Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants

Ho, Vincent; Gupta, Aditya K.; Kaufmann, Roland; Todd, Gail; Vanaclocha, F.; Takaoka, Roberto; Fölster‐Holst, Regina; Potter, Paul; Marshall, Katherine; Thurston, Mark; Bush, Christopher; Cherill, Robert

doi:10.1067/mpd.2003.65

Cited by 165 publications

(182 citation statements)

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“…20,27,[30][31][32]44 The favorable safety and tolerability profile of 1% pimecrolimus cream demonstrated in published pediatric studies 35,[37][38][39]43,44 is supported by the data summarized in this review. The combined analysis of the results from 4 pharmacokinetic studies conducted with 35 infants with AD indicated that pimecrolimus blood concentrations after topical applications were consistently low, irrespective of the level of disease severity and percentage of TBSA involved.…”

Section: Discussionmentioning

confidence: 62%

“…In the majority of these studies, [35][36][37][38][39] most of the full clinical benefit was observed within the first 1 week after the start of pimecrolimus treatment and maximal improvement was achieved within 3 months, after which the level of improvement was sustained. The use of 1% pimecrolimus cream decreased markedly between 3 and 9 months of treatment and remained low thereafter (Fig 2), with patients having on average ϳ44% to 57% treatment-free days from the ninth month onward.…”

Section: Patients and Use Of 1% Pimecrolimus Creammentioning

confidence: 99%

“…A total of 1133 infants (age: 3-23 months) with mild to severe AD were treated intermittently with 1% pimecrolimus cream for up to 2 years. The results of clinical studies in this population of patients [35][36][37][38][39][40] demonstrated that the use of 1% pimecrolimus cream induces rapid symptom relief, prevents progression to major flares, increases the number of diseasefree days, improves the quality of life of patients and their parents, and is well tolerated. Some of the clinical studies also provided evidence that, at variance with TCSs, 1% pimecrolimus cream retains its clinical effectiveness when used for extended periods 35,38,39 and can be discontinued without any risk of disease rebound.…”

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confidence: 99%

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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Pimecrolimus is a calcineurin inhibitor developed for the topical treatment of atopic dermatitis. During the clinical development of 1% pimecrolimus cream, 1133 patients 3 to 23 months of age with mild to severe atopic dermatitis were treated for up to 2 years. The objective of this review is to discuss the safety and tolerability of 1% pimecrolimus cream among infants, on the basis of the combined results from all studies (4 pharmacokinetic studies and 6 clinical trials) conducted among these patients. Pimecrolimus blood concentrations measured for 35 patients were consistently low (Յ1 ng/mL in Ͼ80% of samples), irrespective of the disease severity and extent, and remained low during intermittent treatment for up to 1 year. The level of systemic exposure to pimecrolimus among infants was comparable to that observed for older pediatric patients enrolled in the same studies and treated in the same way with 1% pimecrolimus cream, which indicated that young pediatric patients are not at higher risk of significant percutaneous absorption of topically applied pimecrolimus, despite their large skin surface area/body mass ratio. The 6 clinical trials included a total of 1098 infants, who were treated for periods ranging from 4 weeks to 2 years. Most of these patients (60%) had moderate to severe disease at baseline. The most frequently reported adverse events were common childhood disorders such as nasopharyngitis, pyrexia, upper respiratory tract infections, ear infections, and bronchitis. During the double-blind (DB) studies or DB phases of studies, the incidence rates for the most frequently reported adverse events were similar for patients who received 1% pimecrolimus cream and patients who received the vehicle, except for the incidence of teething, which was higher among the pimecrolimus-treated infants (relative risk: 2.02; 95% confidence interval: 1.32-3.27). Treatment with 1% pimecrolimus cream was not associated with an increase in the overall incidence of nonskin infections, compared with the vehicle (relative risk: 1.015; 95% confidence interval: 0.88 -1.18). The incidence density (ID) rates for total bacterial, fungal, parasitic, and viral skin infections during the DB studies or DB phases of www.pediatrics.org/cgi

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Section: Discussionmentioning

confidence: 62%

Section: Patients and Use Of 1% Pimecrolimus Creammentioning

confidence: 99%

mentioning

confidence: 99%

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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“…Bu baflar› oran›, Eichenfield ve arkadafllar› taraf›n-dan yap›lan çal›flmadaki baflar› oran›na oldukça yak›nd›r 22 . Ashcroft ve arkadafllar›n›n 2005 y›l›nda yapt›¤›, pimekrolimus ve takrolimusun etkinlik ve tolerabilitesini de¤erlendi-ren, 25 kontrollü çal›flmay› içeren bir metaanalizde %1 pimekrolimus krem ile kontrol grubunun karfl›laflt›r›ld›¤›, toplam 783 hastan›n kat›ld›¤› 4 çal›flmada, hastalar›n 3 hafta sonunda tam veya tama yak›n iyileflmesi de¤erlendirilmifltir 14,[22][23][24][25] . Bu ça-l›flmalar›n sonucunda 3. haftada pimekrolimus, kontrol grubuna göre belirgin olarak daha etkili bulunmufltur.…”

Section: Tart›flmaunclassified

“…Bu ça-l›flmalar›n sonucunda 3. haftada pimekrolimus, kontrol grubuna göre belirgin olarak daha etkili bulunmufltur. Çal›flma-lar›n ikisinde, pimekrolimusun 6 hafta sonunda da kontrol grubuna göre belirgin olarak daha etkili oldu¤u bildirilmifltir 22,23 . Bizim çal›flmam›zda da tedavinin ilerleyen haftalar›n-da baflar› oran› artm›flt›r ve bu art›fl istatistiksel olarak anlaml› bulunmufltur (4 ve 6'nc› haftalar için p=0,005, di¤er haftalar için p<0,0001).…”

Section: Tart›flmaunclassified

Efficacy of Pimecrolimus 1% Cream in Various Clinical Forms of Atopic Dermatitis

İkizler¹,

Karabacak²,

Karabudak³

et al. 2010

turkderm

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ÖzetAmaç: Atopik dermatit bilindi¤i gibi farkl› klinik tiplerde karfl›m›za ç›kar. Bu deneysel çal›flman›n temel amac›, atopik dermatitin bu tipleri aras›nda pimekrolimusun etkinli¤ini karfl›laflt›rmakt›r. Gereç ve Yöntem: Çal›flmaya 2-38 yafllar› aras›nda, 50'si erkek, 20'si kad›n, toplam 70 hasta al›nd›. Hastalar›n 22'si (%31,4) çocuktu (2-10 yafl). Hastalarda, solunum yolu allerjisi, total IgE yüksekli¤i, deri "prick" test pozitifli¤i ve tetikleyici allerjenler araflt›r›ld›. Hastalar Wüthrich s›n›flamas›na göre, "mikst", "pür intrinsik" ve "pür ekstrinsik" olarak s›n›fland›r›ld›. Hastalara 6 hafta boyunca günde iki kez %1 pimekrolimus krem tedavisi uyguland› ve hastalar SCORAD indeksi kullan›larak de¤erlendirildi. Bulgular: Sonuç olarak hastalar›n %58,6's›nda (n=41) tedavi baflar›l›, %4,3'ünde (n=3) tedavi k›smen baflar›l›, %37,1'inde (n=26) tedavi baflar›s›z bulundu. 35 hastada tam remisyon elde edildi. Tedavi öncesi ve sonras›ndaki SCORAD de¤erleri aras›ndaki fark, istatistiksel olarak anlaml› bulundu (p<0,0001). Sonuç: Çal›flmada, mikst, pür intrinsik ve pür ekstrinsik atopik dermatit tipleri aras›nda pimekrolimus etkinli¤i karfl›laflt›r›l-d›¤›nda, pür intrinsik tipte pimekrolimus daha etkili bulunmas›na ra¤men bu durum istatistiksel olarak anlaml› de¤ildi (p=0,75). Yine, pimekrolimus etkinli¤i aç›s›ndan, hafif ve orta fliddetli atopik dermatit hastalar› aras›nda, istatistiksel olarak anlaml› bir fark saptanmad›. (p=0,107) Ayr›ca, bu çal›flmada optimum tedavi süresinin eriflkinlerde yaklafl›k 6 hafta, çocuklarda ise 4 hafta oldu¤u kan›s›na var›ld›. (Türkderm 2010; 44: 83-7) Anahtar Kelimeler: Atopik dermatit, tedavi, pimekrolimus, etkinlik SummaryBackground and Design: Atopic dermatitis shows some different clinical appearances.The main aim of this experimental study is to compare the efficacy of pimecrolimus among these clinical subgoups of atopic dermatitis. Material and Method: A total of 70 patients, 50 male and 20 female, aged between 2-38 years were included in the study. Twenty-two patients (%31.4) were pediatric (2-10 years). Patients were investigated in regard to high levels of total IgE, airway allergy, positive skin prick test and triggering allergens. Patients were classified as: mixed, pure intrinsic and pure extrinsic according to Wüthrich classification. Pimecrolimus 1% cream was applied to the patients twice daily for 6 weeks and patients were evaluated with SCORAD index before and after treatment. Results: FAs a result, 58.6% of the patients (n=41) had a successful therapy with pimecrolimus while 4.3% (n=3) had partially successful. Thirty-five patients achieved full remission. The difference between the SCORADs before and after the treatment was found to be statistically significant (p<0.0001). Conclusion: In this study, efficacy of pimecrolimus was compared to mixed, pure intrinsic and pure extrinsic types of atopic dermatitis. Although pimecrolimus was more effective in the pure intrinsic type, it was not statistically significant (p=0,75). There was also an insignificant difference b...

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Topical pimecrolimus for eczema

Ashcroft

Chen

Garside

et al. 2007

Cochrane Database of Systematic Reviews

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Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants

Cited by 165 publications

References 16 publications

Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

Efficacy of Pimecrolimus 1% Cream in Various Clinical Forms of Atopic Dermatitis

Topical pimecrolimus for eczema

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