Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, safety

Soter, Nicholas A.; Fleischer, Alan B.; Webster, Guy F.; Monroe, Eugene W.; Lawrence, Ira

doi:10.1067/mjd.2001.109817

Cited by 218 publications

(199 citation statements)

References 26 publications

Supporting

Mentioning

177

Contrasting

Unclassified

Order By: Relevance

“…All anatomical structures of the kidney may be involved: arterial hyalinosis is frequently irreversible owing to prolonged vasoconstriction or the regulation of NFAT and smooth muscle (14). Tubulointerstitial injuries classically described as stripped fibrosis and tubular atrophy are multifactorial in origin, resulting from an increase in free radicals (15), an upregulation of TGF-b (16) leading to epithelial to mesenchymal transition (52), or an activation of the reninangiotensin-aldosterone system with an increase in aldosterone (53). Other tubular lesions are seen and include isometric tubular vacuolization and inclusion bodies due to an increase in lysozymes and giant mitochondria (54).…”

Section: Nephrotoxicity Of Cnismentioning

confidence: 99%

Calcineurin Inhibitors: 40 Years Later, Can’t Live Without …

Azzi

Sayegh

Mallat

2013

The Journal of Immunology

284

210

View full text Add to dashboard Cite

Calcineurin inhibitors (CNIs) revolutionized the field of organ transplantation and remain the standard of care 40 years after the discovery of cyclosporine. The early impressive results of cyclosporine in kidney transplant recipients led to its subsequent use in other organ transplant recipients and for treatment of a variety of autoimmune diseases as well. In this review, we examine the discovery of CNIs, their mechanism of action, preclinical and clinical studies with CNIs, and the usage of CNIs in nontransplant recipients. We review the mechanisms of renal toxicity associated with CNIs and the recent efforts to avoid or reduce usage of these drugs. Although minimization strategies are possible, safe, and of potential long-term benefit, complete avoidance of CNIs has proven to be more challenging than initially thought.

show abstract

Section: Nephrotoxicity Of Cnismentioning

confidence: 99%

Calcineurin Inhibitors: 40 Years Later, Can’t Live Without …

Azzi

Sayegh

Mallat

2013

The Journal of Immunology

284

210

View full text Add to dashboard Cite

show abstract

“…The main objective was to evaluate whether tacrolimus would be a safer alternative to steroid treatment in the eyelid region by not inducing a rise in IOP. Tacrolimus 0.1% was chosen because of significantly better effect than that of tacrolimus 0.03% without increase in adverse events, 11,12 and because of proven similar anti-inflammatory properties to a midpotent steroid. 19 The clobetasone butyrate ointment was selected because of the ointment-base with White Vaseline that it shares with the tacrolimus formulation on sale in Sweden, thereby facilitating masking.…”

Section: Discussionmentioning

confidence: 99%

“…A serious safety signal of malignant tumour appearance has emerged for systemic tacrolimus treatment, 30 but concerning topical administration, several studies have demonstrated only a minimal absorption of the drug. 12,17,19 However, carcinogenesis at the application site has been shown in a mouse model. 31 In addition, single incidents of malignancy in humans after topical tacrolimus application have been reported, 32 but to date there is no evidence of an increased risk.…”

Section: Discussionmentioning

confidence: 99%

“…9 As an alternative to steroids, tacrolimus ointment is a valid therapeutic option for atopic dermatitis since more than 5 years. [10][11][12] Successful treatment of eyelid eczema in AKC patients has further been documented in case series 7,13 and three noncontrolled open-label studies. [14][15][16] To the best of our knowledge, no comparative trial of tacrolimus ointment and steroid ointment for eyelid dermatitis has been performed.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis

Nivenius

Ploeg

Jung³

et al. 2006

Eye

View full text Add to dashboard Cite

Aims The main objective of this explorative study was to evaluate if tacrolimus ointment could be safer than corticosteroid ointment, with special reference to the intraocular pressure in the treatment of eyelid eczema in patients with atopic keratoconjunctivitis (AKC). Secondary aims were to compare the effects of the treatments on eyelid eczema and their potential impact on ocular surface inflammation. Methods Tacrolimus 0.1% ointment and clobetasone butyrate 0.05% ointment were compared in a double-masked explorative crossover study. In total, 25 AKC patients were included. Each ointment was applied twice daily for 3 weeks, with 2 weeks of washout before, between, and after treatments. Efficacy was determined by eye examination and the patients' own symptom scoring. Cytology and cytokine measurements were performed on tear samples. Safety parameters were intraocular pressure, presence of bacteria and fungi, and the patients' reports of adverse events. The validity of the crossover design was explored with analysis of variance, and the effect of each medication was calculated with paired t-test and Wilcoxon paired test. Results A total of 20 patients completed the study. Both treatments were effective in reducing signs and symptoms of eyelid eczema, with a near superior benefit for tacrolimus in terms of eczema (total skin score) signs (P ¼ 0.05). No serious adverse events occurred and interestingly, intraocular pressure was not evidently affected by either treatment. Conclusion Tacrolimus 0.1% ointment is a promising alternative therapy for eyelid eczema in AKC patients. Long-term studies are needed to further determine the value of tacrolimus in this patient group.

show abstract

“…Níveis séricos mais elevados ocorreram de maneira significativa entre pacientes com extensas áreas acometidas, com lesões mais graves, com maior quantidade de medicamento utilizada ou em pacientes de raça negra. Esses estudos mostraram ainda não haver diferenças significativas entre os efeitos adversos relatados nas populações com relação às diferenças de níveis séricos detectados 22,23 .…”

Section: Conhecendo O Tacrolimounclassified

Calcineurin inhibitors in the treatment of allergic dermatitis

Castro

2006

J Pediatr (Rio J)

View full text Add to dashboard Cite

Objective: To review the role of calcineurin inhibitors in the treatment of allergic dermatitis, focusing on mechanisms of action, efficacy and topical and systemic adverse effects.Sources: Articles written in English and published in MEDLINE using the following keywords: pimecrolimus, tacrolimus, calcineurin inhibitors. Original articles that presented controlled and open studies for assessing efficacy, tolerability and adverse effects were selected. Review articles and case series were also evaluated; the latter was only considered for assessing adverse effects. The official websites of the Food and Drug Administration and of manufacturers of calcineurin inhibitors were also used. Summary of the findings:The data showed that calcineurin inhibitors are efficient in the treatment of mild to severe atopic dermatitis, leading to improvement in symptoms, reduction in number of attacks and need of topical corticotherapy. Calcineurin inhibitors have good tolerability and few topical adverse effects. To date, there has been no evidence to support higher prevalence of neoplasia in patients using these drugs; however, an adequate pharmacovigilance system has been set up to assess this aspect. Conclusions:Calcineurin inhibitors, which are a new drug class in the treatment of allergic dermatitis, are efficient, well tolerated and have few adverse effects. Calcineurin inhibitors should always be used according to recommended guidelines, and patients should always be followed by the physician during and after their administration.J Pediatr (Rio J). 2006;82(5 Suppl):S166-72: Pimecrolimus, tacrolimus, calcineurin inhibitors. ResumoObjetivo: Revisar o papel dos inibidores da calcineurina no tratamento das dermatoses alérgicas, com ênfase nos mecanismos de ação, eficácia e efeitos adversos tópicos e sistêmicos.Fontes dos dados: Artigos de língua inglesa publicados na MEDLINE, considerando as palavras chave: pimecrolimus, tacrolimo, calcineurin inhibitors. Foram selecionados os artigos originais que apresentaram estudos controlados e estudos abertos para avaliação da eficácia, tolerabilidade e eventos adversos. Também foram avaliados artigos de revisão e relatos e série de casos, sendo estes últimos considerados apenas para avaliação de efeitos adversos. Foram consultados os sites oficiais da Food and Drug Administration e dos fabricantes de inibidores da calcineurina. Síntese dos dados:Os dados mostraram que inibidores de calcineurina são eficientes no tratamento da dermatite atópica leve a grave, levando a melhora dos sintomas, diminuição do número de crises e necessidade de corticoterapia tópica. Apresentam boa tolerabilidade e poucos efeitos adversos tópicos. Até o momento, não há evidências que sustentem a maior prevalência de neoplasias nos pacientes que utilizam esses medicamentos; entretanto, um adequado sistema de farmacovigilância está montado para avaliar esse aspecto.Conclusões: Os inibidores de calcineurina são uma nova classe de medicamentos para o tratamento das dermatoses alérgicas. São eficazes, tolerado...

show abstract

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: Part II, safety

Cited by 218 publications

References 26 publications

Calcineurin Inhibitors: 40 Years Later, Can’t Live Without …

Calcineurin Inhibitors: 40 Years Later, Can’t Live Without …

Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis

Calcineurin inhibitors in the treatment of allergic dermatitis

Contact Info

Product

Resources

About