Is tacrolimus (FK506) ointment effective for treating psoriasis?

Efficacy of Tacrolimus Ointment for Psoriasis

Tacrolimus 0.1% ointment is effective for treating facial, genital, and intertriginous psoriasis, but not for chronic plaque psoriasis on other body areas. 1, 2

Efficacy by Anatomical Location

Facial and Intertriginous Psoriasis

• Tacrolimus 0.1% ointment is recommended as an off-label treatment option for facial and intertriginous psoriasis with a strength of recommendation C 1
• In a double-blind, randomized, vehicle-controlled study of 167 patients with facial or intertriginous psoriasis, 65.2% of patients treated with tacrolimus 0.1% ointment were clear or almost clear after 8 weeks compared to 31.5% with vehicle 1, 2
• Significant improvement can be seen as early as day 8 of treatment, with 24.8% of patients showing clearance or excellent improvement compared to 5.8% with vehicle 2

Genital Psoriasis

• Tacrolimus 0.1% ointment is recommended for off-label use as monotherapy for pediatric psoriasis of the genital region 1
• Case reports show clearance of penile psoriasis in pediatric patients after 3 weeks of treatment 1

Plaque Psoriasis on Other Body Areas

• Tacrolimus ointment is not generally effective for chronic plaque psoriasis on non-facial, non-intertriginous areas 1, 3
• A pilot study comparing tacrolimus 0.3% ointment to calcipotriol and placebo found no statistically significant difference between tacrolimus and placebo for plaque psoriasis (33.3% vs 42.9% reduction in severity) 3

Application and Dosing

• Apply tacrolimus 0.1% ointment twice daily to affected areas 1, 4
• For pediatric patients (2-15 years), the approved concentration is 0.03% 5
• For adults (16 years and above), the preferred concentration is 0.1% 5
• Neither concentration is approved for children under 2 years of age 5

Mechanism of Action

• Tacrolimus is a macrolide antibiotic that acts by inhibiting calcineurin, which in turn inhibits T-lymphocyte activation 1
• It is structurally similar to cyclosporine but up to 100 times more potent in vitro 1

Safety and Side Effects

• Most common side effect is burning and itching at application site, which generally reduces with continued use 1, 4
• This side effect can be mitigated by not applying immediately after bathing 1
• The FDA has implemented a "black box" warning for tacrolimus ointment due to the theoretical risk for malignancy development, though clinical evidence to date does not reveal any causal link 1, 4
• Caution is advised when using tacrolimus in patients receiving ultraviolet light therapy 1, 5

Special Populations

Pediatric Use

• Tacrolimus 0.03% ointment is approved for children 2 years and older for atopic dermatitis 1, 5
• For pediatric psoriasis, studies show good efficacy:
  • A single-center, open-label study of 11 children (ages 6-15 years) with facial or inverse psoriasis reported clearance or excellent improvement within 30 days in 8 patients 1
  • A retrospective chart review of 12 children with facial psoriasis showed clearance within 2 weeks using tacrolimus 0.1% 1

Pregnancy and Nursing

• Tacrolimus is pregnancy category C 1
• It is found in human milk and is not recommended for nursing mothers 1

Comparative Efficacy

• For plaque psoriasis, calcipotriol (62.5% reduction) is more effective than tacrolimus (33.3% reduction) 3
• For facial and intertriginous areas, tacrolimus is preferred over topical corticosteroids due to reduced risk of skin atrophy 1, 4

Clinical Pearls and Pitfalls

• Tacrolimus should be considered as a first-line treatment for facial psoriasis to avoid steroid-induced skin atrophy 6
• Subsequent flares after initial clearance respond well to repeat treatment 1
• Do not use tacrolimus under occlusion for plaque psoriasis as this may not improve efficacy 3
• Systemic (oral) tacrolimus has shown efficacy for severe plaque psoriasis (80.37% improvement in PASI scores) but is not commonly used due to potential side effects 1, 7