Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group.

BACKGROUND: Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions. METHODS: This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting. RESULTS: A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07-1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11-1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn. CONCLUSIONS: Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

Top-50 cited articles on cysticercosis and neurocysticercosis.

BACKGROUND: Identifying the most highly cited papers in a given field can help researchers and professionals understand the milestones and research areas that are generating the most impact. This study aimed to identify and describe the 50 most frequently cited manuscripts on cysticercosis and neurocysticercosis. METHODS: We identified the 50 most cited papers (articles and reviews) on cysticercosis and neurocysticercosis from the MEDLINE database and indexed in Web of Science-Core Collection, analyzing their bibliographic and content characteristics. RESULTS: The most cited documents comprised 29 (58%) original articles and 21 (42%) reviews, the bulk of which were narrative reviews (n = 17), with a negligible presence of other types of reviews with high-level scientific evidence. Six journals published 42% of the articles. In addition to the USA, Mexico and Peru were prominent countries of origin among leading researchers. The main research topics were the central nervous system and epilepsy on the one hand, and diagnostic and therapeutic approaches on the other. CONCLUSION: Our findings shed light on the dissemination of knowledge about cysticercosis and neurocysticercosis in recent decades, identifying the most highly cited contributions that have driven research in the field.

Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group.

BACKGROUND: Tildrakizumab is a humanized, IgG1/κ antibody that interacts with the p19 subunit of interleukin 23. It is approved for the treatment of moderate-to-severe plaque psoriasis. Real-world evidence on the effectiveness and safety of tildrakizumab is limited. OBJECTIVES: To assess the effectiveness and safety of tildrakizumab at 24 weeks in patients with moderate-to-severe plaque psoriasis in routine clinical practice. METHODS: Retrospective, observational, multicentre study including adult patients with moderate-to-severe plaque psoriasis treated with tildrakizumab under real-life conditions. Patient data were extracted from anonymized electronic medical records. Statistical analysis was performed using SPSS22. RESULTS: A total of 190 patients were included. About 53.9% were men with a mean age of 51.45 (SD 3.9) and a mean BMI of 29.13 (SD 6.21). About 79.8% (132 out of 190) of patients had previously received biological therapy (BT) and 17.3% (33 out of 191) had psoriatic arthritis. Baseline PASI was 10.7 (SD 6.53). Up to 109 patients reached Week 24 and at this point mean baseline PASI decreased to 1.7 (SD 4.8), representing an 88.79% mean PASI reduction. At 6 months, 87.1% and 40.3% of the treated patients achieved PASI ≤3 and ≤1, respectively. At Week 24 mean BSA decreased from 13.2 (SD 10.07) to 1.6 (SD 4.40) and mean DLQI went from 12.5 (SD 7.12) to 1.2 (SD 3.27). Multivariate analysis showed no differences when effectiveness was correlated with gender, obesity, psoriatic arthritis or prior exposure to BT. The rate of adverse events (AE) was 5.9% (11 out of 190), where infections were the most frequent AE (4 out of 11). One patient suffered a haemorrhagic ictus and one patient died due to causes unrelated to the study. CONCLUSION: Tildrakizumab was effective and safe in a large cohort of patients with moderate-to-severe plaque psoriasis treated in a routine clinical setting.

Criteria used to define tumor necrosis factor-alpha inhibitors failure in patients with moderate-to-severe psoriasis: a systematic literature review.

BACKGROUND: Determining tumor necrosis factor-alpha inhibitors (anti-TNF-α) failure is still a challenge in the management of moderate-to-severe psoriasis. Thus, our comprehensive systematic literature review aimed to gather information on the criteria used to define anti-TNF-α failure. We also aimed to discover the main reasons for anti-TNF-α failure and define subsequently administered treatments. MATERIALS AND METHODS: We conducted a systematic review following review and reporting guidelines (Cochrane and PRISMA). International (Medline/PubMed and Cochrane Library) and Spanish databases (MEDES, IBECS), and gray literature were consulted to identify publications issued until April 2021 in English or Spanish. RESULTS: Our search yielded 58 publications. Of these, 37 (63.8%) described the criteria used to define anti-TNF-α primary or secondary failure. Criteria varied across studies, although around 60% considered Psoriasis Area and Severity Index (PASI)-50 criteria. Nineteen (32.8%) reported the reasons for treatment failure, including the lack or loss of efficacy and safety-related problems, mainly infections. Finally, 29 (50%) publications outlined the treatments administered after anti-TNF-α: 62.5% reported a switch to another anti-TNF-α and 37.5% to interleukin (IL)-inhibitors.Our findings suggest a need to standardize the management of anti-TNF-α failure and reflect the incorporation of new targets, such as IL-inhibitors, in the treatment sequence.KEY MESSAGESIn the treatment of psoriasis, the primary and secondary anti-TNF-α failure criteria differ widely in the scientific literature.The strictest efficacy criteria for defining anti-TNF-α failure, or those recommended by guidelines such as PASI75, were underused both in clinical trials and observational studies.Most studies failed to consider patient-reported outcomes in assessing psoriasis treatment efficacy, which contrasts with recent recommendations on the inclusion of patient-reported HRQoL as a supporting criterion when considering clinical outcomes.

Global research on cysticercosis and neurocysticercosis: A bibliometric analysis.

Background: Cysticercosis is a parasitic infection caused by the larval stage Taenia solium. As a neglected tropical disease that is also difficult to diagnose, cysticercosis constitutes an important public health and research challenge. To characterize the development of research on cysticercosis and neurocysticercosis, considering the level of scientific evidence provided and the contribution of different countries to research, according to their endemic nature and their income level. Methods: Indexed publications on cysticercosis and neurocysticercosis were retrieved from the MEDLINE database, and the evolution of scientific production and the topic areas addressed in the body of research were analyzed. Results: A total of 7,860 papers published between 1928 and 2021 were analyzed. The volume of annual publications increased over time, standing at over 200 documents/year since 2010. Case studies constitute the main study design (27.4% of the documents with available information, n = 2,155), with fewer studies that provide the highest levels of scientific evidence, such as clinical studies (1.9%, n = 149) or systematic reviews (0.8%, n = 63). The most productive journals belong to the Parasitology and Tropical Medicine categories. Although the USA is the most productive country (n = 2,292), countries where Tenia solium is endemic, such as India (n = 1,749), Brazil (n = 941) and Peru (n = 898) also stand out, as does Mexico (n = 1,414). However, other endemic countries in Latin America and sub-Saharan Africa show little participation in the research. The level of international collaboration by country is very uneven, with some countries presenting very low values, such as India (9.9% of documents in international collaboration) or Brazil (18.7%); while there is evidence of intense international collaboration in countries like Peru (91.3%), Tanzania (88.2%) or Kenya (93.1%). Research output has coalesced in three thematic clusters: basic research in animals; parasitism, animal health, and zoonoses; and the diagnosis and therapeutic approach in diseases associated with cysticercosis and neurocysticercosis. Conclusions: The generation of knowledge on cysticercosis presents different features from other areas of research, such as the outstanding contribution of only some endemic countries; and the relevance of comprehensive approaches to research (animal and human health). Studies that provide higher levels of scientific evidence should be promoted, as should research in endemic areas.

The Essential Role of IL-17 as the Pathogenetic Link between Psoriasis and Metabolic-Associated Fatty Liver Disease.

Interleukin 17 (IL-17) is an effector cytokine that plays a key role in the pathogenesis of both psoriasis and metabolic-associated fatty liver disease (MAFLD), a condition that is more prevalent and severe in patients with psoriasis. In liver inflammation, IL-17 is mainly produced by CD4+ T (TH17) and CD8+ T cells (Tc17), although numerous other cells (macrophages, natural killer cells, neutrophils and Tγδ cells) also contribute to the production of IL-17. In hepatocytes, IL-17 mediates systemic inflammation and the recruitment of inflammatory cells to the liver, and it is also implicated in the development of fibrosis and insulin resistance. IL-17 levels have been correlated with progression from MAFLD to steatohepatitis, cirrhosis, and even hepatocellular carcinoma. Clinical trials have shown that inhibiting IL-17A in patients with psoriasis could potentially contribute to the improvement of metabolic and liver parameters. A better understanding of the key factors involved in the pathogenesis of these chronic inflammatory processes could potentially lead to more efficient treatment for both psoriasis and MAFLD, and help to develop holistic strategies to improve the management of these patients.

Epidemiological and Clinical Features in Very Old Men and Women (≥80 Years) Hospitalized with Aortic Stenosis in Spain, 2016-2019: Results from the Spanish Hospital Discharge Database.

(1) Background: The aging population poses challenges for hospital systems. Aortic stenosis is among the most frequent diseases in very old patients. The aim of this study was to describe gender and age differences in the clinical characteristics of very old patients hospitalized with aortic stenosis (AoS) in Spain from 2016 to 2019. (2): Methods: A retrospective observational study analyzing data from the national surveillance system for hospital data. Variables analyzed were age group, sex, length of stay, deaths, and comorbidity. (3) Results: The analysis included 46,967 discharges. Altogether, 7.6% of the admissions ended in death. The main reason for admission was heart failure (34.3%), and this increased with age (80−84 years: 26% versus 95−99 years: 56.6%; p < 0.001). The main treatment procedure was the transcatheter aortic valve replacement (12.7%), performed in 14.3% of patients aged 80−84 versus 0.5% in patients aged 95−99 (p < 0.001). In the multivariable analysis, women were admitted with more comorbidities (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.06−1.20). Mortality was similar, albeit women were admitted less for syncope (OR 0.83, 95% CI 0.74−0.93). Women also underwent fewer coronary catheterizations (OR 0.81, 95% CI 0.77−0.87) and echocardiograms (OR 0.96, 95% CI 0.94−0.98). (4) Conclusions: Aortic stenosis leads to a high number of hospital admissions. Women with AoS presented more heart failure and less cardiovascular pathology than men. Also, women are admitted with fewer episodes of syncope and have fewer ultrasounds and catheterizations.

Comorbidities in Patients with Autoimmune Bullous Disorders: Hospital-Based Registry Study.

The incidence of autoimmune bullous disorders has increased over the years, especially in elderly patients with multiple comorbidities, which has stimulated research into their association with other diseases. We performed a retrospective observational study used the Minimum Basic Data Set of hospital discharges to review records of patients admitted to Spanish public hospitals between 2016 and 2019 with a diagnosis of any autoimmune bullous disorder. The objectives were to describe the comorbidity profile and the clinical-epidemiological characteristics of patients with pemphigus and pemphigoid, and analyze the evolution of the incidence of these diseases. The study included 1950 patients with pemphigus and 5424 patients with pemphigoid. Incidence increased from 2016 to 2019. The main comorbidities were hypertension (40.19%) and diabetes mellitus (28.57%). Compared to patients with pemphigoid, those with pemphigus had a higher prevalence of neoplasms, osteoporosis, solid metastases and malignant lymphoma, while the prevalence of hypertension, kidney disease, diabetes, heart failure, dementia, chronic obstructive pulmonary disease and Parkinson's disease was higher in the pemphigoid group (p < 0.05). Therefore, since autoimmune bullous disorders are associated with diverse comorbidities and their incidence has risen in recent years, the establishment of strategies to prevent the main comorbidities in these patients is justified.

PASI 100 response rates in moderate to severe psoriasis: a systematic literature review and analysis of clinical practice guidelines.

BACKGROUND: Response to treatments in psoriasis can be assessed using the PASI response 50, 75, 90 or 100. Achieving a PASI 100 response would mean a complete resolution of the patient's basal lesions. Therefore, PASI 100 score has been increasingly used in the context of research, but its role in daily practice is currently controversial. OBJECTIVE: (1) To analyze PASI 100 response rates to pharmacological treatments; (2) To examine clinical practice guidelines (CPGs) recommendations/comments on PASI 100. METHODS: We conducted a systematic literature review (SLR). Selection criteria concerned patients with psoriasis, reporting PASI 100. RESULTS: Overall, 65 studies were included. Patients on methotrexate achieved at 16 weeks a PASI 100 of 7.3%. For TNF inhibitors rates were: 3.7-11.1% at 12 weeks, 13.7-20% at 16 weeks, 10.7-24% at 24 weeks and 21.8-34.8% at 1 year. IL-17 inhibitors achieved 23.3-44% at 12 weeks, 44.3-57.2% at 16 weeks, 39.7-67.5% at 24 weeks and 41.4-67.5% at 1 year. And the reported by IL-12/23 inhibitors were 12%/23.8% at 12 weeks, 32.7%/50% at 16 weeks, 44% at 24 weeks and 41.8%/56.3% at 1 year. PASI 100 response is scarcely commented in the CPGs. CONCLUSIONS: PASI 100 response rate is an endpoint fundamentally restricted to research.

Therapeutic goals and treatment response evaluation in moderate to severe psoriasis: an experts opinion document.

OBJECTIVE: To critically analyse and define therapeutic objectives, response to treatment evaluation and related decisions in psoriasis. METHODS: Expert consensus meetings, a systematic and narrative reviews and a collaborative Delphi procedure were carried out. A steering committee from the Spanish Group of Psoriasis was established who based on the reviews generated a set of related statements. Subsequently, a group of 40 experts tested their agreement with the statements, through 3 Delphi rounds. RESULTS: We found a great variability in clinical guidelines regarding to the definition of treatment goal and the response. In general, treatment failure was considered if a PASI50 is not achieved. The panel of experts agreed on (1) clearly differentiate between ideal and a realistic goals when establishing the therapeutic goal in moderate to severe psoriasis; (2) treatment goals should be in general established regardless of the type of drug for psoriasis; (3) treatment failure if PASI75 response is not reached; (4) an absolute PASI is in general preferred to the rate of PASI improvement from baseline; (5) disease characteristics, patients and physicians opinions/needs and treatment adherence influence treatment goals. CONCLUSIONS: A clear treatment decision making framework is vital to improve management of psoriasis.KEY MESSAGESPsoriasis characteristics, patients and physicians opinions/needs and treatment adherence influence treatment goals.Different disease indexes could be used to assess treatment response but absolute PASI is preferredIn general psoriasis treatment failure should be considered if PASI75 response is not reached.

Non-alcoholic fatty liver disease is associated with bacterial translocation and a higher inflammation response in psoriatic patients.

Psoriasis and non-alcoholic fatty liver disease (NAFLD) are both inflammatory diseases. The study objective was to estimate the risk of NAFLD, non-alcoholic steatohepatitis, and liver fibrosis (by liver stiffness and liver biopsy) in patients with psoriasis and to determine the epidemiological, clinical, immunological (TNF-α, IL-2, IL-6, IL-12, IL-17, IL-23, and TGF-ß) characteristics, and bacterial translocation. Of the 215 psoriatic patients included, 91 presented NAFLD (prevalence: 42.3%). Compared to patients with psoriasis alone, those with NAFLD were significantly more likely to have metabolic syndrome, diabetes, dyslipidemia, body mass index ≥ 30 kg/m2, homeostatic model assessment of insulin resistance ≥ 2.15, and greater psoriasis area severity index. NAFLD patients also had significantly higher levels of TNF-α (p = 0.002) and TGF-ß (p = 0.007) and a higher prevalence of bacterial translocation (29.7% vs. 13.7%; p = 0.004). Liver stiffness measurement was over 7.8 kPa in 17.2% (15/87) of NAFLD patients; 13 of these underwent liver biopsy, and 5.7% (5/87) had liver fibrosis, while 1.1% (1/87) had advanced fibrosis or non-alcoholic steatohepatitis. In conclusion the prevalence of NAFLD in patients with psoriasis is high and associated with a higher prevalence of metabolic syndrome features, bacterial translocation and a higher pro-inflammatory state. It is worth mentioning that liver fibrosis and non-alcoholic steatohepatitis are not frequent in this population of patients.

Top-cited articles in cerebrospinal fluid leak (rhinorrhea and otorrhea) (1945-2018).

INTRODUCTION: As scientific knowledge has grown in biomedicine, it has also become necessary to develop tools to manage and understand the body of evidence. In that sense, bibliometrics has become a consolidated discipline for analyzing scientific activity, enabling the characterization of a particular field or area of knowledge by means of the quantification of the bibliographic characteristics of scientific publications. OBJECTIVE: The objective of this study was to determine the most frequently cited articles in the field of cerebrospinal fluid rhinorrhea and otorrhea. METHODS: The searches took place on the Clarivate Analytics Web of Science platform, which includes the MEDLINE database. The study period was limited to 1945-2018. RESULTS: The 101 most cited articles in the field of cerebrospinal fluid leak were published in 36 journals, and the most important specialties contributing to the literature were neurosurgery and otorhinolaryngology. Of the 101 top-cited articles, 70% were published from 1990 to 2018, with two distinct periods of high scientific productivity: 1990-1999 and 2000-2009. In the first period, the main topic of research interest was endoscopic sinus surgery for cerebrospinal fluid fistulas, whereas from 2000 to 2009, documents focused more on surgical aspects of extended skull base approaches. The articles received 73-767 citations. The top article over the whole study period was "A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap" by Hadad et al., which was published 2006 in Laryngoscope. Its publication represented an inflection point in the literature on cerebrospinal fluid leak and endoscopic skull base surgery, and it gave rise to numerous other research publications. CONCLUSION: Different surgical innovations in the field of cerebrospinal fluid leak sparked two different periods of intense scientific activity. Otorhinolaryngology and neurosurgery were the dominant specialties. The most frequent topic studied was endoscopic surgery; others included clinical and diagnostic features, neurinoma surgery, and cerebrospinal fluid leak related to temporal bone fractures.

A snapshot of pneumonia research activity and collaboration patterns (2001-2015): a global bibliometric analysis.

BACKGROUND: This article describes a bibliometric review of the scientific production, geographical distribution, collaboration, impact, and subject area focus of pneumonia research indexed on the Web of Science over a 15-year period. METHODS: We searched the Web of Science database using the Medical Subject Heading (MeSH) of "Pneumonia" from January 1, 2001 to December 31, 2015. The only document types we studied were original articles and reviews, analyzing descriptive indicators by five-year periods and the scientific production by country, adjusting for population, economic, and research-related parameters. RESULTS: A total of 22,694 references were retrieved. The number of publications increased steadily over time, from 981 publications in 2001 to 1977 in 2015 (R2 = 0.956). The most productive country was the USA (38.49%), followed by the UK (7.18%) and Japan (5.46%). Research production from China increased by more than 1000%. By geographical area, North America (42.08%) and Europe (40.79%) were most dominant. Scientific production in low- and middle-income countries more than tripled, although their overall contribution to the field remained limited (< 15%). Overall, 18.8% of papers were the result of an international collaboration, although this proportion was much higher in sub-Saharan Africa (46.08%) and South Asia (23.43%). According to the specific MeSH terms used, articles focused mainly on "Pneumonia, Bacterial" (19.99%), followed by "Pneumonia, Pneumococcal" (7.02%) and "Pneumonia, Ventilator-Associated" (6.79%). CONCLUSIONS: Pneumonia research increased steadily over the 15-year study period, with Europe and North America leading scientific production. About a fifth of all papers reflected international collaborations, and these were most evident in papers from sub-Saharan Africa and South Asia.

Nonalcoholic fatty liver disease puts patients with psoriasis at greater cardiovascular risk.

BACKGROUND/OBJECTIVE: Psoriasis and nonalcoholic fatty liver disease (NAFLD) are inflammatory diseases associated with increased cardiovascular risk, but no studies have evaluated cardiovascular risk in patients with both. The objective was to assess cardiovascular risk in patients with psoriasis and NAFLD. MATERIAL AND METHODS: Cross-sectional, single-centre study in patients with moderate to severe psoriasis. Participants underwent liver ultrasound to determine the presence of NAFLD. Cardiovascular risk was evaluated using the calibrated Framingham function and Systematic Coronary Risk Evaluation (SCORE) charts. Statistical analyses included a descriptive analysis, chi-square tests for comparing independent samples and stepwise multiple logistic regression to identify associations with the two risk scores. RESULTS: Psoriatic patients with NAFLD had significantly higher odds of moderate to very high 10-year cardiovascular risk compared to those without NAFLD, according to SCORE (71.5% versus 29.2%; odds ratio [OR] 6.0, 95% confidence interval [CI] 3.3-11.1; P < 0.001). Using both the SCORE and Framingham assessment methods, moderate to very high cardiovascular risk was independently associated with metabolic syndrome (Framingham: adjusted odds ratio [ORa] 5.5, 95% CI 2.3-12.9, P < 0.001; SCORE: ORa 4.7, 95% CI 1.9-11.7, P = 0.001) and systemic treatment (Framingham: ORa 3.4, 95% CI 1.4-8.5, P = 0.009; SCORE: ORa 3.2, 95% CI 1.2-8.2, P = 0.021). Using SCORE, cardiovascular risk was also associated with NAFLD (ORa of 2.8, 95% CI 1.2-6.6, P = 0.014). CONCLUSION: Psoriasis plus NAFLD confers higher cardiovascular risk at 10 years than psoriasis alone. In comorbid patients, more intense diagnostic efforts and follow-up are justified.

A prospective multicenter study assessing effectiveness and safety of secukinumab in a real-life setting in 158 patients.

BACKGROUND: Secukinumab is a first-in-class interleukin 17A monoclonal antibody that has demonstrated an excellent safety and efficacy profile in phase 3 studies. OBJECTIVE: To evaluate the effectiveness of secukinumab in daily clinical practice and to understand the clinical and epidemiologic characteristics of patients treated with secukinumab in clinical settings. METHODS: In this multicenter prospective observational study, we recruited adult patients with moderate-to-severe plaque psoriasis from 12 hospitals in Spain during January-December 2016. These patients were treated with secukinumab and prospectively followed at 12-week intervals for 52 weeks. RESULTS: In total, 158 patients were recruited to the study. A Psoriasis Area and Severity Index (PASI) score improvement ≥75% over baseline (PASI-75) was achieved by 57%, 83.5%, 89%, and 78.5% of patients at weeks 4, 12, 24, and 52, respectively. PASI-90 was achieved in 27.8%, 62%, 64.6%, and 63.2% of patients at weeks 4, 12, 24, and 52, respectively; PASI-75 and PASI-90 responders were significantly more common among patients with a body mass index <30 kg/cm2 and patients without previous biologic therapy failures. LIMITATIONS: Observational study. Time from onset of psoriasis was not evaluated. CONCLUSION: Secukinumab is a safe treatment with effectiveness rates similar to those found in its phase 3 studies. These rates endure up to a year from start of treatment.

Topics and PRISMA Checklist Compliance for Meta-analyses in Dermatology: Journal Case Study.

Meta-analyses are usually the final step of systematic reviews and provide robust scientific evidence (1,2). The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement is a useful tool to improve the reporting of meta-analyses (3). There are few data available on the current topics and characteristics of meta-analyses in dermatology or on the clarity and comprehensiveness of the information they report (4-8). This case study aims to describe the meta-analyses published in the British Journal of Dermatology (BJD) and assess whether the data they contain are reported fully according to the PRISMA Statement. We conducted a descriptive study of all meta-analyses indexed in PubMed between January 1, 2010, and December 31, 2014. To identify the manuscripts, we used PubMed to search all articles published in the BJD classified by MEDLINE as "meta-analysis." We excluded all trials that did not involve human patients and all secondary analyses of previously published data. Study topics were not mutually exclusive. Two review authors collected the data, resolving any disagreements through discussion. We extracted the following data from each included study: country of origin, number of authors, research topic, funding (yes/no), type of funding, type of population, number and type of databases searched, initial and final number of studies, study type, and number of patients included. In addition, we applied the PRISMA 27-item checklist to all manuscripts. Twenty-seven meta-analyses were published during the study period. Germany was the main country where the studies were conducted (25.9%). The most common topic was psoriasis (n=11; 40.7%). The mean number of authors was 4.8. Thirteen (48.1%) documents received funding. Only five (18.5%) studies included the pediatric population. The mean number of databases consulted was four. All meta-analyses used the PubMed database; 18 (66.7%) used Cochrane and 17 (63.0%) used Embase. The mean number of included studies in the analyses was 31.1. The main study design was case-control (48.1%), followed by cohort (40.7%) and randomized controlled trials (33.3%) (Table 1). Most documents completed the 27 items on the PRISMA checklist correctly. In total, 51.9% of the reports were identified as both systematic reviews and meta-analyses and 48.1% as meta-analyses only. A structured summary was provided in 40.7% of cases. All the publications described the rationale in the introduction, and most (85.2%) correctly explained the objectives (including at least four of five sub-items). Regarding methods, only 18.5% of the studies specified a protocol or registration number. Eligibility criteria and information sources were explained in all the documents. Most of the documents fulfilled the criteria listed under search (96.3%), data collection process (88.9%), data items(85.5%), and summary measures (88.9%). In Methods and Results, the publications included the following items in the respectively indicated proportions: study selection (100.0% and 95.3%), risk of bias in individual studies (70.4% and 63.0%), synthesis of results (92.6 and 100.0%), risk of bias across studies (66.7 and 70.4%), and additional analyses (70.4 and 81.5%). All studies described the study characteristics, and 96.3% presented the results of individual studies. The summary of evidence, limitations, and conclusions were provided in all the publications. Similarly, all the documents detailed sources of funding (Table 2). To sum up, we observed that most of the studies in the BJD correctly recorded the items included in the PRISMA checklist. The meta-analyses mainly concerned psoriasis, which is consistent with a previous study on randomized trials in BJD finding that psoriasis was the main topic (5). A limitation of our study was that the meta-analyses included were published in a single journal, so the results are not generalizable to all dermatology journals. However, this is a novel study of PRISMA checklist compliance in dermatology meta-analyses, and we consider it important to validate and build on these results through larger studies including more journals specializing in dermatology.

The reach of Spanish-language YouTube videos on physical examinations made by undergraduate medical students.

This study was conducted to evaluate the performance and reach of YouTube videos on physical examinations made by Spanish university students. We analyzed performance metrics for 4 videos on physical examinations in Spanish that were created by medical students at Miguel Hernández University (Elche, Spain) and are available on YouTube, on the following topics: the head and neck (7:30), the cardiovascular system (7:38), the respiratory system (13:54), and the abdomen (11:10). We used the Analytics application offered by the YouTube platform to analyze the reach of the videos from the upload date (February 17, 2015) to July 28, 2017 (2 years, 5 months, and 11 days). The total number of views, length of watch-time, and the mean view duration for the 4 videos were, respectively: 164,403 views (mean, 41,101 views; range, 12,389 to 94,573 views), 425,888 minutes (mean, 106,472 minutes; range, 37,889 to 172,840 minutes), and 2:56 minutes (range, 1:49 to 4:03 minutes). Mexico was the most frequent playback location, followed by Spain, Colombia, and Venezuela. Uruguay, Ecuador, Mexico, and Puerto Rico had the most views per 100,000 population. Spanish-language tutorials are an alternative tool for teaching physical examination skills to students whose first language is not English. The videos were especially popular in Uruguay, Ecuador, and Mexico.

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.

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.

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

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.