Related Experiment Video
Updated: May 29, 2026
Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study
Johanna M Mandelin1, Andris Rubins, Anita Remitz
1Skin and Allergy Hospital, University of Helsinki, Helsinki, Finland.
Insights
Tacrolimus 0.03% ointment significantly improved atopic dermatitis (AD) in infants under two years old. The treatment was well-tolerated, showing results comparable to those in older children.
Area of Science:
- Dermatology
- Pediatrics
- Immunology
Background:
- Atopic dermatitis (AD) is a chronic inflammatory skin condition.
- Tacrolimus ointment is an established treatment for moderate to severe AD in children aged two years and older.
- Limited data exists on the efficacy and tolerability of tacrolimus ointment in infants under two years old.
Purpose of the Study:
- To evaluate the efficacy and tolerability of tacrolimus 0.03% ointment in infants with atopic dermatitis.
- To assess clinical improvement and safety in infants aged less than two years over a 24-month period.
Main Methods:
- A 24-month open-label phase II study involving 50 infants with AD.
- Tacrolimus 0.03% ointment applied to affected areas until clearance, with re-treatment for exacerbations.
- Pharmacokinetic data was collected from a prior trial.
Main Results:
- Significant improvement in Eczema Area and Severity Index (EASI) scores and body surface area affected.
- 63.3% of patients achieved "cleared" or "excellent" clinical response, with 85.7% of parents reporting significant improvement.
- Treatment was well-tolerated; common adverse events included infections and pruritus, with low systemic tacrolimus absorption.
Conclusions:
- Tacrolimus 0.03% ointment demonstrates substantial clinical improvement in infants with atopic dermatitis.
- The treatment's tolerability in infants is comparable to that observed in older children.
- This study supports the use of tacrolimus ointment for managing AD in infants under two years old.
Background:
Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2 years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2 years at start of treatment.
Methods:
Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24-month open-label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment.
Results:
Mean ± SD Eczema Area and Severity Index (EASI) score improved, from 11.2 ± 10.5 baseline to 2.6 ± 4.1 at endpoint (24 months); mean affected body surface area decreased from 25.2 ± 21.1% to 5.1 ± 9.0%, with improvement on all items of the Physicians' Assessment of Individual Signs. The Physicians' Global Evaluation of Clinical Response showed a result of "cleared"/"excellent" for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as "much better." Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application-site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0 ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250 ng/ml).
Conclusions:
Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.
