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Psoriasis: HELP
Articles from Wisconsin
Based on 83 articles published since 2010
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These are the 83 published articles about Psoriasis that originated from Wisconsin during 2010-2020.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Guideline Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. 2020

Menter, Alan / Gelfand, Joel M / Connor, Cody / Armstrong, April W / Cordoro, Kelly M / Davis, Dawn M R / Elewski, Boni E / Gordon, Kenneth B / Gottlieb, Alice B / Kaplan, Daniel H / Kavanaugh, Arthur / Kiselica, Matthew / Kivelevitch, Dario / Korman, Neil J / Kroshinsky, Daniela / Lebwohl, Mark / Leonardi, Craig L / Lichten, Jason / Lim, Henry W / Mehta, Nehal N / Paller, Amy S / Parra, Sylvia L / Pathy, Arun L / Prater, Elizabeth Farley / Rahimi, Robert S / Rupani, Reena N / Siegel, Michael / Stoff, Benjamin / Strober, Bruce E / Tapper, Elliot B / Wong, Emily B / Wu, Jashin J / Hariharan, Vidhya / Elmets, Craig A. ·Baylor Scott and White, Dallas, Texas. · University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. · University of Alabama, Birmingham, Alabama. · University of Southern California, Los Angeles, San Francisco. · Department of Dermatology, University of California, San Francisco School of Medicine, San Diego, California. · Mayo Clinic, Rochester, Minnesota. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York, New York. · University of Pittsburgh, Pittsburgh, Pennsylvania. · University of California, San Diego, San Diego, California. · Patient Advocate, National Psoriasis Foundation, Portland, Oregon. · University Hospitals Cleveland Medical Center, Cleveland, Ohio. · Massachusetts General Hospital, Boston, Massachusetts. · Icahn School of Medicine at Mount Sinai, New York, New York. · Central Dermatology, St Louis, Missouri. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Dermatology and Skin Surgery, Sumter, South Carolina. · Colorado Permanente Medical Group, Centennial, Colorado. · University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. · Pediatric Dermatology Society Alliance. · Emory University School of Medicine, Atlanta, Georgia. · Central Connecticut Dermatology, Cromwell, Connecticut; Yale University, New Haven, Connecticut. · Michigan Medicine, University of Michigan, Ann Arbor, Michigan. · San Antonio Uniformed Services Health Education Consortium, Joint-Base San Antonio, Texas. · Dermatology Research and Education Foundation, Irvine, California. · American Academy of Dermatology, Rosemont, Illinois. Electronic address: vhariharan@aad.org. ·J Am Acad Dermatol · Pubmed #32119894.

ABSTRACT: Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 2% of the world's population. In this guideline, we focus the discussion on systemic, nonbiologic medications for the treatment of this disease. We provide detailed discussion of efficacy and safety for the most commonly used medications, including methotrexate, cyclosporine, and acitretin, and provide recommendations to assist prescribers in initiating and managing patients on these treatments. Additionally, we discuss newer therapies, including tofacitinib and apremilast, and briefly touch on a number of other medications, including fumaric acid esters (used outside the United States) and therapies that are no longer widely used for the treatment of psoriasis (ie, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus).

2 Guideline Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. 2019

Menter, Alan / Strober, Bruce E / Kaplan, Daniel H / Kivelevitch, Dario / Prater, Elizabeth Farley / Stoff, Benjamin / Armstrong, April W / Connor, Cody / Cordoro, Kelly M / Davis, Dawn M R / Elewski, Boni E / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice B / Kavanaugh, Arthur / Kiselica, Matthew / Korman, Neil J / Kroshinsky, Daniela / Lebwohl, Mark / Leonardi, Craig L / Lichten, Jason / Lim, Henry W / Mehta, Nehal N / Paller, Amy S / Parra, Sylvia L / Pathy, Arun L / Rupani, Reena N / Siegel, Michael / Wong, Emily B / Wu, Jashin J / Hariharan, Vidhya / Elmets, Craig A. ·Baylor Scott and White, Dallas, Texas. · University of Connecticut, Farmington, Connecticut; Probity Medical Research, Waterloo, Ontario, Canada. · University of Pittsburgh, Pittsburgh, Pennsylvania. · University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. · Emory University School of Medicine, Atlanta, Georgia. · University of Southern California, Los Angeles, San Francisco. · University of Alabama, Birmingham, Alabama. · University of California, San Francisco School of Medicine, Department of Dermatology, San Francisco, California. · Mayo Clinic, Rochester, Minnesota. · University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York. · University of California San Diego, San Diego, California. · National Psoriasis Foundation, Portland, Oregon. · University Hospitals Cleveland Medical Center, Cleveland, Ohio. · Massachusetts General Hospital, Boston, Massachusetts. · Central Dermatology, St. Louis, Missouri. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Dermatology and Skin Surgery, Sumter, South Carolina. · Colorado Permanente Medical Group, Centennial, Colorado. · San Antonio Uniformed Services Health Education Consortium, Joint-Base San Antonio. · Dermatology Research and Education Foundation, Irvine, California. · American Academy of Dermatology, Rosemont, Illinois. Electronic address: vhariharan@aad.org. ·J Am Acad Dermatol · Pubmed #30772098.

ABSTRACT: Psoriasis is a chronic, inflammatory multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations based on the available evidence. The treatment of psoriasis with biologic agents will be reviewed, emphasizing treatment recommendations and the role of the dermatologist in monitoring and educating patients regarding benefits as well as associated risks.

3 Guideline Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. 2019

Elmets, Craig A / Leonardi, Craig L / Davis, Dawn M R / Gelfand, Joel M / Lichten, Jason / Mehta, Nehal N / Armstrong, April W / Connor, Cody / Cordoro, Kelly M / Elewski, Boni E / Gordon, Kenneth B / Gottlieb, Alice B / Kaplan, Daniel H / Kavanaugh, Arthur / Kivelevitch, Dario / Kiselica, Matthew / Korman, Neil J / Kroshinsky, Daniela / Lebwohl, Mark / Lim, Henry W / Paller, Amy S / Parra, Sylvia L / Pathy, Arun L / Prater, Elizabeth Farley / Rupani, Reena / Siegel, Michael / Stoff, Benjamin / Strober, Bruce E / Wong, Emily B / Wu, Jashin J / Hariharan, Vidhya / Menter, Alan. ·University of Alabama, Birmingham, Alabama. · Central Dermatology, St. Louis, Missouri. · Mayo Clinic, Rochester, Minnesota. · University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. · National Psoriasis Foundation, Portland, Oregon. · National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. · University of Southern California, Los Angeles, California. · Department of Dermatology, University of California San Francisco School of MedicineSan Francisco, California. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York, New York. · University of Pittsburgh, Pennsylvania. · University of California San Diego, San Diego, California. · Baylor Scott and White, Dallas, Texas. · University Hospitals Cleveland Medical Center, Cleveland, Ohio. · Massachusetts General Hospital, Boston, Massachusetts. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Dermatology and Skin Surgery, Sumter, South Carolina. · Colorado Permanente Medical Group, Centennial, Colorado. · University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. · Icahn School of Medicine at Mount Sinai, New York, New York. · Emory University School of Medicine, Atlanta, Georgia. · University of Connecticut, Farmington, Connecticut; Probity Medical Research, Waterloo, Canada. · San Antonio Uniformed Services Health Education Consortium, Joint-Base San Antonio, Texas. · Dermatology Research and Education Foundation, Irvine, California. · American Academy of Dermatology, Rosemont, Illinois. Electronic address: vhariharan@aad.org. ·J Am Acad Dermatol · Pubmed #30772097.

ABSTRACT: Psoriasis is a chronic, inflammatory, multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations on the basis of available evidence.

4 Editorial Asthma and psoriasis: What do they have in common? IL-17A! 2019

Busse, William W. ·From the Department of Medicine, University of Wisconsin Hospital. Electronic address: wwb@medicine.wisc.edu. ·J Allergy Clin Immunol · Pubmed #31557502.

ABSTRACT: -- No abstract --

5 Editorial Core Outcome Sets for Psoriasis Clinical Trials: Definition, Consensus, and Acceptance. 2018

Strober, Bruce E / Gordon, Kenneth B. ·Department of Dermatology, University of Connecticut Health Center, Farmington. · Probity Medical Research, Waterloo, Ontario, Canada. · Medical College of Wisconsin, Milwaukee. ·JAMA Dermatol · Pubmed #29874363.

ABSTRACT: -- No abstract --

6 Editorial Advancing paediatric psoriasis treatment options for children. 2017

Tollefson, M / Siegel, D. ·Mayo Clinic, Rochester, MN, U.S.A. · Medical College of Wisconsin, Milwaukee, WI, U.S.A. ·Br J Dermatol · Pubmed #29313933.

ABSTRACT: -- No abstract --

7 Review IL-23 inhibitors for moderate-to-severe psoriasis. 2018

Ibler, Erin / Gordon, Kenneth B. ·Department of Dermatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. · Department of Dermatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. kegordon@mcw.edu. ·Semin Cutan Med Surg · Pubmed #30215632.

ABSTRACT: Since the identification of high levels of interleukin 23 (IL- 23) in psoriasis lesional skin, as well as finding that IL-23 was the most important source of the p40 subunit shared by IL-12 and IL-23, significant effort has been made in identifying potential new drugs that specifically block the unique IL-23 p19 subunit. At this time, 2 inhibitors of IL-23 p19 have been approved by the United States Food and Drug Administration, guselkumab and tildrakizumab. Two other agents, risankizumab and mirikizumab, have completed phase 3 and phase 2 of development, respectively. Pivotal trials in the development of these agents and clinical use of the approved agents are discussed. Thus far, this class of medications seems to provide a high level of efficacy, along with infrequent dosing and very favorable safety results.

8 Review Ocular features of the HLA-B27-positive seronegative spondyloarthropathies. 2018

Jhaj, Gurdeep / Kopplin, Laura J. ·Department of Ophthalmology & Visual Sciences, Medical College of Wisconsin Eye Institute, Milwaukee, Wisconsin, USA. ·Curr Opin Ophthalmol · Pubmed #30148724.

ABSTRACT: PURPOSE OF REVIEW: The seronegative spondyloarthropathies are a closely related group of inflammatory diseases that include ankylosing spondylitis, psoriatic arthritis, reactive arthritis, enteropathic arthritis, inflammatory bowel disease and undifferentiated spondyloarthritis. This review focuses on the spectrum of ocular manifestations associated with these diseases and the current approaches in treating these ocular manifestations. It also highlights the role ophthalmologists can play in identifying and appropriately treating human leukocyte antigen B27 (HLA-B27) associated uveitis and the associated spondyloarthropathies in order to limit ocular and systemic morbidity. RECENT FINDINGS: Evolving treatment paradigms for the seronegative spondyloarthropathies should direct the choice in therapeutic agent for difficult to control associated uveitis. Biologic therapies, particularly tumor necrosis factor inhibitors, are playing an increasing role in the treatment. SUMMARY: Acute anterior uveitis is the most common ocular manifestation in HLA-B27 positive seronegative spondyloarthropathies. Suspicion for HLA-B27 associated uveitis should prompt a careful clinical history and rheumatologic referral if symptoms of an inflammatory arthropathy are present. Therapy is tailored based on severity of ocular and systemic manifestations with interventions from topical corticosteroids to immunomodulating agents available in treating these diseases.

9 Review Practical Strategies for Optimizing Management of Psoriasis. 2018

Wu, Jashin J / Armstrong, April W / Gordon, Kenneth B / Menter, M Alan. ·Director of Dermatology Research Department of Dermatology Kaiser Permanente Los Angeles Medical Center Los Angeles, California. · Associate Professor of Clinical Dermatology Associate Dean for Clinical Research Keck School of Medicine of the University of Southern California Los Angeles, California. · Professor and Chair Department of Dermatology Medical College of Wisconsin Milwaukee, Wisconsin. · Chairman, Division of Dermatology Baylor University Medical Center Dallas, Texas. ·Semin Cutan Med Surg · Pubmed #29614139.

ABSTRACT: Approximately 30% of patients with moderate plaque psoriasis and 20% of those with severe psoriasis have inadequate disease control with their current therapeutic regimens. Among the factors that affect treatment efficacy are drug selection and lack of patient adherence to treatment, which is often due to patient frustration that psoriasis is a chronic, multisystemic, and incurable disease. By forming a strong therapeutic alliance with patients and by asking them about their expectations for treatment, clinicians have a better chance of providing patients with more effective and durable relief from their psoriasis symptoms. Semin Cutan Med Surg 37(supp2):S52-S55.

10 Review Common and Not-So-Common Comorbidities of Psoriasis. 2018

Menter, M Alan / Armstrong, April W / Gordon, Kenneth B / Wu, Jashin J. ·Chairman, Division of Dermatology Baylor University Medical Center Dallas, Texas. · Associate Professor of Clinical Dermatology Associate Dean for Clinical Research Keck School of Medicine of the University of Southern California Los Angeles, California. · Professor and Chair Department of Dermatology Medical College of Wisconsin Milwaukee, Wisconsin. · Director of Dermatology Research Department of Dermatology Kaiser Permanente Los Angeles Medical Center Los Angeles, California. ·Semin Cutan Med Surg · Pubmed #29614138.

ABSTRACT: Plaque psoriasis is increasingly recognized as a multisystemic disease whose most common comorbidities include psoriatic arthritis, cardiovascular disease, metabolic syndrome, overweight/obesity, inflammatory bowel disease, and depression. The presence of such comorbidities affects the therapeutic choices for clinicians. Patients often visit dermatologists more frequently than they do other clinicians, so it is incumbent upon dermatologists to recognize and address early signs of psoriatic comorbidities to prevent further deterioration and improve their patients' quality of life. Semin Cutan Med Surg 37(supp2):S48-S51.

11 Review Treating to Target-A Realistic Goal in Psoriasis? 2018

Gordon, Kenneth B / Armstrong, April W / Menter, M Alan / Wu, Jashin J. ·Professor and Chair Department of Dermatology Medical College of Wisconsin Milwaukee, Wisconsin. · Associate Professor of Clinical Dermatology Associate Dean for Clinical Research Keck School of Medicine of the University of Southern California Los Angeles, California. · Chairman, Division of Dermatology Baylor University Medical Center Dallas, Texas. · Director of Dermatology Research Department of Dermatology Kaiser Permanente Los Angeles Medical Center Los Angeles, California. ·Semin Cutan Med Surg · Pubmed #29614137.

ABSTRACT: For many patients, the new biologic therapies for psoriasis can improve Psoriasis Area and Severity Index (PASI) scores in a relatively short time. But when results are less than optimal, patients often become frustrated. By providing effective medical treatment using a treat-to-target strategy, clinicians can relieve symptoms and halt disease progression. Although body surface area (BSA) and PASI scores are appropriate for analyzing results of clinical trials, clinicians need to use more patient-centered assessments of patients' progress such as the Dermatology Life Quality Index (DLQI) and Psoriasis Symptom Inventory (PSI), as well as other validated patientreported outcomes, which can enable them to set realistic and achievable goals for individual patients. Semin Cutan Med Surg 37(supp2):S44-S47.

12 Review The Evolving Landscape of Psoriasis Treatment. 2018

Armstrong, April W / Gordon, Kenneth B / Menter, M Alan / Wu, Jashin J. ·Associate Professor of Clinical Dermatology Associate Dean for Clinical Research Keck School of Medicine of the University of Southern California Los Angeles, California. · Professor and Chair Department of Dermatology Medical College of Wisconsin Milwaukee, Wisconsin. · Chairman, Division of Dermatology Baylor University Medical Center Dallas, Texas. · Director of Dermatology Research Department of Dermatology Kaiser Permanente Los Angeles Medical Center Los Angeles, California. ·Semin Cutan Med Surg · Pubmed #29614136.

ABSTRACT: The process of discovering new drugs for plaque psoriasis has revealed much about the multisystemic nature of the disease. Current and emerging biologic agents may reliably achieve a Psoriasis Area and Severity Index (PASI 75) up to 90. Initially, clinicians select therapies based on the severity of the psoriasis. Although mild disease can be treated with topical agents, for patients with moderate to severe disease, concurrent therapy with oral systemic agents, biologics, and/ or phototherapy needs to be considered. In some instances, clinicians may need to combine medications to provide patients with rapid relief of symptoms. Semin Cutan Med Surg 37(supp2):S39-S43.

13 Review Role of sebaceous glands in inflammatory dermatoses. 2015

Shi, Vivian Y / Leo, Michael / Hassoun, Lauren / Chahal, Dev S / Maibach, Howard I / Sivamani, Raja K. ·Department of Dermatology, University of California, Davis, California. · School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin. · School of Medicine, University of California, Davis, California. · David Geffen School of Medicine, University of California, Los Angeles, California. · Department of Dermatology, University of California, San Francisco, California. · Department of Dermatology, University of California, Davis, California. Electronic address: rksivamani@ucdavis.edu. ·J Am Acad Dermatol · Pubmed #26386632.

ABSTRACT: Skin is an important interface between the host and its environment. Inflammatory dermatoses often have disrupted skin barrier function, rendering patients more susceptible to allergenic triggers leading to an exaggerated immune response. The skin surface lipid film, an important component of the skin barrier, comprises a mixture of keratinocyte and sebaceous gland-derived lipids. Recent evidence demonstrated that defective keratinocyte lipid synthesis predisposes for the development of atopic dermatitis. However, the important role of sebaceous gland-derived lipids in skin inflammatory diseases may be underrecognized. This overview focuses on the importance of the contribution of sebaceous glands to barrier function. Sebaceous gland alteration may play a role in the pathogenesis of common skin diseases including acne vulgaris, atopic dermatitis, psoriasis, rosacea, and seborrheic dermatitis.

14 Review Chemokine receptors in the pathogenesis and therapy of psoriasis. 2012

Mabuchi, Tomotaka / Chang, Timothy W / Quinter, Suzanne / Hwang, Sam T. ·Department of Dermatology, Medical College of Wisconsin, WI, USA. mabuchi@is.icc.u-tokai.ac.jp ·J Dermatol Sci · Pubmed #22177422.

ABSTRACT: Chemokine receptors are G-protein-coupled, seven-transmembrane-spanning surface receptors that play key roles in cell trafficking, cell motility, and survival. These receptors are activated by small molecular weight chemotactic cytokines called chemokines. Chemokine receptors and their corresponding chemokine ligands play roles in the migration and localization of normal T cells (and other cells) during physiological responses in inflamed or infected skin. In psoriasis, the chemokine receptor CCR6 is expressed on the Th17 cells and γδ T cells, which produce a variety of cytokines (IL17 and IL22 among others), that play a role in the immunological activation. CCR6 and its ligand, CCL20, are highly expressed in psoriatic skin lesion and CCR6 is essential for the development of the psoriasiform phenotype following IL23 injection in mouse skin. In this review, we focus on the roles of chemokine receptors, particularly of CCR6, in the pathogenesis of psoriasis and discuss chemokine receptors as novel therapeutic targets for psoriasis.

15 Review Psoriatic arthritis: update on pathophysiology, assessment and management. 2011

Mease, Philip J. ·Seattle Rheumatology Associates, 1101 Madison St Ste 1000, Seattle, WA 98104, USA. pmease@nwlink.com ·Ann Rheum Dis · Pubmed #21339225.

ABSTRACT: Psoriatic arthritis (PsA) is classified as a spondyloarthropathy and characterised by synovitis, enthesitis, dactylitis and spondylitis usually manifesting as skin and nail psoriasis. Our understanding about the PsA disease state, its genetics, pathophysiology and comorbidities, as well as the ability to assess and treat the disease, has advanced as a result of significant collaborative efforts by rheumatologists and dermatologists in the development of classification criteria, outcome measures to assess the various clinical domains, and treatment trials with agents also used for diseases such as rheumatoid arthritis (RA) and psoriasis. Biological agents, especially the antitumour necrosis factors, have demonstrated significant efficacy and reasonable safety in all clinical domains of the disease, resulting in amelioration of clinical symptoms, inhibition of structural damage and improvement of function and quality of life. Although there is considerable overlap with RA, there are some differences in pathophysiology and approach to assessment and management that are important to consider. This paper reviews these subjects, with an emphasis on recent data.

16 Review The importance of stereochemistry on the actions of vitamin D. 2011

Chiellini, G / DeLuca, Hector F. ·Department of Biochemistry, University of Wisconsin-Madison, Madison, WI 53706-1544, USA. ·Curr Top Med Chem · Pubmed #21291397.

ABSTRACT: The seco-steroid hormone 1α,25-dihydroxyvitamin D(3) [1α,25(OH)(2)D(3)] is the most potent natural metabolite of vitamin D(3) and regulates primarily calcium and phosphate homeostasis, but also as a regulator of specific differentiation and of the immune system. Most, if not all, of the biological actions of 1α,25(OH)(2)D(3) are mediated through its specific receptor, the vitamin D receptor (VDR), which is a member of the nuclear receptor superfamily acting as a ligand-dependent transcription factor with coactivators. 1α,25(OH)(2)D(3) has significant therapeutic potential in the treatment of osteoporosis, rickets, secondary hyperparathyroidism, psoriasis, and renal osteodystrophy. However, the use of 1α,25(OH)(2)D(3) itself is limited because it induces significant hypercalcemia. Vitamin D is a highly flexible molecule and a very large number of analogs have been synthesized by industry and academia in an attempt to provide beneficial therapeutic agents with low calcemic activity. Chemical modifications of every portion of the vitamin D(3) molecule (the A, C, and D rings, the 17β-aliphatic side chain, and the 5,6,7,8-diene moiety) have been reported, with the most of the interesting analogs resulting from a combination of several modifications. The three-dimensional structure of both rat and human VDR-LBD have provided significant information for our understanding of the structure-function relationship (SFR) of vitamin D and some synthetic analogs. In this review, we focus on the current understanding of the relationship between selected stereochemical modifications of key structural components (i.e. A-ring, CD-ring and Side-chain) of the 1α,25(OH)(2)D(3) molecule and their effect on biological potency and selectivity. Based on current information, suggestions for the structure-based design of therapeutically valuable vitamin D analogs will conclude the review.

17 Clinical Trial Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis. 2020

Langley, Richard G B / Reich, Kristian / Strand, Vibeke / Feldman, Steven R / Paul, Carle / Gordon, Kenneth / Warren, Richard B / Toth, Darryl / Nikaï, Enkeleida / Zhu, Baojin / Goldblum, Orin / Edson-Heredia, Emily / Carlier, Hilde / Burge, Russel / Lin, Chen-Yen / Hollister, Kristin / Augustin, Matthias. ·Division of Dermatology, Department of Medicine, Dalhousie University, 6054 Coburg Road, Halifax, NS, Canada. richardgblangley@gmail.com. · Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany. · Biopharmaceutical Consultant, Portola Valley, CA, USA. · Wake Forest University Health Sciences, Winston-Salem, NC, USA. · Toulouse University, Toulouse, France. · Medical College of Wisconsin, Milwaukee, WI, USA. · The Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. · Probity Medical Research, Windsor, ON, Canada. · Eli Lilly Benelux S.A., Brussels, Belgium. · Eli Lilly and Company, Indianapolis, IN, USA. · Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany. ·Qual Life Res · Pubmed #31655974.

ABSTRACT: PURPOSE: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis. METHODS: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups. RESULTS: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60. CONCLUSIONS: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

18 Clinical Trial Consistent responses with guselkumab treatment in Asian and non-Asian patients with psoriasis: An analysis from VOYAGE 1 and VOYAGE 2. 2019

Reich, Kristian / Song, Michael / Li, Shu / Jiang, Jingzhi / Youn, Sang Woong / Tsai, Tsen-Fang / Choe, Yong Beom / Huang, Yu-Huei / Gordon, Kenneth B. ·Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany. · Janssen Research & Development, LLC, Spring House, Pennsylvania, USA. · Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. · National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. · Konkuk University School of Medicine, Seoul, South Korea. · Chang Gung Memorial Hospital and School of Medicine, Chang Gung University, Taoyuan City, Taiwan. · Medical College of Wisconsin, Milwaukee, Wisconsin, USA. ·J Dermatol · Pubmed #31631377.

ABSTRACT: Guselkumab, an interleukin-23 blocker, was superior to placebo and adalimumab and well-tolerated in phase 3 psoriasis studies (VOYAGE 1 and VOYAGE 2). This analysis evaluated the consistency of response in the Asian subpopulation in VOYAGE 1 and VOYAGE 2. Study designs were identical through week 24; patients were randomized to guselkumab, placebo, or adalimumab. Investigator's Global Assessment (IGA), Psoriasis Area and Severity Index (PASI), safety, and pharmacokinetic and immunogenicity data from VOYAGE 1 and VOYAGE 2 were pooled and compared by race (Asian, n = 199; non-Asian, n = 1630). At week 16, treatment differences between guselkumab and placebo were 78.2 (95% confidence interval [CI], 66.9-89.6) and 76.4 (95% CI, 72.7-80.2) percentage points for IGA 0/1 (score of 0 or 1) and 70.1 (95% CI, 60.0-80.1) and 68.5 (95% CI, 64.9-72.2) percentage points for PASI 90 (≥90% improvement) in the Asian and non-Asian populations, respectively. Treatment differences between guselkumab and adalimumab were 31.1 (95% CI, 17.7-44.6) and 16.1 (95% CI, 11.2-21.0) percentage points for IGA 0/1 and 24.9 (95% CI, 9.4-40.5) and 23.2 (95% CI, 17.7-28.6) percentage points for PASI 90 in the Asian and non-Asian populations, respectively. Similar results were observed at week 24. Safety was generally similar between populations and among treatment groups. Median serum guselkumab concentrations over time were comparable between the populations. Comparable responses between the Asian and non-Asian populations in this analysis suggest that the overall efficacy, safety, and the resulting benefit/risk analyses from VOYAGE 1 and VOYAGE 2 are applicable to Asian populations.

19 Clinical Trial Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase-3, randomized, placebo-controlled trial. 2019

Elewski, B E / Baker, C S / Crowley, J J / Poulin, Y / Okun, M M / Calimlim, B / Geng, Z / Reyes Servin, O / Rich, P A. ·School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. · Skin & Cancer Foundation Inc and Probity Medical Research, Carlton, Vic., Australia. · Bakersfield Dermatology, Bakersfield, CA, USA. · Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, QC, Canada. · Fort Healthcare, Fort Atkinson, WI, USA. · AbbVie Inc, North Chicago, IL, USA. · Oregon Health and Science University Hospital, Portland, OR, USA. ·J Eur Acad Dermatol Venereol · Pubmed #31304993.

ABSTRACT: BACKGROUND: Few clinical trials have evaluated long-term treatment of nail psoriasis with biologics. OBJECTIVE: Safety and efficacy of adalimumab [ADA; Humira AbbVie Inc, North Chicago, IL, USA)] long-term treatment (52 weeks) was evaluated in a phase-3, randomized trial in patients with moderate-to-severe plaque psoriasis and concomitant moderate-to-severe fingernail psoriasis. Results from the first 26 weeks (Period A) have been reported. METHODS: Patients receiving 40 mg ADA every other week or placebo in Period A, continued with or switched to 40 mg ADA every-other-week treatment in the subsequent 26-week open-label extension (OLE) period. Main efficacy evaluations were ≥75% improvement in total-fingernail modified Nail Psoriasis Severity Index (mNAPSI 75) and achievement of Physician's Global Assessment for Fingernail Psoriasis of clear or minimal disease (PGA-F 0/1) with a ≥2-grade improvement from baseline, across the trial for patients who continued ADA from Period A through the OLE (Continuous-ADA Population). Safety was evaluated during the OLE and for patients receiving ADA at any time during the study (All-ADA Population). RESULTS: Of the 217 patients initially randomized in Period A, 188 (86.6%; 94 in each treatment group) entered the OLE after completion of or early escape from Period A. For the Continuous-ADA Population (N = 109), endpoint achievement rates improved from OLE entry (Week 26) to Week 52, including total-fingernail mNAPSI 75 (47.4-54.5%); PGA-F 0/1 (51.1-55.6%) and total-fingernail mNAPSI = 0 (6.6-17.9%). Serious adverse event and serious infection rates for the All-ADA Population (N = 203) were 6.9% and 3.4%, respectively. CONCLUSIONS: In this population of psoriasis patients with concomitant, moderate-to-severe nail psoriasis, long-term efficacy and improvement in signs and symptoms of nail disease were demonstrated after every-other-week ADA treatment, including incremental improvements in rate of total clearance of nail disease. No new safety risks were identified for patients receiving at least one ADA dose across 52 weeks.

20 Clinical Trial Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. 2018

Papp, Kim / Gordon, Kenneth / Thaçi, Diamant / Morita, Akimichi / Gooderham, Melinda / Foley, Peter / Girgis, Ihab G / Kundu, Sudeep / Banerjee, Subhashis. ·From K. Papp Clinical Research and Probity Medical Research, Waterloo (K.P.), the SKiN Centre for Dermatology and Probity Medical Research, Peterborough (M.G.), and Queen's University, Kingston (M.G.) - all in Ontario, Canada · Medical College of Wisconsin, Milwaukee (K.G.) · the University of Luebeck, Luebeck, Germany (D.T.) · Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan (A.M.) · the University of Melbourne, St. Vincent's Hospital Melbourne, Skin and Cancer Foundation, and Probity Medical Research, Melbourne, VIC, Australia (P.F.) · and Bristol-Myers Squibb, Princeton, NJ (I.G.G., S.K., S.B.). ·N Engl J Med · Pubmed #30205746.

ABSTRACT: BACKGROUND: Tyrosine kinase 2 (TYK2) signaling pathways, which mediate cytokine signaling, are implicated in the pathophysiology of psoriasis. Selective inhibitors of TYK2 may be effective in treating psoriasis. METHODS: We conducted a phase 2, double-blind trial of a TYK2 inhibitor, BMS-986165, in adults with moderate-to-severe psoriasis, excluding patients with a previous lack of response to agents targeting cytokine signaling through the same tyrosine kinase pathway. Patients were randomly assigned to receive the drug orally at a dose of 3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, or 12 mg daily or to receive placebo. The primary end point was a 75% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 12 (higher scores indicate greater severity of psoriasis). RESULTS: A total of 267 patients received at least one dose in an intervention group of the trial. At week 12, the percentage of patients with a 75% or greater reduction in the PASI score was 7% (3 of 45 patients) with placebo, 9% (4 of 44 patients) with 3 mg of BMS-986165 every other day (P=0.49 vs. placebo), 39% (17 of 44 patients) with 3 mg daily (P<0.001 vs. placebo), 69% (31 of 45 patients) with 3 mg twice daily (P<0.001 vs. placebo), 67% (30 of 45 patients) with 6 mg twice daily (P<0.001 vs. placebo), and 75% (33 of 44 patients) with 12 mg daily (P<0.001 vs. placebo). There were three serious adverse events in patients receiving the active drug, as well as one case of malignant melanoma 96 days after the start of treatment. CONCLUSIONS: Selective inhibition of TYK2 with the oral agent BMS-986165 at doses of 3 mg daily and higher resulted in greater clearing of psoriasis than did placebo over a period of 12 weeks. Larger and longer-duration trials of this drug are required to determine its safety and durability of effect in patients with psoriasis. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT02931838 .).

21 Clinical Trial Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. 2018

Gordon, Kenneth B / Strober, Bruce / Lebwohl, Mark / Augustin, Matthias / Blauvelt, Andrew / Poulin, Yves / Papp, Kim A / Sofen, Howard / Puig, Lluís / Foley, Peter / Ohtsuki, Mamitaro / Flack, Mary / Geng, Ziqian / Gu, Yihua / Valdes, Joaquin M / Thompson, Elizabeth H Z / Bachelez, Hervé. ·Medical College of Wisconsin, Milwaukee, WI, USA. Electronic address: kegordon@mcw.edu. · University of Connecticut Health Center and Probity Medical Research, Farmington, CT, USA. · Icahn School of Medicine at Mount Sinai, New York, NY, USA. · University Medical Center Hamburg-Eppendorf, Hamburg, Germany. · Oregon Medical Research Center, Portland, OR, USA. · Centre Dermatologique du Québec Métropolitain, Québec, QC, Canada. · K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada. · University of California, Los Angeles, CA, USA; School of Medicine, Los Angeles, CA, USA. · Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. · University of Melbourne, Parkville, Skin & Cancer Foundation Inc, Carlton, Probity Medical Research, Carlton, and St Vincent's Hospital Melbourne, Fitzroy VIC, Australia. · Jichi Medical University, Shimotsuke, Japan. · Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA. · AbbVie, North Chicago, IL, USA. · AbbVie, Redwood City, CA, USA. · Saint-Louis Hospital, AP-HP, Sorbonne Paris Cité Université Paris Diderot, INSERUM UMR 1163, Institut Imagine, Paris, France. Electronic address: herve.bachelez@aphp.fr. ·Lancet · Pubmed #30097359.

ABSTRACT: BACKGROUND: Risankizumab is a humanised IgG1 monoclonal antibody that binds to the p19 subunit of interleukin-23, inhibiting this key cytokine and its role in psoriatic inflammation. We aimed to assess the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. METHODS: UltIMMa-1 and UltIMMa-2 were replicate phase 3, randomised, double-blind, placebo-controlled and active comparator-controlled trials done at 139 sites in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain, and the USA. Eligible patients were 18 years or older, with moderate-to-severe chronic plaque psoriasis. In each study, patients were stratified by weight and previous exposure to tumour necrosis factor inhibitor and randomly assigned (3:1:1) by use of interactive response technology to receive 150 mg risankizumab, 45 mg or 90 mg ustekinumab (weight-based per label), or placebo. Following the 16-week double-blind treatment period (part A), patients initially assigned to placebo switched to 150 mg risankizumab at week 16; other patients continued their originally randomised treatment (part B, double-blind, weeks 16-52). Study drug was administered subcutaneously at weeks 0 and 4 during part A and at weeks 16, 28, and 40 during part B. Co-primary endpoints were proportions of patients achieving a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16 (non-responder imputation). All efficacy analyses were done in the intention-to-treat population. These trials are registered with ClinicalTrials.gov, numbers NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2), and have been completed. FINDINGS: Between Feb 24, 2016, and Aug 31, 2016, 506 patients in UltIMMa-1 were randomly assigned to receive 150 mg risankizumab (n=304), 45 mg or 90 mg ustekinumab (n=100), or placebo (n=102). Between March 1, 2016, and Aug 30, 2016, 491 patients in UltIMMa-2 were randomly assigned to receive 150 mg risankizumab (n=294), 45 mg or 90 mg ustekinumab (n=99), or placebo (n=98). Co-primary endpoints were met for both studies. At week 16 of UltIMMa-1, PASI 90 was achieved by 229 (75·3%) patients receiving risankizumab versus five (4·9%) receiving placebo (placebo-adjusted difference 70·3% [95% CI 64·0-76·7]) and 42 (42·0%) receiving ustekinumab (ustekinumab-adjusted difference 33·5% [22·7-44·3]; p<0·0001 vs placebo and ustekinumab). At week 16 of UltIMMa-2, PASI 90 was achieved by 220 (74·8%) patients receiving risankizumab versus two (2·0%) receiving placebo (placebo-adjusted difference 72·5% [95% CI 66·8-78·2]) and 47 (47·5%) receiving ustekinumab (ustekinumab-adjusted difference 27·6% [16·7-38·5]; p<0·0001 vs placebo and ustekinumab). In UltIMMa-1, sPGA 0 or 1 at week 16 was achieved by 267 (87·8%) patients receiving risankizumab versus eight (7·8%) receiving placebo (placebo-adjusted difference 79·9% [95% CI 73·5-86·3]) and 63 (63·0%) receiving ustekinumab (ustekinumab-adjusted difference 25·1% [15·2-35·0]; p<0·0001 vs placebo and ustekinumab). In UltIMMa-2, 246 (83·7%) patients receiving risankizumab versus five (5·1%) receiving placebo (placebo-adjusted difference 78·5% [95% CI 72·4-84·5]) and 61 (61·6%) receiving ustekinumab achieved sPGA 0 or 1 at week 16 (ustekinumab-adjusted difference 22·3% [12·0-32·5]; p<0·0001 vs placebo and ustekinumab). The frequency of treatment-emergent adverse events in UltIMMa-1 and UltIMMa-2 was similar across risankizumab (part A: 151 [49·7%] of 304 and 134 [45·6%] of 294; part B: 182 [61·3%] of 297 and 162 [55·7%] of 291), placebo (part A: 52 [51·0%] of 102 and 45 [45·9%] of 98), ustekinumab (part A: 50 [50·0%] of 100 and 53 [53·5%] of 99; part B: 66 [66·7%] of 99 and 70 [74·5%] of 94), and placebo to risankizumab (part B: 65 [67·0%] of 97 and 61 [64·9%] of 94) treatment groups throughout the study duration. INTERPRETATION: Risankizumab showed superior efficacy to both placebo and ustekinumab in the treatment of moderate-to-severe plaque psoriasis. Treatment-emergent adverse event profiles were similar across treatment groups and there were no unexpected safety findings. FUNDING: AbbVie and Boehringer Ingelheim.

22 Clinical Trial Anxiety and depression in patients with moderate-to-severe psoriasis and comparison of change from baseline after treatment with guselkumab vs. adalimumab: results from the Phase 3 VOYAGE 2 study. 2018

Gordon, K B / Armstrong, A W / Han, C / Foley, P / Song, M / Wasfi, Y / You, Y / Shen, Y-K / Reich, K. ·Medical College of Wisconsin, Milwaukee, WI, USA. · University of Southern California, Los Angeles, CA, USA. · Janssen Research & Development, LLC, Spring House, PA, USA. · The University of Melbourne, St. Vincent's Hospital Melbourne, Skin & Cancer Foundation Inc., Carlton, VIC, Australia. · Dermatologikum Berlin, Berlin, Germany. ·J Eur Acad Dermatol Venereol · Pubmed #29706008.

ABSTRACT: BACKGROUND: Anxiety and depression are clinically significant comorbidities associated with psoriasis. Improvements in psoriasis are known to decrease anxiety and depression. Guselkumab, an anti-interleukin-23 monoclonal antibody, has demonstrated efficacy and safety for the treatment of moderate-to-severe psoriasis. OBJECTIVE: Assess improvements in anxiety and depression with guselkumab vs. placebo and adalimumab using the Hospital Anxiety and Depression Scale (HADS). METHODS: In VOYAGE 2, a Phase 3, randomized, double-blind, placebo- and adalimumab-controlled study, patients received placebo (through week 16 followed by crossover to guselkumab), guselkumab, or adalimumab through week 24. HADS consists of two subscales measuring anxiety (HADS-A) and depression (HADS-D), with scores ranging from 0 to 21 and higher scores indicating more severe symptoms. Scores ≥8 indicate instrument-defined anxiety or depression. Severity of psoriasis was assessed using the Psoriasis Area and Severity Index (PASI). RESULTS: Among 989 patients randomized (with baseline HADS measurements), mean HADS-A and HADS-D scores were 6.8 ± 4.2 and 5.3 ± 4.2, respectively; 38.6% of patients reported HADS-A ≥8 and 27.7% HADS-D ≥8 at baseline. At week 16, a significantly greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (51.4% vs. 25.9%; P < 0.001) or HADS-D <8 (59.2% vs. 27.0%; P < 0.001) vs. placebo patients. At week 24, a greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (58.4% vs. 42.9%; P = 0.028) or HADS-D <8 (59.8% vs. 46.4%; P = 0.079) vs. adalimumab patients. PASI improvements correlated with improvement in anxiety (r = 0.27; P < 0.0001) and depression (r = 0.25; P < 0.0001) scores in patients with baseline HADS-A or HADS-D ≥8. Greater improvements in HADS were also observed at week 16 in guselkumab-treated patients vs. placebo using a more stringent cut-off of HADS ≥11. CONCLUSION: Guselkumab treatment was associated with greater improvements in symptoms of anxiety and depression scores in patients with psoriasis compared with placebo and adalimumab.

23 Clinical Trial Efficacy and safety of ixekizumab over 4 years of open-label treatment in a phase 2 study in chronic plaque psoriasis. 2018

Zachariae, Claus / Gordon, Kenneth / Kimball, Alexandra B / Lebwohl, Mark / Blauvelt, Andrew / Leonardi, Craig / Braun, Daniel / McKean-Matthews, Missy / Burge, Russel / Cameron, Gregory. ·University Hospital of Copenhagen Gentofte, Copenhagen, Denmark. Electronic address: claus.zachariae@regionh.dk. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Harvard Medical School, Boston, Massachusetts. · Mount Sinai Medical Center, New York, New York. · Oregon Medical Research Center, Portland, Oregon. · Department of Dermatology, Saint Louis University School of Medicine, St. Louis, Missouri. · Eli Lilly and Company, Indianapolis, Indiana. · Syneos Health, Ann Arbor, Michigan. ·J Am Acad Dermatol · Pubmed #29653208.

ABSTRACT: BACKGROUND: Ixekizumab has demonstrated improvement in patients with moderate-to-severe psoriasis by selectively targeting interleukin-17A, which is a proinflammatory cytokine that is important in the pathogenesis of psoriasis. OBJECTIVE: To report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial. METHODS: Analysis was by last observation carried forward. Patients received ixekizumab, 120 mg, and then 80 mg subcutaneously once every 4 weeks. RESULTS: Of the patients who completed the randomized placebo-controlled trial, 93% entered the OLE. A 75% reduction in the Psoriasis Area Severity Index score was reported in 82% of patients at week 208 of the OLE. A static Physician's Global Assessment score of 0 or 1 was reported in 64% of patients, and a score of 0 was reported in 45% at week 208. Patients' Dermatology Life Quality Index and Itch Visual Analog Scale scores decreased when compared with baseline. Improvements were observed in other efficacy and health outcome measures. Serious adverse events were observed in 16.7% of patients, and 87% had 1 or more treatment-emergent adverse events. Three patients had serious infections. One patient reported 2 major cardiovascular events. LIMITATIONS: The study was unblinded and lacked a placebo or active comparator. CONCLUSIONS: Efficacy was shown to be maintained for up to 4 years of ixekizumab treatment.

24 Clinical Trial Long-term optimization of outcomes with flexible adalimumab dosing in patients with moderate to severe plaque psoriasis. 2018

Gniadecki, R / Leonardi, C L / Gordon, K B / Gu, Y / Geng, Z / Nader, A / Teixeira, H D. ·Division of Dermatology, Faculty of Medicine, University of Alberta, Edmonton, AB, Canada. · Department of Dermatology, University of Copenhagen, Bispebjerg Hospital, Copenhagen, Denmark. · Saint Louis University Medical School, St. Louis, MO, USA. · Medical College of Wisconsin, Milwaukee, WI, USA. · AbbVie Inc., North Chicago, IL, USA. ·J Eur Acad Dermatol Venereol · Pubmed #29524255.

ABSTRACT: BACKGROUND: The recently updated dosing recommendation for adalimumab for moderate to severe plaque psoriasis states that patients with inadequate response to adalimumab every other week (EOW) after 16 weeks may benefit from an increase in dosing frequency to 40 mg every week (EW). OBJECTIVE: To determine the long-term efficacy of adalimumab in patients with psoriasis with flexibility to escalate and de-escalate between EOW and EW dosing. METHODS: Data from an open-label study in patients with psoriasis who had received adalimumab in phase 2/3 studies and their extensions were included. Patients initially received 40 mg adalimumab EOW for 24 weeks. From weeks 24-252, patients whose Psoriasis Area and Severity Index response was <50% (PASI 50) could have their dose-escalated to 40 mg EW and were re-evaluated at 6 and 12 weeks and then every 12 weeks thereafter. Patients who had their dose-escalated and achieved a PASI 75 response were de-escalated to EOW and could re-escalate to EW if response fell below PASI 50 again; no further de-escalation was allowed. Changes in PASI scores were reported at the last visit before dose escalation or de-escalation. RESULTS: By week 24, 64.1% of patients in the overall population (n = 1256) achieved ≥PASI 75 response, 40.3% ≥PASI 90 response and 21.7% PASI 100 response. Patients who had a Optimizing therapy by temporarily increasing the dosing of adalimumab to EW in patients with psoriasis and an inadequate response to adalimumab 40 mg EOW permitted the achievement and long-term maintenance of clinical improvement.

25 Clinical Trial Improvement in itch and other psoriasis symptoms with brodalumab in phase 3 randomized controlled trials. 2018

Gottlieb, A B / Gordon, K / Hsu, S / Elewski, B / Eichenfield, L F / Kircik, L / Rastogi, S / Pillai, R / Israel, R. ·New York Medical College, at Metropolitan Hospital, New York, NY, USA. · Medical College of Wisconsin, Milwaukee, WI, USA. · Temple University School of Medicine, Philadelphia, PA, USA. · University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA. · University of California, San Diego School of Medicine and Rady Children's Hospital, San Diego, CA, USA. · Icahn School of Medicine at Mount Sinai, New York, NY, USA. · Ortho Dermatologics, Bridgewater, NJ, USA. · Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals North America LLC), Petaluma, CA, USA. · Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA. ·J Eur Acad Dermatol Venereol · Pubmed #29512200.

ABSTRACT: BACKGROUND: Patients with psoriasis have lesional symptoms, including itch, which can reduce quality of life. The efficacy and safety of brodalumab, an interleukin-17 receptor A antagonist, in treating moderate-to-severe psoriasis have been reported in three randomized, controlled, phase 3 trials (AMAGINE-1/-2/-3). OBJECTIVE: The effect of brodalumab on lesional symptoms was assessed using the psoriasis symptom inventory (PSI), a validated patient-reported instrument. METHODS: Patients were randomized to receive brodalumab (140 or 210 mg every 2 weeks [Q2W]), placebo (AMAGINE-1/-2/-3), or ustekinumab (AMAGINE-2/-3) during a 12-week induction phase, followed by a maintenance phase through week 52. Patients electronically rated the severity of PSI items (itch, burning, stinging, pain, redness, scaling, cracking and flaking) during the previous 24 h on a scale of 0 (not at all severe) to 4 (very severe). At each visit, the PSI total score responder status was assessed, with responders defined as having an average weekly total inventory score ≤8 with no item score >1 at week 12. RESULTS: Across AMAGINE-1/-2/-3, brodalumab was associated with improvements in PSI total scores and itch scores vs. placebo from week 2 through week 12 (P < 0.001 in both domains). In AMAGINE-2/-3, brodalumab 210 mg Q2W demonstrated faster onset of PSI total score and itch responses (week 2, 22.1% and 36.4%, respectively) vs. ustekinumab (week 2, 6.9% and 17.1%, respectively) and was associated with improved itch responses vs. ustekinumab after 52 weeks of constant treatment. CONCLUSION: Brodalumab demonstrated rapid, robust improvements in symptoms assessed by the PSI, including itch, vs. placebo and ustekinumab.

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