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

Paller, Amy S.; Lebwohl, Mark; Fleischer, Alan B.; Antaya, Richard J.; Langley, Richard; Kirsner, Robert S.; Blum, Robin R.; Rico, M. Joyce; Jaracz, Eileen; Crowe, Andrew; Linowski, Gregory J.

doi:10.1016/j.jaad.2004.12.038

Cited by 138 publications

(110 citation statements)

References 17 publications

(18 reference statements)

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“…There is ample documented experience with the oral formulation of tacrolimus demonstrating its effectiveness as a systemic immunosuppressant and its risk associated with systemic immunosuppression, namely, the risk of immunosuppression-related lymphoproliferative diseases [e.g., Epstein-Barr virus (EBV), positive B cell lymphomas] [28, 29]. Topically applied tacrolimus ointment at concentrations of 0.03 or 0.1% has been shown to be effective in the treatment of AD and is approved for the treatment of moderate to severe AD [30,31,32,33,34]. …”

Section: Topical Treatments For Admentioning

confidence: 99%

“…In several short-term studies, tacrolimus ointment has been shown to be an effective treatment for AD in adults and children [30, 31, 33, 34, 84]. Patients treated with tacrolimus ointment, 0.03 and 0.1% applied twice daily for up to 6 weeks showed improvement in outcomes such as modified EASI and Investigator Global AD Assessment.…”

Section: Clinical Experience With Topical Calcineurin Inhibitorsmentioning

confidence: 99%

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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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Section: Topical Treatments For Admentioning

confidence: 99%

Section: Clinical Experience With Topical Calcineurin Inhibitorsmentioning

confidence: 99%

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

2005

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“…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. The safety profiles of the 2 drugs were similar.…”

Section: What This Study Addsmentioning

confidence: 83%

“…A recent pooled analysis of 413 adults and 650 pediatric patients participating in 3 randomized studies found that tacrolimus was more effective than pimecrolimus, based on a variety of measures. 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: 99%

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 tacrolimus kenőcs a pimecrolimus krémhez képest hatékonyabb, a bőrtünetek javulását rövidebb időn belül meghozza úgy a kezeletlen, mint a lokális kortikoszteroidokkal előkezelt bőrön (13,14).…”

Section: Kalcineurin Gátlók Hatékonysága Atópiás Dermatitisbenunclassified

The use of calcineurin inhibitors in atopic dermatitis

Varga¹,

Kemény²

2017

BVSZ

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ÖSSZEFOGLALÁS Key words: calcineurin -tacrolimuspimecrolimus -atopic dermatitis Történeti áttekintés, molekulaszerkezetA helyileg alkalmazható kalcineurin gátló gyógyszerek legalább olyan áttörést jelentettek az atópiás dermatitis (AD) kezelésében, mint a lokális kortikoszteroidok. A kalcineurin gát-lók első tagja az FK506, vagy tacrolimus, amely egy immunszuppresszív hatású makrolid lakton, melyet Japánban a Tsukuba hegy közelében, a Streptomyces tsukubaensis baktériumból izoláltak 1987-ben (1). Elnevezése is innen szár-mazik "Tsukuba macrolide immunosuppressant". A tacrolimus egy jól tolerált, immunszuppresszív gyógyszer, melyet szisztémás formában 1994 óta alkalmaznak a transzplantá-ciós orvostudományban a szervkilökődés megelőzésére (2). Hatásmechanizmusa a ciklosporinhoz hasonló, de T-sejt aktivációt gátló hatása mintegy 10-100x nagyobb.Immunmediált gyulladásos bőrbetegségek kezelésére helyi immunszupresszív stratégiát többször próbáltak alkalmazni, de a ciklosporin helyileg alkalmazva nem bizonyult hatásosnak (3), mivel nagyobb molekulamérete miatt helyileg alkalmazva nem jut be a bőrbe. Ezzel szemben a tacrolimus kisebb molekulatömege miatt bőrön keresztül is alkalmazható, és hatékonynak mutatkozott gyulladásos bőrbetegségek kezelésére (4,5). Az első randomizált vizsgálatot a tacrolimus haté-konyságáról atópiás dermatitisben Ruzicka és mtsai végez-ték 1997-ben, mely során a különböző koncentrációkban alkalmazott késztményeket hatékonynak találták (5).A pimecrolimus a Streptomyces hygroscopicus var. Ascomyceticus-ból izolált természetes immunmoduláns. A pimecrolimus állatkísérletes modellekben még szisztémás alkalmazás esetén is magas bőr iránti szelektív gyulladásgát-ló aktivitást mutat, ugyanakkor a szisztémás immunszuppresszió minimális (6,7). HatásmechanizmusFiziológiás körülmények között a T-sejt receptor (TCR) aktiválódása intracelluláris kálciumnövekedést okoz, mely 235 Levelező szerző: Kemény Lajos dr.

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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

Cited by 138 publications

References 17 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

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

The use of calcineurin inhibitors in atopic dermatitis

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