Background
Atopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically Tacrolimus ointment (in its 2 manufactured strengths of 01% and 003%) might be an alternative treatment Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs)

Objectives
To assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments

Search methods
We searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database) We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials We contacted specialists in the field for unpublished data

A separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013 We also scrutinised the US Food and Drug Administration (FDA) websites for adverse effects information

Selection criteria
All randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments

Data collection and analysis
Two authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as SCORAD (SCORing Atopic Dermatitis), the EASI (Eczema Area and Severity Index), and BSA (Body Surface Area) scores

Main results
We included 20 studies, with 5885 participants The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses

A single trial showed that tacrolimus 01% was better than low-potency TCS by the physician's assessment (risk ratio (RR) 309, 95% confidence interval (CI) 214 to 445, 1 study, n = 371, moderate-quality evidence) It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 132, 95% CI 117 to 149, 1 study, n = 972, moderate level of evidence) and for some of the secondary outcomes Compared with pimecrolimus 1%, people treated with tacrolimus were almost twice as likely to improve by the physician's assessment (RR 180, 95% CI 134 to 242, 2 studies, n = 506, moderate quality of evidence) Compared with the lower concentration of 003%, the tacrolimus 01% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 082, 95% CI 072 to 092, 6 studies, n = 1640, high-quality evidence) Tacrolimus 01% compared with moderate-to-potent TCS showed no difference by the physician's assessment, and 2 secondary outcomes (1 study, 377 participants) and a marginal benefit favouring tacrolimus 01% was found by the participant's assessment (RR 121, 95% CI 113 to 129, 1 study, n = 974, low quality of evidence) and SCORAD

Based on data from 2 trials, tacrolimus 003% was superior to mild TCS for the physician's assessment (RR 258, 95% CI 196 to 338, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 164, 95% CI 141 to 190, 1 study, n = 416, moderate quality of evidence) One trial showed moderate benefit of tacrolimus 003% compared with pimecrolimus 1% on the physician's assessment (RR 142, 95% CI 102 to 198, 1 study, n = 139, low-quality evidence), but the effects were equivocal when evaluating BSA In the comparison of tacrolimus 003% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes), but in two studies, a marginal benefit favouring the corticosteroid group was found for the EASI and BSA scores

Burning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 003% (RR 248, 95% CI 196 to 314, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections Symptoms observed were mild and transient The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects

Serious adverse events were rare; occurred in both the tacrolimus and corticosteroid groups; and in most cases, were considered to be unrelated to the treatment No cases of lymphoma were noted in the included studies nor in the non-comparative studies Cases were only noted in spontaneous reports, cohorts, and case-control studies Systemic absorption was rarely detectable, only in low levels, and this decreased with time Exception is made for diseases with severe barrier defects, such as Netherton's syndrome, lamellar ichthyosis, and a few others, with case reports of a higher absorption We evaluated clinical trials; case reports; and in vivo, in vitro, and animal studies; and didn't find any evidence that topical tacrolimus could cause skin atrophy

Authors' conclusions
Tacrolimus 01% was better than low-potency corticosteroids, pimecrolimus 1%, and tacrolimus 003% Results were equivocal when comparing both dose formulations to moderate-to-potent corticosteroids Tacrolimus 003% was superior to mild corticosteroids and pimecrolimus Both tacrolimus formulations seemed to be safe, and no evidence was found to support the possible increased risk of malignancies or skin atrophy with their use The reliability and strength of the evidence was limited by the lack of data; thus, findings of this review should be interpreted with caution We did not evaluate costs

/pdf/topical-tacrolimus-for-atopic-dermatitis-29cfs9cyxp.pdf

Topical tacrolimus for atopic dermatitis.

The goal of this study was to perform a meta-analysis on randomized controlled trials of topical therapies compared against their vehicles, and systemic therapies compared against their placebos, and to record how these therapies changed the magnitude of pruritus associated with atopic dermatitis. A systematic search of the literature was performed using Medline, Embase, and the Cochrane Controlled Clinical Trials Register, as well as follow-up references in retrieved articles. Data regarding the magnitude of the change in pruritus was extracted from eligible publications and categorized according to the type of treatment modality. Standard inverse variance fixed-effects meta-analysis was used to calculate the pooled estimates for randomized controlled trials falling under each type of treatment. Overall, the topical treatments were more successful at reducing atopic pruritus compared to the systemic treatments. Calcineurin inhibitors were the most effective antipruritic agent. Key words: pruritus; atopic dermatitis; eczema; meta-analysis.

Relieving the pruritus of atopic dermatitis: a meta-analysis.

Background: Eczema is a very common chronic inflammatory skin condition.
Objectives: To update the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) systematic review of treatments for atopic eczema, published in 2000, and to inform health-care professionals, commissioners and patients about key treatment developments and research gaps.
Data sources: Electronic databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Skin Group Specialised Register, Latin American and Caribbean Health Sciences Literature (LILACS), Allied and Complementary Medicine Database (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched from the end of 2000 to 31 August 2013. Retrieved articles were used to identify further randomised controlled trials (RCTs).
Review methods: Studies were filtered according to inclusion criteria and agreed by consensus in cases of uncertainty. Abstracts were excluded and non-English language papers were screened by international colleagues and data were extracted. Only RCTs of treatments for eczema were included, as other forms of evidence are associated with higher risks of bias. Inclusion criteria for studies included availability of data relevant to the therapeutic management of eczema; mention of randomisation; comparison of two or more treatments; and prospective data collection. Participants of all ages were included. Eczema diagnosis was determined by a clinician or according to published diagnostic criteria. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. We used a standardised approach to summarising the data and the assessment of risk of bias and we made a clear distinction between what the studies found and our own interpretation of study findings.
Results: Of 7198 references screened, 287 new trials were identified spanning 92 treatments. Trial reporting was generally poor (randomisation method: 2% high, 36% low, 62% unclear risk of bias; allocation concealment: 3% high, 15% low, 82% unclear risk of bias; blinding of the intervention: 15% high, 28% low, 57% unclear risk of bias). Only 22 (8%) trials were considered to be at low risk of bias for all three criteria. There was reasonable evidence of benefit for the topical medications tacrolimus, pimecrolimus and various corticosteroids (with tacrolimus superior to pimecrolimus and corticosteroids) for both treatment and flare prevention; oral ciclosporin; oral azathioprine; narrow band ultraviolet B (UVB) light; Atopiclair™ and education. There was reasonable evidence to suggest no clinically useful benefit for twice-daily compared with once-daily topical corticosteroids; corticosteroids containing antibiotics for non-infected eczema; probiotics; evening primrose and borage oil; ion-exchange water softeners; protease inhibitor SRD441 (Serentis Ltd); furfuryl palmitate in emollient; cipamfylline cream; and Mycobacterium vaccae vaccine. Additional research evidence is needed for emollients, bath additives, antibacterials, specialist clothing and complementary and alternative therapies. There was no RCT evidence for topical corticosteroid dilution, impregnated bandages, soap avoidance, bathing frequency or allergy testing.

Scoping systematic review of treatments for eczema

Atopic eczema (AE) is a common chronic inflammatory skin condition. Whilst many AE treatment options are available, the evidence to support their efficacy varies in depth and quality. In 2000, an NIHR HTA systematic review identified and evaluated existing randomised controlled trials (RCTs) of AE treatments. To ensure continuing utility, the NIHR commissioned an update to the review. Here, we present an overview of the updated report and key findings.
Systematic reviews and RCTs of AE treatments that included participants with AE (criteria based or diagnosed) were identified using: MEDLINE, EMBASE, CENTRAL, LILACS, AMED, CINAHL and Cochrane Skin Group Specialised Register (searched to August 31st 2013 (RCTs) and 31st December 2015 (systematic reviews)). Outcome measures included: symptoms, AE severity, quality-of-life, and adverse effects. Study quality was assessed using the Cochrane Collaboration risk of bias tool.
Of the 287 new RCTs identified, only 22 (8%) were judged to be low risk of bias. When combined with RCTs from the previous review (n= 254), we found ‘reasonable evidence of benefit’ for corticosteroids, calcineurin inhibitors, Atopiclair™, ciclosporin, azathioprine, ultraviolet light and education programmes.
Interventions with reasonable evidence of ‘no benefit’ included some dietary interventions, ion exchange water softeners, multiple daily applications of topical corticosteroids and antibiotic-containing corticosteroids for non-infected AE. Many common treatments lack evidence of efficacy and warrant further evaluation.
The evidence base for AE is still hampered by poor trial design and reporting. The trials included in this review were used to establish the Global Resource of Eczema Trials (GREAT) Database.

/pdf/what-is-the-evidence-base-for-atopic-eczema-treatments-a-4z1j63l2pt.pdf

What is the evidence base for atopic eczema treatments? A summary of published randomized controlled trials.

It is unclear which quality of life instruments have thus far been used in eczema trials. Therefore, we aimed to identify these instruments. We searched the Global Resource of Eczema Trials (GREAT) database for reports of randomized controlled trials. Information on patient-reported outcomes, particularly quality of life, was extracted from eligible studies. 287 full texts reporting on 303 trials and 72 abstracts were included. 63/303 studies (20.8%) assessed quality of life and used 18 named and 4 unnamed instruments. The Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI), the Infant's Dermatitis Quality of Life Index (IDQOL), and the Dermatitis Family Impact (DFI) were the most common measures in adults, children, infants, and caregivers, respectively. In conclusion, only about one fifth of eczema trials include a quality of life measure as outcome. Many different instruments are used, limiting the possibilities of comparing and synthesising individual trials' findings.

http://epub.uni-regensburg.de/33333/1/607%29%204610.pdf

Eczema Trials: Quality of Life Instruments Used and Their Relation to Patient-Reported Outcomes. A Systematic Review

Background Mainstay treatments for atopic dermatitis include cutaneous hydration, antihistamines and topical glucocorticoids. To avoid side effects associated with long term and higher potency topical corticosteroids, further topical immunosuppressive agents should be tried. Topical tacrolimus has been extensively studied and shows promise in treatment of inflammatory skin diseases such as atopic dermatitis. Objective To determine the safety and efficacy of tacrolimus in atopic dermatitis. Patients and method In this randomized, case-control study, out of 60 patients with atopic dermatitis (age ranging 2 to 45 years), 30 (case) were treated with tacrolimus (0.03%) ointment twice daily and 30 (control) were treated with vaseline twice daily for up to 3 weeks. Evaluation included per cent body durface area (%BSA) affected, individual signs of atopic dermatitis, the Severity Score of Atopic dermatitis (SCORAD), and the patient’s assessment of pruritus. Result The outcome variables like erythema, edema/papulation, oozing/crusting, excoriation, pruritus, body surface area involved and SCORAD in the case group improved significantly compared to those in the control group (p< 0.001, <0.001, <0.001, <0.005, <0.001, <0.001 and <0.001, respectively). After 3 weeks of tacrolimus, all variables except lichenification score responded significantly. Significantly higher number complained of burning sensation in cases (20%) as compared to none in the control group. Conclusion Topical 0.03% tacrolimus is more effective than the vehicle alone.

https://www.jpad.com.pk/index.php/jpad/article/view/572/545

Efficacy of topical tacrolimus in atopic dermatitis

Background Mainstay treatments for atopic dermatitis include cutaneous hydration, antihistamines and topical glucocorticoids. To avoid side effects associated with long term and higher potency topical corticosteroids, further topical immunosuppressive agents should be tried. Topical tacrolimus has been extensively studied and shows promise in treatment of inflammatory skin diseases such as atopic dermatitis. Objective To determine the safety and efficacy of tacrolimus in atopic dermatitis. Patients and method In this randomized, case-control study, out of 60 patients with atopic dermatitis (age ranging 2 to 45 years), 30 (case) were treated with tacrolimus (0.03%) ointment twice daily and 30 (control) were treated with vaseline twice daily for up to 3 weeks. Evaluation included per cent body durface area (%BSA) affected, individual signs of atopic dermatitis, the Severity Score of Atopic dermatitis (SCORAD), and the patient's assessment of pruritus. Result The outcome variables like erythema, edema/papulation, oozing/crusting, excoriation, pruritus, body surface area involved and SCORAD in the case group improved significantly compared to those in the control group (p< 0.001, <0.001, <0.001, <0.005, <0.001, <0.001 and <0.001, respectively). After 3 weeks of tacrolimus, all variables except lichenification score responded significantly. Significantly higher number complained of burning sensation in cases (20%) as compared to none in the control group. Conclusion Topical 0.03% tacrolimus is more effective than the vehicle alone.

Efficacy of topical tacrolimus in atopic

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Efficacy of topical tacrolimus in atopic dermatitis

Efficacy of topical tacrolimus in atopic