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Deepak MW Balak,1,2 Stefano Piaserico,3 Ismail Kasujee4 1Department of Dermatology, LangeLand Ziekenhuis, Zoetermeer, the Netherlands; 2Department of Dermatology, Ghent University Hospital, Ghent, Belgium; 3Dermatology Unit, Department of Medicine, University of Padova, Padova, Italy; 4Almirall GMA, Barcelona, SpainCorrespondence: Deepak MW Balak Email balak.dmw@gmail.comAbstract: There is increasing interest in the association between psoriasis and non-alcoholic fatty liver disease (NAFLD), which is a prevalent liver disease characterized by excessive fat storage and inflammation that can progress to fibrosis and cancer. Patients with psoriasis have a two-fold higher risk to develop NAFLD and a higher risk to progress to more severe liver disease. Psoriasis and NAFLD share common risk factors such as smoking, alcohol consumption, and the presence of metabolic syndrome and its component disorders. In addition, both psoriasis and NAFLD hinge upon a systemic low-grade inflammation that can lead to a vicious cycle of progressive liver damage in NAFLD as well as worsening of the underlying psoriasis. Other important shared pathophysiological pathways include peripheral insulin resistance and oxidative stress. NAFLD should receive clinical awareness as important comorbidity in psoriasis. In this review, we assess the recent literature on the epidemiological and pathophysiological relationship of psoriasis and NAFLD, discuss the clinical implications of NAFLD in psoriasis patients, and summarize the hepatotoxic and hepatoprotective potential of systemic psoriasis therapies.Keywords: non-alcoholic fatty liver disease, psoriasis, fumaric acid esters, Nrf2-activation

Summary: Background: Omalizumab is approved as an add‐on therapy for the treatment of chronic spontaneous urticaria (CSU) in patients with inadequate response to H1‐antihistamine treatment. The urticaria control test (UCT) is a reliable, concise tool developed as an alternative to the 7‐day urticaria activity score (UAS7) – the standard for CSU disease activity assessment. Objectives: This prospective, open‐label, phase IV study evaluated the efficacy and safety of omalizumab in French adult patients with CSU nonresponsive to H1‐antihistamine treatment. Materials and methods: Patients [n = 136; stratified 1 : 2 (with angio‐oedema : without angioedema)] received omalizumab 300 mg subcutaneously every 4 weeks for 12 weeks. Study assessments included UCT, UAS7, angio‐oedema activity score and d‐dimer levels (exploratory objective). Results: At Week 12, 74·6% of the patients achieved disease control [UCT score ≥ 12 (primary endpoint)] and 67·7% of patients showed well‐controlled disease (UAS7 ≤ 6). There was a strong negative correlation between UCT score and UAS7 at Week 12 (Spearman's correlation coefficient −0·839). Mean plasma d‐dimer concentration was elevated at baseline (1002·1 ng mL−1) and decreased notably at Week 8 (455 ng mL−1). Among the nine patients with a very high baseline d‐dimer concentration (> 3000 ng mL−1), eight were responders (UAS7 ≤ 6) at Week 12. Conclusions: Omalizumab was efficacious in patients with CSU nonresponsive to H1‐antihistamines. The UCT was a reliable tool for disease assessment and the scores correlated well with UAS7. This study does not support the usefulness of d‐dimer to monitor long‐term disease prognosis in adult urticaria; however, it may indicate patients who respond to omalizumab. What's already known about this topic? Omalizumab is recommended as the third‐line treatment for chronic spontaneous urticaria (CSU), as an add‐on to H1‐antihistamines.The urticaria control test (UCT) is a recently validated tool for disease control assessment in patients with CSU.Elevated plasma levels of d‐dimer observed in some patients with CSU suggests a potential role of d‐dimer as a biomarker in CSU treatment response and prognosis. What does this study add? Omalizumab controlled symptoms and improved quality of life in French patients with moderate‐to‐severe CSU.UCT was a reliable tool for the assessment of urticaria control.d‐dimers are elevated in some patients with CSU and change in response to treatment with omalizumab.This study does not support the usefulness of d‐dimer to monitor long‐term disease prognosis in adult urticaria; however, it may indicate patients who respond to omalizumab. Linked Comment: Giménez‐Arnau. Br J Dermatol 2019; 180:12–13. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Background: Flare patterns are not routinely considered in the severity classification or in clinical decision-making of atopic dermatitis (AD), but frequent or severe flares may contribute considerably to the disease burden., Objectives: To characterize patients with AD in relation to their flare pattern and compare flare patterns to disease severity, life quality and treatment satisfaction., Methods: Patients with AD from the Danish Skin Cohort were included if they had active AD with and available data on number of flare-ups within the last 12 months. Categorical variables were presented as frequencies and percentages, whereas numerical variables were presented as median and interquartile ranges (IQR). Between-group differences were tested with chi-squared tests., Results: A total of 1557 patients were included, with 57 reporting 0 flares, 698 (1-5 flares), 324 (6-10 flares) and 478 reporting >10 flares during the past 12 months. Both the severity measured by PO-SCORAD and the impairment of life quality measured by DLQI were higher among patients with more flares (median [IQR] PO-SCORAD: 13.0 [5.6-22.3], 29.7 [20.8-40.6], 36.3 [26.7-47.6]and 42.9 [30.7-55.6], respectively for the four flares strata, and median [IQR] DLQI: 1.0 [0.0-2.0], 3.0 [1.0-7.0], 4.0 [1.8-9.0] and 7.0 [3.0-11.0]). Satisfaction with the current treatment was generally higher among patients with no flares. However, 36.8%, 24.6% and 23.7% of patients with 1-5, 6-10 and >10 flares reported being extremely or very satisfied with their current treatment., Conclusions: Patients with many flares often report a higher severity and impairment of life quality compared to patients with fewer flares. Information on flaring could benefit treatment decisions, thereby decreasing undertreatment of patients with mild AD but severe flaring., (© 2024 European Academy of Dermatology and Venereology.)

Background: The Patient-Reported Outcomes in Actinic Keratosis (PROAK) study evaluated patient- and clinician-reported outcomes (PRO; ClinRO) during 24 weeks of follow-up among adult patients with actinic keratosis (AK) on the face or scalp who were administered tirbanibulin 1% ointment in real-world community practices in the United States.  Methods: Quality of life (QoL) was assessed by Skindex-16 at week (W) 8. Additionally, effectiveness (Investigator Global Assessment [IGA]), PRO and ClinRO (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire), safety, and tolerability were assessed at W8 and W24., Results: The safety population included 300 patients; the full analysis set included 290 patients (278 patients at W24). At W8, a statistically significant difference (P<0.03) was observed for Skindex-16 domains in all assessed subgroups. Clinicians and patients reported high global satisfaction (mean [SD] scores of 74.9 [23.9] and 72.0 [24.6], respectively) at W24. Overall skin appearance improved from baseline to W24 (83.6% clinicians; 78.5% patients). IGA success (IGA score of 0-1) was achieved by 71.9% of patients at W24 with a similar % at W8 (73.8%) suggesting a stable effectiveness over time. About 5% of patients reported at least one adverse event, 4% reported at least one serious adverse event and no patients reported serious adverse drug reactions. At W8, the most frequently reported local skin reactions were mild/moderate erythema (47.6%) and flaking/scaling (49.6%)., Conclusions: Treatment with tirbanibulin demonstrated effectiveness in the management of AK lesions and a favorable safety and tolerability profile. Furthermore, QoL was improved as early as W8, and both patients and clinicians reported high levels of treatment satisfaction, independently of patients' characteristics. J Drugs Dermatol. 2024;23(5):338-346. doi:10.36849/JDD.8264.

Background: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients’ functioning and activities of daily living (ADL) are needed., Methods: A 12-week, single-arm, prospective cohort study was conducted in patients ≥9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (>12 years) and caregivers (for patients 9-11 years). Additional assessments included parental/caregiver perspectives on children’s AV., Results: A total of 253 patients completed the study. Following 12-weeks of treatment, there were significant (P ≤.0001) changes from baseline in the proportion of patients responding that they never or rarely: felt angry (31.6%), worried about AV worsening (28.9%), had thoughts about AV (20.9%), had a certain level of worries about AV (38.7%), altered their social media/selfie activity (23.7%), had an impact on real-life plans due to AV (22.9%), made efforts to hide AV (21.3%), felt picked-on/judged due to AV (15.0%), were concerned about their ability to reach future goals due to AV (13.8%), or had sleep impacted due to AV (18.2%). No significant change from baseline was observed for parent/caregiver’s understanding of the child’s AV concerns, from both patient and parent/caregiver perspectives., Conclusions: Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice. J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11.

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.)

Competing Interests: Conflicts of interest JCH has served as a consultant and/or speaker for Almirall, Cassiopea, Cutera, EPI, Galderma, Journey, L’Oréal, Ortho Dermatologics, SolGel, Sun Pharmaceutical Industries, and Vyne. AA has served as a research investigator and/or scientific advisor to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences, Dermira, Eli Lilly and Company, EPI Health, Incyte, Janssen Pharmaceuticals, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharmaceutical Industries, and UCB. RGF has served as a consultant to Almirall and Ortho Dermatologics. EAR has served as a consultant for Allergan, Almirall, Bristol-Myers Squibb, L’Oréal, Ortho Dermatologics, and UCB. AFA has received grant/research support (funds to institution) from Almirall, Amgen, Arcutis, Bausch Health, Bristol-Myers Squibb, Cara Therapeutics, Dermavant Sciences, Galderma, LEO Pharma, Menlo Therapeutics, and Novartis; has served as a consultant/advisory board member for AbbVie, Allergan, Almirall, Amgen, Arcutis, Bausch Health, Beiersdorf, Bristol-Myers Squibb, Cutera, Dermavant Sciences, Eli Lilly and Company, Galderma, Janssen Pharmaceuticals, LEO Pharma, L’Oréal, Pfizer, Sanofi-Regeneron, SolGel, Swiss American, UCB, VisualDx, and Vyne; and has served as a speaker for Bristol-Myers Squibb, Pfizer, and Sanofi-Genzyme. RJS and IK are employees of Almirall. AG is a former employee of Almirall.

Background: Tildrakizumab (TIL) is an interleukin (IL)-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis with long-term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed., Objectives: The TRIBUTE study (open-label, Phase IV) assessed the efficacy and impact on health-related quality of life (HRQoL) of TIL 100 mg in adult moderate-to-severe psoriasis patients (naïve to IL-23/Th17 pathway inhibitors) in conditions similar to clinical practice., Methods: Key efficacy measure was Psoriasis Area Severity Index (PASI). HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) and Skindex-16. Additional patient-reported outcomes included Pain-, Pruritus- and Scaling-Numerical Rating Scale (NRS), Medical Outcome Study (MOS)-Sleep, Work Productivity and Activity Impairment (WPAI), Patient Benefit Index (PBI) and Treatment Satisfaction Questionnaire for Medication (TSQM)., Results: One hundred and seventy-seven patients were enrolled (six patients did not complete the study). After 24 weeks, the proportion of patients achieving PASI scores ≤ 3, PASI 75, PASI 90 and DLQI 0/1 was 88.4%, 92.5%, 74.0% and 70.4%, respectively. Skindex-16 overall score improved (mean absolute change from baseline, MACB [95%CI]: -53.3 [-58.1, -48.5]). Significant benefits (MACB [95%CI]) were found on pruritus-, pain- and scaling-NRS scores (-5.7 [-6.1, -5.2], -3.5 [-4.1, -3.0] and -5.7 [-6.2, -5.2], respectively), MOS-Sleep (-10.4 [-13.3, -7.4] Sleep problems Index II) and WPAI (-36.4 [-42.6, -30.2] activity impairment, -28.2 [-34.7, -21.7] productivity loss, -27.0 [-32.9, -21.1] presenteeism and -6.8 [-12.1, -1.5] absenteeism). 82.7% of patients reported PBI ≥ 3 and the mean (SD) global TSQM score was high (80.5 [18.5]). Only one serious treatment-emergent adverse event was reported (not-related to TIL)., Conclusions: TIL 100 mg treatment after 24 weeks in conditions close to real clinical practice showed a quick and high improvement in psoriasis signs and HRQoL. Patient reported improvements in sleep outcomes and work productivity, relevant benefits and high treatment satisfaction. The safety profile was favourable and consistent with Phase III trials., (© 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: Current assessments on topical treatment attributes in actinic keratosis (AK) do not evaluate safety, effectiveness, and satisfaction from both clinician and patient perspectives, creating an unmet need for more comprehensive AK-specific measures that fully capture the patient experience., Objective: To develop an actinic keratosis-specific expert panel questionnaire (AK-EPQ) of patient-reported outcomes and clinician-reported outcomes for use in research studies., Methods: Using interviews of patients with AK and targeted literature reviews, a 9-person consensus panel of dermatologists with expertise in AK treatment was convened to develop the AK-EPQ to assess AK-specific patient-reported outcomes and clinician-reported outcomes., Results: Nine expert advisers achieved consensus on 11 AK-EPQ items that encompass patient and clinician perspectives of treatment-related local skin reactions, clinical and cosmetic outcomes associated with AK, and satisfaction with treatment; the AK-EPQ will be first implemented in the Patient-Reported Outcomes for Actinic Keratosis study (NCT05260073)., Limitations: The AK-EPQ does not directly measure quality of life, although it can be used with validated quality of life instruments., Conclusion: The newly developed AK-EPQ elicits insights into the patient and clinician experience with AK treatments. Comparative probing of these perspectives may help optimize precision medicine in AK treatment., Competing Interests: Dr Berman has served as an investigator, speaker, advisory board member, or consultant for Aclaris, Almirall, AiViva Biopharma, Biofrontera, Evommune, Ferndale Laboratories, Inc, Galderma Laboratories, L.P., GlaxoSmithKline, Lemonex, LEO Pharma, Mediwound, Mino Labs, Miragen, NOVAN, Novartis Pharmaceuticals Corp, Pfizer, Pierre Fabre, PHD Biosciences, Pulse Biosciences, Sensus, and Sirnaomics. Dr Armstrong served as a research investigator and/or scientific adviser to AbbVie, BI, BMS, EPI, Incyte, LEO, UCB, Janssen, Lilly, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, and Pfizer. Dr Lebwohl receives research funding from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc, and is a consultant for Aditum Bio, Almirall, AltruBio Inc, AnaptysBio, Arcutis, Inc, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle BioSciences, Corrona, Dermavant Sciences, Dr. Reddy’s Laboratories, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. Dr Grada is the former Head of R&D and Medical Affairs at Almirall, US. Dr Bhatia has been an adviser, consultant, and investigator for AbbVie, Almirall, Arcutis, Arena, Biofrontera, BMS, BI, Brickell, Dermavant, EPI Health, Ferndale, Galderma, Genentech, InCyte, ISDIN, J&J, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, P&G, Regeneron, Sanofi, Stemline, SunPharma, and Verrica. Dr Patel has received honoraria from Regeneron and Almirall, has served as a consultant for PhD Biosciences and Jounce Therapeutics, and has served as a speaker for Regeneron and Sanofi. Dr Rigel has served as a consultant for Almirall, Castle BioSciences, DermTech, and SciBase. Dr Del Rosso has served as a research investigator, consultant/adviser, or speaker for AbbVie, Aclaris, Almirall, Amgen (Celgene), AnaptysBio, Arcutis, Athenex, Bausch (Ortho Dermatologics), Biofrontera, BioPharmX, Biorasi, Blue Creek, Botanix, Brickell, Bristol-Myers Squibb, Cara Therapeutics, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Ferndale, Galderma, Genentech, Incyte, Jem Health, LEO Pharma, La Roche-Posay, Lilly (Dermira), MC2, NOVAN, Pfizer, Ralexar, Regeneron, Sanofi-Genzyme, Sente, Solgel, Sonoma (Intraderm), Sun Pharma, UCB, Verrica, and VYNE (Foamix/Menlo). Dr Schlesinger has received grant/research funding from AbbVie, Aclaris, Allergan, Almirall, Anterios, AOBiome, Arcutis Premier Research, Astellas Pharma US, Inc, Athenex, Biofrontera, Biorasi, Boehringer Ingelheim, Brickell Biotech, Bristol-Myers Squibb, Cara Therapeutics, Castle BioScience, Celgene, Centocor Ortho Biotech (now Janssen Biotech), ChemoCentryx, Coherus Biosciences, Concert Pharmaceutical, Corrona, Cutanea Life Sciences, Dermavant, Dermira (now Lilly), DT Pharmacy & DT Collagen, EPI Health, Galderma (Nestle), Janssen Pharmaceuticals, Inc, Kiniksa, LEO, Lilly, Merz, Nimbus, Novartis, Pfizer, Processa, Pulse Biosciences, Regeneron, Sanofi Genzyme, Sisaf, and Trevi; has received honoraria from AbbVie, Allergen, Almirall, Biofrontera AG, Bristol-Myers Squibb, Castle BioScience, EPI Health, Foundation for Research and Education in Dermatology (FRED), Galderma, Merz, Novartis, Regeneron, and Sun Pharma; has served as a speaker, advisory board member, or consultant for AbbVie, Allergan, Almirall, Amgen, Biofrontera AG, Bristol-Meyers Squibb, Castle BioScience, Celgene, CMS Aesthetics DCME, DUSA/Sun Pharma, EPI Health, Foundation for Research and Education in Dermatology (FRED), Genentech, Greenway Therapeutix, Kintor, Merz, Nextphase, Novartis, Pharmatecture, Prolacta Biosciences, Pulse Biosciences, Regeneron, Remedly, Inc, Sanofi Genzyme, Sun Pharma, UCB, and Verrica; has received consulting fees from Lilly, Ortho Dermatologics, Pierre Fabre, Plasmed, Regeneron, and Skinceuticals/L’Oreal; has been involved in the CME Program for MED Learning Group; has been involved with OncLive SSC Insights Filming/Stacy Jaffe for MJH Associates; has served as Co-Chair of AAD AK Guideline Committee and Co-Chair of AAD Performance Measurement Work Group; is a member of AAD Performance Measurement Committee; and owns stock in Remedly, Inc. Dr Kircik has served as an investigator, speaker, advisory board member, or consultant for Abbott Laboratories, Aclaris, Inc, Allergan, Inc, Almirall, Anacor Pharmaceuticals, Inc, Assos Pharma, Astellas Pharma US, Inc, Asubio Pharma Co, Ltd, Berlex Laboratories (Bayer Healthcare Pharmaceuticals), Biogen-Idec, Inc, Biolife, Biopelle, Boehringer Ingelheim, Breckinridge Pharma, Celgene Corporation, Centocor, Inc, Colbar, CollaGenex, Combinatrix, Connetics Corporation, Coria, Dermik Laboratories, Dermira, Inc, Dow Pharmaceutical Sciences, Inc, Dusa Pharmaceuticals, Inc, Eli Lilly & Co, Embil Pharmaceutical Co, Ltd, EOS, Ferndale Laboratories, Inc, Galderma Laboratories, LP, Genentech, Inc, GlaxoSmithKline, PLC, Health Point Ltd, Idera, Inc, Innocutis Medical, LLC, Innovail, Intendis, Inc, Johnson & Johnson, Laboratory Skin Care, Inc, Leo Pharmaceuticals, Inc, L’Oreal SA, 3M, Maruho Co, Ltd, Medical International Technologies, Medicis Pharmaceutical Corp, Merck & Co, Inc, Merz, Nano Bio Corporation, Novartis Pharmaceutical Corporation, Noven Pharmaceuticals, Inc, Nucryst Pharmaceuticals Corporation, Obagi Medical Products, Inc, Onset, Ortho Dermatologics, OrthoNeutrogena, PediaPharma, Inc, Promius Pharma, LLC, PharmaDerm, Pfizer, Inc, PuraCap, QLT, Inc, Quatrix, Quinnova, Serono (Merck-Serono International SA), SkinMedica, Inc, Stiefel Laboratories, Inc, Sun Pharmaceutical Industries, Ltd, Taro, TolerRx, Inc, Triax, UCB, Inc, Valeant Pharmaceuticals North America LLC, Warner-Chilcott, XenoPort, Inc, and ZAGE. Dr Salem is an employee of Almirall, US. Dr Narayanan is an employee of Avant Health LLC, and has served as a consultant for Almirall, Biogen, Johnson & Johnson, Sarepta Therapeutics, SeaGen, and Takeda. Dr Kasujee is an employee of Almirall, Spain., (© 2024 Published by Elsevier Inc. on behalf of the American Academy of Dermatology, Inc.)

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: As with most medicines historically, clinicians prescribing tildrakizumab have relied on information derived from registration studies undertaken in a prospective controlled clinical trial setting. More recently, clinicians, policymakers, and commissioners increasingly rely on real-world data to inform both policy and practice., Methods: A retrospective real-world data study was undertaken at four specialist dermatology departments in the United Kingdom. All adult patients treated with tildrakizumab for moderate-to-severe plaque psoriasis were included, with data being collected for 122 patients., Results: Psoriatic patients on tildrakizumab tended to be overweight (median body mass index of 32 (range 19-59) (n = 61); 26/68 (38%) < 90 kg, 32/68 (47%) between 90 and 120 kg, and 10/68 (15%) > 120 kg). The study population had high levels of comorbidities (83/116, 72%), multiple special sites (39/117, 33%), and histories of biological treatments (81/100, 81%). Most patients (61/80, 76%) initiated on tildrakizumab were switched from another biological treatment. Tildrakizumab was effective, with 91/122 (75%) patients remaining on treatment for the duration of the study-a median of 12 months per patient (range 1-29 months)-and achieving a change in median Psoriasis Area and Severity Index (PASI) from 12 to 0.35 and in Dermatology Life Quality Index (DLQI) from 20 to 0. The response rate was 57/66 (86%) when tildrakizumab was used as the first- or second-line biologic compared to 19/31 (61%) when used as the third- to seventh-line. Thirty-three (78.6%) patients over 90 kg of weight received the 200-mg dose of tildrakizumab. All but one (n = 8) patient with body weight over 120 kg maintained response over time. There was one treatment discontinuation; a patient who had a local sensitivity reaction., Conclusions: In UK clinical practice, tildrakizumab was well tolerated and effective at doses of 100 mg or 200 mg in a range of patient phenotypes., (© 2022. The Author(s).)

Background: Absolute Psoriasis Area and Severity Index (PASI) is a key endpoint in psoriasis management. Petto et al. [Pharm Stat. 2019;18(1):4-21] developed a statistical method to estimate the proportion of patients reaching absolute PASI response given baseline PASI score and proportion of patients achieving relative improvements at predefined time points., Objectives: To test this method on clinical data from two phase 3 tildrakizumab trials (reSURFACE 1/2) comparing estimated absolute PASI ≤1/≤2/≤3/≤5 responses with reference responses from clinical databases., Methods: Reference PASI responses of ≤1/≤2/≤3/≤5 were extracted from clinical databases. Estimation of absolute PASI ≤1/≤2/≤3/≤5 response rates at week (W) 12 and W28 by treatment and trial were performed. Differences between estimated and reference responses were analysed. Bland-Atman limits of agreement and Passing-Bablok regression to assess variations between estimated and reference responses were performed., Results: Differences between estimated and reference absolute PASI ≤1/≤2/≤3/≤5 responses at W12 and W28 by treatment and trial were of little clinical relevance with an overall mean difference in PASI response proportion of -2.2% (e.g., for the tildrakizumab 100-mg arm, original proportions of patients achieving PASI of ≤1/≤2/≤3/≤5 at W28 were 38.5%/52.2%/63.5%/73.9% and 39.8%/54.8%/63.6%/76.9% [reSURFACE 1 and 2, respectively] vs. estimated proportions of 33.2%/49.8%/62.5%/78.3% and 34.3%/51.6%/64.5%/79.9%). Limits of agreement were -7.1% to 1.4% at W12 and -6.8% to 4.3% at W28. Scatterplots revealed linearity that stood the cusum test in Passing-Bablok regression with slope 1.14 (95% confidence intervals: 1.06 to 1.20)., Conclusion: Good estimates of absolute PASI response rates were achieved with the application of the statistical method to tildrakizumab data reported in the phase 3 studies, in particular in the verum study arms. Our data support the method provided by Petto et al. [2019] to estimate proportions of psoriasis patients reaching absolute PASI value thresholds using relative PASI improvements., (© 2022 S. Karger AG, Basel.)

We conducted a large global survey, Still Fighting for Breath, in patients with severe persistent asthma, 10 years after the Fighting for Breath survey to assess the impact of disease on patients' lives and to determine if control and management have changed in recent years. Data were collected from 1333 adults (aged >18 years) and caregivers of children (aged 6-17 years) with severe persistent asthma from nine countries through an online survey conducted in 2016 by GfK. A decade after the first survey, our results showed that the impact of severe asthma has not changed significantly and a high proportion of patients with severe asthma remain inadequately controlled. A large discrepancy was observed between the proportion of patients who perceived their asthma to be well controlled (42%) and the proportion of patients who reported to be well controlled as per the Global Initiative for Asthma (GINA) assessment (6%). Although most patients perceived their asthma to be controlled, many experienced frequent symptoms that affected their daily lives. Thus, there is a need for improved management (support and strategies) of patients with severe persistent asthma and improved coordination of efforts that would enable these patients to achieve better disease control., Competing Interests: Conflict of interest: P. Katsaounou reports an ERS fellowship at Novartis, during the conduct of the study; and personal fees from GSK, Chiesi, Menarini, Pfizer, Boehringer Ingelheim, outside the submitted work. Conflict of interest: M. Odemyr reports grants from AirLiquide Healthcare, grants from ALK Abellò, grants from AstraZeneca, grants from Boehringer Ingelheim, grants from Chiesi, grants from GSK, grants from Novartis, grants from TEVA, grants from Regeneron, grants from SigAirHandling, grants from Stallergenes, and grants from Sanofi Genzyme, outside the submitted work; and is Vice President of the Swedish Asthma and Allergy Association, who receives no funds from companies in the pharmaceutical sector. M. Odemyr is also President of the European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) who receives unrestricted core and project funding from corporate sources, in addition to membership fees and EU project funding. M. Odemyr is a volunteer and receives no remuneration. EFA develops sustainable corporate partnership with funders where both remain independent and fosters transparency. The EFA Code of Ethics and Framework for Sustainable Partnership are available at www.efanet.org as well as the annual accounts 2017 (www.efanet.org/annual-report/2017/financials/transparency-and-acknowledgements). Conflict of interest: O. Spranger has nothing to disclose. Conflict of interest: M. Hyland reports grants and personal fees from Novartis, grants from AstraZenneca, and personal fees from GSK, outside the submitted work. Conflict of interest: C. Kroegel has nothing to disclose. Conflict of interest: R. Gore reports nonfinancial support from Novartis UK, outside the submitted work. Conflict of interest: F. Menzella has nothing to disclose. Conflict of interest: M. Morais-Almeida has nothing to disclose. Conflict of interest: M. Gasser reports that Novartis funded the market research survey conducted by GfK Switzerland, during the conduct of the study. Conflict of interest: I. Kasujee is an employee of Novartis Pharma AG. Conflict of interest: C. Domingo Ribas reports personal fees from Novartis, personal fees from GSK, personal fees from Sanofi, from AstraZeneca, from ALK, and personal fees and other support from Menarini, from Orion, outside the submitted work. Conflict of interest: L. Garcia Conde is an employee of Novartis Pharma AG.

Bronchial asthma (BA) is a chronic inflammatory disease with a marked heterogeneity in pathophysiology and etiology. The heterogeneity of BA may be related to the inducing mechanism(s) (allergic vs non-allergic), the histopathological background (eosinophilic vs non-eosinophilic), and the clinical manifestations, particularly in terms of severity and frequency of exacerbations. Asthma can be divided into at least two different endotypes based on the degree of Th2 inflammation (T2 'high' and T2 'low'). For patients with severe uncontrolled asthma, monoclonal antibodies (mAbs) against immunoglobulin E (IgE) or interleukin (IL)-5 are now available as add-on treatments. Treatment decisions for individual patients should consider the biological background in terms of the "driving mechanisms" of inflammation as this should predict the patients' likely responses to treatment. The question is not whether an anti-IgE or an anti-eosinophilic strategy is more effective, but rather what the mechanism is at the origin of the airway. While IgE is involved early in the inflammatory cascade and can be considered as a cause of allergic asthma, eosinophilia can be considered a consequence of the whole process. This article discusses the different roles of the IgE and IL-5/eosinophil pathways in the pathogenic mechanisms of airway inflammation occurring in allergic asthma, and the possible reasons to choose an anti-IgE mAb or anti-IL-5 treatment.

Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic asthma. There has been a steady accumulation of evidence on the long-term effectiveness of omalizumab; however, data on real-life outcomes beyond one year of treatment is limited. In this study, we report on long-term outcomes of omalizumab treatment. We collected data from our severe asthma registry on hospitalisations, exacerbations, corticosteroid sparing, asthma control, lung function, biomarkers and side effects, to determine if the benefit was sustained and treatment was safe on the long term. Forty-five patients [mean age 44.9 years (range 19-69), females 37/45 (82%), mean duration of omalizumab treatment = 60.7 ± 30.9 months (range 23-121) were included in the analysis. We observed a reduction in the annual acute asthma related hospital admissions for the total population from 207 at baseline to 40 on treatment (80.7% reduction), whilst the per patient annual hospitalisations were reduced from a mean of 4.8 to 0.89 post-omalizumab treatment (p < 0.00001). There was a 76.7% reduction in daily mean maintenance OCS dose (prednisolone equivalent) from 25.8 mg (n = 43) to 6.0 mg (p < 0.0001), associated with clinically significant improvement in asthma control questionnaire (ACQ) from mean score of 4.1 (range 3.7-4.7) to 2.27 (range 0.5-4.1) p < 0.0001. The mean % predicted FEV 1 has improved from 59.2% at baseline to 75.7% on treatment (p = 0.001). There was a statistically non-significant reduction in median peripheral blood eosinophils (PBE) from 300 cells/μl (range 40-1050) at baseline to 175 cells/μl (range 0-1500) post-treatment (p = 0.068), and statistically significant reduction of median fraction exhaled nitric oxide (FeNO) level from 37 parts per billion (range 12-178) to 24 ppb (range 7-50) (p = 0.0067). The work/school missed days were reduced in 17/19 patients who were at employment or school. The overall safety profile of the treatment seemed acceptable and was consistent with published experience. In conclusion, results from this real-life study demonstrate that improved outcomes in patients with severe allergic asthma are sustained with longer-term omalizumab therapy., (Copyright © 2017 Elsevier Ltd. All rights reserved.)