Tacrolimus topical ointment is used as second-line therapy for short-term treatment and noncontinuous chronic treatment of moderate to severe atopic dermatitis (eczema) in immunocompetent adults and children 2-15 years of age who are unable to tolerate or have not responded to standard therapies (i.e., corticosteroids) or for whom standard therapies are inadvisable because of potential risks. Because of the potential for increased risk of malignancies, tacrolimus ointment should be used only as a second-line agent for short-term and intermittent treatment.
(See Carcinogenicity under Warnings/Precautions: Warnings, in Cautions.)
Tacrolimus topical ointment is not indicated for use in children younger than 2 years of age.
(See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Efficacy of tacrolimus ointment in the treatment of atopic dermatitis was established in 3 randomized, double-blind, vehicle-controlled, multicenter clinical studies (2 in adults and 1 in children). In these clinical studies, application of tacrolimus ointment to atopic dermatitis lesions twice daily for up to 12 weeks produced substantial clinical improvement, decreased the percentage of the body surface area affected, and alleviated the signs and symptoms of the disease (e.g., pruritus, edema, erythema, excoriation, lichenification, oozing, scaling skin), with improvement usually evident within 1 week.
Results of an analysis of pooled data from the 2 clinical studies in adults found that approximately 28, 37, or 7% of patients with moderate to severe atopic dermatitis who received the 0.03% ointment, the 0.1% ointment, or vehicle, respectively, experienced at least 90% improvement (based on the physician's global evaluation of clinical response); of the patients treated successfully (at least 90% improvement) with the 0.03 or the 0.1% ointment, 35 or 41%, respectively, relapsed within 2 weeks following the end of treatment. The success rate for tacrolimus 0.03% ointment was lower in patients with severe atopic dermatitis at baseline (20%), in patients with extensive (75-100%) body surface area involvement (5%), and in black patients (16%).
In the clinical study involving children 2-15 years of age with moderate to severe atopic dermatitis, the 0.1% ointment appeared to provide no added benefit over the 0.03% ointment. Approximately 36, 41, or 7% of children receiving the 0.03% ointment, the 0.1% ointment, or vehicle, respectively, experienced at least 90% improvement (based on the physician's global evaluation of clinical response); however, 54% of the children treated successfully (at least 90% improvement) with tacrolimus 0.03% ointment relapsed within 2 weeks following the end of treatment.
For systemic uses, see 92:44.