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Psoriasis: HELP
Articles by Craig L. Leonardi
Based on 72 articles published since 2008
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Between 2008 and 2019, C. Leonardi wrote the following 72 articles about Psoriasis.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 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.

2 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.

3 Guideline European S3-guidelines on the systemic treatment of psoriasis vulgaris. 2009

Pathirana, D / Ormerod, A D / Saiag, P / Smith, C / Spuls, P I / Nast, A / Barker, J / Bos, J D / Burmester, G-R / Chimenti, S / Dubertret, L / Eberlein, B / Erdmann, R / Ferguson, J / Girolomoni, G / Gisondi, P / Giunta, A / Griffiths, C / Hönigsmann, H / Hussain, M / Jobling, R / Karvonen, S-L / Kemeny, L / Kopp, I / Leonardi, C / Maccarone, M / Menter, A / Mrowietz, U / Naldi, L / Nijsten, T / Ortonne, J-P / Orzechowski, H-D / Rantanen, T / Reich, K / Reytan, N / Richards, H / Thio, H B / van de Kerkhof, P / Rzany, B. · ·J Eur Acad Dermatol Venereol · Pubmed #19712190.

ABSTRACT: Of the 131 studies on monotherapy or combination therapy assessed, 56 studies on the different forms of phototherapy fulfilled the criteria for inclusion in the guidelines. Approximately three-quarters of all patients treated with phototherapy attained at least a PASI 75 response after 4 to 6 weeks, and clearance was frequently achieved (levels of evidence 2 and 3). Phototherapy represents a safe and very effective treatment option for moderate to severe forms of psoriasis vulgaris. The onset of clinical effects occurs within 2 weeks. Of the unwanted side effects, UV erythema from overexposure is by far the most common and is observed frequently. With repeated or long-term use, the consequences of high, cumulative UV doses (such as premature aging of the skin) must be taken into consideration. In addition, carcinogenic risk is associated with oral PUVA and is probable for local PUVA and UVB. The practicability of the therapy is limited by spatial, financial, human, and time constraints on the part of the physician, as well as by the amount of time required by the patient. From the perspective of the cost-bearing institution, phototherapy has a good cost-benefit ratio. However, the potentially significant costs for, and time required of, the patient must be considered.

4 Guideline Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. 2008

Gottlieb, Alice / Korman, Neil J / Gordon, Kenneth B / Feldman, Steven R / Lebwohl, Mark / Koo, John Y M / Van Voorhees, Abby S / Elmets, Craig A / Leonardi, Craig L / Beutner, Karl R / Bhushan, Reva / Menter, Alan. ·Department of Dermatology, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA. ·J Am Acad Dermatol · Pubmed #18423261.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this second of 5 sections of the guidelines of care for psoriasis, we give an overview of psoriatic arthritis including its cardinal clinical features, pathogenesis, prognosis, classification, assessment tools used to evaluate psoriatic arthritis, and the approach to treatment. Although patients with mild to moderate psoriatic arthritis may be treated with nonsteroidal anti-inflammatory drugs and/or intra-articular steroid injections, the use of disease-modifying antirheumatic drugs, particularly methotrexate, along with the biologic agents, are considered the standard of care in patients with more significant psoriatic arthritis. We will discuss the use of disease-modifying antirheumatic drugs and the biologic therapies in the treatment of patients with moderate to severe psoriatic arthritis.

5 Guideline Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. 2008

Menter, Alan / Gottlieb, Alice / Feldman, Steven R / Van Voorhees, Abby S / Leonardi, Craig L / Gordon, Kenneth B / Lebwohl, Mark / Koo, John Y M / Elmets, Craig A / Korman, Neil J / Beutner, Karl R / Bhushan, Reva. ·Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #18423260.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this first of 5 sections of the guidelines of care for psoriasis, we discuss the classification of psoriasis; associated comorbidities including autoimmune diseases, cardiovascular risk, psychiatric/psychologic issues, and cancer risk; along with assessment tools for skin disease and quality-of-life issues. Finally, we will discuss the safety and efficacy of the biologic treatments used to treat patients with psoriasis.

6 Editorial Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. 2012

Strober, Bruce E / Armour, Katherine / Romiti, Ricardo / Smith, Catherine / Tebbey, Paul W / Menter, Alan / Leonardi, Craig. ·Department of Dermatology, University of Connecticut School of Medicine, Farmington, Connecticut 06032, USA. strober@uchc.edu ·J Am Acad Dermatol · Pubmed #22243723.

ABSTRACT: The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide.

7 Review From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. 2017

Armstrong, April W / Siegel, Michael P / Bagel, Jerry / Boh, Erin E / Buell, Megan / Cooper, Kevin D / Callis Duffin, Kristina / Eichenfield, Lawrence F / Garg, Amit / Gelfand, Joel M / Gottlieb, Alice B / Koo, John Y M / Korman, Neil J / Krueger, Gerald G / Lebwohl, Mark G / Leonardi, Craig L / Mandelin, Arthur M / Menter, M Alan / Merola, Joseph F / Pariser, David M / Prussick, Ronald B / Ryan, Caitriona / Shah, Kara N / Weinberg, Jeffrey M / Williams, MaryJane O U / Wu, Jashin J / Yamauchi, Paul S / Van Voorhees, Abby S. ·Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: aprilarmstrong@post.harvard.edu. · National Psoriasis Foundation, Portland, Oregon. · Windsor Dermatology, East Windsor, New Jersey; University Medical Center of Princeton at Plainsboro, Plainsboro, New Jersey. · Tulane University School of Medicine, New Orleans, Louisiana. · University Hospitals Case Medical Center, Cleveland, Ohio. · University of Utah School of Medicine, Salt Lake City, Utah. · University of California, San Diego School of Medicine, La Jolla, California. · Northwell Health and Hofstra North Shore University Hospital, Long Island Jewish Medical Center School of Medicine, Manhasset, New York. · University of Pennsylvania, Philadelphia, Pennsylvania. · Tufts University School of Medicine, Boston, Massachusetts. · University of California San Francisco Medical Center, San Francisco, California. · Icahn School of Medicine at Mount Sinai, New York, New York. · St Louis University Medical School, St Louis, Missouri. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Baylor University Medical Center and Texas A&M Health Science Center, Dallas, Texas. · Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. · Eastern Virginia Medical School, Norfolk, Virginia; Virginia Clinical Research Inc, Norfolk, Virginia. · George Washington University, Washington, District of Columbia. · Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. · Keck School of Medicine, University of Southern California, Los Angeles, California. · Kaiser Permanente Los Angeles Medical Center, Los Angeles, California. · Division of Dermatology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California. · Eastern Virginia Medical School, Norfolk, Virginia. ·J Am Acad Dermatol · Pubmed #27908543.

ABSTRACT: BACKGROUND: An urgent need exists in the United States to establish treatment goals in psoriasis. OBJECTIVE: We aim to establish defined treatment targets toward which clinicians and patients with psoriasis can strive to inform treatment decisions, reduce disease burden, and improve outcomes in practice. METHODS: The National Psoriasis Foundation conducted a consensus-building study among psoriasis experts using the Delphi method. The process consisted of: (1) literature review, (2) pre-Delphi question selection and input from general dermatologists and patients, and (3) 4 Delphi rounds. RESULTS: A total of 25 psoriasis experts participated in the Delphi process. The most preferred instrument was body surface area (BSA). The most preferred time for evaluating patient response after starting new therapies was at 3 months. The acceptable response at 3 months postinitiation was either BSA 3% or less or BSA improvement 75% or more from baseline. The target response at 3 months postinitiation was BSA 1% or less. During the maintenance period, evaluation every 6 months was most preferred. The target response at every 6 months maintenance evaluation is BSA 1% or less. LIMITATIONS: Although BSA is feasible in practice, it does not encompass health-related quality of life, costs, and risks of side effects. CONCLUSION: With defined treatment targets, clinicians and patients can regularly evaluate treatment responses and perform benefit-risk assessments of therapeutic options individualized to the patient.

8 Review Antibodies in the Treatment of Psoriasis: IL-12/23 p40 and IL-17a. 2016

Leonardi, Craig L. · ·Semin Cutan Med Surg · Pubmed #27551698.

ABSTRACT: The anti-tumor necrosis factor (TNF)-α agents represent the second generation of psoriasis therapy. Research has produced a third generation of biologic treatments, some of which offer greater efficacy than the TNF-α inhibitors. This article reviews the data documenting the efficacy and safety of three types of biologics.

9 Review Ten years on: the impact of biologics on the practice of dermatology. 2015

Leonardi, Craig L / Romiti, Ricardo / Tebbey, Paul W. ·Saint Louis University School of Medicine, 1034 South Brentwood Boulevard, Suite 600, St Louis, MO 63117-1206, USA. Electronic address: Craig.leonardi@centralderm.com. · University of São Paulo, São Paulo, Brazil. · International Psoriasis Council, St Louis, MO, USA. ·Dermatol Clin · Pubmed #25412787.

ABSTRACT: This review delivers a commentary on the first decade of biologics' use in psoriasis and provides a glimpse of the pipeline of therapies currently in development for psoriasis that will enhance the therapeutic armamentarium available to the dermatologist. In addition, the authors revisit the rationale for the development of biological therapies, inventory the available therapies of today, and retrospectively assess their impact on the dermatology practice as it relates to the management of patients with psoriasis.

10 Review Therapeutic development in psoriasis. 2014

Sobell, Jeffrey M / Leonardi, Craig L. ·Assistant Professor of Dermatology, Tufts School of Medicine; Director, Psoriasis Treatment Center, Skincare Physicians, Chestnut Hill, MA. · Clinical Professor of Dermatology, Saint Louis University Central Dermatology, St Louis, MO. ·Semin Cutan Med Surg · Pubmed #25268599.

ABSTRACT: Advances in molecular biology have provided the basis for development of new therapeutic approaches to psoriasis. New, more effective therapies target specific molecules in the inflammatory cascade involved in the pathogenesis of psoriasis.The biologic era of psoriasis therapy began with inhibitors of T-cell activation, tumor necrosis factor-α, and interleukin (IL)-12/23. Continued investigation has led to therapies and therapeutic candidates that target IL-17, IL-23, phosphodiesterase-4, and isomers of Janus kinase.

11 Review Research gaps in psoriasis: opportunities for future studies. 2014

Ryan, Caitriona / Korman, Neil J / Gelfand, Joel M / Lim, Henry W / Elmets, Craig A / Feldman, Steven R / Gottlieb, Alice B / Koo, John Y M / Lebwohl, Mark / Leonardi, Craig L / Van Voorhees, Abby S / Bhushan, Reva / Menter, Alan. ·Psoriasis Research Center, Baylor University Medical Center, Dallas, Texas. · Department of Dermatology, Murdough Family Center for Psoriasis, University Hospitals Case Medical Center, Cleveland, Ohio. · Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · Department of Dermatology, University of Alabama at Birmingham, Birmingham, Alabama. · Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina. · Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts. · Department of Dermatology, University of California-San Francisco, California. · Department of Dermatology, Mount Sinai School of Medicine, New York, New York. · Saint Louis University, St Louis, Missouri. · Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania. · American Academy of Dermatology, Schaumburg, Illinois. Electronic address: rbhushan@aad.org. ·J Am Acad Dermatol · Pubmed #24126079.

ABSTRACT: Over the past 2 decades, considerable progress has been made to further elucidate the complex pathogenesis of psoriasis, facilitating the development of a new armamentarium of more effective, targeted therapies. Despite these important advances, substantial deficits remain in our understanding of psoriasis and its treatment, necessitating further research in many areas. In the sixth section of the American Academy of Dermatology Psoriasis Guidelines of Care, gaps in research and care were identified. We discuss the most important gaps in research that currently exist and make suggestions for studies that should be performed to address these deficits. These encompass both basic science and clinical research studies, including large, prospective epidemiologic studies to determine the true prevalence and natural history of psoriasis; further molecular studies in patients with psoriatic and psoriatic arthritis to understand the function of psoriasis susceptibility genes and to identify novel therapeutic targets; studies to examine the role of environmental factors in the development of psoriasis; further investigation of the relationship between psoriasis and cardiometabolic disease; studies that examine the role of adjunctive therapies such as psychological interventions in appropriate patient groups; and finally, studies to identify biomarkers of disease severity and treatment response to optimize patient therapy.

12 Review The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. 2011

Leonardi, Craig / Papp, Kim / Strober, Bruce / Reich, Kristian / Asahina, Akihiko / Gu, Yihua / Beason, Joseph / Rozzo, Stephen / Tyring, Stephen. ·Central Dermatology, St. Louis, MO 63117, USA. Craig.Leonardi@centralderm.com ·Am J Clin Dermatol · Pubmed #21834597.

ABSTRACT: BACKGROUND: A favorable benefit-risk profile has been established for adalimumab, with up to 5 years of treatment in 13 clinical trials in patients with moderate to severe chronic plaque psoriasis. OBJECTIVE: The aim of this analysis was to assess the long-term safety of all adalimumab exposure in all psoriasis clinical trials. METHODS: A total of six sets of data were analyzed as follows: (i) all cumulative safety data from all exposure for all adalimumab-treated patients in the 13 clinical trials in moderate to severe psoriasis (All Adalimumab Treatment Population) through April 2007, November 2008, and November 2009, respectively; (ii) longitudinal data for 1403 patients treated with adalimumab 40 mg every other week (eow) dosing (Every Other Week Population) through June 2007 and April 2010; and (iii) data from placebo-controlled periods of clinical trials. Adverse events that occurred up to 70 days after the final dose of adalimumab were analyzed. RESULTS: During placebo-controlled periods, a total of 572 patients had 173.0 patient-years (PYs) of exposure to placebo and 1188 patients had 370.5 PYs of exposure to adalimumab. Adverse event incidence rates, expressed as events per 100 PYs (events/100 PYs), for placebo- and adalimumab-treated patients for serious adverse events were 7.52 and 8.64, and for serious infectious adverse events were 2.89 and 2.43, respectively. In the 2007, 2008, and 2009 All Adalimumab Treatment Population there were, respectively, 1819 patients (2424.7 PYs), 2197 patients (4351.9 PYs), and 3010 patients (4844.7 PYs), with serious adverse event incidence rates of 6.51, 7.22, and 8.36 events/100 PYs, and serious infectious adverse event rates of 1.32, 1.38, and 1.65 events/100 PYs. In the 2007 and 2010 Every Other Week Population (n = 1403), there were 1883.5 and 2854.1 total PYs of exposure, respectively, with serious adverse event incidence rates of 6.32 and 6.87 events/100 PYs, and serious infectious adverse event rates of 1.33 and 1.37 events/100 PYs, respectively. CONCLUSIONS: Multiple lines of evidence from a total of six sets of safety data, with treatment for up to 5 years, including results from all adalimumab-treated patients, and a subset of patients treated with 40 mg eow dosing, did not show evidence of cumulative toxicity, and showed adverse event rates that were generally stable or decreased with increased mean per-patient exposure.

13 Review Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. 2011

Anonymous2160686 / Menter, Alan / Korman, Neil J / Elmets, Craig A / Feldman, Steven R / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice / Koo, John Y M / Lebwohl, Mark / Leonardi, Craig L / Lim, Henry W / Van Voorhees, Abby S / Beutner, Karl R / Ryan, Caitriona / Bhushan, Reva. ·Psoriasis Research Center, Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #21306785.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In the first 5 parts of the American Academy of Dermatology Psoriasis Guidelines of Care, we have presented evidence supporting the use of topical treatments, phototherapy, traditional systemic agents, and biological therapies for patients with psoriasis and psoriatic arthritis. In this sixth and final section of the Psoriasis Guidelines of Care, we will present cases to illustrate how to practically use these guidelines in specific clinical scenarios. We will describe the approach to treating patients with psoriasis across the entire spectrum of this fascinating disease from mild to moderate to severe, with and without psoriatic arthritis, based on the 5 prior published guidelines. Although specific therapeutic recommendations are given for each of the cases presented, it is important that treatment be tailored to meet individual patients' needs. In addition, we will update the prior 5 guidelines and address gaps in research and care that currently exist, while making suggestions for further studies that could be performed to help address these limitations in our knowledge base.

14 Review Etanercept: an evolving role in psoriasis and psoriatic arthritis. 2010

Prodanovich, Srdjan / Ricotti, Carlos / Glick, Brad P / Inverardi, Luca / Leonardi, Craig L / Kerdel, Francisco. ·Florida Academic Dermatology Centers, 1400 NW 12th Avenue, 33136 Miami, FL, USA. ·Am J Clin Dermatol · Pubmed #20586498.

ABSTRACT: Tumor necrosis factor alpha (TNFalpha) plays a key pathophysiological role in psoriasis and psoriatic arthritis (PsA). Recent interest has thus focused on the clinical potential of TNFalpha antagonists (e.g. etanercept) in these settings. In psoriasis, several large pooled analyses and well-designed clinical trials documented the significant clinical efficacy and generally favorable tolerability of etanercept for up to 96 weeks. Similarly, in PsA, a large phase III trial showed that, etanercept significantly reduced arthritic symptoms and inhibited radiographic disease progression; sustained clinical benefit was again evident for up to 2 years. Etanercept is at the forefront of psoriatic disease management, and continued evolution and evaluation of the compound - for example, in detailed comparative studies and economic analyses - is likely to confirm a key role for etanercept in the treatment of psoriasis and PsA.

15 Review Alefacept for psoriasis. 2010

Heffernan, Michael P / Leonardi, Craig L. ·Central Dermatology, St. Louis, MO 63117, USA. heffernan@centralderm.com ·Semin Cutan Med Surg · Pubmed #20430308.

ABSTRACT: -- No abstract --

16 Clinical Trial Maintenance of skin clearance with ixekizumab treatment of psoriasis: Three-year results from the UNCOVER-3 study. 2018

Leonardi, Craig / Maari, Catherine / Philipp, Sandra / Goldblum, Orin / Zhang, Lu / Burkhardt, Nicole / Ball, Susan / Mallbris, Lotus / Gonzalez, Pablo / Fernández-Peñas, Pablo / Puig, Luis. ·Central Dermatology, St. Louis, Missouri. Electronic address: Craig.Leonardi@centralderm.com. · Innovaderm Research Inc, Montreal, Quebec, Canada; Medical University of Graz, Graz, Austria. · Charité Universitätsmedizin Berlin, Berlin, Germany. · Eli Lilly and Company, Indianapolis, Indiana. · Buenos Aires Skin SA, Buenos Aires, Argentina. · Department of Dermatology, Westmead Hospital Dermatology Service, The University of Sydney, Westmead, Australia. · Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. ·J Am Acad Dermatol · Pubmed #29803904.

ABSTRACT: BACKGROUND: Psoriasis is a chronic disease that may require long-term treatment. Ixekizumab (IXE), which is a high-affinity monoclonal antibody that selectively targets interleukin 17A, is an approved therapy for patients with moderate-to-severe plaque psoriasis. OBJECTIVE: To evaluate the efficacy and safety of IXE through 156 weeks from the UNCOVER-3 study in patients who were treated with the recommended dose regimen (160 mg of IXE at week 0, 80 mg every 2 weeks up to week 12, and 80 mg every 4 weeks thereafter). METHODS: Patients randomized to IXE every 2 weeks, IXE every 4 weeks, etanercept twice weekly, or placebo were switched to IXE every 4 weeks during the long-term extension period. Efficacy data were summarized by using the as-observed, multiple imputation, and modified nonresponder imputation methods. RESULTS: At week 156, 80.5% of patients had achieved at least a 75% improvement from baseline in their Psoriasis Area Severity Index (PASI) score, 66.0% had achived at least a 90% improvement from baseline in their PASI score, and 45.1% had achieved a 100% improvement from baseline in their PASI score with use of the modified nonresponder imputation method, and 97.2% and 86.2% of patients had achived at least a 75% improvement from baseline in their PASI score with use of the as-observed and multiple imputation methods, respectively. Similar response rates were observed in patients with baseline scalp, nail, or palmoplantar involvement. No new safety signals were identified through year 3. LIMITATIONS: No placebo or active comparison after week 12. CONCLUSION: IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.

17 Clinical Trial Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). 2018

Gottlieb, Alice B / Blauvelt, Andrew / Thaçi, Diamant / Leonardi, Craig L / Poulin, Yves / Drew, Janice / Peterson, Luke / Arendt, Catherine / Burge, Daniel / Reich, Kristian. ·New York Medical College at Metropolitan Hospital, New York, New York. Electronic address: gottlieba@nychhc.org. · Oregon Medical Research Center, Portland, Oregon. · Comprehensive Centre Inflammation Medicine, University Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany. · Central Dermatology, St. Louis, Missouri; Saint Louis University School of Medicine, St. Louis, Missouri. · Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada. · Dermira, Inc, Menlo Park, California. · UCB Pharma, Raleigh, North Carolina. · UCB Pharma, Brussels, Belgium. · Dermatologikum Hamburg, Hamburg, Germany; SCIderm Research Institute, Hamburg, Germany. ·J Am Acad Dermatol · Pubmed #29660421.

ABSTRACT: BACKGROUND: Certolizumab pegol, the only Fc-free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. OBJECTIVE: Assess certolizumab efficacy and safety versus placebo in phase 3 studies. METHODS: Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and ≥2-point improvement. Safety was assessed by treatment-emergent adverse events. RESULTS: Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. LIMITATION: There was no active comparator. CONCLUSION: Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.

18 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.

19 Clinical Trial Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. 2018

Ryan, Caitriona / Sobell, Jeffrey M / Leonardi, Craig L / Lynde, Charles W / Karunaratne, Mahinda / Valdecantos, Wendell C / Hendrickson, Barbara A. ·Department of Dermatology, Blackrock Clinic, Co. Dublin, Ireland. caitrionaryan80@gmail.com. · Department of Dermatology, Tufts University School of Medicine, Boston, MA, USA. · Department of Dermatology, St. Louis University, St. Louis, MO, USA. · Department of Medicine, University of Toronto, Toronto, ON, Canada. · AbbVie Inc., North Chicago, IL, USA. ·Am J Clin Dermatol · Pubmed #29380251.

ABSTRACT: BACKGROUND: Adalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions. OBJECTIVE: Our objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications. METHODS: The safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study). RESULTS: No new safety risks or increased rates of particular adverse events (AEs) were identified with EW dosing. In patients with HS or psoriasis, the overall safety of adalimumab 40-mg EOW and EW was generally comparable. In studies of adalimumab for non-dermatologic indications, including Crohn's disease, ulcerative colitis, and rheumatoid arthritis, the overall AE rates were similar for EW and EOW dosing. CONCLUSION: In patients with HS or psoriasis, the safety of adalimumab EW and EOW was comparable and consistent with the expected adalimumab AE profile. The safety of adalimumab EW dosing in patients with dermatologic conditions is supported by data comparing adalimumab EW and EOW dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00918255, NCT01468207, NCT01468233, NCT00645814, NCT00077779, NCT00055497, NCT01070303, NCT00195715, NCT00348283, NCT00385736, NCT00408629, and NCT00573794.

20 Clinical Trial Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR). 2017

Blauvelt, A / Ferris, L K / Yamauchi, P S / Qureshi, A / Leonardi, C L / Farahi, K / Fakharzadeh, S / Hsu, M-C / Li, S / Chevrier, M / Smith, K / Goyal, K / Chen, Y / Muñoz-Elías, E J / Callis Duffin, K. ·Oregon Medical Research Center, Portland, OR, U.S.A. · Department of Dermatology, University of Pittsburgh, Pittsburgh, PA, U.S.A. · Dermatology Institute and Skin Care Center, Santa Monica, CA, U.S.A. · Geffen School of Medicine at UCLA, Los Angeles, CA, U.S.A. · Dermatology, Warren Alport Medical School of Brown University, Rhode Island Hospital, Providence, RI, U.S.A. · Dermatology, Saint Louis University School of Medicine, Saint Louis, MO, U.S.A. · Janssen Pharmaceuticals Inc., Horsham, PA, U.S.A. · Janssen Research & Development LLC, Spring House, PA, U.S.A. · Janssen Research & Development LLC, Titusville, NJ, U.S.A. · Janssen Research & Development LLC, Horsham, PA, U.S.A. · Janssen Research & Development LLC, San Diego, CA, U.S.A. · Dermatology, University of Utah, Salt Lake City, UT, U.S.A. ·Br J Dermatol · Pubmed #28600818.

ABSTRACT: BACKGROUND: Phase III studies showed that some patients maintained response for ≥ 6 months following ustekinumab discontinuation. OBJECTIVES: To assess clinical responses with extended ustekinumab maintenance dosing intervals. METHODS: Adults with moderate-to-severe plaque psoriasis received ustekinumab at weeks 0, 4 and 16 during open-label treatment. Patients achieving a week-28 Physician's Global Assessment (PGA) score of cleared/minimal (PGA = 0/1) were randomized 1 : 4 to group 1 [approved every 12 weeks (q12 wk) maintenance] or group 2 (q12-24 wk; response-based dosing determined by time to loss of PGA = 0/1). Key end points included the number of visits with PGA = 0/1 (primary end point) and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) between weeks 88 and 112, and PGA/PASI responses between weeks 28 and 112. RESULTS: Overall, 378 patients achieved PGA = 0/1 at week 28 and were randomized to group 1 (n = 76) or group 2 (n = 302). Patients in group 1 had numerically greater mean numbers of visits with PGA = 0/1 than group 2 and also with PASI 75 from week 88 to 112. A higher proportion of patients in group 1 (55%) than group 2 (39%) had PGA = 0/1 at all seven visits from week 88 to 112. Maintenance of response was observed with dose-interval extension beyond q12 wk in a subset of patients. Extending the dosing interval did not affect antibody development or safety. CONCLUSIONS: Efficacy was better maintained among week-28 PGA responders randomized to continue q12 wk ustekinumab vs. extending maintenance dosing based on clinical response, although some patients maintained high levels of efficacy with up to q24 wk dosing.

21 Clinical Trial The effect of bodyweight on the efficacy and safety of ixekizumab: results from an integrated database of three randomised, controlled Phase 3 studies of patients with moderate-to-severe plaque psoriasis. 2017

Reich, K / Puig, L / Mallbris, L / Zhang, L / Osuntokun, O / Leonardi, C. ·Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany. · Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. · Eli Lilly and Company, Indianapolis, IN, USA. · St. Louis University School of Medicine, St. Louis, MO, USA. ·J Eur Acad Dermatol Venereol · Pubmed #28370467.

ABSTRACT: BACKGROUND: There is concern that increased bodyweight may impact efficacy of some therapies used to treat psoriasis. OBJECTIVE: To evaluate the effect of bodyweight on response to ixekizumab treatment in patients with moderate-to-severe psoriasis. METHODS: Patients were characterized under three bodyweight categories (<80 kg, 80 to <100 kg, ≥100 kg) in this preplanned subgroup analysis from an integrated database of three multicenter, randomised, double-blind, controlled Phase 3 clinical studies (UNCOVER-1, UNCOVER-2 and UNCOVER-3). In the first 12 weeks of each study, patients were randomly assigned to receive subcutaneous placebo, 80-mg ixekizumab every 2 weeks (IXE Q2W) or every 4 weeks (IXE Q4W) after a starting dose of 160-mg ixekizumab, or 50-mg etanercept twice weekly (UNCOVER-2 and UNCOVER-3 only). RESULTS: This analysis included 3855 patients with baseline bodyweight in the IXE Q4W (N = 1159), IXE Q2W (N = 1168), placebo (N = 789) and etanercept (N = 739) groups. Distribution of patients across bodyweight categories was similar between treatment groups. Baseline demographics and patients characteristics were generally consistent across treatment groups within each bodyweight category. Across all bodyweight categories, a significantly higher percentage of patients treated with IXE Q2W or IXE Q4W than with placebo or etanercept achieved PASI 75, PASI 90 or PASI 100 at Week 12. No meaningful differences in PASI 75 response rates were observed across bodyweight categories. Some numerical differences in PASI 90 and PASI 100 response rates were observed between bodyweight categories with IXE Q2W providing numerically higher response rates than IXE Q4W. The incidence of treatment-emergent adverse events was similar in the treatment groups and across bodyweight categories. CONCLUSION: Ixekizumab was efficacious in the treatment of moderate-to-severe psoriasis regardless of bodyweight. The safety profile of ixekizumab was also similar across bodyweight categories, and no safety signals were identified specific to any of the bodyweight categories.

22 Clinical Trial Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. 2017

Paul, Carle / Leonardi, Craig / Menter, Alan / Reich, Kristian / Gold, Linda Stein / Warren, Richard B / Møller, Anders / Lebwohl, Mark. ·Paul Sabatier University and Larrey Hospital, Toulouse, France. · Saint Louis University School of Medicine, St. Louis, MO, USA. · Baylor University Medical Center, Dallas, TX, USA. · Dermatologikum Hamburg and SCIderm GmbH, Hamburg, Germany. · Henry Ford Health System, Detroit, MI, USA. · The Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. · LEO Pharma A/S, Ballerup, Denmark. · Department of Dermatology, Icahn School of Medicine at Mount Sinai, 5 E 98th St, New York, NY, 10029, USA. lebwohl@aol.com. ·Am J Clin Dermatol · Pubmed #28236223.

ABSTRACT: BACKGROUND: Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy. OBJECTIVE: The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study. METHODS: Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index. RESULTS: Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001). CONCLUSION: Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS. GOV IDENTIFIER: NCT02132936.

23 Clinical Trial Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3). 2017

Reich, Kristian / Leonardi, Craig / Lebwohl, Mark / Kerdel, Francisco / Okubo, Yukari / Romiti, Ricardo / Goldblum, Orin / Dennehy, Ellen B / Kerr, Lisa / Sofen, Howard. ·a Dermatologikum Hamburg and SCIderm GmbH , Hamburg , Germany. · b Department of Dermatology , Saint Louis University School of Medicine , St Louis , MO , USA. · c Department of Dermatology , Icahn School of Medicine at Mount Sinai , New York , NY , USA. · d Florida Academic Dermatology Center , Miami , FL , USA. · e Department of Dermatology , Tokyo Medical University , Shinjuku , Tokyo , Japan. · f Department of Dermatology Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo , São Paulo , Brazil. · g Eli Lilly and Company , Indianapolis , IN , USA. · h Department of Medicine, Division of Dermatology , UCLA David Geffen School of Medicine , Los Angeles , CA , USA. ·J Dermatolog Treat · Pubmed #27759463.

ABSTRACT: BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVE: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224) and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every two weeks (Q2W) or every four weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg bi-weekly etanercept through Week 12. Patients entering the open-label long-term extension (LTE) (UNCOVER-3) received ixekizumab Q4W; UNCOVER-1 and UNCOVER-2 included a blinded maintenance period in which static physician global assessment (sPGA) 0/1 responders were re-randomized to placebo, ixekizumab Q4W, or 80 mg ixekizumab every 12 weeks (Q12W) through Week 60. RESULTS: In patients with moderate-to-severe psoriasis with baseline scalp involvement, PSSI 90 and 100 were achieved at Week 12 in higher percentages of patients treated with ixekizumab Q2W (81.7% and 74.6%) or ixekizumab Q4W (75.6% and 68.9%) compared with patients treated with placebo (7.6% and 6.7%; p < .001 each ixekizumab arm versus placebo) or etanercept (55.5% and 48.1%; p < .001 each ixekizumab arm versus etanercept). These outcomes were maintained through Week 60 of the maintenance (UNCOVER-1 and UNCOVER-2) and LTE (UNCOVER-3) period in patients who continued on ixekizumab Q4W. CONCLUSION: Ixekizumab was efficacious in treating scalp psoriasis in patients with moderate-to-severe psoriasis, with most patients achieving complete or near-complete resolution of scalp psoriasis and maintaining this response over 60 weeks.

24 Clinical Trial The Aerosol Foam Formulation of the Fixed Combination Calcipotriene Plus Betamethasone Dipropionate Improves the Health-Related Quality of Life in Patients With Psoriasis Vulgaris: Results from the Randomized PSO-FAST Study. 2016

Leonardi, Craig / Bagel, Jerry / Yamauchi, Paul / Pariser, David / Xu, Zhenyi / Moller, Anders / Osterdal, Marie Louise / Stein Gold, Linda. · ·J Drugs Dermatol · Pubmed #27537999.

ABSTRACT: INTRODUCTION: Psoriasis has a major impact on patient quality of life, similar to that seen in other chronic diseases, eg, diabetes. Health-related quality of life (HRQoL) measures are commonly included in clinical trial designs, capturing the disease burden and therapeutic success of a treatment. In the randomized, double-blind, phase III PSO-FAST (Psoriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study (nCT01866163), fixed combination calcipotriene (Cal) 0.005% plus betamethasone dipropionate (BD) 0.064% aerosol foam was compared with vehicle. By treatment end, 53% of patients using Cal/BD foam achieved treatment success.
OBJECTIVE: To compare the impact on HRQoL of Cal/BD foam vs vehicle in patients with mild-to-severe psoriasis.
METHOD: HRQoL was assessed by dermatology life-quality index (DLQI; baseline, weeks 1, 2, 4) and EQ-5D-5L (EQ-5D; baseline, week 4) questionnaires. A DLQI score of 0 (range, 0-30) indicates no effect on the patient's life; an EQ-5D utility score of 1 (range, 0-1) and an EQ-5D visual analog scale (VAS) score of 100 (range, 1-100) indicate perfect health.
RESULTS: 426 patients were randomized (Cal/BD foam, n=323; vehicle, n=103). Baseline mean DLQI scores were 9.9 (Cal/BD foam) and 10.3 (vehicle). The impact of psoriasis on HRQoL (EQ-5D utility score) at baseline was primarily driven by pain/discomfort (Cal/BD foam: 69.9%; vehicle: 65.0%) and anxiety/depression (Cal/BD foam: 45.3%; vehicle 44.7%). There was a greater improvement from baseline in DLQI score for Cal/BD foam vs vehicle at week 4 (-7.0 vs -4.4; P<.001); increased improvement was also seen in EQ-5D scores. At week 4, 48.1% of patients using Cal/BD foam reported no effect of psoriasis on their lives (DLQI = 0/1), and of patients using Cal/BD foam with baseline DLQI scores ≥5, 81.2% achieved a ≥5-point improvement.
CONCLUSION: Cal/BD aerosol foam improved HRQoL after 4 weeks, with most patients experiencing a clinically meaningful improvement and almost 50% reporting no impairment.

J Drugs Dermatol. 2016;15(8):981-987.

25 Clinical Trial Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. 2016

Gordon, Kenneth B / Blauvelt, Andrew / Papp, Kim A / Langley, Richard G / Luger, Thomas / Ohtsuki, Mamitaro / Reich, Kristian / Amato, David / Ball, Susan G / Braun, Daniel K / Cameron, Gregory S / Erickson, Janelle / Konrad, Robert J / Muram, Talia M / Nickoloff, Brian J / Osuntokun, Olawale O / Secrest, Roberta J / Zhao, Fangyi / Mallbris, Lotus / Leonardi, Craig L / Anonymous3690871 / Anonymous3700871 / Anonymous3710871. ·From the Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago (K.B.G.) · Oregon Medical Research Center, Portland (A.B.) · K. Papp Clinical Research and Probity Medical Research, Waterloo, ON (K.A.P.), and the Department of Medicine, Division of Dermatology, Dalhousie University, Halifax, NS (R.G.L.) - both in Canada · the Department of Dermatology, University of Münster, Münster (T.L.), and SCIderm Research Institute and Dermatologikum Hamburg, Hamburg (K.R.) - both in Germany · the Department of Dermatology, Jichi Medical University, Shimotsuke-shi, Japan (M.O.) · Lilly Research Laboratories, Eli Lilly, Indianapolis (D.A., S.G.B., D.K.B., G.S.C., J.E., R.J.K., T.M.M., B.J.N., O.O.O., R.J.S., F.Z., L.M.) · and the Department of Dermatology, Saint Louis University School of Medicine, St. Louis (C.L.L.). ·N Engl J Med · Pubmed #27299809.

ABSTRACT: BACKGROUND: Two phase 3 trials (UNCOVER-2 and UNCOVER-3) showed that at 12 weeks of treatment, ixekizumab, a monoclonal antibody against interleukin-17A, was superior to placebo and etanercept in the treatment of moderate-to-severe psoriasis. We report the 60-week data from the UNCOVER-2 and UNCOVER-3 trials, as well as 12-week and 60-week data from a third phase 3 trial, UNCOVER-1. METHODS: We randomly assigned 1296 patients in the UNCOVER-1 trial, 1224 patients in the UNCOVER-2 trial, and 1346 patients in the UNCOVER-3 trial to receive subcutaneous injections of placebo (placebo group), 80 mg of ixekizumab every 2 weeks after a starting dose of 160 mg (2-wk dosing group), or 80 mg of ixekizumab every 4 weeks after a starting dose of 160 mg (4-wk dosing group). Additional cohorts in the UNCOVER-2 and UNCOVER-3 trials were randomly assigned to receive 50 mg of etanercept twice weekly. At week 12 in the UNCOVER-3 trial, the patients entered a long-term extension period during which they received 80 mg of ixekizumab every 4 weeks through week 60; at week 12 in the UNCOVER-1 and UNCOVER-2 trials, the patients who had a response to ixekizumab (defined as a static Physicians Global Assessment [sPGA] score of 0 [clear] or 1 [minimal psoriasis]) were randomly reassigned to receive placebo, 80 mg of ixekizumab every 4 weeks, or 80 mg of ixekizumab every 12 weeks through week 60. Coprimary end points were the percentage of patients who had a score on the sPGA of 0 or 1 and a 75% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at week 12. RESULTS: In the UNCOVER-1 trial, at week 12, the patients had better responses to ixekizumab than to placebo; in the 2-wk dosing group, 81.8% had an sPGA score of 0 or 1 and 89.1% had a PASI 75 response; in the 4-wk dosing group, the respective rates were 76.4% and 82.6%; and in the placebo group, the rates were 3.2% and 3.9% (P<0.001 for all comparisons of ixekizumab with placebo). In the UNCOVER-1 and UNCOVER-2 trials, among the patients who were randomly reassigned at week 12 to receive 80 mg of ixekizumab every 4 weeks, 80 mg of ixekizumab every 12 weeks, or placebo, an sPGA score of 0 or 1 was maintained by 73.8%, 39.0%, and 7.0% of the patients, respectively. Patients in the UNCOVER-3 trial received continuous treatment of ixekizumab from weeks 0 through 60, and at week 60, at least 73% had an sPGA score of 0 or 1 and at least 80% had a PASI 75 response. Adverse events reported during ixekizumab use included neutropenia, candidal infections, and inflammatory bowel disease. CONCLUSIONS: In three phase 3 trials involving patients with psoriasis, ixekizumab was effective through 60 weeks of treatment. As with any treatment, the benefits need to be weighed against the risks of adverse events. The efficacy and safety of ixekizumab beyond 60 weeks of treatment are not yet known. (Funded by Eli Lilly; UNCOVER-1, UNCOVER-2, and UNCOVER-3 ClinicalTrials.gov numbers NCT01474512, NCT01597245, and NCT01646177, respectively.).

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