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1.
BMC Med Res Methodol ; 23(1): 294, 2023 12 14.
Article in English | MEDLINE | ID: mdl-38097923

ABSTRACT

OBJECTIVES: This research-on-research substudy uses a data-driven approach to investigate the range of appraisal tools in non-Cochrane systematic reviews and meta-analyses registered in the International Prospective Register of Systematic Reviews (PROSPERO). STUDY DESIGN AND SETTING: A comprehensive web scraping of all completed non-Cochrane registrations in PROSPERO from February 2011 to December 2017 was performed. The focus was classifying the appraisal tools based on study type, assessment aspects, and research topics. RESULTS: After analyzing 17,708 complete records, we found a predominant use of methodological quality assessment tools compared to those for reporting quality or risk of bias (RoB). This indicates a greater emphasis on methodological rigor in the studied protocols. Various tools for assessing methodological quality were observed, reflecting the complexity of such evaluations. Instruments designed for evaluating methodological or reporting quality were mainly intended for non-randomized clinical trials or observational studies, unlike RoB tools more commonly used in randomized clinical trials. No distinct trends in tool usage were observed in specific research conditions or domains, suggesting that tool choice is influenced more by study design than research topic. CONCLUSION: This study provides insights into the preferential use of various assessment tools in conducting non-Cochrane systematic reviews, as evidenced in PROSPERO records. The findings reveal various methodological assessment tools, underscoring their versatility across different study designs and research areas.


Subject(s)
Meta-Analysis as Topic , Research Design , Systematic Reviews as Topic , Humans , Bias
2.
Actas Dermosifiliogr ; 113(4): 401-406, 2022 Apr.
Article in English, Spanish | MEDLINE | ID: mdl-35428502

ABSTRACT

Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs.


Subject(s)
Biological Products , Psoriasis , Adolescent , Biological Products/therapeutic use , Child , Humans , Psoriasis/chemically induced , Psoriasis/drug therapy , Psoriasis/epidemiology , Registries
3.
Med Oral Patol Oral Cir Bucal ; 26(6): e762-e769, 2021 Nov 01.
Article in English | MEDLINE | ID: mdl-34023839

ABSTRACT

BACKGROUND: The objective of this study was to analyse the association between oral and general health variables and 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 study and 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 multinomial logistic 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 XI taken 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-perceived health, 6.31 (CI 95% 2.89-13.80, p<0.001). In the model adjusted for tooth mobility, bone or respiratory diseases, 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 significantly more frequent in women, and increased with age. Xerostomia was associated to several systemic diseases, psychological 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 measures designed to improve the quality of life of individuals with xerostomia.


Subject(s)
Quality of Life , Xerostomia , Adult , Cross-Sectional Studies , Female , Humans , Male , Obesity/complications , Obesity/epidemiology , Pilot Projects , Surveys and Questionnaires , Xerostomia/epidemiology , Xerostomia/etiology
4.
Eur J Pediatr ; 179(8): 1255-1265, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32096070

ABSTRACT

Extrauterine growth restriction (EUGR) is a frequent morbidity of preterm infants that can affect short- and long-term prognosis as it involves different EUGR-related alterations in growth and neurological development, as well as cardiometabolic risk. However, knowledge about the prognosis of EUGR is scarce. Thus, the objective of this study is to review the evidence regarding EUGR-related comorbidities in childhood by a systematic approach. This review was carried out using the Joanna Briggs Institute Reviewers' Manual Methodology and the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses)-Search Extension for scoping review. The MEDLINE and EMBASE databases were used to identify papers published until September 2017. Twenty-four publications were included and 19 examined cohort studies. EUGR is mainly associated with (1) lower weight, length, and head circumference measures in childhood; (2) poor neurodevelopment; and (3) alterations in cardiometabolic risk markers. The definition for EUGR and the populations studied differ among authors.Conclusion: EUGR is mainly associated with poor growth and neurodevelopment, as well as with cardiometabolic alterations in childhood. Evidence is based on observational studies with variability in the included populations due to the lack of consensus regarding the definition for EUGR. Finding a gold standard definition becomes paramount in order to select phenotypes at risk later in life. What is known? • EUGR is a frequent condition of preterm infants. Up to date little is known about the effect of the metabolic programming on prognosis. What is new? • The available evidence, which is based on observational studies with variability in the population and the existing different definitions for EUGR, do not enable appropriate data collection. EUGR is mainly associated with poor growth and neurodevelopment, as well as with cardiometabolic alterations in childhood.


Subject(s)
Growth Disorders/epidemiology , Infant, Premature, Diseases/epidemiology , Neurodevelopmental Disorders/epidemiology , Cardiometabolic Risk Factors , Child , Child, Preschool , Comorbidity , Humans , Infant , Infant, Newborn , Infant, Premature , Prognosis , Risk Factors
5.
Med Oral Patol Oral Cir Bucal ; 24(2): e181-e189, 2019 Mar 01.
Article in English | MEDLINE | ID: mdl-30818310

ABSTRACT

BACKGROUND: Oral ulcers caused by methotrexate (MTX) at low doses are a known side effect of this drug. Although increasingly more patients are medicated with MTX, these painful ulcers, without traumatic origin and resistant to any type of treatment, are not usually identified by health professionals as a side effect of the medication. MATERIAL AND METHODS: In the absence of a consensus protocol for the effective treatment of oral lesions produced by MTX, the objective of this article was to review and analyse the information from articles related to oral ulcers produced by low-dose MTX and to record the clinical management performed and the MTX dose given to the patient. Data sources - Medline, Web of Science, and Cochrane Library. Participants - Patients treated with low-dose MTX (less than 25 mg/week). Interventions - Management of oral lesions caused by MTX. Study eligibility criterion, study appraisal and synthesis method: An initial search was carried out in the aforementioned databases with the terms 'methotrexate AND oral OR ulcer'. The search was carried out using both medical subject heading (MeSH) terms and a free search between January 2003 and January 2018. Of the results obtained, two independent researchers analysed abstracts that met the search criteria, that is, those that mentioned oral ulcers produced by MTX at low doses. Next, both researchers read the complete article and determined whether it met the following inclusion criteria: written in English, specified the dose of MTX prescribed for the patient and specified the protocol of action for the ulcers. A third investigator acted as a mediator in cases of dispute. Agreement was calculated using Cohen's kappa coefficient, with a k value of 0.82. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guide for systematic reviews was used. RESULTS: The initial search resulted in a total of 66 articles, of which 30 were selected to assess their inclusion in this study. Finally, 16 met the inclusion criteria. Using the Pierson and Newcastle-Ottawa scales and Bradford Hill criteria modified for studies of case series and "in relation to a case", 2 were rated as high quality, 2 were rated as low quality and 12 were rated as medium quality. The limitations of this study are based on the fact that all of the articles available to carry out the systematic review were "in relation to a case or series of cases", with the heterogeneity of data that this implies. CONCLUSIONS: Evidence on the management of oral ulcers in the oral cavity produced by MTX at low doses is scarce due to the heterogeneity of data and the measures adopted in the selected studies. Therefore, it seems that this management is relegated to the perception of the clinician rather than to a specific protocol of action. Studies with a longer follow-up duration and larger sample size are needed to guide different health professionals on the management of these lesions.


Subject(s)
Methotrexate/administration & dosage , Methotrexate/therapeutic use , Oral Ulcer/drug therapy , Administration, Oral , Databases, Factual , Humans , Methotrexate/adverse effects , Treatment Outcome
6.
Br J Dermatol ; 179(4): 863-871, 2018 10.
Article in English | MEDLINE | ID: mdl-29723914

ABSTRACT

BACKGROUND: Cancer risk following long-term exposure to systemic immunomodulatory therapies in patients with psoriasis is possible. OBJECTIVES: To assess a dose-response relationship between cumulative length of exposure to biological therapy and risk of cancer. METHODS: Four national studies (a healthcare database from Israel, and prospective cohorts form Italy, Spain and the U.K. and Republic of Ireland) collaborating through Psonet (European Registry of Psoriasis) participated in these nested case-control studies, including nearly 60 000 person-years of observation. 'Cases' were patients who developed an incident cancer. Patients with previous cancers and benign or in situ tumours were excluded. Four cancer-free controls were matched to each case on year of birth, sex, geographic area and registration year. Follow-up for controls was censored at the date of cancer diagnosis for the matched case. Conditional logistic regression was performed by each registry. Results were pooled using random-effects meta-analysis. RESULTS: A total of 728 cases and 2671 controls were identified. After matching, differences between cases and controls were present for the Charlson Comorbidity Index in all three registries, and in the prevalence of previous exposure to psoralen-ultraviolet A and smoking (the British Association of Dermatologists Biologic Interventions Register only). The risk of first cancers was not significantly associated with cumulative exposure to biologics (adjusted odds ratio per year of exposure 1·02, 95% confidence interval 0·92-1·13). Results were similar if squamous and basal cell carcinomas were included in the outcome. CONCLUSIONS: Cumulative length of exposure to biological therapies in patients with psoriasis in real-world clinical practice does not appear to be linked to a higher risk of cancer after several years of use.


Subject(s)
Biological Products/adverse effects , Dermatologic Agents/adverse effects , Immunologic Factors/adverse effects , Neoplasms/epidemiology , Psoriasis/drug therapy , Biological Products/administration & dosage , Dermatologic Agents/administration & dosage , Dose-Response Relationship, Drug , Europe/epidemiology , Humans , Immunologic Factors/administration & dosage , Incidence , Israel/epidemiology , Neoplasms/chemically induced , Neoplasms/immunology , Psoriasis/immunology , Registries/statistics & numerical data , Time Factors
7.
Br J Dermatol ; 176(3): 594-603, 2017 Mar.
Article in English | MEDLINE | ID: mdl-27292159

ABSTRACT

A new generation of biologics targeting the interleukin-23-T helper 17 pathway has been developed. This study aimed to assess the short-term effectiveness and safety of these new agents using a network meta-analysis. Twenty-seven randomized clinical trials (10 629 patients) were identified by a comprehensive systematic literature review (PROSPERO 2015: CRD42015025472). Quality of evidence was assessed following Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations approach. Efficacy and safety outcomes at weeks 10-16 were compared using a random-effects network meta-analysis within a frequentist framework to estimate pooled odds ratios (ORs) of direct and indirect comparisons among the therapeutic options. There were six direct drug-to-drug comparisons in the network, with a high degree of consistency between the direct and indirect evidence. From the available evidence, infliximab 5 mg kg-1 every 8 weeks [OR 118·89, 95% confidence interval (CI) 60·91-232·04] and secukinumab 300 mg every 4 weeks (OR 87·07, 95% CI 55·01-137·82) are shown to be among the most effective short-term treatments, but are ranked as the biologics most likely to produce any adverse event or an infectious adverse event, respectively. Ustekinumab 90 mg every 12 weeks, the third most efficacious treatment (OR 73·67, 95% CI 46·97-115·56), was the only agent that did not show increased risk of adverse events compared with placebo. Treatment recommendations should also consider long-term outcomes and costs.


Subject(s)
Biological Factors/therapeutic use , Dermatologic Agents/therapeutic use , Interleukin-23/metabolism , Psoriasis/drug therapy , Th17 Cells/drug effects , Adult , Biological Factors/adverse effects , Chronic Disease , Dermatologic Agents/adverse effects , Female , Humans , Male , Middle Aged , Patient Safety , Treatment Outcome
8.
Br J Dermatol ; 176(6): 1633-1644, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28192600

ABSTRACT

BACKGROUND: The quality of systematic reviews and meta-analyses on psoriasis, a chronic inflammatory skin disease that severely impairs quality of life and is associated with high costs, remains unknown. OBJECTIVES: To assess the methodological quality of systematic reviews published on psoriasis. METHODS: After a comprehensive search in MEDLINE, Embase and the Cochrane Database (PROSPERO: CDR42016041611), the quality of studies was assessed by two raters using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Article metadata and journal-related bibliometric indices were also obtained. Systematic reviews were classified as low (0-4), moderate (5-8) or high (9-11) quality. A prediction model for methodological quality was fitted using principal component and multivariate ordinal logistic regression analyses. RESULTS: We classified 220 studies as high (17·2%), moderate (55·0%) or low (27·8%) quality. Lower compliance rates were found for AMSTAR question (Q)5 (list of studies provided, 11·4%), Q10 (publication bias assessed, 27·7%), Q4 (status of publication included, 39·5%) and Q1 (a priori design provided, 40·9%). Factors such as meta-analysis inclusion [odds ratio (OR) 6·22; 95% confidence interval (CI) 2·78-14·86], funding by academic institutions (OR 2·90, 95% CI 1·11-7·89), Article Influence score (OR 2·14, 95% CI 1·05-6·67), 5-year impact factor (OR 1·34, 95% CI 1·02-1·40) and article page count (OR 1·08, 95% CI 1·02-1·15) significantly predicted higher quality. A high number of authors with a conflict of interest (OR 0·90, 95% CI 0·82-0·99) was significantly associated with lower quality. CONCLUSIONS: The methodological quality of systematic reviews published about psoriasis remains suboptimal. The type of funding sources and author conflicts may compromise study quality, increasing the risk of bias.


Subject(s)
Meta-Analysis as Topic , Psoriasis , Review Literature as Topic , Authorship , Conflict of Interest , Dermatology/statistics & numerical data , Ethics, Research , Humans , Journal Impact Factor , Periodicals as Topic/ethics , Periodicals as Topic/standards , Publication Bias , Research Support as Topic
9.
J Eur Acad Dermatol Venereol ; 31(6): 1021-1028, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28252811

ABSTRACT

BACKGROUND: There are a limited number of studies comparing psoriasis patients without psoriatic arthritis (PsA) to those with arthritis. Previous results are controversial. OBJECTIVES: To perform a comparative analysis of the phenotype, baseline comorbidities, therapeutic profile and incidence of adverse events (particularly overall adverse events, infections and infestations, malignancies and psychiatric disorders) among psoriatic patients with/without PsA. METHODS: All the patients on the Biobadaderm registry, a prospective inception cohort of psoriasis patients on systemic therapy, were included. Patients were divided into two groups: those with psoriasis without arthritis at the time of entry into the cohort (Pso group) and those with psoriasis and psoriatic arthritis (PsA group) at entry. Patients were followed until the censorship date (last visit in a lost-to-follow-up patient, or 10 November 2015, whichever occurred first). We excluded all the patients who developed any kind of signs and/or symptoms of joint involvement during the follow-up. A descriptive analysis was performed. We estimated incidence ratios (IRR) of adverse events during systemic treatment using a mixed-effects Poisson regression. RESULTS: We included 2120 patients: 1871 (88%) patients with psoriasis without arthritis and 249 (12%) with psoriasis and PsA. The follow-up time was 5020 patients-year in the Pso group and 762 patients-year in the PsA group. Patients with PsA had more comorbidities, particularly hypertension and liver disease; used a higher number of systemic therapies, particularly anti-TNFα drugs and combination therapy; and presented more adverse events (IRR adjusted = 1.29; 95% CI: [1.05-1.58]), particularly serious adverse events (IRR adjusted = 1.51; 95% CI: [1.01-2.26]) and infections/infestations (IRR adjusted = 1.88; 95% CI: [1.27-2.79]), independently of the associated comorbidities and present/past therapies. CONCLUSIONS: Given the differences between patients with psoriasis alone or with psoriasis associated with PsA, patients with psoriasis and PsA should be followed and managed more closely and with specific attention.


Subject(s)
Arthritis, Psoriatic/physiopathology , Phenotype , Registries , Adult , Aged , Arthritis, Psoriatic/complications , Female , Humans , Male
10.
J Eur Acad Dermatol Venereol ; 31(10): 1700-1708, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28485816

ABSTRACT

BACKGROUND: Little is known about the adverse events (AEs) that lead to suspension of systemic treatments for psoriasis in clinical practice. OBJECTIVE: The study aimed to investigate AEs associated with discontinuation of systemic therapy in patients with psoriasis in a clinical setting (Biobadaderm). MATERIALS AND METHODS: Multicentre, prospective, cohort study of patients with moderate-to-severe plaque psoriasis receiving systemic therapies from January 2008 to November 2015, in 12 hospitals in Spain. The incidence rate (IR) was used to compare biologics and classic systemic therapies. RESULTS: A total of 4218 courses of treatment were given to 1938 patients. A total of 447 (11%) treatments were discontinued due to AEs. The IR of AE associated with discontinuation of systemic therapies was 13 events/100 patient-years (PY) (95% CI: 12.14-13.93), 9.34 events/100 PY (95% CI: 8.44-10.33) for biologics and 19.67 (95% CI: 17.9-21.6) events/100 PY for classics (P < 0.001). Of 810 discontinuation-related AEs, 117 (14%) were serious. The highest IRs were for cyclosporine [49.18/100 PY (95% CI: 41.91-57.72)] and infliximab [26.52/100 PY (95% CI: 20.98-33.51). Ustekinumab presented the lowest IR (2.6/100 PY (95% CI: 1.83-3.69). LIMITATIONS: Observational study with potential selection bias. CONCLUSION: Biologic therapies are associated with a lower rate of discontinuation-related AEs than are classic therapies in real clinical practice. Ustekinumab showed the lowest incidence.


Subject(s)
Biological Products/adverse effects , Dermatologic Agents/adverse effects , Psoriasis/drug therapy , Substance Withdrawal Syndrome/physiopathology , Adult , Adverse Drug Reaction Reporting Systems , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Severity of Illness Index , Spain
11.
Actas Dermosifiliogr ; 108(1): 52-58, 2017.
Article in English, Spanish | MEDLINE | ID: mdl-27658689

ABSTRACT

BACKGROUND AND OBJECTIVE: We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases. METHODS: Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures. RESULTS: Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. The largest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis. CONCLUSION: Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size.


Subject(s)
Antirheumatic Agents/administration & dosage , Biological Factors/administration & dosage , Immunosuppressive Agents/administration & dosage , Postoperative Complications/prevention & control , Preoperative Care , Psoriasis/drug therapy , Adult , Aged , Anesthesia/methods , Antibiotic Prophylaxis , Antirheumatic Agents/adverse effects , Biological Factors/adverse effects , Contraindications, Drug , Elective Surgical Procedures , Female , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Postoperative Complications/chemically induced , Psoriasis/complications , Registries , Retrospective Studies , Spain/epidemiology , Surgical Procedures, Operative , Treatment Outcome
12.
J Eur Acad Dermatol Venereol ; 30(11): 1942-1950, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27329511

ABSTRACT

BACKGROUND: Few reported studies compare drug survival in moderate-to-severe psoriasis vulgaris. OBJECTIVES: To describe and compare drug survival of systemic drugs, including biologic agents (infliximab, etanercept, adalimumab and ustekinumab) and classical drugs (acitretin, ciclosporin and methotrexate) in moderate-to-severe psoriasis. METHODS: This was a multicenter, prospective, cohort study of patients receiving systemic therapies between 2008 and 2013 in 12 hospitals in Spain. Baseline data and drug discontinuation were collected. Drug survival is presented using Kaplan-Meier survival curves. We compared adjusted risk ratios of serious adverse events (AEs) with results of survival analysis for AEs. RESULTS: A total of 1956 patients were included for analysis (1240 exposed to biologics during follow-up and 1076 to classic therapies). Median follow-up time was 3.3 years (0.0-5.1 years). There were 2209 discontinuations out of 3640 therapy cycles started. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%). Biologics showed a higher drug survival than classics and the pattern of survival results for all outcomes (positive or negative) were very similar. Adjusted risk ratios of serious AEs did not agree with results of survival analysis. LIMITATIONS: A limitation is that this is an observational study with potential selection bias. CONCLUSION: Survival as a proxy measure of drug safety in psoriasis is inadequate.


Subject(s)
Dermatologic Agents/therapeutic use , Psoriasis/drug therapy , Registries , Humans , Prospective Studies
13.
J Eur Acad Dermatol Venereol ; 29(5): 858-64, 2015 May.
Article in English | MEDLINE | ID: mdl-25185962

ABSTRACT

BACKGROUND: Psoriasis patients over 65 years-old (elderly) constitute a growing group, underrepresented in clinical trials, and likely to be more prone to adverse events. OBJECTIVE: To describe safety of systemic psoriasis therapy in patients over 65 years-old compared to younger patients. METHODS: Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were grouped in elderly (≥ 65 years old) and younger patients. Rates of adverse events were described by severity and type, and the risks compared in both groups, taking into account exposure to classic or biologic drugs, using Cox regression. RESULTS: 175 (9.8%) of 1793 patients were elderly. Overall risk of adverse events was not higher in elderly (drug group adjusted HR 1.09 (95%CI: 0.93-1.3)). Serious adverse events were more common in elderly (drug group adjusted HR 3.2 (95%CI: 2.0-5.1)). Age adjusted HR of all adverse events was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR 0.7 (95%CI: 0.6-0.7)). Age did not seem to modify the effect of therapy (biologic vs. classic) in the risk of adverse events (likelihood ratio test for interaction, p = 0.12 for all adverse events, p = 0-09 for serious adverse events). CONCLUSIONS: Serious adverse events are more common in elderly patients, although they may be related to other variants that are associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk of adverse events in the whole group. We found no differences in this association between young and elderly. These results are reassuring, although uncontrolled confounding could not be excluded as an explanation for these findings, and the power of the study to detect differences was low.


Subject(s)
Biological Products/adverse effects , Dermatologic Agents/adverse effects , Psoriasis/drug therapy , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Antibodies, Monoclonal/adverse effects , Child , Child, Preschool , Female , Humans , Immunosuppressive Agents/adverse effects , Infant , Male , Middle Aged , Registries , Spain , Young Adult
14.
J Eur Acad Dermatol Venereol ; 29(1): 156-63, 2015 Jan.
Article in English | MEDLINE | ID: mdl-24684267

ABSTRACT

BACKGROUND: Biobadaderm is the Spanish registry of psoriasis patients receiving systemic treatment in clinical practice. OBJECTIVE: To compare the safety of biologics and classic systemic treatment. METHODS: Prospective cohort of patients receiving biologics and classic systemic therapies between 2008 and 2013 in 12 hospitals are included. We registered demographic data, diagnoses, comorbidities, treatments and adverse events (AE). We obtained raw relative risks (RR) for specific AE. Multivariate analysis consisted of Cox models adjusting for age, gender, chronic hepatic disease and previous cancer. RESULTS: A total of 1030 patients received biologics (2061 AE in 3681 person-years), 926 patients classic systemic drugs (1015 AE in 1517 person-years). Ninety-three per cent of AE in both groups were non-serious, 6% serious and 0.003% fatal. The age- and gender-adjusted hazard ratio of AE was lower in the biologics group [hazard ratio 0.6 (95% CI: 0.5-0.7)].We found no differences in rates of serious and mortal AE. Some system organ class AE rates differed between both groups. As limitations: Prescription bias might affect the incidence of AE in both groups. Association of drug and AE was based on timing: associations might not be causal. CONCLUSION: Patients receiving biologics had lower risk of AE. We did not find differences in the risk of serious or fatal AE.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Biological Products/adverse effects , Immunosuppressive Agents/adverse effects , Keratolytic Agents/adverse effects , Psoriasis/drug therapy , Acitretin/adverse effects , Adalimumab , Adult , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Cyclosporine/adverse effects , Etanercept , Female , Humans , Immunoglobulin G/adverse effects , Infliximab , Male , Methotrexate/adverse effects , Middle Aged , Proportional Hazards Models , Prospective Studies , Receptors, Tumor Necrosis Factor , Registries , Risk Assessment , Spain , Ustekinumab
15.
Actas Dermosifiliogr ; 106(8): 638-43, 2015 Oct.
Article in English, Spanish | MEDLINE | ID: mdl-26141003

ABSTRACT

BACKGROUND: With the advent of biologic drugs in the management of moderate to severe psoriasis, there may have been a shift in therapeutic approach from rotational strategies to a unidirectional progression from topical treatments to the highest rung of the therapeutic ladder. We studied the frequency of switching from classic to biologic therapy and vice versa in a cohort of patients with psoriasis over a period of up to 5 years. METHODS: Patients are included in the BIOBADADERM prospective registry when they are first prescribed any specific conventional or biologic systemic treatment. The data for each patient refer to the follow-up period from the time they entered the cohort until October 2013. To describe the pattern of switches from classic to biologic therapy and vice versa, we used the data in the registry on the first day of every 365-day period following the date each patient was included in the cohort. RESULTS: In total, 47.3% of the patients (926/1956) were prescribed a classic systemic drug and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up. CONCLUSIONS: The proportion of patients receiving biologic therapy increased with longer follow-up.


Subject(s)
Dermatologic Agents/therapeutic use , Dermatology/trends , Psoriasis/drug therapy , Biological Products/therapeutic use , Case-Control Studies , Dermatologic Agents/classification , Drug Substitution/trends , Drug Utilization/trends , Follow-Up Studies , Humans , Prospective Studies , Spain
17.
J Eur Acad Dermatol Venereol ; 28(7): 907-14, 2014 Jul.
Article in English | MEDLINE | ID: mdl-23848131

ABSTRACT

BACKGROUND: There are few data on the prevalence of obesity in the general psoriasis population and on the real impact of obesity on the management of psoriasis patients in the clinical setting. OBJECTIVES: To evaluate the prevalence of overweight and obesity in patients with moderate-to-severe psoriasis compared to the general population and to assess the relationship between Body Mass Index (BMI) and the risk of discontinuing treatment. METHODS: Patients registered on Biobadaderm, a prospective registry, were grouped according the different categories of BMI and compared to the general Spanish population. Drug survival was analysed considering only drug withdrawal due to lack of effectiveness, remission and adverse events. RESULTS: A total of 1162 moderate-to-severe psoriasis patients on systemic conventional or biological treatment were recruited. The prevalence of obesity was found to be significantly higher in psoriasis patients than in the general Spanish population (P < 0.001). In multivariate analysis a 5-unit increase in BMI, similar to a change in BMI category from normal weight to overweight and from overweight to obesity, was associated with a 12% increased risk of discontinuing therapy due to lack of effectiveness (HR 1.12, 95% CI: 1.01-1.24) and with a 17% increased risk of having an adverse event (HR 1.17, 95% CI: 1.02-1.36), both independently of the drug used. CONCLUSIONS: Patients with moderate-to-severe psoriasis had a higher prevalence of obesity than the general population. Increased BMI was associated with an increased risk of treatment discontinuation due to lack of effectiveness and a higher risk of adverse events.


Subject(s)
Biological Products/adverse effects , Biological Products/therapeutic use , Body Mass Index , Obesity/complications , Obesity/epidemiology , Psoriasis/drug therapy , Severity of Illness Index , Withholding Treatment , Comorbidity , Humans , Multivariate Analysis , Overweight/complications , Overweight/epidemiology , Prevalence , Prospective Studies , Psoriasis/epidemiology , Registries , Risk Factors , Spain/epidemiology , Treatment Outcome
18.
Acta Ortop Mex ; 38(1): 29-43, 2024.
Article in Spanish | MEDLINE | ID: mdl-38657149

ABSTRACT

Recently, it has been recognized that changes in sagittal alignment and spinopelvic mobility due to alterations of the lumbosacral spine can influence the dislocation of a hip replacement. The biggest difficulties for this problem are: a) the bibliography related to this topic has been written in English and there is confusion in its terminology; b) there is no consensus on what parameters should be used to identify, measure, and estimate the risks of dislocation occurring; c) the basic concepts that interrelate spinal disorders and prosthetic dislocation are not clearly understood; and d) spine and hip surgeons pursue different goals. The objective of this narrative review is to overcome the aforementioned difficulties by using a strategy to answer some questions: Is hip dislocation really a problem? What is the interrelationship between alterations in the pelvic spinal balance and the dislocation of a prosthesis? How is sagittal balance and lumbosacral mobility defined and how can their alterations be measured? What are their compensatory mechanisms to achieve a good functioning and how these mechanisms can be used to correctly orient the acetabulum? To document this review, we consulted the databases of PubMed, Scopus, SciELO and Google Scholar with the keywords: Spinopelvic, Total Hip Arthroplasty, Hip Dislocation, Spine-Pelvis-hip Arthroplasty. The articles that, in the author's opinion, were the most objective and/or relevant for the study of this topic were selected.


Recientemente se ha reconocido que los cambios en alineación sagital y la movilidad espino-pélvica por alteraciones de la columna lumbosacra pueden ejercer influencia en la luxación de una prótesis de cadera. Las mayores dificultades para este problema son: a) que la bibliografía relacionada con este tema se ha escrito en idioma inglés y hay confusiones en su terminología; b) no hay consenso de cuáles son los parámetros que deben utilizarse para identificarla, medirla y para estimar los riesgos de que ocurra una luxación; c) no se conocen con claridad los conceptos básicos que interrelacionen los trastornos de la columna y la luxación protésica; y d) que los cirujanos de columna y artroplásticos de cadera persiguen diferentes objetivos. Esta revisión narrativa persigue como objetivo allanar las dificultades antes mencionadas, utilizando como estrategia contestar algunas preguntas: ¿la luxación de cadera es realmente un problema?; ¿cuál es la interrelación entre las alteraciones en el balance espino-pélvico y la luxación de una prótesis?; ¿cómo se define el balance sagital y la movilidad lumbosacra y cómo se pueden medir sus alteraciones?; ¿cuáles son sus mecanismos compensatorios para lograr un buen funcionamiento, y cómo se pueden aprovechar estos mecanismos para orientar correctamente el acetábulo? Para documentar esta revisión se consultaron las bases de datos de PubMed, Scopus, SciELO y Google Académico con las palabras clave: Spinopelvic, Total Hip Arthroplasty, Hip Dislocation, Spine-Pelvis-hip Arthroplasty. Se seleccionaron los artículos que a juicio del autor fueron los más objetivos y/o relevantes para el estudio de este tema.


Subject(s)
Arthroplasty, Replacement, Hip , Hip Dislocation , Humans , Arthroplasty, Replacement, Hip/methods , Hip Dislocation/prevention & control , Hip Dislocation/etiology , Pelvis , Spine/surgery , Postoperative Complications/prevention & control
19.
Oral Dis ; 19(3): 279-86, 2013 Apr.
Article in English | MEDLINE | ID: mdl-22892006

ABSTRACT

OBJECTIVE: To investigate oral carcinogenesis in hamster induced by the topical application of 7,12-dimethyl benzanthracene (DMBA) to evaluate the different lesions produced and the possible preventive effects of the phenolic compounds apigenin (flavone) and carnosic acid (diterpene). MATERIALS AND METHODS: Thirty-two Syrian hamsters were divided into three groups: I: 0.5% DMBA (n = 12); II: 0.5% DMBA + potassium apigenin (n = 8); III: 0.5% DMBA + carnosic acid (n = 12). All the animals were sacrificed after 11 weeks, and a macroscopic and light microscopic study was made of the lesions. RESULTS: The largest number of neoplasms, showing the most aggressive biological behavior, corresponded to the control group. The group treated with potassium apigenin ranked second in tumor incidence, although the tumors were not very aggressive behavior. In the group treated with carnosic acid, only one malignancy was recorded, showing the smallest volume of all the recorded tumor lesions. CONCLUSIONS: Our findings indicate that both potassium apigenin and carnosic acid have chemoprotective effects against carcinogenesis induced by DMBA in hamster.


Subject(s)
Abietanes/therapeutic use , Apigenin/therapeutic use , Mouth Neoplasms/prevention & control , Plant Extracts/therapeutic use , 9,10-Dimethyl-1,2-benzanthracene/pharmacology , Animals , Carcinogenesis/chemically induced , Cricetinae , Drug Screening Assays, Antitumor , Male , Mouth Neoplasms/chemically induced
20.
J Eur Acad Dermatol Venereol ; 27(11): 1366-74, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23134268

ABSTRACT

INTRODUCTION: The incidence of tuberculosis (TB) or the prevalence of latent tuberculosis infection (LTBI) in psoriasis patients has not been described in the Spanish population. We carried out a study with the objectives: (i) To describe the incidence of TB in patients with psoriasis on systemic treatment in the Spanish population; (ii) To determine the prevalence of LTBI in patients who are candidates for biological treatment; and (iii) To investigate the level of compliance with current recommendations for LTBI and TB screening. METHODS: Data were obtained from BIOBADADERM (Spanish registry for systemic biological and non-biological treatments in psoriasis). An analysis was performed of the exposed cohort to determine the prevalence of LTBI and to describe compliance with the screening guidelines. RESULTS: A total of 1425 patients were registered in BIOBADADERM. They included 793 (56%) patients exposed to biological treatment and 632 (44%) treated with conventional systemic drug. Overall follow-up was 3720 person-years. Of the 793, 20.5% (163) were diagnosed with LTBI before starting biological treatment. The rate of active TB for the exposed cohort was 145 cases × 100,000 patient-years (95% CI 54-389). No case of TB was found in the control group. Screening for LTBI was performed in 83% of the exposed sample. CONCLUSION: Patients with psoriasis who are exposed to biological treatment appear to be at greater risk for tuberculosis. In Spain, up to 20% of patients with psoriasis who are candidates for biological therapy have LTBI. There continues to be a significant percentage of errors in compliance with clinical guidelines.


Subject(s)
Latent Tuberculosis/complications , Psoriasis/complications , Tuberculosis/complications , Adult , Cohort Studies , Female , Guideline Adherence , Humans , Incidence , Latent Tuberculosis/epidemiology , Male , Middle Aged , Practice Guidelines as Topic , Prevalence , Psoriasis/epidemiology , Severity of Illness Index , Spain/epidemiology , Tuberculosis/epidemiology
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