Safety of topical calcineurin inhibitors in atopic dermatitis: Evaluation of the evidence

@article{Spergel2006SafetyOT,
  title={Safety of topical calcineurin inhibitors in atopic dermatitis: Evaluation of the evidence},
  author={Jonathan M. Spergel and Donald Y. M. Leung},
  journal={Current Allergy and Asthma Reports},
  year={2006},
  volume={6},
  pages={270-274}
}
  • J. SpergelD. Leung
  • Published 1 July 2006
  • Medicine, Biology
  • Current Allergy and Asthma Reports
Topical calcineurin inhibitors (pimecrolimus, Elidel, East Hanover, NJ; and tacrolimus, Protopic, Tokyo, Japan) have been approved for the use in atopic dermatitis since the year 2000. These compounds represent a relatively safe class of topical anti-inflammatory, nonsteroidal therapy. However, in January of 2006, the US Food and Drug Administration issued a black box warning on these compounds about possible concerns of increased long-term malignancy risk due to systemic immunosuppression. To… 

Topical Calcineurin Inhibitors and Malignancy Risk

A systematic review and meta-analysis of the evidence regarding the TCIs safety found the role of TCIs unlikely to be a significant risk factor of lymphoma in patients with atopic dermatitis and treated with TCIs.

Topical Calcineurin Inhibitors for Atopic Dermatitis: Review and Treatment Recommendations

  • W. Carr
  • Medicine, Biology
    Pediatric Drugs
  • 2013
Based on post-marketing surveillance of spontaneous, literature, and solicited reports, it is reported here that the lymphoma incidence in the topical pimecrolimus-exposed population is up to approximately 54-fold less than that seen in the general US population.

[Topical pimecrolimus and tacrolimus and the risk of cancer].

Topical Calcineurin Inhibitors and Lymphoma Risk: Evidence Update with Implications for Daily Practice

A historical overview of the boxed warning requirement is provided and the preclinical, clinical, and epidemiological evidence that has thus far failed to substantiate a relationship between TCI use and malignancy is critically evaluated.

Topical Calcineurin Inhibitors in Pediatric Atopic Dermatitis

Overall, TCIs have an established safety and efficacy profile as long-term maintenance therapy in children with AD and data from several well designed studies support the efficacy of TCIs in the treatment of AD.

Calcineurin inhibitors in the treatment of allergic dermatitis.

Calcineurin inhibitors, which are a new drug class in the treatment of allergic dermatitis, are efficient, well tolerated and have few adverse effects.

Topical calcineurin inhibitors for the treatment of vulvar dermatoses.

References

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Immunomodulation and Safety of Topical Calcineurin Inhibitors for the Treatment of Atopic Dermatitis

Preclinical and clinical data suggest a greater skin selectivity and larger safety margin for topical pimecrolimus, a safe and effective alternative to topical corticosteroids in children with mild and moderate AD.

Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children.

Patients in the pimecrolimus group experienced significantly fewer AD flares than those in the control group, according to the primary efficacy analysis on ranked flares of AD (Van Elteren test).

Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents.

Pimecrolimus cream 1% appears to be a safe and effective alternative to currently used therapies for AD and atopic dermatitis in children and adults.

A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group.

The short-term application of tacrolimus ointment is effective in the treatment of atopic dermatitis, with the sensation of burning being the main side effect.

Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients

Three weeks treatment of children and infants with extensive atopic dermatitis, using pimecrolimus cream 1% twice daily, is well tolerated and results in minimal systemic exposure, at which no systemic effect is expected.

Low Systemic Exposure after Repeated Topical Application of Pimecrolimus (Elidel®, SD Z ASM 981) in Patients with Atopic Dermatitis

Pimecrolimus cream appears suitable for the long-term management of atopic dermatitis and was well tolerated locally and systemically.

Topical Calcineurin Inhibitors Decrease the Production of UVB-Induced Thymine Dimers from Hairless Mouse Epidermis

It is suggested that topical calcineurin inhibitors prevent DNA photodamage due to a filter effect of both vehicle and active components, whereas they do not affect the clearance of DNA photoproducts.