Publications by authors named "Herrera-Ceballos E"

80 Publications

Adverse events associated with discontinuation of the biologics/classic systemic treatments for moderate-to-severe plaque psoriasis: data from the Spanish Biologics Registry, Biobadaderm.

J Eur Acad Dermatol Venereol 2017 Oct 6;31(10):1700-1708. Epub 2017 Jun 6.

Research Unit, Fundación Piel Sana Academia Española de Dermatología y Venereología, Madrid, Spain.

Background: Little is known about the adverse events (AEs) that lead to suspension of systemic treatments for psoriasis in clinical practice.

Objective: The study aimed to investigate AEs associated with discontinuation of systemic therapy in patients with psoriasis in a clinical setting (Biobadaderm).

Materials And Methods: Multicentre, prospective, cohort study of patients with moderate-to-severe plaque psoriasis receiving systemic therapies from January 2008 to November 2015, in 12 hospitals in Spain. The incidence rate (IR) was used to compare biologics and classic systemic therapies.

Results: A total of 4218 courses of treatment were given to 1938 patients. A total of 447 (11%) treatments were discontinued due to AEs. The IR of AE associated with discontinuation of systemic therapies was 13 events/100 patient-years (PY) (95% CI: 12.14-13.93), 9.34 events/100 PY (95% CI: 8.44-10.33) for biologics and 19.67 (95% CI: 17.9-21.6) events/100 PY for classics (P < 0.001). Of 810 discontinuation-related AEs, 117 (14%) were serious. The highest IRs were for cyclosporine [49.18/100 PY (95% CI: 41.91-57.72)] and infliximab [26.52/100 PY (95% CI: 20.98-33.51). Ustekinumab presented the lowest IR (2.6/100 PY (95% CI: 1.83-3.69).

Limitations: Observational study with potential selection bias.

Conclusion: Biologic therapies are associated with a lower rate of discontinuation-related AEs than are classic therapies in real clinical practice. Ustekinumab showed the lowest incidence.
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http://dx.doi.org/10.1111/jdv.14314DOI Listing
October 2017

Comparison of phenotype, comorbidities, therapy and adverse events between psoriatic patients with and without psoriatic arthritis. Biobadaderm registry.

J Eur Acad Dermatol Venereol 2017 Jun 12;31(6):1021-1028. Epub 2017 Apr 12.

Research Unit, Fundacion Piel Sana Academia Española de Dermatologia y Venereologia, Madrid, Spain.

Background: There are a limited number of studies comparing psoriasis patients without psoriatic arthritis (PsA) to those with arthritis. Previous results are controversial.

Objectives: To perform a comparative analysis of the phenotype, baseline comorbidities, therapeutic profile and incidence of adverse events (particularly overall adverse events, infections and infestations, malignancies and psychiatric disorders) among psoriatic patients with/without PsA.

Methods: All the patients on the Biobadaderm registry, a prospective inception cohort of psoriasis patients on systemic therapy, were included. Patients were divided into two groups: those with psoriasis without arthritis at the time of entry into the cohort (Pso group) and those with psoriasis and psoriatic arthritis (PsA group) at entry. Patients were followed until the censorship date (last visit in a lost-to-follow-up patient, or 10 November 2015, whichever occurred first). We excluded all the patients who developed any kind of signs and/or symptoms of joint involvement during the follow-up. A descriptive analysis was performed. We estimated incidence ratios (IRR) of adverse events during systemic treatment using a mixed-effects Poisson regression.

Results: We included 2120 patients: 1871 (88%) patients with psoriasis without arthritis and 249 (12%) with psoriasis and PsA. The follow-up time was 5020 patients-year in the Pso group and 762 patients-year in the PsA group. Patients with PsA had more comorbidities, particularly hypertension and liver disease; used a higher number of systemic therapies, particularly anti-TNFα drugs and combination therapy; and presented more adverse events (IRR adjusted = 1.29; 95% CI: [1.05-1.58]), particularly serious adverse events (IRR adjusted = 1.51; 95% CI: [1.01-2.26]) and infections/infestations (IRR adjusted = 1.88; 95% CI: [1.27-2.79]), independently of the associated comorbidities and present/past therapies.

Conclusions: Given the differences between patients with psoriasis alone or with psoriasis associated with PsA, patients with psoriasis and PsA should be followed and managed more closely and with specific attention.
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http://dx.doi.org/10.1111/jdv.14188DOI Listing
June 2017

Rational Design and Synthesis of Efficient Sunscreens To Boost the Solar Protection Factor.

Angew Chem Int Ed Engl 2017 03 27;56(10):2632-2635. Epub 2017 Jan 27.

Department of Chemistry, Centro de Investigación en Síntesis Química (CISQ), Universidad de La Rioja, Madre de Dios 53, 26006, Logroño, Spain.

Skin cancer incidence has been increasing in the last decades, but most of the commercial formulations used as sunscreens are designed to protect only against solar erythema. Many of the active components present in sunscreens show critical weaknesses, such as low stability and toxicity. Thus, the development of more efficient components is an urgent health necessity and an attractive industrial target. We have rationally designed core moieties with increased photoprotective capacities and a new energy dissipation mechanism. Using these scaffolds, we have synthesized a series of compounds with tunable properties suitable for their use in sunscreens, and enhanced properties in terms of stability, light energy dissipation, and toxicity. Moreover, some representative compounds were included in final sunscreen formulations and a relevant solar protection factor boost was measured.
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http://dx.doi.org/10.1002/anie.201611627DOI Listing
March 2017

Survival of classic and biological systemic drugs in psoriasis: results of the BIOBADADERM registry and critical analysis.

J Eur Acad Dermatol Venereol 2016 Nov 22;30(11):1942-1950. Epub 2016 Jun 22.

Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain.

Background: Few reported studies compare drug survival in moderate-to-severe psoriasis vulgaris.

Objectives: To describe and compare drug survival of systemic drugs, including biologic agents (infliximab, etanercept, adalimumab and ustekinumab) and classical drugs (acitretin, ciclosporin and methotrexate) in moderate-to-severe psoriasis.

Methods: This was a multicenter, prospective, cohort study of patients receiving systemic therapies between 2008 and 2013 in 12 hospitals in Spain. Baseline data and drug discontinuation were collected. Drug survival is presented using Kaplan-Meier survival curves. We compared adjusted risk ratios of serious adverse events (AEs) with results of survival analysis for AEs.

Results: A total of 1956 patients were included for analysis (1240 exposed to biologics during follow-up and 1076 to classic therapies). Median follow-up time was 3.3 years (0.0-5.1 years). There were 2209 discontinuations out of 3640 therapy cycles started. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%). Biologics showed a higher drug survival than classics and the pattern of survival results for all outcomes (positive or negative) were very similar. Adjusted risk ratios of serious AEs did not agree with results of survival analysis.

Limitations: A limitation is that this is an observational study with potential selection bias.

Conclusion: Survival as a proxy measure of drug safety in psoriasis is inadequate.
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http://dx.doi.org/10.1111/jdv.13682DOI Listing
November 2016

Sun Protection Habits and Attitudes Among Healthcare Personnel in a Mediterranean Population.

J Cancer Educ 2016 12;31(4):789-795

Dermatology Department, University of Málaga, Málaga, Spain.

Health professionals are key agents in healthcare promotion. In the field of skin cancer, they play a crucial role in the development of prevention strategies in the community. This paper aims to describe the sun exposure attitudes and habits of public healthcare professionals in the western Costa del Sol (Spain). A cross-sectional descriptive study was conducted in the Costa del Sol healthcare district to analyse sun exposure and protection practices and habits, and attitudes to tanning and sun protection. The respondents, all healthcare personnel in various professional categories and workplace situations, were asked to complete a self-administered questionnaire. Six hundred forty-three workers in the Costa del Sol healthcare district took part in the study. Of these participants, 450 were healthcare professionals. Of the 450 health professionals, 226 (50.2 %) were nurses or auxiliary nursing staff, and the remaining 224 were doctors. These two groups presented differences regarding habits of sun exposure: 15.3 % of the doctors went to the beach at least 30 days a year, compared to 30.9 % of the nurses (p < 0.001). With respect to workplace situation, there were differences (p < 0.001) between the sunburn events reported by healthcare staff who worked in hospitals (52.4 %) compared to those working in primary healthcare (30.4 %); comparable differences were found with respect to attitudes toward the use of sunscreen creams (p = 0.014). This study identifies two distinct subgroups within healthcare personnel: on one hand, primary healthcare professionals, who are key agents for future policy strategies, and on the other, specialist healthcare professionals, who are more likely to suffer sunburn events and therefore toward whom strategies should be addressed to encourage them to change their sun exposure attitudes and habits and sun protection practices.
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http://dx.doi.org/10.1007/s13187-015-0913-1DOI Listing
December 2016

Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry.

J Invest Dermatol 2017 02 25;137(2):313-321. Epub 2016 Sep 25.

Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain; Dermatology Derpartment, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.

Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2-3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1-2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17-2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08-2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02-1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1-8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8-13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27-8.24).
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http://dx.doi.org/10.1016/j.jid.2016.08.034DOI Listing
February 2017

Management of Biologic Therapy in Moderate to Severe Psoriasis in Surgical Patients: Data From the Spanish Biobadaderm Registry.

Actas Dermosifiliogr 2017 Jan - Feb;108(1):52-58. Epub 2016 Sep 20.

Servicio de Dermatología, Hospital Infanta Leonor, Madrid, España.

Background And Objective: We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases.

Methods: Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures.

Results: Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. The largest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis.

Conclusion: Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size.
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http://dx.doi.org/10.1016/j.ad.2016.08.003DOI Listing
November 2017

Infrared radiation increases skin damage induced by other wavelengths in solar urticaria.

Photodermatol Photoimmunol Photomed 2016 Sep;32(5-6):284-290

Photobiological Dermatology Laboratory, Medical Research Center, Department of Dermatology and Medicine, Faculty of Medicine, University of Málaga, Málaga, Spain.

Background: Photodermatoses are typically investigated by analyzing the individual or combined effects of ultraviolet A (UVA), ultraviolet B (UVB), and visible light using light sources that simulate portions of the solar spectrum. Infrared radiation (IRR), however, accounts for 53% of incident solar radiation, but its effects are not taken into account in standard phototest protocols.

Aims: The aim was to analyze the effects of IRR, alone and combined with UVA and visible light on solar urticaria lesions, with a distinction between infrared A (IRA) and infrared B (IRB).

Methods: We performed standard phototests with UVA and visible light in four patients with solar urticaria and also tested the effects after blocking IRB with a water filter. To analyze the direct effect of IRR, we performed phototests with IRA and IRB.

Results: Initial standard phototests that were all positive found the induction of erythema and whealing, while when IRR was blocked from the UVA and visible light sources, three of the patients developed no lesions, while the fourth developed a very small wheal.

Conclusion: These results suggest that IRR has the potential to produce and exacerbate lesions caused by other types of radiation. Consideration of these effects during phototesting could help prevent diagnostic errors.
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http://dx.doi.org/10.1111/phpp.12270DOI Listing
September 2016

Bullous Pemphigoid on the Areola of Breast.

Actas Dermosifiliogr 2017 04 26;108(3):260. Epub 2016 May 26.

Servicio de Dermatología, Hospital Universitario Virgen de la Victoria, Málaga, España.

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http://dx.doi.org/10.1016/j.ad.2015.12.014DOI Listing
April 2017

Immunophenotypic Shift Associated With Angiocentricity and Cytoxic Characteristics in a Case of Mycosis Fungoides.

Actas Dermosifiliogr 2016 Oct 18;107(8):697-9. Epub 2016 May 18.

Servicio de Dermatología, Hospital Universitario Virgen de la Victoria, Málaga, España.

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http://dx.doi.org/10.1016/j.ad.2016.04.006DOI Listing
October 2016

Development of clinical prediction models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis, based on the BIOBADADERM cohort.

J Dermatolog Treat 2016 25;27(3):203-9. Epub 2015 Sep 25.

o Department of Dermatology , Hospital Universitario 12 de Octubre , Madrid , Spain.

Background: Identifying patients likely to have very good or bad results from systemic psoriasis therapy could improve efficiency of therapy.

Objective: To develop prognostic models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis.

Methods: Multivariable logistic regression of a prospective multicenter cohort of psoriatic patients in clinical practice (6449 person-years of follow-up). We used as possible predictors demographic characteristics, comorbidities, characteristics of the psoriasis (type, PASI, arthritis), history of past therapy at entry in the cohort, and history of response to previous cycles while in the cohort. We defined good response to a treatment cycle as either cycle end due to disease remission or a cycle longer than 2 years that does not end later due to inefficacy in the follow-up period. Bad response to a treatment cycle was defined as a cycle that is finished due to inefficacy, based on the physician judgment, after more than 3 months of treatment.

Results: Patients with fewer previous therapies, lower body mass index, older at start of therapy, and with previous history of good responses to therapy are more likely to have positive results of therapy. However, the predictive characteristics of models are poor.

Conclusion: Predictive models of clinical response to systemic drugs in psoriasis with the studied variables do not seem to outperform drug selection by a dermatologist.
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http://dx.doi.org/10.3109/09546634.2015.1088130DOI Listing
October 2016

Does the treatment ladder for systemic therapy in moderate to severe psoriasis only go up? The percentage of patients with severe psoriasis on biologics increases over time.

Actas Dermosifiliogr 2015 Oct 30;106(8):638-43. Epub 2015 Jun 30.

Hospital Universitari Germans Trías i Pujol, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain.

Background: With the advent of biologic drugs in the management of moderate to severe psoriasis, there may have been a shift in therapeutic approach from rotational strategies to a unidirectional progression from topical treatments to the highest rung of the therapeutic ladder. We studied the frequency of switching from classic to biologic therapy and vice versa in a cohort of patients with psoriasis over a period of up to 5 years.

Methods: Patients are included in the BIOBADADERM prospective registry when they are first prescribed any specific conventional or biologic systemic treatment. The data for each patient refer to the follow-up period from the time they entered the cohort until October 2013. To describe the pattern of switches from classic to biologic therapy and vice versa, we used the data in the registry on the first day of every 365-day period following the date each patient was included in the cohort.

Results: In total, 47.3% of the patients (926/1956) were prescribed a classic systemic drug and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up.

Conclusions: The proportion of patients receiving biologic therapy increased with longer follow-up.
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http://dx.doi.org/10.1016/j.ad.2015.04.013DOI Listing
October 2015

Effect of time to sentinel-node biopsy on the prognosis of cutaneous melanoma.

Eur J Cancer 2015 Sep 10;51(13):1780-93. Epub 2015 Jun 10.

Servicio de Dermatología, Instituto de Biomedicina de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria/Universidad de Málaga, Boulevard Louis Pasteur, 32, 29071 Málaga, Spain. Electronic address:

Introduction: In patients with primary cutaneous melanoma, there is generally a delay between excisional biopsy of the primary tumour and sentinel-node biopsy. The objective of this study is to analyse the prognostic implications of this delay.

Patients And Method: This was an observational, retrospective, cohort study in four tertiary referral hospitals. A total of 1963 patients were included. The factor of interest was the interval between the date of the excisional biopsy of the primary melanoma and the date of the sentinel-node biopsy (delay time) in the prognosis. The primary outcome was melanoma-specific survival and disease-free survival.

Results: A delay time of 40 days or less (hazard ratio (HR), 1.7; confidence interval (CI), 1.2-2.5) increased Breslow thickness (Breslow ⩾ 2 mm, HR, > 3.7; CI, 1.4-10.7), ulceration (HR, 1.6; CI, 1.1-2.3), sentinel-node metastasis (HR, 2.9; CI, 1.9-4.2), and primary melanoma localised in the head or neck were independently associated with worse melanoma-specific survival (all P < 0.03). The stratified analysis showed that the effect of delay time was at the expense of the patients with a negative sentinel-node biopsy and without regression.

Conclusion: Early sentinel-node biopsy is associated with worse survival in patients with cutaneous melanoma.
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http://dx.doi.org/10.1016/j.ejca.2015.05.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4768477PMC
September 2015

Defining the dermoscopic characteristics of fast-growing cutaneous melanomas.

Melanoma Res 2015 Jun;25(3):269-72

aUnidad de Gestión Clínica de Dermatología, Instituto de Biomedicina de Málaga (IBIMA), Hospital Universitario Virgen de la Victoria/Universidad de Málaga, Málaga bServicio de Dermatología, Hospital Universitario San Cecilio cServicio de Dermatología dServicio de Anatomía Patológica, Instituto Valenciano de Oncología, Valencia, Spain.

A high growth rate in melanomas has been associated with a more aggressive phenotype and worse survival. The aim of this study was to define the dermoscopic characteristics associated with this type of cutaneous melanoma. We carried out a retrospective study of 132 cutaneous melanomas, analyzing certain clinical characteristics and the most important dermoscopic variables related to the melanomas. Fast-growing melanomas were considered to be those with a growth rate of more than 0.5 mm per month. Fast-growing melanomas more often lacked an atypical network, were symmetrical, presented ulceration, and were hypopigmented. The dermoscopic vascular pattern often showed atypical irregular vessels and milky-red areas. The association of these two is a specific characteristic. Fast-growing melanomas have a characteristic phenotype and dermoscopy can be useful for their identification.
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http://dx.doi.org/10.1097/CMR.0000000000000157DOI Listing
June 2015

Human Hair as a Natural Sun Protection Agent: A Quantitative Study.

Photochem Photobiol 2015 Jul-Aug;91(4):966-70. Epub 2015 Mar 12.

Photobiological Dermatology Laboratory, Medical Research Centre, Department of Dermatology and Medicine, Faculty of Medicine, University of Málaga, Malaga, Spain.

The rising incidence of skin cancers attributable to excessive sun exposure has become a major health concern worldwide. While numerous studies have analyzed the sun protective effect of sunscreens, clothing and antioxidants, none to date have measured the photoprotective effect of hair, despite clinical evidence that individuals with balding or thinning hair are at greater risk of skin lesions that can progress to cancer, hence the recommendation to use hats or umbrellas. We analyzed the level of protection offered by hair according to hair density, thickness and color using the spectral transmittance and corrected for relative erythema effectiveness. Our results show that hair provides a barrier against both UVB and UVA radiation which is significantly increased with respect to the hair density, thickness and the presence of melanins. This is the first study to quantify sun protection factor offered by hair, namely hair ultraviolet protection factor (HUPF). We believe that hair should be recognized as an important natural sun barrier in the prevention of UV-induced skin cancers.
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http://dx.doi.org/10.1111/php.12433DOI Listing
December 2015

Predictors of sentinel lymph node status in cutaneous melanoma: a classification and regression tree analysis.

Actas Dermosifiliogr 2015 Apr 20;106(3):208-18. Epub 2015 Jan 20.

Servicio de Dermatología, Instituto Valenciano de Oncología, Valencia. España.

Objective: The main aim of this study was to identify predictors of sentinel lymph node (SN) metastasis in cutaneous melanoma.

Patients And Methods: This was a retrospective cohort study of 818 patients in 2 tertiary-level hospitals. The primary outcome variable was SN involvement. Independent predictors were identified using multiple logistic regression and a classification and regression tree (CART) analysis.

Results: Ulceration, tumor thickness, and a high mitotic rate (≥6 mitoses/mm(2)) were independently associated with SN metastasis in the multiple regression analysis. The most important predictor in the CART analysis was Breslow thickness. Absence of an inflammatory infiltrate, patient age, and tumor location were predictive of SN metastasis in patients with tumors thicker than 2mm. In the case of thinner melanomas, the predictors were mitotic rate (>6 mitoses/mm(2)), presence of ulceration, and tumor thickness. Patient age, mitotic rate, and tumor thickness and location were predictive of survival.

Conclusions: A high mitotic rate predicts a higher risk of SN involvement and worse survival. CART analysis improves the prediction of regional metastasis, resulting in better clinical management of melanoma patients. It may also help select suitable candidates for inclusion in clinical trials.
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http://dx.doi.org/10.1016/j.ad.2014.10.012DOI Listing
April 2015

Safety of classic and biologic systemic therapies for the treatment of psoriasis in elderly: an observational study from national BIOBADADERM registry.

J Eur Acad Dermatol Venereol 2015 May 3;29(5):858-64. Epub 2014 Sep 3.

Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.

Background: Psoriasis patients over 65 years-old (elderly) constitute a growing group, underrepresented in clinical trials, and likely to be more prone to adverse events.

Objective: To describe safety of systemic psoriasis therapy in patients over 65 years-old compared to younger patients.

Methods: Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were grouped in elderly (≥ 65 years old) and younger patients. Rates of adverse events were described by severity and type, and the risks compared in both groups, taking into account exposure to classic or biologic drugs, using Cox regression.

Results: 175 (9.8%) of 1793 patients were elderly. Overall risk of adverse events was not higher in elderly (drug group adjusted HR 1.09 (95%CI: 0.93-1.3)). Serious adverse events were more common in elderly (drug group adjusted HR 3.2 (95%CI: 2.0-5.1)). Age adjusted HR of all adverse events was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR 0.7 (95%CI: 0.6-0.7)). Age did not seem to modify the effect of therapy (biologic vs. classic) in the risk of adverse events (likelihood ratio test for interaction, p = 0.12 for all adverse events, p = 0-09 for serious adverse events).

Conclusions: Serious adverse events are more common in elderly patients, although they may be related to other variants that are associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk of adverse events in the whole group. We found no differences in this association between young and elderly. These results are reassuring, although uncontrolled confounding could not be excluded as an explanation for these findings, and the power of the study to detect differences was low.
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http://dx.doi.org/10.1111/jdv.12688DOI Listing
May 2015

Survival rate of etanercept for psoriasis in real life: a multicentre observational study.

Eur J Dermatol 2014 Sep-Oct;24(5):619-20

Dermatology Department, Hospital Universitario Virgen de la Victoria, s/n. 29071-Málaga, Spain., Dermatology and Medicine Department, University of Málaga, Spain.

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http://dx.doi.org/10.1684/ejd.2014.2400DOI Listing
August 2015

New advances in protection against solar ultraviolet radiation in textiles for summer clothing.

Photochem Photobiol 2014 Sep-Oct;90(5):1199-206. Epub 2014 Jun 18.

Photobiological Dermatology Laboratory, Medical Research Centre, Department of Dermatology and Medicine, Faculty of Medicine, University of Malaga, Malaga, Spain.

Clothing is considered one of the most important tools for photoprotection against harmful solar ultraviolet radiation (UVR). The standard for sun-protective clothing is based on erythema despite other biological effects of UVR on the skin. We analyzed the potential protection against UVR in fabrics destined for summer clothing based on several action spectra. We examined 50 garments classified by type of fabric composition, structure of the fiber yarn and color. The ultraviolet protection factor was calculated based on fabric ultraviolet transmittance corrected for erythema according to the EU standard E-13758 as well as the UVA transmittance of fabrics. UVR protection was also analyzed in base of different action spectra as for previtamin D3, nonmelanoma skin cancer, photoimmunosuppression and photoaging. Most knitted fabrics used for sports T-shirts offered excellent ratings for ultraviolet protection while normal shirts showed very low ratings, particularly against photoaging. The cover is the most influential variable in fabric photoprotection, having an exponential relationship with the UPF. The relation between cover and UVA protection was linearly negative. Information about ultraviolet protection in textiles used for summer clothing should be included in labeling as some types of fabrics, especially those used for shirts, offer very low UVR protection.
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http://dx.doi.org/10.1111/php.12292DOI Listing
September 2015

Risk of adverse events in psoriasis patients receiving classic systemic drugs and biologics in a 5-year observational study of clinical practice: 2008-2013 results of the Biobadaderm registry.

J Eur Acad Dermatol Venereol 2015 Jan 31;29(1):156-63. Epub 2014 Mar 31.

Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.

Background: Biobadaderm is the Spanish registry of psoriasis patients receiving systemic treatment in clinical practice.

Objective: To compare the safety of biologics and classic systemic treatment.

Methods: Prospective cohort of patients receiving biologics and classic systemic therapies between 2008 and 2013 in 12 hospitals are included. We registered demographic data, diagnoses, comorbidities, treatments and adverse events (AE). We obtained raw relative risks (RR) for specific AE. Multivariate analysis consisted of Cox models adjusting for age, gender, chronic hepatic disease and previous cancer.

Results: A total of 1030 patients received biologics (2061 AE in 3681 person-years), 926 patients classic systemic drugs (1015 AE in 1517 person-years). Ninety-three per cent of AE in both groups were non-serious, 6% serious and 0.003% fatal. The age- and gender-adjusted hazard ratio of AE was lower in the biologics group [hazard ratio 0.6 (95% CI: 0.5-0.7)].We found no differences in rates of serious and mortal AE. Some system organ class AE rates differed between both groups. As limitations: Prescription bias might affect the incidence of AE in both groups. Association of drug and AE was based on timing: associations might not be causal.

Conclusion: Patients receiving biologics had lower risk of AE. We did not find differences in the risk of serious or fatal AE.
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http://dx.doi.org/10.1111/jdv.12492DOI Listing
January 2015

Acute generalized exanthematous pustulosis induced by gliclazide: a case report.

Int J Dermatol 2013 Dec;52(12):1591-3

Department of Dermatology, Hospital Virgen de la Victoria, Málaga, Spain E-mail:

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http://dx.doi.org/10.1111/j.1365-4632.2012.05521.xDOI Listing
December 2013

Body mass index in patients with moderate-to-severe psoriasis in Spain and its impact as an independent risk factor for therapy withdrawal: results of the Biobadaderm Registry.

J Eur Acad Dermatol Venereol 2014 Jul 15;28(7):907-14. Epub 2013 Jul 15.

Hospital Universitari Germans Trías i Pujol, Badalona, Universitat Autònoma de Barcelona, Barcelona.

Background: There are few data on the prevalence of obesity in the general psoriasis population and on the real impact of obesity on the management of psoriasis patients in the clinical setting.

Objectives: To evaluate the prevalence of overweight and obesity in patients with moderate-to-severe psoriasis compared to the general population and to assess the relationship between Body Mass Index (BMI) and the risk of discontinuing treatment.

Methods: Patients registered on Biobadaderm, a prospective registry, were grouped according the different categories of BMI and compared to the general Spanish population. Drug survival was analysed considering only drug withdrawal due to lack of effectiveness, remission and adverse events.

Results: A total of 1162 moderate-to-severe psoriasis patients on systemic conventional or biological treatment were recruited. The prevalence of obesity was found to be significantly higher in psoriasis patients than in the general Spanish population (P < 0.001). In multivariate analysis a 5-unit increase in BMI, similar to a change in BMI category from normal weight to overweight and from overweight to obesity, was associated with a 12% increased risk of discontinuing therapy due to lack of effectiveness (HR 1.12, 95% CI: 1.01-1.24) and with a 17% increased risk of having an adverse event (HR 1.17, 95% CI: 1.02-1.36), both independently of the drug used.

Conclusions: Patients with moderate-to-severe psoriasis had a higher prevalence of obesity than the general population. Increased BMI was associated with an increased risk of treatment discontinuation due to lack of effectiveness and a higher risk of adverse events.
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http://dx.doi.org/10.1111/jdv.12208DOI Listing
July 2014

Interstitial granulomatous dermatitis and arthritis revealing oesophageal carcinoma.

Clin Exp Dermatol 2013 Jul;38(5):501-3

1Department of Dermatology, University Hospital Virgen de la Victoria, Málaga, Spain.

Interstitial granulomatous dermatitis and arthritis (IGDA) is an uncommon clinicopathological condition that may occur in association with a number of systemic disorders. We present a novel case of IGDA in association with oesophageal squamous cell carcinoma (SCC). A 67-year-old man with a 3-month history of arthritis presented with several erythematous indurated plaques on his lateral trunk and arms. An oesophagogastroduodenoscopy showed an irregular mass 20 mm in size in the proximal third of the oesophagus, and on histopathological examination of a biopsy, the mass was identified as a poorly differentiated SCC. Histopathological examination of a skin biopsy found features consistent with interstitial granulomatous dermatitis. The combination of clinicopathological correlation and laboratory findings led to the diagnosis of IGDA. This association has not been previously described, to our knowledge.
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http://dx.doi.org/10.1111/j.1365-2230.2012.04458.xDOI Listing
July 2013

Birt-Hogg-Dubé syndrome in a patient with melanoma and a novel mutation in the FCLN gene.

Int J Dermatol 2013 Mar;52(3):323-6

Department of Dermatology, Hospital Virgen de la Victoria, Malaga, Spain.

Birt-Hogg-Dubé syndrome (BHDS) is an autosomal dominant genodermatosis characterized by the presence of three skin tumors (fibrofolliculomas, trichodiscomas, and acrochordons), together with an increased risk for other tumors, especially renal tumors, caused by a mutation in folliculin, an oncogene suppressor protein. The association of this syndrome with melanoma is very unusual. We report the case of a 54-year-old man with a history of melanoma who had multiple white facial papules. His son also presented similar facial lesions. Histopathologic study showed fibrofolliculomas. These clinical and histopathologic features suggested the diagnosis of BHDS. Genetic study revealed a novel heterozygous mutation p.S185P in exon 6 of the FLCN gene. To date, the association between melanoma and BHDS has rarely been described. As the pathogenic mechanism responsible for melanoma seems to be the same as that responsible for neoplasms in BHDS, the authors consider the melanoma a manifestation of BHDS. Thus, during the periodic follow-up of patients with BHDS, we recommend periodic exhaustive skin examination and excisional biopsy of any suspicious pigmented lesion.
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http://dx.doi.org/10.1111/j.1365-4632.2012.05742.xDOI Listing
March 2013

Tumor-like lesions grouped on a patient's leg.

Actas Dermosifiliogr 2013 Mar 26;104(2):159-60. Epub 2012 Nov 26.

Servicio de Dermatología, Hospital Clínico Universitario, Málaga, España.

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http://dx.doi.org/10.1016/j.ad.2012.06.011DOI Listing
March 2013

Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate-severe psoriasis in Spain. BIOBADADERM registry.

J Eur Acad Dermatol Venereol 2013 Nov 8;27(11):1366-74. Epub 2012 Nov 8.

Hospital Universitario la Princesa, MadridUnidad de investigación Fundación AEDV, MadridHospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran CanariaHospital General Universitario de Valencia, ValenciaHospital Universitario Germans Trias i Pujol, BadalonaHospital Universitario Virgen de la Victoria, MálagaHospital Clinic de Barcelona, BarcelonaHospital del Mar, Parc de Salut Mar, BarcelonaFundación Hospital Alcorcon, MadridHospital Universitario Reina Sofía, CordobaHospital Infanta Leonor, MadridHospital Universitario Germans Trias i Pujol, BadalonaHospital Universitario 12 de Octubre, MadridHospital General Universitario de Alicante, AlicanteHospital Universitario Virgen de la Macarena, SevillaHospital Universitario la Princesa, Madrid, Spain.

Introduction: The incidence of tuberculosis (TB) or the prevalence of latent tuberculosis infection (LTBI) in psoriasis patients has not been described in the Spanish population. We carried out a study with the objectives: (i) To describe the incidence of TB in patients with psoriasis on systemic treatment in the Spanish population; (ii) To determine the prevalence of LTBI in patients who are candidates for biological treatment; and (iii) To investigate the level of compliance with current recommendations for LTBI and TB screening.

Methods: Data were obtained from BIOBADADERM (Spanish registry for systemic biological and non-biological treatments in psoriasis). An analysis was performed of the exposed cohort to determine the prevalence of LTBI and to describe compliance with the screening guidelines.

Results: A total of 1425 patients were registered in BIOBADADERM. They included 793 (56%) patients exposed to biological treatment and 632 (44%) treated with conventional systemic drug. Overall follow-up was 3720 person-years. Of the 793, 20.5% (163) were diagnosed with LTBI before starting biological treatment. The rate of active TB for the exposed cohort was 145 cases × 100,000 patient-years (95% CI 54-389). No case of TB was found in the control group. Screening for LTBI was performed in 83% of the exposed sample.

Conclusion: Patients with psoriasis who are exposed to biological treatment appear to be at greater risk for tuberculosis. In Spain, up to 20% of patients with psoriasis who are candidates for biological therapy have LTBI. There continues to be a significant percentage of errors in compliance with clinical guidelines.
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http://dx.doi.org/10.1111/jdv.12011DOI Listing
November 2013

Changes in photoinduced cutaneous erythema with topical application of a combination of vitamins C and E before and after UV exposure.

J Dermatol Sci 2012 Jun 3;66(3):216-20. Epub 2012 Apr 3.

Photobiological Dermatology Laboratory, Medical Research Center, Department of Dermatology and Medicine, Faculty of Medicine, University of Malaga, Campus Universitario de Teatinos s/n, E-29071, Malaga, Spain.

Background: Ultraviolet radiation is harmful for human skin, and photodamaging pathologies such as actinic erythema, are formerly described as a consequence of UV direct effect on DNA and indirectly by local immune reactions. However, the degree of participation of oxidative stress in actinic erythema and the role of antioxidants in photoprotection are still not fully understood.

Objective: To evaluate the possible palliative role of a combination of the antioxidants vitamins C and E in human cutaneous erythema when applied topically before and after UV exposure.

Materials And Methods: The study included 20 volunteers of phototypes II, II-III and III with no solar exposure for two months prior to the study. The volunteers were submitted to a phototest consisting on the analysis of the minimal erythemal dose (MED) under different treatments: 1. Untreated irradiated skin; 2. Irradiated skin previously treated with vehicle; 3. Irradiated skin previously treated with a combination of vitamins (2.5% vit E-5% vit C); and 4. Skin treated with the antioxidant combination after irradiation. Cutaneous erythema was evaluated 24h after exposure and the MED was calculated for each treatment.

Results: The application of vehicle did not significantly affect the MED compared to untreated irradiated skin. Application of the antioxidant combination, prior to irradiation, increased the MED in all phototypes compared with untreated irradiated skin with an average increase of 36.9%. Antioxidants applied after exposure promoted an average increase of the MED by 19.8%.

Conclusions: Combination of topical antioxidants (vitamins C and E) shows photoprotection activity against erythema, mainly owing to their high absorption properties. Moreover, their antioxidant activity could be considered as additive, and independent of their optical properties.
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http://dx.doi.org/10.1016/j.jdermsci.2012.03.010DOI Listing
June 2012

Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials.

Arch Dermatol 2012 Apr;148(4):463-70

Department of Dermatology, Complexo Hospitalario de Pontevedra, SERGAS (Servizo Galego de Saude), Pontevedra, Spain.

Objective: To describe the use of systemic therapy for psoriasis (biologic and nonbiologic [classic] drugs) in patients not adequately represented in randomized controlled trials (RCTs) and the risk of serious adverse events (SAEs) in these patients.

Design: A registry inception cohort was used.

Setting: Thirteen dermatology departments in Spain participated.

Patients: A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy were evaluated. A total of 1042 patients (2179 person-years) were included.

Exposure: Inadequate representation in trials was defined as the presence of any of the following factors: elderly age (>70 years); type of psoriasis other than chronic plaque psoriasis; history of infection caused by hepatitis B, hepatitis C, or human immunodeficiency virus; history of cancer (excluding nonmelanoma skin cancer); and chronic renal or hepatic disease.

Main Outcome Measures: Serious adverse events as defined by the International Conference on Harmonization were evaluated.

Results: In all, 29.8% of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients exposed to biologics had an adjusted increased risk of SAEs (incidence rate ratio, 2.3; 95% CI, 1.1-4.8) that was similar in patients eligible and ineligible for RCTs.

Conclusions: Patients ineligible for RCTs are an important proportion (30%) of those receiving systemic therapy for psoriasis. These patients have a higher risk of SAEs and should be closely monitored. Patients exposed to biologics (whether these patients are eligible for RCTs or ineligible) are susceptible to the same increase in risk of SAEs, but biologics add to a higher baseline risk in patients who are ineligible for RCTs. The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients.
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http://dx.doi.org/10.1001/archdermatol.2011.2768DOI Listing
April 2012

Prediction of sentinel lymph node positivity by growth rate of cutaneous melanoma.

Arch Dermatol 2012 May;148(5):577-84

Servicio de Dermatología, Hospital Virgen de la Victoria, Málaga, Spain.

Objective: To determine whether growth rate (GR) of cutaneous melanoma predicts the histological sentinel lymph node (SLN) positivity.

Design: Retrospective cohort study.

Setting: Two tertiary melanoma referral centers.

Patients: A total of 698 patients with invasive primary cutaneous melanoma in whom the SLN was identified between January 1, 2000, and June 30, 2010.

Main Outcome Measure: Based on previous studies, a surrogate measure for GR in primary invasive melanoma was calculated as the ratio of Breslow thickness to time to melanoma development.

Results: The SLN was positive in 20.2% of patients. Multivariate logistic regression analysis revealed that GR, Breslow thickness, and the presence of microscopic satellitosis were independently associated with SLN positivity. The probability of SLN positivity was 8.2% for slow-growth melanomas (<0.10 mm/mo) compared with 19.8% for intermediate-growth melanomas (0.10-0.50 mm/mo) and 37.7% for fast-growth melanomas (>0.50 mm/mo). Growth rate was not an independent predictive factor for survival.

Conclusion: Growth rate of primary cutaneous melanoma, together with Breslow thickness and the presence of microscopic satellitosis, predicts the histological SLN positivity.
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http://dx.doi.org/10.1001/archdermatol.2011.2522DOI Listing
May 2012
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