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

Current Allergy and Asthma Reports

Volumn 6, Issue 4, 2006, Pages 270-274

  Spergel, Jonathan M ^b   Leung, Donald Y M ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFLAMMATORY AGENT; CALCINEURIN INHIBITOR; CORTICOSTEROID; PIMECROLIMUS; TACROLIMUS;

ATOPIC DERMATITIS; B CELL LYMPHOMA; CANCER RISK; CLINICAL TRIAL; CORTICOSTEROID INDUCED OSTEOPOROSIS; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HODGKIN DISEASE; HUMAN; IMMUNE DEFICIENCY; INFECTION; LARGE CELL LYMPHOMA; MALIGNANT NEOPLASTIC DISEASE; NEUROENDOCRINE DISEASE; NONHUMAN; POSTMARKETING SURVEILLANCE; REVIEW; SKIN ATROPHY; SKIN CANCER; SKIN LYMPHOMA; SOLID TUMOR; T CELL LYMPHOMA; TELANGIECTASIA; UNITED STATES;

CALCINEURIN; DERMATITIS, ATOPIC; DERMATOLOGIC AGENTS; DRUG TOXICITY; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; NEOPLASMS; TACROLIMUS; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33745956277     PISSN: 15297322     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11882-006-0059-7     Document Type: Review

References (34)

1. Taieb A, Hanifin J, Cooper K, et al.: Proceedings of the 4th Georg Rajka International Symposium on Atopic Dermatitis, Arcachon, France, September 15-17, 2005. J Allergy Clin Immunol 2006, 117:378-390.
2. Grassberger M, Baumruker T, Enz A, et al.: A novel anti-inflammatory drug, SDZ ASM 981, for the treatment of skin diseases: in vitro pharmacology. Br J Dermatol 1999, 141:264-273.
3. Van Leent EJ, Ebelin ME, Burtin P, et al.: Low systemic exposure after repeated topical application of pimecrolimus (Elidel), SD Z ASM 981) in patients with atopic dermatitis. Dermatology 2002, 204:63-68.
4. Hultsch T, Kapp A, Spergel J: Immunomodulation and safety of topical calcineurin inhibitors for the treatment of atopic dermatitis. Dermatology 2005, 211:174-187.
5. Wellington K, Jarvis B: Topical pimecrolimus: a review of its clinical potential in the management of atopic dermatitis. Drugs 2002, 62:817-840.
6. Luger T, Van Leent EJ, Graeber M, et al.: SDZ ASM 981: an emerging safe and effective treatment for atopic dermatitis. Br J Dermatol 2001, 144:788-794.
7. Eichenfield L, Lucky A, Boguniewicz M, et al.: Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol 2002, 46:495-504.
8. Paller AS, Lebwohl M, Fleischer AB Jr, et al.: Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol 2005, 52:810-822.
9. Boguniewicz M, Fiedler VC, Raimer S, et al.: A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. Pediatric Tacrolimus Study Group. J Allergy Clin Immunol 1998, 102:637-644.
10. Ruzicka T, Bieber T, Schopf E, F, et al.: A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group. N Engl J Med 1997, 337:816-821.
11. Paller AS, McAlister RO, Doyle JJ, Jackson A: Perceptions of physicians and pediatric patients about atopic dermatitis, its impact, and its treatment. Clin Pediatr (Phila) 2002, 41:323-332.
12. Staab D, Kaufmann R, Brautigam M, Wahn U: Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial. Pediatr Allergy Immunol 2005, 16:527-533.
13. Drake L, Prendergast M, Maher R, et al.: The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis. J Am Acad Dermatol 2001, 44:S65-S72.
14. Fonacier L, Spergel J, Charlesworth EN, et al.: Report of the Topical Calcineurin Inhibitor Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol 2005, 115:1249-1253.
15. Novartis-Pharmeutical: Elidel prescribing information. (Package insert): 2006.
16. Astellas-Pharmaceutical: Protopic prescribing information. (Package insert): 2006.
17. Allen B, Lakhanpaul M, Morris A, et al.: Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child 2003, 88:969-973.
18. Harper J, Green A, Scott G, et al.: First experience of topical SDZ ASM 981 in children with atopic dermatitis. Br J Dermatol 2001, 144:781-787.
19. Harper J, Smith C, Rubins A, et al.: A multicenter study of the pharmacokinetics of tacrolimus ointment after first and repeated application to children with atopic dermatitis. J Invest Dermatol 2005, 124:695-699.
20. Pediatric Advisory Committee Meeting of the US Food Drug Administration. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4089b2.htm
21. Astellas-Pharmaceutical: Data on file: 2006.
22. SEER cancer statistics review, 1975-2001. http://seer.cancer.gov/csr/ 1975_2001/.
23. Hill DJ, Sporik R, Thorburn J, Hosking CS: The association of atopic dermatitis in infancy with immunoglobulin E food sensitization. J Pediatr 2000, 137:475-479.
24. Naylor M, Elmets C, Jaracz E, Rico JM: Non-melanoma skin cancer in patients with atopic dermatitis treated with topical tacrolimus. J Dermatol Treat 2005, 16:149-153.
25. Miller D, Weinstock M: Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol 1995, 30:774-778.
26. Tran C, Lubbe J, Sorg O, et al.: Topical calcineurin inhibitors decrease the production of UVB-induced thymine dimers from hairless mouse epidermis. Dermatology 2005, 211:341-347.
27. Papp KA, Breuer K, Meurer M, et al.: Long-term treatment of atopic dermatitis with pimecrolimus cream 1% in infants does not interfere with the development of protective antibodies after vaccination. J Am Acad Dermatol 2005, 52:247-253.
28. Stiehm ER, Roberts RL, Kaplan MS, et al.: Pneumococcal seroconversion after vaccination for children with atopic dermatitis treated with tacrolimus ointment. J Am Acad Dermatol 2005, 53:S206-S213.
29. Packet insert: Protopic (tacrolimus 0.03 and 0.1%) ointment. Rockville, MD: US Food and Drug Administration.
30. Wahn U, Bos JD, Goodfield M, et al.: Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children. Pediatrics 2002, 110:e2.
31. Ringer Ellingsen A, Brandt Sorensen F, Overgaard Larsen J, et al.: Stereological quantification of lymphocytes in skin biopsies from atopic dermatitis patients. Acta Dermatol Venereol 2001, 81:258-262.
32. Hanifin JM, Paller AS, Eichenfield L, et al.: Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. J Am Acad Dermatol 2005, 53:S186-S194.
33. Reitamo S, Ortonne JP, Sand C, et al.: A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol 2005, 152:1282-1289.
34. Paul C, Cork M, Rossi AB, et al.: Safety and tolerability of 1% pimecrolimus cream among infants: experience with 1133 patients treated for up to 2 years. Pediatrics 2006, 117:e118-e128.