Jonathan Batchelor

The Eczema Priority Setting Partnership: a collaboration between patients, carers, clinicians and researchers to identify and prioritize important research questions for the treatment of eczema.

Background  Eczema is a common condition, yet there are uncertainties regarding many frequently used treatments. Knowing which of these uncertainties matter to patients and clinicians is important, because they are likely to have different priorities from those of researchers and funders.

What's new in atopic eczema? An analysis of systematic reviews published in 2008 and 2009.

This review summarizes clinically important findings from nine systematic reviews of the causes, treatment and prevention of atopic eczema (AE) published between August 2008 and August 2009. Two systematic reviews concluded that there is a strong and consistent association between filaggrin (FLG) mutations and development of eczema. The associations between FLG mutations and atopic sensitization, rhinitis and asthma are weaker than between FLG mutations and eczema, especially if those who also have eczema are excluded. The relationship between transforming growth factor levels in breast milk and eczema development is still unclear. A further systematic review found no strong evidence of a protective effect of exclusive breastfeeding for at least 3 months against eczema, even in those with a positive family history of atopy. Based on a systematic review and meta‐analysis of six randomized controlled trials, supplementation with omega‐3 and omega‐6 oils is unlikely to play an important role in the primary prevention of eczema or allergic diseases in general. There is little evidence to support dietary restrictions of certain foods in unselected children with AE. There is also little evidence to suggest a clinically useful benefit from using probiotics in patients with established eczema. A systematic review of topical pimecrolimus and tacrolimus added little additional information to previous reviews, and did not provide any new data on long‐term safety. Both of these drugs work in AE, and may reduce flares and usage of topical corticosteroids; however, there is still uncertainty about how they compare with topical corticosteroids.

Feasibility, double-blind, randomised, placebo- controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trial: Home Intervention of Light therapy)

BackgroundHand-held NB-UVB units are lightweight devices that may overcome the need to treat vitiligo in hospital-based phototherapy cabinets, allowing early treatment at home that may enhance the likelihood of successful repigmentation. The pilot Hi-Light trial examined the feasibility of conducting a large multi-centre randomised controlled trial (RCT) on the use of such devices by exploring recruitment, adherence, acceptability, and patient education.MethodsThis was a feasibility, double-blind, multi-centre, parallel group randomised placebo-controlled trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home. The overall duration of the trial was seven months; three months recruitment and four months treatment. Participants were randomly allocated to active or placebo groups (2:1 ratio). The primary outcome measure was the proportion of eligible participants who were willing to be randomised. The secondary outcomes included proportion of participants expressing interest in the trial and fulfilling eligibility criteria, withdrawal rates and missing data, proportion of participants adhering to and satisfied with the treatment, and incidence of NB-UVB short-term adverse events.ResultsEighty-three percent (45/54) of vitiligo patients who expressed interest in the trial were willing to be randomised. Due to time and financial constraints, only 29/45 potential participants were booked to attend a baseline hospital visit. All 29 (100%) potential participants were confirmed as being eligible and were subsequently randomised. Willingness to participate in the study for General Practice (family physicians) surgeries and hospitals were 40% and 79%, respectively; 86% (25/29) of patients adhered to the treatment and 65% (7/11) of patients in the active group had some degree of repigmentation. Only one patient in the active group reported erythema grade 3 (3%). Both devices (Dermfix 1000 NB-UVB and Waldmann NB-UVB 109) were acceptable to participants.ConclusionsHand-held NB-UVB devices need evaluation in a large, pragmatic RCT. This pilot trial has explored many of the uncertainties that need to be overcome before embarking on a full scale trial, including the development of a comprehensive training package and treatment protocol. The study has shown strong willingness of participants to be randomised, very good treatment adherence and repigmentation rates, and provided evidence of feasibility for a definitive trial.Trial registrationNCT01478945

Silk garments plus standard care compared with standard care for treating eczema in children: a randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial)

Background The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. Methods and findings This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of −1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Trial registration Current Controlled Trials ISRCTN77261365

Validation of the Vitiligo Noticeability Scale: a patient‐reported outcome measure of Vitiligo treatment success

Patient‐reported outcome measures are rarely used in vitiligo trials. The Vitiligo Noticeability Scale (VNS) is a new patient‐reported outcome measure assessing how ‘noticeable’ vitiligo patches are after treatment. The noticeability of vitiligo after treatment is an important indicator of treatment success from the patients perspective.

Adalimumab vs Methotrexate for the Treatment of Chronic Plaque Psoriasis

Jonathan M. Batchelor, BMedSci, BM BS, MRCP(UK); John R. Ingram, DM, MRCP(UK); Hywel Williams, MSc, PhD, FRCP; Department of Dermatology, Addenbrooke’s Hospital, Cambridge, England (Dr Batchelor); Department of Dermatology, University Hospital of Wales, Heath Park, Cardiff (Dr Ingram); Centre of Evidence-Based Dermatology, University of Nottingham, King’s Meadow Campus, Nottingham, England (Dr Williams)

Alitretinoin as a potential advance in the management of severe chronic hand eczema

Question: Is oral alitretinoin, at a dose of 10 or 30 mg once daily, an effective and safe treatment for severe chronic hand eczema (CHE) refractory to topical corticosteroids? Design: Randomized controlled trial. Setting: Multicenter trial performed in 111 dermatology outpatient clinics in Europe and Canada. Patients: A total of 1032 patients with severe chronic hand eczema of at least 6 months’ duration and refractory to standard therapy were randomized; 759 completed the trial period. Study groups had similar baseline characteristics. Interventions: Participants were randomized in a 1:2:2 ratio to receive placebo, 10-mg alitretinoin doses, or 30-mg alitretinoin doses daily for 24 weeks (or only 12 weeks if their hand eczema responded to treatment by this time). Main Outcome Measures: The primary end point was treatment response, defined as a physician global assessment (PGA) of “clear” or “almost clear” at the end of therapy. Secondary end points included time to relapse during a further 24 weeks of follow-up after treatment discontinuation and a patient global assessment (PaGA) of “clear” or “almost clear” at the end of therapy. Results: Treatment response occurred in 48%, 28%, and 17% of patients in the 30-mg alitretinoin, 10-mg alitretinoin, andplacebogroups, respectively (P .001when tested for heterogeneity with the Pearson 2 test). The difference between both alitretinoin doses and placebo were statistically significant (P .001 for 30-mg and P=.004 for 10-mg doses compared with placebo). These response rates correspond to a number needed to treat (NNT) of about 4 (95% confidence interval [CI], 2.63-4.25) for 30-mg alitretinoin and 10 (95% CI, 5.76-23.42) for 10-mg alitretinoin compared with placebo. Median time to relapse was 5.5, 6.2, and 5.4 months for the 30-mg, 10-mg, and placebo groups, respectively. The PaGA response was 40%, 24%, and 15% in the 3 groups, respectively. Headache was the most common adverse event and occurred in 20%, 11%, and 6% in the 3 groups, respectively.

The prevalence of psychological co-morbidity in people with vitiligo: a systematic review and meta-analysis

Vitiligo is a chronic disorder causing skin depigmentation with global prevalence varying from 0·2% to 1·8%. U.K. guidelines recommend assessment of psychological state during clinical evaluation of vitiligo. However, the prevalence of psychological comorbidity in people with vitiligo has not been described.

Prospective registration of clinical trials published in the British Journal of Dermatology

Readers of the BJD will know that reports of randomized controlled clinical trials (RCTs) are a core component of the journal’s content. Indeed, high-quality reports of RCTs are at the heart of the journal’s aim to publish the highest-quality dermatology research. A recent editorial by Williams highlighted the journal’s long history of publishing high-quality, highly cited trials. One of this editorial’s authors (J.B.) is Clinical Trials Section Editor for the BJD. This role involves reviewing all RCTs submitted to the journal and ensuring they are reported in a clear and transparent manner. In order to encourage this, the journal requests that all submissions of RCTs include a completed CONSORT checklist (www.consort-statement.org). We aim for the RCTs published in the BJD to be reported clearly enough for readers to be able to make their own judgements of their quality and validity. So far, so good. But does this mean that the BJD has its house fully in order with respect to the RCTs it publishes? Well, not quite. There are two sources of bias in RCT reporting that can have a detrimental impact on the scientific record, and the BJD needs to play its part in avoiding them. The first of these is publication bias. Instead of considering only the RCTs that are published, it is also worth considering those that never see the light of day. It is a well-known fact that as many as 50% of trials never get published. This ‘publication bias’ may exist because the trialists decide that it is not worth trying to publish their results if they do not identify an exciting new treatment that is going to transform care. Journals are also guilty of tending to be more interested in studies that show ‘positive’ findings; this has been demonstrated in the dermatology literature.

Quality of life in people with vitiligo: a systematic review and meta-analysis

Vitiligo is cosmetically disfiguring and has profound psychosocial effects due to stigmatization, problems in sexual function, anxiety, self-esteem and difficulty finding employment. Previous studies suggest a reduction in quality of life (QoL) due to vitiligo, but to date no systematic review has quantified this in comparison to people without vitiligo. Therefore, the aim of this review was to compare QoL in people with and without vitiligo.