Sensitization to textile dyes in Spain: Epidemiological situation (2019-2022).

BACKGROUND: Current frequency and features for positivity to textile dye mix (TDM) in Spain are unknown. OBJECTIVES: To study the frequency, clinical features and simultaneous positivity between TDM, para-phenylenediamine (PPD) and specific disperse dyes. MATERIALS AND METHODS: We analysed all consecutive patients patch-tested with TDM from the Spanish Contact Dermatitis Registry (REIDAC), from 1 January 2019 to 31 December 2022. Within this group, we studied all selected patients patch-tested with a textile dye series. RESULTS: Out of 6128 patients analysed, 3.3% were positive to the TDM and in 34% of them, the sensitization was considered currently relevant. TDM positivity was associated with working as a hairdresser/beautician and scalp, neck/trunk and arm/forearm dermatitis. From TDM-positive patients, 57% were positive to PPD. One hundred and sixty-four patients were patch-tested with the textile dye series. Disperse Orange 3 was the most frequent positive dye (16%). One of every six cases positive to any dye from the textile dye series would have been missed if patch-tested with the TDM alone. CONCLUSIONS: Positivity to TDM is common in Spain and often associated with PPD sensitization. TDM is a valuable marker of disperse dyes allergy that should be part of the Spanish and European standard series.

2-Hydroxyethyl methacrylate (2-HEMA) sensitization, a global epidemic at its peak in Spain?

BACKGROUND: A global epidemic of allergic contact dermatitis to (meth)acrylates has been described in relation to the widespread use of manicure products. OBJECTIVES: To evaluate the frequency of sensitization to 2-hydroxyethyl methacrylate (2-HEMA) among consecutively patch tested patients with eczema in Spain; the percentage of current relevance; the MOAHLFA index; and, the potential sources of exposure to (meth)acrylates. METHODS: From January 2019 to December 2022, 2-HEMA 2% pet. was prospectively patch tested in 24 REIDAC (Spanish Allergic Contact Dermatitis Registry) centres. RESULTS: Six thousand one hundred thirty-four patients were consecutively patch tested with 2-HEMA 2% pet. 265/6134 (4.3%) were positive. Positive reactions of current relevance were identified to involve 184/265 (69%). The efficiency (number of patch tests needed to detect relevant positive patch test reactions) was 34 (6134/184). The variable 'occupational' was found to be significantly associated with a higher risk for relevant positive reactions to 2-HEMA (OR: 10.9; 95% CI: 8.1-14.9). CONCLUSION: (Meth)acrylate sensitization is a prevalent health issue in Spain. 2-HEMA 2% pet. has been identified to be a highly effective (meth)acrylate allergy marker in the GEIDAC baseline series. The responsible authorities should implement policies guaranteeing accurate labelling of industrial, medical, and consumer materials while ensuring the enforcement of said labelling through appropriate legal means.

Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.

Hospitalizações e óbitos associados à influenza no Brasil: uma estimativa da incidência no período de 2010 a 2016 / Influenza burden of disease in Brazil 2010 to 2016

Objetivo: Estimar a incidência de hospitalizações e óbitos associados à influenza no Brasil de 2010 a 2016. Método: Foram utilizados registros de altas hospitalares e óbitos pelos códigos CID J09-J18, dados de vigilância laboratorial de influenza e projeções censitárias populacionais ajustadas pelo percentual de usuários de serviços públicos de saúde. Foi realizada meta-análise para determinar as incidências de hospitalizações e óbitos por faixa etária nas cinco regiões geográficas do Brasil. Resultados: As estimativas foram de 645.661 hospitalizações e 160.089 óbitos por influenza, de 2010 a 2016. As maiores incidências de internação ocorreram em idosos com ≥65 anos (258,6/100.000) e crianças <5 anos (180,1/100.000), enquanto os óbitos se destacaram entre os indivíduos de ≥65 anos (142,9/100.000) e de 50 a 64 anos (22,1/100.000). Foram encontradas diferenças regionais, com as taxas mais elevadas nas regiões Centro-Oeste, Sudeste e Sul. Conclusão: A carga da influenza no Brasil é preocupante, com elevado número de hospitalizações e óbitos pela doença. As diferenças regionais e de faixa etária fornecem evidências para apoiar a política de vacinação e o aprimoramento do sistema de vigilância da influenza.

Candidate Allergens for Inclusion in the Spanish Standard Series Based on Data from the Spanish Contact Dermatitis Registry. / Alérgenos candidatos para ser incluidos en la serie estándar española a partir de los datos del Registro Español de Dermatitis de Contacto.

BACKGROUND: Standard patch test series must be updated using objective data on allergen sensitization. The Spanish standard series was last updated in 2016 and the European series in 2019, and the inclusion of several emerging allergens needs to be evaluated. MATERIAL AND METHODS: We conducted a prospective, observational, multicenter study of consecutive patients from the registry of the Spanish Contact Dermatitis and Skin Allergy Research Group (GEIDAC) who were patch tested in 2019 and 2020 with linalool hydroperoxide, limonene hydroperoxide, 2-hydroxyethyl-methacrylate, benzisothiazolinone, octylisothiazolinone, textile dye mix (TDM), sodium metabisulfite, propolis, bronopol, Compositae mix II, diazolidinyl urea, imidazolidinyl urea, decyl glucoside, and lauryl glucoside. RESULTS: We analyzed data for 4654 patients tested with diazolidinyl urea, imidazolidinyl urea, and bronopol, and 1890 tested with the other allergens. The values for the MOAHLFA index components were 30% for male, 18% for occupational dermatitis, 15% for atopic dermatitis, 29% for hand, 6.5% for leg, 23% for face, and 68% for age > 40 years. Sensitization rates above 1% were observed for 7 allergens: linalool hydroperoxide, 2-hydroxyethyl-methacrylate, benzisothiazolinone, limonene hydroperoxide, TDM, sodium metabisulfite, and propolis. Three allergens had a current relevance rate of over 1%: linalool hydroperoxide, 2-hydroxyethyl-methacrylat, and limonene hydroperoxide. Benzisothiazolinone and TDM had a relevance rate of between 0.9% and 1%. CONCLUSIONS: Our results indicate that 7 new allergens should be considered when extending the Spanish standard patch test series. The data from our series could be helpful for guiding the next extension of the European baseline series.

Should methyldibromo glutaronitrile continue to be used in the European baseline Series? A REIDAC national cross-sectional study.

BACKGROUND: Methyldibromo glutaronitrile (MDBGN) was one of the most frequent and relevant allergens found in patch testing at the beginning of this century. In 2008, this preservative was banned from cosmetics in Europe and ever since the prevalence of contact allergy to MDBGN has progressively decreased. Despite that gradual decline, MDBGN is still patch-tested in most baseline series. This study assessed the frequency of MDBGN sensitization, epidemiological characteristics of allergic patients, and the relevance of positive patch tests in a nationwide Spanish registry (REIDAC). PATIENTS AND METHODS: We evaluated consecutively patch-tested patients in all participating centres. Using these data, we calculated the proportion of patients with positive patch tests to MDBGN from June 2018 to June 2020 and evaluated the relevance of the positive patch tests. RESULTS: One hundred and fourteen out of 5072 (2.24 %) tested patients were sensitized to MDBGN. Clinical current relevance was confirmed in only one case. CONCLUSION: Although the frequency of contact allergy to MDBGN remains high, no clinical significance was found in most of these patients (5072 tests needed to obtain one relevant positive result). The clinical usefulness of this allergen seems weak and its continued inclusion in the European baseline series is questionable.

Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort.

The effect of sex on systemic therapy for psoriasis has not been well studied. The aim of this study was to analyse a large multicentre Spanish cohort of 2,881 patients with psoriasis (58.3% males), followed from January 2008 to November 2018, to determine whether sex influences prescription, effectiveness of therapy, and the risk of adverse events. The results show that women are more likely than men to be prescribed biologics. There were no differences between men and women in effectiveness of therapy, measured in terms of drug survival. Women were more likely to develop adverse events, but the difference in risk was small and does not justify different management. Study limitations include residual confounding and the use of drug survival as a proxy for effectiveness.

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. METHODS: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. RESULTS: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.

Safety and effectiveness of conventional systemic therapy and biological drugs in patients with moderate to severe psoriasis and HIV infection: a retrospective multicenter study.

Background: The management of HIV-positive patients with psoriasis is controversial and limited to individual cases or short series of patients. Objectives: To evaluate the safety and effectiveness of conventional and biologic immunosuppressive drugs in the treatment of patients with psoriasis and concomitant HIV infection. Methods: A retrospective multicenter study was conducted. The study included data from 2008 to 2016. Inclusion criteria were: HIV adult patients with moderate-to-severe psoriasis, HIV viral load determinations at baseline and at least after 6 months of treatment, and systemic immunosuppressive treatment for at least 6 months. A descriptive analysis was performed. Results: Twenty-three patients with plaque-type psoriasis and HIV infection (five with AIDS) were included. Median follow-up time was 3.2 years. The main drugs used were etanercept, methotrexate, and ustekinumab. In most cases, viral load and CD4 cell count not only remained stable but also improved throughout the follow-up. Six patients presented severe adverse events during the follow-up, four of them in the AIDS stage. At the end of the follow-up period, 76.5% of the patients had achieved a PASI 75. Conclusion: Biologic drugs, both anti-TNF alpha agents and ustekinumab, seem to have an acceptable safety profile and high effectiveness in HIV-positive patients.

Study of Cognitive Function in Children Treated with Propranolol for Infantile Hemangioma.

BACKGROUND: Oral propranolol is considered the first choice for the treatment of infantile hemangiomas (IHs). There is a concern that administering propranolol in newborns and infants could induce adverse effects in learning and memory processes in the long term. The purpose of this study was to assess cognitive and memory functions in children who had been treated with propranolol for IH during their infancy. METHODS: A total of 23 children between 5 and 7.5 years of age who had been treated with oral propranolol for IH during infancy were tested for cognitive functions with the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) test and for memory functions with the Test of Memory and Learning (TOMAL). RESULTS: Comparison of our sample with a normal distribution by a Shapiro-Wilk W test showed no significant difference for any of the composite scores in the WPPSI-IV and TOMAL tests except for positive asymmetry and concentration of scores around average (p = 0.01) in the WPPSI-IV composite score (mean intelligence), due to one atypically high score. CONCLUSIONS: The distribution of scores for intelligence and memory scales in our study population was similar to that in the reference general population. These results fail to support any significant disturbance in intelligence and memory development in children treated during infancy with propranolol for IH.

Epidemiological role of dogs since the human leishmaniosis outbreak in Madrid.

BACKGROUND: Canine leishmaniosis (CanL) has been in the spotlight since the 2009 outbreak of human leishmaniosis in Madrid. In the framework of the Leishmaniosis Surveillance Programme set up in Madrid, this study examines Leishmania-specific seroprevalences in stray dogs for the outbreak area and rest of the Madrid region over the period spanning from the outbreak to the present (2009-2016). These data are of interest because stray dogs could be sentinels for disease surveillance in endemic areas. Since 2011, we have also been monitoring owned dogs in the outbreak area. METHODS: Over the study period, Leishmania infantum seroprevalence was determined in 2,123 stray dogs from the outbreak and non-outbreak areas. A serological study was also performed for owned dogs in the outbreak area: high-risk dogs such as hunting or farm dogs (n = 1,722) and pets (n = 1372). All dogs were examined and blood was collected. The variables recorded for each animal were: breed, age, sex, and clinical history indicating if the animal was healthy or clinically suspected of having any disease, and if they showed a clinical picture compatible with CanL. RESULTS: Seroprevalences of L. infantum in stray dogs were similar in the two areas examined: 4.7% (20 out of 346) in the outbreak area and 5.4% (96 out of 1,777) in the remaining Madrid region (χ 2 = 0.080, P = 0.777). A significant association was found between seroprevalence and age (z = -6.319; P < 0.001). Seroprevalence in owned dogs in the outbreak area was 2.1% in high-risk dogs (37 out of 1,722) and 1.2% in pets (17 out of 1,372) (χ 2 = 3.561, P = 0.0591). CONCLUSIONS: Both stray and owned dogs do not seem to play an important role in maintaining the transmission cycle of L. infantum in the Madrid outbreak area. The stable seroprevalence of infection observed in sentinel dogs suggests the good clinical management and prevention of CanL by local practitioners in owned dogs.

Serious infections in patients with rheumatoid arthritis and other immune-mediated connective tissue diseases exposed to anti-TNF or rituximab: data from the Spanish registry BIOBADASER 2.0.

Data on infections in patients exposed to biologic therapies are mainly focused on rheumatoid arthritis (RA). Little is known about the safety profile in other immune-mediated connective tissue diseases (ICTD). The purpose of this study was to describe and to compare the risk of serious infections (SI) in patients with RA and other ICTD on anti-TNF or rituximab and to identify predictors of SI. We analyzed RA or other ICTD patients on anti-TNF or rituximab included in the Spanish registry BIOBADASER 2.0 (2000-2011). For each disease group, incidence rate (IR), mortality rate (MR) and IR ratio (IRR) of SI with 95% CI were estimated. Risks were then standardized by age and sex to the general population. Risk factors for SI were assessed by Poisson regression models. A total of 3,301 patients on anti-TNF (n = 3,166) or rituximab (n = 135), of which 176 (5%) had ICTD other than RA, were analyzed. IR of SI was higher in non-RA ICTD than in RA, with an IRR of 3.15 (95% CI 1.86, 5.31) before adjustment and 1.96 (95% CI 1.06, 3.65) after adjustment for age, comorbidity and corticoid use. Mortality due to infections was higher in ICTD although it did not reach statistical significance. Age, disease duration, comorbidities, corticosteroids and ICTD different to RA were all independently associated with SI. Patients with ICTD other than RA are at a high risk of SI when prescribed anti-TNF or rituximab, partly due to the excess comorbidity and immunosuppressive co-treatment, but also to the inflammatory disease. When evaluating the risk/benefit ratio of off-label medications in ICTD patients, age, comorbidities and corticoid use should carefully be taken into account, applying adequate preventive measures.

Reducing the need for central dual-energy X-ray absorptiometry in postmenopausal women: efficacy of a clinical algorithm including peripheral densitometry.

We evaluated the efficacy of a triage approach based on a combination of osteoporosis risk-assessment tools plus peripheral densitometry to identify low bone density accurately enough to be useful for clinical decision making in postmenopausal women. We conducted a cross-sectional diagnostic study in postmenopausal Caucasian women from primary and tertiary care. All women underwent dual-energy X-ray absorptiometric (DXA) measurement at the hip and lumbar spine and were categorized as osteoporotic or not. Additionally, patients had a nondominant heel densitometry performed with a PIXI densitometer. Four osteoporosis risk scores were tested: SCORE, ORAI, OST, and OSIRIS. All measurements were cross-blinded. We estimated the area under the curve (AUC) to predict the DXA results of 16 combinations of PIXI plus risk scores. A formula including the best combination was derived from a regression model and its predictability estimated. We included 505 women, in whom the prevalence of osteoporosis was 20 %, similar in both settings. The best algorithm was a combination of PIXI + OST + SCORE with an AUC of 0.826 (95 % CI 0.782-0.869). The proposed formula is Risk = (-12) × [PIXI + (-5)] × [OST + (-2)] × SCORE and showed little bias in the estimation (0.0016). If the formula had been implemented and the intermediate risk cutoff set at -5 to 20, the system would have saved 4,606.34 in the study year. The formula proposed, derived from previously validated risk scores plus a peripheral bone density measurement, can be used reliably in primary care to avoid unnecessary central DXA measurements in postmenopausal women.

Implications of a new radiological approach for the assessment of Paget disease.

In the present study, we quantified the proportion of skeletal involvement of Paget disease of bone (PDB) not captured by an abdominal X-ray. We also analyzed extension and severity over time and tested the hypothesis that X-rays from selected areas could replace bone scans for mapping PBD. We examined whole skeletal (99m)TC-MDP bone scans from 208 consecutive untreated patients. Pagetic bones included in an abdominal X-ray were delimited; disease extension and activity were calculated using Coutris's index as well as Renier's index and serum alkaline phosphatase (AP) values, respectively. The study period (1965-2007) was divided into quartiles according to the date of the diagnosis. The percentage of patients with PDB captured by an abdominal X-ray was 79 % (95 % CI 74-85 %). In the last quartile vs. the first quartile, PDB was diagnosed at a more advanced age (67 ± 11 vs. 57 ± 9 years, respectively), with a lower median extension (4 vs. 7) and similar median activity (32 vs. 35) but less activity through median AP values (183 vs. 485 UI/L). The skeletal locations to X-ray in order to capture up to 93 % of PDB extension were the abdomen, skull with facial bones, and both tibias. In conclusion, one-fifth of patients are underdiagnosed when assessing prevalence of PDB by an X-ray of the abdomen, and there is a secular trend to presentation in older patients with a decreasing extension of the disease. A set of X-rays that includes abdomen, skull with facial bones, and both tibias provides a reliable alternative to bone scans.

Variabilidad en el consumo de recursos en pacientes con espondiloartritis en España. Datos descriptivos preliminares del estudio emAR II / Variability in resource consumption in patients with spondyloarthritis in Spain. Preliminary descriptive data from the emAR II study

Objetivo. Describir la variabilidad en el manejo de las espondiloartritis (EsA) en España en términos de consumo de recursos sanitarios y la utilización de técnicas. Métodos. Revisión de 1.168 historias clínicas de pacientes con EsA atendidos en servicios de reumatología de hospitales españoles, seleccionadas aleatoriamente. Se analizaron las variables sociodemográficas y las variables relacionadas con el consumo de recursos sanitarios. Resultados. El número total de visitas médicas a reumatología fue de 5.908, con una tasa de 254 consultas/100 pacientes-año. El número total de visitas a enfermería reumatológica fue de 775, con una tasa de 39 visitas/100 pacientes-año, y se produjeron 446 ingresos, lo que representa una tasa de 22 por 100 pacientes-año. El número de ingresos debidos a la EsA fue de 89, con una tasa de 18 ingresos/100 pacientes-año. El total de visitas a otros especialistas fue de 4.307, con una tasa de 200/100 pacientes-año. El número total de cirugías ortopédicas fue de 41, lo que da lugar a una tasa de 1,8 cirugías/100 pacientes-año. Conclusiones. Los datos de visita al reumatólogo y de cirugía protésica de pacientes con EsA en España son similares a la mayoría de los estudios publicados en nuestro entorno; sin embargo, otros aspectos referentes al uso de recursos sanitarios son diferentes en comparación con otros países. Estos datos pueden contribuir para conocer y mejorar aspectos organizativos del manejo de la EsA en los hospitales españoles (AU)

Objective. Our objective was to describe the variability in the management of spondyloarthritis (SA) in Spain in terms of healthcare resources and their use. Methods. A review of 1168 medical files of patients seen in randomly selected Spanish hospital rheumatology departments. We analyzed demographic variables and variables related to the consumption of health resources. Results. The total number of visits to rheumatology were 5,908 with a rate of 254 visits/100 patient-years. The total number of visits to rheumatology specialty nurses was 775, with a rate of 39 visits/100 patient-years, and there were 446 hospitalizations, representing a rate of 22 per 100 patient-years. The number of admissions due to SA was 89, with a rate of 18 admissions/100 patient-years. Total visits to other specialists was 4,307 with a rate of 200/100 patient-years. The total number of orthopedic surgeries was 41, which leads to a rate of 1.8 surgeries/100 patient-years. Conclusions. The data regarding visits to the rheumatologist and prosthetic surgery of patients with in Spain is similar to most studies published in our environment, however, other aspects concerning the use of health resources are different compared to other countries. This data may help to understand and improve organizational aspects of management of SA in Spanish hospitals (AU)