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Psoriasis: HELP
Articles from Utah
Based on 93 articles published since 2008
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These are the 93 published articles about Psoriasis that originated from Utah during 2008-2019.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Guideline 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty. 2017

Goodman, Susan M / Springer, Bryan / Guyatt, Gordon / Abdel, Matthew P / Dasa, Vinod / George, Michael / Gewurz-Singer, Ora / Giles, Jon T / Johnson, Beverly / Lee, Steve / Mandl, Lisa A / Mont, Michael A / Sculco, Peter / Sporer, Scott / Stryker, Louis / Turgunbaev, Marat / Brause, Barry / Chen, Antonia F / Gililland, Jeremy / Goodman, Mark / Hurley-Rosenblatt, Arlene / Kirou, Kyriakos / Losina, Elena / MacKenzie, Ronald / Michaud, Kaleb / Mikuls, Ted / Russell, Linda / Sah, Alexander / Miller, Amy S / Singh, Jasvinder A / Yates, Adolph. ·Susan M. Goodman, MD, Lisa A. Mandl, MD, MPH, Peter Sculco, MD, Barry Brause, MD, Kyriakos Kirou, MD, Ronald MacKenzie, MD, Linda Russell, MD: Hospital for Special Surgery/Weill Cornell Medicine, New York, New York. Electronic address: goodmans@hss.edu. · Bryan Springer, MD: OrthoCarolina Hip and Knee Center, Charlotte, North Carolina. · Gordon Guyatt, MD: McMaster University, Hamilton, Ontario, Canada. · Matthew P. Abdel, MD: Mayo Clinic, Rochester, Minnesota. · Vinod Dasa, MD: Louisiana State University, New Orleans. · Michael George, MD: University of Pennsylvania, Philadelphia. · Ora Gewurz-Singer, MD: University of Michigan, Ann Arbor. · Jon T. Giles, MD, MPH: Columbia University, New York, New York. · Beverly Johnson, MD: Albert Einstein College of Medicine, Bronx, New York. · Steve Lee, DO: Kaiser Permanente, Fontana, California. · Susan M. Goodman, MD, Lisa A. Mandl, MD, MPH, Peter Sculco, MD, Barry Brause, MD, Kyriakos Kirou, MD, Ronald MacKenzie, MD, Linda Russell, MD: Hospital for Special Surgery/Weill Cornell Medicine, New York, New York. · Michael A. Mont, MD: Cleveland Clinic, Cleveland, Ohio. · Scott Sporer, MD: Midwest Orthopaedics at Rush, Chicago, Illinois. · Louis Stryker, MD: University of Texas Medical Branch, Galveston. · Marat Turgunbaev, MD, MPH, Amy S. Miller: American College of Rheumatology, Atlanta, Georgia. · Antonia F. Chen, MD, MBA: Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. · Jeremy Gililland, MD: University of Utah, Salt Lake City. · Mark Goodman, MD, Adolph Yates, MD: University of Pittsburgh, Pittsburgh, Pennsylvania. · Arlene Hurley-Rosenblatt, ANP: Rockefeller University, New York, New York. · Elena Losina, PhD: Brigham and Women's Hospital, Boston, Massachusetts. · Kaleb Michaud, PhD: National Data Bank for Rheumatic Diseases, Wichita, Kansas and University of Nebraska Medical Center, Omaha. · Ted Mikuls, MD, MSPH: University of Nebraska Medical Center, Omaha. · Alexander Sah, MD: Dearborn-Sah Institute for Joint Restoration, Fremont, California. · Jasvinder A. Singh, MBBS, MPH: University of Alabama at Birmingham. ·J Arthroplasty · Pubmed #28629905.

ABSTRACT: OBJECTIVE: This collaboration between the American College of Rheumatology and the American Association of Hip and Knee Surgeons developed an evidence-based guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA). METHODS: A panel of rheumatologists, orthopedic surgeons specializing in hip and knee arthroplasty, and methodologists was convened to construct the key clinical questions to be answered in the guideline. A multi-step systematic literature review was then conducted, from which evidence was synthesized for continuing versus withholding antirheumatic drug therapy and for optimal glucocorticoid management in the perioperative period. A Patient Panel was convened to determine patient values and preferences, and the Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of evidence and the strength of recommendations, using a group consensus process through a convened Voting Panel of rheumatologists and orthopedic surgeons. The strength of the recommendation reflects the degree of certainty that benefits outweigh harms of the intervention, or vice versa, considering the quality of available evidence and the variability in patient values and preferences. RESULTS: The guideline addresses the perioperative use of antirheumatic drug therapy including traditional disease-modifying antirheumatic drugs, biologic agents, tofacitinib, and glucocorticoids in adults with RA, SpA, JIA, or SLE who are undergoing elective THA or TKA. It provides recommendations regarding when to continue, when to withhold, and when to restart these medications, and the optimal perioperative dosing of glucocorticoids. The guideline includes 7 recommendations, all of which are conditional and based on low- or moderate-quality evidence. CONCLUSION: This guideline should help decision-making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high-quality direct randomized controlled trial data.

2 Guideline 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty. 2017

Goodman, Susan M / Springer, Bryan / Guyatt, Gordon / Abdel, Matthew P / Dasa, Vinod / George, Michael / Gewurz-Singer, Ora / Giles, Jon T / Johnson, Beverly / Lee, Steve / Mandl, Lisa A / Mont, Michael A / Sculco, Peter / Sporer, Scott / Stryker, Louis / Turgunbaev, Marat / Brause, Barry / Chen, Antonia F / Gililland, Jeremy / Goodman, Mark / Hurley-Rosenblatt, Arlene / Kirou, Kyriakos / Losina, Elena / MacKenzie, Ronald / Michaud, Kaleb / Mikuls, Ted / Russell, Linda / Sah, Alexander / Miller, Amy S / Singh, Jasvinder A / Yates, Adolph. ·Hospital for Special Surgery/Weill Cornell Medicine, New York, New York. · OrthoCarolina Hip and Knee Center, Charlotte, North Carolina. · McMaster University, Hamilton, Ontario, Canada. · Mayo Clinic, Rochester, Minnesota. · Louisiana State University, New Orleans. · University of Pennsylvania, Philadelphia. · University of Michigan, Ann Arbor. · Columbia University, New York, New York. · Albert Einstein College of Medicine, Bronx, New York. · Kaiser Permanente, Fontana, California. · Cleveland Clinic, Cleveland, Ohio. · Midwest Orthopaedics at Rush, Chicago, Illinois. · University of Texas Medical Branch, Galveston. · American College of Rheumatology, Atlanta, Georgia. · Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. · University of Utah, Salt Lake City. · University of Pittsburgh, Pittsburgh, Pennsylvania. · Rockefeller University, New York, New York. · Brigham and Women's Hospital, Boston, Massachusetts. · National Data Bank for Rheumatic Diseases, Wichita, Kansas, and University of Nebraska Medical Center, Omaha. · University of Nebraska Medical Center, Omaha. · Dearborn-Sah Institute for Joint Restoration, Fremont, California. · University of Alabama at Birmingham. ·Arthritis Rheumatol · Pubmed #28620948.

ABSTRACT: OBJECTIVE: This collaboration between the American College of Rheumatology and the American Association of Hip and Knee Surgeons developed an evidence-based guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA). METHODS: A panel of rheumatologists, orthopedic surgeons specializing in hip and knee arthroplasty, and methodologists was convened to construct the key clinical questions to be answered in the guideline. A multi-step systematic literature review was then conducted, from which evidence was synthesized for continuing versus withholding antirheumatic drug therapy and for optimal glucocorticoid management in the perioperative period. A Patient Panel was convened to determine patient values and preferences, and the Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of evidence and the strength of recommendations, using a group consensus process through a convened Voting Panel of rheumatologists and orthopedic surgeons. The strength of the recommendation reflects the degree of certainty that benefits outweigh harms of the intervention, or vice versa, considering the quality of available evidence and the variability in patient values and preferences. RESULTS: The guideline addresses the perioperative use of antirheumatic drug therapy including traditional disease-modifying antirheumatic drugs, biologic agents, tofacitinib, and glucocorticoids in adults with RA, SpA, JIA, or SLE who are undergoing elective THA or TKA. It provides recommendations regarding when to continue, when to withhold, and when to restart these medications, and the optimal perioperative dosing of glucocorticoids. The guideline includes 7 recommendations, all of which are conditional and based on low- or moderate-quality evidence. CONCLUSION: This guideline should help decision-making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high-quality direct randomized controlled trial data.

3 Review Dactylitis: A hallmark of psoriatic arthritis. 2018

Kaeley, Gurjit S / Eder, Lihi / Aydin, Sibel Z / Gutierrez, Marwin / Bakewell, Catherine. ·University of Florida College of Medicine, 653-1 West 8th St., LRC 2nd Floor L-14, Jacksonville, FL 32209. Electronic address: Gurjit.Kaeley@jax.ufl.edu. · Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Canada. · University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. · Division of Musculoskeletal and Rheumatic Diseases, Instituto Nacional de Rehabilitación, Mexico City, Mexico. · Intermountain Healthcare, Salt Lake City, UT. ·Semin Arthritis Rheum · Pubmed #29573849.

ABSTRACT: OBJECTIVE: Dactylitis-long considered a hallmark clinical feature of psoriatic arthritis (PsA)-occurs in 16-49% of patients with PsA. In this review, we discuss the pathology of dactylitis in PsA and clinical and imaging tools used to diagnose and monitor dactylitis. METHODS: PubMed literature searches were conducted using the terms psoriatic arthritis, dactylitis, pathology, imaging, ultrasound, magnetic resonance imaging, clinical, and indices. Articles were deemed relevant if they provided insight into the pathology, diagnosis, and/or monitoring of dactylitis in PsA, or if they discussed clinical or imaging indices used to assess dactylitis. RESULTS: Dactylitis in PsA often occurs asymmetrically, involves the feet more than the hands, and affects multiple digits simultaneously. Although dactylitis can be assessed clinically, imaging (radiography, ultrasound, magnetic resonance imaging, and bone scintigraphy) has provided key insights by documenting the various anatomic targets affected. Although inflammation can occur in most of the digital compartments, the nail has not been as well studied in dactylitic digits. Outcome measures for dactylitis range from dichotomous documentation to the Leeds dactylometer. Imaging outcome tools utilizing magnetic resonance imaging or ultrasound are under development. CONCLUSION: Dactylitis, which is associated with more erosive forms of PsA, is often the inaugural feature of PsA and may be the only feature for months to years. Early diagnosis and treatment of PsA favors better outcomes, possibly mitigating radiographic progression and destructive changes. Ultrasound and magnetic resonance imaging are useful tools that have not only shed light on the diverse tissues affected in dactylitis but can also be used to document ongoing inflammation. Ultrasound imaging dactylitis scores are being developed that will assist in diagnosing and documenting which compartments optimally respond to various treatment modalities.

4 Review Enthesitis: A hallmark of psoriatic arthritis. 2018

Kaeley, Gurjit S / Eder, Lihi / Aydin, Sibel Z / Gutierrez, Marwin / Bakewell, Catherine. ·Division of Rheumatology, University of Florida College of Medicine, Jacksonville, 653-1 West 8th St., LRC 2nd Floor L-14, Jacksonville, FL, 32209. Electronic address: Gurjit.Kaeley@jax.ufl.edu. · Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, Canada. · University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. · Division of Musculoskeletal and Rheumatic Diseases, Instituto Nacional de Rehabilitación, Mexico City, Mexico. · Intermountain Healthcare, Salt Lake City, UT. ·Semin Arthritis Rheum · Pubmed #29429762.

ABSTRACT: OBJECTIVE: To describe the growing importance of enthesitis in patients with psoriatic arthritis (PsA) and discuss the advantages and disadvantages of clinical and imaging methods currently used to assess enthesitis. METHODS: PubMed literature searches were conducted using the terms psoriatic arthritis, entheses, enthesitis, pathology, imaging, ultrasound, magnetic resonance imaging, clinical, and indices. Articles were deemed relevant if they provided insight into the pathology, monitoring, and/or diagnosis of enthesitis in PsA, or if they discussed clinical or imaging indices used to assess enthesitis. RESULTS: Enthesitis is an early manifestation of PsA that is associated with increased disease activity and reduced quality of life. A variety of clinical indices exist to assess enthesitis in PsA; however, the Leeds Enthesitis Index and Maastricht Ankylosing Spondylitis Enthesitis Score index have been the most frequently used indices in recent clinical trials. Limitations of these indices include an inability to discern structural involvement, risk of missing subclinical enthesitis, and lack of sensitivity in detecting enthesitis, especially in patients with central sensitization and/or pain amplification. Such limitations have led to the emergent importance of imaging techniques in the assessment of enthesitis. Although there have been recent advances in magnetic resonance imaging, ultrasound (US) appears to be the preferred method for detecting enthesitis because it allows for accurate assessment of the soft-tissue components of entheses and also for new bone formation. Hypoechogenicity, increased thickness of tendon insertion, calcifications, enthesophytes, erosions, and Doppler activity have been identified as important US characteristics of enthesitis. CONCLUSION: Enthesitis is thought to be integrally involved in the pathogenesis of PsA and is associated with worse prognostic outcomes in patients with PsA. A validated US index with entheses that are less confounded by mechanical factors and obesity would be the most effective measure of enthesitis in PsA. As imaging techniques continue to advance, our understanding of enthesitis and its involvement in PsA will also improve.

5 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.

6 Review microRNAs in Psoriasis. 2016

Hawkes, Jason E / Nguyen, Giang Huong / Fujita, Mayumi / Florell, Scott R / Callis Duffin, Kristina / Krueger, Gerald G / O'Connell, Ryan M. ·Department of Dermatology, University of Utah, Salt Lake City, Utah, USA. · Department of Dermatology, University of Colorado, Aurora, Colorado, USA. · Department of Pathology, University of Utah, Salt Lake City, Utah, USA. Electronic address: ryan.oconnell@path.utah.edu. ·J Invest Dermatol · Pubmed #26802234.

ABSTRACT: Psoriasis is a chronic inflammatory skin condition resulting from a complex interplay among the immune system, keratinocytes, susceptibility genes, and environmental factors. However, the pathogenesis of psoriasis is not completely elucidated. microRNAs represent a promising class of small, noncoding RNA molecules that function to regulate gene expression. Although microRNA research in psoriasis and dermatology is still relatively new, evidence is rapidly accumulating for the role of microRNAs in the pathogenesis of psoriasis and other chronic inflammatory conditions. In this article, we present a comprehensive review of what is known about microRNAs and their role in the pathogenesis of psoriasis.

7 Review Effect of tonsillectomy on psoriasis: a systematic review. 2015

Rachakonda, Tara D / Dhillon, Jaskaran S / Florek, Aleksandra G / Armstrong, April W. ·Department of Internal Medicine, University of Utah, Salt Lake City, Utah. · Department of Dermatology, University of California at Davis School of Medicine, Sacramento, California. · Department of Dermatology, University of Colorado at Denver, Anschutz Medical Campus, Aurora, Colorado. · Department of Dermatology, University of Colorado at Denver, Anschutz Medical Campus, Aurora, Colorado. Electronic address: aprilarmstrong@post.harvard.edu. ·J Am Acad Dermatol · Pubmed #25455609.

ABSTRACT: BACKGROUND: Streptococcal infection is associated with psoriasis onset in some patients. Whether tonsillectomy decreases psoriasis symptoms requires a systematic review of the literature. OBJECTIVE: We sought to determine whether tonsillectomy reduces psoriasis severity through a comprehensive search of over 50 years of literature. METHODS: We searched MEDLINE, CINAHL, Cochrane, EMBASE, Web of Science, and OVID databases (from August 1, 1960, to September 12, 2013) and performed a manual search of selected references. We identified observational studies and clinical trials examining psoriasis after tonsillectomy. RESULTS: We included data from 20 articles from the last 53 years with 545 patients with psoriasis who were evaluated for or underwent tonsillectomy. Of 410 reported cases of patients with psoriasis who underwent tonsillectomy, 290 experienced improvement in their psoriasis. Although some patients who underwent tonsillectomy experienced sustained improvement in psoriasis, others experienced psoriasis relapse after the procedure. LIMITATIONS: Fifteen of 20 publications were case reports or series that lacked control groups. Publication bias favoring reporting improved cases needs to be considered. CONCLUSION: Tonsillectomy may be a potential option for patients with recalcitrant psoriasis associated with episodes of tonsillitis. Studies with long-term follow-up are warranted to determine more clearly the extent and persistence of benefit of tonsillectomy in psoriasis.

8 Review Diet and psoriasis, part III: role of nutritional supplements. 2014

Millsop, Jillian W / Bhatia, Bhavnit K / Debbaneh, Maya / Koo, John / Liao, Wilson. ·Department of Dermatology, University of California, San Francisco, California; University of Utah School of Medicine, Salt Lake City, Utah. · Department of Dermatology, University of California, San Francisco, California; Rush Medical College, Rush University Medical Center, Chicago, Illinois. · Department of Dermatology, University of California, San Francisco, California; University of California, Irvine, School of Medicine, Irvine, California. · Department of Dermatology, University of California, San Francisco, California. · Department of Dermatology, University of California, San Francisco, California. Electronic address: LiaoWi@derm.ucsf.edu. ·J Am Acad Dermatol · Pubmed #24780177.

ABSTRACT: Patients with psoriasis are increasingly turning to the use of alternative and complementary medicine to manage their psoriasis. Patients often inquire about what dietary supplements may be beneficial, including the use of oral vitamin D, vitamin B12, selenium, and omega-3 fatty acids in fish oils. In this review we examine the extent to which each of these common nutritional interventions has been studied for the treatment of psoriasis. We weighed evidence from both controlled and uncontrolled prospective trials. The evidence of benefit was highest for fish oils. For other supplements, there is need for additional large, randomized clinical trials to establish evidence of efficacy.

9 Review Diet and psoriasis, part II: celiac disease and role of a gluten-free diet. 2014

Bhatia, Bhavnit K / Millsop, Jillian W / Debbaneh, Maya / Koo, John / Linos, Eleni / Liao, Wilson. ·Department of Dermatology, University of California, San Francisco, California; Rush Medical College, Rush University Medical Center, Chicago, Illinois. · Department of Dermatology, University of California, San Francisco, California; University of Utah School of Medicine, Salt Lake City, Utah. · Department of Dermatology, University of California, San Francisco, California; University of California, Irvine, School of Medicine, Irvine, California. · Department of Dermatology, University of California, San Francisco, California. · Department of Dermatology, University of California, San Francisco, California. Electronic address: liaowi@derm.ucsf.edu. ·J Am Acad Dermatol · Pubmed #24780176.

ABSTRACT: Patients with psoriasis have been shown to have a higher prevalence of other autoimmune diseases including celiac disease, a condition marked by sensitivity to dietary gluten. A number of studies suggest that psoriasis and celiac disease share common genetic and inflammatory pathways. Here we review the epidemiologic association between psoriasis and celiac disease and perform a meta-analysis to determine whether patients with psoriasis more frequently harbor serologic markers of celiac disease. We also examine whether a gluten-free diet can improve psoriatic skin disease.

10 Review Psoriasis and risk of venous thromboembolism: a systematic review and meta-analysis. 2014

Ungprasert, Patompong / Sanguankeo, Anawin / Upala, Sikarin / Suksaranjit, Promporn. ·From the Department of Medicine, Faculty of Medicine Siriraj Hospital, Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang road, Bangkok, 10700, Thailand and Department of Cardiology, University of Utah, School of Medicine, 30 N 1900 E, Salt Lake City, Utah, 84132, USA patompong.ungprasert@bassett.org. · From the Department of Medicine, Faculty of Medicine Siriraj Hospital, Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang road, Bangkok, 10700, Thailand and Department of Cardiology, University of Utah, School of Medicine, 30 N 1900 E, Salt Lake City, Utah, 84132, USA. ·QJM · Pubmed #24713224.

ABSTRACT: BACKGROUND: Several chronic inflammatory disorders, such as rheumatoid arthritis and systemic lupus erythematosus, have been shown to increase venous thromboembolism (VTE) risk but the data on psoriasis is unclear. METHODS: We conducted a systematic review and meta-analysis of observational studies that reported odds ratio, relative risk, hazard ratio or standardized incidence ratio comparing VTE risk in patients with psoriasis vs. non-psoriasis participants. Pooled risk ratio and 95% confidence intervals were calculated using a random effect, generic inverse variance method. RESULT: Four studies were identified and included in our data analysis. The pooled risk ratio of VTE in patients with psoriasis was 1.46 (95% CI, 1.29-1.66). The statistical heterogeneity of this meta-analysis was high with an I(2) of 86%. CONCLUSION: Our study demonstrated a statistically significant increased VTE risk among patients with psoriasis.

11 Review Diet and psoriasis, part I: Impact of weight loss interventions. 2014

Debbaneh, Maya / Millsop, Jillian W / Bhatia, Bhavnit K / Koo, John / Liao, Wilson. ·Department of Dermatology, University of California, San Francisco, California; University of California, Irvine, School of Medicine, Irvine, California. Electronic address: Maya.debbaneh@gmail.com. · Department of Dermatology, University of California, San Francisco, California; University of Utah School of Medicine, Salt Lake City, Utah. · Department of Dermatology, University of California, San Francisco, California; Rush Medical College, Rush University Medical Center, Chicago, Illinois. · Department of Dermatology, University of California, San Francisco, California. ·J Am Acad Dermatol · Pubmed #24709272.

ABSTRACT: One of the most frequently asked questions by patients with psoriasis is whether dietary changes can improve their condition. Included in this discussion is whether dietary weight loss can benefit their skin disease. Obesity has been associated with a proinflammatory state and several studies have demonstrated a relationship between body mass index and psoriasis severity. However, the question of whether weight loss interventions can impact psoriasis outcome is less clear. Here, we review the literature to examine the efficacy of weight loss interventions, both dietary and surgical, on psoriasis disease course.

12 Review Development of a disease activity and responder index for psoriatic arthritis--report of the Psoriatic Arthritis Module at OMERACT 11. 2014

Coates, Laura C / FitzGerald, Oliver / Mease, Philip J / Gladman, Dafna D / Strand, Vibeke / Goel, Niti / Campbell, Ina / Krueger, Gerald / McHugh, Neil J / Helliwell, Philip S. ·From the Division of Rheumatic and Musculoskeletal Disease, University of Leeds, UK; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute, University College Dublin, Dublin, Ireland; Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, Washington, USA; Division of Rheumatology, Department of Medicine, University of Toronto, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Immunology/Rheumatology, Stanford University, Palo Alto, California; Division of Rheumatology, Department of Medicine, Duke University Medical Center, Durham, and General Medicine Therapeutic Delivery Unit, Quintiles, Morrisville, North Carolina; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal National Hospital for Rheumatic Diseases and University of Bath, Bath, UK. ·J Rheumatol · Pubmed #24488420.

ABSTRACT: This module reflected work within the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) to develop and validate composite disease activity measures in psoriatic arthritis (PsA). At the Outcome Measures in Rheumatology (OMERACT) 8 Meeting, a core set of domains to be assessed in randomized controlled trials (RCT) and longitudinal observational studies of PsA was agreed upon. At OMERACT 10, 5 proposed composite responder definitions for PsA were reviewed and discussed, including new data from the GRACE (GRAppa Composite Exercise) study. At OMERACT 11, ongoing retrospective analyses of RCT data using the 3 proposed measures (Composite Psoriatic Disease Activity Index, Psoriatic Arthritis Disease Activity Score, and Arithmetic Mean of the Desirability Function) were discussed in detail. There was agreement that developing composite outcome measures for use in RCT and longitudinal observational studies in PsA was important. Concerns were expressed regarding development of a single measure that encompassed diverse domains, such as joint counts, quality of life (QOL), and disability measures. It was emphasized that the use of any composite measure should include the ability to differentiate between activity in individual domains, such as enthesitis or psoriasis, such that the effect of each could be assessed independently. It was also agreed that patients would be systematically involved in further development and refinement of composite measures. Future plans include qualitative work with patients to explore their experience of disease activity and statistical modeling to explore how each of the proposed measures will perform in different disease subgroups.

13 Review Ustekinumab: a review in the treatment of plaque psoriasis and psoriatic arthritis. 2012

Zaghi, Daniel / Krueger, Gerald G / Callis Duffin, Kristina. ·Department of Dermatology, School of Medicine, University of Utah School of Medicine, Salt Lake City, UT 84132, USA. daniel.zaghi@hsc.utah.edu ·J Drugs Dermatol · Pubmed #22270196.

ABSTRACT: Psoriasis is a complex, multigenic immune/inflammatory-mediated disorder that variably affects the skin, nails, and joints. In September 2009, ustekinumab (Stelara®), a monoclonal antibody that targets interleukin 12 (IL-12) and 23 (IL-23), was approved in the United States for treatment of moderate-to-severe plaque psoriasis. The drug's mechanism of action is derived from extensive immunologic and genomic research identifying IL-12 and IL-23 of the Th1 and Th17 inflammatory pathways, respectively, as key mediators of psoriasis. Ustekinumab is a completely human monoclonal antibody to the shared p40 subunit of IL-12 and IL-23. The drug has demonstrated efficacy, short-term safety, and convenience of use in the treatment of plaque psoriasis and psoriatic arthritis. Though long-term safety concerns remain, ustekinumab adds to the current treatment armamentarium and holds promise to improve quality of life. This is a concise and current review of ustekinumab in the treatment of plaque psoriasis and psoriatic arthritis, with focus on data from the seven published clinical trials.

14 Review Genetic variations in cytokines and cytokine receptors associated with psoriasis found by genome-wide association. 2009

Duffin, Kristina Callis / Krueger, Gerald G. ·Department of Dermatology, School of Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah 84132-2409, USA. kcallis@derm.med.utah.edu ·J Invest Dermatol · Pubmed #18830267.

ABSTRACT: Genetic variants have long been suspected to be important in psoriasis. Recent work has suggested that HLA-Cw6 on chromosome 6 is the risk variant in the PSORS1 [MIM 177900] susceptibility locus that confers the greatest risk for early onset of psoriasis. Although numerous minor susceptibility loci have been identified by linkage analysis, few biologically relevant candidates have been discovered within these intervals. Recent large-scale genome-wide association studies have yielded new candidates in genes encoding cytokines with functional relevance to psoriasis. Polymorphisms within the genes encoding the IL-12 p40 subunit, IL12B, and one of the IL-23 receptor subunits, IL23R, have been replicated in US and European populations and overlap with risk of Crohn's disease. Polymorphisms within the gene encoding IL-13, a Th2 cytokine, also confer risk for psoriasis. Variants of the gene IL15 encoding IL-15 have been identified that associate with psoriasis in a Chinese population. These discoveries pose the challenge of elucidating the role of common genetic variants in susceptibility to and manifestations of psoriasis.

15 Review Genetics of psoriasis and psoriatic arthritis: update and future direction. 2008

Duffin, Kristina Callis / Chandran, Vinod / Gladman, Dafna D / Krueger, Gerald G / Elder, James T / Rahman, Proton. ·Department of Dermatology, University of Utah, Salt Lake City, Utah, USA. ·J Rheumatol · Pubmed #18609743.

ABSTRACT: Psoriasis and psoriatic arthritis (PsA) both have substantive genetic determinants. Numerous candidate regions and genes have now been replicated in disease susceptibility, and to a lesser extent in disease expression, in both disease entities. Intensive efforts are now under way or are being planned to perform genome-wide association scans (GWAS) in psoriasis and PsA. A major determinant of success for GWAS is likely to be accumulation of multiple large well-phenotyped cohorts, sophisticated data management, and verification of the findings. At the 2007 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members of the GRAPPA genetics committee presented a discussion of the genetics of psoriasis and PsA, including future trends. This article is a summary of that presentation and a review of the literature.

16 Clinical Trial Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). 2018

Nash, Peter / Ohson, Kamal / Walsh, Jessica / Delev, Nikolay / Nguyen, Dianne / Teng, Lichen / Gómez-Reino, Juan J / Aelion, Jacob A / Anonymous3041016. ·Department of Medicine, University of Queensland, Brisbane, Queensland, Australia. · Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada. · Department of Internal Medicine, Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, Utah, USA. · Celgene Corporation, Summit, New Jersey, USA. · Hospital Clínico Universitario, Santiago, Spain. · West Tennessee Research Institute, Jackson, Tennessee, USA. ·Ann Rheum Dis · Pubmed #29343507.

ABSTRACT: OBJECTIVE: Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. METHODS: Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. RESULTS: Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast's safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0-24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo). CONCLUSIONS: In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports. TRIAL REGISTRATION NUMBER: NCT01925768; Results.

17 Clinical Trial Assessing clinical response and defining minimal disease activity in plaque psoriasis with the Physician Global Assessment and body surface area (PGA × BSA) composite tool: An analysis of apremilast phase 3 ESTEEM data. 2017

Gottlieb, Alice B / Merola, Joseph F / Chen, Rongdean / Levi, Eugenia / Duffin, Kristina Callis. ·New York Medical College, Valhalla, New York. Electronic address: alicegottliebderm@gmail.com. · Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. · Celgene Corporation, Summit, New Jersey. · University of Utah, Salt Lake City, Utah. ·J Am Acad Dermatol · Pubmed #29132853.

ABSTRACT: -- No abstract --

18 Clinical Trial The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. 2017

Bagel, Jerry / Duffin, Kristina Callis / Moore, Angela / Ferris, Laura K / Siu, Kimberly / Steadman, Jennifer / Kianifard, Farid / Nyirady, Judit / Lebwohl, Mark. ·Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey. Electronic address: dreamacres1@aol.com. · Department of Dermatology, University of Utah, Salt Lake City, Utah. · Arlington Research Center, Arlington, Texas; Baylor Medical Center, Dallas, Texas. · Department of Dermatology, University of Pittsburgh Medical Center, University of Pittsburgh, Pittsburgh, Pennsylvania. · Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. · Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. ·J Am Acad Dermatol · Pubmed #28780364.

ABSTRACT: BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.

19 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.

20 Clinical Trial Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A). 2017

Callis Duffin, K / Bagel, J / Bukhalo, M / Mercado Clement, I J / Choi, S L / Zhao, F / Gill, A / Pangallo, B / Shuler, C / Mallbris, L / Jackson, K. ·Department of Dermatology, University of Utah, Salt Lake City, UT, USA. · Psoriasis Treatment Center of Central New Jersey, Windsor, NJ, USA. · Altman Dermatology Associates, Arlington Heights, IL, USA. · Lilly-NUS Centre for Clinical Pharmacology, Singapore City, Singapore. · Eli Lilly and Company, Indianapolis, IN, USA. · Eli Lilly and Company, Windlesham, UK. ·J Eur Acad Dermatol Venereol · Pubmed #27500949.

ABSTRACT: BACKGROUND: The efficacy of ixekizumab, an anti-interleukin-17A (anti-IL-17A) monoclonal IgG4 antibody, was demonstrated in moderate-to-severe psoriasis patients when administered via prefilled syringe (PFS). OBJECTIVE: To evaluate the effect of two drug delivery devices on the pharmacokinetics (PK) of ixekizumab as well as efficacy and safety with both devices. METHODS: In the first 12 weeks of an open-label, phase 3 study, moderate-to-severe psoriasis patients were randomized to ixekizumab delivery via PFS or autoinjector device. Randomization was stratified by weight (<80 kg, 80-100 kg, >100 kg), injection assistance (yes/no) and injection site (arm, thigh or abdomen). Following a 160-mg initial dose at week 0, patients received subcutaneous 80-mg ixekizumab as a single injection every 2 weeks for 12 weeks. Blood samples were collected following the initial 160-mg dose on days 2, 4, 7, 10 and 14 for PK analysis. Primary PK parameters were maximum concentration (C RESULTS: Of 204 randomized patients, 192 were included in the PK analysis (PFS: 94; autoinjector: 98). The PFS and autoinjector showed similar geometric mean C CONCLUSION: The PK, efficacy and safety of ixekizumab administered subcutaneously by PFS and autoinjector were similar. Clinicaltrials.gov number: NCT01777191 https://clinicaltrials.gov/ct2/show/NCT01777191.

21 Clinical Trial Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. 2016

Kavanaugh, Arthur / van der Heijde, Désirée / Beutler, Anna / Gladman, Dafna / Mease, Philip / Krueger, Gerald G / McInnes, Iain B / Helliwell, Philip / Coates, Laura C / Xu, Stephen. ·University of California, San Diego, La Jolla. · Leiden University Medical Center, Leiden, The Netherlands. · Janssen Research & Development, Spring House, Pennsylvania. · University of Toronto, Toronto, Ontario, Canada. · Swedish Medical Center, Seattle, Washington, and University of Washington, Seattle. · University of Utah, Salt Lake City. · University of Glasgow, Glasgow, UK. · Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK. ·Arthritis Care Res (Hoboken) · Pubmed #25779603.

ABSTRACT: OBJECTIVE: To evaluate long-term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO-REVEAL trial. METHODS: The GO-REVEAL trial was a phase III, randomized, double-blind trial with placebo-control through week 24 followed by an open-label extension of golimumab 50/100 mg treatment up to 5 years. In these post-hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0-100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point). RESULTS: Treatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P < 0.0001), week 24 (28.1% versus 7.7%; P < 0.0001), and week 52 (42.4% versus 30.2%; P = 0.037). MDA was achieved at least once by ∼50% of golimumab-treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1-unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321-0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290-0.795]; P = 0.004) consecutive visits. CONCLUSION: Among golimumab-treated PsA patients, better long-term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA.

22 Clinical Trial Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. 2015

Lebwohl, Mark / Strober, Bruce / Menter, Alan / Gordon, Kenneth / Weglowska, Jolanta / Puig, Lluis / Papp, Kim / Spelman, Lynda / Toth, Darryl / Kerdel, Francisco / Armstrong, April W / Stingl, Georg / Kimball, Alexa B / Bachelez, Herve / Wu, Jashin J / Crowley, Jeffrey / Langley, Richard G / Blicharski, Tomasz / Paul, Carle / Lacour, Jean-Philippe / Tyring, Stephen / Kircik, Leon / Chimenti, Sergio / Callis Duffin, Kristina / Bagel, Jerry / Koo, John / Aras, Gary / Li, Joanne / Song, Wenjie / Milmont, Cassandra E / Shi, Yifei / Erondu, Ngozi / Klekotka, Paul / Kotzin, Brian / Nirula, Ajay. ·From the Icahn School of Medicine at Mount Sinai, New York (M.L., L.K.) · University of Connecticut School of Medicine, Farmington (B.S.) · Probity Medical Research (B.S., L.S., D.T.) and XLR8 Medical Research (D.T.), Windsor, ON, K Papp Medical Research (K.P.), Waterloo, ON, and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada · Baylor University Medical Center, Dallas (A.M.) · Northwestern University, Feinberg School of Medicine, Chicago (K.G.) · Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław (J.W.), and Lubelskie Centrum Diagnostyczne, Świdnik (T.B.) - both in Poland · Hospital de la Santa Creu i Sant Pau, Barcelona (L.P.) · Veracity Clinical Research, Woolloongabba, QLD, Australia (L.S.) · Florida Academic Dermatology Center, Miami (F.K.) · University of Colorado, Denver (A.W.A.) · Medizinische Universität Wien, Vienna, Austria (G.S.) · Massachusetts General Hospital and Harvard Medical School, Boston (A.B.K.) · Sorbonne Paris Cité Université Paris Diderot, Assistance Publique-Hôpitaux de Paris Hôpital Saint Louis, Paris (H.B.), Paul Sabatier University, Toulouse (C.P.), and University Hospital of Nice, Nice (J.-P.L.) - all in France · Kaiser Permanente Los Angeles Medical Center, Los Angeles (J.J.W.), Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield (J.C.), University of California, San Francisco, San Francisco (J.K.), and Amgen, Thousand Oaks (G.A., J.L., W.S., C.E.M., Y.S., N.E., P.K., B.K., A.N.) - all in California. · University of Texas Health Science Center, Houston (S.T.) · DermResearch, Louisville, KY (L.K.) · University of Rome Tor Vergata, Rome (S.C.) · University of Utah Medical Center, Salt Lake City (K.C.D.) · and the Psoriasis Treatment Center of Central New Jersey, East Windsor (J.B.). ·N Engl J Med · Pubmed #26422722.

ABSTRACT: BACKGROUND: Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis. METHODS: In two phase 3 studies (AMAGINE-2 and AMAGINE-3), patients with moderate-to-severe psoriasis were randomly assigned to receive brodalumab (210 mg or 140 mg every 2 weeks), ustekinumab (45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg), or placebo. At week 12, patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks, every 4 weeks, or every 8 weeks; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks, and patients receiving placebo received 210 mg of brodalumab every 2 weeks. The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75% reduction in the psoriasis area-and-severity index score (PASI 75) and a static physician's global assessment (sPGA) score of 0 or 1 (clear or almost clear skin), as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100% reduction in PASI score (PASI 100). RESULTS: At week 12, the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo (86% and 67%, respectively, vs. 8% [AMAGINE-2] and 85% and 69%, respectively, vs. 6% [AMAGINE-3]; P<0.001); the rates of sPGA scores of 0 or 1 were also higher with brodalumab (P<0.001). The week 12 PASI 100 response rates were significantly higher with 210 mg of brodalumab than with ustekinumab (44% vs. 22% [AMAGINE-2] and 37% vs. 19% [AMAGINE-3], P<0.001). The PASI 100 response rates with 140 mg of brodalumab were 26% in AMAGINE-2 (P=0.08 for the comparison with ustekinumab) and 27% in AMAGINE-3 (P=0.007). Rates of neutropenia were higher with brodalumab and with ustekinumab than with placebo. Mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo. Through week 52, the rates of serious infectious episodes were 1.0 (AMAGINE-2) and 1.3 (AMAGINE-3) per 100 patient-years of exposure to brodalumab. CONCLUSIONS: Brodalumab treatment resulted in significant clinical improvements in patients with moderate-to-severe psoriasis. (Funded by Amgen; AMAGINE-2 and AMAGINE-3 ClinicalTrials.gov numbers, NCT01708603 and NCT01708629.).

23 Clinical Trial A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. 2015

Gordon, Kenneth B / Duffin, Kristina Callis / Bissonnette, Robert / Prinz, Jörg C / Wasfi, Yasmine / Li, Shu / Shen, Yaung-Kaung / Szapary, Philippe / Randazzo, Bruce / Reich, Kristian. ·From the Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago (K.B.G.) · the Department of Dermatology, University of Utah School of Medicine, Salt Lake City (K.C.D.) · Innovaderm Research, Montreal (R.B.) · the Department of Dermatology, Ludwig-Maximilians-Universität München, Munich (J.C.P.), and the Dermatologikum Hamburg, Hamburg (K.R.) - both in Germany · and Janssen Research and Development, Spring House (Y.W., S.L., Y.-K.S., P.S., B.R.), and the Department of Dermatology, University of Pennsylvania, Philadelphia (B.R.) - both in Pennsylvania. ·N Engl J Med · Pubmed #26154787.

ABSTRACT: BACKGROUND: Little is known about the effect of specific anti-interleukin-23 therapy, as compared with established anti-tumor necrosis factor therapies, for the treatment of moderate-to-severe plaque psoriasis. METHODS: In a 52-week, phase 2, dose-ranging, randomized, double-blind, placebo-controlled, active-comparator trial, we compared guselkumab (CNTO 1959), an anti-interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis. A total of 293 patients were randomly assigned to receive guselkumab (5 mg at weeks 0 and 4 and every 12 weeks thereafter, 15 mg every 8 weeks, 50 mg at weeks 0 and 4 and every 12 weeks thereafter, 100 mg every 8 weeks, or 200 mg at weeks 0 and 4 and every 12 weeks thereafter) through week 40, placebo, or adalimumab (standard dosage for psoriasis). At week 16, patients in the placebo group crossed over to receive guselkumab at a dose of 100 mg every 8 weeks. The primary end point was the proportion of patients with a Physician's Global Assessment (PGA) score of 0 (indicating cleared psoriasis) or 1 (indicating minimal psoriasis) at week 16. RESULTS: At week 16, the proportion of patients with a PGA score of 0 or 1 was significantly higher in each guselkumab group than in the placebo group: 34% in the 5-mg group, 61% in the 15-mg group, 79% in the 50-mg group, 86% in the 100-mg group, and 83% in the 200-mg group, as compared with 7% in the placebo group (P≤0.002 for all comparisons). Moreover, the proportion was significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (58%) (P<0.05 for all comparisons). At week 16, the proportion of patients with at least a 75% improvement in Psoriasis Area and Severity Index scores was significantly higher in each guselkumab group than in the placebo group (P<0.001 for all comparisons). At week 40, the proportion of patients with a PGA score of 0 or 1 remained significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (71%, 77%, and 81%, respectively, vs. 49%) (P<0.05 for all comparisons). Between week 0 and week 16, infections were observed in 20% of the patients in the guselkumab groups, 12% in the adalimumab group, and 14% in the placebo group. CONCLUSIONS: The results of this phase 2 trial suggest that guselkumab may be an effective therapy for plaque psoriasis and that control of psoriasis can be achieved with specific anti-interleukin-23 therapy. (Funded by Janssen Research and Development; X-PLORE ClinicalTrials.gov number, NCT01483599.).

24 Clinical Trial Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis. 2015

Langley, R G / Rich, P / Menter, A / Krueger, G / Goldblum, O / Dutronc, Y / Zhu, B / Wei, H / Cameron, G S / Heffernan, M P. ·Division of Clinical Dermatology and Cutaneous Science, Department of Medicine, Dalhousie University, Halifax, NS, Canada. · Department of Dermatology, Oregon Health & Science University School of Medicine, Portland, OR, USA. · Department of Dermatology, University of Texas Southwestern Medical Center Southwestern Medical School, Dallas, TX, USA. · Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT, USA. · Eli Lilly and Company, Indianapolis, IN, USA. ·J Eur Acad Dermatol Venereol · Pubmed #25693783.

ABSTRACT: BACKGROUND: Scalp and nail psoriasis have a major impact on quality of life and are traditionally resistant to therapy. Ixekizumab is a monoclonal antibody that targets IL-17A, a key cytokine in psoriasis pathogenesis. OBJECTIVE: Changes in nail and scalp psoriasis associated with ixekizumab treatment were evaluated in a post hoc analysis of a phase 2 study comprising a 20-week randomized, placebo-controlled (RCT) period and 48 weeks of an open-label extension (OLE) period. METHODS: There were 142 patients with moderate-to-severe plaque psoriasis at baseline of the RCT. Patients were randomized to receive placebo, 10, 25, 75 or 150 mg of ixekizumab injected subcutaneously at weeks 0, 2, 4, 8, 12 and 16. In the OLE, all patients received 120 mg ixekizumab every 4 weeks. Nail Psoriasis Severity Index (NAPSI) and Psoriasis Scalp Severity Index (PSSI) were used to evaluate nail and scalp psoriasis respectively. Fifty-eight (41.0%) patients had nail psoriasis (NAPSI > 0) and 105 (74.0%) had scalp psoriasis (PSSI > 0) at baseline; these cases were evaluated for the present analyses. RESULTS: At RCT week 20, patients with scalp psoriasis in the 25-, 75- and 150-mg groups had significant mean change and percent improvement from baseline PSSI of -16.3 (75.3%; P = 0.001), -11.6 (83.7%; P = 0.001) and -18.2 (82.2%; P < 0.001) respectively compared to -6.0 (18.8%) in placebo. Patients with nail psoriasis in the 75- and 150-mg groups had significant improvements from baseline NAPSI of -26.3 (63.8%; P = 0.003) and -23.1 (52.6%; P = 0.009) respectively compared to 0.4 (-1.7%) in placebo. By OLE week 48, 78.0% of patients with scalp psoriasis and 51.0% of patients with nail psoriasis experienced complete resolution of lesions (PSSI = 0 or NAPSI = 0). CONCLUSIONS: Ixekizumab monotherapy improved scalp psoriasis quickly with maintenance of clinical response and complete resolution of plaques in the majority of patients. Additionally, over 50.0% of patients with nail psoriasis experienced complete resolution of nail lesions by OLE week 48.

25 Clinical Trial Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up. 2015

Langley, R G / Lebwohl, M / Krueger, G G / Szapary, P O / Wasfi, Y / Chan, D / Hsu, M C / You, Y / Poulin, Y / Korman, N / Prinz, J C / Reich, K / Anonymous1220809. ·Dalhousie University, 4195 Dickson Building, 5820 University Avenue, Halifax, NS, Canada. · Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A. · University of Utah Health Sciences Center, Salt Lake City, UT, U.S.A. · Janssen Research & Development, LLC, Spring House, PA, U.S.A. · Centre de Recherche Dermatologique du Quebec Metropolitain, Universite Laval, Quebec City, QC, Canada. · University Hospitals Case Medical Center, Cleveland, OH, U.S.A. · University of Munich, Munich, Germany. · Dermatologikum Hamburg, Hamburg, Germany. ·Br J Dermatol · Pubmed #25307931.

ABSTRACT: BACKGROUND: Evaluation of the dosing flexibility and long-term efficacy of biological agents is limited. OBJECTIVES: To evaluate the long-term efficacy and safety of ustekinumab with and without dosing adjustment in the 5-year PHOENIX 2 study. METHODS: Patients were randomized to placebo or ustekinumab (45 or 90 mg) at weeks 0, 4, then every 12 weeks; patients receiving placebo crossed-over at week 12. Dosing adjustments were permitted at/beyond week 28 for early adjusters (weeks 28 or 40 per response); late adjusters (during long-term extension per investigator judgement); and nonadjusters (maintained randomized treatment throughout the study). Efficacy and safety were evaluated through weeks 244 and 264, respectively. RESULTS: In the overall population, 70% (849 of 1212) of ustekinumab-treated patients completed treatment through week 244, with high proportions of patients responding to the 45-mg and 90-mg doses, respectively: 75% improvement in Psoriasis Area and Severity Index (PASI 75) (76·5% and 78·6%) and PASI 90 (50·0% and 55·5%). Approximately 20% of patients were early adjusters, 30% were late adjusters and 50% were nonadjusters. Approximately half of the late adjusters initiated adjustments after already achieving PASI 75. Improved response was generally observed following dosing adjustments. Through week 264, safety event rates did not increase and event rates were generally comparable between dose groups and between patients with and without dosing adjustment. CONCLUSIONS: Treatment with ustekinumab for up to 5 years was safe and effective. Improved response was generally demonstrated following dosing adjustments; further investigations are required to quantify actual incremental benefits. The results also suggest that some patients may desire treatment goals beyond PASI 75.

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