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Background: Functional impairment is the main consideration when it comes to choosing therapy for infantile hemangiomas (IH). However, since most hemangiomas are treated for cosmetic reasons, it is important to know the cosmetic outcome assessed by the parents., Objective: To evaluate the aesthetic outcomes of IH, considering the characteristics of the lesions and the treatments used., Patients and Methods: The Spanish Infantile Hemangioma Nationwide Prospective Cohort (2016-2022) recruited all consecutive patients diagnosed with IH in 12 Spanish hospitals. The children included had two photos of the IH lesion (at both baseline and at the end of the study). A panel of parents blindly assessed all available photos using a scale from 0 (worst cosmetic outcomes) to 10 (best cosmetic outcomes). The different scores - both before and after treatment - as well as the outcomes percent considered excellent (≥9) were described and compared. We analyzed the effect of receiving different therapies and performed causal model analyses estimating the mean treatment effect of parents' assessments., Results: The median follow-up was 3.1years. A total of 824 photos were evaluated. Baseline aesthetic impact was higher in the propranolol group vs the topical timolol and observation treatment groups (1.85 vs 3.14 vs 3.66 respectively; P<.001). After treatment, the aesthetic impact was similar between both treatment groups (7.59 vs 7.93 vs 7.90; P>.2). The causal model could only be applied to the comparison between topical timolol and observation, revealing no differences whatsoever., Conclusion: This is the first prospective cohort to analyze the aesthetic outcome of IH. The final aesthetic results of the three therapies were similar, with nearly 40% of patients achieving excellent aesthetic outcomes., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Psoriasis is a chronic inflammatory dermatosis whose clinical and topographic distribution requires differential diagnosis, or the possible association with allergic contact dermatitis (ACD), requiring patch testing (PT) as part of the diagnostic procedure., Objectives: To describe the epidemiological, clinical, and allergic profile of patients with a primary or secondary diagnosis of psoriasis undergoing PT and compare them with patients with a diagnosis of ACD at the end of the diagnostic process., Methods: Cross-sectional study with data from REIDAC from 2018 through 2023 of selected patients with a diagnosis of psoriasis and/or ACD., Results: A total of 11 502 patients were included, 513 of whom had been diagnosed with primary or secondary psoriasis, 3640 with ACD, and 108 with both diseases. Men were more predominant in the groups of patients with psoriasis, psoriasis+ACD, and lesions were more predominantly seen in the hands with little association with atopic factors vs the ACD group. The rate of positivity in PT to the 2022 Spanish battery of allergens was lower in the group with psoriasis only in 27% of the patients. The most common allergens found in the psoriasis group were also the most common ones found in the overall ACD population., Conclusions: Overall, 36.2% of psoriatic patients tested positive in PT to the 2022 Spanish battery of allergens, which proved that this association is not uncommon. Overall, psoriatic patients had a higher mean age, were more predominantly men, and showed more hand involvement., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: The past 5 years have seen a proliferation of new treatments for atopic dermatitis (AD). We analyzed recent drug survival data for cyclosporine in this setting. Because the Spanish National Healthcare system requires patients with AD to be treated with cyclosporine before they can be prescribed other systemic treatments, drug survival for cyclosporine may be shorter than in other diseases., Material and Method: Multicenter, observational, prospective cohort study using data from the Spanish Atopic Dermatitis Registry (BIOBADATOP). Data from the Spanish Registry of Systemic Treatments in Psoriasis (BIOBADADERM) were used to create a comparison cohort., Results: We analyzed data for 130 patients with AD treated with cyclosporine (median drug survival, 1 year). Median cyclosporine survival in the psoriasis comparison group (150 patients) was 0.37 years. Drug survival was significantly longer in AD than in psoriasis (P<.001)., Conclusion: Drug survival of cyclosporine in the BIOBADATOP registry is similar to that described in other series of patients with AD and longer than that observed in the BIOBADADERM psoriasis registry., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities., Material and Methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022., Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community)., Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities., Material and Methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022., Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community)., Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., Competing Interests: Conflicts of interest J.M.C. has participated as a speaker and/or advisor and/or principal investigator/senior investigator in clinical trials sponsored by for Celgene, Janssen, Lilly, Leo Pharma, Novartis, Pfizer, MSD, Biogen, Mylan, Amgen, AbbVie and Sandoz. A.G.-Q. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator and subinvestiator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. R.R.-D. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. A.S.-T. has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis and Pfizer. M.L.-V. acted as a consultant and speaker and participated in clinical trials for Janssen-Cilag, AbbVie, Boehringer, Celgene, Pfizer, Novartis, Lilly, Almirall, UCB, Kyowa Kirin and Leo Pharma. E.H.-A. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene and AbbVie. P.d.l.C. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Biogen, Celgene, Amgen, Sandoz, Sanofi and Leo Pharma. O.B.-R. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, Pfizer, Novartis, Lilly, Celgene, Leo Pharma, Amgen, Boehringer, UCB and Almirall. L.L.-E. participated as advisory board member and received educational grants from Janssen, AbbVie, MSD, Lilly, Novartis, LeoPharma and Pfizer. I.B. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc., Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo Pharma, UCB, Pfizer-Wyeth and MSD. M.F. has participated as speaker and/or advisor for Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie Celgene and Almirall. A.M. acted as consultant and/or speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Lilly, Novartis. L.R. acted as a consultant and speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, Celgene and Leo Pharma. J.R.-M. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by AbbVie, Almirall, Janssen, Leo Pharma, Novartis, UCB, Pfizer, Lilly, Amgen and Boehringer Ingelheim. G.C. has been reimbursed by Janssen, AbbVie, Novartis, Pfizer, MSD and Celgene for advisory service and conference attendance. C.G.-D. participated as advisory board member for AbbVie, Almirall and speaker for Janssen, Lilly and Celgene. C.P.-M. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Celgene and Leo Pharma. E.D.A. has participated as a speaker and/or and/or PI/SI clinical trials sponsored by Amgen, Almirall, Janssen, Lilly, Leo Pharma, Novartis, UCB and AbbVie. J.A.S.-P. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene, AbbVie, Amgen, Sanofi, Almirall and Pfizer. D.P.R.-G. has been reimbursed by Pfizer, Janssen, Celgene, AbbVie, Novartis and LeoPharma for advisory services and conference attendance. I.G.D. received travel grants for congresses from AbbVie, MSD, Pfizer and Sanofi., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

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., (Copyright © 2021 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objective: Skin lesions are a common reason for consulting a primary care physician. Current legislation in Spain states that purely aesthetic skin problems that do not pose a health problem are not to be treated within the National Health Service. The aim of this study was to estimate the proportion of referrals from primary care physicians to dermatologists that were for cystic lesions or benign tumors and could potentially have been avoided., Material and Methods: We consulted cases registered in the DIADERM study dataset, which is representative of dermatology practice in Spain, and collected the main diagnoses given on referring patients from primary care. A referral diagnosis was classified as potentially avoidable if it corresponded to one of the primary care discharge diagnoses listed in a consensus paper of the Andalusian section of the Spanish Academy of Dermatology and Venereology (AEDV)., Results: We collected 2171 main reasons for first-visit referrals to dermatologists; 686 of them (31.6%) were for cystic lesions or benign tumors and classified as potentially avoidable. In 478 cases (22%) the patients were discharged on the first visit. The most frequent diagnoses in such cases were seborrheic keratosis (9.3%) and melanocytic nevus (8.6%)., Conclusions: Nearly a third of referrals from primary care to a dermatologist were for cystic lesions and benign tumors and could have been avoided. A clearer understanding of our caseload can be useful for improving planning, training, and health care system management., (Copyright © 2019 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Introduction: Dermatologists perform most of their work in outpatient or private clinics. Data on the diagnoses made by dermatologists in these settings are lacking, however, as outpatient activity, unlike hospital activity, is difficult to code. The aim of this study was to analyze the diagnoses made by members of the Spanish Academy of Dermatology and Venereology (AEDV) at dermatology clinics in Spain., Methodology: We selected a random sample of AEDV dermatologists drawn from the AEDV list and stratified by geographic area. The selected dermatologists received instructions on how to collect the data required. Each participant recorded the diagnosis reached and other data for patients seen during 2 specified periods: 3 days in January and 3 days in May. The diagnoses were subsequently coded by a dermatologist expert in applying the International Classification of Diseases (10th revision). In view of the complex nature of the sample, data were analyzed with standard error and finite population corrections., Results: The sample consisted of 124 dermatologists. Of these, 65% participated in the first phase of the study and 59% in the second. An estimated 621 562 patients (95% CI, 368 130-874 995) visit the dermatologist every month in Spain. This is the equivalent of 28 (25-31) patients per day per clinic. The most common diagnosis recorded was actinic keratosis, followed by basal cell carcinoma and melanocytic nevus. The vast majority of visits took place at the clinic, but 1% of patients (0.3%-3%) were assessed using teledermatology., Conclusions: This is the first study in Spain to analyze diagnoses made by AEDV members at outpatient dermatology clinics. Our findings show a high volume of activity and will be useful for guiding health care planning, resource use, and future studies., (Copyright © 2018. Publicado por Elsevier España, S.L.U.)

Registers facilitate the collection and communication of safety concerns. There are as many different register structures as registers, making the merging of rare data and comparison between registers difficult. BIOBADASER, the Safety Register of the Spanish Society of Rheumatology has served as template for other registers within the specialty, BIOBADAMERICA, and outside rheumatology, BIOBADADERM. Here we present the limitations and strengths of such template registers.

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.

Objective: To describe the results of different statistical ways of addressing radiographic outcome affected by missing data--multiple imputation technique, inverse probability weights and complete case analysis--using data from an observational study., Methods: A random sample of 96 RA patients was selected for a follow-up study in which radiographs of hands and feet were scored. Radiographic progression was tested by comparing the change in the total Sharp-van der Heijde radiographic score (TSS) and the joint erosion score (JES) from baseline to the end of the second year of follow-up. MI technique, inverse probability weights in weighted estimating equation (WEE) and CC analysis were used to fit a negative binomial regression., Results: Major predictors of radiographic progression were JES and joint space narrowing (JSN) at baseline, together with baseline disease activity measured by DAS28 for TSS and MTX use for JES. Results from CC analysis show larger coefficients and s.e.s compared with MI and weighted techniques. The results from the WEE model were quite in line with those of MI., Conclusion: If it seems plausible that CC or MI analysis may be valid, then MI should be preferred because of its greater efficiency. CC analysis resulted in inefficient estimates or, translated into non-statistical terminology, could guide us into inaccurate results and unwise conclusions. The methods discussed here will contribute to the use of alternative approaches for tackling missing data in observational studies.

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.

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., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

Objective: To compare the outcome of early rheumatoid arthritis (RA) patients in a country where early clinics were established versus the outcome of patients in nonprotocolized clinics., Methods: We compared 2 multicenter cohorts: an RA cohort derived from an early arthritis registry set in 36 reference hospitals in which a specific intervention was established (Evaluation of a Model for Arthritis Care in Spain [SERAP]), and a historical control cohort of patients with early RA attending 34 rheumatology departments (Prognosis in Rheumatoid Arthritis [PROAR] cohort). Effectiveness was tested by comparing the change in the Disease Activity Score in 28 joints (DAS28), the change in the Health Assessment Questionnaire (HAQ), and the change in the Sharp/van der Heijde radiologic score using marginal structural models., Results: A total of 161 early RA patients were recruited in the PROAR cohort and 447 in the SERAP cohort. Being a SERAP patient was inversely correlated with activity, resulting in a decrease of -0.24 (95% confidence interval [95% CI] -0.39, -0.08) units in the population average of the DAS28 after adjustment was made. Moreover, intervention may be seen as a protective factor of radiologic damage, with a decrease of -0.05 (95% CI -0.09, -0.01) units in the logarithm of the total Sharp/van der Heijde score. On the other hand, a decrease in functional impairment was detected, but intervention was not statistically associated with HAQ changes., Conclusion: Preventing major radiographic progression in a 2-year term inside structured and organized special programs for the management of disease, such as early arthritis clinics, are effective compared to nonprotocolized referrals, treatment, and followup., (Copyright © 2012 by the American College of Rheumatology.)

Objective: To investigate in rheumatoid arthritis (RA) the rate and reason of discontinuation of tumour necrosis factor (TNF) antagonists over the past decade., Methods: RA patients in BIOBADASER 2.0 were stratified according to the start date of their first TNF antagonist into 2000-3, 2004-6 and 2007-9 interval years. Cumulative incidence function of discontinuation for inefficacy or toxicity was estimated with the alternative reason as competing risk. Competing risks regression models were used to measure the association of study groups with covariates and reasons for discontinuation. Association is expressed as subhazard ratios (SHR)., Results: 2907 RA patients were included in the study. Competing risk regression for inefficacy shows larger SHR for patients starting treatment in 2004-6 (SHR 2.57; 95% CI 1.55 to 4.25) and 2007-9 (SHR 3.4; 95% CI 2.08 to 5.55) than for those starting in 2000-3, after adjusting for TNF antagonists, clinical activity and concomitant treatment. Competing risk regression analysis for adverse events revealed no differences across the three time intervals., Conclusions: In RA, the discontinuation rate of TNF antagonists in the first year of treatment is higher more recently than a decade ago, inefficacy being the main reason for the increased rate. The rate of discontinuation for adverse events has remained stable.

Objectives: To assess the retention rate of TNF antagonists in elderly patients suffering from chronic arthropathies and to identify predictive variables of discontinuation by inefficacy or by adverse events (AEs)., Methods: All patients treated with TNF antagonists in BIOBADASER 2.0, with a diagnosis of either RA or spondyloarthritis (SpA: AS and PsA) were included and classified as <65 (younger) or ≥65 years of age (older) at start of the treatment. Cumulative incidence function for discontinuation (inefficacy or AE) was estimated as being the alternative reason for a competing risk. Competing-risks regression models were used to measure the association between study groups, covariates and reason for discontinuation., Results: A total of 4851 patients were studied; 2957 RA (2291 in the younger group and 666 in the older group) and 1894 SpA (1795 in the younger group and 99 in the older group). Retention curves were statistically differently stratified by age groups, with the SpA younger group having the largest retention rate. Competing-risks regression models showed that in the older group, AEs were the most common reason for discontinuation regardless of the diagnosis of the patient and TNF antagonist molecule, whereas in the younger group, the most common cause of discontinuation was inefficacy., Conclusion: In conclusion, factors predicting discontinuation of TNF antagonists due to AEs are older age and diagnosis of RA. On the other hand, younger age predicts discontinuation due to lack of efficacy.

Objective: To identify characteristics of early arthritis units, that may be associated with better referral eficiency., Methods: A national survey of the 36 early arthritis units (EAU) in Spanish Rheumatology Units in 2004 (SERAP project). Survey collected information about general practitioners (GP) educational program to improve knowledge and practical skills of early arthritis, networking and feed-back system and referral efficiency. EAU were classified in two groups according to 25 and 50% of inappropriate referral process, respectively., Results: Thirty four of the 36 (94%) EAU, answered the survey. GP were trained in only 1 medical meeting in the primary care clinic, with one or more rheumatologists responsible of GP education. Fourteen of the 34 EAU (42.4%) regularly interacted with GP and only 20 (39.4%) contacted the GP who were responsible for the wrong referral process. Median lag time for referral to the Rheumatology out-patient clinic, was 73 days (15-365 days). The percentage of wrongly referred patients was between 0 and 80% (38% ± 21). Only 10 EAU (27.8%) referred patients appropriately according to the most strict criteria (25% of inappropriate referral) and 27 EAU (75%), according to 50% of inappropriate referral criteria., Conclusions: Only two aspects of the EAU implementation strategy were associated with better referral efficiency: 1) interaction with the GP responsible of the inappropriate referral process and 2) a lower median lag time for referral to the Rheumatology out-patient clinic., (2010 Elsevier España, S.L. All rights reserved.)

Objective: To update the information on long-term safety of biological therapies used for the treatment of rheumatic diseases., Methods: BIOBADASER is a safety registry of biological therapies established by the Spanish Society of Rheumatology. A description of BIOBADASER 2.0, a cohort composed of 14 centres within BIOBADASER is reported from 2000 until 2009., Results: The 14 centres have registered 5,493 patients, who have received 8,081 cycles of treatment with biological therapies. 30% (1,666) has received treatment with more than one biologic agent during follow-up. There have been 3,784 treatment discontinuations, with inefficacy or loss of efficacy being the most frequent cause (1,453; 38%), followed by adverse events (1,297; 34%). Up to 7,289 adverse events (AE) have been reported, of which 80% (5,764) were considered as non serious, nearly 19% (1,340) were notified as serious and about 2% (110) were fatal. The most frequent AE were infections (2,668; 37%), followed by general problems and administration related events (10%). Cardiovascular events and cancer amounted a 7% of the total AE., Conclusions: There does not seem to be a trend regarding different risks in BIOBADASER 2.0 with respect to the general registry, or to previous years., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)