Long‐term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two‐year open‐label study

Mandelin, Johanna; Рубинс, Андрис; Remitz, Anita; Cirule, Kristine; Dickinson, James; Ho, Vincent; Mäkelä, Mika J.; Rubins, Silvestrs; Reitamo, Sakari; Undre, Nasrullah

doi:10.1111/j.1365-4632.2011.05015.x

Cited by 35 publications

(32 citation statements)

References 14 publications

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“…The combined mean improvement for the cohort was 63.9%; responders averaged 84.1% improvement and partial to nonresponders averaged 21.7% improvement. While differing in clinical scoring approaches, these results are consistent with previous open-label phase II studies on currently approved topical calcineurin and PDE-4 inhibitors (26,27). In this trial, all adult patients who appeared responsive to treatment reported sustained or even additional clinical improvement after the washout phase ( Figure 2, D and E).…”

Section: R Mucosa Was Associated With Clinical Improvement and Safetsupporting

confidence: 80%

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis

et al. 2018

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Section: R Mucosa Was Associated With Clinical Improvement and Safetsupporting

confidence: 80%

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis

et al. 2018

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“…The efficacy of long‐term monotherapy with tacrolimus ointment has been shown in children and adults . Less data are available for children under 2 years of age . Pimecrolimus cream has been studied in infants and children in a combination regimen with TCS, the latter being given if a flare occurred.…”

Section: Topical Anti‐inflammatory Treatmentmentioning

confidence: 99%

ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients

Wollenberg

Oranje²,

Deleuran

et al. 2016

Acad Dermatol Venereol

359

488

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Atopic dermatitis (AD) is a clinically defined, highly pruritic, chronic inflammatory skin disease of children and adults. The diagnosis is made using evaluated clinical criteria. Disease activity is best measured with a composite score assessing both objective signs and subjective symptoms, such as SCORAD. The management of AD must consider the clinical and pathogenic variabilities of the disease and also target flare prevention. Basic therapy includes hydrating topical treatment, as well as avoidance of specific and unspecific provocation factors. Anti-inflammatory treatment of visible skin lesions is based on topical glucocorticosteroids and the topical calcineurin inhibitors tacrolimus and pimecrolimus. Topical calcineurin inhibitors are preferred in sensitive locations. Tacrolimus and mid-potent steroids are proven for proactive therapy, which is long-term intermittent anti-inflammatory therapy of the frequently relapsing skin areas. Systemic anti-inflammatory or immunosuppressive treatment is indicated for severe refractory cases. Biologicals targeting key mechanisms of the atopic immune response are promising emerging treatment options. Microbial colonization and superinfection may induce disease exacerbation and can justify additional antimicrobial treatment. Systemic antihistamines (H1R-blockers) may diminish pruritus, but do not have sufficient effect on lesions. Adjuvant therapy includes UV irradiation, preferably UVA1 or narrow-band UVB 311 nm. Dietary recommendations should be patient specific and elimination diets should only be advised in case of proven food allergy. Allergen-specific immunotherapy to aeroallergens may be useful in selected cases. Psychosomatic counselling is recommended to address stress-induced exacerbations. 'Eczema school' educational programmes have been proven to be helpful for children and adults.

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“…In addition, there are substantial differences in the number of patients studied (and duration of treatment) with each drug (Table 3) [63, 81, 116–118]. At the time of approval, pimecrolimus cream had been studied in more pediatric patients, including infants, for significantly longer durations, yet the indications for both drugs in these regards are remarkably similar.…”

Section: Critical Evaluation Of the Evidencementioning

confidence: 99%

Topical Calcineurin Inhibitors and Lymphoma Risk: Evidence Update with Implications for Daily Practice

Siegfried

Jaworski

Hebert³

2013

Am J Clin Dermatol

122

128

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Topical calcineurin inhibitors (TCIs), commercially available since 2000–2001, are the first and only topical medications approved for chronic treatment of atopic dermatitis (AD) in pediatric patients and remain a welcomed alternative to topical corticosteroids. In January 2006, the US Food and Drug Administration (FDA) issued a boxed warning requirement based on a theoretical risk of malignancy (including lymphoma) with TCI use. However, in the years since, analyses of epidemiologic and clinical data have failed to demonstrate a causal relationship between TCI use and malignancy or lymphoma risk, especially for pimecrolimus cream. In fact, the observed number of malignancies and lymphomas observed both in post-marketing surveillance and reported to the FDA using its adverse events reporting system is much lower among TCI-exposed patients than the expected number for the general population. Furthermore, among children enrolled in post-marketing pediatric registry studies for both tacrolimus and pimecrolimus followed for up to 5.5 years [10,724 patient-years (PY)] or 6.5 years (16,219 PY), respectively, the observed number of malignancies and lymphomas is very low and similar to the number expected for a sample of similar size in the general population. In addition to reporting these comparative malignancy and lymphoma data, this article provides a historical overview of the boxed warning requirement and critically evaluates the preclinical, clinical, and epidemiological evidence that has thus far failed to substantiate a relationship between TCI use and malignancy. The authors also provide practical clinical advice for optimizing AD management and patient care in the context of the boxed warning.

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Long‐term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two‐year open‐label study

Abstract: Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.

Cited by 35 publications

References 14 publications

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis

ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients

Topical Calcineurin Inhibitors and Lymphoma Risk: Evidence Update with Implications for Daily Practice

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