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Consensus terminology for preclinical phases of psoriatic arthritis for use in research studies: results from a Delphi consensus study.

ABSTRACT: The concept of psoriatic arthritis (PsA) prevention is gaining increased interest owing to the physical limitation, poor quality of life and low remission rates that are achieved with current therapies for PsA. The psoriasis-to-PsA transition offers a unique opportunity to identify individuals at increased risk of developing PsA and to implement preventive strategies. However, identifying individuals at increased risk of developing PsA is challenging as there is no consensus on how this population should be defined. This Consensus Statement puts forward recommended terminology from the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) for defining specific subgroups of individuals during the preclinical and early clinical phases of PsA to be used in research studies. Following a three-round Delphi process, consensus was reached for three terms and definitions: 'increased risk for PsA', 'psoriasis with asymptomatic synovio-entheseal imaging abnormalities' and 'psoriasis with musculoskeletal symptoms not explained by other diagnosis'. These terms and their definitions will enable improved identification and standardization of study populations in clinical research. In the future, as increasing evidence emerges regarding the molecular and clinical features of the psoriasis-to-PsA continuum, these terms and definitions will be further refined and updated.

SUBMITTER: Perez-Chada LM

PROVIDER: S-EPMC7997804 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Consensus terminology for preclinical phases of psoriatic arthritis for use in research studies: results from a Delphi consensus study.

Perez-Chada Lourdes M LM Haberman Rebecca H RH Chandran Vinod V Rosen Cheryl F CF Ritchlin Christopher C Eder Lihi L Mease Philip P Reddy Soumya S Ogdie Alexis A Merola Joseph F JF Scher Jose U JU

Nature reviews. Rheumatology 20210215 4

The concept of psoriatic arthritis (PsA) prevention is gaining increased interest owing to the physical limitation, poor quality of life and low remission rates that are achieved with current therapies for PsA. The psoriasis-to-PsA transition offers a unique opportunity to identify individuals at increased risk of developing PsA and to implement preventive strategies. However, identifying individuals at increased risk of developing PsA is challenging as there is no consensus on how this populati ...[more]

PMID: 33589818

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Project description:BackgroundTelehealth has emerged as an alternative model for treatment delivery and has become an important component of health service delivery. However, there is inconsistency in the use of terminologies and a lack of research priorities in telehealth in musculoskeletal pain. The purpose of this international, multidisciplinary expert panel assembled in a modified three-round e-Delphi survey is to achieve a consensus on research priorities and for the standard terminology for musculoskeletal pain telehealth practice.MethodsIn this international modified e-Delphi survey, we invited an expert panel consisting of researchers, clinicians, consumer representatives, industry partners, healthcare managers, and policymakers to participate in a three-round e-Delphi. Expert panels were identified through the Expertscape website, PubMed database, social media, and a snowball approach. In Round 1, potential research priorities and terminologies were presented to panel members. Panel members rated the agreement of each research priority on a 5-point Likert scale and an 11-point numerical scale, and each terminology on a 5-point Likert scale for the "telehealth in musculoskeletal pain " field over rounds. At least 80% of the panel members were required to agree to be deemed a consensus. We analyzed the data descriptively and assessed the stability of the results using the Wilcoxon matched-pairs signed rank test.ResultsWe performed an international e-Delphi survey from February to August 2022. Of 694 invited people, 160 panel members participated in the first round, 133 in the second round (83% retention), and 134 in the third round (84% retention). Most of the panel members were researchers 76 (47%), clinicians 57 (36%), and consumer representatives 9 (6%) of both genders especially from Brazil 31 (19%), India 22 (14%), and Australia 19 (12%) in the first round. The panel identified fourteen telehealth research priorities spanned topics including the development of strategies using information and communication technology, telehealth implementation services, the effectiveness and cost-effectiveness of telehealth interventions, equity of telehealth interventions, qualitative research and eHealth literacy in musculoskeletal pain conditions from an initial list of 20 research priorities. The consensus was reached for "digital health" and "telehealth" as standard terminologies from an initial list of 37 terminologies.ConclusionAn international, multidisciplinary expert consensus recommends that future research should consider the 14 research priorities for telehealth musculoskeletal pain reached. Additionally, the terms digital health and telehealth as the most appropriate terminologies to be used in musculoskeletal telehealth research.RegisterOpen Science Framework ( https://osf.io/tqmz2/ ).

Project description:IntroductionPsoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1 year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2 years.MethodsBE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40 mg every 2 weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE).ResultsA total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104 weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100.ConclusionsBimekizumab was well tolerated for up to 2 years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2 years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms.Trial registrationBE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).

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Consensus terminology for preclinical phases of psoriatic arthritis for use in research studies: results from a Delphi consensus study.

Publications

Consensus terminology for preclinical phases of psoriatic arthritis for use in research studies: results from a Delphi consensus study.

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