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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.

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.

There is a lack of real practice studies comparing ustekinumab and ixekizumab effectiveness and safety. The main aim of this study was to compare the effectiveness and safety of both drugs used to treat moderate-to-severe psoriasis patients over 52 weeks. The secondary objective was to identify which clinical variables could have an impact on its effectiveness. A retrospective observational study was carried out, comparing the first 28 patients treated with ustekinumab after its commercialization was compared to the first 35 patients treated with ixekizumab. Although a higher level of skin clearance was achieved with ixekizumab with a PASI 90 and 100 response of 54.3% and 40% compared to 42.9% and 25% for ustekinumab, these differences were not statistically significant. Ixekizumab achieved a higher PASI 90 response in those patients with BMI > 27 (slightly overweight), which was statistically significant (P = .024). Ustekinumab had a greater survival at 52 weeks than ixekizumab, with a trend towards statistical significance (P = .052). Ixekizumab achieved higher skin clearance rates (PASI 90 and 100 response) than ustekinumab, with no statistically significant differences. However, ixekizumab should be specially considered in overweight patients., (© 2020 Wiley Periodicals LLC.)

Background and Objectives: Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years., Material and Methods: Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018)., Results: Anti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period., Conclusions: The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs., (Copyright © 2020. Publicado por Elsevier España, S.L.U.)

Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed., Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry., Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort., Results: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5)., Limitations: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered., Conclusion: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products., (Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

There are no studies which directly compare efficacy in Psoriasis Area and Severity Index (PASI) response of secukinumab and ixekizumab. The main aim of this study was to compare the efficacy and safety of both drugs used to treat moderate-to-severe psoriasis patients over 52 weeks. Secondary objectives were to identify which factors related to prior biologic treatment influenced their efficacy and analyze data obtained at 12 weeks. A retrospective observational study was carried out, in which a group of the first 59 patients treated with secukinumab after its commercialization, was compared with another group of the first 29 patients treated with ixekizumab. The PASI 75, 90, and 100 response obtained at 52 weeks was 64.4%, 49.2%, and 41.4% for secukinumab and 75.9%, 62.1%, and 41.4% for ixekizumab, respectively, with no statistically significant differences. Regarding previous biological treatment, both treatments showed a decrease in efficacy as the number of prior biologics increases. No differences were found between secukinumab and ixekizumab in bio-naïve or bio-experienced patients, with the exception of a higher PASI 75 response at week 52 for ixekizumab in those patients with two or more previous biologics (P = .039) Secukinumab and ixekizumab have demonstrated high efficacy and safety, with no statistically significant differences., (© 2020 Wiley Periodicals LLC.)

A descriptive retrospective, study comparing the first 29 patients who received ustekinumab at our unit following its approval in September 2009 with 30 patients who received secukinumab after its marketing in Spain in November 2015 was conducted. The secukinumab treatment group showed higher whitening rates and a higher percentage of patients reached a psoriasis area and severity index (PASI) 75 response (89.65 vs. 73.33%, p = .108) than those in the ustekinumab treatment group at Week 52. The number of patients achieving a PASI 90 response was particularly remarkable and statistically significant (82.75 vs. 43.33%, p = .002). Better PASI 75 response rates were also observed in the secukinumab group than in the ustekinumab group after 52 weeks in biologic-naïve patients (89 vs. 72%, p = .586) and among those previously treated with one line (92 vs. 100%, p = 1.00) or with two or more previous biologic lines (88 vs. 62%, p = .336). These differences were greater in the number of patients reaching a PASI 90 response in the secukinumab group than in the ustekinumab group in biologic-naïve patients (78 vs. 63%, p = .642) and in those previously treated with one (92 vs. 50%, p = .083) or with two or more treatment lines (75 vs. 31%, p = .080). These regular-practice results overlap or surpass those obtained in the CLEAR clinical trial., (© 2019 Wiley Periodicals, Inc.)

Introduction and Objectives: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy., Material and Method: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology., Results: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects., Conclusions: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis., (Publicado por Elsevier España, S.L.U.)

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., (© 2017 European Academy of Dermatology and Venereology.)

Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2-3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1-2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17-2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08-2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02-1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1-8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8-13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27-8.24)., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (© 2016 European Academy of Dermatology and Venereology.)

Background: Identifying patients likely to have very good or bad results from systemic psoriasis therapy could improve efficiency of therapy., Objective: To develop prognostic models for good or bad response to classic systemic drugs, anti-TNFs, and ustekinumab in psoriasis., Methods: Multivariable logistic regression of a prospective multicenter cohort of psoriatic patients in clinical practice (6449 person-years of follow-up). We used as possible predictors demographic characteristics, comorbidities, characteristics of the psoriasis (type, PASI, arthritis), history of past therapy at entry in the cohort, and history of response to previous cycles while in the cohort. We defined good response to a treatment cycle as either cycle end due to disease remission or a cycle longer than 2 years that does not end later due to inefficacy in the follow-up period. Bad response to a treatment cycle was defined as a cycle that is finished due to inefficacy, based on the physician judgment, after more than 3 months of treatment., Results: Patients with fewer previous therapies, lower body mass index, older at start of therapy, and with previous history of good responses to therapy are more likely to have positive results of therapy. However, the predictive characteristics of models are poor., Conclusion: Predictive models of clinical response to systemic drugs in psoriasis with the studied variables do not seem to outperform drug selection by a dermatologist.

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., (Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.)

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., (© 2014 European Academy of Dermatology and Venereology.)

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., (© 2014 European Academy of Dermatology and Venereology.)

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., (© 2013 European Academy of Dermatology and Venereology.)

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., (© 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.)

Objective: To describe the use of systemic therapy for psoriasis (biologic and nonbiologic [classic] drugs) in patients not adequately represented in randomized controlled trials (RCTs) and the risk of serious adverse events (SAEs) in these patients., Design: A registry inception cohort was used., Setting: Thirteen dermatology departments in Spain participated., Patients: A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy were evaluated. A total of 1042 patients (2179 person-years) were included., Exposure: Inadequate representation in trials was defined as the presence of any of the following factors: elderly age (>70 years); type of psoriasis other than chronic plaque psoriasis; history of infection caused by hepatitis B, hepatitis C, or human immunodeficiency virus; history of cancer (excluding nonmelanoma skin cancer); and chronic renal or hepatic disease., Main Outcome Measures: Serious adverse events as defined by the International Conference on Harmonization were evaluated., Results: In all, 29.8% of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients exposed to biologics had an adjusted increased risk of SAEs (incidence rate ratio, 2.3; 95% CI, 1.1-4.8) that was similar in patients eligible and ineligible for RCTs., Conclusions: Patients ineligible for RCTs are an important proportion (30%) of those receiving systemic therapy for psoriasis. These patients have a higher risk of SAEs and should be closely monitored. Patients exposed to biologics (whether these patients are eligible for RCTs or ineligible) are susceptible to the same increase in risk of SAEs, but biologics add to a higher baseline risk in patients who are ineligible for RCTs. The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients.

Etanercept is a tumor necrosis factor alfa (TNFalpha) antagonist whose efficacy and safety in the treatment of psoriasis have been proven in many clinical trials. Nevertheless, few studies evaluate the efficacy and safety of this therapy in patients after discontinuation and readministration. Our study aimed to evaluate the efficacy and safety of etanercept in daily clinical practice for the treatment of patients with moderate-to-severe plaque psoriasis. The study also examines the discontinuation and readministration of the treatment. We carried out a retrospective observational study that collected data on 66 patients with moderate-to-severe psoriasis treated with etanercept at 25 mg or 50 mg twice weekly (BIW) at intermittent intervals over a period of 3.4 years. The following variables were evaluated during each of the retreatment cycles: outcome of the psoriasis area severity index (PASI) [PASI 50, PASI 75, and PASI 90], joint pain, and nail involvement. A significant fall in the PASI during each treatment cycle was observed. During cycle 1, the evaluation of the PASI was significantly lower for patients who started treatment with 50 mg BIW at weeks 12 and 24, even after the dose was reduced at week 12. After each treatment cycle was completed, the mean time to relapse was 3 months. When treatment was reintroduced after a relapse, the response rate was similar to that observed in the initial cycle. Joint pain and nail involvement improved significantly in each of the treatment cycles. In no case did we observe a relapse after therapy was interrupted, conversion of the morphology of psoriasis, or severe adverse events. We conclude that clinical efficacy and safety are maintained over time, and in the successive retreatment cycles. The interest of our study lies in the fact that several cycles of reinitiation and discontinuation of treatment are examined.

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]