Long-Term Efficacy and Safety of Pimecrolimus Cream 1% in Adults with Moderate Atopic Dermatitis

Meurer, Michael; Fartasch, Manigé; Albrecht, Gisela; Vogt, Thomas; Worm, Margitta; Ruzicka, Thomas; Altmeyer, Peter; Schneider, D.; Weidinger, Gottfried; Braeutigam, Matthias

doi:10.1159/000078462

Cited by 94 publications

(93 citation statements)

References 13 publications

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“…Short- and long-term trials including pediatric and adult patients with AD have demonstrated the effectiveness of pimecrolimus [35,36,37,38,39,40,41,42,43,44]. …”

Section: Topical Treatments For Admentioning

confidence: 99%

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

2005

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Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin condition that primarily affects children. Topical corticosteroids have been the mainstay of treatment since the late 1950s. While providing excellent short-term efficacy, topical corticosteroid usage is limited by potential adverse effects, including impairment of the function and viability of Langerhans cells/dendritic cells. The recently introduced topical calcineurin inhibitors pimecrolimus cream 1% (Elidel^®) and tacrolimus ointment 0.03 and 0.1% (Protopic^®) exhibit a more selective mechanism of action and do not affect Langerhans cells/dendritic cells. For the immune system of young children ‘learning’ to mount a balanced Th1/Th2 response, this selective effect has particular benefits. In clinical experience, topical calcineurin inhibitors have been shown to be a safe and effective alternative to topical corticosteroids in almost 7 million patients (>5 million on pimecrolimus; >1.7 million on tacrolimus). Topical pimecrolimus is primarily used in children with mild and moderate AD, whereas tacrolimus is used preferentially in more severe cases. None of the topical calcineurin inhibitors have been associated with systemic immunosuppression-related malignancies known to occur following long-term sustained systemic immunosuppression with oral immunosuppressants (e.g., tacrolimus, cyclosporine A, and corticosteroids) in transplant patients. Preclinical and clinical data suggest a greater skin selectivity and larger safety margin for topical pimecrolimus.

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“…Short- and long-term trials including pediatric and adult patients with AD have demonstrated the effectiveness of pimecrolimus [35,36,37,38,39,40,41,42,43,44]. …”

Section: Topical Treatments For Admentioning

confidence: 99%

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

2005

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“…[2][3][4][5] This shift in focus has highlighted methodological issues regarding the definition of a flare, for which there is currently no clear guidance or agreement.…”

Section: Discussionmentioning

confidence: 99%

“…The CASM-DE-01 Study Group defined relapse in their 2 articles as a period of at least 3 consecutive days in which moderately potent topical corticosteroid application was considered necessary (a named corticosteroid was selected for use in each participating country). 3,15 In this group's second article in 2004, they specified that the corticosteroids must be considered necessary by the investigator in their definition of flare, 3 a point that was not clear in the 2002 article. 15 Zaki et al 16 stated that the need to use potent topical corticosteroids or further systemic treatment constituted a relapse.…”

Section: Behavioral Definitionmentioning

confidence: 99%

What Is Meant by a “Flare” in Atopic Dermatitis?

Langan¹,

Kim²,

Williams³

2006

Arch Dermatol

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“…During the development program, several double-blind (DB) and open-label (OL) clinical studies were conducted in adult and paediatric patients treated intermittently with pimecrolimus cream 1% for up to 2 years [22, 23, 31,38,39,40,41,42,43]. No clinically relevant systemic side effects and no clinically significant treatment-related laboratory abnormalities were observed in these studies.…”

Section: Adverse Events In Clinical Trialsmentioning

confidence: 99%

An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance

et al. 2007

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In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel®) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has afavourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2–5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.

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Long-Term Efficacy and Safety of Pimecrolimus Cream 1% in Adults with Moderate Atopic Dermatitis

Cited by 94 publications

References 13 publications

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

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

What Is Meant by a “Flare” in Atopic Dermatitis?

An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance

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