Ignacio García-Doval

Clinical Trials, Epidemiology, Dermatology
MD, MScEpid, PhD
36.54

Publications

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    ABSTRACT: Biologic medications increase dramatically the burden of a chronic and high prevalent disease like psoriasis. The objective of the study was to quantify the use of dose reduction or dose escalation strategies, not reflected in the drug summary of product characteristics, in clinical practice. An observational, cross-sectional study of a subset of patients from the Spanish Registry for Systemic Treatments in Psoriasis (BIOBADADERM) treated for over six consecutive months with the same biologic agent. The study included 637 patients. At the cut-off date, the initial dose had been reduced in 223 patients (35%; 95% CI: 31.3-38.9%) and escalated in 46 (7.2%; 95% CI: 5.3-9.5%). When compared with the patients treated with standard doses, the patients on reduced doses had a lower PASI score at the cut-off date (a mean 2.6 versus 1; -1.6 points) and exhibited greater improvement in PASI since the start of biologic therapy (mean reduction over baseline 75% versus 87%). By contrast, the patients receiving an escalated dose had higher PASI scores (2.6 versus 8.0) and showed less improvement in PASI (75% versus 46.8%). Off-label doses of biologic agents for psoriasis are frequent in clinical practice. This information is especially relevant for pharmacoeconomic models.
    Journal of Dermatological Treatment 04/2015; DOI:10.3109/09546634.2015.1034070 · 1.76 Impact Factor
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    ABSTRACT: A 5% risk of reactivation of hepatitis B virus (HBV) infection has been reported in patients with diseases other than psoriasis treated with tumor necrosis factor inhibitors. The aim of this study was to investigate the risk of HBV reactivation in patients with a past history of HBV infection who were receiving biologic therapy for psoriasis. This was a multicenter study of 20 patients with psoriasis who were treated with at least 1 biologic agent. All the patients had serologic evidence of past HBV infection (positive total hepatitis B core antibody and negative hepatitis B surface antibody). We analyzed the clinical, serological, and liver function variables recorded before, during, and at the end of follow-up. The viral load at the end of follow-up was also analyzed for all patients. None of the patients fulfilled the criteria for HBV reactivation at the end of a median follow-up period of 40 months. Combining our data with data from other studies of psoriasis patients with a past history of HBV infection who were treated with a biologic, we calculated a maximum estimated risk of HBV reactivation for a mean follow-up period of 30 months of 2.7 reactivations per 100 patients. Biologic therapy did not cause HBV reactivation in our series of patients. Nonetheless, because of the potentially serious complications associated with HBV reactivation, it is important to measure viral load in patients with a history of HBV infection prior to initiation of biologic therapy to rule out occult carriage. These patients should also be monitored regularly in conjunction with a hepatologist. Copyright © 2014 Elsevier España, S.L.U. y AEDV. All rights reserved.
    Actas Dermo-Sifiliográficas 03/2015; DOI:10.1016/j.ad.2015.01.010
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    ABSTRACT: Phototherapy is a treatment option for atopic dermatitis recommended by several guidelines. To perform a systematic review of the efficacy of different modalities of phototherapy and photochemotherapy in moderate to severe atopic dermatitis. We considered all randomized clinical trials (RCTs) performed in patients with atopic dermatitis, and accepted all outcome measures. Articles were identified via an online search of the MEDLINE (via Ovid) and Embase databases and the Cochrane Central Register of Controlled Trials. We also searched for clinical trials registered in Current Controlled Trials and in the World Health Organization's International Clinical Trials Registry Platform. Twenty-one RCTs (961 patients) were included in the qualitative analysis. Two of the trials included children and adolescents (32 patients). The efficacy of narrow-band UV-B and UV-A1 phototherapy was similar for the different outcome measures contemplated. Two RCTs assessed the efficacy of psoralen plus UV-A therapy (PUVA). No serious adverse events were described. In general, the publications reviewed were characterized by a high risk of bias and poor reporting of methodology and results. There is evidence for the use of narrow-band UV-B and UV-A1 phototherapy in moderate to severe atopic dermatitis. Evidence supporting the use of PUVA in atopic dermatitis is scarce and there is little information on the use of phototherapy in childhood. For the purpose of future studies, it would be advisable to use comparable criteria and scales for the evaluation of disease severity and patients, to standardize radiation methods, and to establish a minimum follow-up time. Copyright © 2014 Elsevier España, S.L.U. y AEDV. All rights reserved.
    Actas Dermo-Sifiliográficas 02/2015; DOI:10.1016/j.ad.2014.12.017
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    Actas Dermo-Sifiliográficas 01/2015;
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    Actas Dermo-Sifiliográficas 01/2015; DOI:10.1016/j.ad.2014.10.016
  • I García-Doval
    Actas Dermo-Sifiliográficas 01/2015; DOI:10.1016/j.ad.2014.11.006
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    I. García-Doval
    Actas Dermo-Sifiliográficas 01/2015;
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    Journal of the American Academy of Dermatology 11/2014; 71(5):1008–1011. DOI:10.1016/j.jaad.2014.05.038 · 5.00 Impact Factor
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    ABSTRACT: Hidradenitis suppurativa (HS) or acne inversa is a chronic inflammatory process that affects the apocrine glands of the skin folds. Recent histological investigations suggests that HS involving an entire hair follicle with follicular hyperkeratosis in early stages. HS has a prevalence of approximately between 1 and 2% and most often affects obese patients and smokers.1-3 HS is characterised by abscesses and nodules and often involves fistulas and scarring. Fistulas are extremely uncomfortable and cause recurrent infections. Thus, HS interferes severely in the quality of life of patients and the treatment options have limited efficacy. Relapses are frequent when fistulas play a fundamental role.This article is protected by copyright. All rights reserved.
    British Journal of Dermatology 09/2014; 172(4). DOI:10.1111/bjd.13385 · 4.10 Impact Factor
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    ABSTRACT: 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.Results175 (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.
    Journal of the European Academy of Dermatology and Venereology 09/2014; DOI:10.1111/jdv.12688 · 3.11 Impact Factor
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    ABSTRACT: Es poco conocida la disponibilidad y el empleo de la hospitalización dermatológica, así como su evolución temporal y el porcentaje de enfermedades potencialmente dermatológicas que ingresan en otros servicios. Los objetivos de nuestro estudio son describir los ingresos dermatológicos en el Sistema Nacional de Salud en España entre los años 2005 y 2010 y los ingresos por proceso patológico susceptible de ser ingresado en dermatología en el SNS en el año 2010. Los datos del estudio han sido obtenidos del registro de altas de hospitalización y atención ambulatoria especializada del Ministerio de Sanidad, Servicios Sociales e Igualdad (conjunto mínimo básico de datos [CMBD]). En los años incluidos en nuestro estudio no observamos descenso en las tasas de ingresos médicos; sı´ descienden los ingresos quirúrgicos. Existe gran variabilidad en la actividad de ingresos dermatológicos en las distintas provincias en la hospitalización dermatológica y la mayoría de las enfermedades dermatológicas que ingresan no lo hacen en servicios de dermatología. Little is known about the availability and use of dermatological hospitalization, or its temporal trends and the percentage of potentially dermatological diseases treated by non-dermatology departments. The objectives of our study were to describe the dermatological admissions rate in Spain between 2005 and 2010, as well as the hospitalization rate by diseases suitable for treatment in a dermatology department in the publicly-funded health system in 2010. Data were obtained from Spain’s Ministry of Health, Social Services and Equality (Minimum Data Set [MDS]) book of records for hospitalizations and outpatient specialist care. In the years covered by our study, surgical admissions decreased but medical admissions were unchanged. There was wide variability among the Spanish provinces in their rates of dermatology-related hospitalizations. Most patients with dermatological diseases were admitted to services other than the dermatology department.
    Piel 05/2014; DOI:10.1016/j.piel.2014.05.005
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    ABSTRACT: Introduction and objectives Systematic reviews —the most comprehensive type of literature review— should be taken into account before a clinical trial or a narrative review on a topic is undertaken. The objective of this study was to describe the use of systematic reviews in clinical trials and narrative reviews in dermatology. Material and methods This was a descriptive cross-sectional study. We selected randomized clinical trials and narrative reviews from the dermatological clinical research journals identified as most important (according to impact factor) and from Actas Dermosifiliográficas, and studied the bibliographies to ascertain whether the authors made reference to existing systematic reviews and Cochrane reviews. Results Of the 72 clinical trials for which a systematic review was available, 24 (33.3%) cited at least 1 review; reference was made to relevant Cochrane reviews in 15.6% of cases and to non-Cochrane reviews in 32%. In the case of the 24 narrative reviews for which a review was available, 10 (41.7%) cited at least 1 review; Cochrane reviews were cited in 20% and non-Cochrane reviews in 35.3%.In the case of Actas Dermosifiliográficas, very few clinical trials were found and the findings for narrative review articles were similar to those observed for the other journals. Conclusions Systematic reviews are not often taken into account by the authors of clinical trials and narrative reviews and this may lead to redundant studies and publications. Authors appear to use Cochrane reviews even less than non-Cochrane reviews and are therefore ignoring one of the main sources of available evidence.
    Actas Dermo-Sifiliográficas 04/2014; DOI:10.1016/j.ad.2013.10.017
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    ABSTRACT: 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.ResultsA 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.
    Journal of the European Academy of Dermatology and Venereology 03/2014; 29(1). DOI:10.1111/jdv.12492 · 3.11 Impact Factor
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    ABSTRACT: Systematic reviews -the most comprehensive type of literature review- should be taken into account before a clinical trial or a narrative review on a topic is undertaken. The objective of this study was to describe the use of systematic reviews in clinical trials and narrative reviews in dermatology. This was a descriptive cross-sectional study. We selected randomized clinical trials and narrative reviews from the dermatological clinical research journals identified as most important (according to impact factor) and from Actas Dermosifiliográficas, and studied the bibliographies to ascertain whether the authors made reference to existing systematic reviews and Cochrane reviews. Of the 72 clinical trials for which a systematic review was available, 24 (33.3%) cited at least 1 review; reference was made to relevant Cochrane reviews in 15.6% of cases and to non-Cochrane reviews in 32%. In the case of the 24 narrative reviews for which a review was available, 10 (41.7%) cited at least 1 review; Cochrane reviews were cited in 20% and non-Cochrane reviews in 35.3%.In the case of Actas Dermosifiliográficas, very few clinical trials were found and the findings for narrative review articles were similar to those observed for the other journals. Systematic reviews are not often taken into account by the authors of clinical trials and narrative reviews and this may lead to redundant studies and publications. Authors appear to use Cochrane reviews even less than non-Cochrane reviews and are therefore ignoring one of the main sources of available evidence.
    Actas Dermo-Sifiliográficas 01/2014;
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    A. Batalla, I. García-Doval, G. Peón, C. de la Torre
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    ABSTRACT: Background and objectives The study of quality of life in patients with skin disorders has become more important in recent decades. In the case of lupus erythematosus, most quality-of-life studies have focused on the systemic form of the disease, with less attention being paid to the cutaneous form. The main objective of this study was to evaluate quality of life in patients with cutaneous lupus erythematosus (CLE) using a dermatology-specific questionnaire: the Dermatology Life Quality Index (DLQI). Our secondary objective was to investigate associations between DLQI scores and other aspects of the disease. Material and methods Thirty-six patients with CLE completed the DLQI questionnaire. Other factors assessed were disease severity (measured using the Cutaneous Lupus Erythematosus Disease Area and Severity Index), time since diagnosis, body surface area affected, previous and current treatments, and the presence of criteria for systemic lupus erythematosus (SLE). Results According to the DLQI, CLE had a moderate, very large, or extremely large effect on quality of life in 50% of the patients analyzed (18/36). No significant associations were found between DLQI scores and disease severity, time since diagnosis, body surface area affected, number, type, or duration of pharmacologic treatments, or the presence or absence of SLE criteria. Conclusion CLE has a significant and lasting effect on patient quality of life. This effect is probably primarily due to multiple factors, including the chronic nature of the disease, the visibility of the lesions, and the fact that they can cause disfigurement.
    Actas Dermo-Sifiliográficas 11/2013; 104(9):800–806. DOI:10.1016/j.ad.2013.04.005
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    P. Davila-Seijo, A. Batalla, I. Garcia-Doval
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    ABSTRACT: Introducción y objetivos Las revisiones sistemáticas son una de las fuentes más importantes de Medicina basada en la evidencia. No obstante, existe una impresión de que estas revisiones rara vez aportan resultados con evidencia suficiente para cambiar nuestra práctica. El objetivo de este trabajo es determinar el porcentaje de revisiones publicadas por el Cochrane Skin Group (Grupo Cochrane de Piel) con resultados útiles para guiar nuestras decisiones clínicas. Material y métodos Se ha realizado un análisis bibliométrico de las revisiones sistemáticas realizadas por el Cochrane Skin Group y publicadas hasta el 16 de agosto de 2012. Se obtuvieron un total de 55 revisiones, las cuales fueron analizadas y clasificadas de forma independiente por 2 investigadores en: 0) no existe evidencia suficiente para apoyar o rechazar ninguna intervención; 1) no existe evidencia suficiente para rechazar o apoyar una intervención pero sí existe suficiente evidencia para hacer recomendaciones o sugerencias; y 2) existe una fuerte evidencia para apoyar o rechazar una intervención. Resultados Del total de las revisiones publicadas por el Cochrane Skin Group el 25,5% (14/55) no mostraban evidencia suficiente en ninguna de las intervenciones estudiadas para sustentar su rechazo o aprobación. Un 29,1% (16/55) obtuvo resultados con una fuerte evidencia a favor o en contra de alguna de las intervenciones estudiadas y el 45,5% (25/55) mostraba evidencia suficiente, aunque no fuerte, para hacer sugerencias o recomendaciones. Conclusiones La mayoría de las revisiones sistemáticas del Cochrane Skin Group aportan información útil para mejorar nuestra actividad clínica. Los clínicos deberían leerlas y compararlas con su práctica actual.
    Actas Dermo-Sifiliográficas 10/2013; 104(8):679–684. DOI:10.1016/j.adengl.2012.12.009
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    P Davila-Seijo, A Batalla, I Garcia-Doval
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    ABSTRACT: The ichthyoses comprise a group of inherited disorders of keratinization. Because of the need for lifelong treatment, it is important that therapies are beneficial, safe, and well tolerated. We sought to review the evidence on existing treatments for the congenital ichthyoses, excluding ichthyosis vulgaris. We undertook a systematic review using the methodology of the Cochrane Collaboration. Articles published in MEDLINE, EMBASE, and CENTRAL and registered clinical trials were screened. Randomized controlled trials involving patients with the inherited ichthyoses, either syndromic or nonsyndromic but excluding ichthyosis vulgaris, were considered. Six trials met the inclusion criteria. Topical treatments including 5% urea, 20% propylene glycol alone or in combination with 5% lactic acid, calcipotriol ointment, and liarozole 5% cream showed therapeutic benefit. Oral liarozole, a retinoic acid metabolism blocking agent, showed no advantage over oral acitretin. Most studies were performed on a small sample of patients and lacked methodological and reporting quality. The small number of trials and the nearly constant positive results make publication bias likely. The absence of standardization of outcome measures precluded the comparison of studies. Topical treatments including emollients, calcipotriol ointment, and liarozole cream seem to have therapeutic benefit and a good safety profile, although the use of topical calcipotriol is limited by a maximum weekly dose of 100 g. The advantage of oral liarozole over acitretin is uncertain. Multicenter trials comparing oral and topical interventions and evaluation of long-term outcomes are needed.
    Journal of the American Academy of Dermatology 07/2013; 69(4). DOI:10.1016/j.jaad.2013.05.017 · 5.00 Impact Factor
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    ABSTRACT: 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. 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. 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. 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. 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.
    Journal of the European Academy of Dermatology and Venereology 07/2013; 28(7). DOI:10.1111/jdv.12208 · 3.11 Impact Factor
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    ABSTRACT: Dystrophic epidermolysis bullosa (DEB) is a rare disease that represents a heavy burden for both the patient and the health care system. There are currently no data on the prevalence of DEB in Spain. To determine the prevalence of DEB in Spain. We used data from 3 incomplete population-based sources (hospital dermatology departments, diagnostic laboratories performing antigenic mapping, genetic testing or both, and the Spanish Association of Epidermolysis Bullosa Patients [DEBRA]) and combined them using the 3-source capture-recapture methodology. We identified 152 living DEB patients. The estimated prevalence of DEB was 6.0 cases per million (95% CI, 4.2-11.8) in adults and 15.3 (95% CI, 10.4-40.8) in children under 18 years of age. The data indicated that 77% of the patients were not being followed up in specialized centers of reference; 65% had not had a genetic diagnosis, and 76% were not members of DEBRA. The prevalence of DEB in Spain is 6.0 patients per million (95% CI, 4.2-11.8), a figure higher than previous estimates in many areas, but similar to those found in other southern Europe countries. The north-south difference may represent real geographic differences in prevalence, but it might be due to the fact that most of the data come from registries with a lower than expected catchment. Many patients are not being followed up in centers of reference, do not have genetic diagnosis, and are not members of patients' associations, suggesting that there is room for considerable improvement in their care.
    Actas Dermo-Sifiliográficas 06/2013; DOI:10.1016/j.ad.2013.03.006

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