British journal of dermatology.
`v. 171, no. 5 (Nov. 2014)
`General Collection
`W1 BR526
`2015-01-20 11:02:07
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`British Journal of Dermatology
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`1888-2014
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`OFFICIAL JOURNAL OFTHE BRITISH ASSOCIATION or DERMATOLOGISTS
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`CFAD V. Anacor, IPR2015-01776 ANACOR EX. 2166 - 2/25
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`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2166 - 2/25
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`

`
`British Journal of Dermatology
`Volume 171, Number 5, November 2014
`
`CONTENTS
`
`(:3
`
`Snippets
`
`Editor's Choice—selected highlights from BJD 17 1 (5)
`Clinical Snippets—selected highlights from IID 134(1 1)
`
`Editorials
`
`The quest for excellence (part 1): becoming a reviewer for the British Journal of Dcrnmtology
`].R.INGRAM
`
`Global dermatology: more than the sum ofits parts it.J,n,\Y
`I’hotoder1natology over the past 125 years tt.i<(>rL,\Ni>'1‘s
`
`Commentaries
`
`Tidying up the diversity ofIgG-‘1--related skin disease v.n,\ M Aoucin AND Mi()iIYAM:\
`Radiotherapy for skin cancer: as good as surgery? 1=.ts,\Rt<E‘i‘iti_ia1-:
`Hair diameter vs. hair density in male androgenetic alopecia It.oi<UY,\MA
`BARAF, naevi and melanoma: a complex relationship I-t.i<1‘r'rLL-‘it
`Advanced basal cell carcinoma: how rare is the diagnosis? l3,:\./\1_DABz\GlI AND S.T.ARRON
`Hand eczema and tobacco: lifting the smoke screen 'i‘.AGNI:'R
`Lifestyle intervention should be an essential component ofmetlical care for skin disease:
`a challenging task I..N/\Ll)I
`Psoriatic nail disease, a predictor ofpsoriatic arthritis R.i'n\R,\N AND ii.sioUitt;i_=iiissoN
`
`Guidelines
`
`British Association of Dermatologists’ guidelines for the management ofonychomycosis
`20l;1‘M.1\l\/llll£N_J‘T.l.ll/\ll, V.M;\I),\N, M.i=.Motit> Mus'r,\i>,\ AND M.i:1cti,\iit>soN
`
`Review articles
`
`IgG-'i-—related skin disease Y.'I‘OKUl’.:\, ii.r,\t:1, ll.Yr\Ni\GII(‘iiI, Y M:\]tM.\, :\iK:\SUY:\, TITO
`M.M.\ui<.\vv,\ AND it ii/\SlIIZUMl:'
`
`Utility of radiotherapy for treatment ofbasal cell carcinoma: a review M.t‘IlO, L GORl)()N
`.\.iu:Mi3iisL,\i< AND 'r.c.s‘woo
`
`Meeting report
`
`Pachyonychia congenita cornered: report on the 1 1th Aimual International Pachyonychia
`Congenita Consortium Meeting I€.A.()"I'OOL1:',
`it.t..i<,\st=,\1t, L-:st>1tueii1;n, M.iz.sc1i\v,\iz'rz /\Ni)
`i..it1rTIiE
`
`Cover Pliotograpli
`Psetitlolytnphoina. Br] Dcrniutiil I71: ‘)S‘)—67.
`
`This material was copied
`at‘ the NLM and may be
`SL2 Eject US {iciiayright Laws
`
`
`
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`
`
`
`
`
`CFAD v. Anacor, IPR2015-01776 ANACOR EX. 2166 - 3/25
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`

`
`G U I D E L I N E S
`
`BJD
`British Journal of Dermatology
`
`British Association of Dermatologists’ guidelines
`for the management of onychomycosis 2014
`M. Ameen,1 J.T. Lear,2,3 V. Madan,2,3 M.F. Mohd Mustapa4 and M. Richardson2,5
`
`1Royal Free London NHS Foundation Trust, Pond Street, London NW3 2QG, U.K.
`2Manchester Academic Health Science Centre (MAHSC), University of Manchester, 46 Grafton Street, Manchester M13 9NT, U.K.
`3Salford Royal NHS Foundation Hospital, Stott Lane, Salford M6 8HD, U.K.
`4British Association of Dermatologists, Willan House, 4 Fitzroy Square, London W1T 5HQ, U.K.
`5Mycology Reference Centre Manchester, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, U.K.
`
`Correspondence
`Mahreen Ameen.
`E-mail: m.ameen@nhs.net
`
`Accepted for publication
`21 July 2014
`
`Funding sources
`None.
`
`Conflicts of interest
`J.T.L. has acted as a consultant for Novartis (nonspecific); M.R. has acted as a
`consultant for Reckitt Benckiser (specific).
`
`The authors are listed in alphabetical order.
`
`M.A., J.T.L., V.M. and M.R. are members of the guideline development group,
`with technical support provided by M.F.M.M.
`
`This is an updated guideline prepared for the British Association of Dermatologists
`(BAD) Clinical Standards Unit, which includes the Therapy & Guidelines (T&G)
`Subcommittee. Members of the Clinical Standards Unit who have been involved are
`J.R. Hughes (Chairman T&G), A. Sahota, M. Griffiths, A.J. McDonagh, S. Pun-
`jabi, D.A. Buckley, I. Nasr, V.J. Swale, C.E. Duarte Williamson, P.M. McHenry,
`N.J. Levell, T. Leslie, E. Mallon, K. Towers (British National Formulary), R. Davis
`(British Dermatological Nursing Group), C. Saunders (British Dermatological Nurs-
`ing Group), S.E. Haveron (BAD Scientific Administrator), L.S. Exton (BAD Infor-
`mation Scientist) and M.F. Mohd Mustapa (BAD Clinical Standards Manager).
`
`Produced in 2003 by the British Association of Dermatologists; reviewed and
`updated 2014
`
`1.0 Purpose and scope
`
`The overall objective of the guideline is to provide up-to-date,
`evidence-based recommendations for the management of ony-
`chomycosis. The document aims to (i) offer an appraisal of all
`relevant literature since January 2002, focusing on any key
`developments; (ii) address important, practical clinical ques-
`tions relating to the primary guideline objective, for example
`accurate diagnosis and identification of cases, and suitable
`treatment to minimize the duration of disease and discomfort;
`(iii) provide guideline recommendations and, where appropri-
`ate, with some health economic implications; and (iv) discuss
`potential developments and future directions.
`The guideline is presented as a detailed review with high-
`lighted recommendations for practical use in the clinic,
`in
`addition to an updated patient information leaflet [available
`on the British Association of Dermatologists’ (BAD) website,
`www.bad.org.uk].
`
`2.0 Stakeholder involvement and peer review
`
`The guideline development group consisted of consultant der-
`matologists and a consultant mycologist. The draft document
`was circulated to the BAD membership, the British Dermato-
`logical Nursing Group, the Primary Care Dermatological Soci-
`ety and the North West Region Kidney Patient Association for
`comments, and was peer reviewed by the Clinical Standards
`Unit of the BAD (made up of the Therapy & Guidelines Sub-
`committee) prior to publication.
`
`DOI 10.1111/bjd.13358
`
`3.0 Methodology
`
`NICE has accredited the process used by the British Association of
`Dermatologists to produce guidelines. Accreditation is valid for 5 years
`from May 2010. More information on accreditation, and full details of
`our accreditation can be viewed at www.nice.org.uk/accreditation.
`
`This set of guidelines has been developed using the BAD’s rec-
`ommended methodology1 and with reference to the Appraisal
`of Guidelines Research and Evaluation (AGREE II) instrument
`(www.agreetrust.org).2 Recommendations were developed for
`implementation in the National Health Service using a process
`of considered judgement based on the evidence. The PubMed,
`Medline and Embase databases were searched for meta-analy-
`ses, randomized and nonrandomized controlled clinical trials,
`case series, case reports and open studies involving onycho-
`mycosis published in the English language from January 2002
`
`© 2014 British Association of Dermatologists
`
`British Journal of Dermatology (2014) 171, pp937–958
`
`937
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`
`938 BAD guidelines for onychomycosis 2014, M. Ameen et al.
`
`to February 2014; search terms and strategies are detailed in
`Data S1 (see Supporting Information). Additional relevant ref-
`erences were also isolated from citations in the reviewed liter-
`ature, as well as
`from additional,
`independent
`targeted
`literature searches carried out by the coauthors. The prelimin-
`ary results were split into four, with each consultant coauthor
`screening the identified titles; those relevant for first-round
`inclusion were selected for further scrutiny. The abstracts for
`the shortlisted references were then reviewed and the full
`papers of relevant material were obtained. The structure of the
`guidelines was then discussed and different coauthors were
`allocated separate subsections. Each coauthor then performed a
`detailed appraisal of the relevant literature, and all subsections
`were subsequently collated and edited to produce the final
`guidelines.
`
`Trichophyton rubrum, followed by Trichophyton interdigitale. Zoophilic
`species are seldom involved, and usually only in fingernail
`infections.
`
`6.2 Epidemiology
`
`Onychomycosis is among the most common nail disorders in
`adults, accounting for 15–40% of all nail diseases.7 Onycho-
`mycosis is most prevalent in older adults but, because of the
`limited number of large-scale studies, the actual incidence of
`the condition is difficult to assess. Moreover, many reports do
`not distinguish between dermatophytosis and other forms of
`onychomycosis, or between infections of the fingernails and
`toenails. It has been estimated that onychomycosis occurs in
`about 3% of the adult population in the U.K.8
`
`4.0 Limitations of the guideline
`
`6.3 Aetiology
`
`This document has been prepared on behalf of the BAD and is
`based on the best data available when the document was pre-
`pared. It is recognized that under certain conditions it may be
`necessary to deviate from the guidelines and that the results of
`future studies may require some of
`the recommendations
`herein to be changed. Failure to adhere to these guidelines
`should not necessarily be considered negligent, nor should
`adherence to these recommendations constitute a defence
`against a claim of negligence. Limiting the review to English
`language references was a pragmatic decision but the authors
`recognize that this may exclude some important information
`published in other languages.
`
`5.0 Plans for guideline revision
`
`The proposed revision for this set of recommendations is
`scheduled for 2019; where necessary,
`important
`interim
`changes will be updated on the BAD website.
`
`6.0 Background
`
`6.1 Definition
`
`The term tinea unguium is used to describe dermatophyte
`infections of the fingernails or toenails.3–5 Onychomycosis is a
`less specific term used to describe fungal disease of the nails.
`The condition is worldwide in distribution. In addition to der-
`matophytes, it can be caused by a number of other moulds
`and by Candida species. Some of the contributing factors caus-
`ing this disease are occlusive footwear, repeated nail trauma,
`genetic predisposition and concurrent disease, such as diabe-
`tes, poor peripheral circulation and HIV infection, as well as
`other forms of immunosuppression.
`There is wide geographical and racial variation in the aetio-
`logical agents of onychomycosis, but in the U.K. 85–90% of
`nail infections are due to dermatophytes and about 5% are
`due to nondermatophyte moulds.4–6 The most commonly
`implicated
`dermatophyte
`is
`the
`anthropophilic
`species
`
`Many risk factors for onychomycosis have been identified.
`They include increasing age, peripheral vascular disease,
`trauma and hyperhidrosis. Fungal nail disease is more preva-
`lent in men and in individuals with other nail problems such
`as psoriasis, in persons with immunosuppressive conditions
`such as diabetes mellitus or HIV infection, and in those taking
`immunosuppressive medications. Tinea unguium is associated
`with tinea pedis in up to one-third of cases. The difference
`between the incidence of onychomycosis in men and women
`might be a reflection of the degree to which individuals are
`concerned about the appearance of their nails. Likewise, the
`higher incidence of onychomycosis in older individuals could
`be due to the greater likelihood of younger patients seeking
`treatment at an earlier stage. Although infrequent, onychomy-
`cosis can affect children and is most likely due to the wearing
`of occlusive footwear.
`
`6.3.1 Onychomycosis in children
`
`There are few reports studying the aetiology of onychomyco-
`sis in children. A recent study from Spain illustrates the spec-
`and disease patterns.9 To study
`trum of
`causal
`agents
`childhood dermatophyte onychomycosis, a retrospective study
`was carried out of children < 16 years of age, with dermato-
`phyte onychomycosis diagnosed between 1987 and 2007. Of
`4622 nail samples from 3550 patients, 218 came from 181
`children up to 16 years old. Onychomycosis caused by derma-
`tophytes was demonstrated in 28 cases (15 5%). T. rubrum (18
`cases) was the most prevalent species, followed by T. tonsurans
`(five cases), T. mentagrophytes var.
`interdigitale (four cases) and
`T. mentagrophytes var. mentagrophytes (one case). Concomitant der-
`matophytosis at other locations was confirmed in seven cases
`(25%). Toenail onychomycosis was associated with tinea pedis
`in five cases. Distal and lateral subungual onychomycosis was
`the most common clinical pattern. The superficial white type
`was found in two cases of toenail onychomycosis caused by
`T. rubrum and T. tonsurans. During the period of study, only
`5 1% of all
`investigated people were children aged up to
`
`British Journal of Dermatology (2014) 171, pp937–958
`
`© 2014 British Association of Dermatologists
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`16 years. Onychomycosis tended to increase in prevalence
`over the years and represented 15 5% of all nail dystrophies
`in children. The findings emphasized that dermatologists must
`consider onychomycosis in the differential diagnosis of nail
`alterations in children and always perform a mycological study
`to confirm the diagnosis.
`
`6.3.2 Onychomycosis in athletes
`
`Specific aspects of athletics lead to a higher prevalence of ony-
`chomycosis in athletes, such as trauma, previous tinea pedis
`infection, increased sweating and increased exposure to infec-
`tious dermatophytes.10 A study of
`Icelandic
`swimmers
`observed a threefold increase in the occurrence of onychomy-
`cosis in swimmers (23%) compared with the general popula-
`tion (8%),11 and the Achilles survey demonstrated a 1 5 times
`higher prevalence of onychomycosis in athletes compared
`with nonathletes.12 Fungus invading the nail can spread to the
`foot
`to cause tinea pedis when activated by periods of
`increased warmth and humidity or impaired immunity. More-
`over, the presence of one infection may increase the risk of
`the other occurring. The key predisposing factors that contrib-
`ute to infection in sports persons are the speed/intensity
`involved with sport (runners), the sudden starting and stop-
`ping nature of the sport (e.g. tennis, squash, football, cricket
`and ice skating), practising sports without protective footwear
`(e.g. gymnasts, ballet dancers), frequency of nail injuries, pre-
`valent use of synthetic clothing and shoes that retain sweat,
`water sports and communal bathing.10
`
`6.3.3 Onychomycosis in diabetics
`
`Diabetics are almost three times more likely to develop ony-
`chomycosis than nondiabetics.13 Diabetics may have increased
`difficulty in doing regular foot check-ups due to obesity or
`complications of diabetes such as retinopathy and/or cataracts.
`This may contribute to diabetics (typically with poor circula-
`tion of
`the lower extremities, neuropathy and impaired
`wound healing) having a generally higher risk of developing
`complications from onychomycosis. Diseased nails, with thick
`sharp edges, can injure the surrounding skin tissue and result
`in pressure erosion of the nail bed, injuries that may go unno-
`ticed in diabetics due to sensory neuropathy. The injury may
`act as an entry point for bacteria, fungi or other pathogens,
`leading to limb-threatening complications or even possible
`amputation of the lower extremities. Approximately 34% of
`all diabetics have onychomycosis, as the worldwide diabetic
`population displays many of the risk factors associated with
`increased prevalence of the disease.14
`Studies investigating the dermatophyte species in diabetic
`individuals are limited.13 In agreement with the majority of pre-
`vious studies, recent reports have found that the most common
`causative agent for tinea pedis and onychomycosis was T. ru-
`brum, followed by T. mentagrophytes in diabetic patients.15 The
`types and frequency patterns of dermatophyte species in diabetic
`patients were similar to those in the immunocompetent group.
`
`BAD guidelines for onychomycosis 2014, M. Ameen et al. 939
`
`6.3.4 Age and sex
`
`in the
`reported to be more prevalent
`is
`Onychomycosis
`elderly and appears to occur more frequently in men.5,16
`Approximately 20% of the population aged over 60 years,
`and up to 50% of subjects aged over 70 years are reported to
`have onychomycosis.5 The correlation between increasing age
`and onychomycosis may be attributed to reduced peripheral
`circulation,
`inactivity, suboptimal
`immune status, diabetes,
`larger and distorted nail surfaces, slower-growing nails, diffi-
`culty in grooming the nails and maintaining foot hygiene,
`frequent nail injury and increased exposure to disease-causing
`fungi.
`
`6.3.5 Genetics
`
`Some recent studies suggest a genetic basis for susceptibility
`to onychomycosis.17 Familial patterns of distal lateral onycho-
`mycosis were caused by T. rubrum infection that appeared to
`be unrelated to interfamilial transmission. Several studies have
`reported the autosomal dominant pattern of inheritance associ-
`ated with T. rubrum infection and highlighted the increased risk
`of developing onychomycosis in subjects where at least one
`parent had onychomycosis.17
`
`6.3.6 Immunodeficiency
`
`Individuals infected with HIV have an increased risk of devel-
`oping onychomycosis when their T-lymphocyte count is as
`3 (normal range 1200–1400), and their
`low as 400 cells mm
`onychomycoses tend to be more widespread, usually aff