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Brodalumab, a human monoclonal antibody that targets interleukin-17 receptor A (IL-17RA), is approved in the US and EU for treatment of adults with moderate-to-severe plaque psoriasis. Although brodalumab has demonstrated efficacy and safety vs placebo in clinical trials of patients with psoriasis and psoriatic arthritis (PsA), real-world evidence is needed to evaluate long-term effectiveness and safety of brodalumab in routine care. This interim analysis of the German Psoriasis Registry PsoBest examined patient profiles, treatment outcomes, and drug survival of first-time use of brodalumab for 12 months in adult patients with moderate-to-severe plaque-type psoriasis (with and without PsA) (data cutoff: June 30, 2021). Clinician and patient-reported outcomes of the total cohort ( n  = 227; PsA, n  = 38) indicated a rapid response to brodalumab treatment within the first 3 months, which was maintained up to 12 months. The overall one-year drug survival rate was 76.2%, the mean time to discontinuation was 8.3 months. Reasons for discontinuation were mainly loss/lack of effectiveness, followed by adverse events, contraindication and skin clearance. In sum, brodalumab demonstrated rapid and sustained effectiveness and was well-tolerated over 12 months in German patients with moderate-to-severe psoriasis and PsA in a real-world setting.

Background: Brodalumab, a fully human monoclonal immunoglobulin IgG2 antibody that binds the human interleukin 17 receptor subunit A, is available for the treatment of moderate-to-severe plaque psoriasis in Europe since September 2017, but so far there are only a few studies on its use in real-world conditions., Objectives: To assess the management of moderate-to-severe psoriasis with brodalumab 210 mg in daily practice after 12 and 52 weeks (W). In addition, patient profiles and treatment pathways are described., Methods: LIBERO is a prospective, multicenter, non-interventional study including adult patients with plaque psoriasis treated with brodalumab 210 mg., Results: In total, 638 patients (65% male, mean age: 49.3 ± 14.4 years) from 148 sites in Germany were enrolled. The majority suffered from severe (51.1%) or very severe (13.1%) psoriasis according to physician global assessment (PGA0-5). When starting with brodalumab, 58.5% were biologic naïve and 41.5% were previously treated with another biologic, mainly adalimumab (18.5%) and secukinumab (17.9%). About 74.0% of patients met the primary endpoint of an absolute PASI ≤3 at ~W12 (n = 618, LOCF). The mean PASI was reduced significantly as of ~W2 from 17.2 (±11.7) to 9.7 (±8.8) and improved further to 3.3 (±6.3) at ~W12 (p < 0.001). At ~W52 85.5% of patients reached a PGA0/1-response (primary endpoint) and 54.1% patients were assessed as completely clear (PGA0) (both n = 399, as observed). Effectiveness of brodalumab was confirmed in relevant subgroup analysis by previous treatment regimen. Most frequently reported adverse events were nasopharyngitis (4.6%), psoriasis (4.6%) and arthralgia (4.1%), new safety signals were not detected., Conclusions: This representative, non-interventional study confirms the short- and long-term effectiveness and safety profile of brodalumab in the management of psoriasis in daily practice as well as in relevant treatment pathways., (© 2024 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background and Objectives: Flexible biologic therapy dosing regimens in psoriasis management are common, but data from routine care in Germany are scarce. This study evaluated treatment adjustments for biologic therapies commonly prescribed in Germany., Patients and Methods: Charts for up to 100 consecutive patients treated at 29 centers were reviewed. Data were extracted for adults (aged 18-65 years) with moderate-to-severe plaque psoriasis treated with adalimumab, guselkumab, ixekizumab, secukinumab, or ustekinumab for ≥ 36 weeks. The primary endpoint was time to first treatment adjustment. Secondary endpoints included frequency of and reasons for treatment adjustments. Time to treatment adjustment was analyzed using Kaplan-Meier methods., Results: Among 982 patients, 297 treatment adjustments in 240 (24.4%) patients were identified. The mean (median; interquartile range) time to first treatment adjustment (n = 223) was 8.4 (4.0; 2.0-12.0) months (secukinumab: 14.1 [10.0; 4.0-21.0], adalimumab: 11.0 [7.0; 3.0-14.5], ustekinumab: 11.0 [6.0; 2.0-16.0], ixekizumab: 5.8 [3.0; 2.0-8.5], guselkumab: 5.1 [3.0; 2.0-7.0]). The most frequent adjustment type was starting concomitant treatment(s) (10.4% of patients); insufficient skin effectiveness was the most frequent reason for adjustment., Conclusions: Biological treatment adjustments are frequent in moderate-to-severe psoriasis; flexible dosing regimens would support optimal management., (© 2024 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by Wiley‐VCH GmbH on behalf of Deutsche Dermatologische Gesellschaft.)

Background: Patient-reported outcomes are relevant in clinical practice showing patient benefits, supporting clinicians' decision-making, and contributing to the delivery of high standards of care. Digital monitoring of patient-reported outcomes is still rare. The Patient Benefit Index (PBI) measures benefits and goals from patients' views and may be relevant for regular documentation and shared decision-making., Objective: This study aimed to develop electronic versions of the PBI to examine their feasibility and acceptability in clinical practice for patients with psoriasis., Methods: We developed an app and a web version of the existing, valid PBI using focus groups and cognitive debriefings with patients before conducting a quantitative survey on its feasibility and acceptability. Conduction took part in an outpatient dermatology care unit in Germany. Descriptive and subgroup analyses were conducted., Results: A total of 139 patients completed the electronic PBIs (ePBIs) and took part in the survey. The ePBI was understandable (n=129-137, 92.8%-98.6%) and feasible, for example, easy to read (n=135, 97.1%) and simple to handle (n=137, 98.5%). Acceptability was also high, for example, patients can imagine using and discussing the ePBI data in practice (n=91, 65.5%) and documenting it regularly (n=88, 63.3%). They believe it could support treatment decisions (n=118, 84.9%) and improve communication with their physician (n=112, 81.3%). They can imagine filling in electronic questionnaires regularly (n=118, 84.9%), even preferring electronic over paper versions (n=113, 81.2%). Older and less educated people show less feasibility, but the latter expected the relationship with their physician to improve and would be more willing to invest time or effort., Conclusions: The app and web version of the PBI are usable and acceptable for patients offering comprehensive documentation and patient participation in practice. An implementation strategy should consider patients' needs, barriers, and facilitators but also physicians' attitudes and requirements from the health care system., (©Marina Otten, Vahid Djamei, Matthias Augustin. Originally published in JMIR Dermatology (http://derma.jmir.org), 09.08.2024.)

Background: Limited data exist on the characteristics of SARS-CoV-2 infections in German patients with psoriasis or psoriasis arthritis (PsA). This study analyses COVID-19 prevalence and severity of symptoms in these patients., Patients and Methods: Participants of the German registries PsoBest and CoronaBest were surveyed in February 2022. Descriptive analyses were conducted., Results: 4,818 patients were included in the analysis, mean age of 56.4 years. Positive SARS-CoV-2 tests were reported by 737 (15.3%) patients. The most frequently reported acute symptoms were fatigue (67.3%), cough (58.8%), and headache (58.3%). Longer-lasting symptoms after COVID-19 were reported by 231 of 737 patients after the acute phase. For most patients (92.9%), systemic treatment for their psoriasis or PsA was not modified during the pandemic. Patients positively tested for SARS-CoV-2 were younger on average and had more often changes in the therapy of psoriasis than negatively tested patients (8.5% vs. 5.4%)., Conclusions: In this cohort of patients with psoriasis or PsA undergoing systemic treatment, SARS-CoV-2 infections were common but less frequent than in the general German population. No risk signals for more severe COVID-19 or increased infection rates were observed in the patients. In addition, systemic treatments remained largely unchanged, so that no risks can be attributed to these therapies., (© 2024 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by Wiley‐VCH GmbH on behalf of Deutsche Dermatologische Gesellschaft.)

Importance: Generalized pustular psoriasis (GPP) lacks internationally accepted definitions and diagnostic criteria, impeding timely diagnosis and treatment and hindering cross-regional clinical and epidemiological study comparisons., Objective: To develop an international consensus definition and diagnostic criteria for GPP using the modified Delphi method., Evidence Review: The rarity of GPP presents a challenge in acquiring comprehensive published clinical data necessary for developing standardized definition and criteria. Instead of relying on a literature search, 43 statements that comprehensively addressed the fundamental aspects of the definitions and diagnostic criteria for GPP were formulated based on expert reviews of 64 challenging GPP cases. These statements were presented to a panel of 33 global GPP experts for voting, discussion, and refinements in 2 virtual consensus meetings. Consensus during voting was defined as at least 80% agreement; the definition and diagnostic criteria were accepted by all panelists after voting and in-depth discussion., Findings: In the first and second modified Delphi round, 30 (91%) and 25 (76%) experts participated. In the initial Delphi round, consensus was achieved for 53% of the statements, leading to the approval of 23 statements that were utilized to develop the proposed definitions and diagnostic criteria for GPP. During the second Delphi round, the final definition established was, "Generalized Pustular Psoriasis is a systemic inflammatory disease characterized by cutaneous erythema and macroscopically visible sterile pustules." It can occur with or without systemic symptoms, other psoriasis types, and laboratory abnormalities. GPP may manifest as an acute form with widespread pustules or a subacute variant with an annular phenotype. The identified essential criterion was, "Macroscopically visible sterile pustules on erythematous base and not restricted to the acral region or within psoriatic plaques.", Conclusions and Relevance: The achievement of international consensus on the definition and diagnostic criteria for GPP underscores the importance of collaboration, innovative methodology, and expert engagement to address rare diseases. Although further validation is needed, these criteria can serve as a reference point for clinicians, researchers, and patients, which may contribute to more accurate diagnosis and improved management of GPP.

Background: Topical agents are an essential component of psoriasis therapy., Objectives: To develop a new version of the patient-reported Patient Benefit Index assessing the importance and achievement of treatment goals in topical psoriasis therapy in adult patients (PBI-TOP)., Methods: Through semi-structured interviews, focus groups and free-text questionnaires, patients reported their needs in topical treatment. Based on qualitative content analysis, items were developed by a consensus group and were refined in cognitive debriefing interviews. A pilot validation assessed the PBI-TOP and convergent criteria [Dermatology Life Quality Index (DLQI); Psoriasis Area and Severity Index (PASI); affected Body Surface Area (BSA)]., Results: Thirty patients (26-72 years, mean 47; 60% male) reported various treatment goals relating to the themes 'effectiveness' and 'characteristics of the preparation'. Twenty patients took part in cognitive debriefings (22-84 years, mean 50.6, 50% male). There were 154 patients who participated in the pilot validation (18-85 years, mean 46.9, 63.6% male). An importance-weighted total score on overall effectiveness and three subscales based on exploratory factor analysis were defined: effectiveness on symptoms, effectiveness on quality of life (QoL), and characteristics of the preparation. All scores showed excellent internal consistency (α > 0.9). The global effectiveness score correlated significantly with DLQI (r = -0.41), PASI (r = -0.32) and BSA (r = -0.22). The effectiveness subscales (symptoms; QoL) correlated significantly with DLQI (r = -0.41; -0.32) and PASI (r = -0.27; -0.33). The score on characteristics of the preparation correlated significantly with the DLQI (r = -0.34)., Conclusions: The PBI-TOP showed good feasibility and favourable psychometric characteristics in this pilot validation., Competing Interests: Conflicts of interest C.B. has received speaker honoraria, research grants and/or awards from Amgen/Celgene, AstraZeneca, Bauerfeind, Hartmann, Helios Klinik Leisnig, Janssen-Cilag, Kreussler, Lilly, Mapi Group, medi, Pfizer, Stiefel Laboratories, The EuroQol Group and Urgo. M.A. has served as a consultant, or has been a paid speaker, or has received institutional grants for studies sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Abbvie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer and UCB Pharma; he is license holder of the Patient Benefit index., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

There are regional differences in the prevalence of psoriasis between countries, as well as within countries. However, regional determinants of differences in prevalence are not yet understood. The aim of this study was to identify sociodemographic and environmental determinants of regional prevalence rates for psoriasis. Analyses were based on German outpatient billing data from statutory health insurance, together with data from databases on sociodemographic and environment factors at the county level (N = 402) for 2015-2017. Descriptive statistics were calculated for all variables. To identify determinants for prevalence at the county level, spatiotemporal regression analysis was performed, with prevalence as the dependent variable, and the number of physicians, mean age, mean precipitation, sunshine hours, mean temperature, level of urbanity, and the German Index of Socioeconomic Deprivation (GISD) as independent variables. Mean prevalence of psoriasis increased from 168.63 per 10,000 in 2015 to 173.54 per 10,000 in 2017 for Germany as a whole, with high regional variation. Five determinants were detected (p < 0.05). The prevalence increased by 4.18 per 10,000 persons with SHI with each GISD unit, and by 3.76 per 10,000 with each year increase in age. Each additional hour of sunshine resulted in a decrease of 0.04 and each °C increase in mean temperature resulted in an increase of 4.22. Each additional dermatologist per 10,000 inhabitants resulted in a decrease of 0.07. In conclusion, sociodemographic and environmental factors result in significant differences in prevalence of psoriasis, even within-country.

Psoriasis causes detriment in a person's physical, mental and social health which impairs their quality of life (QoL). However, the current psoriasis management may not adequately address all relevant health domains. Since the goal of healthcare is to restore or maintain health, health outcomes should include all areas of the patient's overall health. Life satisfaction, QoL and patient well-being are essential to a comprehensive approach to the disease. With the inclusion of more people-centred policies, care of patients with psoriasis should evolve towards a holistic and integrated assessment of the disease impact, including subjective measures of well-being in order to encompass all aspects of health. The main objective of this expert review is to give the concept of well-being a place as an entity within the holistic therapeutic approach for patients with psoriasis. Identifying and defining common goals beyond the skin with the patient and testing them throughout the course of treatment will benefit and enhance treatment success. We propose a series of recommendations for application in clinical practice, providing tangible clinical guidance for implementing well-being in the management of psoriasis. Among the recommendations are the need to initially listen to the patient, to know their level of empowerment or what they want to achieve, their preferences in decision making, the evaluation of not only the physical but also the emotional impact of the disease (well-being), the definition of the aspects that can generate a cumulative deterioration of the disease throughout life, and a continuous assessment of the patient's preferences with the opinion of the expert clinician and the integration of the knowledge of external clinical evidence., (© 2023 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background and Objectives: Few studies are available on the epidemiology of psoriasis and psoriatic arthritis in Germany. The aim of this study was to estimate this prevalence based on different case definitions., Methods: Statutory health insurance (SHI) data were examined (2017 to 2019). Prevalence was analyzed and validated using three different case definitions: (1) At least one inpatient or outpatient diagnosis within one year, (2) additionally at least two outpatient diagnoses within one year, (3) additionally within three years., Results: The administrative prevalence of psoriasis including psoriatic arthritis ranged from 1.90% to 2.51%. For all case definitions, the prevalence increased with age, decreasing from the age of 70 with psoriasis and from the age of 65 with psoriatic arthritis. Males were more likely to be affected at an older age (p <0.0001), while in the under-20 age group, more girls were affected (p  =  0.04)., Conclusions: Psoriasis is a common skin disease in Germany. The internal diagnoses validation showed that in future studies with claims data, the narrow and broad criteria should be used to identify patients with psoriasis, depending on the research question., (© 2023 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by Wiley-VCH GmbH on behalf of Deutsche Dermatologische Gesellschaft.)

Digital health interventions (DHI) potentially improve the efficiency and effectiveness of dermatological care. Currently, an overview clustering and characterizing the evidence on DHIs is missing. This systematic mapping of the literature aims to analyse published research on DHIs in dermatology to identify trends and gaps in research. For this purpose, a systematic search of the MEDLINE database was conducted in August 2022 to identify original publications on DHIs in dermatology. Data on country, targeted audience, DHI category, indication, outcome parameter and study design were extracted. Out of 12,009 records identified in MEDLINE, 403 studies were included in the final analysis. Studies on DHIs mainly performed in western countries, headed by the United States (n = 133), Germany (n = 32) and Spain (n = 23). Of all identified DHIs, 261 targeted healthcare providers (HCP), 66 clients (e.g. patients, caregivers, healthy individuals) and 67 both clients and HCPs. A majority of DHIs focussed on establishing a diagnosis (n = 254). Every other study analysed store-and-forward teledermatology (n = 187), followed by artificial intelligence applications for image analysis (n = 65). The most often analysed DHI category for clients was a support of health behaviour change (n = 31). Monitoring of clients was targeted by 77 studies. Skin cancer (n = 148), wounds (n = 29) and psoriasis (n = 29) were the most targeted indications by DHIs. Most studies analysed diagnostic performance (n = 166), fewer studies analysed acceptance (n = 92) and effectiveness (n = 98). Usability (n = 32) and efficiency (n = 36) were investigated only to a small extent. Studies on DHIs in dermatology have focused on teledermatology and AI applications, with an emphasis on skin cancer diagnosis. Apart from that, a range of DHIs for different user groups, purposes and indications were identified, demonstrating the broad potential for DHIs in dermatology. Further research with a wider set of outcome parameters is needed to fully understand the potential of DHIs and ensure their sustainable implementation into dermatological care., (© 2023 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system., Objectives and Methods: A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8., Results: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated., Conclusion: CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience., (© 2023 MC2 Therapeutics and University Hospital Frankfurt am Main. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Enhanced treatment options for psoriasis and growing use of guidelines increased the potential to better quality of psoriasis care in Europe. The aim of the PsoBarrier EU study is to compare the quality and processes of psoriasis care in four European countries with different healthcare systems, based on validated quality indicators. This cross-sectional survey was conducted in dermatology centres in Denmark, Germany, Poland and Spain on 1,304 patients, using standardized patient and physician questionnaires. Measured by quality of psoriasis care indicators, patients in Poland had the most critical outcomes, such as the highest disease severity (Psoriasis Area and Severity Index; PASI) and lowest health-related quality of life (Dermatology Life Quality Index; DLQI). This indicates differences in psoriasis care, with Polish participants experiencing more severe psoriasis and its consequences. Differences in the healthcare systems, which create barriers to accessing treatments, could explain variations in quality of care.

The impact of dermatological diseases goes beyond symptoms and often includes psychosocial burden. Self-stigmatization plays a key role in this relationship and was compared in patients with psoriasis and atopic dermatitis to evaluate the validity of cross-disease stigmatization models. In total, 101 patients per indication were included in this cross-sectional study. Besides sociodemographic and clinical data, patient-reported outcome measures relating to self-stigmatization, depression, anxiety, and quality of life were compared across groups. Sociodemographic and clinical factors were tested for their moderating effects between self-stigmatization and quality of life. Group mean comparisons yielded no significant differences in self-stigmatization between patient groups. In both diseases, self-stigmatization significantly predicted depression and anxiety symptoms as well as quality of life. Current symptoms, not having close social relationships, and lower age predicted self-stigma in patients with psoriasis, whereas the involvement of sensitive body areas, the sum of previous treatments, and female sex were predictors in patients with atopic dermatitis. In both groups, symptoms had significantly moderating effects. The results underline the relevance of self-stigmatization in patients with chronic skin diseases. Awareness should be raised, screening implemented, and psychosocial support offered early on. Assessments, conceptual models of self-stigma, and interventions are probably applicable for both diseases.

Background and Objective: Demographic change confers significance to healthcare management of chronic diseases like psoriasis. There are few studies on the care of older people with psoriasis, particularly for the nursing home setting. It was investigated whether the number of psoriasis patients with specialist contact changes before vs. after nursing home admission., Material and Methods: We analyzed claims data of a German health insurance company including a cohort of newly admitted nursing home residents aged 65 years and older between 2011 and 2014, who received a diagnosis of psoriasis 1 year before nursing home admission. Outpatient care was compared between the years before vs. after nursing home admission. We conducted a multivariate regression analysis for identifying predictors for dermatological care., Results: The study cohort included 718 insured persons (Ø83 years). Proportion of patients who had contact to a dermatologist significantly decreased after nursing home entry (44.6% before vs. 40.1% after nursing home entry). Strongest predictors for dermatological care after entry were a previously existing dermatological contact (odds ratio, OR 3.87, 95% confidence interval, CI 2.70-5.54) and prescription for topical steroids (OR 1.61, 95% CI 1.14-2.28)., Conclusion: The analysis of health insurance data showed a pertinent decrease in the use of outpatient dermatological care after institutionalization. The evaluation of the adequacy of care is difficult due to the used database without clinical information. As long as no further investigations of this vulnerable patient group are available, the care of psoriasis patients of old age should be closely monitored. Dermatological knowledge of the skin in old age is an essential prerequisite for this., (© 2022. The Author(s).)

Introduction: Psoriasis is a chronic inflammatory skin disease that negatively impacts the quality of life of patients and their families. However, the most commonly used decision-making tools in psoriasis, Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), do not fully capture the impact of psoriasis on patients' lives. In contrast, the well-established 5-item WHO Well-being Index (WHO-5) assesses the subjective psychological well-being of patients. Moreover, while drug innovations became available for psoriasis, data on the impact of these therapies on patients' lives and their closest environment (family, physicians) are limited. This study will assess the effect of tildrakizumab, an interleukin-23p19 inhibitor, on the overall well-being of patients with moderate-to-severe psoriasis. Moreover, the long-term benefit of tildrakizumab on physicians' satisfaction and partners' lives of patients with psoriasis will be evaluated., Methods and Analysis: This non-interventional, prospective, observational, real-world evidence study will involve multiple sites in Europe and approximately 500 adults with moderate-to-severe psoriasis treated with tildrakizumab. Each patient will be followed for 24 months. The primary endpoint is well-being measured by the WHO-5 questionnaire. Key secondary endpoints include Physician's Satisfaction and partner's quality of life (FamilyPso). Other endpoints will evaluate skin-generic quality of life (DLQI-R), Treatment Satisfaction Questionnaire for Medication (TSQM-9), Treatment-related Patient Benefit Index 'Standard', 10 items (PBI-S-10) and work productivity and activity impairment due to psoriasis (WPAI:PSO). Statistical analyses will be based on observed cases. Multiple imputations will be performed as a sensitivity analysis, and adverse events will be reported., Ethics and Dissemination: The study will be conducted according to the protocol, which received ethics committee approval and applicable regulatory requirements of each participating country. The results will be disseminated through scientific publications and congress presentations., Trail Registration Number: ClinicalTrials.gov Identifier: NCT04823247 (Pre-results)., Competing Interests: Competing interests: MA has served as consultant for, or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Abbvie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli-Lilly, GSK, Janssen-Cilag, Leo Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB and Xenoport. RS has been an advisor and/or received speaker honoraria and/or received grants from AbbVie, Almirall, Beiersdorf, Janssen, LEO Pharma and Novartis. ED has the following conflict of interests: Advisory Board member, consultant, grants, research support, participation in clinical trials, honorarium for speaking, research support, with the following pharmaceutical companies: Abbvie/Abbott, Almirall, Amgen, Janssen-Cilag, Leo Pharma, Novartis, Pfizer, MSD-Schering-Plough, Celgene, Lilly and UCB. PL received honoraria and/or grants as an investigator, speaker, and/or advisory board member for AbbVie, Almirall, Actelion, Celgene, Janssen, Lilly, Sanofi, Leo, UCB, and Novartis. EdJ has received research grants for the independent research fund of the department of dermatology of the Radboud University Medical Center Nijmegen, The Netherlands from AbbVie, Leo Pharma, Janssen Pharmaceuticals, Novartis, Pfizer, and UCB and has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Almirall, Celgene, Galapagos, Janssen Pharmaceutica, Leo Pharma, Lilly, Novartis, Sanofi and UCB. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboud University Medical Center Nijmegen (Radboudumc), The Netherlands. GF has acted as speaker and consultant for AbbVie, Almirall, Eli Lilly, Leo Pharma, Janssen, Novartis and UCB. LN received consultation fees from Abbvie, Amgen, Boehringer Inghelheim, Celgene, Eli Lilly, IBSA, Menarini, Janssen, Novartis, and Sanofi. AN declares being a consultant and advisor and/or receiving speaking fees and/or grants and/or served as an investigator in clinical trials for AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GSK, LEO Pharma, Janssen-Cilag, MSD, Novartis, Pfizer, Sandoz, Sanofi, Serono and UCB. JL has been a speaker/advisor for and her institution received grants from AbbVie, Almirall, Argenx, BMS, Celgene, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer and UCB. ZR has been an advisor, investigator, and/or speaker for Novartis, Janssen-Cilag, Lilly, eo-Pharma, Celgene, Pfizer, UCB, Amgen, Almirall, MSD, and MEDAC. SG has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: AbbVie, Affibody AB, Akari Therapeutics Plc, Almirall-Hermal, Amgen, Anaptys Bio, Argenx BV, AstraZeneca AB, Biogen Idec, Bioskin, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly, Forward Pharma, Galderma, Hexal AG, Incyte Inc, Janssen-Cilag, Johnson & Johnson, Kymab, Leo Pharma, Medac, MSD, Neubourg Skin Care GmbH, Novartis, Pfizer, Principia Biopharma, Regeneron Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi-Aventis, Trevi Therapeutics and UCB Pharma. EM and IK are employees of Almirall. TO has served as medical advisor for Almirall. UM has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: AbbVie, Aditxt, Almirall, Amgen, Aristea, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Dr Reddy’s, Eli Lilly, Foamix, Formycon, Immunic, Janssen, LEO Pharma, Medac, MetrioPharm, Novartis, Phi-Stone, Pierre Fabre, Sanofi-Aventis and UCB Pharma., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction/background: Manifestations of psoriasis in special areas are difficult to treat and are associated with a high disease burden and significant quality of life (QoL) impairment. Topical therapies may be inadequate for these patients, necessitating systemic treatment., Objective: The objective of EMBRACE was to evaluate the impact on QoL, efficacy and safety of apremilast 30 mg BID in patients with limited skin involvement with plaque psoriasis manifestations in special areas and impaired QoL., Methods: EMBRACE (NCT03774875) was a phase 4, randomized, placebo-controlled, multinational study. Patients had plaque psoriasis not controlled by topical therapy; lack of response, contraindication or intolerance to conventional first-line systemic therapy; psoriasis in ≥1 special area (including visible locations, scalp, nails, genital areas or palmoplantar areas); Psoriasis Area and Severity Index (PASI) ≥3 to ≤10; and Dermatology Life Quality Index (DLQI) >10. The primary endpoint was DLQI response (≥4-point reduction) at Week 16., Results: Of 277 randomized patients (apremilast: n = 185; placebo: n = 92), 221 completed Week 16 (apremilast: n = 152; placebo: n = 69). The primary endpoint (≥4-point reduction in DLQI at Week 16) was met by significantly more patients receiving apremilast (73.3%) versus placebo (41.3%; p < 0.0001). Significantly greater improvement in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremilast versus placebo in itch numeric rating scale (-2.5 vs. -0.9, p < 0.0001) and skin discomfort/pain visual analog scale (-21.5 vs. -5.4, p = 0.0003) and greater achievement of Patient Benefit Index ≥1 (77% vs. 40%, p < 0.0001) at Week 16. No new safety signals were observed., Conclusions: Apremilast significantly improved skin-related QoL in patients with limited skin involvement with plaque psoriasis in special areas and highly impaired QoL. The safety profile was consistent with prior apremilast studies., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30 th European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS. CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/TS with no adverse drug reactions with a frequency >1%. In the NCT03308799 study, CAL/BDP cream demonstrated a substantial improvement in the proportion of participants achieving a minimum 4-point improvement on the peak pruritus numeric rating scale (NRS) score compared with vehicle at Weeks 1, 4 and 8. CAL/BDP cream also improved quality of life (QoL), as assessed through the Dermatology Life Quality Index (DLQI), and the EQ-VAS at Week 8 compared with active comparator. Treatment convenience of CAL/BDP cream, as measured by the Psoriasis Treatment Convenience Scale, was superior to CAL/BDP gel/TS at all studied timepoints, including questions addressing formulation's greasiness and overall treatment satisfaction. Finally, an indirect comparison following the Bucher's method of adjusted indirect comparison and the difference-in-differences method was conducted to compare CAL/BDP cream and CAL/BDP foam, as both therapies have been compared to CAL/BDP gel/TS. Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains., (© 2022 European Academy of Dermatology and Venereology.)

Background: Patients' understanding of the systemic nature of psoriatic disease (PsD) remains insufficiently explored., Objectives: The objective of this study was to assess patients' understanding of PsD, associated comorbidities, disease burden, and relationships with healthcare professionals (HCPs)., Methods: Psoriasis and Beyond was a cross-sectional, quantitative online survey conducted in patients with a self-reported, physician-given diagnosis of moderate to severe psoriasis (body surface area [BSA] &gt;5% to &lt;10%, affecting sensitive and/or prominent body parts or BSA ≥10%) at its worst, with/without psoriatic arthritis (PsA). Patients were recruited through online panels by the Institut de Publique Sondage d'Opinion Secteur (Ipsos SA) and patient advocacy groups., Results: Overall, 4,978 respondents with psoriasis completed the online survey from 20 countries across Australia, Asia, Europe, and the Americas; 30% of patients also reported having concomitant PsA. Overall, 69% of patients with psoriasis had heard that their disease was part of a systemic disease, and 60% had heard of the term "psoriatic disease." Despite this, recognition of common manifestations and comorbidities associated with PsD was low. Among psoriasis-only patients (n = 3,490), 38% screened positive using the Psoriasis Epidemiology Screening Tool (PEST), indicative of potential PsA. Overall, 48% of patients reported that their disease had a very large to extremely large effect on quality of life (QoL; Dermatology Life Quality Index [DLQI] score, 11-30); only 13% of patients reported no impact of the disease on QoL (DLQI, 0-1). Most patients had experienced stigma and discrimination (82%) and a negative impact on relationships (81%) in their lives. Overall, 59% of patients were not involved in deciding their treatment goals: 58% of all treated patients (n = 4,757) and 64% of treated patients with concomitant PsA (n = 1,409) were satisfied with their current treatment., Conclusions: These results highlight that patients may not fully understand the systemic nature of their disease, were frequently uninvolved in deciding treatment goals, and were often not satisfied with their current treatment. Increasing patients' participation in their care can facilitate shared decision-making between patients and HCPs, which may result in better treatment adherence and patient outcomes. Furthermore, these data indicate that policies should be implemented to protect against stigma and discrimination, which are commonly experienced by patients with psoriasis., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Background: Interleukin-23 inhibitors are effective and safe for treating moderate-to-severe plaque psoriasis., Objectives: To evaluate the efficacy and safety of mirikizumab in adult patients with moderate-to-severe plaque psoriasis through 52 weeks in a phase III randomized controlled trial., Methods: OASIS-1 (NCT03482011) was a double-blind, placebo-controlled, randomized withdrawal, phase III trial. Patients (n = 530, randomized 4 : 1) received subcutaneous mirikizumab 250 mg or placebo every 4 weeks (Q4W) through week 16. Coprimary endpoints were superiority of mirikizumab vs. placebo on static Physician's Global Assessment (sPGA; score of 0 or 1 with ≥ 2-point improvement) and ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90, responders) at week 16. Mirikizumab responders were rerandomized (1 : 1 : 1) to mirikizumab 250 mg every 8 weeks (Q8W), mirikizumab 125 mg Q8W, or placebo Q8W through week 52. Secondary endpoints were evaluated at weeks 16 and 52. Safety was monitored in all patients., Results: All primary and key secondary endpoints were met. At week 16, sPGA(0,1) responses were significantly greater with mirikizumab (293 of 423, 69·3%) than placebo (seven of 107, 6·5%) (P < 0·001). PASI 90 response was also greater with mirikizumab (272 of 423, 64·3%) than placebo (seven of 107, 6·5%) (P < 0·001). Significantly more patients in the mirikizumab arms achieved PASI 75 and PASI 100 (mirikizumab 349, 82·5% and 137, 32·4%; placebo 10, 9·3% and 1, 0·9%, respectively; all P < 0·001). At week 52, PASI 90, PASI 100 and sPGA(0,1) responses were mirikizumab 250Q4W/placeboQ8W (N = 91; 19%, 10%, 18%), mirikizumab 250Q4W/125Q8W (N = 90; 86%, 59%, 86%) and mirikizumab 250Q4W/250Q8W (N = 91; 86%, 60%, 82%; all P < 0·001), respectively. Rates of serious adverse events were similar across treatments (induction: mirikizumab 1·2% vs. placebo 1·9%; maintenance: mirikizumab 250Q4W/125Q8W 1%, mirikizumab 250Q4W/250Q8W 3% vs. placebo 3%). No deaths occurred., Conclusions: Mirikizumab was superior to placebo at week 16 and maintained efficacy through week 52, with no new safety signals. What is already known about this topic? Interleukin (IL)-23 is a key cytokine in the pathogenesis of psoriasis. Drugs targeting the p19 subunit of IL-23 have recently been approved for the treatment of adult patients with moderate-to-severe plaque psoriasis. Patients with moderate-to-severe plaque psoriasis achieved significantly greater improvements in skin measures and patient-reported quality-of-life measures after 16 weeks when treated every 8 weeks with mirikizumab compared with placebo in a phase II clinical trial. What does this study add? Compared with placebo, mirikizumab demonstrated high levels of efficacy at week 16 in a large phase III trial; safety profiles were similar between the mirikizumab and placebo arms. After week 16, patients maintained on doses of mirikizumab 250 mg every 8 weeks (Q8W) or 125 mg Q8W showed similar efficacy and favourable safety profiles over 52 weeks, whereas patients switched to placebo gradually lost efficacy over time., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Objectives: Fumaric acid esters (FAEs) are a well-established treatment option for long-term therapy of moderate to severe plaque psoriasis. This study examines effectiveness of FAEs for the treatment of plaque psoriasis in real-world practice at 12 months and if patient characteristics affect the odds of clinical response., Methods: A descriptive, multivariable logistic regression analysis was conducted in a cohort drawn from the German registry PsoBest. Baseline patient characteristics were assessed as potential treatment effect modifiers., Results: 444 patients (mean age 47.0 years, 39.0% female) were eligible for response analysis using nonresponder imputation at month 12. Of these, 39.6% achieved clinical response, i.e. Psoriasis Area and Severity Index (PASI) ≤ 3 or skin clearance. In logistic regression analysis ( R 2 = 0.114), only baseline PASI was a significant factor: patients with PASI < 10 had a 4 times higher odds ( p  ≤ .001, OR 4.088), patients with PASI of 10-20 a twofold higher odds of response ( p  ≤ .044, OR 1.961) compared to those with PASI > 20. Neither sex, age, body weight, disease duration, comorbidity nor pretreatment had an impact on the odds of response ( p  > .05)., Conclusions: FAEs showed a favorable response at 12 months, largely independent of patient characteristics.

Background: Randomized controlled trials of secukinumab have shown sustained efficacy and a favourable safety profile in multiple manifestations of psoriatic disease., Objectives: To assess the long-term, real-world retention, effectiveness and safety of secukinumab in routine clinical practice for the treatment of moderate-to-severe plaque-type psoriasis (PsO)., Methods: SERENA (CAIN457A3403) is a large, ongoing, longitudinal, observational study conducted at 438 sites and 19 countries for an expected duration of up to 5 years in adult patients with moderate-to-severe PsO, psoriatic arthritis and ankylosing spondylitis. Patients received ≥16 weeks of secukinumab treatment before enrolment. This interim analysis presents data from PsO patients, who were enrolled in the study between October-2016 and October-2018 and were observed for ≥2 years., Results: In total, 1756 patients (67.3% male) with a mean age of 48.4 years and body mass index of 28.8 kg/m 2 were included in the analysis. The secukinumab treatment retention rates after 1, 2 and 3 years in the study were 88.0%, 76.4% and 60.5%, respectively. Of the 648 patients who discontinued the study, the most common reasons included lack of efficacy (42.6%), adverse event (17.4%), physician decision (12.2%) and subject decision (11.6%). Mean ± SD absolute PASI was 21.0 ± 13.0 at the start of treatment (n = 1,564). At baseline, the mean ± SD PASI score reduced to 2.6 ± 4.8 and remained low at Year 1 (2.3 ± 4.3), Year 2 (1.9 ± 3.6) and Year 3 (1.9 ± 3.5). The safety profile of secukinumab during the SERENA study was consistent with its known safety profile, with no new safety signals reported. Particularly, low rates of inflammatory bowel disease (0.3%; Incidence Rate [IR]:0.15), candida infections (3.1%; IR:1.43) and MACE (0.9%; IR:0.37) were observed., Conclusions: Secukinumab showed high treatment persistence, sustained effectiveness and a favourable safety profile up to 3 years of follow-up in the real-world population of PsO patients observed in SERENA., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Objectives: While stress plays a paramount role on the onset/exacerbation of psoriasis, via overactivation of the hypothalamic-pituitary-adrenal axis and increased release of pro-inflammatory cytokines, cutaneous inflammatory response induces, in turn, anxiety/depression symptoms, via body disfigurement and stigmatisation. The intensity of pruritus and anogenital involvement are additional risk factors for psychological comorbidity.Aims were to (1) examine the effects of intensity of pruritus and anogenital psoriasis on disease burden and psychological comorbidity and (2) identify the variables associated with the presence of clinically significant depression, anxiety, and dysmorphic concerns., Design: Cross-sectional study., Setting: Conducted at the University Medical Center Hamburg-Eppendorf (UKE)., Participants: 107 patients with psoriasis (mean age = 46.3, SD = 14.6 years; 53.3% male): 64 with none/mild pruritus; 43 with moderate/severe pruritus; 31 with anogenital psoriasis; 76 not affected in the anogenital area., Primary/secondary Outcomes Measures: Disease severity was assessed with Psoriasis Area and Severity Index and intensity of pruritus was rated by patients. Patient-reported outcomes included the Dermatology Life Quality Index, ItchyQoL, Patient Benefit Index, Perceived Stigmatisation Questionnaire, and Relationship and Sexuality Scale. Psychological morbidity was assessed with the Patient Health Questionnaire, Generalised Anxiety Disorder, and Dysmorphic Concern Questionnaire., Results: Patients with moderate/severe pruritus reported more quality of life impairments, depression, anxiety and dysmorphic concerns, and less treatment benefits than those with none/mild pruritus. Moderate/severe pruritus had a deleterious effect on depression and stigmatisation for patients without anogenital involvement. Less patient benefits were associated with a higher likelihood of clinically significant depression/anxiety., Conclusion: Pruritus induces significant burden and psychological morbidity, particularly for patients without anogenital involvement. However, coping strategies used by patients with anogenital psoriasis might be dysfunctional for overall psychosocial adaptation. Patient-centred healthcare might be the best way to prevent psychological comorbidity., Ethics Approval: Ethics Committee of the Medical Association of Hamburg (process number PV6083, 28 May 2019)., Competing Interests: Competing interests: MA has served as consultant and/or paid speaker for and/or has received research grants and/or honoraria for consulting and/or scientific lectures for and/or got travel expenses reimbursed and/or participated in clinical trials sponsored by LEO Pharma. RS has received speaker and/or research honoraria and/or travel expenses by LEO Pharma., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Demographic changes are causing a rapid increase in the number of people over 65 years of age. This is associated with an increase in the number of multimorbid patients in need of care. Nationally as well as internationally, there is little information on the treatment of psoriasis patients in the nursing home setting and on the question of how this is influenced by entry into a nursing home., Objective: The aim was to discuss the results of previous routine data analyses on the treatment of psoriasis patients in nursing homes with medical providers (dermatologists, general practitioners, nursing service managers, and nursing staff) on the basis of interviews and focus groups, to identify difficulties in the treatment and finally to derive recommendations for action regarding sustainable gerontodermatological treatment., Materials and Methods: Qualitative guideline-based interviews and focus groups with dermatologists (n = 5), general practitioners (GPs, n = 7), nurses (n = 7), and care managers (n = 2) were conducted. The data were evaluated by content analysis., Results: The analyses resulted in 344 statements, which could be categorized into 14 main topics. The results show that there is a need for improvement in the quality of care for people with skin diseases, especially psoriasis, in nursing homes. This is evident at both the medical and nursing levels. According to the providers (N = 21), this can be addressed in particular through increased remote consultations (telemedicine), dermatological training for GPs and nurses, and closer cooperation between the individual disciplines., Conclusion: Remote consultations, but also a specific guideline on the "skin of the ageing person" can be useful to improve the dermatological care situation in nursing homes and thus increase the well-being of those affected., (© 2022. The Author(s).)

Background: The quality of dermatology consultations is partly determined by how clinicians approach patient care. The term 'Personal Models' describes the explanatory frameworks of thoughts, feelings and experiences that drive behaviour. One study found that clinicians' personal models, specifically their beliefs about autonomy and patient self-management, influenced the degree to which clinicians engage patients in shared decision making during consultations. Further research is needed to further explore how clinicians' personal models inform and affect the quality of patient care., Objectives: To explore how clinicians' personal models inform shared decision making and consultation style in managing people living with psoriasis in the context of a new treatment, Apremilast., Methods: A framework analysis of qualitative semi-structured telephone interviews with 13 dermatologists from the UK and Germany who participated in a novel medicine trial for psoriasis called APPRECIATE., Results: Two themes were derived from the data. Theme 1, 'personal working models of patient care', comprised two subthemes: 'patient-centredness: a continuum' and 'stereotypes and assumptions'. Theme 2, 'impact of personal working models on patient care', included three subthemes: 'shared decision making: a continuum', 'consultation skills' and 'impact of concerns about Apremilast on prescribing behaviour'., Conclusions: Although many dermatologists endorsed a patient-centred approach, not all reported working in this way. Clinicians' personal models, their beliefs, stereotypes, personal perceptions and assumptions about patients are likely to affect their prescribing behaviour and shared decision making. Additional specialized training and education could increase patient-centredness and whole-person management., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Background: Obesity is a common comorbidity of psoriasis and can attenuate response to biologic treatment., Objectives: To investigate the efficacy, safety and tolerability of secukinumab 300 mg every 2 weeks (Q2W) vs. secukinumab 300 mg every 4 weeks (Q4W) in patients with a higher bodyweight., Methods: In this multicentre, double-blind, parallel-group trial, 331 patients with moderate-to-severe chronic plaque psoriasis weighing ≥ 90 kg were randomized to receive secukinumab 300 mg Q2W or secukinumab 300 mg Q4W. Patients who did not achieve Psoriasis Area and Severity Index (PASI) 90 at week 16 on the Q4W regimen were reallocated to remain on the Q4W regimen or uptitrate to Q2W., Results: At week 16, Q2W dosing (n = 165) led to significantly higher PASI 90 responses vs. Q4W [n = 166; 73.2% vs. 55.5%, one-sided P-value = 0.0003, odds ratio estimate (95% confidence intervals): 2.3 (1.4-3.8)]. At week 52, higher efficacy responses were maintained in the Q2W arm (n = 165) vs. Q4W (n = 83); PASI 75: 88.9% vs. 74.8%; PASI 90: 76.4% vs. 52.4%; PASI 100: 46.7% vs. 27.3%; Investigator's Global Assessment 0/1: 75.9% vs. 55.6% and Dermatology Life Quality Index 0/1: 66.1% vs. 48.8%. PASI 90 nonresponders at week 16 who uptitrated to Q2W (n = 31) showed higher efficacy responses at week 32 (16 weeks post-uptitration, PASI 90: 38.7% vs. 16.5%) vs. those who remained on Q4W (n = 40). Safety results were comparable across treatment arms and consistent with the established secukinumab safety profile., Conclusions: Secukinumab 300 mg Q2W demonstrated superior and sustained efficacy compared with Q4W in patients with moderate-to-severe plaque psoriasis weighing ≥ 90 kg. PASI 90 nonresponders derived additional benefits from uptitration to a Q2W regimen (ClinicalTrials.gov identifier: NCT03504852). What is already known about this topic? Obesity is a common comorbidity of psoriasis and can attenuate response to biologic treatment. Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin-17A in the treatment of moderate-to-severe plaque psoriasis. Subgroup analyses of previous study results and pharmacokinetic/pharmacodynamic modelling data suggest that heavier patients may benefit from higher exposure to secukinumab through an increased dosing frequency [300 mg every 2 weeks (Q2W) vs. every 4 weeks (Q4W)]. What does this study add? Over 52 weeks, secukinumab 300 mg Q2W demonstrated superior efficacy compared with secukinumab 300 mg Q4W in patients with moderate-to-severe plaque psoriasis weighing ≥90 kg, with comparable safety results, consistent with the established secukinumab safety profile. In patients who did not achieve PASI 90 at week 16 on the Q4W regimen, uptitration to the Q2W regimen at week 16 resulted in improved efficacy responses through week 52 after switching., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Generalized pustular psoriasis (GPP) is a rare, severe, potentially life-threatening, autoinflammatory, neutrophilic skin disease that may be accompanied by fever and leukocytosis. This paper describes the current state of knowledge on GPP in terms of classification, (differential) diagnosis and prevalence. We present a comparison of the genetics and pathoimmunology of GPP and psoriasis vulgaris with the central mechanisms of autoimmunology and autoinflammation. The currently available therapeutic options, expert recommendations for therapy, and data from early clinical trials investigating targeted therapies will be summarized. We present the results of our discussion with 13 experts for psoriasis vulgaris and GPP and give an integrated overview of indication and therapy based on our personal experience and present an outlook on further research questions. Collectively, this article highlights the high unmet need in GPP, as there exists no satisfactory method of diagnosis or treatment to date and new treatment options will be of great therapeutic benefit to those affected., (© 2022 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.)

Background: Biologic psoriasis treatments are differentiated by efficacy, side effects, and other attributes., Objective: Determine attributes of biologic psoriasis treatments that drive patients' treatment choices., Methods: Respondents (USA: n  = 300; Germany: n  = 300) with moderate-to-severe psoriasis completed a discrete-choice-experiment survey, choosing between hypothetical treatments characterized by attributes with varying levels: chance of clear skin after 1 year, number of first-year treatments, first-year risks of mild-to-moderate injection site reaction (ISR) and serious infection, and years of proven efficacy/safety., Results: U.S. respondents most valued clear skin (conditional relative importance, 1.88; p  < .05). While other attributes were of generally equivalent importance, ISR risk outweighed serious-infection risk (1.06 vs. 0.70; p  < .05). German respondents placed greatest importance on ISR risk (1.61; p  < .05) and clear skin (1.49; p  < .05)., Limitations: Respondents evaluated hypothetical treatments and were recruited from web panels., Conclusions: Clear skin and ISR risk are stronger drivers of treatment choice than injection frequency and infection risk.

Background: Rosacea is a common chronic skin condition, but data on its epidemiology and related comorbidities are scarce., Objectives: To analyze the prevalence and associated cutaneous comorbidities of rosacea in Germany., Methods: Voluntary dermatological full-body examinations were conducted between 2001 and 2016 in more than 500 German companies by experienced dermatologists and documented electronically. Point-prevalence rates were calculated, and associations were tested with chi-squared tests and logistic regression analysis., Results: A total of 161,269 participants (mean age was 43.2 ± 10.9 years; 55.5% male) were included; 2.1% had rosacea (men: 2.1%, women 2.1%, mean age 50.7 ± 9.3 years). The prevalence of rosacea increased significantly with age (16-29 years: 0.3%; 30-39 years: 0.9%; 40-49 years: 2.0%; 50-59 years: 3.5%; 60-70 years: 5.7%). Furthermore, there was a significant decreasing prevalence from skin type I toward type IV (skin type I: 3.2%; II: 2.2%; III: 1.5%; IV: 0.4%). The most frequent dermatological comorbidities were: telangiectasia (OR = 2.5), folliculitis (OR = 1.8), seborrheic dermatitis (OR = 1.6), acne (OR = 1.6), tinea pedis (OR = 1.4), psoriasis (OR = 1.4), spider veins (OR = 1.1), and hemangioma (OR = 1.1)., Conclusions: Rosacea is a common skin condition that is most prevalent above the age of 65 years. Rosacea patients have an increased risk for associated comorbidities. Therefore, the diagnostic and therapeutic process for rosacea patients must ensure an integrated, complete dermatological approach in terms of medical care., (© 2021 The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

The aim of this work was to systematically collect all previously published population-based epidemiological data on skin diseases in Germany. The present part 2 of the publication series deals with non-infectious skin diseases. The results on cutaneous tumor diseases (part 1) and infectious skin diseases (part 3) form the other parts of this publication series. A systematic literature search was performed using PubMed/MEDLINE for the period of the last 15 years. With the aim of including all dermatologic diseases, a diagnostic list was developed based on the ICD-11 catalogue. This list included 1,347 skin diseases and formed the basis for the search. The literature search yielded 4,650 hits, of which 72 were included in the synthesis. Among them were 37 publications on non-infectious skin diseases. Among these, psoriasis and atopic eczema were the most common. The highest lifetime prevalence was found for acne. This work is the first systematic literature review that aimed to report all available epidemiological data on skin diseases in Germany. It was found that representative data on many non-infectious diseases are not yet available. Among the included studies, there was a high heterogeneity regarding the methodology. Nevertheless, the utility of these epidemiological data is wide-ranging and can serve as a reference of various epidemiological questions., (© 2022 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by John Wiley & Sons Ltd on behalf of Deutsche Dermatologische Gesellschaft.)

Psoriasis is a chronic disease with high impact on patients' health and their quality of life. Psoriasis often occurs along with other comorbidities, but it is not yet clear what role the comorbidities play in regional psoriasis prevalence. This study investigates the temporal and regional variation of the psoriasis comorbidities diabetes mellitus type II, obesity, hypertension, affective disorders in Germany and their association with psoriasis prevalence. This analysis based on the population set of ambulatory claims data (2010-2017) of the statutory health insurance (SHI) in Germany (approx. 70.3 million people in 2017). Psoriasis comorbidities rates were determined on county level. We performed descriptive spatiotemporal analyses of psoriasis comorbidity prevalence rates. In addition, we identified and compared spatial clusters and examined regional variations using spatial statistical methods. The results show strong regional variations (northeast to south gradient) and an increasing psoriasis prevalence (max. 28.8%) within the observation period. Considering the comorbidities, results indicate comparable spatial prevalence patterns for diabetes mellitus type II, obesity and hypertension. This means that the highest prevalence of comorbidities tends to be found where the psoriasis prevalence is highest. The spatiotemporal cluster analyses could once again confirm the results. An exception to this is to be found in the case of affective disorders with different spatial patterns. The results of the studies show the first spatiotemporal association between psoriasis prevalence and comorbidities in Germany. The causalities must be investigated in more detail in order to be able to derive measures for improved care., Competing Interests: The authors have declared that no competing interests exist.

Background: Physician-reported clinical outcome and quality of life (QoL) measures are currently used to assess outcomes and direct treatment of plaque psoriasis. However, people with psoriasis may have different criteria for judging treatment success., Objectives: To build a unified consensus on the definition of 'freedom from disease' from a European stakeholder group, including people with psoriasis, dermatologists and nurses., Methods: The modified Delphi consensus methodology was used to define 'freedom from disease', with a consensus group consisting of people with psoriasis, nurses and dermatologists. This methodology involved people with psoriasis during the entire process and consisted of a 15-member Facilitating Consensus Panel to drive the programme content and a larger Voting Consensus Panel to vote on defining 'freedom from disease'. The Facilitating Panel agreed on disease domains, and aspects of each domain were put forward to the Voting Consensus Panel to establish relative importance. Following two voting rounds, a meeting was held to agree on a final consensus statement., Results: The Facilitating Panel consisted of six patient advocacy group representatives, three specialist nurses and six dermatologists. Voting rounds 1 and 2 were completed by 166 and 130 respondents from the Voting Consensus Panel, respectively. The outputs from both rounds of voting were similar, focusing on normality of living, symptom control, and a relationship of mutual respect and trust between the individual with psoriasis and their healthcare professional. The consensus statement emphasizes that 'freedom from disease' is multifaceted and includes the following domains 'management of clinical symptoms', 'psychosocial elements', 'QoL and well-being', 'treatment' and 'healthcare team support'. 'Freedom from disease' means all aspects are addressed., Conclusions: Freedom from disease in psoriasis is a multicomponent concept including five main domains. This diverse and multifaceted patient perspective will help us to improve understanding of the outcomes of treatment interventions in people with psoriasis., (© 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background: The fully human monoclonal antibody guselkumab is an effective treatment option for patients with moderate to severe psoriasis., Objective: The objective of this study was to examine the cost per responder of guselkumab compared with other targeted therapies for the treatment of moderate to severe plaque psoriasis in Germany., Methods: A one-year cost per responder model was developed based on efficacy and safety data from a published network meta-analysis. Drug, treatment administration, resource use, and adverse event costs were included in the analysis. The primary analysis assessed the cost per Psoriasis Area and Severity Index (PASI) 90 responder at week 16. Additional analyses were conducted at year 1. In the year 1 analyses, treatment response was assessed at the end of the induction period (week 16) to determine which patients continued onto maintenance therapy (responders) and which patients moved onto a subsequent adalimumab or secukinumab therapy (non-responders)., Results: At week 16, the cost per PASI 90 responder was lower for guselkumab than all comparators except adalimumab and brodalumab. Similarly, in the year 1 analyses, guselkumab had a lower cost per PASI 90 responder than all comparators except brodalumab., Conclusions: Guselkumab is a cost-effective therapy option in Germany.

This study is a retrospective analysis using data collected from the Adelphi Paediatric Psoriasis Disease-Specific Programme cross-sectional survey. Despite being treated for their psoriasis, a substantial proportion of paediatric patients presented with moderate (18.3%) or severe (1.3%) disease at sampling; 42.9% and 92.0% had a body surface area (BSA) of >10%, and 38.8% and 100.0% had a Psoriasis Area Severity Index (PASI) score >10, respectively. Overall, 69.9% of patients had only ever been treated with a topical therapy for their psoriasis. For patients with moderate or severe disease at sampling, 16.3% and 14.4% were currently receiving conventional systemics or biologic therapy, respectively. There is a clinical unmet need in this paediatric population; a considerable percentage of patients still experienced moderate or severe disease and persistent psoriasis symptoms, with numerous body areas affected. A significant proportion of patients were undertreated, which may explain the high burden of disease observed.

Background: The identification of early treatment factors that predict the long-term success of maintenance therapy for psoriasis may help optimize individual therapy., Objective: To determine early treatment response rates to ixekizumab and ustekinumab and assess whether early response was associated with stable long-term response to these treatments in patients with moderate-to-severe psoriasis., Methods: This post hoc subgroup analysis of the IXORA-S study (NCT02561806) measured disease severity using the Psoriasis Area Severity Index (PASI) and determined the percentage of patients treated with ixekizumab or ustekinumab who showed PASI 50 at week 2 or 4 (early response) and assessed whether early response was associated with maintaining complete (PASI 100) or almost complete (PASI 90) skin clearance at 80% of monthly visits during weeks 16&minus;52 of treatment (stable response). Nonresponder imputation was used for missing PASI response status., Results: A numerically higher portion of patients treated with ixekizumab were early responders and were significantly more likely to achieve a stable PASI 90 response (P&lt;.0001) or PASI 100 response (P&lt;.0001) than patients treated with ustekinumab. Patients treated with ixekizumab or ustekinumab who were early responders were more likely to achieve a stable response of PASI 90 or 100 (odds ratio&gt;1)., Conclusion: In patients with moderate-to-severe psoriasis treated with ixekizumab or ustekinumab, early response was a significant factor in maintaining stable complete or almost complete skin clearance. Therefore, rapid response is a clinically relevant factor to consider when optimizing individual therapeutic strategies. J Drugs Dermatol. 2022;21(2):122-126. doi:10.36849/JDD.6063.

Background: Plaque psoriasis is a common, chronic and relapsing inflammatory skin disease clinically characterized by erythema and scaling desquamation. As over 90% of psoriasis patients benefit from topical therapies, local treatments continue to play an eminent role in management strategies. One such topical treatment is the fixed dose combination of calcipotriol (CAL) and betamethasone dipropionate (BDP)., Objectives: Pooled analysis of two different phase 3 clinical trails to compare superiority regarding efficacy, safety and quality of life (QoL) between CAL/BDP PAD-cream and CAL/BDP TS., Methods: The data from two phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trials enrolling patients with psoriasis were pooled and analysed. Investigational products included a CAL/BDP cream based on PAD™ Technology (PAD-cream) designed for high skin penetration and increased patient preference, an active control (marketed CAL/BDP topical suspension/gel, in the following abbreviated as CAL/BDP TS) and cream vehicle, which were applied once daily for 8 weeks., Results: Efficacy and safety of the novel CAL/BDP PAD-cream formulation for the topical treatment of psoriasis demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP TS (31.9%; P < 0.0001), the mean per cent reduction in mPASI for CAL/BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP TS (P < 0.0001) and DLQI 0/1 was obtained by 43.8% in the CAL/BDP PAD-cream group versus 34.2% in the CAL/BDP TS group (P = 0.0005). There was no adverse drug reaction reported with a frequency of >1%, associated with the CAL/BDP PAD-cream., Conclusions: The novel fixed dose combination CAL/BDP PAD-cream offers greater efficacy, superior patient QoL and equivalent favourable safety for the topical treatment of psoriasis, in comparison to the currently available topical suspension/gel., (© 2021 MC2 Therapeutics. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background: Psoriasis (Pso) and atopic dermatitis (AD) are chronic skin diseases that result in significant physical and psychological impairment, financial burden, and loss of quality of life. According to previous data, there are regional differences in healthcare., Objectives: The aim was to analyse the epidemiology as well as the treatment of insured people with Pso and AD in Germany in a regional comparison., Methods: Data of the insurance company Techniker Krankenkasse for the year 2019 regarding treatment prevalences as well as drug prescriptions on the regional level for all physicians were examined., Results: In 2019 the overall prevalence of Pso was 2.5% (about 2 million insured people in Germany) and AD was 4.2% (about 3.6 million insured people). In Pso, new guideline-compliant drugs were frequently utilised, yet systemic glucocorticosteroids (GCS) were still disproportionally prescribed. Regionally, there were pronounced disparities with higher prescription rates of the new drugs in the north and east. Insured people with AD most frequently received topical GCS (approx. 88%), of which most were class III (66%), and significantly less frequently calcineurin inhibitors (< 10%), which also conform to guidelines. Systemically, GCS were by far most commonly used (about 25% of all insured people with drug prescriptions). Dupilumab, the only long-term drug approved in 2019, was very rarely prescribed, accounting for less than 1%. Again, large regional differences similar to Pso were found., Conclusion: Pso and AD show relevant disparities and gaps in drug care in the regional comparison despite uniform national guidelines and patient needs. The barriers to appropriate modern pharmaceuticals need to be clarified and mitigated., (© 2021. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumor necrosis factor biologic., Objectives: To report 3-year outcomes from the CIMPACT (NCT02346240) phase 3, CZP in moderate to severe plaque psoriasis, randomized controlled trial., Methods: Adults were randomized 3:3:3:1 to CZP 200 mg every other week (Q2W), CZP 400 mg Q2W, etanercept biweekly or placebo. At Week 16, CZP- and etanercept-treated PASI 75 responders were re-randomized to CZP 200 mg Q2W, CZP 400 mg Q4W, CZP 400 mg Q2W or placebo for maintenance treatment; PASI 75 non-responders entered an open-label escape CZP 400 mg Q2W arm. Patients entering the open-label extension (OLE; Weeks 48-144) from blinded treatment received CZP 200 mg Q2W., Results: Double-blinded results have been reported previously. 261 patients received 200 mg Q2W upon OLE entry. PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16-144 (Week 144: 96.2%). In patients dosed down at Week 48 (double-blinded 400 mg to 200 mg Q2W), PASI 75 decreased (Week 48: 98.7%; Week 144: 85.9%). In patients who received placebo through Weeks 16-48, PASI 75 response decreased (Week 48: 60.4%), then increased following Week 48 switch to 200 mg Q2W (Week 144: 95.1%). 48 and 36 patients initially randomized to 200 and 400 mg Q2W, respectively, were Week 16 PASI 75 non-responders and entered the escape arm; at Week 144, 71.8% and 78.2% achieved PASI 75. No new safety signals were identified., Conclusions: Response to CZP was durable over three years; no new safety signals were identified., (© 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Background: Few systematic data on sex-related treatment responses exist for psoriasis., Objectives: To evaluate sex differences with respect to systemic antipsoriatic treatment., Methods: Data from patients with moderate-to-severe psoriasis in the PsoBest or Swiss Dermatology Network of Targeted Therapies (SDNTT) registries were analysed. Treatment response was defined as achieving a ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75) or PASI ≤ 3 at treatment months 3, 6 and 12, supplemented by patient-reported outcomes [i.e. Dermatology Life Quality Index (DLQI) ≤ 1 and delta DLQI ≥ 4]., Results: In total, 5346 patients registered between 2007 and 2016 were included (PsoBest, n = 4896; SDNTT, n = 450). The majority received nonbiological treatment (67·3% male, 69·8% female). Women showed slightly higher PASI response rates after 3 (54·8% vs. 47·2%; P ≤ 0·001), 6 (70·8% vs. 63·8%; P ≤ 0·001) and 12 months (72·3% vs. 66·1%; P ≤ 0·004). A significantly higher proportion of women achieved a reduction in DLQI ≥ 4 [month 3: 61·4% vs 54·8% (P ≤ 0·001); month 6: 69·6% vs. 62·4% (P ≤ 0·001); month 12: 70·7% vs. 64·4% (P ≤ 0·002)]. Regarding PASI ≤ 3, women on biologics showed a significantly superior treatment response compared with men at 3 (57·8% vs. 48·5%; P ≤ 0·004) and 6 months (69·2% vs. 60·9%; P ≤ 0·018). Women in the nonbiological treatment group had a significantly better treatment response (PASI response, PASI 75 and PASI ≤ 3) over 12 months compared with men., Conclusions: We provide evidence that women experience better treatment outcomes with systemic antipsoriatic therapy than men., (© 2021 British Association of Dermatologists.)

Network meta-analyses (NMAs) increasingly assist in treatment decisions in disease areas such as psoriasis, where data from multiple clinical trials (CTs) on a growing number of different drugs become available. This study aimed to characterize NMAs published in psoriasis. A systematic literature search in PubMed was conducted using a structured search protocol based on the PRISMA criteria. Twenty-seven NMAs were identified, including an average of 43 CTs per NMA. Only eight of 27 NMAs (29.6%) were documented in the PROSPERO registry and only 17 (63%) reported following the PRISMA criteria. The mean number of patients per NMA was 19 624 (range: 6113-51 749). Across all NMAs, the drugs most frequently included were ustekinumab (n = 27 NMAs), followed by adalimumab (n = 25), infliximab and etanercept (n = 24 each). In all n = 27 NMAs, placebo comparisons and in n = 25, comparisons with active controls were used for bridging. Effect estimates were performed in all cases, SUCRA in 14. Most frequently used outcomes were Psoriasis Area and Severity Index (PASI) 75 (n = 25) and PASI 90 (n = 24), and Dermatology Life Quality Index (n = 10). NMAs mostly measured induction efficacy (weeks 10-16, n = 25) but rarely long-term outcomes (weeks 48-56, n = 4). Sensitivity analyses were performed in n = 17 (63%) of the studies. Main results varied considerably between studies and depended on the year of publication and thus the number of available drugs and studies. However, the concordance between NMA efficacy rankings based on PASI 75 was high. Although a large number of NMAs have been published on psoriasis showing highly comparable results on efficacy, no sufficient information on the quality criteria was reported, and PROSPERO registry criteria were not followed. This argues in favour of greater standardization of NMA methodology and reporting., (© 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Objectives: Global prevalence rates of psoriasis differ significantly, with lowest rates in the equator region and increasing tendencies towards the north but also differences within-country. Information on regional variations in Germany is missing. This study aims to analyse the change of psoriasis prevalence in Germany over time and to detect regional variations., Design: Cross sectional, spatio-epidemiological study on regional psoriasis prevalence in Germany., Setting: Claims data study based on nationwide outpatient billing data on county level., Methods: Analyses based on outpatient billing data for 2010-2017 derived from all people insured in statutory health insurances (about 72.8 million). We performed descriptive spatio-temporal analyses of prevalence rates using probability mapping and statistical smoothing methods, identified spatial clusters and examined a north-south gradient using spatial statistics., Results: The prevalence increased from 147.4 per 10 000 in 2010 to 173.5 in 2017. In 2017, counties' prevalence rates ranged between 93.8 and 340.9. Decreased rates occurred mainly in southern counties, increased rates in northern and eastern counties. Clusters of low rates occur in southern and south-western Germany, clusters of high rates in the north and north-east. The correlation between counties' latitudes and their prevalence rates was high with Pearson's r=0.65 (p<0.05)., Conclusion: Increased prevalence of psoriasis over time and marked regional variations in Germany were observed which need further investigation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)