CEBD Evidence Update
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Welcome to this month’s CEBD Evidence Update, bringing you the latest evidence-based publications in dermatology, with an emphasis on clinical guidelines and systematic reviews.
CEBD Evidence Updates are compiled by the Centre of Evidence Based Dermatology at the University of Nottingham, with funding from Nottingham University Hospitals NHS Trust, as a service to the dermatology community. An archive of these updates is available on the list home page: CEBD-EVIDENCE-UPDATES.
The title of each item provides a link to the abstract in PubMed. If the paper is open-access (indicated in brown text towards the bottom of the PubMed record) or you have an institutional subscription to the journal concerned, you can access it by clicking on the full text link at the top right of the PubMed record. It is important to appraise the quality of systematic reviews before applying to your practice—we recommend the AMSTAR 2 tool, which is very quick and easy to use. See also this open-access article: Research Techniques Made Simple: Assessing Risk of Bias in Systematic Reviews.
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“This guideline covers diagnosing and managing Lyme disease. It aims to raise awareness of when Lyme disease should be suspected and ensure that people have prompt and consistent diagnosis and treatment. It does not cover preventing Lyme disease.”
“This guideline includes recommendations on:
•being aware of Lyme disease
•symptoms and history taking
•which tests to use and when
•treatment with antibiotics
•treatment and support for ongoing symptoms
•managing Lyme disease in pregnant women and their babies
•information for people with Lyme disease”
“1.1 Avelumab is recommended as an option for treating metastatic Merkel cell carcinoma in adults, only if they have had 1 or more lines of chemotherapy for metastatic disease.
1.2 Avelumab is recommended for use within the Cancer Drugs Fund as an option for treating metastatic Merkel cell carcinoma in adults, only if:
•they have not had chemotherapy for metastatic disease and
•the conditions in the managed access agreement for avelumab are followed.
1.3 This recommendation is not intended to affect treatment with avelumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.”
“Following a full submission:
Dimethyl fumarate (Skilarence®) is accepted for restricted use within NHS Scotland.
Indication under review: for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
SMC restriction: for use in patients in whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate or have failed and who are considered unsuitable for biologic therapy given their current disease state or personal preference.
In a 16 week, double-blind, phase III study, dimethyl fumarate was superior to placebo and non-inferior to a fumaric acid ester product at improving the symptoms of moderate to severe plaque psoriasis in adults.”
Draft guidance from NICE does not recommend the use of dupilumab as proposed, as it was not considered a cost effective use of limited NHS resources.
Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, Gieler U, Girolomoni G, Lau S, Muraro A, Czarnecka-Operacz M, Schäfer T, Schmid-Grendelmeier P, Simon D, Szalai Z, Szepietowski JC, Taïeb A, Torrelo A, Werfel T, Ring J; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS).
J Eur Acad Dermatol Venereol. 2018 May;32(5):657-682. doi: 10.1111/jdv.14891.
“This guideline was developed as a joint interdisciplinary European project, including physicians from all relevant disciplines as well as patients. It is a consensus-based guideline, taking available evidence from other guidelines, systematic reviews and published studies into account. This first part of the guideline covers methods, patient perspective, general measures and avoidance strategies, basic emollient treatment and bathing, dietary intervention, topical anti-inflammatory therapy, phototherapy and antipruritic therapy, whereas the second part covers antimicrobial therapy, systemic treatment, allergen-specific immunotherapy, complementary medicine, psychosomatic counselling and educational interventions.”
Hatemi G, Christensen R, Bang D, Bodaghi B, Celik AF, Fortune F, Gaudric J, Gul A, Kötter I, Leccese P, Mahr A, Moots R, Ozguler Y, Richter J, Saadoun D, Salvarani C, Scuderi F, Sfikakis PP, Siva A, Stanford M, Tugal-Tutkun I, West R, Yurdakul S, Olivieri I, Yazici H.
Ann Rheum Dis. 2018 Apr 6. pii: annrheumdis-2018-213225. doi: 10.1136/annrheumdis-2018-213225. [Epub ahead of print]
“The recommendations on the medical management of mucocutaneous, joint, eye, vascular, neurological and gastrointestinal involvement of BS [Behçet's syndrome] were modified; five overarching principles and a new recommendation about the surgical management of vascular involvement were added. These updated, evidence-based recommendations are intended to help physicians caring for patients with BS. They also attempt to highlight the shortcomings of the available clinical research with the aim of proposing an agenda for further research priorities.”
Ingen-Housz-Oro S, Duong TA, Bensaid B, Bellon N, de Prost N, Lu D, Lebrun-Vignes B, Gueudry J, Bequignon E, Zaghbib K, Royer G, Colin A, Do-Pham G, Bodemer C, Ortonne N, Barbaud A, Fardet L, Chosidow O, Wolkenstein P; French National Reference Center for Toxic Bullous Dermatoses.
Orphanet J Rare Dis. 2018 Apr 10;13(1):56. doi: 10.1186/s13023-018-0793-7.
“This PNDS, written by the French National Reference Center for Toxic Bullous Dermatoses was updated in 2017 (https://www.has-sante.fr/portail/jcms/c_1012735/fr/necrolyse-epidermique-syndromes-de-stevens-johnson-et-de-lyell). The cornerstone of the management of these patients during the acute phase is an immediate withdrawal of the responsible drug, patient management in a dermatology department, intensive care or burn units used to dealing with this disease, supportive care and close monitoring, the prevention and treatment of infections, and a multidisciplinary approach to sequelae. Based on published data, it is not currently possible to recommend any specific immunomodulatory treatment. Only the culprit drug and chemically similar molecules must be lifelong contraindicated.”
Dissemond J, Jockenhöfer F, Miller A, Kurzhals G, Noori S, Reich-Schupke S, Schlaeger M, Schubert E, Stücker M, Weberschock T, Jungkunz HW.
J Dtsch Dermatol Ges. 2018 Apr;16(4):512-523. doi: 10.1111/ddg.13496.
“These guidelines focus on patients of all age groups and genders exhibiting skin lesions caused by dermal lymphostasis. Specific recommendations are provided with respect to the diagnosis and differential diagnosis of the various clinical manifestations. In this context, comorbid skin diseases such as atopic dermatitis, psoriasis, hidradenitis suppurativa, urticaria, and contact dermatitis will be highlighted, including their treatment and associated specific risks.”
Asano Y, Fujimoto M, Ishikawa O, Sato S, Jinnin M, Takehara K, Hasegawa M, Yamamoto T, Ihn H.
J Dermatol. 2018 Apr 23. doi: 10.1111/1346-8138.14161. [Epub ahead of print]
“We established diagnostic criteria and severity classification of localized scleroderma because there is no established diagnostic criteria or widely accepted severity classification of the disease. Also, there has been no clinical guideline for localized scleroderma, so we established its clinical guideline ahead of all over the world. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of localized scleroderma.”
Asano Y, Jinnin M, Kawaguchi Y, Kuwana M, Goto D, Sato S, Takehara K, Hatano M, Fujimoto M, Mugii N, Ihn H.
J Dermatol. 2018 Apr 23. doi: 10.1111/1346-8138.14162. [Epub ahead of print]
“We have revised the clinical guideline based on the newest evidence. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of SSc [systemic sclerosis].”
Al-Dhubaibi MS, Settin AA.
Int J Health Sci (Qassim). 2018 Mar-Apr;12(2):70-79.
“The initial search yielded 408 records of which 15 articles were selected. The 15 clinical trials included 3734 patients with CHE [chronic hand eczema]. Among alitretinoin-treated patients, the PGA [physician global assessment] effect size was directly proportional to the drug dosage, ranging from 40% to 69%, while the PaGA [patient global assessment] score ranged from 28.8% to 62.4%, and mTLSS [modified total lesion symptom score] ranged from 60.4% to 76.9%, much higher than placebo. A higher drug dose was about twice as effective as lower dose. The odds ratio for a better outcome with drug treatment taking duration into account was about 3-4 times that versus placebo. In conclusions, alitretinoin cleared lesions in about 50% of cases, particularly using a higher dose for a longer duration.”
Armstrong AW, Betts KA, Signorovitch JE, Sundaram M, Li J, Ganguli AX, Wu EQ.
Curr Med Res Opin. 2018 Apr 5:1-17. doi: 10.1080/03007995.2018.1457516. [Epub ahead of print]
“RESULTS: Compared with supportive care, the NNT [number needed to treat] to achieve PASI-75 was 1.18 for ixekizumab, 1.29 for secukinumab 300 mg, 1.37 for infliximab, 1.48 for adalimumab, 1.53 for secukinumab 150 mg, 1.58 for ustekinumab, 2.25 for etanercept, and 3.71 for apremilast. The one-year incremental cost per PASI-75 responder relative to supportive care was $59,830 for infliximab, $88,775 for secukinumab 300 mg, $91,837 for adalimumab, $95,898 for ixekizumab, $97,363 for ustekinumab, $105,131 for secukinumab 150 mg, $129,665 for apremilast, and $159,328 for etanercept. Results were similar for PASI-90.
CONCLUSION: The NNT and incremental cost per responder are meaningful ways to assess comparative effectiveness and cost effectiveness among psoriasis treatments.”
Carrascosa JM, Rebollo F, Gómez S, de la Cueva P.
J Dermatolog Treat. 2018 Apr 19:1-20. doi: 10.1080/09546634.2018.1467536. [Epub ahead of print]
“RESULTS: We finally included 12 RCT. Compared with placebo, ETN [etanercept] significantly improved quality of life, patient global assessment, pruritus and pain in the short and medium term, fatigue in the short term (although the effect size and differences with placebo are unclear). ETN also produces a high patient's satisfaction, which increases over time and is higher compared with placebo and might improve depressive symptoms in the long term.
CONCLUSIONS: ETN is an effective option for improving PROs [patient reported outcomes] in patients with moderate-to-severe psoriasis.”
Juan S, Jiabi Z.
Joint Bone Spine. 2018 Apr 7. pii: S1297-319X(18)30050-2. doi: 10.1016/j.jbspin.2018.03.007. [Epub ahead of print]
“RESULTS: Among the 3850 records retrieved, 24 articles met the inclusion criteria, including 10 on rheumatoid arthritis (RA), 4 on axial spondyloarthritis (axSpA), 4 on Crohn's disease (CD), 4 on psoriasis (Ps), and 2 on psoriasic arthritis (PsA). Four biological disease-modifying anti-rheumatic drugs (bDMARDs)-anti-TNF agents, T cell co-stimulation inhibitor (abatacept), IL-6 inhibitor (tocilizumab), and B-cell depletion therapy (rituximab)-were involved. The meta-analysis showed that the odds to reach a good response or achieve remission were lower in obese (BMI > 30kg/m2) than non-obese (BMI ≤ 30kg/m2) patients who were treated with anti-TNF agents (good responder% in RA: OR 0.34, 95% CI 0.18-0.64; remission% in RA: OR 0.36, 95% CI 0.21-0.59; BASDAI50% in axSpA: OR 0.41, 95% CI 0.21-0.83), but no significant difference between obese and non-obese was found in patients treated with abatacept (good responder% in RA: OR 0.75, 95% CI 0.42-1.36; remission% in RA: OR 0.84, 95% CI 0.65-1.09) and tocilizumab (good responder% in RA: OR 1.08, 95% CI 0.44-2.63; remission% in RA: OR 0.91, 95% CI 0.50-1.66).
CONCLUSION: Obesity hampered the effect of anti-TNF agents, but not those of abatacept and tocilizumab, suggesting that a personalized treatment strategy should be considered for obese patients with inflammatory diseases.”
Cook LC, Hanna C, Foulke GT, Seiverling EV.
J Clin Aesthet Dermatol. 2018 Apr;11(4):41-42. Epub 2018 Apr 1.
“Results: After eliminating those papers that did not meet inclusion requirements, the authors identified 201 studies for their review, with the majority consisting of case reports. The most commonly studied inflammatory conditions were psoriasis, lupus, and lichen planus. There was congruence among the studies identified in terms of the most common dermoscopic findings for each of these diseases. Conclusions: The use of dermoscopy in the evaluation of inflammatory dermatoses is a promising option. However, more rigorous studies are needed to determine the sensitivity and specificity of the dermoscopic findings for many inflammatory skin conditions.”
Aune D, Snekvik I, Schlesinger S, Norat T, Riboli E, Vatten LJ.
Eur J Epidemiol. 2018 Apr 21. doi: 10.1007/s10654-018-0366-z. [Epub ahead of print]
“The summary relative risk (RR) for a 5 unit increment in BMI [body mass index] was 1.19 (95% CI 1.10-1.28, I2 = 83%, n = 7). The association appeared to be stronger at higher compared to lower levels of BMI, pnonlinearity < 0.0001, and the lowest risk was observed at a BMI around 20. The summary RR was 1.24 (95% CI 1.17-1.31, I2 = 0%, pheterogeneity = 0.72, n = 3) per 10 cm increase in waist circumference, 1.37 (95% CI 1.23-1.53, I2 = 0%, pheterogeneity = 0.93, n = 3) per 0.1 unit increase in waist-to-hip ratio, and 1.11 (95% CI 1.07-1.16, I2 = 47%, pheterogeneity = 0.15, n = 3) per 5 kg of weight gain. Adiposity as measured by BMI, waist circumference, waist-to-hip ratio, and weight gain is associated with increased risk of psoriasis.”
Ungprasert P, Raksasuk S.
Int Urol Nephrol. 2018 Apr 11. doi: 10.1007/s11255-018-1868-z. [Epub ahead of print]
“RESULTS: A total of four retrospective cohort studies with 199,808 patients with psoriasis were included. The risk of incident CKD [chronic kidney disease] and ESRD [end-stage renal disease] was significantly increased among patients with psoriasis with the pooled risk ratio of 1.34 (95% CI, 1.14-1.57) and 1.29 (95% CI, 1.05-1.60), respectively.
CONCLUSION: A significantly increased risk of incident CKD and ESRD among patients with psoriasis compared with individuals without psoriasis was demonstrated in this study.”
Int J Health Sci (Qassim). 2018 Jan-Feb;12(1):33-9.
“Results: A total of 2132 eligible articles were identified by the electronic search. The titles and abstracts of 954 articles fulfilled the criteria of midline search. 20 articles were included after application of inclusion standards and full-text review. These 20 studies included 2046 psoriatic patients with or without arthritis and 6508 healthy controls. 14 studies show a positive correlation between Vitamin D deficiency and psoriasis. These 14 studies included 1249 psoriatic patients with or without arthritis and 680 healthy controls. Remaining six studies, including 797 psoriatic patients with or without arthritis and 5828 healthy controls do not depict a positive correlation between the two variables under study.
Conclusion: There exists a correlation of psoriasis with deficiency of Vitamin D. However, there is a need for larger scale case-control studies to assess how far Vitamin D deficiency plays a role in psoriasis.”
None found this month.
Rat C, Hild S, Rault Sérandour J, Gaultier A, Quereux G, Dreno B, Nguyen JM.
J Med Internet Res. 2018 Apr 13;20(4):e135. doi: 10.2196/jmir.9392.
“RESULTS: The results of the 25 studies included 13 concentrated on store-and-forward teledermatology, and 12 analyzed automated smartphone apps. Store-and-forward teledermatology opens several new perspectives, such as it accelerates the care course (less than 10 days vs 80 days), and the related procedures were assessed in primary care populations. However, the concordance between the conclusion of a teledermatologist and the conclusion of a dermatologist who conducts a face-to-face examination depended on the study (the kappa coefficient range was .20 to .84, median κ=.60). The use of a dermoscope may improve the concordance (the kappa coefficient range was .29 to .87, median κ=.74). Regarding automated smartphone apps, the major concerns are the lack of assessment in clinical practice conditions, the lack of assessment in primary care populations, and their low sensitivity, ranging from 7% to 87% (median 69%). In this literature review, up to 20% of the photographs transmitted were of insufficient quality. The modalities of picture taking and encryption of the data were only partially reported.
CONCLUSIONS: The use of store-and-forward teledermatology could improve access to a dermatology consultation by optimizing the care course. Our review confirmed the absence of evidence of the safety and efficacy of automated smartphone medical apps. Further research is required to determine quality criteria, as there was major variability among the studies.”
Chicas-Sett R, Morales-Orue I, Rodriguez-Abreu D, Lara-Jimenez P.
Clin Transl Radiat Oncol. 2017 Dec 23;9:5-11. doi: 10.1016/j.ctro.2017.12.004. eCollection 2018 Feb.
“Background: In the last years, limited studies have described that radiotherapy could produce important distant responses in unirradiated sites, the so-called "abscopal effect". Recent evidence suggests that radiotherapy induces antigen release from tumor, in this way activating the immune system. However, radiotherapy alone is rarely enough to induce the systemic response requested for control of the metastases. With the advent of immunotherapy, the immune checkpoint inhibitors (ICI) have demonstrated impressive efficacy in various metastatic cancers. Currently, preclinical and clinical studies have reported a significant increase of abscopal responses in patients treated with the combination of radiotherapy and ICI. The purpose of this review was summarizing the clinical studies combining radiotherapy and ipilimumab (ipi), particularly focusing on abscopal responses…”
“Results: A total of 16 studies met the inclusion criteria. These studies included a total of 451 patients, and in 5/16 studies the patients were treated on research protocols and followed-up prospectively. The median reported abscopal effect and OS were 26.5% and 19 months, respectively. The median toxicity ≥ Grade 3 was 18.3% ranged from 10% to 20%.
Conclusion: Early clinical outcomes reports suggest that the combination of ipilimumab and RT may improve survival in metastatic melanoma patients. The abscopal responses become a clinically relevant effect of such combination and should be studied in controlled randomized trials.”
Appleton SE, Fadel Z, Williams JS, Bezuhly M.
Plast Reconstr Surg. 2018 Mar 20. doi: 10.1097/PRS.0000000000004395. [Epub ahead of print]
“RESULTS: Ninety-three studies were identified representing 35,276 patients with thin melanoma who underwent SLN [sentinel lymph node] biopsy. Of these patients, 952 had a positive SLN biopsy for an event rate of 5.1 percent (95% CI 4.1-6.3). Significant associations were identified between SLN positivity and Breslow thickness greater than 0.75 mm but less than 1.0 mm, mitotic rate, ulceration, and Clark's level >IV. Seven studies reported on VGP [vertical growth phase], which was strongly associated with SLN positivity (odds ratio 4.3; 95% CI, 2.5- 7.7).
CONCLUSION: To date, this is the largest meta-analysis to examine predictors of SLN biopsy positivity in thin melanoma. VGP had a strong association with SLN biopsy positivity, providing support for its inclusion in standardized pathological reporting.”
Qi F, Yin Z, Wang G, Zeng S.
Ann Dermatol. 2018 Apr;30(2):129-135. doi: 10.5021/ad.2018.30.2.129. Epub 2018 Feb 21.
Final 12 eligible publications involving Caucasian population were performed in this study, including 1,071 metastatic melanoma patients, 154 primary melanoma patients, and 211 normal controls. MGMT promoter methylation was significantly higher in primary or metastatic melanoma than in normal controls (p<0.05). No difference of MGMT promoter methylation was found in primary and metastatic melanoma (p=0.432). When metastatic melanoma was compared to normal controls, subgroup analysis showed the correlation between MGMT promoter methylation and different sample materials (tissue: OR=7.01, p<0.001 and blood: OR=12.04, p=0.005). MGMT promoter methylation was not associated with response to drug therapy and the prognosis in overall survival and progression-free survival for multivariate analysis. Our results show that MGMT promoter methylation may be correlated with the increased risk of primary or metastatic melanoma. Based on blood samples, MGMT promoter methylation may become a noninvasive biomarker for the detection of metastatic melanoma. Further additional clinical studies are necessary.
Silva ESD, Tavares R, Paulitsch FDS, Zhang L.
Eur J Dermatol. 2018 Apr 5. doi: 10.1684/ejd.2018.3251. [Epub ahead of print]
“The overall meta-analysis did not show a significant association between skin cancer and sunscreen use (odds ratio (OR) = 1.08; 95% CI: 0.91-1.28, I2 = 89.4%). Neither melanoma (25 studies; 9,813 cases) nor non-melanoma skin cancer (five studies; 857 cases) were associated with sunscreen use, with a pooled OR (95% CI) of 1.10 (0.92-1.33) and 0.99 (0.62-1.57), respectively. The cumulative evidence before the 1980s showed a relatively strong positive association between melanoma and sunscreen use (cumulative OR: 2.35; 95% CI: 1.66-3.33). The strength of the association between risk of skin cancer and sunscreen use has constantly decreased since the early 1980s, and the association was no longer statistically significant from the early 1990s. While the current evidence suggests no increased risk of skin cancer related to sunscreen use, this systematic review does not confirm the expected protective benefits of sunscreen against skin cancer in the general population.”
Tejera-Vaquerizo A, García-Doval I, Llombart B, Cañueto J, Martorell-Calatayud A, Descalzo-Gallego MA, Sanmartín O.
J Dermatol. 2018 Apr 27. doi: 10.1111/1346-8138.14342. [Epub ahead of print]
“Based on the 23 studies included in the systematic review, the proportion of patients with cSCC [cutaneous squamous cell carcinoma] and positive SLN [sentinel lymph node] biopsy findings was 8% (95% confidence interval, 5.1-10.8%; I2 = 44.51%). We found no studies reporting on predictors of SLN involvement in cSCC or on the prognostic utility of this finding following adjustment for confounders. The rate of positive SLN in cSCC is less than previously reported. Criteria for recommending SLN biopsy as a staging tool for cSCC vary considerably from study to study, and none of the studies were large enough to reliably identify predictors of SLN positivity. No randomized controlled trials have yet analyzed whether SLN biopsy may improve the prognosis of cSCC. More studies are required on the prognostic value of SLN positivity and the associated risk factors in cSCC.”
Lhote R, Lambert J, Lejeune J, Gottlieb J, Badaoui A, Battistella M, Roux J, Pages C, Vercellino L, Vilmer C, Le Maignan C, Escande C, MBarek B, Bagot M, Lebbé C, Basset-Seguin N.
Acta Derm Venereol. 2018 Apr 12. doi: 10.2340/00015555-2942. [Epub ahead of print]
“To evaluate the efficacy and the impact of this technique on prognosis of cutaneous squamous cell carcinoma, 37 patients (Saint Louis Hospital, Paris – France) who underwent sentinel lymph node biopsy and 290 cases from the literature were analyzed. Our work shows that the rate of positive sentinel lymph node biopsy was 0.14 [0.09–0.22] and that relapse-free survival and overall survival were not different regarding to sentinel lymph node status (log-rank test; p = 0.08 and p = 0.31, respectively) suggesting that it is not a mandatory procedure for cutaneous squamous cell carcinoma management.”
G Ital Dermatol Venereol. 2018 Apr 19. doi: 10.23736/S0392-0488.18.05998-9. [Epub ahead of print]
“EVIDENCE SYNTHESIS: Most current studies on DL-PDT [daylight photodynamic therapy] have limited follow-up periods of 3 to 6 months. Only 2 randomized, intra-individual studies provided efficacy data on AK treatment at 12 month-follow-up and supported the long-term efficacy of this novel treatment modality showing a low recurrence rate, varying from 8.7% to 13%. Current evidences for other NMSCs [non-melanoma skin cancers] are limited and efficacy seems to be not as good as for AK.
CONCLUSIONS: DL-PDT is a very promising treatment for mild to moderate AKs of the face and scalp. Efficacy outcomes of DL-PDT are similar to those of c-PDT [conventional photodynamic therapy] in the short-term. Additional studies are required to increase our knowledge on DL-PDT long-term efficacy, as limited data are currently available.”
Wang Y, Lan GB, Peng FH, Xie XB.
Oncotarget. 2017 Dec 16;9(20):15375-15385. doi: 10.18632/oncotarget.23841. eCollection 2018 Mar 16.
“Renal transplant recipients were found to display a higher risk of all cancers (standard incidence ratio [SIR]: 2.89; 95% CI: 2.13-3.91; P < 0.001), gastric cancer (SIR: 1.93; 95% CI: 1.60-2.34; P < 0.001), colon cancer (SIR: 1.85; 95% CI: 1.53-2.23; P < 0.001), pancreatic cancer (SIR: 1.53; 95% CI: 1.23-1.91; P < 0.001), hepatocellular carcinoma (SIR: 2.45; 95% CI: 1.63-3.66; P < 0.001), lung cancer (SIR: 1.68; 95% CI: 1.29-2.19; P < 0.001), thyroid cancer (SIR: 5.04; 95% CI: 3.79-6.71; P < 0.001), urinary bladder cancer (SIR: 3.52; 95% CI: 1.48-8.37; P = 0.004), renal cell cancer (SIR: 10.77; 95% CI: 6.40-18.12; P < 0.001), non-melanoma skin cancer (SIR: 12.14; 95% CI: 6.37-23.13; P < 0.001), melanoma (SIR: 2.48; 95% CI: 1.08-5.67; P = 0.032), Hodgkin's lymphoma (SIR: 4.90; 95% CI: 3.09-7.78; P < 0.001), non-Hodgkin lymphoma (SIR: 10.66; 95% CI: 8.54-13.31; P < 0.001), lip cancer (SIR: 29.45; 95% CI: 17.85-48.59; P < 0.001), breast cancer (SIR: 1.11; 95% CI: 1.00-1.24; P = 0.046), and ovarian cancer (SIR: 1.60; 95% CI: 1.23-2.07; P < 0.001). However, renal transplantation did not significantly influence the risks of uterine cancer (P = 0.171), and prostate cancers (P = 0.188).”
Joseph J, Zobniw C, Davis J, Anderson J, Trinh VA.
Ann Pharmacother. 2018 Apr 1:1060028018768809. doi: 10.1177/1060028018768809. [Epub ahead of print]
“DATA SYNTHESIS: Avelumab is a fully human monoclonal antibody that inhibits programmed death ligand-1, which reverses T-cell exhaustion and induces antitumor responses. Avelumab is safe and effective in previously treated metastatic MCC [Merkel cell carcinoma] based on a phase II trial of previously treated patients with objective response rates in 28 of 88 patients, including 10 complete responses and 19 partial responses. Median overall survival (OS) was 12.9 months, and 1-year progression-free survival and OS were 30% and 52%, respectively. Grade 3 treatment-related side effects included lymphopenia (2 patients), serum creatine phosphokinase increase (1 patient), aminotransferase elevation (1 patient), and serum cholesterol increase (1 patient). Relevance to Patient Care and Clinical Practice: This review outlines the pharmacology and clinical trial data for avelumab in metastatic MCC and guides clinicians on avelumab's place in therapy.
CONCLUSIONS: Avelumab is the first Food and Drug Administration-approved medication for metastatic MCC and provides an advantage of durable responses and possibly improved tolerability compared with traditional platinum-based chemotherapy. Clinical trials are under way to expand its utility into the adjuvant and frontline settings.”
Magalhaes C, Vardasca R, Mendes J.
Skin Res Technol. 2018 Mar 25. doi: 10.1111/srt.12469. [Epub ahead of print]
“RESULTS: In total, 55 articles were encountered, resulting in 14 publications for revision after applying the exclusion criteria. It was denoted that IRT [infrared thermal imaging] have [sic] been used to characterize and distinguish between malignant and benign neoplasms and different skin cancer types. IRT has also been successfully applied in the treatment evaluation of these types of lesions.
CONCLUSION: Trends and future challenges have been established to improve the application of IRT in this field, disclosing that dynamic thermography is a promising tool for early identification of oncological skin conditions.”
Rosumeck S, Nast A, Dressler C.
Cochrane Database Syst Rev. 2018 Apr 2;4:CD012994. doi: 10.1002/14651858.CD012994. [Epub ahead of print]
“AUTHORS' CONCLUSIONS: We found that for the most part, there was no difference detected in the efficacy of permethrin compared to systemic or topical ivermectin. Overall, few and mild adverse events were reported. Our confidence in the effect estimates was mostly low to moderate. Poor reporting is a major limitation.”
Fernando SM, Tran A, Cheng W, Rochwerg B, Kyeremanteng K, Seely AJE, Inaba K, Perry JJ.
Ann Surg. 2018 Apr 18. doi: 10.1097/SLA.0000000000002774. [Epub ahead of print]
“RESULTS: From 2,290 citations, we included 23 studies (n = 5982). Of physical examination signs, pooled sensitivity and specificity for fever was 46.0% and 77.0% respectively, for hemorrhagic bullae 25.2% and 95.8%, and for hypotension 21.0% and 97.7%. Computed tomography (CT) had sensitivity of 88.5% and specificity of 93.3%, while plain radiography had sensitivity of 48.9% and specificity of 94.0%. Finally, LRINEC [Laboratory Risk Indicator for Necrotizing Fasciitis] ≥ 6 had sensitivity of 68.2% and specificity of 84.8%, while LRINEC ≥ 8 had sensitivity of 40.8% and specificity of 94.9%.
CONCLUSIONS: Absence of any 1 physical examination feature (eg, fever or hypotension) is not sufficient to rule-out NSTI [necrotizing soft tissue infection]. CT is superior to plain radiography. LRINEC had poor sensitivity, and should not be used to rule-out NSTI. Given the poor sensitivity of these tests, a high clinical suspicion warrants early surgical consultation for definitive diagnosis and management.”
Hanretty AM, Gallagher JC.
Pharmacotherapy. 2018 Apr 20. doi: 10.1002/phar.2118. [Epub ahead of print]
“DATA SYNTHESIS: In total, 23 RCTs met our criteria for inclusion. All trials compared single-agent antibiotics for a short and long antibiotic course in six common infections: community-acquired pneumonia, ventilator-associated pneumonia, intra-abdominal infections, skin and soft tissue infections, uncomplicated cystitis, and complicated cystitis or pyelonephritis.
CONCLUSIONS: Clinicians can decrease net antibiotic use by recommending shorter courses where evidence supports them. Antimicrobial stewardship programs that systematically address treatment duration may significantly impact institutional antibiotic use without negatively affecting patient care.”
Lacouture ME, Anadkat M, Jatoi A, Garawin T, Bohac C, Mitchell E.
Clin Colorectal Cancer. 2017 Dec 13. pii: S1533-0028(16)30278-X. doi: 10.1016/j.clcc.2017.12.004. [Epub ahead of print]
“Overall, 269 reports were reviewed (nonrandomized trials, n = 120; randomized trials, n = 31; retrospective studies, n = 15; reviews, n = 39). Dermatologic toxicity of any grade occurs in most patients who receive anti-EGFR [epidermal growth factor receptor] therapy; approximately 10% to 20% of patients experienced grade 3/4 toxicity. The most common dermatologic toxicities include papulopustular/acneiform rash, xerosis, and pruritus; however, nail changes, hair abnormalities, and ocular conditions also occur. Guidance for managing these toxicities includes the use of inexpensive emollient ointments and moisturizers, avoidance of sun exposure, avoidance of irritants, and the use of short showers. Several studies also found that preemptive treatment was more effective than reactive treatment at limiting the incidence and severity of skin toxicity. With appropriate treatment, the dermatologic toxicities associated with anti-EGFR monoclonal antibody therapy can be managed, minimizing patient discomfort and the need for therapy interruption and/or discontinuation. Additionally, preemptive treatment can reduce dermatologic toxicity severity, ultimately yielding better quality of life.”
Gabrielli S, Langlois A, Ben-Shoshan M.
Int Arch Allergy Immunol. 2018 Apr 3. doi: 10.1159/000487556. [Epub ahead of print]
“RESULTS: Eighty-five studies were included in the systematic review, assessing a total of 1,030 participants. Immediate (within 1 h of exposure) hypersensitivity reactions were reported in > 25% of the articles, while cutaneous nonimmediate reactions were similarly reported in about 25% of the articles. The remaining articles reported Steven-Johnson syndrome/toxic epidermal necrolysis, fixed drug eruptions, and cross-intolerance reactions. Five pediatric studies were included in our meta-analysis. The prevalence of acetaminophen hypersensitivity reaction among children undergoing oral challenge was 10.1% (95% confidence interval 4.5-15.5).”
Chiu YJ, Perng CK, Ma H.
Lasers Med Sci. 2018 Apr 26. doi: 10.1007/s10103-018-2516-7. [Epub ahead of print]
“Six studies with a total of 184 patches/patients were included in the present meta-analysis. The combination therapy group had significantly superior results than that of the control group (≥ 75% re-pigmentation, risk ratio [RR] 2.80, 95% confidence interval [CI] 1.29-6.07; ≥ 50% re-pigmentation, RR 2.26, 95% CI 1.23-5.9; < 25% re-pigmentation, RR 0.57, 95% CI 0.43-0.75). Limitations of the study included the small number of studies and sample size, inadequate blinding of participants, and variation between therapy protocols. Meta-analysis revealed that using fractional CO2 laser in combination with conventional treatments is efficient and safe, and may be considered as an adjunct therapeutic option for patients with refractive non-segmental vitiligo.”
Lee SW, Juhasz M, Mobasher P, Ekelem C, Mesinkovska NA.
J Drugs Dermatol. 2018 Apr 1;17(4):457-463.
“RESULTS: Seven articles were included in this systematic review. In all studies, there was significant decrease in the rate of hair loss, increase in total and terminal hair counts, and positive hair growth assessment with topical FNS [finasteride]. Both scalp and plasma DHT [dihydrotestosterone] significantly decreased with application of topical FNS; no changes in serum testosterone were noted.
CONCLUSION: Preliminary results on the use of topical FNS are limited, but safe and promising. Continued research into drug-delivery, ideal topical concentration and application frequency, side effects, and use for other alopecias will help to elucidate the full extent of topical FNS' use.”
Motosk O CC, Khouri KS, Poudrier G, Sinno S, Hazen A.
Plast Reconstr Surg. 2018 May;141(5):1115-1123. doi: 10.1097/PRS.0000000000004279.
“RESULTS: Of the 22 articles included in the analysis, seven studies used platelet-rich plasma alone for facial rejuvenation, seven in combination with fat grafting, two for treatment of acne scarring, and six for treatment of androgenic alopecia. Individual study procedures, means of evaluation, and significant results are summarized. Although the majority of studies in this review report positive results, significant variation exists in preparation protocols and in the number and frequency of clinical treatments.
CONCLUSIONS: The majority of studies report positive results for all indications evaluated in this review, but the procedure is limited by the lack of a standardized method for preparation and application of platelet-rich plasma. The extent to which significant variability in platelet-rich plasma preparation and/or application methods may affect clinical outcomes is not completely clear. In the interim, we present a consolidation of platelet-rich plasma treatment techniques and outcomes currently in use to help guide physicians in their clinical practice.”
Lee S, Kim BJ, Lee CH, Lee WS.
J Eur Acad Dermatol Venereol. 2018 Apr 6. doi: 10.1111/jdv.14987. [Epub ahead of print]
“RESULTS: In all, 14 studies including a total of 1,255 AA [alopecia areata] subjects and 784 non-AA control were analyzed. The mean serum 25-hydroxyvitamin D level was significantly lower in AA subjects (-8.52 ng/dL; 95% confidential interval; -5.50 to -11.53). The subjects with AA had higher odds of vitamin D deficiency of vitamin D deficiency (odds of 3.55; 2.03 to 6.20, mean prevalence of 75.5%; 60.8 to 86.0%). However, it was difficult to find clear correlation between serum 25-hydroxyvtamin D level and extent of hair loss in AA.
CONCLUSION: The AA subjects had lower serum 25-hydroxyvitamin D level and vitamin D deficiency was highly prevalent compared to non-AA controls. Hence, Vitamin D deficiency should be assessed in AA patients. Furthermore, nutritional supplementation of vitamin D or topical vitamin D analogues can be considered for AA patients with vitamin D deficiency. The limitation of this study is the highly [sic] heterogeneity of the included studies.”
None found this month.
Suva G, Sharma T, Campbell KE, Sibbald RG, An D, Woo K.
Int Wound J. 2018 Mar 30. doi: 10.1111/iwj.12901. [Epub ahead of print]
“A lack of pressure injury assessment and management knowledge by health care professionals was an overriding theme in the education literature. Some of the methods preferred for pressure injury education among nurses and physicians included information technology (eg, e-learning) with technology support and the use of high-quality wound pictures. Although the evidence is scarce, the literature did highlight specific system- and organisation-level barriers and enablers that influence practice change, including inter-professional communication and human resource investments. In conclusion, (1) the current evidence on the education and system-level enablers, barriers, and strategies to optimise pressure injury best practices requires further investigation, and (2) multi-faceted, up-stream, evidence-based approaches for pressure injury care are essential to improve health care and patient-related outcomes.”
Novoa M, Baselga E, Beltran S, Giraldo L, Shahbaz A, Pardo-Hernandez H, Arevalo-Rodriguez I.
Cochrane Database Syst Rev. 2018 Apr 18;4:CD006545. doi: 10.1002/14651858.CD006545.pub3.
“We found there to be a limited evidence base for the treatment of infantile haemangiomas: a large number of interventions and outcomes have not been assessed in RCTs.Our key results indicate that in the management of IH in children, oral propranolol and topical timolol maleate are more beneficial than placebo in terms of clearance or other measures of resolution, or both, without an increase in harms. We found no evidence of a difference between oral propranolol and topical timolol maleate with regard to reducing haemangioma size, but we are uncertain if there is a difference in safety. Oral propranolol is currently the standard treatment for this condition, and our review has not found evidence to challenge this. However, these results are based on moderate- to very low-quality evidence.”
Wang JY, Ighani A, Ayala AP, Akita S, Lara-Corrales I, Alavi A.
J Cutan Med Surg. 2018 Apr 1:1203475418770570. doi: 10.1177/1203475418770570. [Epub ahead of print]
“Seventy-seven studies met our inclusion criteria. One study was a randomized controlled trial, 30 were observational studies, and 46 were case reports or case series. There is significant heterogeneity among the methods used. We reviewed 1239 patients in total. Of the 197 treated with oral propranolol, 191 (97.0%) achieved complete ulcer healing. Thirty-one patients failed corticosteroid therapy (oral, intralesional, or topical) and were subsequently successfully treated with other therapies. Surgical resections were typically performed for larger hemangiomas and those causing complications. None of the therapies discussed appear to offer significant advantages over others. Therefore, treatment decisions should be individualized based on location of disease, extent, symptoms, feasibility, cost, and parental preference.”
Seyed Jafari SM, Cazzaniga S, Hunger RE.
G Ital Dermatol Venereol. 2018 Apr 19. doi: 10.23736/S0392-0488.18.05977-1. [Epub ahead of print]
“Selection of appropriate treatment for mycosis fungoides is based on prognostic factors and overall clinical stage at diagnosis. In the past decade, clinical success has been reported using photodynamic therapy as an alternative target-specific therapy to treat mycosis fungoides. This review aimed to summarize the current advances in management of mycosis fungoides by administration of photodynamic therapy.”
Castillo B, Vera N, Ortega-Loayza AG, Seminario-Vidal L.
J Am Acad Dermatol. 2018 Mar 27. pii: S0190-9622(18)30486-9. doi: 10.1016/j.jaad.2018.03.032. [Epub ahead of print] No abstract available.
“Simple dressings (topical creams or ointments covered with bandages) and modern dressings (fiber, biologic, and synthetic) were studied. The most commonly used dressings in the wound care of SJS/TEN were biosynthetic dressings followed by silver-impregnated fiber dressings...”
“Compared with simple dressings, modern dressings offer the advantage of reduced number of dressing changes, which results in improved patient comfort. However, there is no apparent impact of their use in regard to healing time. Most studies did not report side effects or cost of dressings. No adverse events related to the dressings were documented...”
“In conclusion, the use of modern dressings should be considered as part of standard therapy due to less frequent dressing changes and improved reported patient comfort. Further clinical studies are warranted as their influence on healing time is yet to be determined.”
Ng QX, De Deyn MLZQ, Venkatanarayanan N, Ho CYX, Yeo WS.
J Inflamm Res. 2018 Mar 28;11:135-142. doi: 10.2147/JIR.S160964. eCollection 2018.
“Results: A total of 12 studies, with a total of 358 SJS/TEN [Stevens-Johnson syndrome/toxic epidermal necrolysis] patients were reviewed. Two studies were excluded from the meta-analysis as they did not report SCORe of toxic epidermal necrosis/predicted mortality data; one was excluded because of possible data irregularities. Meta-analysis of nine studies revealed a significant reduction in mortality risk with cyclosporine therapy (standardized mortality ratio 0.320; 95% CI: 0.119-0.522; P=0.002). Cyclosporine was also generally well tolerated with little adverse effects or increased infection, albeit the patients tended to be critically ill. Publication bias was observed in the funnel plot and Egger test (P=0.0467).
Conclusion: Currently available evidence are predominantly open trials and retrospective studies with a significant risk of bias, perhaps owing to the rarity and life-threatening nature of the condition. Given its immunomodulatory actions, cyclosporine could be a potential treatment option for SJS/TEN in addition to best supportive measures. Further confirmation with robust randomized, controlled trials or larger case series is necessary and should be encouraged.2
Paxton D, Pauling JD.
Semin Arthritis Rheum. 2018 Feb 14. pii: S0049-0172(17)30765-5. doi: 10.1016/j.semarthrit.2018.02.005. [Epub ahead of print]
“CONCLUSIONS: High levels of potential bias relating to study confounding and statistical analysis make it difficult to draw conclusions regarding the prognostic role of NC [nailfold capillaroscopy] in SSc [systemic sclerosis]. There is strong evidence supporting an association between NC abnormalities (particularly capillary loss) and disease severity (particularly vascular manifestations such as DU [digital ulcer], calcinosis and PAH [pulmonary arterial hypertension]). Evolution of NC appearances may represent a more important predictor of disease progression which could have important implications for the future use of NC in the routine longitudinal assessment and management of SSc.”
Cook LC, Hanna C, Foulke GT, Seiverling EV.
J Clin Aesthet Dermatol. 2018 Apr;11(4):41-42. Epub 2018 Apr 1.
See above under Psoriasis & psoriatic arthritis
Am J Dermatopathol. 2018 Apr 11. doi: 10.1097/DAD.0000000000001148. [Epub ahead of print]
“CONCLUSIONS: Recent studies report that telepathology increases access to specialists, reduces interpretive errors and health care expenditures, improves the efficiency of workflow, and optimizes patient outcomes. It also facilitates international collaboration by widening global access to dermatopathology services and providing educational resources in underserved areas. However, the quality and regulations of digital slide imaging in teledermatopathology need to be improved.”
Motosko CC, Ault AK, Kimberly LL, Gothard MD, Ho RS, Hazen A.
J Am Acad Dermatol. 2018 Apr 21. pii: S0190-9622(18)30633-9. doi: 10.1016/j.jaad.2018.04.034. [Epub ahead of print]
“RESULTS: Systematic review identified 20 studies, all of which employed various spin strategies, broadly classified as either inappropriate statistical analysis or inappropriate interpretation of results. Most commonly used strategies included use of multiple primary outcomes (95%), inappropriate extrapolation of the results from specific outcome to global improvement (95%), focus on within-group comparison (75%), and focus on interim analyses to give more weight to nonsignificant findings (65%).
LIMITATIONS: Classification of spin strategies is subjective and may not encompass all methods used by studies in the published literature.
CONCLUSIONS: Findings in this study may inform efforts to reduce spin in the dermatologic literature.”
Boozalis E, Patel S.
J Dermatolog Treat. 2018 Apr 19:1-20. doi: 10.1080/09546634.2018.1467540. [Epub ahead of print]
“RESULTS: The terms "fragrance-free," "hypoallergenic," "non-comedogenic," and "oil-free" on cosmetic product labels are not regulated by any governing body and provide varied clinical utility. Products labeled as having "natural ingredients" are not necessarily safer or less irritating to patients with atopy or a history of allergic contact dermatitis. Despite the increasing popularity of "paraben-free" cosmetics, parabens are safe for patients in the quantities used in cosmetic products and can be safely used in patients who don't exhibit contact dermatitis to this preservative.
CONCLUSION: A working knowledge of common cosmetic ingredients may help dermatologists counsel patients on which products to avoid for their specific dermatologic conditions.”
Asayesh H, Peykari N, Pavaresh-Masoud M, Esmaeili Abdar M, Tajbakhsh R, Mousavi SM, Djalalinia S, Noroozi M, Qorbani M, Mahdavi-Gorabi A.
J Cosmet Dermatol. 2018 Mar 25. doi: 10.1111/jocd.12531. [Epub ahead of print]
“RESULTS: We found 1229 records; from them, a total of eight studies comprising 917 hemodialysis patients were included. In all of studies, skin discoloration, pruritus and xerosis have the highest prevalence. According to random-effect meta-analysis model, the pooled prevalence of skin discoloration, pruritus, ecchymosis, xerosis, and half-and-half nail in hemodialysis patients were 48.03% (95% CI: 45.09-51.01), 52.85% (95%CI: 49.23-56.47), 19.88 (95% CI: 17.57-22.19), 51.14% (95% CI: 48.25-54.02), and 18.50% (95% CI: 16.0-21.0), respectively.
CONCLUSIONS: [T]his study shows that the prevalence of dermatological manifestations seems high among the hemodialysis patients in Iran, and skin discoloration, pruritus, and xerosis are more common.”
Groen JW, Krastev TK, Hommes J, Wilschut JA, Ritt MJPF, van der Hulst RRJW.
Plast Reconstr Surg Glob Open. 2017 Dec 22;5(12):e1606. doi: 10.1097/GOX.0000000000001606. eCollection 2017 Dec.
“Results: Eighteen clinical articles were included, reporting on 3,073 patients in total over a mean follow-up period of 13.9 months. Meta-analysis showed an overall complication rate of 6% (95% CI 3.0-14.0), with hematoma/ecchymosis (5%), fat necrosis/oil cysts (2%), and irregular fat distribution and scars (both 2%) being among the most reported. No major complications were reported, and the overall patient satisfaction rate was 81%.
Conclusion: Although the evidence in this systematic review is still limited and plagued by heterogeneity between studies, AFT [autologous fat transfer] seems to be a promising method in facial rejuvenation with fewer complications than other fillers and high patient satisfaction rates. Further large-cohort, preferably multicenter, RCTs should substantiate these results through quantifiable volumetric assessment tools and validated patient questionnaires, while adhering to predetermined nomenclature in terms of complications.”
Brotzman EA, Sandoval LF, Crane J.
Dermatol Surg. 2018 May;44(5):661-669. doi: 10.1097/DSS.0000000000001464.
“RESULTS: Eight studies were identified and reviewed. The use of nitrous oxide/oxygen mixture resulted in a significant reduction in pain when used for photodynamic therapy, botulinum toxin therapy for hyperhidrosis of both the palms and axilla, aesthetic procedures involving various laser procedures, and in the treatment of bed sores and leg ulcers. However, pain scores were higher when nitrous oxide/oxygen was used in the debridement of chronic ulcers when compared with the use of topical anesthesia. In addition, nitrous oxide has been reported effective at reducing pain in hair transplants, dermabrasion, excision and repairs, and pediatric procedures.
CONCLUSION: Current literature provides some evidence that nitrous oxide, used alone or as adjunct anesthesia, is effective at providing analgesia for many dermatologic procedures. Nitrous oxide has many potential applications in dermatology; however, further evidence from randomized controlled trials is needed.”
Milone M, Velotti N, Manigrasso M, Anoldo P, Milone F, De Palma GD.
Surgeon. 2018 Apr 23. pii: S1479-666X(18)30043-X. doi: 10.1016/j.surge.2018.03.009. [Epub ahead of print]
“RESULTS: Fifteen studies were included in the analysis. The number of patients varied from 50 to 1165 with a mean follow-up from 58.36 to 240 months. The overall incidence of recurrence was of 0.138; the resulting incidence of open healing, midline closure and out-midline closure were of 17.9%, 16.8% and 10% respectively.
CONCLUSIONS: Interestingly, our data reveal a rate of relapsing disease higher than the one defined in previous studies both for the overall PSD and for each surgical procedure. A long-term follow-up of at least 5 years, should be considered the gold standard in pilonidal sinus surgery benchmarking. From our results, we can state that open healing and midline closure should not be considered effective for their high frequency of relapse disease and midline primary closure should be preferred.”
Motosk O CC, Khouri KS, Poudrier G, Sinno S, Hazen A.
Plast Reconstr Surg. 2018 May;141(5):1115-1123. doi: 10.1097/PRS.0000000000004279.
See above under Hair & nail disorders
None found this month.
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication for Cimzia “for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.”
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the following indication: “YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.” It notes: “Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.”
“Pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications. This event may also be associated with vasculitis and other comorbidities. Prompt investigations should be considered when pulmonary alveolar haemorrhage is suspected to confirm the diagnosis.
Methotrexate should be withdrawn from patients with pulmonary symptoms and a thorough investigation should be made to exclude infection. If methotrexate induced lung disease is suspected treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.”
The SmPC has been updated with inclusion of benzyl alcohol as an excipient and a warning that it may cause allergic reactions or mild local irritation. Abdominal pain has also been added as an uncommon possible adverse reaction.
The SmPC now warns that severe cutaneous adverse reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel (used for adjunctive treatment of seizures in epilepsy). Patients should be advised of signs and symptoms and monitored closely for skin reactions.
The SmPC now includes swelling of the face as a new adverse event (frequency not known).
Chalmers JR, Thomas KS, et al.
Br J Dermatol. 2018 Apr 19. doi: 10.1111/bjd.16543. [Epub ahead of print]
“It was agreed by consensus that the long-term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long-term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon.”
Holtsche MM, Goletz S, van Beek N, Zillikens D, Benoit S, Harman K, Walton S, English J, Sticherling M, Chapman A, Levell NJ, Groves R, Williams HC, König IR, Schmidt E; BLISTER Study Group.
Br J Dermatol. 2018 Apr 1. doi: 10.1111/bjd.16553. [Epub ahead of print]
OBJECTIVES: To analyze distinct autoantibody profiles for the prediction of the disease course in a well characterized cohort of BP sera.
METHODS: 143 patients of the BLISTER trial consented to participate in this serological study. Sera taken at baseline were analyzed by (i) indirect immunofluorescence (IF) (ii) anti-BP180 NC16A and anti-BP230 ELISA, and (iii) immunoblotting with various substrates. Results were then linked with clinical parameters including age, Karnofsky score, number of blisters, related adverse events, and mortality.
RESULTS: Disease activity correlated with IgG anti-BP180 levels but not with levels of anti-BP230 IgG and anti-BP180 IgE. High levels of both anti-BP180 IgG and anti-BP230 IgG were associated with a low Karnofsky score. The presence of anti-BP230 IgG was more frequent in older patients. Those with higher total IgE serum levels suffered from less adverse events. Higher IgG anti-BP180 levels were associated with an increased 1-year mortality rate.
CONCLUSIONS: Analysis of the autoantibody profile is not only of diagnostic relevance but may also be helpful in predicting the course of the disease.
Haines RH, Thomas KS, Montgomery AA, Ravenscroft JC, Akram P, Chalmers JR, Whitham D, Duley L, Eleftheriadou V, Meakin G, Mitchell EJ, White J, Rogers A, Sach T, Santer M, Tan W, Hepburn T, Williams HC, Batchelor J.
BMJ Open. 2018 Apr 3;8(4):e018649. doi: 10.1136/bmjopen-2017-018649.
“The HI-Light Vitiligo Trial is a multicentre, three-arm, parallel group, pragmatic, placebo-controlled RCT. 516 adults and children with actively spreading, but limited, vitiligo are randomised (1:1:1) to one of three groups: mometasone furoate 0.1% ointment plus dummy NB-UVB light, vehicle ointment plus NB-UVB light or mometasone furoate 0.1% ointment plus NB-UVB light. Treatment of up to three patches of vitiligo is continued for up to 9 months with clinic visits at baseline, 3, 6 and 9 months and four post-treatment questionnaires.The HI-Light Vitiligo Trial assesses outcomes included in the vitiligo core outcome set and places emphasis on participants' views of treatment success. The primary outcome is proportion of participants achieving treatment success (patient-rated Vitiligo Noticeability Scale) for a target patch of vitiligo at 9 months with further independent blinded assessment using digital images of the target lesion before and after treatment. Secondary outcomes include time to onset of treatment response, treatment success by body region, percentage repigmentation, quality of life, time-burden of treatment, maintenance of response, safety and within-trial cost-effectiveness.”
Novoa M, Baselga E, Beltran S, Giraldo L, Shahbaz A, Pardo-Hernandez H, Arevalo-Rodriguez I.
Cochrane Database Syst Rev. 2018 Apr 18;4:CD006545. doi: 10.1002/14651858.CD006545.pub3.
See above under Other disorders affecting the skin
Katz KA, Williams HC, van der Wouden JC.
Pediatr Dermatol. 2018 Mar;35(2):282-283. doi: 10.1111/pde.13398. No abstract available.
This is a letter commenting on a review of treatment options for molluscum contagiosum which concluded that the evidence supports the use of imiquimod cream. The letter concludes:
“The evidence clearly indicates that clinicians should not prescribe imiquimod to treat MC [molluscum contagiosum]. Furthermore, review articles should more comprehensively review available data, including FDA documents, and should stop including imiquimod as a treatment option for MC; the investigators who conducted the RCTs should, at long last, publish them; and to ensure that children truly benefit from BPCA [Best Pharmaceuticals for Children Act] studies, the U.S. Congress should amend the law to require publication of all BPCA studies in peer‐reviewed medical journals.”
Mohandas P, Ravenscroft J, Bewley A.
G Ital Dermatol Venereol. 2018 Apr 19. doi: 10.23736/S0392-0488.18.06019-4. [Epub ahead of print]
“Dermatitis Artefacta (DA) or Artefactual skin disease (ASD) is a factitious skin disorder rarely reported in the paediatric population. Skin lesions are produced deliberately either consciously or in a dissociative state to satisfy an underlying psychological need. Children may present with acutely formed skin changes or with chronic lesions, quite often having seen other specialists during their journey. The mechanism of formation of skin lesions can vary from the application of pigment onto the skin to simulate disease or more destructive techniques like the injection of irritant substances into the skin. Whichever mode used, it is important to focus on why rather than how the lesions are produced. Establishing a strong physician-patient- family relationship is important in managing this condition. The prognosis of the condition is variable, but it has been shown that resolution of the underlying psychosocial stressor leads to improvement of the skin. We advocate a multidisciplinary team approach in managing DA as it has shown to improve outcomes.”
The Centre of Evidence Based Dermatology (CEBD) has an ongoing plan to develop teaching material for healthcare professionals and students with an interest in evidence-based dermatology.
We are pleased to announce the launch of a free online course on systematic searching in PubMed to answer a focused clinical question, written by Douglas Grindlay. This new resource, which is free of charge and available for use across the world, can be accessed at:
There is also an existing online course on how to conduct critical appraisal of a scientific paper in the field of dermatology, which was launched in October 2016:
This one day course will take place on 8th June (at the King’s Meadow Campus, University of Nottingham) and will provide an opportunity to obtain critical appraisal skills and to publish in the British Journal of Dermatology. The faculty includes experts in dermatology who have substantial experience of publishing in high impact journals and being part of journal editorial boards. Early bird discount is available until 8th May. More information on the course and how to register can be found here: https://www.nottingham.ac.uk/research/groups/cebd/index.aspx
We have a job vacancy in the CEBD for a Research Assistant (fixed term) to support the delivery of a Cochrane systematic review and other related aspects of a National Institute for Health Programme Grant on self-care in eczema – Eczema Care Online (ECO). The closing date is Tuesday, 29th May 2018. Please see the job advertisement for further details.
The Lichen Sclerosus Priority Setting Partnership (PSP) was set up to identify and prioritise research questions that are important to people who have lichen sclerosus, the people who care for them, and the health professionals who treat them. The PSP has a list of 38 research areas that have not already been answered, and an online survey is still live for participants to help prioritise these by selecting up to ten questions from the list.
Siegfried EC, Jaworski JC, Eichenfield LF, Paller A, Hebert AA, Simpson EL, Altman E, Arena C, Blauvelt A, Block J, Boguniewicz M, Chen S, Cordoro K, Hanna D, Horii K, Hultsch T, Lee J, Leung DY, Lio P, Milner J, Omachi T, Schneider C, Schneider L, Sidbury R, Smith T, Sugarman J, Taha S, Tofte S, Tollefson M, Tom WL, West DP, Whitney L, Zane L.
Pediatr Dermatol. 2018 Mar 30. doi: 10.1111/pde.13452. [Epub ahead of print]
“Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).”
Rea CJ, Tran KD, Jorina M, Wenren LM, Hawryluk EB, Toomey SL.
Acad Pediatr. 2018 Mar 2. pii: S1876-2859(18)30118-9. doi: 10.1016/j.acap.2018.02.015. [Epub ahead of print]
“METHODS: We conducted a randomized controlled trial between 6/15 and 9/16 at a large, hospital-based pediatric primary care clinic. Participants included children between 1 month and 16 years of age with a diagnosis of eczema. The intervention group received the ECP [Eczema Care Plan] and the control group received usual care. Both groups completed a validated eczema severity scale (POEM) and a QOL [quality of life] scale (IDQOL or CDLQI) before the visit and again approximately one month later.
RESULTS: 211 caregivers completed both the pre- and post- survey (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88% vs. 28%, p<0.001), bleach baths (45% vs. 9%, p<0.001) and wet wraps (50% vs. 7%, p<0.001). They were also more likely to document providing a written plan to families (80% vs. 2%, p<0.001). In the intervention and control groups, eczema severity and QOL improved between the pre- and post- period. However, there was not a significant difference between the groups on either measure ([POEM difference, -0.8; 95%CI: -3.2, 1.7], [IDQOL difference, -0.1, 95%CI: -1.8, 1.6], [CDLQI difference, 0.8; 95%CI: -0.9, 2.6]).
CONCLUSIONS: Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the post-intervention period, the ECP did not augment that improvement.”
A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation - JOELLE study).
Castellsague J, Kuiper JG, Pottegård A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundström A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S.
Clin Epidemiol. 2018 Mar 13;10:299-310. doi: 10.2147/CLEP.S146442. eCollection 2018.
Objective: The aim of this study was to compare incidence rates (IRs) of lymphoma and skin cancer between new users of topical tacrolimus or pimecrolimus and users of moderate- to high-potency topical corticosteroids (TCSs) and untreated subjects.
Methods: This is a multicenter cohort study with frequency matching by strata of propensity scores in population databases in the Netherlands, Denmark, Sweden, and the UK. IR ratios (IRRs) were estimated using Mantel-Haenszel methods for stratified analysis.
Results: We included 19,948 children and 66,127 adults initiating tacrolimus, 23,840 children and 37,417 adults initiating pimecrolimus, 584,121 users of TCSs, and 257,074 untreated subjects. IRs of lymphoma per 100,000 person-years were 10.4 events in children and 41.0 events in adults using tacrolimus and 3.0 events in children and 27.0 events in adults using pimecrolimus. The IRR (95% confidence interval [CI]) for lymphoma, tacrolimus versus TCSs, was 3.74 (1.00-14.06) in children and 1.27 (0.94-1.71) in adults. By lymphoma type, the highest IRR was 3.17 (0.58-17.23) for Hodgkin lymphoma in children and 1.76 (95% CI, 0.81-3.79) for cutaneous T-cell lymphoma (CTCL) in adults. For pimecrolimus versus TCSs, the highest IRR was 1.31 (95% CI, 0.33-5.14) for CTCL in adults. Compared with untreated subjects, adults using TCSs had a higher incidence of CTCL (IRR, 10.66; 95% CI, 2.60-43.75). Smaller associations were found between tacrolimus and pimecrolimus use and the risk of malignant melanoma or nonmelanoma skin cancer.
Conclusion: Use of topical tacrolimus and pimecrolimus was associated with an increased risk of lymphoma. The low IRs imply that even if the increased risk is causal, it represents a small excess risk for individual patients. Residual confounding by severity of atopic dermatitis, increased monitoring of severe patients, and reverse causation could have affected the results.
Takeshita J, Shin DB, Ogdie A, Gelfand JM.
J Invest Dermatol. 2018 Mar 2. pii: S0022-202X(18)30153-2. doi: 10.1016/j.jid.2018.01.039. [Epub ahead of print]
“We identified 187,258 patients with mild, and 12,442 patients with moderate-to-severe psoriasis based on treatment patterns. Using Cox proportional hazards regression, the adjusted hazard ratios (95% confidence intervals [CI]) for serious infection were 1.18 (1.16-1.21) and 1.63 (1.52-1.75) for the mild and moderate-to-severe psoriasis groups, respectively. Among a nested cohort of 8,569 psoriasis patients with disease severity classified by body surface area involvement, similar results were obtained with the exception of an attenuated but significantly increased risk of serious infection among the moderate-to-severe psoriasis group (1.27 [1.10-1.47]). Overall, the risks of opportunistic infection and herpes zoster were significantly increased only among the moderate-to-severe psoriasis group and were associated with immunosuppressive therapy. Our analyses suggest that psoriasis is associated with an increased risk of serious infection, and psoriasis severity is a predictor of serious infection risk.”
Elder DE, Piepkorn M, Barnhill RL, Longton GM, Nelson HD, Knezevich SR, Pepe MS, Carney PA, Titus LJ, Onega T, Tosteson ANA, Weinstock MA, Elmore JG.
J Am Acad Dermatol. 2018 Mar 7. pii: S0190-9622(18)30357-8. doi: 10.1016/j.jaad.2018.02.070. [Epub ahead of print]
“RESULTS: Rates of diagnostic reproducibility and accuracy were highest among pathologists with board certification and/or fellowship training in dermatopathology, and those with ≥5 years of experience. In addition, accuracy was high among pathologists with higher caseload composition and volume of melanocytic lesions.
LIMITATIONS: Data gathered in a test set situation using a classification tool not currently in clinical use.
CONCLUSION: Diagnoses are more accurate among pathologists with specialty training and those with more experience interpreting melanocytic lesions. These findings support the practice of referring difficult cases to more experienced pathologists to improve diagnostic accuracy, although the impact on patient outcomes of these referrals requires additional research.”
Effect of a single prophylactic preoperative oral antibiotic dose on surgical site infection following complex dermatological procedures on the nose and ear: a prospective, randomised, controlled, double-blinded trial.
Rosengren H, Heal CF, Buttner PG.
BMJ Open. 2018 Apr 19;8(4):e020213. doi: 10.1136/bmjopen-2017-020213.
“OBJECTIVES: There is limited published research studying the effect of antibiotic prophylaxis on surgical site infection (SSI) in dermatological surgery, and there is no consensus for its use in higher-risk cases. The objective of this study was to determine the effectiveness of a single oral preoperative 2 g dose of cephalexin in preventing SSI following flap and graft dermatological closures on the nose and ear…”
“RESULTS: Overall 8/69 (11.6%) controls and 1/73 (1.4%) in the intervention group developed SSI (p=0.015; absolute SSI reduction 10.2%; number needed to treat (NNT) for benefit 9.8, 95% CI 5.5 to 45.5). In males, 7/44 controls and 0/33 in the intervention group developed SSI (p=0.018; absolute SSI reduction 15.9%; NNT for benefit 6.3, 95% CI 3.8 to 19.2). SSI was much lower in female controls (1/25) and antibiotic prophylaxis did not further reduce this (p=1.0). There was no difference between the study groups in adverse symptoms attributable to high-dose antibiotic administration (p=0.871).
CONCLUSION: A single oral 2 g dose of cephalexin given before complex skin closure on the nose and ear reduced SSI.”
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Dr Douglas Grindlay
Centre of Evidence Based Dermatology
University of Nottingham
King’s Meadow Campus
Nottingham, NG7 2NR
+44 (0) 115 8468624 | nottingham.ac.uk
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