Embracing unity at OMERACT: Valuing equity, promoting diversity, fostering inclusivity.

OBJECTIVE: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts. METHODS: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability. RESULTS: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %). CONCLUSION: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles.

Diversity, Equity, and Inclusion: Sex and Gender and Intersectionality With Race and Ethnicity in Psoriatic Disease.

Sex (biological attributes associated with being male or female) and gender (sociocultural-driven traits and behaviors related to being a man or a woman) are emerging as important determinants of disease course and response to therapy in patients with psoriasis and psoriatic arthritis (PsA). Although psoriatic disease (PsD) is equally prevalent in men and women, the condition affects them in different and unique ways, giving rise to sex- and gender-related differences in clinical presentation, including baseline disease activity, disease course, and response to treatment. Better understanding of the roles sex and gender play in the development and evolution of PsD has the potential to improve patient care. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) continues its effort to highlight issues related to diversity, equity, and inclusion in people with PsD by dedicating a session during the annual meeting to sex and gender and their intersectionality with race and ethnicity in individuals with PsA.

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021.

Since the second version of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations were published in 2015, therapeutic options for psoriatic arthritis (PsA) have advanced considerably. This work reviews the literature since the previous recommendations (data published 2013-2020, including conference presentations between 2017 and 2020) and reports high-quality, evidence-based, domain-focused recommendations for medication selection in PsA developed by GRAPPA clinicians and patient research partners. The overarching principles for the management of adults with PsA were updated by consensus. Principles considering biosimilars and tapering of therapy were added, and the research agenda was revised. Literature searches covered treatments for the key domains of PsA: peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis; additional searches were performed for PsA-related conditions (uveitis and inflammatory bowel disease) and comorbidities. Individual subcommittees used a GRADE-informed approach, taking into account the quality of evidence for therapies, to generate recommendations for each of these domains, which were incorporated into an overall schema. Choice of therapy for an individual should ideally address all disease domains active in that patient, supporting shared decision-making. As safety issues often affect potential therapeutic choices, additional consideration was given to relevant comorbidities. These GRAPPA treatment recommendations provide up-to-date, evidence-based guidance on PsA management for clinicians and people with PsA.

Promoting Diversity, Equity, and Inclusion for Psoriatic Diseases.

There is increasing evidence of racial and ethnic disparities in the evaluation and treatment of people with psoriasis (PsO) and psoriatic arthritis, and inadequate racial/ethnic diversity in psoriatic disease (PsD) research. At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2021 annual meeting, a program focusing on diversity, equity, and inclusion (DEI) was presented to highlight known health and healthcare disparities in PsD. There is limited understanding of the prevalence and severity of PsD and how it affects quality of life among racial/ethnic minorities with PsD. Educational gaps and lack of diversity in our dermatology workforce may be contributing to challenges in appropriately diagnosing and treating PsO in darker skin types. Racial/ethnic minorities are also inadequately represented in clinical research, including trial recruitment and participation, for PsD. A panel of patient research partners, researchers, and clinicians ended the session with a broad discussion on how GRAPPA can better ensure racial/ethnic DEI in their educational, research, and clinical missions.

Prologue: 2021 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) held its annual meeting in 2021 in an online format due to travel restrictions during the ongoing COVID-19 (coronavirus disease 2019) pandemic. The virtual meeting was attended by 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 (PsD). The virtual meeting allowed a variety of different types of sessions to be held, including the trainee symposium, keynote lectures, interactive sessions (5 Meet the Experts sessions, a debate on first-line therapy, and 5 guided poster sessions), 4 workshops (trainee workshop focusing on the diagnosis of PsD, ultrasound, magnetic resonance imaging, and the International Dermatology Outcome Measures group), updates on a variety of research topics (research findings from the 2020 GRAPPA research grant awardees, 3 basic science talks, Outcome Measures in Rheumatology [OMERACT] Working Group efforts, and Collaborative Research Network progress), current "hot topics" (use of Janus kinase inhibitors, promoting diversity and inclusion in PsD, progress on the updated GRAPPA treatment recommendations, and the introduction of the Young GRAPPA member group), and the presentation of four 2021 GRAPPA grant awardees and election results. In this prologue, we introduce the papers that summarize this meeting.

Appraisal of Candidate Instruments for Assessment of the Physical Function Domain in Patients with Psoriatic Arthritis.

OBJECTIVE: Numerous patient-reported outcome measures (PROM) exist for the measurement of physical function for psoriatic arthritis (PsA), but only a few are validated comprehensively. The objective of this project was to prioritize PROM for measuring physical function for potential incorporation into a standardized outcome measurement set for PsA. METHODS: A working group of 13 members including 2 patient research partners was formed. PROM measuring physical function in PsA were identified through a systematic literature review and recommendations by the working group. The rationale for inclusion and exclusion from the original list of existing PROM was thoroughly discussed and 2 rounds of Delphi exercises were conducted to achieve consensus. RESULTS: Twelve PROM were reviewed and discussed. Six PROM were prioritized: Health Assessment Questionnaire (HAQ) and 4 modifications (HAQ-Disability Index, HAQ-Spondyloarthritis, modified HAQ, multidimensional HAQ), Medical Outcomes Study 36-item Short Form survey physical functioning domain, and the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning module. CONCLUSION: Through discussion and Delphi exercises, we achieved consensus to prioritize 6 physical function PROM for PsA. These 6 PROM will undergo further appraisal using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1.

Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

BACKGROUND: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research. DESIGN: Prospective, multicenter, multinational, cross-sectional study. METHODS AND ANALYSES: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information. ETHICS: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.

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

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.

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

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.

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials: A Report from the OMERACT Equity Special Interest Group.

OBJECTIVE: Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments. METHODS: We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda. RESULTS: We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient's response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.

Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

OBJECTIVE: The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. METHODS: The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. RESULTS: Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. CONCLUSION: Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

Certolizumab pegol.

Certolizumab pegol (Cimzia(®)) is currently the only PEGylated anti-TNFα biologic approved for the treatment of rheumatoid arthritis and Crohn disease. The product, developed by UCB, is a humanized antigen-binding fragment (Fab') of a monoclonal antibody that has been conjugated to polyethylene glycol. Certolizumab pegol was approved as a treatment for rheumatoid arthritis in the EU, US and Canada in 2009, and as a treatment for Crohn disease in Switzerland in 2007 and the US in 2008. Certolizumab pegol is entering into an increasingly competitive marketplace, especially in rheumatoid arthritis, but clinical data demonstrate benefits across a range of clinical, radiographic and patient reported outcomes.