Efficacy and safety of tacrolimus ointment in patients with moderate to severe atopic dermatitis - Malaysian experience
- Author:
Ng TG
;
Mardziah A
;
Roshidah BB
;
Heng YH
;
Najeeb A
;
Lo Kang SC
;
Pubalan M
;
Loh LC
;
Suraiya HH
- Publication Type:Journal Article
- Keywords:
tacrolimus, atopic dermatitis
- From:Malaysian Journal of Dermatology
2009;22(-):47-54
- CountryMalaysia
- Language:English
-
Abstract:
Objectives To evaluate the efficacy and safety of tacrolimus ointment 0.1% in adult and 0.03% in
pediatric patients with moderate to severe atopic dermatitis in Malaysia.
Methods This is an open-labeled and single arm multi-center study. 36 adult and 37 pediatric
patients were enrolled. Tacrolimus ointment is applied twice daily for four weeks. The primary
efficacy outcome is based on the Physician’s Global Evaluation of Clinical Response (PG) at Week
4. The secondary efficacy outcomes are Eczema Area and Severity Index (EASI) score, changes
from baseline in individual scores of signs and symptoms and body surface area affected and
Patients Assessment of Treatment Effects.
Results Overall success rate were 97.1% and 91.2% in the adult and pediatric groups respectively.
The decline in EASI, percentage of total BSA affected and patient’s assessment of pruritus were
significant (P<0.001). Of adults and pediatric patients, 97.2% and 75.7% respectively reported
adverse effect. The most common adverse effect reported was skin burning sensation in 91.7% adult
patients and pruritus in 67.6% pediatric patients.
Conclusion Tacrolimus ointment 0.1% in adult and 0.03% in pediatric patients is effective for the
treatment of moderate to severe atopic dermatitis in Malaysia.
