Publications by authors named "Kristina Callis Duffin"

118 Publications

Instruments Measuring Physical Function for Psoriatic Arthritis Endorsed at GRAPPA 2020 Annual Meeting: Updates of the GRAPPA-OMERACT Working Group.

J Rheumatol Suppl 2021 Jun;97:60-63

D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group provided updates at the 2020 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. Working groups were set up for the 4 prioritized domains: enthesitis, fatigue, structural damage, and physical function. Two instruments for measurement of physical function were provisionally endorsed: (1) the Health Assessment Questionnaire-Disability Index and (2) the physical functioning domain in the Medical Outcomes Study 36-item Short Form survey.
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http://dx.doi.org/10.3899/jrheum.201679DOI Listing
June 2021

Pustular Psoriasis and Associated Musculoskeletal Disorders.

J Rheumatol Suppl 2021 Jun;97:34-38

P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Harehills Lane, Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.

Pustular psoriasis (PsO) is an uncommon variant of PsO that may present in a generalized or localized fashion with or without musculoskeletal or systemic inflammatory involvement.Generalized pustular PsO (GPP) presents as a widespread acute or subacute pustular eruption that may be familial and is often associated with severe flares and systemic inflammation. The palmoplantar pustulosis variant is localized to palms and soles, whereas acrodermatitis continua of Hallopeau is localized to the nail apparatus. Patients with pustular PsO may have overlapping plaque PsO and may develop psoriatic arthritis (PsA). Pustulosis is also a feature of both synovitis, acne, pustulosis, hyperostosis, osteomyelitis (SAPHO) syndrome and chronic non-bacterial osteomyelitis. At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting, members were given an overview of the cutaneous features of pustular PsO, SAPHO, and recent insights into the genetics of GPP, leading to new targeted drug therapies and the development of validated endpoints.
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http://dx.doi.org/10.3899/jrheum.201673DOI Listing
June 2021

Psoriasis and Psoriatic Arthritis in the Context of the COVID-19 Pandemic: A Plenary Session From the GRAPPA 2020 Annual Meeting.

J Rheumatol Suppl 2021 Jun;97:24-29

J.F. Merola, MD, MMSc, Harvard Medical School, Brigham and Women's Hospital, Department of Dermatology and Department of Medicine, Division of Rheumatology and Immunology, Boston, Massachusetts, USA.

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.
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http://dx.doi.org/10.3899/jrheum.201671DOI Listing
June 2021

Prologue: 2020 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

J Rheumatol Suppl 2021 Jun;97:1-3

L.V. McFarland, MS, PhD, Consultant, Public Health Reserves Corps, Seattle, Washington, USA.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) held its annual meeting in 2020 in an online format due to travel restrictions during the coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic. The virtual meeting was attended by 351 rheumatologists, dermatologists, representatives of biopharmaceutical companies, and patient research partners. Similar to previous years, GRAPPA's annual meeting focused on the 3 overlapping missions of education, research, and clinical care of psoriatic disease. Trainee sessions this year included the annual trainee symposium and a grant-writing workshop. Plenary sessions included updates on COVID-19 and psoriatic disease from multispecialty and patient perspectives, and updates on pustular psoriasis and associated musculoskeletal manifestations. Progress on research and updates were presented for the following groups: Collaborative Research Network, Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Working Group, International Dermatology Outcome Measures, Composite Measures, Education Committee, and Treatment Guidelines. New this year were 3 concurrent workshops on ultrasound assessment of joints and entheses, magnetic resonance imaging of psoriatic arthritis, and pustular psoriasis efficacy endpoints; 6 "Meet the Expert" sessions; and facilitated "poster tours." In our prologue, we introduce the papers that summarize this meeting.
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June 2021

Psoriasis and Psoriatic Arthritis in the Context of the COVID-19 Pandemic: A Plenary Session From the GRAPPA 2020 Annual Meeting.

J Rheumatol 2021 Mar 15. Epub 2021 Mar 15.

As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. RH has received funding from the National Psoriasis Foundation, NIH/ NIAMS T32AR069515, The Riley Family Foundation, The Snyder Family Foundation, Bloomberg Philanthropies Covid-19 Response Initiative Grant, and the Rheumatology Research Foundation. 1P.J. Mease, MD, MACR, Rheumatology Research, Swedish Medical Center/ Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington; 2L.H. Calabrese, DO, Professor of Medicine, Cleveland Clinic Lerner College of Medicine, RJ Fasenmyer Chair of Clinical Immunology, Cleveland Clinic, Cleveland, Ohio; 3K. Callis Duffin, MD, MS, Professor and Chair, Department of Dermatology, University of Utah, Salt Lake City, Utah; 4R. Haberman, MD, MSCI, Clinical Instructor, Department of Medicine, Division of Rheumatology, NYU Grossman School of Medicine, New York, New York; 5R. Firmino, GRAPPA Patient Research Partner; 6J.U. Scher, MD, Department of Medicine, NYU Grossman School of Medicine, New York, New York; 7L. Schick, GRAPPA Patient Research Partner; 8K. Winthrop, MD, MPH, Oregon Health & Science University- Portland State University School of Public Health, Portland, Oregon; 9J.F. Merola, MD, MMSc, Harvard Medical School, Brigham and Women's Hospital, Department of Dermatology and Department of Medicine, Division of Rheumatology and Immunology, Boston, Massachusetts, USA. The authors report the following conflicts of interest: PJM with AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, SUN Pharma, and UCB; KCD with Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Regeneron, Boehringer Ingelheim, and Ortho Dermatologic; RH with Janssen; JUS with AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, and UCB; KW with Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Regeneron, Sanofi, AstraZeneca, Novartis, and BMS; JFM with Merck, Bristol Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres, and Leo Pharma. LHC, LS, and RF declare no conflicts. Address correspondence to Dr. P.J. Mease, Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, Seattle, WA 98122, USA. Email:

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.
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http://dx.doi.org/10.3899/jrheum.201671DOI Listing
March 2021

Pustular Psoriasis and Associated Musculoskeletal Disorders.

J Rheumatol 2021 Mar 15. Epub 2021 Mar 15.

As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. K. Callis Duffin, MD, MS, Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; H. Bachelez, MD, PhD, Department of Dermatology, Hôpital Saint-Louis, AP-HP, and Laboratory of Genetic Skin Diseases, Imagine Institute, Université de Paris, Paris, France; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center/ Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington, USA; C. Rosen, Division of Dermatology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada; A. Garg, MD, Chair, Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA; E. Zudak, BFA, Vice President, Strategic Partnerships, WCG Trifecta, Indianapolis, Indiana, USA; O. Elkayam, MD, V. Furer, MD, Rheumatology Department, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; J.F. Merola, MD, MMSc, Harvard Medical School, Brigham and Women's Hospital, Department of Dermatology and Department of Medicine, Division of Rheumatology and Immunology, Boston, Massachusetts, USA; J. Chau, GRAPPA Patient Research Partner, Hong Kong; M. Kishimoto, MD, Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Harehills Lane, Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. KCD received grants/is an investigator for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Regeneron, Boehringer Ingelheim; is on the speakers bureau for Novartis (nonpromotional only); and is a consultant/on the advisory board for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Ortho Dermatologic, and Boehringer Ingelheim. PJM received research grants, consultation fees, and/or speaker honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, and UCB. AG received grants/is an investigator for the National Psoriasis Foundation, UCB, Incyte; and is a consultant/on the advisory board for AbbVie, Amgen, Asana Biosciences, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, Janssen, Pfizer, UCB, and Viela Biosciences. JFM is consultant and/or investigator for Merck, Bristol Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres, and Leo Pharma. MK receives consulting fees and/or honoraria from AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma. OE receives consulting fees or honoraria from AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Roche, Pfizer, Boehringer Ingelheim, and Novartis. This paper does not require institutional review board approval. Address correspondence to Dr. K. Callis Duffin, University of Utah, 4A330 Dermatology, SOM, 30 North 1900 East, Salt Lake City, UT 84132, USA. Email:

Pustular psoriasis (PsO) is an uncommon variant of PsO that may present in a generalized or localized fashion with or without musculoskeletal or systemic inflammatory involvement. Generalized pustular PsO (GPP) presents as a widespread acute or subacute pustular eruption that may be familial and is often associated with severe flares and systemic inflammation. The palmoplantar pustulosis variant is localized to palms and soles, whereas acrodermatitis continua of Hallopeau is localized to the nail apparatus. Patients with pustular PsO may have overlapping plaque PsO and may develop psoriatic arthritis (PsA). Pustulosis is also a feature of both synovitis, acne, pustulosis, hyperostosis, osteomyelitis (SAPHO) syndrome and chronic nonbacterial osteomyelitis. At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting, members were given an overview of the cutaneous features of pustular PsO, SAPHO, and recent insights into the genetics of GPP, leading to new targeted drug therapies and the development of validated endpoints.
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March 2021

Instruments Measuring Physical Function for Psoriatic Arthritis Endorsed at GRAPPA 2020 Annual Meeting: Updates of the GRAPPA-OMERACT Working Group.

J Rheumatol 2021 Mar 1. Epub 2021 Mar 1.

As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. The authors are members of the Outcome Measures in Rheumatology (OMERACT), an organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and receives arms-length funding from 36 sponsors. YYL is funded by the Clinician Scientist award of the National Medical Research Council, Singapore (NMRC/CSA-INV/0022/2017). The views expressed are those of the author(s) and not necessarily those of the NMRC. AMO is funded by the Jerome L. Greene Foundation Scholar Award, the Staurulakis Family Discovery Award, the Rheumatology Research Foundation, and the National Institutes of Health (NIH) through the Rheumatic Diseases Resource-based Core Center (P30-AR053503, Cores A and D; and P30-AR070254, Cores A and B). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the NIH, the National Institute of Arthritis Musculoskeletal and Skin Diseases (NIAMS), or the Rheumatology Research Foundation (RRF). AO is funded by the Rheumatology Research Foundation and NIH/NIAMS K23 AR063764 and R01 AR072363. RC (the Parker Institute) is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). AJM is funded by the National Psoriasis Foundation Psoriatic Disease Research Fellowship. LCC is funded by a National Institute of Health Research (NIHR) Research Clinician Scientist award. The research was supported by the NIHR Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Y.Y. Leung, MB ChB, MD, Associate Professor, Duke-NUS Medical School, and Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; A.M. Orbai, MD, MHS, Assistant Professor of Medicine, Director, Psoriatic Arthritis Program, Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; W. Tillett, BSc, MB ChB, PhD, MRCP, Consultant Rheumatologist, Senior Lecturer, Royal National Hospital for Rheumatic Diseases, University of Bath, Bath, UK; A. Ogdie, MD, MSCE, Associate Professor of Medicine and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; L. Eder, MD, PhD, Women's College Research Institute, Women's College Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; N. Goel, MD, Patient Research Partner, Consultant, Caduceus Biomedical Consulting, LLC, and Adjunct Assistant Professor, Duke University School of Medicine, Durham, North Carolina, USA; P. Hojgaard, MD, PhD, Department of Rheumatology, Holbaek Hospital, Holbaek, and the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; R. Holland, MBBS, Concord Repatriation General Hospital, Sydney, Australia; A.J. Mathew, MBBS, DNB, DM, Associate Professor in Rheumatology, Christian Medical College, Vellore, India and Clinical Research Fellow, Psoriatic Arthritis Program, University Health Network, University of Toronto, Toronto, Ontario, Canada; C.A. Lindsay, PharmD, Patient Research Partner, VP Professional and Advocacy Relations, Aurinia Pharma U.S., Inc., Rockville, Maryland, USA; A. Antony, MBBS, Monash University School of Clinical Sciences, Monash Medical Centre, Clayton, Melbourne, Australia; J. Chau, GRAPPA Patient Research Partner, Hong Kong; R. Christensen, BSc, MSc, PhD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, and Professor of Biostatistics and Clinical Epidemiology, Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark; L.C. Coates, MB ChB, PhD, Associate Professor, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, and University of Washington School of Medicine, Seattle, Washington, USA; V. Strand, MD, Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; O. FitzGerald, MD, FRCPI, FRCP(UK), Consultant Rheumatologist and Newman Clinical Research Professor, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; M. de Wit, PhD, Patient Research Partner, Amsterdam, The Netherlands; K. Callis Duffin, MD, MS, Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada. LE has been on advisory boards or received educational/research grants from Novartis, UCB, Eli Lily, Pfizer, and Janssen. There are no conflicts of interest from other co-authors. This paper does not require institutional review board approval. Address correspondence to Dr. Y.Y. Leung, Department of Rheumatology and Immunology, Singapore General Hospital, 20 College Road, The Academia, Singapore. Email:

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group provided updates at the 2020 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. Working groups were set up for the 4 prioritized domains: enthesitis, fatigue, structural damage, and physical function. Two instruments for measurement of physical function were provisionally endorsed: (1) the Health Assessment Questionnaire-Disability Index and (2) the physical functioning domain in the Medical Outcomes Study 36-item Short Form survey.
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http://dx.doi.org/10.3899/jrheum.201679DOI Listing
March 2021

Prologue: 2020 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

J Rheumatol 2021 Feb 15. Epub 2021 Feb 15.

As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. The source of support to enable these meetings was provided in 2020 by AbbVie, Amgen, Eli Lilly & Co., Janssen, Novartis, Pfizer, UCB, Bristol Myers Squibb, Gilead, Boehringer-Ingelheim, and SunPharma. In addition, our Innovation Partner in 2020 was Nordic Bioscience. K. Callis Duffin, MD, MS, Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; A.B. Gottlieb, MD, PhD, Clinical Professor of Dermatology, Department of Dermatology, Icahn School of Medicine at Mount Sinai, and Co-chair, GRAPPA Publication Committee, New York, New York, USA; D. O'Sullivan, BE, GRAPPA Patient Research Partner, Our Lady's Hospice & Care Services, Rheumatic & Musculoskeletal Disease Unit, Dublin, Ireland; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, Senior Scientist, Krembil Research Institute, Director, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; L.V. McFarland, MS, PhD, Consultant, Public Health Reserves Corps, Seattle, Washington, USA. KCD reports the following conflicts of interest: grants/investigator for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Regeneron, Boehringer-Ingelheim; speaker's bureau for Novartis (nonpromotional only); consultant/advisory board for Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Bristol Myers Squibb, Stiefel, Novartis, Pfizer, Sienna, UCB, Ortho Dermatologic, Boehringer-Ingelheim. There are no conflicts of interest for all other coauthors. Address correspondence to Dr. K. Callis Duffin, University of Utah, 4A330 Dermatology, SOM, 30 North 1900 East, Salt Lake City, UT 84132, USA. Email:

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) held its annual meeting in 2020 in an online format due to travel restrictions during the coronavirus disease 2019 (COVID‑19; caused by SARS-CoV-2) pandemic. The virtual meeting was attended by 351 rheumatologists, dermatologists, representatives of biopharmaceutical companies, and patient research partners. Similar to previous years, GRAPPA's annual meeting focused on the 3 overlapping missions of education, research, and clinical care of psoriatic disease. Trainee sessions this year included the annual trainee symposium and a grant-writing workshop. Plenary sessions included updates on COVID-19 and psoriatic disease from multispecialty and patient perspectives, and updates on pustular psoriasis and associated musculoskeletal manifestations. Progress on research and updates were presented for the following groups: Collaborative Research Network, Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Working Group, International Dermatology Outcome Measures, Composite Measures, Education Committee, and Treatment Guidelines. New this year were 3 concurrent workshops on ultrasound assessment of joints and entheses, magnetic resonance imaging of psoriatic arthritis, and pustular psoriasis efficacy endpoints; 6 "Meet the Expert" sessions; and facilitated "poster tours." In our prologue, we introduce the papers that summarize this meeting.
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February 2021

Assessing psoriasis severity: psychometric validation of overall physician global assessment (OPGA).

J Am Acad Dermatol 2021 Jan 16. Epub 2021 Jan 16.

Department of Dermatology, University of Utah, Salt Lake City, UT. Electronic address:

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http://dx.doi.org/10.1016/j.jaad.2021.01.014DOI Listing
January 2021

The GRAPPA-OMERACT Working Group: 4 Prioritized Domains for Completing the Core Outcome Measurement Set for Psoriatic Arthritis 2019 Updates.

J Rheumatol Suppl 2020 Jun;96:46-49

From Duke-National University of Singapore (NUS) Medical School, Singapore, Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, University of Bath, Bath, UK; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Women's College Research Institute, Women's College Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Concord Repatriation General Hospital, Sydney, Australia; Monash University School of Clinical Sciences, Monash Medical Centre, Clayton, Melbourne, Australia; Caduceus Biomedical Consulting LLC, Raleigh; Duke University School of Medicine, Durham, North Carolina; Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; Double X Management Inc., Prosper, Texas; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; University of Toronto, Krembil Research Institute, and Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) working group provided updates at the 2019 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. The working group prioritized 4 domains, including musculoskeletal disease activity (enthesitis and dactylitis), fatigue, physical function, and structural damage. In this report, the working group summarizes its progress in standardizing the core outcome set for these 4 domains.
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http://dx.doi.org/10.3899/jrheum.200127DOI Listing
June 2020

Methotrexate in Psoriasis and Psoriatic Arthritis.

J Rheumatol Suppl 2020 Jun;96:31-35

From the Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts; Department of Pediatrics, Research Associate, Johns Hopkins University School of Medicine, Baltimore, Maryland; Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, Washington; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA.

Methotrexate (MTX) is the most commonly prescribed first-line therapy in psoriatic arthritis (PsA) internationally and is also commonly used in the treatment of psoriasis. However, data supporting its use in PsA are limited and significant toxicities can occur. This article summarizes a debate at the 2019 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting that focused on the use of MTX in psoriasis and PsA. Four clinicians and 1 patient research partner presented clinical study data and the patient experience summarizing the efficacy, tolerability, and toxicity of MTX for both skin and musculoskeletal manifestations. A survey of attending GRAPPA members collected data on current and planned future use of MTX across the world.
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http://dx.doi.org/10.3899/jrheum.200124DOI Listing
June 2020

Proceedings of the 2019 GRAPPA Collaborative Research Network Meeting.

J Rheumatol Suppl 2020 Jun;96:25-30

From the School of Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Cambridge University Hospitals National Health Service (NHS) Foundation Trust, Cambridge, UK; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Medicine, Division of Rheumatology, University of Toronto, Toronto Western Hospital, Krembil Research Institute, Toronto, Ontario, Canada; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; Patient Research Partner, Our Lady's Hospice and Care Services, Dublin, Ireland; Swedish Medical Center/Providence-St. Joseph Health and University of Washington, Seattle, Washington, USA; University of Southern California, Los Angeles, California; University of Utah, Salt Lake City, Utah, USA; Bradford Hospitals NHS Foundation Trust, Bradford, UK; Amsterdam University Medical Centers/University of Amsterdam, Department of Clinical Immunology and Rheumatology Amsterdam, Infection & Immunity Institute, Amsterdam, the Netherlands; Division of Allergy, Immunology, and Rheumatology, University of Rochester Medical Center, Rochester, New York, USA; Department of Rheumatology, St. Vincent's University Hospital Dublin, Dublin, Ireland.

At the 2019 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis-Collaborative Research Network annual meeting, the group presented its progress in selecting a database platform; items to include in an electronic case report form (eCRF); and standardized operating procedures (SOP) for the collection, processing, storage, and transport of biomaterial. A pilot investigator-initiated study was also proposed that, in addition to addressing an area of unmet need, would allow for the testing of both the eCRF and SOP.
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http://dx.doi.org/10.3899/jrheum.200123DOI Listing
June 2020

Prologue: 2019 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

J Rheumatol Suppl 2020 Jun;96:1-3

From GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis), Seattle, Washington; University of Utah, Salt Lake City, Utah, USA; University of Toronto, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; Duke University School of Medicine, Durham, North Carolina, USA; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

The 2019 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held in Paris, France, and was attended by rheumatologists, dermatologists, representatives of biopharmaceutical companies, and patients. As in previous years, GRAPPA members held a symposium for trainees to discuss their research in psoriatic disease with experts in the field. Other subjects featured during the annual meeting included a composites workshop to review continuous composite measures; the GRAPPA-Collaborative Research Network's third annual meeting; the need for a precision medicine approach to the treatment of psoriatic disease; updates from working groups in International Dermatology Outcome Measures and Outcome Measures in Rheumatology; a debate on the effectiveness of methotrexate in the treatment of psoriatic arthritis (PsA); updating recommendations for optimal treatment approaches for patients with PsA; an update on GRAPPA's research and educational projects; and the GRAPPA ultrasound (US) working group's goal to optimize the evaluation of enthesitis in patients with PsA using US through the development of a diagnostic US enthesitis tool. In this Prologue, we introduce the papers that summarize that meeting.
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http://dx.doi.org/10.3899/jrheum.200119DOI Listing
June 2020

A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).

J Invest Dermatol 2020 09 21;140(9):1784-1793.e2. Epub 2020 Feb 21.

National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.

Psoriasis, a chronic immune-mediated disease, is associated with an increased risk of cardiovascular events and mortality. Secukinumab selectively neutralizes IL-17A and has reported high efficacy with a favorable safety profile in various psoriatic disease manifestations. Subsequent to the 12-week randomized, placebo-controlled, double-blind treatment period, patients with moderate-to-severe psoriasis received secukinumab for 40 weeks. Vascular inflammation using F-2-fluorodeoxyglucose-positron emission tomography/computed tomography imaging and blood-based cardiometabolic was assessed at week 0, 12, and 52. The difference in change in aortic inflammation from baseline to week 12 for secukinumab (n = 46) versus placebo (n = 45) was -0.053 (95% confidence interval = -0.169 to 0.064; P= 0.37). Small increases in total cholesterol, low-density lipoprotein, and low-density lipoprotein particles, but no changes in markers of inflammation, adiposity, insulin resistance, or predictors of diabetes, were observed with secukinumab treatment compared with placebo. At week 52, reductions in TNF-α (P= 0.0063) and ferritin (P= 0.0354), and an increase in fetuin-A (P= 0.0024), were observed with secukinumab treatment compared with baseline. No significant changes in aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance were observed with secukinumab treatment compared with baseline. Secukinumab exhibited a neutral impact on aortic vascular inflammation and biomarkers of cardiometabolic disease after 52 weeks of treatment.
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http://dx.doi.org/10.1016/j.jid.2020.01.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7434644PMC
September 2020

Examination of Treatment Satisfaction Instruments in Psoriasis: 2017 Results from the Psoriasis Working Group of the International Dermatology Outcome Measures (IDEOM).

Dermatology 2021 28;237(2):151-157. Epub 2020 Jan 28.

Department of Dermatology, University of Southern California Keck School of Medicine, Los Angeles, California, USA,

Background/aims: In dermatology clinical trials, assessment of patients' treatment satisfaction is crucial but often lacking. To address this need, IDEOM's Psoriasis Working Group seeks to evaluate, develop, and validate treatment satisfaction instruments for the psoriasis population. The Psoriasis Working Group aimed to determine (1) factors affecting psoriasis patients' satisfaction with their therapies, (2) adequacy of two commonly used generic treatment satisfaction instruments in reflecting the psoriasis patients' perspective, and (3) whether a need exists to develop a new treatment satisfaction instrument.

Methods: Patient perspectives on satisfaction with treatment efficacy, safety, convenience, and overall satisfaction were elicited.Stakeholders were presented with information regarding the feasibility and content validity of two generic treatment instruments, the Treatment Satisfaction Questionnaire for Medication (TSQM) and the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). We conducted a nominal group discussion and survey to determine whether stakeholders considered these instruments feasible and adequate to address treatment satisfaction for psoriasis therapies.

Results: Forty-five stakeholders participated in the nominal group discussion and survey. 53% of participants voted that the TSQM and SATMED-Q are not adequate and that we should create a new dermatology-specific treatment satisfaction instrument. Patients and other stakeholders also provided feedback on aspects of treatment satisfaction important to them. These include speed of onset and durability of therapeutic effect of a medication, permanence of side effects, and convenience of administering the medication.

Conclusion: Stakeholders, including patients and providers, determined that generic treatment satisfaction questionnaires are not adequate to evaluate treatment satisfaction in psoriasis patients.
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http://dx.doi.org/10.1159/000501582DOI Listing
January 2020

Characterization of Patients with Psoriasis in Challenging-to-Treat Body Areas in the Corrona Psoriasis Registry.

Dermatology 2021 21;237(1):46-55. Epub 2020 Jan 21.

Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Background: Real-world studies evaluating patients with challenging-to-treat localizations of psoriasis (scalp, nail, and palmoplantar) are limited.

Objective: To characterize patients with versus without psoriasis in challenging-to-treat areas seen in routine US clinical practice.

Methods: This retrospective observational study included all adult patients with psoriasis enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 who initiated a biologic therapy at registry enrollment. Patients were stratified by the presence of scalp, nail, or palmoplantar psoriasis (nonmutually exclusive groups). Patient demographics, clinical char-acteristics, disease activity, and patient-reported outcome measures (pain, fatigue, itch, EuroQol visual analog scale [EQ VAS], Dermatology Life Quality Index [DLQI], and Work Productivity and Activity Impairment questionnaire [WPAI]) were assessed at registry enrollment and compared between patients with versus without each challenging-to-treat area using nonparametric Kruskal-Wallis tests for continuous variables and χ2 or Fisher exact tests for categorical variables. Generalized linear regression models were used to estimate differences in disease activity and patient-reported outcomes between patients with versus without each challenging-to-treat area.

Results: Among 2,042 patients with psoriasis (mean age [±SD], 49.6 ± 14.7 years; 51.5% male), 38.4% had psoriatic arthritis (PsA), 38.1% had scalp psoriasis, 16.0% had nail psoriasis, 10.9% had palmoplantar psoriasis, and 26.2% had a combination of ≥2 challenging-to-treat areas and PsA; only 34.2% had body plaque psoriasis without PsA or challenging-to-treat areas. Patients in all challenging-to-treat groups reported higher (mean [95% CI]) itch (scalp, 58.01 [57.62-58.40] vs. 54.35 [53.99-54.72]; nail, 56.42 [56.02-56.81] vs. 55.59 [55.20-55.97]; palmoplantar, 60.22 [59.86-60.59] vs. 55.15 [54.79-55.54]) and lower EQ VAS (scalp, 68.12 [67.78-68.48] vs. 69.46 [69.12-69.81]; nail, 66.21 [65.89-66.55] vs. 69.48 [69.14-69.83]; palmoplantar, 66.21 [66.07-66.75] vs. 69.29 [68.94-69.94]) scores than those without the respective challenging-to-treat localization. Patients with nail or palmoplantar psoriasis reported higher pain, fatigue, and DLQI scores than those without. Higher proportions of patients with scalp or palmoplantar psoriasis reported work impairment compared with those without.

Conclusion: Two-thirds of patients with psoriasis who initiated biologic therapy had PsA and/or ≥1 challenging-to-treat area. Patients with challenging-to-treat areas had worse patient-reported outcome scores than those without, indicating a significant burden of challenging-to-treat areas on patients' quality of life.
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http://dx.doi.org/10.1159/000504841DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845438PMC
January 2020

Investigator and Patient Global Assessment Measures for Psoriasis Clinical Trials: A Systematic Review on Measurement Properties from the International Dermatology Outcome Measures (IDEOM) Initiative.

Am J Clin Dermatol 2020 Jun;21(3):323-338

Department of Dermatology, Keck School of Medicine of the University of Southern California, 1975 Zonal Avenue, KAM 510, MC 9034, Los Angeles, CA, USA.

Background And Objective: The International Dermatology Outcome Measures (IDEOM) has defined a core set of domains to be measured in all psoriasis clinical trials. This set comprises the following domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global, patient global, and treatment satisfaction. The next step is to define how to measure these domains. The objective of this article was to evaluate the quality of available instruments to assess 'investigator global' and 'patient global' domains to identify the most appropriate instruments.

Methods: Reviewers conducted a systematic literature review to retrieve studies on the measurement properties of instruments including either an investigator global assessment or a patient global assessment. Following the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, three independent reviewers rated the quality of each study. We then performed a qualitative synthesis of the evidence.

Results: We identified nine investigator global assessments and three patient global assessments, reflecting substantial variability in global assessment instruments. Overall, most measures lacked evidence for content validity and feasibility. The Lattice System-Physician Global Assessment, Product of the Investigator Global Assessment and Body Surface Area, and the professional-Simplified Psoriasis Index had higher levels of evidence for validity, reliability, and/or responsiveness than the 5- and 6-point investigator global assessments. The self-assessment-Simplified Psoriasis Index was the only patient global assessment with evidence for validity, reliability, and responsiveness.

Conclusions: The 5- and 6-point investigator global assessments, which are the most widely used investigator global assessments in registered clinical trials, have less evidence for measurement properties as compared with the Lattice System-Physician Global Assessment, professional-Simplified Psoriasis Index, and the Product of the Investigator Global Assessment and Body Surface Area. However, all instruments lack evidence for content validity and feasibility. Further validation studies of investigator global assessments and patient global assessments are required to recommend the best global measure for psoriasis clinical trials.
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http://dx.doi.org/10.1007/s40257-019-00496-wDOI Listing
June 2020

Achieving Consensus on Patient-Reported Outcome Measures in Clinical Practice for Inflammatory Skin Disorders: On Behalf of International Dermatology Outcome Measures and the American Academy of Dermatology.

J Am Acad Dermatol 2019 Sep 13. Epub 2019 Sep 13.

Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia, and Atlanta Veterans Administration Medical Center, Decatur, GA.

Background: The International Dermatology Outcome Measures and the American Academy of Dermatology recently agreed on a physician-reported global severity measure to demonstrate quality of care in inflammatory dermatoses. Because patient-reported outcome measures (PROMs) are also important, we aimed to achieve consensus on a PROM for clinical practice.

Methods: Patients and providers participated in a consensus-building study using a modified-Delphi technique. Voting focused on identifying: (i)minimal set of assessments for clinical practice; (ii)patient-global assessments (PtGAs); (iii)Skindex instruments; and (iv)final instrument selection for quality improvement.

Results: Among 53 stakeholders, >70% agreed that identification of patient goals, assessment of treatment harm and assessment of the adequacy of treatment response were the minimal assessments for clinical practice. The most preferred PtGA was a 5-point PtGA (0=clear to 4=severe) with an optional check-box: "worst ever". A new metric assessing change since treatment initiation called "trajectory measure" was proposed. Stakeholders preferred Skindex instruments over PtGAs and a trajectory measure for clinical practice.

Conclusions: PtGAs as standalone measures do not adequately capture the patient's assessment of disease severity or impact of care. The combination of PtGAs with Skindex or other measure of health-related quality of life may provide a more comprehensive evaluation of patients in clinical practice.
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http://dx.doi.org/10.1016/j.jaad.2019.09.008DOI Listing
September 2019

Feasibility and Utility of the Psoriasis Symptom Inventory (PSI) in Clinical Care Settings: A Study from the International Psoriasis Council.

Am J Clin Dermatol 2019 Oct;20(5):699-709

Santa Casa de Misericórdia de Porto Alegre Hospital, Porto Alegre, Brazil.

Background: The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome measure designed to assess psoriasis signs and symptoms.

Objectives: The aim was to assess the usefulness of the PSI in enhancing patient care in the clinical setting.

Methods: Eight dermatology clinics in six countries enrolled adults representing the full spectrum of psoriasis severity who regularly received care at the clinic. Patients were administered the eight-item PSI (score range 0-32; higher scores indicate greater severity) while waiting for the physician; the physician conducted a static physician global assessment (sPGA) and estimated psoriasis-affected body surface area (BSA) at the same visit. Physicians completed a brief questionnaire after each patient visit, and were interviewed about the PSI after all patients were seen.

Results: The clinics enrolled 278 patients; mean [standard deviation (SD)] psoriasis-affected BSA was 7.6% (11.4). Based on BSA, 47.8% had mild psoriasis, 29.1% had moderate psoriasis, and 23.0% had severe psoriasis. Based on sPGA, 18.7% were clear/almost clear, 67.3% were mild/moderate, and 14.0% were severe/very severe. The mean (SD) PSI total score was 12.2 (8.3). Physicians spent a mean (SD) 4.9 (4.8) min discussing PSI findings with their patients (range 0-20 min). Key benefits of PSI discussions included the following: new information regarding symptom location and severity for physicians; prompting of quality-of-life discussions; better understanding of patient treatment priorities; change in treatment regimens to target specific symptoms or areas; and improvement of patient-physician relationship.

Conclusions: The PSI was useful for treated and untreated patients to enhance patient-physician communication, and influenced treatment decisions.
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http://dx.doi.org/10.1007/s40257-019-00458-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764927PMC
October 2019

A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies.

BMC Dermatol 2019 06 7;19(1). Epub 2019 Jun 7.

Pfizer Inc, 445 Eastern Point Road, Groton, CT, 06340, USA.

Background: Several different Physician Global Assessment (PGA) versions have been used in clinical studies as a co-primary end point to evaluate psoriasis severity. Tofacitinib is an oral Janus kinase inhibitor. We performed an analysis of the PGA using data from studies of tofacitinib in moderate to severe chronic plaque psoriasis.

Methods: Data from 3641 patients with moderate to severe chronic plaque psoriasis, enrolled in one of four phase III tofacitinib studies (OPT Pivotal 1 and 2, OPT Compare and OPT Retreatment), were used to evaluate a three-item PGA scale.

Results: Confirmatory Factor Analyses showed that equal weighting of the three items (erythema, induration and scaling) was appropriate. The PGA demonstrated acceptable test-retest reliability (Intraclass Correlation Coefficient, 0.7) and internal consistency (Cronbach's Coefficient Alpha ≥ 0.9 at primary time points). The Clinically Important Difference was estimated as 0.55 (95% confidence interval: 0.546-0.563). Known-group validity was shown by demonstrating that PGA scores could discriminate between different degrees of disease severity. The PGA was significantly correlated with other clinical end points in the studies (Psoriasis Area and Severity Index, r = 0.75-0.79; Dermatology Life Quality Index, r = 0.44-0.57; Patient Global Assessment, r = 0.66-0.72).

Conclusions: Consistent with previous findings from a phase II study, these results indicate that this PGA is a valid, reliable instrument for evaluating disease severity in clinical studies of psoriasis.
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http://dx.doi.org/10.1186/s12895-019-0088-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6555979PMC
June 2019

Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study.

J Am Acad Dermatol 2019 Oct 1;81(4):923-930. Epub 2019 Jun 1.

Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address:

Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life.

Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life.

Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks.

Results: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70).

Limitations: Small sample size, secondary analysis, generalizability.

Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.
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http://dx.doi.org/10.1016/j.jaad.2019.05.080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6746579PMC
October 2019

Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials.

J Am Acad Dermatol 2020 Jan 1;82(1):54-61. Epub 2019 Jun 1.

Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address:

Background: The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies.

Objective: To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms.

Methods: Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting.

Results: Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative.

Limitations: Only International Dermatology Outcome Measures members participated in the consensus meeting.

Conclusion: The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).
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http://dx.doi.org/10.1016/j.jaad.2019.05.075DOI Listing
January 2020

The GRAPPA-OMERACT Psoriatic Arthritis Working Group at the 2018 Annual Meeting: Report and Plan for Completing the Core Outcome Measurement Set.

J Rheumatol Suppl 2019 Jun;95:33-37

From the Duke-NUS Medical School, Singapore; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah; Kezar Life Sciences, San Francisco; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California; Duke University School of Medicine, Durham, North Carolina; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington, USA; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Royal National Hospital for Rheumatic Diseases, University of Bath, Bath, UK; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam, the Netherlands; Women's College Research Institute, Women's College Hospital, Department of Medicine, University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group reported at the 2018 GRAPPA annual meeting on the outcome of the OMERACT 2018 Conference in Terrigal, Australia. The working group presented the endorsement of the 66/68 joint count for the assessment of peripheral arthritis and the provisional endorsement of the PsA Impact of Disease 12 questionnaire for the assessment of PsA-specific health-related quality of life in PsA randomized controlled trials and observational studies. In this report, the group presents its plan to seek OMERACT endorsement for outcome measures that address the domains of MSK disease activity for enthesitis and dactylitis, physical function, fatigue, and structural damage following the OMERACT Filter 2.1 methodology.
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http://dx.doi.org/10.3899/jrheum.190122DOI Listing
June 2019

Proceedings of the 2018 GRAPPA Collaborative Research Network Meeting.

J Rheumatol Suppl 2019 Jun;95:11-19

From the Rheumatology Research Unit, Cambridge University Hospitals National Health Service (NHS) Foundation Trust, Cambridge; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Bradford Hospitals NHS Foundation Trust, Bradford, UK; Department of Medicine, Division of Rheumatology, University of Toronto; Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Swedish Medical Center/Providence-St. Joseph Health, Seattle, Washington; University of Southern California, Los Angeles, California; University of Utah, Salt Lake City, Utah; Division of Allergy, Immunology, and Rheumatology, University of Rochester Medical Center, Rochester, New York, USA; Conway Institute for Biomolecular Research, University College Dublin; Our Lady's Hospice and Care Services; Department of Rheumatology, St. Vincent's University Hospital, Dublin, Ireland; Department of Medical Humanities, Amsterdam University Medical Center, Amsterdam, the Netherlands.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Collaborative Research Network (CRN) intends to launch and secure funding for 3 pilot projects related to psoriatic disease, psoriatic arthritis (PsA), and cutaneous psoriasis (PsC). The first pilot project, a PsA Biomarkers for Joint Damage (BioDAM) pilot, will seek to determine the independent predictive ability of serum biomarkers for joint damage in PsA. The second pilot project will aim to identify predictors of the development of PsA among patients with PsC. The third pilot project will aim to identify biomarkers that predict treatment response in PsA and PsC. These pilot projects will prompt the development of clinical protocols to operate across participating centers, lead to the development of standard operating procedures for the collection and transport of biosamples across international borders, and begin to establish administrative and managerial structures for the CRN. The CRN hopes that the successful completion and research outputs of these 3 pilot projects will demonstrate the CRN's value to prospective collaborators and sponsors and thereby secure sustainable longterm funding.
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http://dx.doi.org/10.3899/jrheum.190118DOI Listing
June 2019

Prologue: 2018 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

J Rheumatol Suppl 2019 Jun;95:1-3

From GRAPPA (Groups for Research and Assessment of Psoriasis and Psoriatic Arthritis), Seattle, Washington; University of Utah, Salt Lake City, Utah; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Kezar Life Sciences, San Francisco, California; Duke University School of Medicine, Durham, North Carolina, USA; University of Toronto; Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada.

The 2018 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held in Toronto, Ontario, Canada, and was attended by rheumatologists, dermatologists, and representatives of biopharmaceutical companies and patients. As in previous years, GRAPPA members held a symposium for trainees to discuss their research in psoriatic disease with experts in the field. Other subjects featured during the annual meeting included GRAPPA-Collaborative Research Network's second annual meeting; the association between psoriatic disease and cardiovascular events; updates from working groups in International Dermatology Outcome Measures (IDEOM) and Outcome Measures in Rheumatology (OMERACT); a 2016 study that benchmarked care in psoriatic arthritis (PsA); the genetic contribution to PsA and strong need for genome-wide association studies on patients with PsA; the GRAPPA Ultrasound Working Group's goal to optimize the evaluation of enthesitis in patients with PsA using ultrasound through the development and validation of new instruments; and an update on GRAPPA's research and educational projects. In this prologue, we introduce the papers that summarize the meeting.
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http://dx.doi.org/10.3899/jrheum.190112DOI Listing
June 2019

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials.

J Rheumatol 2019 08 15;46(8):990-995. Epub 2018 Dec 15.

From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland.

Objective: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).

Methods: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).

Results: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."

Conclusion: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.
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http://dx.doi.org/10.3899/jrheum.181077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6571063PMC
August 2019

The Physician Global Assessment and Body Surface Area composite tool is a simple alternative to the Psoriasis Area and Severity Index for assessment of psoriasis: post hoc analysis from PRISTINE and PRESTA.

Psoriasis (Auckl) 2018 8;8:65-74. Epub 2018 Oct 8.

Pfizer Business Unit (PBU) Syneos Health, Princeton, NJ, United States.

Background: The product of Physician Global Assessment and Body Surface Area (PGA × BSA) is a new outcome measure for psoriasis severity and response to therapy. The objective of this study was to evaluate PGA × BSA as an alternative to Psoriasis Area and Severity Index (PASI) for psoriasis assessments.

Methods: The relationship between PASI and PGA × BSA was assessed in a post hoc analysis of pooled data from the PRISTINE (NCT00663052) and PRESTA (NCT00245960) trials in patients with moderate-to-severe psoriasis who received etanercept 50 mg/week. Data were analyzed using Spearman and intra-class correlation coefficients, effect sizes, scatterplots, Bland-Altman plots, and Kappa statistics.

Results: Spearman correlations at baseline, week 12, and week 24 were strong for PGA × BSA versus PASI (=0.78, 0.87, and 0.90, respectively; all <0.0001) as were intra-class correlations (0.76 [95% confidence interval 0.73-0.80], 0.80 [0.76-0.83], and 0.85 [0.82-0.87], respectively). The effect size was -1.53 for PASI and -0.94 for PGA × BSA (baseline to week 24). Scatterplots and Bland-Altman plots detected a trend across the range of measurement. Kappa statistics (at 12 and 24 weeks) between PASI50/75/90 and 50/75/90% improvement in PGA × BSA showed good agreement (0.58-0.69 at week 12 and 0.63-0.67, respectively; all <0.0001). At baseline, the Spearman correlation coefficients were 0.96, 0.51, 0.19, and 0.17 for PGA × BSA versus BSA, PGA, Patient Global Assessment, and Dermatology Life Quality Index, respectively (all <0.001).

Conclusion: PGA × BSA has advantages over PASI for measuring moderate-to-severe psoriasis; it is intuitive, sensitive, and easy to use.
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http://dx.doi.org/10.2147/PTT.S169333DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6181091PMC
October 2018

Genetic signature to provide robust risk assessment of psoriatic arthritis development in psoriasis patients.

Nat Commun 2018 10 9;9(1):4178. Epub 2018 Oct 9.

Department of Dermatology, University of Michigan Medical School, Ann Arbor, 48109, MI, USA.

Psoriatic arthritis (PsA) is a complex chronic musculoskeletal condition that occurs in ~30% of psoriasis patients. Currently, no systematic strategy is available that utilizes the differences in genetic architecture between PsA and cutaneous-only psoriasis (PsC) to assess PsA risk before symptoms appear. Here, we introduce a computational pipeline for predicting PsA among psoriasis patients using data from six cohorts with >7000 genotyped PsA and PsC patients. We identify 9 new loci for psoriasis or its subtypes and achieve 0.82 area under the receiver operator curve in distinguishing PsA vs. PsC when using 200 genetic markers. Among the top 5% of our PsA prediction we achieve >90% precision with 100% specificity and 16% recall for predicting PsA among psoriatic patients, using conditional inference forest or shrinkage discriminant analysis. Combining statistical and machine-learning techniques, we show that the underlying genetic differences between psoriasis subtypes can be used for individualized subtype risk assessment.
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http://dx.doi.org/10.1038/s41467-018-06672-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177414PMC
October 2018

Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative.

Arch Dermatol Res 2018 Nov 25;310(9):701-710. Epub 2018 Aug 25.

Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included "PsA Symptoms" as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for "PsA Symptoms" in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for "PsA Symptoms", we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. "PsA Symptoms" measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.
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http://dx.doi.org/10.1007/s00403-018-1855-3DOI Listing
November 2018
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