Scholars@Duke
Niti Goel

Niti Goel

Adjunct Assistant Professor in the Department of Medicine
Medicine, Rheumatology and Immunology

Selected Publications

Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 Annual Meeting.

Journal Article J Rheumatol · October 1, 2024 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting was held on July 13 to 15, 2023, in Dublin, Ireland, and was attended by 285 rheumatologists, dermatologists, trainees, patient research partners (PRPs) ... Full text Link to item Cite

Hot Topics: Depression in Individuals With Psoriasis and Psoriatic Arthritis.

Journal Article J Rheumatol · October 1, 2024 Psoriasis and psoriatic arthritis are associated with an increased risk of mental health conditions such as depression and anxiety. People with psoriatic disease (PsD) are also more likely to die by suicide than those without. Mood disorders affect people ... Full text Link to item Cite

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

Journal Article Semin Arthritis Rheum · June 2024 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 w ... Full text Link to item Cite

Generating a list of potentially important contextual factors covering randomized trials, cohorts, and measurement property studies: An OMERACT initiative.

Journal Article Semin Arthritis Rheum · April 2024 OBJECTIVES: To generate candidates for contextual factors (CFs) for each CF type (i.e., Effect Modifying Contextual Factors (EM-CFs), Outcome Influencing Contextual Factors (OI-CFs), and Measurement Affecting Contextual Factors (MA-CFs)) considered importa ... Full text Link to item Cite

Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease.

Journal Article J Rheumatol · February 1, 2024 OBJECTIVE: To evaluate whether the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a responsive instrument in psoriatic arthritis (PsA) and whether it differentiates between axial and peripheral disease activity in PsA. METHODS: Individuals ... Full text Link to item Cite

Patient outcomes in longitudinal observational studies (POLOS) of rheumatoid arthritis: Determining the OMERACT core domain set.

Journal Article Semin Arthritis Rheum · February 2024 OBJECTIVE: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework. METHODS: A three-round online Delphi exercise, including patien ... Full text Link to item Cite

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group.

Journal Article Semin Arthritis Rheum · December 2023 OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to develop ... Full text Link to item Cite

GRAPPA 2022 Patient Research Partners Network Update: Managing Growth.

Journal Article J Rheumatol · November 2023 Seven patient research partners (PRPs) attended the 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) in person, the first in-person annual meeting since the start of the coronavirus disease 2019 (CO ... Full text Link to item Cite

Initiating Evaluation of Composite Outcome Measures for Psoriatic Arthritis: 2022 Updates From the GRAPPA-OMERACT Working Group.

Journal Article J Rheumatol · November 2023 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) working group-comprising rheumatologists, dermatologists, methodologists, and patient research partners ... Full text Link to item Cite

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

Journal Article J Rheumatol · November 2023 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 psor ... Full text Link to item Cite

Proceedings of the GRAPPA 2022 Executive Retreat.

Journal Article J Rheumatol · November 2023 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) leadership congregated for a strategic planning meeting before the 2022 GRAPPA annual meeting in New York, USA. Meeting aims were to review GRAPPA's performance in relation ... Full text Link to item Cite

Screening and Referral Strategies for the Early Recognition of Psoriatic Arthritis Among Patients With Psoriasis: Results of a GRAPPA Survey.

Journal Article J Rheumatol · November 2023 OBJECTIVE: This study aimed to explore the experiences of dermatologists and rheumatologists in the early recognition of psoriatic arthritis (PsA) and to identify potential improvements to the current shared-care model. METHODS: A 24-question survey addres ... Full text Link to item Cite

Imaging With PET/CT of Diffuse CD8 T-Cell Infiltration of Skeletal Muscle in Patients With Inclusion Body Myositis.

Journal Article Neurology · September 12, 2023 BACKGROUND AND OBJECTIVES: Inclusion body myositis (IBM) is a progressive autoimmune skeletal muscle disease in which cytotoxic CD8+ T cells infiltrate muscle and destroy myofibers. IBM has required a muscle biopsy for diagnosis. Here, we administered to p ... Full text Link to item Cite

Patient perspectives on long-term outcomes in rheumatoid arthritis. A qualitative study from the OMERACT patient outcomes in longitudinal studies working group.

Journal Article Semin Arthritis Rheum · February 2023 OBJECTIVES: To identify patient-centered domains with long-term relevance to people with rheumatoid arthritis (RA). METHODS: We conducted semi-structured individual cognitive interviews of patients with RA with at least five years of disease duration, samp ... Full text Link to item Cite

Management of Axial Disease in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations.

Journal Article J Rheumatol · February 2023 OBJECTIVE: Axial involvement in patients with psoriatic arthritis (PsA) is a common subset of this condition, but a unanimous definition has yet to be established. It has been defined by using different criteria, ranging from the presence of at least unila ... Full text Open Access Link to item Cite

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

Journal Article Nat Rev Rheumatol · August 2022 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 review ... Full text Open Access Link to item Cite

Plain Radiographic Instruments for Structural Damage in Peripheral Joints in Psoriatic Arthritis: A Report From the GRAPPA-OMERACT Working Group.

Journal Article J Rheumatol · June 2022 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is focused on the development of a core set of instruments used to assess the do ... Full text Link to item Cite

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

Journal Article J Rheumatol · June 2022 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 atte ... Full text Link to item Cite

Promoting Diversity, Equity, and Inclusion for Psoriatic Diseases.

Journal Article J Rheumatol · June 2022 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 ... Full text Link to item Cite

POS1342 DEPLETION OF KLRG1+ T CELLS IN A FIRST-IN-HUMAN CLINICAL TRIAL OF ABC008 IN INCLUSION BODY MYOSITIS (IBM)

Conference Annals of the Rheumatic Diseases · June 2022 BackgroundInclusion body myositis (IBM), a relentlessly progressive autoimmune skeletal muscle disease, has no effective available pharmacological therapy. A prominent feature of IBM on microscopy is highly differ ... Full text Cite

AB0953 Lack of Racial Diversity in Clinical Trials of Psoriatic Arthritis

Conference Annals of the Rheumatic Diseases · June 2022 BackgroundParticipant diversity in clinical trials of therapeutics in rheumatology is important to understand how persons of different races and ethnicities might respond differently to therapeutics. Specifically, ... Full text Cite

Test-retest Reliability for HAQ-DI and SF-36 PF for the Measurement of Physical Function in Psoriatic Arthritis.

Journal Article J Rheumatol · October 2021 OBJECTIVE: Due to no existing data, we aimed to derive evidence to support test-retest reliability for the Health Assessment Questionnaire-Disability Index (HAQ-DI) and 36-item Short Form Health Survey physical functioning domain (SF-36 PF) in psoriatic ar ... Full text Link to item Cite

Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: An OMERACT 2020 special interest group report.

Journal Article Semin Arthritis Rheum · October 2021 OBJECTIVE: To determine how best to incorporate the patient perspective into rheumatoid arthritis remission criteria. METHODS: At OMERACT 2020, several studies, including a longitudinal multi-centre study testing the validity of adding patient-valued domai ... Full text Link to item Cite

OMERACT Filter 2.1 instrument selection for physical function domain in psoriatic arthritis: Provisional endorsement for HAQ-DI and SF-36 PF.

Journal Article Semin Arthritis Rheum · October 2021 OBJECTIVES: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the phy ... Full text Link to item Cite

Development of a patient-centered core domain set for prospective observational longitudinal outcome studies in rheumatoid arthritis: an OMERACT initiative.

Journal Article Semin Arthritis Rheum · October 2021 OBJECTIVES: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis. METHODS: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient q ... Full text Link to item Cite

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group.

Journal Article Semin Arthritis Rheum · June 2021 BACKGROUND: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical st ... Full text Link to item Cite

Enhancing patient research partner engagement: Research in psoriatic arthritis.

Journal Article Best Pract Res Clin Rheumatol · June 2021 The perspective from individuals with psoriatic arthritis (PsA) can be beneficial to PsA research, increasing the likelihood that the results are meaningful and relevant to PsA patients. While there has been an advancement of patient research partner (PRP) ... Full text Link to item Cite

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

Journal Article J Rheumatol Suppl · June 2021 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 o ... Full text Link to item Cite

OP0229 THE GROUP FOR RESEARCH AND ASSESSMENT OF PSORIASIS AND PSORIATIC ARTHRITIS (GRAPPA) TREATMENT RECOMMENDATIONS 2021

Conference Annals of the Rheumatic Diseases · June 2021 Background:Since the 2015 GRAPPA treatment recommendations were published, therapeutic options and management strategies for psoriatic arthritis (PsA) have advanced considerably. Full text Cite

Outcomes Reported in Prospective Long-Term Observational Studies and Registries of Patients With Rheumatoid Arthritis Worldwide: An Outcome Measures in Rheumatology Systematic Review.

Journal Article Arthritis Care Res (Hoboken) · May 2021 OBJECTIVE: Prospective long-term observational studies (LOS) in rheumatoid arthritis (RA) lack a core set of universally collected outcome measures, particularly patient-centered outcomes, precluding accurate comparisons across studies. Our aim was to iden ... Full text Link to item Cite

Measurement properties of radiographic outcome measures in Psoriatic Arthritis: A systematic review from the GRAPPA-OMERACT initiative.

Journal Article Semin Arthritis Rheum · April 2021 BACKGROUND: Structural damage is as an important outcome in the Psoriatic Arthritis (PsA) Core Domain Set and its assessment is recommended at least once in the development of a new drug. OBJECTIVES: To conduct a systematic review (SR) to identify studies ... Full text Link to item Cite

Patient Characteristics and Indicators of Treatment Initiation with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: A Claims Database Analysis.

Journal Article Rheumatol Ther · March 2021 Repository corticotropin injection (RCI) is indicated as adjunctive, short-term therapy in selected patients with RA. To characterize RCI users and identify predictors of RCI initiation in RA, we compared preindex characteristics, treatment patterns, comor ... Full text Open Access Link to item Cite

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

Journal Article J Rheumatol · March 1, 2021 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 o ... Full text Link to item Cite

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

Journal Article J Rheumatol · January 1, 2021 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 phys ... Full text Link to item Cite

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).

Journal Article Ther Adv Musculoskelet Dis · 2021 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, enthesi ... Full text Open Access Link to item Cite

Clinical trial discrimination of physical function instruments for psoriatic arthritis: A systematic review.

Journal Article Semin Arthritis Rheum · October 2020 OBJECTIVES: Physical function (PF) is a core domain to be measured in randomized controlled trials (RCTs) of psoriatic arthritis (PsA), yet the discriminative performance of patient reported outcome measures (PROMs) for PF in RCTs has not been evaluated sy ... Full text Link to item Cite

GRAPPA 2019 Project Report.

Journal Article J Rheumatol Suppl · June 2020 At the 2019 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members received updates on several ongoing efforts. Among them were updates on research, including the trainee symposium, pilot research gra ... Full text Link to item Cite

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

Journal Article J Rheumatol Suppl · June 2020 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 ... Full text Link to item Cite

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

Journal Article J Rheumatol Suppl · June 2020 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 o ... Full text Link to item Cite

AB0737 MEASUREMENT PROPERTIES OF RADIOGRAPHIC OUTCOME MEASURES IN PSORIATIC ARTHRITIS: A SYSTEMATIC REVIEW FROM THE GRAPPA-OMERACT INITIATIVE

Conference Annals of the Rheumatic Diseases · June 2020 Background:Structural damage was identified as an important outcome domain in the Psoriatic Arthritis (PsA) Core Domain Set and should be assessed at least once in the development of a new therapeutic. Full text Cite

AB0794 CLINICAL TRIAL DISCRIMINATION OF PHYSICAL FUNCTION INSTRUMENTS FOR PSORIATIC ARTHRITIS: A SYSTEMATIC REVIEW

Conference Annals of the Rheumatic Diseases · June 2020 Background:Physical function is a core domain to be measured in randomized controlled trials (RCTs) of psoriatic arthritis (PsA). The discriminative performance of patient reported outcome measures (PROMs) for phy ... Full text Cite

Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice.

Journal Article Ther Innov Regul Sci · March 2020 The National Research Council (NRC) Expert Panel Report on Prevention and Treatment of Missing Data in Clinical Trials highlighted the need for clearly defining objectives and estimands. That report sparked considerable discussion and literature on estiman ... Full text Link to item Cite

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.

Journal Article Ther Innov Regul Sci · March 2020 This paper provides examples of defining estimands in real-world scenarios following ICH E9(R1) guidelines. Detailed discussions on choosing the estimands and estimators can be found in our companion papers. Three scenarios of increasing complexity are ill ... Full text Link to item Cite

Conducting research in psoriatic arthritis: the emerging role of patient research partners.

Journal Article Rheumatology (Oxford) · March 1, 2020 Since 2003, patients have become increasingly involved in research endeavours related to psoriatic arthritis (PsA), progressing into a patient research partner (PRP) role. This paper reviews the general considerations related to PRP involvement in research ... Full text Link to item Cite

Core Outcome Sets Specifically for Longterm Observational Studies: OMERACT Special Interest Group Update in Rheumatoid Arthritis.

Journal Article J Rheumatol · September 2019 OBJECTIVE: This is an update from the Outcome Measures in Rheumatology (OMERACT) Core Outcomes in Longterm Observational Studies Special Interest Group with a focus on rheumatoid arthritis. METHODS: Preliminary data and proposed next steps were outlined an ... Full text Link to item Cite

Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials.

Journal Article J Rheumatol · September 2019 OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology. METHODS: Systematically searching the MEDLINE database on January 24, 2017, we identif ... Full text Link to item Cite

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

Journal Article J Rheumatol · August 2019 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 [rand ... Full text Link to item Cite

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report.

Journal Article J Rheumatol · August 2019 OBJECTIVE: The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculo ... Full text Link to item Cite

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

Journal Article J Rheumatol Suppl · June 2019 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 ... Full text Link to item Cite

GRAPPA 2018 Project Report.

Journal Article J Rheumatol Suppl · June 2019 At the 2018 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members received updates on several ongoing efforts. Among them were updates on GRAPPA's patient research partners; educational initiatives; ... Full text Link to item Cite

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

Journal Article J Rheumatol Suppl · June 2019 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 ... Full text Link to item Cite

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.

Journal Article Ther Innov Regul Sci · April 9, 2019 This paper provides examples of defining estimands in real-world scenarios following ICH E9(R1) guidelines. Detailed discussions on choosing the estimands and estimators can be found in our companion papers. Three scenarios of increasing complexity are ill ... Full text Link to item Cite

Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice.

Journal Article Ther Innov Regul Sci · April 4, 2019 The National Research Council (NRC) Expert Panel Report on Prevention and Treatment of Missing Data in Clinical Trials highlighted the need for clearly defining objectives and estimands. That report sparked considerable discussion and literature on estiman ... Full text Link to item Cite

The effects of cultural background on patient-perceived impact of psoriatic arthritis - a qualitative study conducted in Brazil and France.

Journal Article Adv Rheumatol · October 22, 2018 BACKGROUND: In psoriatic arthritis (PsA) almost all qualitative studies have been performed in European populations. This work aimed to evaluate the impact of PsA in Brazilian and French subjects, as well as to explore cultural differences in the experienc ... Full text Link to item Cite

The Patient Research Partner Network Matures: A Report from the GRAPPA 2017 Annual Meeting.

Journal Article J Rheumatol Suppl · June 2018 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has reached the third of 5 stages of organizational maturity regarding incorporating patient research partners (PRP) into psoriatic arthritis (PsA) and psoriasis research a ... Full text Link to item Cite

Content and Face Validity and Feasibility of 5 Candidate Instruments for Psoriatic Arthritis Randomized Controlled Trials: The PsA OMERACT Core Set Workshop at the GRAPPA 2017 Annual Meeting.

Journal Article J Rheumatol Suppl · June 2018 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is in the process of selecting core instruments for PsA clinical trials. During ... Full text Link to item Cite

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

Journal Article Semin Arthritis Rheum · April 2018 BACKGROUND: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. OBJECTIVES: To synthesize the evidence on measurement properties ... Full text Link to item Cite

Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects.

Journal Article Pharmacol Res Perspect · February 2018 The aims of this randomized, double-blind, three-arm, single-dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as "M923") to each of 2 reference products, and to assess M923's safety an ... Full text Open Access Link to item Cite

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

Journal Article J Rheumatol · December 2017 OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less a ... Full text Link to item Cite

Critical Outcomes in Longitudinal Observational Studies and Registries in Patients with Rheumatoid Arthritis: An OMERACT Special Interest Group Report.

Journal Article J Rheumatol · December 2017 OBJECTIVE: Outcomes important to patients are those that are relevant to their well-being, including quality of life, morbid endpoints, and death. These outcomes often occur over the longterm and can be identified in prospective longitudinal observational ... Full text Link to item Cite

Validating Rheumatoid Arthritis Remission Using the Patients' Perspective: Results from a Special Interest Group at OMERACT 2016.

Journal Article J Rheumatol · December 2017 OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) working group on the patients' perspective on remission in rheumatoid arthritis (RA) has been working on this topic since 2010. At OMERACT 2016, progress and preliminary data on validity of measurem ... Full text Link to item Cite

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

Journal Article J Rheumatol · November 2017 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) Equit ... Full text Link to item Cite

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016.

Journal Article J Rheumatol · October 2017 OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studie ... Full text Link to item Cite

The patient perspective on absence of disease activity in rheumatoid arthritis: a survey to identify key domains of patient-perceived remission.

Journal Article Ann Rheum Dis · May 2017 BACKGROUND: Guidelines suggest treatment in rheumatoid arthritis (RA) to target remission, in close consultation with the patient. Our recent qualitative study of the patients' perspective on remission in RA identified 26 domains. The current study aimed t ... Full text Link to item Cite

Tackling Patient Centricity: A Report from the GRAPPA 2016 Annual Meeting.

Journal Article J Rheumatol · May 2017 In line with the global trend to have disease-related organizations be more patient-centric in their approach, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has made substantial progress incorporating patient research ... Full text Link to item Cite

Proceedings of the GRAPPA 2016 Retreat.

Journal Article J Rheumatol · May 2017 In advance of its 2016 annual meeting, members of the steering committee of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) convened for a strategic planning meeting. The purpose of this advance meeting was to review the ... Full text Link to item Cite

Defining Outcome Measures for Psoriatic Arthritis: A Report from the GRAPPA-OMERACT Working Group.

Journal Article J Rheumatol · May 2017 The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group recently published the updated 2016 psoriatic arthritis (PsA) core domain set, a ... Full text Link to item Cite

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials.

Journal Article Ann Rheum Dis · April 2017 OBJECTIVE: To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. METHODS: We conducted (1) a systematic literature review (SLR) of domains assessed ... Full text Link to item Cite

Biosimilars in rheumatology: understanding the rigor of their development.

Journal Article Rheumatology (Oxford) · February 2017 This article examines the current landscape of biosimilar development in rheumatology. As misperceptions about biosimilars exist regarding their comparability to the reference products for clinical use, we review the development paradigm with the goal of i ... Full text Link to item Cite

Report of the GRAPPA-OMERACT Psoriatic Arthritis Working Group from the GRAPPA 2015 Annual Meeting.

Journal Article J Rheumatol · May 2016 The GRAPPA-OMERACT psoriatic arthritis (PsA) working group is in the process of updating the PsA core domain set to improve and standardize the measurement of PsA outcomes. Work streams comprise literature reviews of domains and outcome measurement instrum ... Full text Link to item Cite

Let's Talk about Inclusion: A Report on Patient Research Partner Involvement in the GRAPPA 2015 Annual Meeting.

Journal Article J Rheumatol · May 2016 Members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) have worked since 2012 to include the patient perspective in their psoriatic arthritis (PsA) research as well as in their annual meetings. Herein, patient resear ... Full text Link to item Cite

Certolizumab Pegol Efficacy Across Methotrexate Regimens: A Pre-Specified Analysis of Two Phase III Trials.

Journal Article Arthritis Care Res (Hoboken) · March 2016 OBJECTIVE: Anti-tumor necrosis factor (anti-TNF) agents are frequently used in combination with methotrexate (MTX) to treat rheumatoid arthritis (RA). We investigated the effect of a background MTX dose, in combination with anti-TNF certolizumab pegol (CZP ... Full text Link to item Cite

Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12.

Journal Article J Rheumatol · January 2016 OBJECTIVE: The treatment of rheumatoid arthritis (RA) should target patient-relevant outcomes, making patient perspective on remission essential. In 2010, patients, physicians, health professionals, and researchers at the Outcome Measures in Rheumatology ( ... Full text Link to item Cite

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

Journal Article J Rheumatol · December 2015 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 lo ... Full text Link to item Cite

Enhanced Patient Involvement and the Need to Revise the Core Set - Report from the Psoriatic Arthritis Working Group at OMERACT 2014.

Journal Article J Rheumatol · November 2015 OBJECTIVE: To discuss the need for revision of the "core set" of domains to be included for assessment in psoriatic arthritis (PsA) randomized controlled trials and longitudinal observational studies, review work undertaken since the 2012 meeting of Outcom ... Full text Link to item Cite

Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.

Journal Article J Rheumatol · October 2015 OBJECTIVE: To assess the current state of reporting of pain outcomes in Cochrane reviews on chronic musculoskeletal painful conditions and to elicit opinions of patients, healthcare practitioners, and methodologists on presenting pain outcomes to patients, ... Full text Link to item Cite

Consensus on the Need for a Hierarchical List of Patient-reported Pain Outcomes for Metaanalyses of Knee Osteoarthritis Trials: An OMERACT Objective.

Journal Article J Rheumatol · October 2015 OBJECTIVE: Although protocol registration for systematic reviews is still not mandatory, reviewers should be strongly encouraged to register the protocol to identify the methodological approach, including all outcomes of interest. This will minimize the li ... Full text Link to item Cite

Building bridges between researchers and patient research partners: A report from the grappa 2014 annual meeting

Journal Article Journal of Rheumatology · June 1, 2015 for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) recently engaged patients as collaborative partners in psoriatic arthritis (PsA) research. We summarize Building Bridges, a session held at the GRAPPA 2014 annual meeting, where inte ... Full text Cite

Review of the psoriatic arthritis working group at OMERACT 12: A report from the GRAPPA 2014 annual meeting

Journal Article Journal of Rheumatology · June 1, 2015 At the 2014 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the psoriatic arthritis (PsA) working group of OMERACT (Outcome Measures in Rheumatology) presented a review of the progress made at the OMER ... Full text Cite

The Biosimilar Landscape: A Systematic Review of Its Current Status.

Journal Article ARTHRITIS & RHEUMATOLOGY · October 1, 2014 Link to item Cite

Patient participation in psoriasis and psoriatic arthritis outcome research: a report from the GRAPPA 2013 Annual Meeting.

Journal Article J Rheumatol · June 2014 For the first time, 8 patients with psoriatic arthritis (PsA) participated as full delegates at the 2013 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Patients were invited to provide their perspecti ... Full text Link to item Cite

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

Journal Article J Rheumatol · April 2014 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 ... Full text Link to item Cite

Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.

Journal Article Rheumatology (Oxford) · December 2012 OBJECTIVE: To investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA. METHODS: In this 12-week, double-blind period of the phase IIIb trial, RA patients with inadequate response to at least one DMAR ... Full text Link to item Cite

Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial.

Journal Article Rheumatology (Oxford) · September 2012 OBJECTIVE: To evaluate the safety and efficacy of 2-year administration of certolizumab pegol (CZP) + MTX in patients with active RA. METHODS: Patients completing 52 weeks in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 trial (52-week ... Full text Link to item Cite

Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.

Journal Article Rheumatology (Oxford) · July 2012 OBJECTIVE: Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400  mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX thera ... Full text Link to item Cite

Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies.

Journal Article Ann Rheum Dis · October 2011 Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number ... Full text Link to item Cite

Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data.

Journal Article Arthritis Rheum · August 2011 OBJECTIVE: To determine whether certolizumab pegol (CZP) dosage escalation from 200 mg to 400 mg every other week benefits some patients with rheumatoid arthritis (RA). METHODS: In the extension of the Rheumatoid Arthritis Prevention of Structural Damage 1 ... Full text Link to item Cite

Developing a construct to evaluate flares in rheumatoid arthritis: a conceptual report of the OMERACT RA Flare Definition Working Group.

Conference J Rheumatol · August 2011 Rheumatoid arthritis (RA) patients and healthcare professionals (HCP) recognize that episodic worsening disease activity, often described as a "flare," is a common feature of RA that can contribute to impaired function and disability. However, there is no ... Full text Link to item Cite

Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.

Journal Article Curr Med Res Opin · February 2011 Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the ... Full text Link to item Cite

The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).

Journal Article Osteoporos Int · May 2010 UNLABELLED: This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. INTRODUCTION: Real or perceived problems in the relationship between academics and the industry have been the su ... Full text Link to item Cite

Certolizumab pegol.

Journal Article MAbs · 2010 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 t ... Full text Link to item Cite

Perceived functioning has ethnic-specific associations in systemic sclerosis: another dimension of personalized medicine.

Journal Article J Rheumatol · December 2009 OBJECTIVE: To measure self-reported physical and mental functioning and associated clinical features at study entry in 3 ethnic groups with systemic sclerosis (SSc). METHODS: Sixty Hispanic, 39 African American, and 104 Caucasian patients with recent-onset ... Full text Link to item Cite

Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study.

Journal Article Ann Rheum Dis · June 2009 BACKGROUND: Tumour necrosis factor alpha (TNFalpha) is a proinflammatory cytokine involved in the pathogenesis of rheumatoid arthritis (RA). Treatment with TNFalpha inhibitors reduces disease activity and improves outcomes for patients with RA. This study ... Full text Link to item Cite

Pulmonary involvement in systemic sclerosis: associations with genetic, serologic, sociodemographic, and behavioral factors.

Journal Article Arthritis Rheum · March 15, 2007 OBJECTIVE: To determine the relative contributions of genetic, clinical, serologic, sociodemographic, and behavioral/psychological variables to early pulmonary involvement in the Genetics versus Environment in Scleroderma Outcome Study cohort. METHODS: At ... Full text Link to item Cite

Primary care house staff attitudes toward osteoporosis management.

Journal Article South Med J · May 2006 OBJECTIVE: This study assessed possible institutional and patient-related factors influencing the delivery of postmenopausal osteoporosis (PMO) care and the diagnostic priority placed on addressing PMO, relative to other common medical conditions, by prima ... Full text Link to item Cite

Fracture Reduction Affects Medicare Economics (FRAME): impact of increased osteoporosis diagnosis and treatment.

Journal Article Osteoporos Int · December 2005 Osteoporosis is a common, debilitating disease affecting US Medicare beneficiaries, yet diagnosis and treatment lag behind medical advances. We estimated the cost of fractures to the Medicare program and the impact of increasing osteoporosis diagnosis and ... Full text Link to item Cite

Mechanical sensation and pain thresholds in patients with chronic arthropathies.

Journal Article J Pain · May 2003 This study measured mechanical sensation and pain thresholds in the cutaneous field overlying the knee joints of rheumatoid arthritis (RA; N = 27) and osteoarthritis (OA; N = 28) patients, compared with age- and weight-matched normal control subjects (Norm ... Full text Link to item Cite

Pericardial effusion and cardiomyopathy following arthritis with parvovirus B19 infection: response to intravenous immunoglobulin.

Journal Article J Clin Rheumatol · October 2001 We describe a 65-year-old female who presented with arthritis involving the small joints of her hand, wrists, and knee, fever, rash, and leukocytosis. During the course of her illness, she developed elevated transaminases, myositis, bilateral pleural effus ... Full text Link to item Cite

Genetic analysis of multiplex rheumatoid arthritis families.

Journal Article Genes Immun · September 1999 To examine the genetic contribution of HLA and non-HLA genes in the etiopathogenesis of rheumatoid arthritis (RA), 60 Caucasian multiplex families were identified and DNA analyzed for over 52 markers including DRB1, DQA1 and DQB1 alleles. Many of the marke ... Full text Link to item Cite

Systemic lupus erythematosus in three ethnic groups. IV. Factors associated with self-reported functional outcome in a large cohort study. LUMINA Study Group. Lupus in Minority Populations, Nature versus Nurture.

Journal Article Arthritis Care Res · August 1999 OBJECTIVE: To identify features of systemic lupus erythematosus (SLE) associated with poor functional outcome as measured by the 36-item Medical Outcomes Study Short Form 36 Health Survey (SF-36). METHODS: Two hundred twenty-four patients with early SLE (7 ... Full text Link to item Cite

Comparison of an enzyme immunoassay to an indirect fluorescent immunoassay for the detection of antinuclear antibodies.

Journal Article Am J Clin Pathol · April 1999 The standard method for detecting antinuclear antibodies (ANAs) is by immunofluorescence assay (IFA), a method that is labor intensive and subjective. In an attempt to overcome these limitations, several commercial enzyme immunoassays (EIAs) have been deve ... Full text Link to item Cite

Familial antiphospholipid antibody syndrome: criteria for disease and evidence for autosomal dominant inheritance.

Journal Article Arthritis Rheum · February 1999 OBJECTIVE: To develop diagnostic criteria for a familial form of antiphospholipid antibody syndrome (APS), identify families with >1 affected member, examine possible modes of inheritance, and determine linkage to potential candidate genes. METHODS: Family ... Full text Link to item Cite

Systemic lupus erythematosus in three ethnic groups: II. Features predictive of disease activity early in its course. LUMINA Study Group. Lupus in minority populations, nature versus nurture.

Journal Article Arthritis Rheum · July 1998 OBJECTIVE: To determine the factors associated with disease activity in patients with recent-onset (< or =5 years) systemic lupus erythematosus (SLE) who were of Hispanic, African-American, or Caucasian ethnicity. METHODS: Incident and prevalent cases of S ... Full text Link to item Cite

Antiphospholipid antibody syndrome: current concepts.

Journal Article Hosp Pract (1995) · February 15, 1998 Antiphospholipid antibody syndrome is a well-recognized cause of hypercoagulability and has multiple manifestations. Patients with an unexplained thrombotic event should be evaluated for the disorder, which can be primary or secondary to another autoimmune ... Full text Link to item Cite

Elevated levels of soluble Fas in systemic lupus erythematosus: Reply

Journal Article ARTHRITIS AND RHEUMATISM · September 1, 1996 Link to item Cite

Genetic analysis of multiplex rheumatoid arthritis families.

Journal Article ARTHRITIS AND RHEUMATISM · September 1, 1996 Link to item Cite

Lack of correlation between serum soluble Fas/APO-1 levels and autoimmune disease.

Journal Article Arthritis Rheum · December 1995 OBJECTIVE: To determine whether elevated soluble Fas/APO-1 (sFas/APO-1) levels are associated with either autoimmune disease or evidence of flares in autoimmune disease. METHODS: Thirty-seven serum samples were retrospectively obtained from normal controls ... Full text Link to item Cite

LACK OF CORRELATION OF SERUM-SOLUBLE FAS LEVELS AND AUTOIMMUNE-DISEASE

Journal Article ARTHRITIS AND RHEUMATISM · September 1, 1995 Link to item Cite