A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis

Kempers, Steven; Boguniewicz, Mark; Carter, Eric; Jarratt, Michael; Pariser, David M.; Stewart, D G; Stiller, Matthew J.; Tschen, Eduardo; Chon, Katie; Wisseh, Steve; Abrams, Beatrice B.

doi:10.1016/j.jaad.2004.01.051

Cited by 109 publications

(152 citation statements)

References 12 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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“…In a 6-week randomized trial conducted in children and adolescents aged 2–17 years with moderate atopic eczema, pimecrolimus produced a shorter duration of erythema or irritation than tacrolimus, typically lasting less than 30 min rather than hours [32]. The duration of these reactions were evaluated at Day 4 because application-site reactions are more common with topical calcineurin inhibitors during the first few days of therapy.…”

Section: Safetymentioning

confidence: 99%

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

et al. 2007

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Atopic eczema is predominantly a disease of children and infants, and is often a significant burden for both the sufferer and the family. Pimecrolimus cream 1% (Elidel®) is a topical calcineurin inhibitor that has been developed for the treatment of inflammatory skin diseases. When applied twice daily, pimecrolimus has been shown to be effective and well tolerated in paediatric patients with mild to moderate atopic eczema, and appears to be particularly suitable for use on the face, the neck and skin folds. Reduction of pruritus or erythema can be seen within 48 hours of initiating treatment, and when used at the first signs or symptoms of recurrence, pimecrolimus can significantly reduce the incidence of flares and the amount of topical corticosteroid used. Long-term pimecrolimus therapy shows that the initial reduction of disease severity (Eczema Area and Severity Index) is sustained and that most patients have minimal residual disease at 2 years. The most common application-site reaction is a mild to moderate, transient, warm/burning sensation occurring in approximately 10% of patients. Blood concentrations of pimecrolimus following topical administration remain low in all patients. Currently there is no evidence for systemic adverse events, immune suppression or alterations in the vaccine response, after short-term or prolonged treatment. In conclusion, pimecrolimus is an effective treatment option for the short-term treatment and long-term control of atopic eczema in paediatric patients.

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“…34 A randomized, investigator-blinded study of pimecrolimus and tacrolimus ointment 0.03% in 141 pediatric patients reported similar efficacy with pimecrolimus and tacrolimus but superior local tolerability and more favorable ratings of product characteristics with pimecrolimus. 33 While we did not examine these specific outcomes in our study, it is possible that the differences in outcomes that we observed were due to differences in tolerability and patient perceptions regarding product characteristics that have been reported elsewhere.…”

Section: Nn Discussionmentioning

confidence: 79%

“…In a randomized, investigatorblinded study of pimecrolimus (n = 71) and tacrolimus ointment 0.03% (n = 70) in pediatric patients with moderate AD, Kempers and colleagues reported that efficacy based on the Investigator Global Atopic Dermatitis Assessment (IGADA) score was not statistically different between groups. 33 However, patients receiving pimecrolimus had less frequent adverse skin reactions lasting more than 30 minutes and were more likely to rate ease of application as excellent or very good. 33 More recently, in a pooled analysis of the results of 3 randomized comparative studies of pimecrolimus versus tacrolimus involving 413 adult and 650 pediatric patients, Paller and colleagues reported that tacrolimus was more effective than pimecrolimus, based on improvement from baseline to 6 weeks or the end of the study in Eczema Area Severity Index (EASI) (52.8% vs. 39.1%, respectively; P <0.001), IGADA scores (treatment success 62.1% vs. 49.8%, P <0.001), and percentage of total body surface area affected (53.6% vs. 41.0%, P <0.001).…”

Section: What This Study Addsmentioning

confidence: 99%

“…33 However, patients receiving pimecrolimus had less frequent adverse skin reactions lasting more than 30 minutes and were more likely to rate ease of application as excellent or very good. 33 More recently, in a pooled analysis of the results of 3 randomized comparative studies of pimecrolimus versus tacrolimus involving 413 adult and 650 pediatric patients, Paller and colleagues reported that tacrolimus was more effective than pimecrolimus, based on improvement from baseline to 6 weeks or the end of the study in Eczema Area Severity Index (EASI) (52.8% vs. 39.1%, respectively; P <0.001), IGADA scores (treatment success 62.1% vs. 49.8%, P <0.001), and percentage of total body surface area affected (53.6% vs. 41.0%, P <0.001). 34 The least squares mean itch scores at baseline were 5.6 in both groups, and tacrolimus patients had lower least squares mean itch scores (2.6) at the end of the study (6 weeks) versus 3.3 for pimecrolimus, P <0.001.…”

Section: What This Study Addsmentioning

confidence: 99%

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Administrative Claims Analysis of Utilization and Costs of Care in Health Plan Members With Atopic Dermatitis Who Had Prior Use of a Topical Corticosteroid and Who Initiate Therapy With Pimecrolimus or Tacrolimus

Delea

Gokhale²,

Makin³

et al. 2007

JMCP

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BACkgroUnD: In the United States, pimecrolimus cream and tacrolimus ointment are approved as second-line therapy for short-term and intermittent noncontinuous long-term treatment of atopic dermatitis (AD) in nonimmunocompromised patients aged 2 years or older who have failed to respond adequately to other topical prescription treatments (e.g., topical corticosteroids), or when those treatments are not advisable; pimecrolimus is indicated for mildto-moderate AD and tacrolimus for moderate-to-severe AD. Comparative data on the effects of pimecrolimus versus tacrolimus on AD-related health care utilization and costs among similar patients seen in typical clinical practice are currently unavailable.

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A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis

Cited by 109 publications

References 12 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

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

Administrative Claims Analysis of Utilization and Costs of Care in Health Plan Members With Atopic Dermatitis Who Had Prior Use of a Topical Corticosteroid and Who Initiate Therapy With Pimecrolimus or Tacrolimus

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