Q: How long does it take for Protopic to work?
A: Protopic can provide rapid clearing. Compared with the vehicle group, significantly more adult patients treated with Protopic 0.1% and 0.03% achieved >90% improvement by week 1 and week 3, respectively.1 Significantly more pediatric patients treated with Protopic 0.03% achieved >90% improvement by week 2.1 However, patients should continue to use Protopic whether they see rapid improvement or not.
Q: Are there any long-term data for the efficacy of Protopic?
A: Yes. Two 1-year clinical trials have shown that maximal improvement was maintained with prolonged (12-month) intermittent treatment with Protopic.2,3 Atopic dermatitis will recur if Protopic treatment is discontinued. In 35% to 54% of patients who had at least 90% improvement at the end of treatment, atopic dermatitis recurred within 2 weeks.1
Q: Are there any localized symptoms with Protopic application and, if so, how long do they last?
A: Some patients have reported a burning or stinging during the first few applications of Protopic. These side effects are generally mild and short lasting in the majority of patients. With Protopic 0.1%, 90% of the skin burning events had a median duration of 15 minutes.
Localized symptoms are most common during the first few days of application and typically improve as lesions heal. Although these sensations are uncomfortable, patients should not be alarmed and should continue to use Protopic because the burning or stinging will usually diminish over time.
In clinical trials, adverse events rarely resulted in discontinuation of treatment.You should tell your patients that to reduce the chance of burning or stinging, they should apply Protopic to dry skin.
Q: If a patient has localized symptoms with Protopic application, what can you tell them?
A: You should tell your patients that to reduce the chance of burning or stinging, they should apply Protopic to dry skin. In clinical trials, adverse events rarely resulted in discontinuation of treatment.4,5 Localized symptoms are most common during the first few days of application and typically improve as lesions heal.1
Q: How is Protopic therapy different from topical corticosteroid therapy?
A: Clinical trials have shown Protopic to be safe and effective for intermittent long-term (up to 12 months) treatment of moderate to severe atopic dermatitis in adults (0.03% and 0.1%) and children (0.03% only). High-potency topical corticosteroids cannot be used for longer than 2 consecutive weeks or on children younger than 12 years. Protopic is safe for dermatologic use anywhere on the body. Topical corticosteroids should not be used on the face, groin, or axillae, where the skin is most sensitive and the risk of absorption is highest. No cutaneous atrophy or adrenal suppression has been demonstrated during clinical trials of Protopic.
Q: The Protopic PI says that patients should "minimize or avoid natural or artificial sunlight exposure." Are there problems associated with Protopic patients who are exposed to sunlight?
A: Tacrolimus is not photoactivated and thus should not have any different effects if exposed to sunlight. As the PI states, there was a shorter "time to skin tumor formation" noted in a photocarcinogenicity study using an animal model designed to produce tumors in all dose groups and animals. In this study, the same tumor amplification factor was noted in the mice receiving vehicle and those receiving commercially available concentrations of Protopic. There was no increased evidence of skin cancer during clinical trials of Protopic.
Q: Can Protopic be used safely with sunscreens?
A: Yes. A chemical stability study of Protopic and several commercially available sunscreens demonstrated no change in the chemistry of Protopic Ointment. Apply sunscreen at least 1 hour after applying Protopic or as instructed by your physician.
Q: Can Protopic be safely applied to the eyelid area?
A: Yes. Protopic can be used anywhere on the body. Clinical trials have shown no evidence of the potential for adverse events of conventional atopic dermatitis treatments, such as skin thinning or glaucoma.
References
1. Protopic* (tacrolimus) Ointment full prescribing information. Deerfield, Ill: Fujisawa Healthcare, Inc.; 2000.
2. Kang S, et al. J Am Acad Dermatol. 2001;44(suppl):S58-S64.
3. Reitamo S, et al. Arch Dermatol. 2000;136:999-1006.
4. Paller A, et al. J Am Acad Dermatol. 2001;44(suppl):S47-S57.
5. Soter NA, et al. J Am Acad Dermatol. 2001;44(suppl):S39-S46.
6. Hanifin JM, et al. J Am Acad Dermatol. 2001;44(suppl):S28-S38.
7. Data on file. Fujisawas Healthcare, Inc. Deerfield, Ill.
8. Krupnick A, et al. Proceedings of the American Academy of Dermatology. March 2001; Washington, DC.