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Background: Current treat-to-target recommendations for atopic dermatitis (AD) may not include high enough treatment targets and do not fully consider patient needs., Objective: To develop recommendations for optimized AD management, including disease severity assessments, treatment goals and targets, and guidance for treatment escalation/modification., Methods: An international group of expert dermatologists drafted a series of recommendations for AD management using insights from a global patient study and 87 expert dermatologists from 44 countries. Experts voted on recommendations using a modified eDelphi voting process., Results: The Aiming High in Eczema/Atopic Dermatitis (AHEAD) recommendations establish a novel approach to AD management, incorporating shared decision-making and a concept for minimal disease activity (MDA). Consensus (≥70% agreement) was reached for all recommendations in 1 round of voting; strong consensus (≥90% agreement) was reached for 30/34 recommendations. In the AHEAD approach, patients select their most troublesome AD feature(s); the clinician chooses a corresponding patient-reported severity measure and objective severity measure. Treatment targets are chosen from a list of 'moderate' and 'optimal' targets, with achievement of 'optimal' targets defined as MDA., Conclusions: Patient and expert insights led to the development of AHEAD recommendations, which establish a novel approach to AD management. Patients were not involved in the eDelphi voting process used to generate consensus on each recommendation. However, patient perspectives were captured in a global, qualitative patient research study that was considered by the experts in their initial drafting of the recommendations., (© 2024 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

BackgroundTwo randomized controlled trials (reSURFACE 1 and 2) have demonstrated the effectiveness of tildrakizumab, a high-affinity, humanized, IgG1κ, anti-interleukin-23 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in the first 28 weeks.ObjectivesTo examine the efficacy of tildrakizumab and its impact on quality of life (QoL) in patients with different levels of week-28 Psoriasis Area and Severity Index (PASI) improvement.MethodsPatients treated with tildrakizumab 100 mg or 200 mg from baseline to week 28 were pooled from reSURFACE 1 and reSURFACE 2 and classified into five mutually exclusive week-28 PASI improvement groups for each dose: PASI 0-49, 50-74, 75-89, 90-99 and 100. Mean PASI improvement and Dermatology Life Quality Index (DLQI) 0/1 over time were examined for each group.ResultsOf 1156 patients, 575 were in the 100-mg and 578 in the 200-mg cohorts, respectively. At week 28, 8.3%, 14.3%, 23.8%, 30.4% and 23.1% in the 100-mg and 4.0%, 18.1%, 19.6%, 29.1% and 29.3% in the 200-mg cohort achieved PASI  50 at week 28 who continued the same dose of tildrakizumab to week 52, mean PASI improvement was maintained or improved over time. Similar results were observed for both doses. Higher proportions of patients achieved DLQI 0/1 in higher week-28 PASI groups, and DLQI 0/1 was maintained or improved to week 52. However, not all patients with PASI 100 had DLQI 0/1.ConclusionPatients unlikely to respond to tildrakizumab could be identified by week 8, and those likely to achieve a PASI ≥ 90 response could be identified as early as week 4. Week-28 PASI improvement level correlated with QoL improvement.

Background: Psoriasis is an inflammatory skin disease that impacts a heterogeneous group of patients and can have multiple clinical manifestations. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis., Objectives: To evaluate the long-term efficacy of risankizumab according to baseline patient characteristics, and for the treatment of high-impact disease manifestations (nail, scalp and palmoplantar psoriasis), through 256 weeks of continuous treatment in the phase 3 LIMMitless study., Methods: This subgroup analysis evaluated pooled data from patients with moderate-to-severe plaque psoriasis who were randomized to risankizumab 150 mg during two double-blind, phase 3, 52-week base studies (UltIMMa-1/2; NCT02684370/NCT02684357) and were enrolled in the phase 3 LIMMitless open-label extension study (NCT03047395). Subgroup assessments included the proportion of patients who achieved ≥90%/100% improvement in Psoriasis Area and Severity Index (PASI 90/100). Among patients with nail, scalp and/or palmoplantar psoriasis in addition to skin psoriasis, assessments included changes from baseline in and resolution of these three psoriatic manifestations., Results: Overall, a numerically similar proportion of patients (N = 525) achieved PASI 90/100 through Week 256, regardless of their baseline age, sex, body mass index, weight, PASI or psoriatic arthritis status. Patients with nail, scalp and/or palmoplantar psoriasis experienced substantial improvements in manifestation-specific indices (mean improvement from baseline to Week 256 of >81%, >94% and >97%, respectively); in patients with all three manifestations (N = 121), 44.6% achieved complete clearance of these manifestations at Week 256., Conclusions: Risankizumab demonstrated generally consistent efficacy through 256 weeks across patient subgroups and showed durable long-term efficacy for psoriatic disease manifestations., (© 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.)

Introduction: Atopic dermatitis (AD), with its hallmark symptoms of pruritus and skin lesions, often impairs patients' quality of life. We assessed time spent with clear/almost clear skin and no/minimal itch during upadacitinib treatment versus placebo or dupilumab among patients with moderate-to-severe AD., Methods: This analysis consisted of a post hoc analysis of Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and Heads Up (NCT03738397). Measure Up 1 and 2 were replicate, randomized, double-blind, placebo-controlled phase 3 studies with patients randomized (1:1:1) to once-daily oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo for 16 weeks. Heads Up was a head-to-head, randomized, double-blind, double-dummy, phase 3b study with patients randomized (1:1) to upadacitinib 30 mg or subcutaneous dupilumab 300 mg for 24 weeks. Skin clearance was assessed with the Eczema Area and Severity Index (EASI) at baseline, weeks 1, 2, and 4, and every 4 weeks thereafter. Itch was assessed using the Worst Pruritus Numerical Rating Scale (WP-NRS) daily over 16 weeks and every 2 weeks thereafter to week 24 in Heads Up., Results: This analysis included 1683 patients in Measure Up 1 and 2 and 673 patients in Heads Up. Through 16 weeks in Measure Up 1 and 2, patients receiving upadacitinib spent 9.8-13.4 times as many days with an EASI 90 response and 7.0-10.3 times as many days with a WP-NRS 0/1 response versus placebo. In Heads Up, patients receiving upadacitinib spent 2.0 and 1.7 times as many days through 16 and 24 weeks, respectively, with an EASI 90 response versus dupilumab. Through 16 and 24 weeks, patients receiving upadacitinib spent 3.0 and 2.6 times as many days, respectively, with a WP-NRS 0/1 response versus dupilumab., Conclusions: Patients with moderate-to-severe AD spent more time with clear/almost clear skin and no/minimal itch with upadacitinib versus placebo or dupilumab., Trial Registration: ClinicalTrials.gov identifier, Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), Heads Up (NCT03738397)., (© 2024. The Author(s).)

Background: Janus kinase inhibitors (JAKi) have the potential to alter the landscape of atopic dermatitis (AD) management dramatically, owing to promising efficacy results from phase III trials and their rapid onset of action. However, JAKi are not without risk, and their use is not appropriate for all patients with AD, making this a medication class that dermatologists should understand and consider when treating patients with moderate-to-severe AD., Objectives: To provide a consensus expert opinion statement from the International Eczema Council (IEC) that provides a pragmatic approach to prescribing JAKi, including choosing appropriate patients and dosing, clinical and laboratory monitoring and advice about long-term use., Methods: An international cohort of authors from the IEC with expertise in JAKi selected topics of interest were placed into authorship groups covering 10 subsections. The groups performed topic-specific literature reviews, consulted up-to-date adverse event (AE) data, referred to product labels and provided analysis and expert opinion. The manuscript guidance and recommendations were reviewed by all authors, as well as the IEC Research Committee., Results: We recommend that JAKi be considered for patients with moderate-to-severe AD seeking the benefits of a rapid reduction in disease burden and itch, oral administration and the potential for flexible dosing. Baseline risk factors should be assessed prior to prescribing JAKi, including increasing age, venous thromboembolisms, malignancy, cardiovascular health, kidney/liver function, pregnancy and lactation, and immunocompetence. Patients being considered for JAKi treatment should be current on vaccinations and we provide a generalized framework for laboratory monitoring, although clinicians should consult individual product labels for recommendations as there are variations among the different JAKi. Patients who achieve disease control should be maintained on the lowest possible dose, as many of the observed AEs occurred in a dose-dependent manner. Future studies are needed in patients with AD to assess the durability and safety of continuous long-term JAKi use, combination medication regimens and the effects of flexible, episodic treatment over time., Conclusions: The decision to initiate JAKi treatment should be shared between the patient and provider, accounting for AD severity and personal risk-benefit assessment, including consideration of baseline health risk factors, monitoring requirements and treatment costs., Competing Interests: Conflicts of interest A.A. has institutional grants with AbbVie, Almirall, Amgen, Arcutis, Bristol-Myers Squibb, Cara Therapeutics, Castle, Dermavant, Galderma, LEO Pharma, Novartis, Valeant (Bausch Health) and Vyne; is an advisory board member or consultant with Pfizer, AbbVie, Allergan, Almirall, Alphyn, Amgen, Apogee, Arcutis, Bausch Health, Beiersdorf, Bristol-Myers Squibb, Cara Therapeutics, Canfield, Castle, Cutera, Dermavant, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, L’Oréal, Ortho, Sanofi Regeneron, Swiss-American, UCB, VisualDx and Vyne; and has given lectures and presentations for Pfizer, Bristol-Myers Squibb, Regeneron and Sanofi Genzyme. V.A. has clinical trials with Sanofi, Eli Lilly and Amgen, and has consulted for AbbVie and Pfizer. R.B. is an advisory board member, consultant, speaker and/or investigator for and receives honoraria and/or grants from AbbVie, Amgen, Apogee, Arcutis, Asana BioSciences, Bellus, BioMimetix, Bluefin, Biomedicine, Boehringer Ingelheim, Boston Pharma, CARA Therapeutic, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma, Merck, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Sanofi, Target RWE, Vyne Therapeutics and Zencor. R.B. is also an employee and shareholder of Innovaderm Research. A.B. has served as a speaker (received honoraria) for Eli Lilly, Pfizer and UCB; has served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, ASLAN, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome and Xencor; and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, DermBiont, Eli Lilly, Evelo, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, UCB Pharma and Ventyx. R.C. has served as an advisor, consultant, speaker and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly, FIDE, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Opsidio, Pfizer, Regeneron, RAPT, Sanofi and UCB. M.J.C. has grants from Hyphens Pharma, Johnson & Johnson, Kymab, LEO Pharma, L’Oréal, Perrigo, Pfizer, Regeneron Pharmaceuticals and Sanofi; and has received personal fees from AbbVie, Astellas Pharma, Boots, Dermavant, Eli Lilly, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L’Oréal, Menlo Therapeutics, Novartis, Oxagen, Perrigo, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals and Sanofi. S.G.D. has grants with Sanofi, Almirall, Johnson & Johnson and LEO Pharma; and has received grants and personal fees from Perrigo, Pfizer and Hyphens Pharma. L.F.E. has served as a consultant, speaker, advisory board member or investigator for AbbVie, Amgen, Apogee, Arcutis, ASLAN, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Target RWE and UCB. K.E. has served as a consultant and/or scientific advisor for AbbVie, Almirall, Bristol-Myers Squibb, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi and UCB; and has received research support from AbbVie, LEO Pharma, Lilly, Janssen and UCB. M.G. has served as an investigator, speaker and/or adviser for AbbVie, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Meiji, Merck, MoonLake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union and Ventyx. E.G.-Y. has research grants from Boehringer Ingelheim, LEO Pharma, Pfizer, Cara Therapeutics, UCB, Kyowa Kirin, RAPT, Amgen, GSK, Incyte, Sanofi, Bristol-Meyers Squibb, ASLAN, Regeneron, AnaptysBio, Concert and Janssen; and has been a consultant for AbbVie, Almirall, Amgen, AnaptysBio, Apogee Therapeutics, Apollo Therapeutics, Artax Biopharma, AstraZeneca, Bristol-Meyers Squibb, Boehringer Ingelheim, Cara Therapeutics, Centrexion Therapeutics, Connect Biopharm, Eli Lilly, Enveda Biosciences, Escient Pharmaceuticals, Fairmount Funds Management, Galderma, Gate Bio, Google Ventures (GV), GSK Immunology, Horizon Therapeutics USA, Incyte, Inmagene, Janssen Biotech, Japan Tobacco, Jasper Therapeutics, Kyowa Kirin, LEO Pharma, Merck, Nektar Therapeutics, Novartis Pharmaceuticals, NUMAB Therapeutics, OrbiMed Advisors, OTSUKA Pfizer, Pharmaxis, Pioneering Medicine VII, Proteologix US, RAPT, Regeneron Pharmaceuticals, Ribon Therapeutics, Sanofi, SATO, Schrödinger, Sun Pharma Advanced Research Company (SPARC), Teva Branded Pharmaceutical Products R&D and UCB. D.-J.H. is or has been a consultant and/or investigator for AbbVie, Almirall, AstraZeneca, Galderma, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi and UCB. A.D.I. has received consulting fees from AbbVie, Almirall, Arena, Benevolent AI, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron and Sanofi; has patents pending with Johnson & Johnson and Regeneron; and is President Elect of the International Eczema Council. N.K. has received honoraria as a speaker/consultant for Sanofi, Maruho, AbbVie, Eli Lilly Japan, Taiho Pharmaceutical, Pfizer, Otsuka Pharmaceutical and LEO Pharma; and has received grants as an investigator from Maruho, Torii Pharmaceutical, AbbVie, Sun Pharma and LEO Pharma. Y.A.L. has received honoraria or fees as a consultant from AbbVie, Sanofi, Janssen, Pfizer, Eli Lilly and Genentech, and as an advisory board member from Sanofi, Regeneron Pharmaceuticals, Pfizer and AbbVie; has received an independent research grant from AbbVie; and has, without personal compensation, provided investigator services for Eli Lilly, Pfizer and AbbVie. D.F.M. has served as a consultant, investigator and/or on the advisory board for Sanofi, AbbVie, Arena, LEO Pharma, Eli Lilly, Galderma, Dermira, Pfizer, BMS, Kineska, Fujisawa, Novartis and Evelo. I.V. has received research support from Sanofi/Regeneron Pharmaceuticals, Pfizer, Eli Lilly, Almirall and AbbVie; personal honoraria for lecturing from Pfizer and AbbVie; and has been a subinvestigator for LEO Pharma. R.L.O. has been involved in clinical trials for Sanofi, Amgen and Lilly, and has been a consultant for AbbVie. A.S.P. has been an investigator for AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, Regeneron and UCB; a consultant for Aegerion Pharma, Azitra, BioCryst, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Johnson & Johnson, Krystal, LEO Pharma, Novartis, Primus, Regeneron, Sanofi Genzyme, Seanergy, TWI Biotechnology and UCB; and has been on data and safety monitoring boards for AbbVie, Abeona, Catawba, Galderma and InMed. D.R. has consulted, spoken for or conducted trials for the following companies: AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, RAPT, Regeneron, Recludix, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, Viela Bio and Zura Bio. J.I.S. has received honoraria as a consultant and/or advisory board member for AbbVie, Aldena, Amgen, AOBiome, Apollo, Arcutis, Arena, Asana, ASLAN, Attovia, BiomX, Biosion, Bodewell, Boehringer Ingelheim, Bristol-Meyers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Invea, Kiniksa, LEO Pharma, My-Or Diagnostics, Nektar, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi Genzyme, Shaperon, TARGET-RWE, Union and UpToDate; has been a speaker for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron and Sanofi Genzyme; and their institution has received grants from Galderma, Incyte and Pfizer. E.L.S. reports personal fees from AbbVie, Amgen, Arcutis, Areteia Therapeutics, Bristol-Myers Squibb, CorEvitas, Corvus, Dermira, Eli Lilly, Evelo Biosciences, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Gilead Sciences, Impetus Healthcare, Incyte, Innovaderm Reche, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LEO Pharma, Merck, MJH Holding, NUMAB Therapeutics, Pfizer, Physicians World, PRImE, Recludix Pharma, Regeneron, Roivant, Sanofi Genzyme, Trevi Therapeutics and Valeant; has received grants from (or serves as Principal investigator role for) AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Castle, CorEvitas, Dermavant, Dermira, Incyte, Lilly, Kymab, Kyowa Kirin, National Jewish Health, LEO Pharma, Pfizer, Regeneron, Sanofi, Target and VeriSkin. S.S. has grants from Almirall, Beiersdorf, LEO Pharma, Galderma and Sanofi; has consulted for and been on advisory boards for AbbVie, Almirall, Beiersdorf, Clexio, Escient, Galderma, Grünenthal, Incyte, Integrity CE, Kiniksa, Klinge Pharma, Lilly, P.G. Unna Academy, Pfizer, Sanofi, touchIME, Vifor and WebMD; and has delivered lectures and presentations for AbbVie, BMS, FOMF, Galderma, LEO Pharma, L’Oréal, MEDahead, Moroscience, Novartis, Sanofi, P. G. Unna Academy, Pfizer, UCB and Vifor. J.P.T. reports, with no relation to the present manuscript, that he has previously been an advisor for AbbVie, Almirall, Arena Pharmaceuticals, OM Pharma, ASLAN Pharmaceuticals, Union Therapeutics, Eli Lilly, LEO Pharma, Pfizer, Regeneron and Sanofi Genzyme; has been a speaker for AbbVie, Almirall, Eli Lilly, LEO Pharma, Pfizer, Regeneron and Sanofi-Genzyme; and has received research grants from Pfizer, Regeneron and Sanofi Genzyme. He is currently an employee of LEO Pharma. J.Y. has served on advisory boards for Sanofi, Incyte and Arcutis; has served as a consultant for the National Eczema Association, iRhthym, O’Glacee and Inner Archways; and has served as site investigator on clinical trials sponsored by AbbVie, Pfizer, Lilly and SmartPractice. C.H., A.A.L., J.I.O., Y.R.-Y., N.S. and G.T. declare no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Introduction: Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials., Methods: High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator's Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10., Results: A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing., Conclusion: In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas., Gov Trial Registration Numbers: NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884., Competing Interests: Declarations. Conflicts of Interest: All details of authors’ affiliation or involvement in an organization or entity with a financial or nonfinancial interest in the subject matter or materials discussed in this manuscript are disclosed. Joseph F. Merola: A consultant and/or investigator for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Pfizer, Novartis, Regeneron, Sanofi, Sun Pharma, and UCB. Alice B. Gottlieb: Received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, Bristol Myers Squibb, Boehringer Ingelheim, Dice Therapeutics, Eli Lilly, Janssen, Novartis, Sanofi, UCB, and Xbiotech; received research/educational grants from AnaptypsBio, Bristol Myers Squibb, Moonlake Immunotherapeutics, Novartis, and UCB; all funds paid to Mount Sinai School of Medicine. Andreas Pinter: Investigator and/or speaker and/or advisor for AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GSK, Hexal, Janssen, LEO Pharma, MC2, Medac, Merck Serono, Mitsubishi Pharma, MSD, MoonLake Immunotherapeutics, Novartis, Pfizer, Regeneron, Roche, Sandoz, Schering-Plough, Tigercat Pharma, and UCB. Boni Elewski: Research support as funding to Case Western Reserve University from AbbVie, AnaptysBio, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Incyte, LEO Pharma, Menlo, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, Valeant, and Vanda; Consultant (honoraria) from Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, LEO Pharma, Menlo, Novartis, Pfizer, Sun Pharma, UCB, Valeant, and Verrica. Melinda Gooderham: Investigator, speaker, consultant, or advisory board member for AbbVie, Akros, Amgen, AnaptysBio, Arcutis, Aslan, Aristea, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, MedImmune, Meiji, Merck, Moonlake Immunotherapeutics, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, and UCB. Richard B. Warren: Consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB; research grants to institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB; honoraria from Astellas, DICE Therapeutics, GSK, and Union Therapeutics. Stefano Piaserico: Served as consultant and/or speaker for AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sandoz, and UCB. Krista Wixted, Nancy Cross, Nicola Tilt, Susanne Wiegratz: Employees and shareholders of UCB. Ulrich Mrowietz: Advisor and/or clinical study investigator for, and/or received honoraria and/or grants from AbbVie, Aditxt, Almirall, Amgen, Aristea, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dr. Reddy’s, Eli Lilly, Formycon, Immunic, Janssen-Cilag, LEO Pharma, Merck, MetrioPharm, Novartis, Phi-Stone, Sanofi-Aventis, Merck Sharp & Dohme, UCB, and Union Therapeutics. Ethical Approval: Reviewed and approved by the relevant IRBs. Clinicaltrials.gov trial registration: NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884. Studies were conducted in accordance with the principles of the Declaration of Helsinki and approved by an independent review board and independent ethics committee. All participants provided informed written consent documented in accordance with local regulations. Written consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors and attested to at the time of article submission to the journal stating that all patients gave consent with the understanding that this information may be publicly available., (© 2024. The Author(s).)

Introduction: In adults with moderate-to-severe atopic dermatitis (AD), rocatinlimab demonstrated significant and progressive improvement in clinical measures of disease severity compared with placebo. This post hoc analysis of a phase 2b study was undertaken to understand the disease burden and to assess the impact of rocatinlimab on patient-reported outcomes (PROs)., Methods: This analysis used baseline data from a multicenter, randomized, double-blind study of adults with moderate-to-severe AD, who completed a Worst Pruritus numerical rating scale (NRS), Sleep Disturbance NRS, and the Dermatology Life Quality Index (DLQI). A mixed model for repeated measures was used to estimate changes in PRO scores from baseline; scores were also compared with clinically meaningful change benchmarks., Results: The analysis included 267 subjects, mean (SD) age 37.9 (14.7) years, 40.8% female; 55.1% grade 3 and 44.9% grade 4 Investigator Global Assessment for AD. Mean (SD) scores were: Worst Pruritus NRS 7.5 (1.9), Sleep Disturbance NRS 5.5 (2.9), DLQI total score 12.6 (7.1). Worst Pruritus and Sleep NRS scores had low positive correlations with SCORing AD (SCORAD) score (r = 0.44, r = 0.45 respectively) and negligible correlations with Eczema Area and Severity Index (EASI) score and area affected (r < 0.30). DLQI score varied by sex, study country, race, age, longer disease duration, disease severity (EASI and SCORAD), presence of asthma, and Worst Pruritus NRS, Sleep disturbance NRS, and DLQI scores. Rocatinlimab showed benefit on all three PROs, with significant improvements from baseline at the end of the double-blind period (week 18) and active treatment extension (week 36). Benefits were maintained over 20 weeks' post-treatment follow-up. The benefit of rocatinlimab treatment on PROs is rapid and maintained for at least 20 weeks following treatment completion., Conclusion: This analysis demonstrates the importance of characterizing the burden of moderate-to-severe AD from the patient's perspective, alongside clinical disease measures, to develop a fuller picture of treatment benefit., Trial Registration: ClinicalTrials.gov identifier, NCT03703102., Competing Interests: Declarations. Conflicts of Interest: Melinda Gooderham has been an investigator, speaker, and/or advisor for: AbbVie, Acelyrin, Alumis, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee Therapeutics, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Cara Therapeutics, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Inmagene, JAMP Pharma, Janssen, LEO Pharma, L’Oreal, MedImmune, Meiji, MoonLake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, and Vyne. Emma Guttman-Yassky is an employee of Mount Sinai; this institution has received research grants from: LEO Pharma, Pfizer, Amgen, GSK, Incyte, Sanofi, Bristol Myers Squibb, ASLAN, Regeneron, AnaptysBio, Concert, Janssen, Q32 Bio, AbbVie, Eli Lilly, Arcutis, and Inmagene. Emma Guttman-Yassky has been a consultant for: AbbVie, Arcutis, Almirall, Amgen, AnaptysBio, Apogee Therapeutics, Apollo Therapeutics Limited, Artax Biopharma Inc., Astria, Bristol Myers Squibb, Boehringer Ingelheim, Calliditas Therapeutics, Cara Therapeutics, Celldex, Centrexion Therapeutics Corporation, Connect Biopharma, Coty, DBV Technologies, Eli Lilly, Enveda Biosciences, Escient Pharmaceuticals, Inc., Fairmount Funds Management LLC, FL2022-001, Inc., Galderma, Gate Bioscience, Google Ventures (GV), GSK Immunology, Incyte, Inmagene, Janssen Biotech, Jasper Therapeutics, Kymera Therapeutics, Kyowa Kirin, Leo Pharma, Matchpoint Therapeutics, Merck, Nektar Therapeutics, Novartis Pharmaceuticals, NUMAB Therapeutics AG, Nuvig, OrbiMed Advisors LLC, Otsuka, Pfizer, Pharmaxis Ltd, Pioneering Medicine VII, Inc., Proteologix US Inc., RAPT, RayThera, Inc., Regeneron Pharmaceuticals, RibonTherapeutics, Inc., Sagiment Biosciences, Sanofi, SATO, Schrödinger, Inc., Sitryx, Sun Pharma Advanced Research Company (SPARC), Takeda, Teva Branded Pharmaceutical Products R&D, Inc., TRex, UCB, and Ventyx Biosciences. Ken Igawa has received a lecture fee from: Sanofi, AbbVie, Lilly, Leo Pharma, Maruho, and Otsuka. Kenji Kabashima has received consulting fees, honoraria, grant support, and/or lecturing fees from: Amgen, Kyowa Kirin, Japan Tobacco, LEO Pharma, Maruho, Mitsubishi Tanabe, Ono Pharmaceutical, Procter & Gamble, Sanofi, Taiho, and Torii Pharmaceutical. Ehsanollah Esfandiari, Angela J Rylands and Angela Williams are employees of Kyowa Kirin International. Ehsanollah Esfandiari has stock options in Kyowa Kirin. Annabel Nixon and Jennifer E. Dent work for Chilli Consultancy, which received payment from Kyowa Kirin International for this work. Eric Simpson received personal fees from AbbVie, Amgen, Arcutis, Areteia Therapeutics, Bristol Myers Squibb, CorEvitas, Corvus, Dermira, Eli Lilly, Evelo Biosciences, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Gilead Sciences, Impetus Healthcare, Incyte, Innovaderm Research, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LEO Pharma, Merck, NUMAB Therapeutics AG, Pfizer, Physicians World LLC, PRImE, Recludix Pharma, Regeneron, Roivant, Sanofi Genzyme, Sitryx Therapeutics, Trevi Therapeutics, and Valeant. Eric Simpson received research grants from or served as a principal investigator for: AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Castle, CorEvitas, Dermavant, Dermira, Incyte, Lilly, Kymab, Kyowa Kirin, National Jewish Health, LEO Pharma, Pfizer, Regeneron, Sanofi, Target, and VeriSkin. Ethical Approval: The trial was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization consolidated Good Clinical Practice guideline, and any applicable national and local laws and regulations. The protocol and all subsequent amendments were reviewed and approved by institutional review boards or independent ethics committees at each site. All subjects provided written informed consent., (© 2024. The Author(s).)

Aim: In the global phase 3 POETYK PSO-1 and PSO-2 trials, significantly greater proportions of deucravacitinib-treated patients met the coprimary endpoints (PASI 75, sPGA 0/1) at Week 16 versus placebo or apremilast-treated patients. This analysis evaluated onset of action and maintenance of response in patients randomized to deucravacitinib and placebo only., Methods: Adults with moderate to severe plaque psoriasis at baseline were randomized 1:2:1 to oral placebo, deucravacitinib, or apremilast. Onset of action was determined through changes from baseline in mean PASI, BSA, BSA × sPGA, and DLQI. Maintenance of response was assessed using PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 response rates through Week 52 in patients who were treated continuously with deucravacitinib, crossed over from placebo to deucravacitinib at Week 16, or received deucravacitinib and achieved PASI 75 by Week 24., Results: Deucravacitinib showed significantly higher increases in mean percent change from baseline in PASI versus placebo by Week 1. Significant improvement versus placebo was observed in all other efficacy measures by Week 8. Efficacy with deucravacitinib was maintained through Week 52., Conclusion: Deucravacitinib displayed efficacy as early as 1 week and clinical responses were maintained over 52 weeks in patients with moderate to severe plaque psoriasis.

Importance: Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates., Objective: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD., Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe])., Intervention: Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks., Main Outcomes and Measures: The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated., Results: Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD = 11.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively; P < .001; INTEGUMENT-2: 42.0% vs 19.7%, respectively; P < .001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (≥95%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site., Conclusions and Relevance: In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability., Trial Registration: ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.

Regulatory T cell (Treg) impairment is implicated in the pathogenesis of chronic inflammatory diseases, but relatively little is known about the therapeutic potential of Treg restoration. Here we present clinical evidence for the Treg-selective interleukin-2 receptor agonist rezpegaldesleukin (REZPEG) in two randomized, double-blind, placebo-controlled Phase 1b trials in patients with moderate-to-severe atopic dermatitis (AD) (NCT04081350) or chronic plaque psoriasis (PsO) (NCT04119557). Key inclusion criteria for AD included an Eczema Area and Severity Index (EASI) score ≥ 16 and a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) ≥ 3, and for PsO included a Psoriasis Area and Severity Index (PASI) score of ≥ 12 and a static Physician's Global Assessment (sPGA) score of ≥ 3. REZPEG is safe and well-tolerated and demonstrates consistent pharmacokinetics in participants receiving subcutaneous doses of 10 to 12 µg/kg or 24 µg/kg once every 2 weeks for 12 weeks, meeting the primary and secondary objectives, respectively. AD patients receiving the higher dose demonstrate an 83% improvement in EASI score after 12 weeks of treatment. EASI improvement of ≥ 75% (EASI-75) and vIGA-AD responses are maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively. These exploratory clinical improvements are accompanied by sustained increases in CD25 bright Tregs. REZPEG thus represents a homeostatic approach to cutaneous disease therapy and holds clinical potential in providing long-term, treatment-free disease control., (© 2024. The Author(s).)

Introduction: Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395)., Methods: Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years., Results: A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100., Conclusion: While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected., (© 2024. The Author(s).)

Importance: New, effective, and well-tolerated oral therapies are needed for treating psoriasis. Zasocitinib, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, is a potential new oral treatment for this disease., Objective: To assess the efficacy, safety, and tolerability of zasocitinib in patients with moderate to severe plaque psoriasis., Design, Setting, and Participants: This phase 2b, randomized, double-blind, placebo-controlled, multiple-dose randomized clinical trial was conducted from August 11, 2021, to September 12, 2022, at 47 centers in the US and 8 in Canada. The study included a 12-week treatment period and a 4-week follow-up period. Key eligibility criteria for participants included age 18 to 70 years; a Psoriasis Area and Severity Index (PASI) score of 12 or greater; a Physician's Global Assessment score of 3 or greater; and a body surface area covered by plaque psoriasis of 10% or greater. Of 287 patients randomized, 259 (90.2%) received at least 1 dose of study treatment., Intervention: Patients were randomly assigned (1:1:1:1:1) to receive zasocitinib at 2, 5, 15, or 30 mg or placebo orally, once daily, for 12 weeks., Main Outcomes and Measures: The primary efficacy end point was the proportion of patients achieving 75% or greater improvement in PASI score (PASI 75) at week 12. Secondary efficacy end points included PASI 90 and 100 responses. Safety was also assessed., Results: In total, 259 patients were randomized and received treatment (mean [SD] age, 47 [13] years; 82 women [32%]). At week 12, PASI 75 was achieved for 9 (18%), 23 (44%), 36 (68%), and 35 (67%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and 3 patients (6%) receiving placebo. PASI 90 responses were consistent with PASI 75. PASI 100 demonstrated a dose response at all doses, with 17 patients (33%) achieving PASI 100 with zasocitinib, 30 mg. Treatment-emergent adverse events occurred for 23 patients (44%) receiving placebo and 28 (53%) to 31 (62%) patients receiving the 4 different doses of zasocitinib, with no dose dependency and no clinically meaningful longitudinal differences in laboratory parameters., Conclusions and Relevance: This randomized clinical trial found that potent and selective inhibition of TYK2 with zasocitinib at oral doses of 5 mg or more once daily resulted in greater skin clearance than placebo over 12 weeks., Trial Registration: ClinicalTrials.gov Identifier: NCT04999839.

Oral Janus kinase inhibitors (JAKi), a class of advanced targeted systemic therapy, have demonstrated efficacy and safety in the treatment of moderate-to-severe atopic dermatitis (AD). Like other small molecules, oral JAKi have the potential for off-target effects including laboratory-related adverse events (AEs). Product labels for oral JAKi recommend an initial laboratory assessment and follow-up 4-12 weeks later to monitor for potential changes, based on evidence from clinical trials across therapeutic indications for oral JAKi, which may not reflect a population of moderate-to-severe AD patients typically seen in routine clinical practice. To address this gap, a panel of eight dermatologists with clinical and research experience with oral JAKi for the management of AD conducted a targeted review of the literature focused on key laboratory-related AEs associated with oral JAKi in the moderate-to-severe AD population. Based on the synthesis of evidence and informed opinion, a set of best practice statements related to fundamental standards of care and consensus recommendations on laboratory monitoring were suggested, and level of agreement was ascertained using a Likert scale from 0 to 100. There was a high level of agreement on three of the four suggested recommendations related to assessment and monitoring of key laboratory parameters and to dose reduction or switching in response to laboratory changes; there was a lower level of agreement related to the frequency of ongoing laboratory monitoring. Appropriate patient selection and laboratory assessment is an important strategy to mitigate the potential risks associated with oral JAKi when treating AD., (© 2024. The Author(s).)

Background: Chronic hand eczema is a fluctuating, inflammatory, pruritic, often painful disease of hands and wrists that strongly impacts quality of life and occupational capabilities of patients. The aim of phase 3 DELTA 1 and DELTA 2 was to assess the efficacy and safety of twice-daily applications of the topical pan-Janus kinase inhibitor delgocitinib cream 20 mg/g versus cream vehicle in adults with moderate to severe chronic hand eczema., Methods: Both trials were randomised, double-blinded, and vehicle-controlled, with DELTA 1 being conducted at 53 trial centres in Canada, France, Germany, Italy, Poland, and the UK and DELTA 2 at 50 trial centres in Belgium, Canada, Denmark, Germany, the Netherlands, Poland, and Spain. Adults (aged ≥18 years) with moderate to severe chronic hand eczema were randomly assigned 2:1 to twice-daily delgocitinib cream 20 mg/g or cream vehicle for 16 weeks. The primary endpoint was Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as IGA-CHE score of 0 (clear) or 1 (almost clear, defined as only barely perceptible erythema). Efficacy and safety were assessed in all patients who were exposed to trial treatment. These trials are registered with ClinicalTrials.gov, NCT04871711 and NCT04872101., Findings: Between May 10, 2021, and Oct 31, 2022, 487 patients (181 male and 306 female) were enrolled in DELTA 1; between May 25, 2021, and Jan 6, 2023, 473 patients (161 male and 312 female) were enrolled in DELTA 2. 325 patients in DELTA 1 and 314 in DELTA 2 were assigned to delgocitinib cream; 162 patients in DELTA 1 and 159 in DELTA 2 were assigned to cream vehicle. At week 16, a greater proportion of delgocitinib-treated patients versus cream vehicle patients had IGA-CHE treatment success (64 [20%] of 325 vs 16 [10%] of 162 in DELTA 1 and 91 [29%] of 313 vs 11 [7%] of 159 in DELTA 2; both trials p≤0·0055). The proportion of patients who reported adverse events was similar with delgocitinib (147 [45%] of 325 in DELTA 1 and 143 [46%] of 313 in DELTA 2) and the cream vehicle (82 [51%] of 162 in DELTA 1 and 71 [45%] of 159 in DELTA 2). Most frequent adverse events occurring in at least 2% of patients were similar in both treatment groups and included COVID-19 and nasopharyngitis., Interpretation: Overall, delgocitinib cream showed superior efficacy versus cream vehicle and was well tolerated over 16 weeks. These results support the clinical benefit of delgocitinib cream as a potential treatment option for patients with moderate to severe chronic hand eczema, who are unable to adequately control their disease with basic skin care practices and topical corticosteroids., Funding: LEO Pharma., Competing Interests: Declaration of interests RB is an advisory board member, consultant, speaker, or investigator for and receives honoraria or grants from AbbVie, Amgen, Apogee, Arcutis, Asana BioSciences, Bellus Health, BioMimetix, Bluefin Biomedicine, Boehringer Ingelheim, Boston, CARA Therapeutic, Clexio, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma, Merck, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Regeneron, Sanofi, Target RWE, Vyne Therapeutics, and Xencor. RB is also an employee and shareholder of Innovaderm Research. RBW has received research grants or consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, GSK, Janssen, Lilly, LEO Pharma, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION. AP has served as an investigator, speaker, or advisor for AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Biontec, Boehringer Ingelheim, BMS, Celgene, Celltrion, GSK, Eli Lilly, Galderma, Hexal, Janssen, LEO Pharma, MC2, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi-Genzyme, Schering-Plough, UCB Pharma, and Zuellig Pharma. TA has given lectures, participated in clinical trials, or been on advisory boards for Sanofi, LEO Pharma, Pfizer, Eli Lilly, Galderma, and AbbVie. MG has been an investigator, speaker, or advisor for AbbVie, Acelyrin, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, InMagene, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union, and Ventyx. MLAS has been a consultant, advisory board member, investigator, or speaker for Sanofi Genzyme, Regeneron Pharmaceuticals, Pfizer, LEO Pharma, Eli Lilly, Galderma, AbbVie, Novartis, and Amgen. M-NC is a consultant, advisory board member, investigator, or speaker for AbbVie, Eli Lilly, LEO Pharma, Novartis, Pfizer, and Sanofi Genzyme. LS has been principal investigator in clinical trials sponsored by or has received personal fees for participation in advisory boards from AbbVie, Amgen, LEO Pharma, Eli Lilly, Novartis, and Sanofi, outside the submitted work. ES-B has served as an investigator or speaker or advisor for AbbVie, Almirall-Hermal, Lilly, LEO Pharma, Pfizer, Sanofi, Novartis, and Galderma. KB, MK, and UP are employees of LEO Pharma. SK and NSV were employees of LEO Pharma. SS is or has been a consultant, advisory board member, investigator, or speaker for LEO Pharma, Sanofi-Aventis, Novartis Pharma, Lilly Pharma, and AbbVie. All investigators had confidentiality agreements with the sponsor., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: Psoriasis involving challenging body areas, such as the scalp, face, palmoplantar surfaces, or nails, can be challenging to treat and negatively affects patient outcomes., Objective: To assess clear responses and cumulative clinical benefits over 5 years of ixekizumab treatment of moderate-to-severe plaque psoriasis in patients with and without baseline involvement of challenging body areas., Methods: This post hoc analysis included patients treated with ixekizumab in the UNCOVER-3 trial. We assessed PASI100 responses through the week (W) 264 and cumulative clinical benefits at W264 (calculated as least-squares mean of the percentage of maximum area under the curve for PASI100 and PASI% improvement and expressed as cumulative clearance days). Statistical differences were calculated via ANCOVA., Results: A total of 385 patients were analyzed: 349 with scalp involvement, 152 with facial involvement, 96 with palmoplantar involvement, and 229 with nail involvement. Proportions of patients achieving PASI100 were numerically similar between patients with and without scalp and nail involvement. More patients without facial and palmoplantar involvement achieved PASI100 at W60 (only palmoplantar), W108, W156, W204, and W264 (only palmoplantar). At W264, cumulative clinical benefits for PASI100 and PASI% improvement were high and similar in both patient groups, with and without challenging body areas. A significant difference (P=0.006) was only observed for PASI% improvement between patients with and without nail involvement., Conclusion: For most efficacy measures, patients treated with ixekizumab over 5 years achieved similar clear responses and cumulative clinical benefits regardless of baseline involvement of challenging body areas. J Drugs Dermatol. 2024;23(8):619-625.&nbsp; doi:10.36849/JDD.8160.

Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EYL has received speaker honorarium from Sanofi and AstraZeneca. IT: none. AWC: none. JB: none. RB is an advisory board member, consultant, speaker, and/or investigator for and receives honoraria and/or grant from AbbVie, Amgen, Arcutis, Asana BioSciences, Bellus Health, BioMimetix, Bluefin Biomedicine, Boehringer-Ingelheim, Boston, CARA Therapeutic, Clexio, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Regeneron, Sanofi, Target RWE and Vyne Therapeutics. RB is also an employee and shareholder of Innovaderm Research. HC: none. ACM: none. MG has been an investigator, speaker, and/or advisor for: AbbVie, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union and Ventyx. NH was on the advisory board/ round table honoraria for L’Oreal, Abbvie, Leo, Sun, Eucerin, Lilly, J&J, Arcutis, Sanofi, and Regeneron. HCHH has been an investigator for and/or speaker for and/or received honoraria from the following companies: Abbvie, Amgen, Arcutis, Bausch Health, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Galderma, GSK, Incyte, Janssen, Leo Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Roche, and UCB. NJL: none. JALM: none. RM: none. KP received honoraria from AbbVie, Acelyrin, Akros, Amgen, Aralez Pharmaceuticals, Bausch Health/Valeant, Boehringer Ingelheim Celgene, Celltrion, Coherus, Dermavant, Dice Pharmaceuticals, Eli Lilly, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, Leo, Meiji Seika Pharma, Merck (MSD), Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, and vTv Therapeutics. KP received clinical research grants from AbbVie, Akros, Amgen, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, CorEvitas, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Merek (MSD), Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB. AMD has received compensation from the British Journal of Dermatology (reviewer and Section Editor), American Academy of Dermatology (guidelines writer), National Eczema Association (grant reviewer), Canadian Dermatology Today (manuscript writer), and Canadian Agency for Drugs and Technologies in Health (consultant). Dr Drucker has received research grants to his institution from the National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, Canadian Institutes for Health Research, US National Institutes of Health, and Physicians Services Incorporated Foundation.

The objective was to study a large, international, ethnically diverse population of patients with atopic dermatitis (AD) to support the creation of patient-centric recommendations for AD management. Qualitative data were generated from 45-min, 1:1 telephone interviews conducted across 15 countries in each patient's native language. Interviews explored the impact of AD on patients' lives, patients' most important symptoms, treatment expectations, and treatment decision-making. Participants were also questioned on their current knowledge of AD scoring systems and what was most important to include in these tools. In total, 88 adult patients (≥ 18 years old) receiving treatment for AD were recruited through a market research database, clinician referrals, and local advertising. All patients were screened to ensure a balanced and diverse sample in terms of age, gender, educational level, employment status, geographic location, and AD severity. Patients involved in market research or activities supporting advocacy groups within the previous 6 months or affiliated with or employed by pharmaceutical companies were excluded. AD had a substantial impact on patients' lives. Itch, skin redness, and dry/flaky skin were the most frequently reported symptoms, with > 75% of patients experiencing these symptoms every 1-3 days. Mental health issues were common and resulted in the greatest negative impact on patients' daily lives. Patients perceived clinicians to underestimate the burden of their AD. Patients had little awareness of AD scoring systems and indicated a preference for these to be more clearly incorporated in clinical practice. For an ideal scoring system, patients favored using a combination of patient-reported and clinician-reported outcomes to reflect disease burden and ensure consistency across all settings. This global study generated diverse patient perspectives on the disease burden of AD, their expectations of treatment, and their views on AD scoring methods. These data provide evidence to support the development of patient-centric recommendations for AD management., (© 2024. The Author(s).)

Secukinumab is a fully human IgG1 antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin-17A. Secukinumab is an effective and well-tolerated treatment for plaque psoriasis. There is a limited real-word evidence for dose optimisation of secukinumab based on clinical response. PURE is a multi-national, prospective, observational study in patients with moderate to severe chronic plaque psoriasis in Canada and Latin America, assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The aim of the current snapshot analysis was to evaluate the effectiveness and safety of on-label dose and updosed secukinumab in patients with plaque psoriasis enrolled in the PURE study. At the time of analysis, 676 patients received secukinumab, of which 84.6% (n = 572) remained on the on-label dose, while 15.4% (n = 104) were updosed. With on-label secukinumab, the absolute Psoriasis Area and Severity Index (PASI) score was reduced from 13.6 at baseline to 1.2 over 36 months, with treatment persistence of 73% at 40 months. At Month 36, 73.2% of the patients receiving on-label secukinumab achieved Investigator's Global Assessment (IGA) 0/1. With updosed secukinumab (300 mg every 2 weeks, 300 mg every 3 weeks, 450 mg every 4 weeks, or 450 mg every 3 weeks), 57.9% of the patients showed improvement in the absolute PASI score at the first visit after updosing, with treatment persistence of 50% at 12 months after updosing. At Month 15, 40% of patients receiving updosed secukinumab achieved IGA 0/1. Patients with previous biologic exposure (odds ratio [OR]: 3.25; 95% confidence interval [CI]: 2.03, 5.18, p < 0.0001) were more likely to be updosed while those with a body weight < 90 kg (OR: 0.49; 95% CI [0.31, 0.77], p = 0.0019) were less likely to be updosed. Previous biologic exposure (HR [hazard ratio]: 1.47; 95% CI [1.24, 1.75], p < 0.0001) and current biologic exposure (secukinumab vs. other indicated therapies: HR 0.57; 95% CI [0.43, 0.75], p = 0.0001) were significantly associated with time to secukinumab updosing. No new or unexpected safety signals were observed with updosed secukinumab. Secukinumab updosing was efficacious and well-tolerated in patients with psoriasis who failed to respond to the approved on-label regimen, suggesting that updosing may be a useful therapeutic option for approved dose non-responders., (© 2024. The Author(s).)

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease resulting from the complex interplay of genetic and environmental factors, meriting exploration using temporally dynamic biomarkers. DNA methylation-based algorithms have been trained to accurately estimate biological age, and deviation of predicted age from true age (epigenetic age acceleration) has been implicated in several inflammatory diseases, including asthma., Objective: We sought to determine the role of epigenetic and biological aging, telomere length, and epigenetically inferred abundance of 7 inflammatory biomarkers in AD., Methods: We performed DNA methylation-based analyses in a pediatric AD cohort (n = 24, mean ± standard deviation [SD] age 2.56 ± 0.28 years) and age-matched healthy subjects (n = 24, age 2.09 [0.15] years) derived from blood using 5 validated algorithms that assess epigenetic age (Horvath, Skin&Blood) and biological age (PhenoAge, GrimAge), telomere length (TelomereLength), and inflammatory biomarker levels., Results: Epigenetic and biological age, but not telomere length, were accelerated in AD patients for 4 algorithms: Horvath (+0.88 years; 95% confidence interval [CI], 0.33 to 1.4; P  = 2.3 × 10 -3 ), Skin&Blood (+0.95 years; 95% CI, 0.67 to 1.2; P  = 1.8 × 10 -8 ), PhenoAge (+8.2 years; 95% CI, 3.4 to 13.0; P  = 1.3 × 10 -3 ), and GrimAge (+1.8 years 95% CI, 0.22 to 3.3; P  = .026). Moreover, patients had increased levels of β 2 microglobulin (+47,584.4 ng/mL; P  = .029), plasminogen activation inhibitor 1 (+3,432.9 ng/mL; P  = 1.1 × 10 -5 ), and cystatin C (+31,691 ng/mL; P  = 4.0 × 10 -5 ), while levels of tissue inhibitor metalloproteinase 1 (-370.7 ng/mL; P  = 7.5 × 10 -4 ) were decreased compared to healthy subjects., Conclusion: DNA methylation changes associated with epigenetic and biological aging, and inflammatory proteins appear early in life in pediatric AD and may be relevant clinical biomarkers of pathophysiology., Competing Interests: This work was supported by funding from the 10.13039/100008582McGill University Faculty of Medicine & Health Sciences, the McGill University Health Centre Foundation, and the International Society of Atopic Dermatitis. Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest., (© 2024 The Author(s).)

Background: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions., Objective: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD)., Methods: In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed., Results: 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events., Limitations: Study limitations include the 8-week treatment period for this chronic condition., Conclusions: Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD., Competing Interests: Conflicts of interest Dr Blauvelt has served as a speaker (received honoraria) for AbbVie, Eli Lilly and Company, Pfizer, and UCB, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. Dr Draelos received a research grant from Arcutis Biotherapeutics, Inc to contribute to the data presented in the paper. Dr Gold is an investigator, advisor and/or speaker for Arcutis, Abbvie, BMS, Lilly, Galderma, AnaptysBio, Amgen, Dermira, Dr Reddy, Ortho Dermatologics, Pfizer, Dermavant, Novartis, Sanofi, Regeneron, Leo, Cutera, UCB. Dr Alonso-Llamazares is an investigator for Arcutis Biotherapeutics, Inc; speaker for Celgene (Amgen), Dermira, Inc (Eli Lilly), Eli Lilly, Ortho Dermatologics, and UCB Pharma; and serves on advisory boards for LEO Pharma. Dr Bhatia is an advisor, consultant, and investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr DuBois is an investigator for and receives grants/research funding from AbbVie, AiViva BioPharma, Inc, Allergan, Inc, Almirall, AnaptysBio, Arcutis Biotherapeutics, Inc, Bausch Health, Bellus Medical, Biofrontera, Inc, Brickell Biotech, Inc, Bristol-Myers Squibb, Caliway Biopharmaceuticals Co., Ltd, Cara Therapeutics, Croma-Pharma GmbH, Dermata Therapeutics, DermBiont, Inc, Dr Reddy's Laboratories, Endo Pharmaceuticals, Inc, Evommune, Inc, Galderma USA, Hexima Ltd., Incyte Corporation, LEO Laboratories Ltd (LEO Pharma), Merck, NFlection Therapeutics, Inc, Palvella Therapeutics, RAPT Therapeutics, and Therapeutics, Inc; is an advisory board member and receives honoraria from RAPT Therapeutics; and is an independent contractor for and receives other financial benefit from Vial Health Technology, Inc. Dr Forman is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Gooderham received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, AnaptysBio, Arcutis Biotherapeutics, Inc, Aristea Therapeutics, Aslan Pharmaceuticals, Bausch, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Dermavant Sciences, Inc, Dermira, Inc, Eli Lilly, Galderma Laboratories, L.P., GSK, plc, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin International, plc, MedImmune, Meiji Seika Pharma, Merck, MoonLake Immunotherapeutics, Nimbus Therapeutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sun Pharma, and UCB Pharma. Dr Green received investigator fees, speaker fees and/or consulting fees from Amgen, AbbVie, Arcutis, BMS, Dermavant, Eli Lilly, Nimbus, OrthoDerm, SunPharma, and UCB. Dr Guenthner is an investigator, consultant, speaker, and/or member of the scientific advisory board for AbbVie, Arcutis, Asana, Dermavant, Edesa Biotech, Foamix, Galderma, Genentech, Incyte, Janssen, Leo, Lilly, Menlo, Novartis, Ortho Derm, Pfizer, Regeneron/Sanofi, and UCB. Dr Hebert has received research grants from Arcutis, Pfizer, Leo, Galderma, Brickell, Lilly, Ortho Dermatologics, and Mayne; has received honoraria from Arcutis, Pfizer, Galderma, Lilly, Ortho Dermatologics, Bristol-Myers Squibb, Janssen, Mayne, Leo, Incyte, Almirall, Verrica, and Vyne; and serves on data safety monitoring boards for Regeneron, Sanofi, GSK, and Bausch. Dr Lain is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Moore received research funds or honoraria from AbbVie, Arcutis, Dermavant, Janssen, Lilly, and Nimbus. Dr Papp received investigator fees, speaker fees, clinical research grants, and/or honoraria from AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Inc, Arcutis Biotherapeutics, Inc, Astellas Pharma US, Avillion LLP, Bausch Health/Valeant Pharmaceuticals International, Inc, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite BioPharma, Celgene, Celltrion Healthcare, Coherus Biosciences, Inc, Dermavant Sciences, Inc, Dermira, Inc, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Forbion, Galapagos, Galderma Laboratories, L.P., Genentech, Gilead, GSK, plc, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Hakko Kirin, LEO Pharma, Medimmune, LLC, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research Inc, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB Pharma, vTv Therapeutics, and Xencor. David M. Pariser is an investigator for and receives grants/research funding and/or honoraria from Almirall, Amgen, AOBiome, LLC, Asana BioSciences, LLC, Bickel Biotechnology, Celgene Corporation, Dermira, Inc, Eli Lilly and Company, LEO Pharma, US, Menlo Therapeutics, Novartis Pharmaceuticals Corp., Novo Nordisk A/S, Ortho Dermatologics, Pfizer Inc, and Regeneron Pharmaceuticals; is a consultant and/or serves on an advisory board for and receives honoraria from Bickel Biotechnology, Biofrontera AG, Dermira, Inc, Novartis Pharmaceuticals Corp., Pfizer Inc, Regeneron Pharmaceuticals, and Sanofi; and is on the Data Safety Monitoring Board and receives honoraria from Bristol-Myers Squibb. Dr Zirwas Received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, Anaptys Bio, Arcutis, Asana, AsepticMD, Avillion, Bausch Health, Cara, Concert, Dermavant, Edessa Biotech, EPI Health, Fit Bit, Galderma, Genentech/Novartis, Incyte, Janssen, L'Oreal, Leo, Level-Ex, Lilly, LUUM, Oculus, Peloton, Pfizer, Regeneron/Sanofi, Sol-Gel, Trevi, UCB, and Vyne. Author Kato, Dr Snyder, Author Krupa, Dr Burnett, Dr Berk, and Dr Chu are employees of Arcutis Biotherapeutics, Inc., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Introduction: Atopic dermatitis (AD) affects multiple areas of the body, some of which may be more refractory to treatment. We evaluated improvements in the Eczema Area and Severity Index (EASI) by body region and clinical signs for each body region in lebrikizumab-treated patients with moderate-to-severe AD., Methods: ADvocate 1 and ADvocate 2 compared lebrikizumab 250 mg as monotherapy every 2 weeks versus placebo for 16 weeks. Efficacy measures included EASI, which rates the extent and severity of four clinical signs (erythema, edema/papulation, excoriation, lichenification) in four body regions (head/neck, upper extremities, trunk, lower extremities). Analyses are post hoc., Results: Mean baseline EASI, body region EASI subscores, and the severity of clinical signs were consistent across both studies (EASI ranging from 16.0 to 72.0). At week 16 in both studies, patients treated with lebrikizumab showed significantly greater percent improvement in EASI across all body regions versus placebo (p ≤ 0.001), with improvements as early as week 2. In ADvocate 1, all clinical signs significantly improved across all body regions at week 16 with lebrikizumab (51.4-71.6% improvement) versus placebo (23.1-43.5%, p ≤ 0.001), with significant improvements as early as week 2 for all signs. Significant improvements for all clinical signs at week 16 were also seen in ADvocate 2 for lebrikizumab (53.5-75.6%) versus placebo (28.5-41.2%, p ≤ 0.001) and as early as week 2 for all body regions and signs except head/neck erythema and lower extremity erythema, edema/papulation, and lichenification, which showed significant improvement by week 4., Conclusions: Lebrikizumab as monotherapy consistently and rapidly reduced the extent of involvement and severity of AD in all EASI clinical signs and body regions, including the head and neck region and clinical sign of lichenification, compared with placebo., Trial Registration: ClinicalTrials.gov identifier: ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967)., (© 2024. The Author(s).)

Background: Atopic dermatitis (AD) is a heterogeneous inflammatory skin disease with different clinical phenotypes based on factors such as age, race, comorbidities, and clinical signs and symptoms. The effect of these factors on therapeutic responses in AD has only been scarcely studied and not for upadacitinib. Currently, there is no biomarker predicting response to upadacitinib. Objectives: Evaluate the efficacy of the oral Janus kinase inhibitor upadacitinib across patient subgroups (baseline demographics, disease characteristics and prior treatment) in patients with moderate‐to‐severe AD. Methods: Data from phase 3 studies (Measure Up 1, Measure Up 2 and AD Up) were utilized for this post hoc analysis. Adults and adolescents with moderate‐to‐severe AD were randomized to receive once daily oral upadacitinib 15 mg, upadacitinib 30 mg or placebo; patients enrolled in the AD Up study received concomitant topical corticosteroids. Data from the Measure Up 1 and Measure Up 2 studies were integrated. Results: A total of 2584 patients were randomized. A consistently greater proportion of patients achieved at least 75% improvement in the Eczema Area and Severity Index, a 0 or 1 on the validated Investigator Global Assessment for Atopic Dermatitis, and improvement in itch (including an achievement of a reduction of ≥4; and score of 0/1 in Worst Pruritus Numerical Rating Scale) with upadacitinib compared with placebo at Week 16, regardless of age, sex, race, body mass index, AD severity, body surface area involvement, history of atopic comorbidities or asthma, or previous exposure to systemic therapy or cyclosporin. Conclusions: Upadacitinib had consistently high skin clearance rates and itch efficacy across subgroups of patients with moderate‐to‐severe AD through Week 16. These results support upadacitinib as a suitable treatment option in a variety of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT03569293 (Measure Up 1), NCT03607422 (Measure Up 2) and NCT03568318 (AD Up). [ABSTRACT FROM AUTHOR]

Kim Blakely,1 Melinda Gooderham2 1Faculty of Medicine, University of Toronto, Toronto, ON, Canada; 2Skin Centre for Dermatology, Peterborough, ON, Canada Abstract: Psoriasis is a chronic inflammatory condition. The age of onset, chronicity, physical, and psychosocial consequences of the disease cause psoriasis to have a significant impact on patient quality of life. Scalp psoriasis is no different, and effective treatment results in an improvement in quality of life. Successful management of scalp psoriasis includes topical therapies that are acceptable to the patient for mild-to-moderate disease, and systemic therapies for recalcitrant or moderate-to-severe disease. The most effective topical therapies are corticosteroid products, or combination products with calcipotriol and corticosteroid. Newer vehicle options provide more attractive and pleasing products for patients and may improve adherence. The current perspectives for management of scalp psoriasis are discussed including available data for systemic therapy of severe disease. Keywords: psoriasis, scalp psoriasis, topical therapies, systemic therapies, biologics

Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe plaque psoriasis. Since scalp psoriasis can be burdensome and challenging to treat with non-systemic therapies, this post hoc analysis focused on scalp psoriasis in patients with moderate-to-severe plaque psoriasis and baseline scalp involvement. The analysis considered a holistic concept of clearance through 5 years of ixekizumab treatment., Methods: Ixekizumab-treated patients with baseline scalp involvement were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials (integrated UNCOVER-1/2 and UNCOVER-3). Analyses were performed on a subpopulation of patients who achieved complete resolution of scalp psoriasis at Week 60 (i.e., Week 60 Psoriasis Scalp Severity Index [PSSI-0] responders) and on the overall patient population (i.e., Week 60 PSSI-0 responders and non-responders), which was used as a reference. Clinical outcomes (PSSI), patient-reported outcomes (Itch Numeric Rating Scale [NRS] score, Skin Pain Visual Analogue Scale [VAS]), quality of life (Dermatology Life Quality Index [DLQI]), and concurrent outcomes were assessed from baseline through 5 years. Descriptive statistics of observed data were reported., Results: After 60 weeks of ixekizumab treatment, 88.4% (UNCOVER-1/2) and 75.9% (UNCOVER-3) of patients with baseline scalp involvement achieved complete clearance (PSSI-0) of scalp psoriasis. Substantial improvements in the clinical outcomes (PSSI), patient-reported outcomes (Itch NRS, Skin Pain VAS), and quality of life (DLQI) were achieved by Week 60 and sustained through Week 264 in the Week 60 PSSI-0 responders and in the overall patient population. Additionally, a significant proportion of Week 60 PSSI-0 responders achieved concurrent complete scalp and skin clearance and quality of life improvement through 5 years., Conclusions: Continued treatment with ixekizumab provided long-term sustained scalp clearance over 5 years to patients with moderate-to-severe plaque psoriasis and baseline scalp involvement, and holistic improvements occurred across clinical outcomes, patient-reported outcomes, and quality of life., Clinical Trial Numbers: NCT01474512 (UNCOVER-1), NCT01597245 (UNCOVER-2), and NCT01646177 (UNCOVER-3)., (© 2024. The Author(s).)

Background: The ALLEGRO phase 2a and 2b/3 studies demonstrated that ritlecitinib, an oral JAK3/TEC family kinase inhibitor, is efficacious at doses of ≥ 30 mg in patients aged ≥ 12 years with alopecia areata (AA)., Objective: The objective of this study was to evaluate the safety of ritlecitinib in an integrated analysis of four studies in AA., Methods: Two cohorts were analyzed: a placebo-controlled and an all-exposure cohort. Proportions and study size-adjusted incidence rates (IRs) of adverse events (AEs) of interest and laboratory abnormalities are reported., Results: In the placebo-controlled cohort (n = 881; median exposure: 169 days), the proportion of ritlecitinib-treated patients with AEs was 70.2-75.4% across doses versus 69.5% in the placebo group; serious AEs occurred in 0-3.2% versus 1.9% for the placebo. A total of 19 patients permanently discontinued due to AEs (5 while receiving the placebo). In the all-exposure cohort (n = 1294), median ritlecitinib exposure was 624 days [2091.7 total patient-years (PY)]. AEs were reported in 1094 patients (84.5%) and serious AEs in 57 (4.4%); 78 (6.0%) permanently discontinued due to AEs. The most common AEs were headache (17.7%; 11.9/100 PY), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (15.5%; 9.8/100 PY), and nasopharyngitis (12.4%; 8.2/100 PY). There were two deaths (breast cancer and acute respiratory failure/cardiorespiratory arrest). Proportions (IRs) were < 0.1% (0.05/100 PY) for opportunistic infections, 1.5% (0.9/100 PY) for herpes zoster, 0.5% (0.3/100 PY) for malignancies (excluding nonmelanoma skin cancer), and 0.2% (0.1/100 PY) for major adverse cardiovascular events., Conclusions: Ritlecitinib is well tolerated with an acceptable safety profile up to 24 months in patients aged ≥ 12 years with AA (video abstract and graphical plain language summary available)., Trial Registries: ClinicalTrials.gov: NCT02974868 (date of registration: 11/29/2016), NCT04517864 (08/18/2020), NCT03732807 (11/07/2018), and NCT04006457 (07/05/2019)., (© 2024. The Author(s).)

Background: Orismilast is a novel oral phosphodiesterase-4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis., Objective: To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis., Methods: This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy end points were analyzed using multiple imputation., Results: Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast vs placebo. Orismilast showed significant improvements in the primary end point, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast -52.6% to -63.7% and placebo, -17.3%; all P <.001). Greater proportions receiving orismilast achieved PASI75 (39.5%-49.0%; P <.05) and PASI90 (22.0%-28.3%; P <.05 for 20 and 40 mg) vs placebo (PASI75, 16.5% and PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed., Limitations: Small sample size, disease severity imbalance between groups, limited duration and diversity in study population., Conclusion: Orismilast demonstrated greater efficacy vs placebo and a safety profile in line with PDE4 inhibition., Competing Interests: Conflicts of interest Dr Warren has received research grants from AbbVie, Almirall, Amgen, Celgene, Janssen, Lilly, Leo Pharma, Novartis, Pfizer, and UCB, and consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, GlaxoSmithKline, Janssen, Lilly, Leo Pharma, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION therapeutics. Dr French has received consulting fees and/or honoraria from AbbVie, AC Immune, Almirall, Amgen, Biotest, Eli Lilly, Galderma, InflaRx, Janssen, Leo Pharma, Novartis, Regeneron, UCB, UNION therapeutics, and Vaderis Therapeutics, and has served as president of the International League of Dermatological Societies. Dr Blauvelt has received research grants from AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx, and honoraria from AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo Pharma, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Pfizer, Rani, Rapt, Regeneron, Sanofi, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, UNION therapeutics, Ventyx, Vibliome, and Xencor. Dr Langley has received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB. Dr Egeberg has received research grants from AbbVie, Danish National Psoriasis Foundation, Eli Lilly, Janssen, Kgl Hofbundtmager Aage Bangs Foundation, Novartis, Pfizer, Boehringer Ingelheim, and Simon Spies Foundation, and consulting fees and/or honoraria and/or travel bursaries from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Galderma, Galapagos NV, Horizon Therapeutics, Janssen, Leo Pharma, Mylan, Novartis, Pfizer, Samsung Bioepis Co Ltd, UCB, and UNION therapeutics. Dr Mrowietz has received honoraria from UNION therapeutics. Dr Hunter has received grant funding from Janssen, Merck Serono, and Pfizer, honoraria and/or consultancy fees and/or travel bursaries from AbbVie, Almirall, DICE Therapeutics, Eli Lilly, Janssen, La Roche-Posay, Leo Pharma, Novartis, Regeneron, Sanofi Genzyme, UCB, and UNION therapeutics, and has acted as an investigator for AbbVie, Almirall, Bayer Pharmaceuticals, DICE Therapeutics, Eli Lilly, Evelo Biosciences Inc, Janssen, Leo Pharma, Novartis, ONO Pharmaceutical Co Ltd, Sanofi Genzyme, UCB, and UNION therapeutics. Dr Gooderham has received research grants from AbbVie, Akros Pharma Inc, Amgen, Arcutis Pharmaceuticals Inc, Asana Bio Sciences, AnaptysBio, Aristea, Bausch Health, Boehringer Ingelheim International, Bristol Myers Squibb, Celgene, Coherus Biosciences, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Leo Pharma, MedImmune, Merck, Meiji, Moonlake, Novartis, Nimbus Therapeutics, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, and Ventyx, consulting fees and/or honoraria and/or travel bursaries from AbbVie, Akros Pharma, Amgen, Arcutis Pharmaceuticals Inc, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and UNION therapeutics, and is the owner of a phototherapy center. Author Soerensen is an employee of UNION therapeutics. Dr Andres has received consulting fees from UNION therapeutics. Dr Sommer is an employee and shareholder of UNION therapeutics, received consulting fees from UNION therapeutics, patents with UNION therapeutics, and serves as a board member of UNION therapeutics. Author Carlsson is an employee of UNION therapeutics. Dr Kjøller is an employee of and shareholder in UNION therapeutics, and serves as chairman of the Danish Life Science Cluster. Strober has received consulting fees and/or honoraria from AbbVie, Alamar, Almirall, Alumis, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Capital One, Connect Biopharma, CorEvitas, Dermavant, Eli Lilly, Evelo Biosciences, Immunic Therapeutics, Incyte, Janssen, Kangpu Pharmaceuticals, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Nimbus, Novartis, Pfizer, Protagonist, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, UNION therapeutics, Ventyxbio, and vTv Therapeutics, shareholder in Connect Biopharma, and Mindera Health, serves as scientific codirector of CorEvitas Psoriasis Registry, and serves as editor-in-chief of the Journal of Psoriasis and Psoriatic Arthritis., (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Vitiligo is a common depigmenting skin disorder with an estimated prevalence of 0.5% to 2% worldwide., Objective: We conducted a study to characterize the presentation of vitiligo in community dermatology clinic setting in Ontario, Canada., Methods: A retrospective cross-sectional study was performed through an electronic chart review at a community dermatology clinic with 2 sites in Ontario, Canada., Results: We found a male to female ratio of 1:1.3. The average age at the time of assessment was 40.8 years (ranging from 7 to 75 years). Sixteen percent of the patients were children (less than 18 years of age). Hands were the most common location for vitiligo (55.8%)., Conclusions: Our findings are in keeping with previously described epidemiologic data. To our knowledge, this is the first Canadian study looking at the population in a community setting., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Competing Interests: Dr Silverberg has received honoraria as a consultant and/or advisory board member for AbbVie, Alamar, Aldena, Amgen, AOBiome, Arcutis, Arena, Asana, Aslan, BiomX, Biosion, Bodewell, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Castle Biosciences, Celgene, Connect BioPharma, Dermavant, Dermira, DermTech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, Menlo, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, Union, and UpToDate; has served as a speaker for AbbVie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; and has received grants (paid to the institution) from Galderma, 10.13039/100017655Incyte, and 10.13039/100004319Pfizer. Author Cronin and Drs Jones and Dave were employees of CorEvitas, LLC at the time of this work. Dr McLean is an employee of CorEvitas, LLC. Dr Greenberg is an employee of CorEvitas, LLC. Dr Strober has received honoraria as a consultant for AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect BioPharma, Dermavant, Eli Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB, Ventyxbio, and vTv Therapeutics; has served as a speaker for AbbVie, Eli Lilly, Janssen, and Sanofi-Genzyme; coscientific director (consulting fee) for CorEvitas’ (Corrona) Psoriasis Registry; and investigator for AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis. Dr Bieber has served as a speaker and/or consultant, and/or investigator for AbbVie, Affibody, Almirall, Amagma, AnaptysBio, AOBiome, Arena, Aristea, Asana Biosciences, ASLAN pharma, Bayer Health, BioVersys, Boehringer Ingelheim, Bristol Myers Squibb, Connect Pharma, Daiichi Sankyo, Dermavant, DICE Therapeutics, Domain Therapeutics, DS Pharma, EQRx, Galderma, Galapagos, Glenmark, GSK, Incyte, Innovaderm, IQVIA, Janssen, Kirin, Kymab, LEO, LG Chem, Lilly, L’Oréal, MSD, Medac, Novartis, Numab, OM-Pharma, Pfizer, Pierre Fabre, Q32 Bio, RAPT, Sanofi/Regeneron, UCB, and Union Therapeutics; and is the founder and chairman of the board of the nonprofit biotech “Davos Biosciences.” Dr Gooderham has served as an investigator, speaker, and/or adviser for AbbVie, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, MoonLake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union, and Ventyx. Dr Paller has served as an investigator for AbbVie, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, and UCB; has served as a consultant for Aegerion Pharma, Azitra, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Castle Creek, Eli Lilly, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi/Genzyme, Seanergy, TWI Biotechnology, and UCB; and as a data safety monitoring board member for AbbVie, Abeona, Catawba, Galderma, and InMed. Dr Simpson has received consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Aslan Pharma, Benevolent AI Bio Limited “BAI,” BiomX Ltd, Bluefin Biomedicine Inc, Boehringer Ingelheim, Boston Consulting Group, Collective Acumen, LLC (CA), Coronado, Dermira, Eli Lilly, Evidera, Excerpta Medica, Galderma, GlaxoSmithKline, Forte Bio RX, Incyte Dermatologics, Janssen, Kyowa Kirin Pharmaceutical Development, Leo Pharm, Medscape LLC, Merck, Novartis, Ortho Galderma, Pfizer, Physicians World LLC, Pierre Fabre Dermo Cosmetique, Regeneron, Roivant, Sanofi-Genzyme, SPARC India, Trevi Therapeutics, WebMD, and Valeant; has served as a speaker for AbbVie, Leo, Eli Lilly, Medscape, Pfizer, Regeneron, Sanofi-Genzyme; has received advisory or steering committee fee from Arena Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin Pharmaceutical Development, Leo, Pfizer, Regeneron and Sanofi-Genzyme; has received grants or contracts from AbbVie, Amgen, Arcutis, Aslan, Celgene, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Kymab, Kyowa Hakko Kirin, Leo Pharmaceuticals, Merck, Novartis, Pfizer, Regeneron, Sanofi, and TARGET-DERM; and has been a PI for CorEvitas (paid to the institution).

Introduction: When assessing the effect of a therapy for psoriasis (PsO), it is important to consider speed of response and cumulative response. However, responses among biologics may differ by body regions. This post hoc analysis compares speed of response and cumulative response for ixekizumab (IXE), an interleukin-17A antagonist, and guselkumab (GUS), an interleukin-23p19 inhibitor, in different body regions of patients with moderate-to-severe plaque PsO participating in the IXORA-R study, up to week 24., Methods: The IXORA-R design has been previously described. Patients received the respective on-label dosing of IXE or GUS. The median time to first Psoriasis Area and Severity Index (PASI) 50, 75, 90, and 100 response (50%, 75%, 90%, and 100% improvement from baseline, respectively) and the cumulative days with clear skin for PASI 50, 75, 90, and 100 responses were assessed in four body regions: head, trunk, upper extremities, and lower extremities., Results: A total of 1027 patients were enrolled and received IXE (N = 520) or GUS (N = 507). Median time to first PASI 50, 75, 90, and 100 response was shortest in the head region, followed by the remaining body regions in both IXE and GUS cohorts. In each body region, IXE was significantly faster than GUS (p < 0.001) in achieving PASI 50, 75, 90, and 100. Through 24 weeks, the number of days with clear skin for PASI 90 and 100 was greater in the head region, followed by trunk, upper extremities, and lastly lower extremities in both IXE and GUS cohorts. In each body region, through 24 weeks, patients on IXE experienced a significantly higher number of days with clear skin for PASI 50, 75, 90, and 100 than patients on GUS (p < 0.01)., Conclusions: As compared to GUS, IXE provided a faster skin clearance and more days with clear skin in all body regions of patients with moderate-to-severe plaque PsO through 24 weeks., Trial Registration Number: https://www., Clinicaltrials: gov/ : NCT03573323 (IXORA-R)., (© 2024. The Author(s).)