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.

Efficacy and safety of anakinra and canakinumab in PSTPIP1-associated inflammatory diseases: a comprehensive scoping review.

Introduction: This scoping review explores the effectiveness of IL-1 pathway inhibitors in managing PSTPIP1-associated inflammatory diseases (PAID). These diseases are marked by abnormal IL-1 pathway activation due to genetic mutations. Methods: Our methodology adhered to a pre-published protocol and involved a thorough search of MEDLINE and EMBASE databases up to February 2022, following the Joanna Briggs Institute Reviewer's Manual and the PRISMA Extension for Scoping Reviews. The review included studies reporting on IL-1 pathway inhibitor use in PAID patients. Results: From an initial pool of 5,225 articles, 36 studies involving 43 patients were selected. The studies predominantly used observational designs and exhibited diversity in patient demographics, treatment approaches, and outcomes. Anakinra and canakinumab demonstrated promise in treating sterile pyogenic arthritis, pyoderma gangrenosum, and acne (PAPA) and PSTPIP1-associated myeloid-related-proteinemia inflammatory (PAMI) syndromes, with scant data on other syndromes. Notably, there was a paucity of information on the adverse effects of these treatments, necessitating cautious interpretation of their safety profile. Conclusion: Current evidence on IL-1 pathway inhibitors for PAID is primarily from observational studies and remains limited. Rigorous research with larger patient cohorts is imperative for more definitive conclusions. Collaborative efforts among specialized research centers and international health initiatives are key to advancing this field.

Effect of Photobiomodulation on Atrophic-Erosive Clinical Forms of Oral Lichen Planus: A Systematic Review.

INTRODUCTION: Oral lichen planus is a chronic autoimmune inflammatory disease of unknown origin, characterized by various clinical forms of which the atrophic-erosive causes patients the greatest symptomatology. For this reason, there are different treatments that improve the associated signs and symptoms. One of these therapies is photobiomodulation (PBM), which, although new, has a high level of acceptance in dentistry based on evidence. However, there are inconsistent results in its application against lichen planus. The aim of this review was to evaluate the effect of photobiomodulation and its effectiveness as a therapeutic alternative for atrophic-erosive lesions. MATERIAL AND METHODS: The databases PubMed, Google Scholar and Cochrane Library were searched to identify studies investigating the photobiomodulation treatment in atrophic-erosive lesions of oral lichen planus. A total of 294 articles were identified, published between 2017 and 2022, and then evaluated; 7 articles that met all the inclusion criteria were included in this study. RESULTS: The type of laser light source used in PBM was the diode laser (four cases), the Nd-YAG laser at the same wavelength of 1064 nm (two cases) and the He-Ne laser (one case). The minimum and maximum wavelengths used were 630 nm and 1064 nm, respectively. Most studies used lesions treated with topical corticosteroids as a control group. The follow-up times of the studies were highly variable. CONCLUSIONS: Photobiomodulation is a treatment that competently combats oral lichen planus lesions by improving signs and symptoms, with no known adverse reactions so far, which makes it more beneficial compared to more conventional therapies, such as corticosteroids, for which side effects have been found.

Use of the Fractal Dimension to Differentiate Epithelium and Connective Tissue in Oral Leukoplakias.

BACKGROUND: Oral leukoplakia (OL) is considered one of the most common potentially malignant oral disorders (OPMD), with a verified increased risk of developing oral cancer. The identification of the dysplasia grade (low-high) is the only consolidated factor used to evaluate this risk. The objective of this study was to verify the role of the fractal dimension (FD) in assessing this dysplasia. METHODS: To begin, 29 OL and 10 normal oral mucosa (NOM) biopsies were retrieved for FD analysis of the epithelial (dime) and the connective (dimc) tissue. RESULTS: In the OL group, the median value of dime is higher (1.67, IQR = 0.12) than for the NOM group (1.56, IQR = 0.08), with statistically significant differences (Wilcoxon test, p = 0.0031). There were no differences in relation to dimc. Significant differences were observed between the non-dysplasia vs. high-grade (p = 0.0156) and low-grade vs. high-grade (p = 0.0049) groups. No significant differences were identified in relation to dimc for the different degrees of dysplasia. For a cut-off point of 1.44 of dime, a specificity of 96.6% was obtained, a sensitivity of 100%, and an AUC = 0.819 (p = 0.003). CONCLUSIONS: FD at the level of the epithelium may be used as a diagnostic tool in OL.

Study of the Effect of Photobiomodulation on a Skin Repair Model in SKH-1 Mice.

Background and objective: Laser applied at low power (400-1100 nm), currently named photobiomodulation (PBM), is a noninvasive therapy to speed up wound healing. The purpose of this study was whether two different laser PBM delivery protocols would impact the skin wound healing in a mouse model. Materials and methods: A total of 24 SKH-1 mice were divided into three groups: Group 1 (control: untreated ulcers), Group 2 (a single postsurgical laser application), and Group 3 (laser each other day for 10 days; total five applications). Laser parameters were 940 nm, 0.4 W, 10 mm spot size, 0.008 J/cm2, 300 sec/wound. Each animal received two skin wounds which were photographed on days 0, 5, and 10 to determine wound closure (ImageJ). Half of the animals in each group were sacrificed on day 5 and the other half on day 10. Samples were routinely processed for histological analysis (re-epithelization, angiogenesis, granulation tissue formation, inflammation, and collagen deposition). Results: The closure of the wounds at the end of the experiment in the animals photobiostimulated each other day was more advanced than in the controls and in those treated only once, in both the macroscopic and microscopic studies. Angiogenesis was higher in both treated groups than in the control in the first study time (day 5). However, inflammation, maturation of the granulation tissue, and collagen deposition only improved when the laser was applied each other day. Conclusions: In our study, with the parameters used, PBM improved the healing of skin wounds when applied every other day and not in a single dose.

A Scoping Review on Use of Drugs Targeting the JAK/STAT Pathway in Psoriasis.

Introduction: The Janus kinase-signal transducer and activator of transcription (JAK/STAT) pathway are known to be involved in inflammatory immune-mediated skin diseases, including psoriasis. The development of drugs targeting the JAK/STAT signaling pathway presents new treatment opportunities for psoriasis. However, the application of JAK inhibitors for the treatment of dermatological disorders is still in its early stages of development. This review summarizes available evidence in an attempt to identify knowledge gaps for conducting further research studies and improving clinical decision-making. Objective: The objective of this study is to conduct a scoping review of the use of drugs targeting the JAK/STAT pathway in the treatment of psoriasis. Methods: A priori protocol for scoping review was published in 2019. The Joanna Briggs Institute Reviewer's Manual and the PRISMA Extension for Scoping Review were used for the review. MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science databases and ClinicalTrials registry were referred to in April 2019 and March 2021, respectively. References in English involving evidence on the use of drugs targeting the JAK/STAT pathway in patients with psoriasis were included. Data charting was performed by two authors using tables and figures. Results: The evidence found on the efficacy and safety of drugs targeting the JAK/STAT pathway in patients with psoriasis comes from 118 articles reporting the results of 34 randomized clinical trials (RCTs). Nine different drugs administered through various routes were identified (systemic: peficitinib, baricitinib, solcitinib, itacitinib, abrocitinib, deucravacitinib, and brepocitinib; topical: ruxolitinib; and both: tofacitinib). Knowledge articles are mainly created and published by pharmaceutical companies and authors through their own funding or by those related to them. Only tofacitinib and deucravacitinib have undergone phase III clinical trials, being the only ones tested with active comparators etanercept and apremilast, respectively. Proportions of Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) were the efficacy variables most frequently studied in systemic treatments. Only two RCTs declared the safety data collected by systematic assessment; the only systemic drug with phase III data was tofacitinib. Tofacitinib 5 mg two times daily (BID)/10 mg BID efficacy was compared with etanercept 50 mg/week and a placebo. At 12-16 weeks, PASI 75/PGA 01 ranges were as follows: 38.07-80%/37.16-67.4% for tofacitinib 5 mg BID; 54.79-100%/50-75.6% for tofacitinib 10 mg BID; 58.8/66.8% for etanercept, date from one only study; and 0-33.3%/9.04-33.3% for the placebo group. Other drugs in earlier stages of development showed values within these ranges. The most frequent adverse events (AEs) were nasopharyngitis and upper respiratory tract infections in all treatment groups. Conclusion: There is increasing evidence on the use of drugs targeting the JAK/STAT pathway as a treatment for psoriasis, although they are in the early phases of development. The trials conducted to date have been financed directly or indirectly by the pharmaceutical industry, which must be taken into account when interpreting the results of the trials. Psoriasis treatment is currently symptomatic and could potentially present a significant risk of toxicity. Therefore, the design of principal efficacy outcome measures considering the impact of the outcome on quality of life and a drug assessment methodology aimed at improving safety would probably strengthen the evidence and decision-making process.

A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.

Oral dryness causes significant health problems both functional (difficulty speaking, chewing and swallowing) and structural in teeth (increased number of infections) and oral mucosa. The main objective of this study is to show an alternative treatment to help stimulate the salivary secretion thus improving the quality of life of the patient. In this study, a salivary stimulation equipment using vibrotactile stimuli is shown. The system has been placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation. The new proposal is capable of stimulating salivary secretion, in a significative way after 7 minutes of use, at least in the cases analyzed, and fulfills low-cost, easy-to-use, and safe technical restrictions. In this setting, this paper suggests the performance of a deep clinical trial to measure the exact efficacy of the prototype and the times and frequencies needed to state the optimal treatment depending in each case.

Subjective Well-Being and Aversion to Macroeconomic Losses: New Evidence.

This work analyses the existence of asymmetric effects on the subjective well-being of the population of different countries in response to changes in the levels of aggregate income. Microdata from the Eurobarometer and the World Values Survey are used for the period 2000-2019. This period includes several economic changes, among which are the strong expansion at the beginning of the century, the Great Recession, and the subsequent recovery. Our study includes several groups of countries. In the broadest case, the study comprises a group of 83 countries and analyses the issue both from a global perspective as well as focusing particular attention on European countries. These asymmetric effects of economic activity are in line with behavioural economics and previous literature and allow us to determine a macroeconomic aversion to losses. The results obtained support the existence of asymmetric effects of changes in aggregate income on subjective well-being, and show that losses generated in recessions require a far more vigorous recovery if they are to be compensated for, and that they might even have permanent effects. Supplementary Information: The online version contains supplementary material available at 10.1007/s10902-021-00401-5.

The risk of hepatic adverse events of systemic medications for psoriasis: a prospective cohort study using the BIOBADADERM registry.

BACKGROUND: Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies. OBJECTIVES: To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug. METHODS: All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs. RESULTS: Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% 18-23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6-10]). Methotrexate (aIRR 3.06 [2.31-4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05-5.35]; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD. CONCLUSIONS: Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.

Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.

Objective: To evaluate the efficacy of photodynamic therapy (PDT) and photobiomodulation (PBM) in the treatment of oral lichen planus (OLP) in comparison with the use of topical corticosteroids. Material and methods: Sixty patients with OLP were randomized to three groups: group 1 photodynamic therapy applied once a week for four sessions, with orabase cream; group 2 low-power laser application with orabase cream; and group 3 inactive laser with triamcinolone acetonide 0.1%. Patient pain was evaluated, and the Thongprasom severity score, the Oral Health Impact Profile-14 (OHIP-14), and the Hamilton anxiety and depression scale at one and three months of follow-up. (ClinicalTrials.gov Identifier: NCT05127083). Results: Pain decreased significantly over time in all groups, though the symptoms relapsed over follow-up at one and three months in group 3. The OHIP-14 score improved significantly in groups 1 and 2 (p < 0.05), and this improvement was maintained after three months. Lesion resolution evaluated by the Thongprasom score at one month showed significant differences between groups 1 and 3 (p = 0.032) and between groups 2 and 3 (p = 0.024). Conclusions: Photodynamic therapy and photobiomodulation once a week for four weeks are safe and non-invasive treatment options, with the important advantage of lacking adverse effects. Further studies are needed to confirm it.

A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial.

OBJECTIVE: xerostomia is a very common problem in the general population. The objective of this study was to determine the efficacy of a new gel and toothpaste in patients with xerostomia, analyze the role of salivary cytokines as biomarkers of xerostomia and assess the possible changes in salivary cytokines following treatment. MATERIALS AND METHODS: A randomized, controlled double-blind clinical study was carried out in 73 patients with xerostomia divided into two groups: placebo and active treatment (cymenol; tocopheryl acetate; D-panthenol; Aloe barbadensis; citrate tribasic dihydrate; fluoride) with oral gel and toothpaste three times a day for four consecutive weeks. The Thomson Xerostomia Inventory was applied, with the assessment of oral quality of life (OHIP-14) at baseline and after four weeks of application of the product. Sialometry was also performed in both groups, with analysis of the IL-1b, IL-6, IL-8 and TNFa levels in saliva. RESULTS: In the active treatment group, the xerostomia scores decreased significantly at the end of the study versus baseline, from 33.47 to 27.93 (p < 0.001). No significant decrease was recorded in the placebo group (34.5 to 32.75; p = 0.190). There were no adverse effects in either group. Regarding the saliva samples, the active treatment group showed significant differences in IL-6 concentration versus the control group (18.55 pg/mL (8-38.28) and 5.83 pg/mL (1.19-12.04), respectively; p = 0.002). No significant differences in salivary cytokines were observed in either the treatment group or the control group. CONCLUSIONS: The use of a new toothpaste and gel developed for patients with xerostomia proved effective, with greater symptom relief than in the placebo group. Further clinical studies involving longer time periods and larger samples are advisable in order to confirm the benefits of the described treatment.

Association between xerostomia, oral and general health, and obesity in adults. A cross-sectional pilot study / Asociación entre xerostomía, salud bucal y general, y obesidad en adultos. Un estudio piloto transversal

Background: The objective of this study was to analyse the association between oral and general health variablesand obesity indicators with the sensation of dry mouth or xerostomia as evaluated on the Xerostomia Inventory(XI).Material and Methods: A total of 354 randomly selected subjects participated in this cross-sectional pilot studyand completed an anonymous questionnaire. Anthropometric, clinical, and xerostomic variables were evaluated.Kruskal-Wallis, ANOVA and Bonferroni test were used for multiple comparisons. ROC curves and multinomiallogistic regression were used to determine the (OR) risk of xerostomia.Results: A total of 30.7 % of respondents reported xerostomia based on XI. The dry mouth question, the XItaken as a “gold standard”, showed a diagnostic sensitivity of 70.37 %, and a specificity of 83.27 % (AUC=0.768,p<0.001). Logistical regression showed the highest xerostomia OR was associated to patients with bad self-per-ceived health, 6.31 (CI 95% 2.89-13.80, p<0.001). In the model adjusted for tooth mobility, bone or respiratorydiseases, and the consumption of anxiolytics and antidepressants, the OR was 3.46 (CI 95% 1.47-8.18, p=0.005).Conclusions: a high prevalence of xerostomia was found in this cross-sectional pilot study, which was significantlymore frequent in women, and increased with age. Xerostomia was associated to several systemic diseases, psycho-logical conditions, and oral functional disorders such as tooth mobility.These preliminary results can serve as the basis for developing guidelines for the application of innovative mea-sures designed to improve the quality of life of individuals with xerostomia.(AU)

Oral status of older people in medium to long-stay health and social care setting: a systematic review.

BACKGROUND: Older patients who spend long periods hospitalized or those who are in a situation of institutionalization represent a risk group in this regard, as many of them suffer a degree of dependence and need help to perform the basic tasks of personal care. It is therefore important to learn more of the oral health status of this group of patients in order to make a proper assessment of the situation and to develop protocols for its management. The purpose of the study was to conduct a systematic review to ascertain the oral health status of older people patients admitted to institutions or hospitalized for a long period of time. METHODS: a systematic review of the literature published in two different databases (PubMed, Embase and Cochrane Library) was carried out, with 12 different combinations of keywords based on the following selection criteria: studies published in the last 5 years, in English and/or Spanish and/or Portuguese, with samples of ≥30 patients, performed in patients older than 65 years, admitted to any type of institution and/or hospital center for at least 7 days and in which the state of hard and/or soft tissues of the oral cavity were evaluated in some way. The selected articles were subjected to a thorough analysis. RESULTS: The search strategy covered 1.014 articles: 689 from Pubmed and 325 from Cochrane Library. After applying the eligibility criteria, five articles were selected for our review. The level of evidence of the articles was, a sample of 773 patients most of them were women with an average age older than 70 years old. CONCLUSIONS: The oral health of patients aged more than 65 is worse than that of the rest population. Long hospital stays or being institutionalized in a residence makes this group susceptible to a worsening of their oral health status. It is necessary to develop protocols for the oral health care of these patients, accompanied by training programs for the personnel responsible.

La vigilancia activa en pacientes con cáncer de próstata localizado. Análisis de adherencia y salida del protocolo / Active surveillance in patients with localized prostate cancer. Analysis of adherence and exit from the protocol

Objetive: VA is currently considered the treatment of choice for patients with low and very low risk prostate cancer. We analyzed the evolution of this treatment strategy in our series and adherence to the protocol. Material and methods: Ambispective study of patients in VA in our center between 2014- 2019. 237 meet inclusion criteria, of which 142 (60%) have a minimum of 12 months of follow- up. Mean age: 68.5 (46-78), median PSA 6.37 ng / ml (1-33). 229 (96.6%) are ISUP 1 and 8 (3.4%) ISUP 2. Objectives are pro- posed to assess our adherence to the protocol. Descriptive statistics are used to communicate the results. Results: According to the classification by risk groups of the NCCN, 145 (61.2%), 49 (20.7%) and 42 (17.7%) were very low risk, low risk and favorable intermedi- ate risk patients, respectively. The median of follow-up is 14 months (0-66). Of the patients with a minimum follow-up of 12 months, 107 (75.4%) were re-biopsied. 80 (33.8%) leave the protocol in these 5 years, 31.3% (25) by their own decision, 55% (44) due to medical criteria, and 11.3% (9) go to WW. After 5 years of follow-up, 99.2% of patients are still alive, 0.8% died of specific non-cancer causes. Of the objectives to assess adherence, 8 are achieved, 1 partially and 1 is not evaluable. Conclusions: VA in our center is already the treatment of choice for very low-risk patients, with a constant increase from year to year. Adherence to the protocol has been favorable during the period of time studied.(AU)

Efficacy and Safety of Janus Kinase Inhibitors in Type I Interferon-Mediated Monogenic Autoinflammatory Disorders: A Scoping Review.

IMPORTANCE: Type I interferon (IFN)-mediated monogenic autoinflammatory disorders (interferonopathies) are childhood-onset rare multisystemic diseases with limited treatment options. The Janus kinase (JAK) inhibitors are promising potential therapeutic candidates for immune-mediated chronic inflammatory skin diseases. OBJECTIVE: To review the use of JAK inhibitors to improve decision-making when treating interferonopathies with cutaneous manifestations. EVIDENCE REVIEW: The MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science databases were searched for studies that used JAK protein inhibitors to treat IFN-related monogenic diseases with cutaneous manifestations in humans. The search results are reported using the scoping review approach. FINDINGS: Seventeen open-label studies assessing the efficacy of ruxolitinib, baricitinib, or tofacitinib reported variable responses in patients with chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (CANDLE) and related syndromes, stimulator of IFN genes [STING]-associated vasculopathy with onset in infancy (SAVI), familial chilblain lupus (FCh-L), gain-of-function mutations of STAT1 (GOF-STAT1), or Aicardi-Goutiéres syndrome. JAK inhibitors improved clinical and analytical parameters and decreased flare numbers, plasma inflammatory markers, and expression of IFN-stimulated genes. BK viremia and upper respiratory infections were the most frequent and severe adverse events. Significant heterogeneity in efficacy assessment methods and poor reporting of safety events were detected. CONCLUSIONS AND RELEVANCE: Evidence of the use of JAK inhibitors in patients with interpheronopathies is scarce and of low methodological quality. Future clinical trials should use validated scales and report drug safety in a more accurate way.

Effect of mesoporous silica and its combination with hydroxyapatite on the regeneration of rabbit's bone defects: A pilot study.

BACKGROUND: Bone volume augmentation is a routine technique used in oral implantology and periodontology. Advances in the surgical techniques and the biomaterials field have allowed a greater accessibility to these treatments. Nevertheless, dehiscence and fenestrations incidence during dental implant procedures are still common in patients with bone loss. OBJECTIVE: The main objective is to evaluate in a pilot experimental study the biological response to mesoporous silica (MS) hybrid scaffolds and its regenerative capacity in different formulations. METHODS: Two defects per rabbit tibia were performed (one for control and other for test) and the biomaterials tested in this study have been used to fill the bone defects, prepared in two different formulations (3D hybrid scaffolds or powdered material, in 100% pure MS form, or 50% MS with 50% hydroxyapatite (HA). Euthanasia was performed 4 months after surgery for bone histopathological study and radiographic images were acquired by computerized microtomography. RESULTS: Results showed that radiographically and histopathologically pure MS formulations lead to a lower biological response, e.g when formulated with HA, the osteogenic response in terms of osteoconduction was greater. CONCLUSIONS: We observed tolerance and lack of toxicity of the MS and HA, without registering any type of local or systemic allergic reaction.

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.

In Vitro Study of Synergic Effect of Cisplatin and Low Molecular Weight Heparin on Oral Squamous Cell Carcinoma.

OBJECTIVES: To evaluate the possible synergic effect of cisplatin and low molecular weight heparin (LMWH) on oral squamous cell carcinoma (OSCC). MATERIALS AND METHODS: Cisplatin and enoxaparin sodium, alone or in combination, were administered at doses of 1, 2, 4, 8 and 10 µM and 0.1, 0.5, 1, 5, 10, 50, and 100 µg/ml, respectively, to the H357 human OSCC line. The effects on cell viability and apoptosis were evaluated after 24, 48, and 72 h and on cell migration after 18 and 24 h. RESULTS: 10 µM concentration of cisplatin produced the greatest decrease in cell viability, with significant differences at 24 (p=0.009), 48 (p=0.001) and 72 h (p = 0.003); the 100 µg/ml dose of enoxaparin produced the greatest decrease in cell viability but without significant differences (p>0.05). When different concentrations of cisplatin and enoxaparin were combined, it was found that 100 µg/ml enoxaparin sodium produced the greatest synergic effect on cell viability reduction. In analyses of apoptosis and cell migration, it was found that the combination of cisplatin at 8 or 10 µM and 100 µg/ml enoxaparin produced a higher rate of apoptosis at 24, 48, and 72 h and a greater reduction in cell migration at 18 and 24 h. CONCLUSIONS: A combination of cisplatin and enoxaparin sodium shows a synergic effect that reduces cell viability and cell migration capacity and increases the apoptosis of human OSCC cells. CLINICAL RELEVANCE: Enoxaparin may be beneficial in chemotherapy for patients with OSCC; this finding requires further clinical and laboratory investigation.

Volumetric study of the maxillary sinus in patients with sinus pathology.

OBJECTIVES: The aim of this study is 1) to obtain the area and volumes of the maxillary sinuses in patients affected by clinically unilateral sinus pathology by comparing the results to the contralateral sinus and 2) to determine the importance of the volumetric measures when diagnosing the percentage of sinus obliteration. MATERIALS AND METHODS: A single-centre observational retrospective clinical study was conducted in 214 patients with clinically unilateral sinus pathologies. Linear (mm), area (mm2) and volume (mm3) measurements were taken from Cone Beam Computed Tomography (CBCT) images of the affected sinus as well as from the contralateral ones. Histopathological study was performed using haematoxylin/eosin and PAS or Groccot stains. The lesions were classified into non-specific sinusitis, polyps, inverted papilloma, fungal sinusitis, cysts, mucocele and other lesions. Chi-squared test, ANOVA for independent samples and Pearson test were used for the statistical analysis. RESULTS: A total of 100 sinuses were measured in 50 patients (28 men and 22 women, with an age of 43.6 years (SD = 18.3), 50 pathological and 50 healthy contralateral sinuses. The three-dimensional occupation volume of the affected sinuses was 97.1 mm3 (62.5%) vs. 40.6 mm3 (22.8%) in the healthy ones (p<0.0001). The medial-lateral width of the sinus in the frontal plane was significantly higher in the cysts group (32.4 mm, CI: 23-41.8 mm). CONCLUSION: In medical terms, the global percentage of occupation determined using the classic manual determination method does not differ from the three-dimensional percentage calculated using specific complex software.

Chemopreventive effect of pomegranate and cocoa extracts on ultraviolet radiation-induced photocarcinogenesis in SKH-1 mice.

Non-melanoma skin cancer (NMSC) has a high and increasing incidence all over the world. Solar radiation is the main aetiology for humans. Although most research into photocarcinogenesis uses UVB as a source of radiation, UVA is also carcinogenic in long term. Pomegranate (PGE) and cocoa (CE) extracts have been used for medicinal purposes for time immemorial. Recently, it has been claimed that some of their properties may be an effective preventative measure against photocarcinogenesis and photoaging, but to date in vivo models have not been tested using RUVA, the objective of the present work. A lower incidence of lesions was observed in SKH-1 mice treated with PGE (p<0.001), and lower incidence of invasive squamous carcinoma in both treatment groups (p<0.001 for PGE and p<0.05 for CE); the PGE group also showed a lower level of cell proliferation than the control group (p<0.001). Significantly greater p53 alteration was observed in the control group than the treatment groups (p<0.001 for PGE and p = 0.05 for CE). No significant differences were found in relation to TIMP-1 and MMP-9. Taken together, the results suggest that oral feeding of PGE and CE to SKH-1 mice affords substantial protection against the adverse effects of RUVA, especially PGE.