation, erythema, pruritus and itching were resolved after the first week. CONCLUSION: Topical tacrolimus ointment is effective and safe in moderate to severe AD. It significantly improved PhGECR, EASI, PaGECR, and QOL in pediatric patients after the first week of treatment and continued through the end of the study. The major adverse events were burning, itching, and pruritus, which were resolved within the first week of therapy. SN - 0125-2208 UR - https://www.unboundmedicine.com/medline/citation/17205874/Efficacy_and_safety_of_tacrolimus_ointment_in_pediatric_Patients_with_moderate_to_severe_atopic_dermatitis_ L2 - http://www.diseaseinfosearch.org/result/9652 DB - PRIME DP - Unbound Medicine ER -