Skip to main content
SpringerLink
Log in

Impact of Topical Calcineurin Inhibitors on Quality of Life in Patients with Atopic Dermatitis

  • Review Article
  • Published:
American Journal of Clinical Dermatology Aims and scope Submit manuscript

Abstract

This review considers randomized trials of topical calcineurin inhibitors in atopic dermatitis that have included quality-of-life (QOL) data. Relatively few trials were identified and several different QOL measures have been used, partly because trial subjects included adults, children, and the parents of affected infants. Tacrolimus 0.1% and 0.03% ointment and pimecrolimus 1% cream were found to be superior to vehicle treatment in terms of QOL for active AD. In adults, tacrolimus 0.1% ointment provided a greater improvement in QOL than the 0.03% strength. Pimecrolimus 1% cream was superior to vehicle treatment for flare prevention in the studies that contained QOL outcomes but no data are available for tacrolimus ointment in this regard. QOL data comparing topical calcineurin inhibitors with other active treatments such as topical corticosteroids are sparse and it would be useful for future randomized trials to include QOL measures as a primary outcome.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Table I
Table II

Similar content being viewed by others

References

  1. Wollenberg A, Bieber T. Atopic dermatitis: from the genes to skin lesions. Allergy 2000; 55: 205–13

    Article  PubMed  CAS  Google Scholar 

  2. Williams HC, Wuethrich B. The natural history of atopic dermatitis. In: Williams HC, editor. Atopic dermatitis: the epidemiology, causes and prevention of atopic eczema. Cambridge: Cambridge University Press, 2000: 41–59

    Chapter  Google Scholar 

  3. The International Study of Asthma and Allergies in Childhood (ISAAC). Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. Lancet 1998; 351: 225–32

    Google Scholar 

  4. Diepgen TL, Blettner M. Analysis of familial aggregation of atopic eczema and other atopic diseases by ODDS RATIO regression models. J Invest Dermatol 1996; 106: 977–81

    Article  PubMed  CAS  Google Scholar 

  5. Larsen FS, Holm NV, Henningen K. Atopic dermatitis: a geneticepidemiologic study in a population-based twin sample. J Am Acad Dermatol 1986; 15: 487–94

    Article  PubMed  CAS  Google Scholar 

  6. Williams HC, Pembroke AC, Forsdyke H, et al. London-born black Caribbean children are at increased risk of atopic dermatitis. J Am Acad Dermatol 1995; 32: 2120–7

    Article  Google Scholar 

  7. Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life (QOL) in children with skin disease and children with other chronic childhood diseases. Br J Dermatol 2006; 155: 145–55

    Article  PubMed  CAS  Google Scholar 

  8. Emerson RM, Williams HC, Allen BR. What is the cost of atopic dermatitis in pre-school children? Br J Dermatol 2001; 143: 514–22

    Article  Google Scholar 

  9. Ellis CN, Drake LA, Prendergast MM, et al. Cost of atopic dermatitis and eczema in the United States. J Am Acad Dermatol 2002; 46: 361–70

    Article  PubMed  Google Scholar 

  10. Finlay AY. Quality of life in atopic dermatitis. J Am Acad Dermatol 2001; 45 Suppl. 1: S67–8

    Google Scholar 

  11. Lewis-Jones MS, Finlay AY. The children’s dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol 1995; 132: 942–9

    Article  PubMed  CAS  Google Scholar 

  12. Lawson V, Lewis-Jones MS, Finlay AY, et al. The family impact of childhood atopic dermatitis: the Dermatitis Family Impact questionnaire. Br J Dermatol 1998; 138: 107–13

    Article  PubMed  CAS  Google Scholar 

  13. Lundberg L, Johannesson M, Silverdahl M, et al. Health-related quality of life in patients with psoriasis and atopic dermatitis measured with SF-36, DLQI and a subjective measure of disease activity. Acta Derm Venereol (Stockh) 2000; 80: 430–4

    Article  CAS  Google Scholar 

  14. Finlay AY. Quality of life impairment in atopic dermatitis and psoriasis. Clin Exp Perspect Sandimmun Ther 1992; 2: 10–11

    Google Scholar 

  15. Basra MK, Finlay AY. The family impact of skin diseases: the Greater Patient concept. Br J Dermatol 2007; 156: 929–37

    Article  PubMed  CAS  Google Scholar 

  16. Whally D, McKenna SP. The impact of childhood atopic dermatitis on the quality of life of the family. PCI J Progress Clin Insights 1999; 7: 10–11

    Google Scholar 

  17. Elliot B. Itching agony. Nurs Times 1990; 86: 72

    Google Scholar 

  18. Daud LR, Garralda ME, David TJ. Psychosocial adjustment in preschool children with atopic eczema. Arch Dis Child 1993; 69: 670–6

    Article  PubMed  CAS  Google Scholar 

  19. Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg 1998; 17: 291–6

    Article  PubMed  CAS  Google Scholar 

  20. Elliot BE, Luker K. The experiences of mothers caring for a child with severe atopic eczema. J Clin Nurs 1997; 6: 241–7

    Article  Google Scholar 

  21. Calman KC. Quality of life in cancer patients: a hypothesis. J Med Ethics 1984; 10: 124–7

    Article  PubMed  CAS  Google Scholar 

  22. Holme SA, Man I, Sharpe JL, et al. The Children’s Dermatology Life Quality Index: validation of the cartoon version. Br J Dermatol 2003; 148: 285–90

    Article  PubMed  CAS  Google Scholar 

  23. Charman C, Chambers C, Williams H. Measuring atopic dermatitis severity in randomised controlled clinical trials: what exactly are we measuring? J Invest Dermatol 2003; 120: 932–41

    Article  PubMed  CAS  Google Scholar 

  24. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis; the SCORAD index. Dermatology 1993; 186: 23–31

    Google Scholar 

  25. Ben-Gashir MA, Seed PT, Hay RJ. Quality of life and disease severity are correlated in children with atopic dermatitis. Br J Dermatol 2004; 150: 284–90

    Article  PubMed  CAS  Google Scholar 

  26. Ben-Gashir MA, Seed PT, Hay RJ. Are quality of family life and disease severity related in childhood atopic dermatitis? J Eur Acad Dermatol Venereol 2002; 16: 455–62

    Article  PubMed  CAS  Google Scholar 

  27. Hanifin JM, Thurston M, Omoto M, et al. The Eczema Area and Severity Index (EASI): assessment of reliability in atopic dermatitis. Clin Exp Dermatol 2001; 10: 11–8

    CAS  Google Scholar 

  28. Touw CR, Kakkaari-Van Roijen L, Verboom P, et al. Quality of life and clinical outcome in psoriasis using intermittent ciclosporin. Br J Dermatol 2001; 144: 967–72

    Article  PubMed  CAS  Google Scholar 

  29. Wahl A, Burckhardt C, Wiklund I, et al. The Norwegian version of the Quality of Life Scale (QOLS-N): a validation and reliability study in patients suffering from psoriasis. Scand J Caring Sci 1998; 12: 215–22

    Article  PubMed  CAS  Google Scholar 

  30. Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol 2000; 142: 931–6

    Article  PubMed  CAS  Google Scholar 

  31. Berth-Jones J, Damstra RJ, Golsch S, et al. Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double-blind, parallel group study. BMJ 2003; 326: 1367–72

    Article  PubMed  CAS  Google Scholar 

  32. Liu J, Albers MW, Wandless TJ, et al. Inhibition of T-cell signalling by immunophilin-ligand complexes correlates with loss of calcineurin phosphatase activity. Biochemistry 1992; 31: 3896–901

    Article  PubMed  CAS  Google Scholar 

  33. 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: 264–73

    Article  PubMed  CAS  Google Scholar 

  34. Kino T, Hatanaka H, Hashimoto M, et al. FK-506, a novel immunosuppressant isolated from a Streptomyces: I. Fermentation, isolation, and physico-chemical and biological characteristics. J Antibiot (Tokyo) 1987; 40: 1249–55

    Article  CAS  Google Scholar 

  35. Hanifin JM, Ling MR, Langley R, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. J Am Acad Dermatol 2001; 44: S28–38

    Article  Google Scholar 

  36. Soter NA, Fleischer Jr AB, Webster GF, et al. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. J Am Acad Dermatol 2001; 44: S39–46

    Article  Google Scholar 

  37. Paller A, Eichenfield LF, Leung DYM, et al. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. J Am Acad Dermatol 2001; 44: S44–57

    Article  Google Scholar 

  38. Boguniewicz M, Fiedler VC, Raimer S, et al. A randomized, vehicle-controlled trial of tacrolimus ointment for the treatment of atopic dermatitis in children. J Allergy Clin Immunol 1998; 102: 637–44

    Article  PubMed  CAS  Google Scholar 

  39. Reitamo S, Van Leent EJM, Ho V, et al. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis. J Allergy Clin Immunol 2002; 109: 539–46

    Article  PubMed  CAS  Google Scholar 

  40. Reitamo S, Harper J, Bos JD, et al. 0.03% tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial. Br J Dermatol 2004; 150: 554–62

    Article  PubMed  CAS  Google Scholar 

  41. Reitamo S, Ortonne JP, Sand C, et al. A multicentre, randomized, doubleblind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol 2005; 152: 1282–9

    Article  PubMed  CAS  Google Scholar 

  42. Kang S, Lucky AW, Pariser D, et al. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. J Am Acad Dermatol 2001; 44: S58–64

    Article  Google Scholar 

  43. Hanifin JM, Leung DYM, Paller A, et al. Tacrolimus ointment monotherapy is safe and effective for the long-term treatment (more than 3 years) of atopic dermatitis in pediatric patients [abstract]. J Allergy Clin Immunol 2003; 111: S130

    Article  Google Scholar 

  44. Arai T, Koyama Y, Suenaga T, et al. Ascomycin, an anti-fungal antibiotic. J Antibiot Series A 1962; 15: 231–2

    CAS  Google Scholar 

  45. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM 981). Semin Cutan Med Surg 2001; 20: 233–41

    Article  PubMed  CAS  Google Scholar 

  46. Meingasser JG, Grassberger M, Fahrngruber H, et al. A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology. Br J Dermatol 1997; 137: 569–76

    Google Scholar 

  47. Hultsch T, Muller KD, Meingasser JG, et al. Ascomycin macrolactam derivative SDZ ASM 981 inhibits the release of granule-associated mediators and of newly synthesized cytokines in RBL 2H3 mast cells in an immunophilindependant manner. Arch Dermatol Res 1998; 290: 501–7

    Article  PubMed  CAS  Google Scholar 

  48. Eichenfield LF, Lucky AW, Boguniewicz M, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild to moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol 2002; 46: 495–504

    Article  PubMed  Google Scholar 

  49. Ho VC, Gupta A, Kaufmann R, et al. Safety and efficacy of non-steroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. J Pediatr 2003; 142: 155–62

    Article  PubMed  CAS  Google Scholar 

  50. 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: e2–9

    Article  Google Scholar 

  51. Meurer M, Föster-Holst R, Wozel G, et al. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology 2002; 205: 271–7

    Article  PubMed  CAS  Google Scholar 

  52. Kapp A, Papp K, Bingham A, et al. Long-term management of atopic dermatitis in infants with topical pimecrolimus, a non-steroid anti-inflammatory drug. J Allergy Clin Immunol 2002; 110: 277–84

    Article  PubMed  CAS  Google Scholar 

  53. Queille-Roussel C, Paul C, Duteil L, et al. The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomised, double-blind, controlled study. Br J Dermatol 2001; 144: 507–13

    Article  PubMed  CAS  Google Scholar 

  54. Kyllonen H, Remitz A, Mandelin JM, et al. Effects of 1 year intermittent treatment with topical tacrolimus monotherapy on skin collagen synthesis in patients with atopic dermatitis. Br J Dermatol 2004; 150: 1174–81

    Article  PubMed  CAS  Google Scholar 

  55. Naylor M, Elmets C, Jarracz E, et al. Non-melanoma skin cancer in patients with atopic dermatitis treated with topical tacrolimus. J Dermatol Treat 2005; 16: 149–53

    Article  CAS  Google Scholar 

  56. Rustin MH. The safety of tacrolimus ointment for the treatment of atopic dermatitis: a review. Br J Dermatol 2007; 157: 861–73

    Article  PubMed  CAS  Google Scholar 

  57. Ashcroft DM, Chen L-C, Garside R, et al. Topical pimecrolimus for eczema. Cochrane Database Syst Rev 2007; (4): CD005500

  58. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210–6

    Article  PubMed  CAS  Google Scholar 

  59. Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol 2005; 153: 486–97

    Article  PubMed  CAS  Google Scholar 

  60. Kawashima M, QOL Research Forum for Patients with Atopic Dermatitis. Quality of life in patients with atopic dermatitis: impact of tacrolimus ointment. Int J Dermatol 2006; 45: 731–6

    CAS  Google Scholar 

  61. Won CH, Seo PG, Park YM, et al. A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea. J Dermatol Treat 2004; 15: 30–4

    Article  CAS  Google Scholar 

  62. Singalavanija S, Noppakun N, Limpongsanuruk W, et al. Efficacy and safety of tacrolimus ointment in pediatric patients with moderate to severe atopic dermatitis. J Med Assoc Thai 2006; 89: 1915–22

    PubMed  Google Scholar 

  63. Sunderkotter C, Weiss JM, Bextermoller R, et al. Post-marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: positive effects on major symptoms of atopic dermatitis and on quality of life. J Dtsch Dermatol Ges 2006; 4: 301–6

    Article  PubMed  Google Scholar 

  64. Hongbo Y, Thomas CL, Harrison MA, et al. Translating the science of quality of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol 2005; 125: 659–64

    Article  PubMed  CAS  Google Scholar 

  65. Whalley D, McKenna SP, Dewar AL, et al. A new instrument for assessing quality of life in atopic dermatitis: international development of the Quality of Life Index for Atopic Dermatitis (QoLIAD). Br J Dermatol 2004; 150: 274–83

    Article  PubMed  CAS  Google Scholar 

  66. McKenna SP, Whalley D, Dewar AL, et al. International development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD). Qual Life Res 2005; 14: 231–41

    Article  PubMed  Google Scholar 

  67. Staab D, Kaufmann R, Brautigam M, et al. Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents’ quality of life: a multicenter, randomized trial: CASM981CDE04-Study Group. Pediatr Allergy Immunol 2005; 16: 527–33

    Article  PubMed  Google Scholar 

  68. McKenna SP, Doward LC, Meads DM, et al. Quality of life in infants and children with atopic dermatitis: addressing issues of differential item functioning across countries in multinational clinical trials. Health Qual Life Outcomes 2007; 5: 45

    Article  PubMed  Google Scholar 

  69. Hunt SM, McKenna SP. The QLDS: a scale for the measurement of quality of life in depression. Health Policy 1992; 22: 307–19

    Article  PubMed  CAS  Google Scholar 

  70. 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: S65–72

    Article  Google Scholar 

  71. Whalley D, Huels J, McKenna SP, et al. The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents’ quality of life in the treatment of pediatric atopic dermatitis. Pediatrics 2002; 110: 1133–6

    Article  PubMed  Google Scholar 

  72. Leo HL, Bender BG, Leung SB, et al. Effect of pimecrolimus cream 1% on skin condition and sleep disturbance in children with atopic dermatitis. J Allergy Clin Immunol 2004; 114: 691–3

    Article  PubMed  CAS  Google Scholar 

  73. Bieber T, Vick K, Folster-Holst R, et al. Efficacy and safety of methylprednisolone aceponate ointment 0.1% compared to tacrolimus 0.03% in children and adolescents with an acute flare of severe atopic dermatitis. Allergy 2007; 62: 184–9

    Article  PubMed  CAS  Google Scholar 

  74. McKenna SP, Whalley D, de Prost Y, et al. Treatment of paediatric atopic dermatitis with pimecrolimus (Elidel, SDZ ASM 981): impact on quality of life and health-related quality of life. J Eur Acad Dermatol Venereol 2006; 20: 248–54

    Article  PubMed  CAS  Google Scholar 

  75. Meads DM, McKenna SP, Kahler K. The quality of life of parents of children with atopic dermatitis: interpretation of PIQoL-AD scores. Qual Life Res 2005; 14: 2235–45

    Article  PubMed  CAS  Google Scholar 

  76. Meurer M, Fartasch M, Albrecht G, et al. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology 2004; 208: 365–72

    Article  PubMed  Google Scholar 

  77. Ashcroft DM, Dimmock P, Garside R, et al. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomized controlled trials. BMJ 2005; 330: 516

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

No sources of funding were used to assist in the preparation of this review. Drs Ingram and Martin have no conflicts of interest that are directly relevant to the content of this review. Dr Finlay is joint copyright owner of the DLQI and CDLQI. He has also given consultancy advice to Novartis and his department has received funding for clinical trials from Fujisawa, now Astellas Pharma Inc.

Author information

Authors and Affiliations

  1. Department of Dermatology, Cardiff University School of Medicine, Heath Park, Cardiff, CF14 4XN, UK

    John R. Ingram, Julie A. Martin & Andrew Y. Finlay

Authors
  1. John R. Ingram
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Julie A. Martin
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Andrew Y. Finlay
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to John R. Ingram.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ingram, J.R., Martin, J.A. & Finlay, A.Y. Impact of Topical Calcineurin Inhibitors on Quality of Life in Patients with Atopic Dermatitis. AM J Clin Dermatol 10, 229–237 (2009). https://doi.org/10.2165/00128071-200910040-00003

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00128071-200910040-00003

Keywords

Search

Navigation