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Background: Treatment persistence is becoming a useful measure to evaluate long‐term effectiveness and safety of biological therapies in real‐world settings. Objective: The main objective of this study was to explore the scientific opinion of a panel of dermatologists and hospital pharmacists to reach a consensus about the impact, causes, and best strategies and interventions that might be associated with improved drug persistence in patients with psoriasis in Spain. Methods: This research was conducted using a modified Delphi method organized in two rounds and involving a panel of 90 dermatologists and 34 hospital pharmacists. A questionnaire of 70 items was developed. The items proposed to reach a consensus included topics such as definitions and measures in the treatment of psoriasis, analysis of treatment persistence, factors that may influence treatment persistence, impact of treatment persistence and economic cost of treatment. Results: Dermatologists reached a consensus on 77.1% of the items proposed, and hospital pharmacists reached a consensus on 71.4%. Both groups agreed that it is important to use standardized measures in the evaluation of treatment maintenance over time. Dermatologists agreed that treatment survival, persistence and retention are synonymous, but hospital pharmacists considered only treatment persistence as a valid term. In addition, panelists agreed that drug persistence is an indicator of success in the treatment of psoriasis that may be influenced by a drug's effectiveness and safety profile, as well as by patient satisfaction. They agreed that the different causes of treatment discontinuation should be considered in Kaplan–Meier analysis of treatment persistence. Moreover, treatment persistence was agreed to decrease the cost of therapy. Conclusion: This Delphi consensus highlights the different perspectives of dermatologists and hospital pharmacists regarding the interpretation of treatment persistence, and the challenge of harmonizing the results obtained. [ABSTRACT FROM AUTHOR]

Psoriasis is a chronic inflammatory disease that affects quality of life and has systemic repercussions as it is associated with several comorbidities, for which reason we have an extensive range of therapeutic resources, including topical agents, phototherapy, classic systemic drugs and emerging biological treatments. One or another treatment will be indicated depending on severity and other factors associated with the patient and the illness. Biological agents have revolutionised the treatment of moderate to severe psoriasis, offering high rates of effectiveness and safety for patients, so improving their quality of life. Tildrakizumab is a new approved by the EMA biological agent, part of a group of drugs with a mechanism of action based on the inhibition of interleukin-23. [ABSTRACT FROM AUTHOR]

Background: Increasing evidence indicates a relationship between psoriasis and metabolic syndrome (MS). We evaluated the prevalence of MS in patients receiving systemic treatment for psoriasis in Spain, and its relationship to cardiovascular disease (CVD). Methods: This cross-sectional, multicenter, non-interventional study enrolled 368 patients with moderate-to-severe psoriasis requiring systemic treatment. Clinical parameters for psoriasis, CV risk factors, MS and CVD were assessed. Descriptive and logistic regression analyses were performed. Results: 352 patients were included (median psoriasis duration: 18 years, plaque psoriasis [95.7%], psoriatic arthritis [22.8%]). Overall, 132 patients (37.5%) fulfilled diagnostic criteria for MS; the most prevalent MS components were high blood pressure and increased waist circumference. Patients with MS were older, more likely to be obese and to have a sedentary lifestyle and hypercholesterolemia than those without MS. CVD was more prevalent in patients with MS than in those without (29.5% versus 15.9%,p = 0.002), particularly coronary heart disease (CHD), myocardial infarction and heart failure. MS was independently associated with CVD (OR 1.98,p = 0.018) and CHD (OR 2.02,p = 0.044). Conclusion: The prevalence of MS was high among patients with moderate-to-severe psoriasis requiring systemic treatment, and was associated with a higher prevalence of CVD. Dermatologists should consider implementing simple screening protocols. [ABSTRACT FROM PUBLISHER]

Incomplete Mohs micrographic surgery (MMS) is the cessation of MMS while the tumour margins remain positive. Zbar retrospectively described a series of 14 incomplete MMS without observing recurrences.1 Madani et al. reported two recurrences among eight cases of incomplete MMS, retrospectively too.2 Neither of these retrospective studies described the rates nor analysed risk factors for recurrence. Incidence rates of tumour recurrence were 12 cases (7.5-19.3) per 100 patient-years after incomplete MMS and 1.4 cases (1.2-1.6) per 100 patient-years after complete MMS (Table 2). [Extracted from the article]

Abstract: Background: The elderly population is increasing and more patients in this group undergo Mohs micrographic surgery (MMS). The few publications investigating MMS in elderly people conclude that it is a safe procedure; however, these are single‐centre studies without a comparison group. Objective: To compare the characteristics of patients, tumours, MMS and 1‐year follow‐up in patients younger than 80 years, with patients older than 80 years at the time of surgery. Methods: Data was analysed from REGESMOHS, a prospective cohort study of patients treated with MMS. The participating centres were 19 Spanish hospitals where at least one MMS is performed per week. Data on characteristics of the patient, tumour and surgery were recorded. Follow‐up data were collected from two visits; the first within 1 month postsurgery and the second within the first year. Results: From July 2013 to October 2016, 2575 patients that underwent MMS were included in the registry. Of them, 1942 (75.4%) were aged <80 years and 633 (24.6%) were ≥80 years old. In the elderly, the tumour size was significantly higher with a higher proportion of squamous cell carcinoma. Regarding surgery, elderly more commonly had tumours with deeper invasion and required a higher number of Mohs surgery stages, leaving larger defects and requiring more time in the operating room. Despite this, the incidence of postoperative complications was the same in both groups (7%) and there were no significant differences in proportion of relapses in the first‐year follow‐up. Conclusion: The risk of short‐term complications and relapses were similar in elderly and younger groups. MMS is a safe procedure in the elderly. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]