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

Jones, Bethan; Flurey, Caroline; Proudman, Susanna; Ferreira, Ricardo J O; Voshaar, Marieke; Hoogland, Wijnanda; Chaplin, Hema; Goel, Niti; Hetland, Merete Lund; Hill, Catherine; Kuriya, Bindee; Mather, Kate; Rasch, L.; Shea, Beverley; Singh, Jasvinder A; Smolen, Josef S; Silva, José António Pereira da; Souza, Savia de; Stamm, Tanja; Studenic, Paul; Wit, Maarten de; Tugwell, Peter; Boers, Maarten

doi:10.1016/j.semarthrit.2021.07.010

Cited by 8 publications

(6 citation statements)

References 16 publications

(14 reference statements)

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“…Their search for a better incorporation of the patient perspective has not yet resulted in a promising set of validated patient-reported outcome measures that can replace the PtGA. In their most recent working group report, they concluded that there is currently insufficient evidence to propose a change to the existing ACR/EULAR remission criteria 28. This report also discussed the concept of a ‘dual-target’ approach, trying to decouple the assessment of disease activity from disease impact in defining remission 25 29.…”

Section: Discussionmentioning

confidence: 99%

“…In their most recent working group report, they concluded that there is currently insufficient evidence to propose a change to the existing ACR/EULAR remission criteria. 28 This report also discussed the concept of a ‘dual-target’ approach, trying to decouple the assessment of disease activity from disease impact in defining remission. 25 29 At this stage, no data are available about the effectiveness and feasibility of such a dual-target approach.…”

Section: Discussionmentioning

confidence: 99%

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American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision

et al. 2022

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ObjectiveIn 2011, the American College of Rheumatology (ACR) and EULAR endorsed provisional criteria for remission in rheumatoid arthritis (RA), both Boolean-based and index-based. Based on recent studies indicating that a higher threshold for the patient global assessment (PtGA) may improve agreement between the two sets of criteria, our goals were to externally validate a revision of the Boolean remission criteria using a higher PtGA threshold and to validate the provisionally endorsed index-based criteria.MethodsWe used data from four randomised trials comparing biological disease-modifying antirheumatic drugs to methotrexate or placebo. We tested the higher proposed PtGA threshold of 2 cm (Boolean2.0) (range 0–10 cm) compared with the original threshold of 1 cm (Boolean1.0). We analysed agreement between the Boolean-based and index-based criteria (Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)) for remission and examined how well each remission definition predicted later good physical function (Health Assessment Questionnaire (HAQ) score≤0.5) and radiographic non-progression.ResultsData from 2048 trial participants, 1101 with early RA and 947 with established RA, were included. The proportion of patients with disease in remission at 6 months after treatment initiation increased when using Boolean2.0 compared with Boolean1.0, from 14.8% to 20.6% in early RA and 4.2% to 6.0% in established RA. Agreement between Boolean2.0 and the SDAI or CDAI remission criteria was better than for Boolean1.0, particularly in early disease. Boolean2.0, SDAI, and CDAI remission criteria had similar positive likelihood ratios (LRs) to predict radiographic nonprogression and a HAQ score of ≤0.5 (positive LR 3.8–4.3). The omission of PtGA (BooleanX) worsened the prediction of good functional outcomes.ConclusionUsing the Boolean 2.0 criteria classifies, more patients as achieving remission and increases the agreement with index-based remission criteria without jeopardising predictive value for radiographic or functional outcomes. This revised Boolean definition and the previously provisionally endorsed index-based criteria were endorsed by ACR and EULAR.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision

et al. 2022

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show abstract

“…Their search for a better incorporation of the patient perspective has not yet resulted in a promising set of validated patient‐reported outcome measures that can replace the PtGA. In their most recent working group report, they concluded that there is currently insufficient evidence to propose a change to the existing ACR/EULAR remission criteria ( 28 ). This report also discussed the concept of a “dual‐target” approach, trying to decouple the assessment of disease activity from disease impact in defining remission ( 25 , 29 ).…”

Section: Discussionmentioning

confidence: 99%

American College of Rheumatology/EULAR Remission Criteria for Rheumatoid Arthritis: 2022 Revision

Studenic

Aletaha

Wit

et al. 2022

Arthritis & Rheumatology

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Objective In 2011, the American College of Rheumatology (ACR) and EULAR endorsed provisional criteria for remission in rheumatoid arthritis (RA), both Boolean‐ and index‐based. Based on recent studies indicating that a higher threshold for the patient global assessment (PtGA) may improve agreement between the 2 sets of criteria, our goals were to externally validate a revision of the Boolean remission criteria using a higher PtGA threshold and to validate the provisionally endorsed index‐based criteria. Methods We used data from 4 randomized trials comparing biologic disease‐modifying antirheumatic drugs to methotrexate or placebo. We tested the higher proposed PtGA threshold of 2 cm (Boolean2.0) (range 0–10 cm) compared to the original threshold of 1 cm (Boolean1.0). We analyzed agreement between the Boolean‐ and index‐based criteria (Simplified Disease Activity Index [SDAI] and Clinical Disease Activity Index [CDAI]) for remission and examined how well each remission definition predicted later good physical function (Health Assessment Questionnaire [HAQ] score ≤0.5) and radiographic nonprogression. Results Data from 2,048 trial participants, 1,101 with early RA and 947 with established RA, were included. The proportion of patients with disease in remission at 6 months after treatment initiation increased when using Boolean2.0 compared to Boolean1.0, from 14.8% to 20.6% in early RA and 4.2% to 6.0% in established RA. Agreement between Boolean2.0 and the SDAI or CDAI remission criteria was better than for Boolean1.0, particularly in early disease. Boolean2.0, SDAI, and CDAI remission criteria had similar positive likelihood ratios (LRs) to predict radiographic nonprogression and a HAQ score of ≤0.5 (positive LR 3.8–4.3). The omission of PtGA (BooleanX) worsened the prediction of good functional outcomes. Conclusion Using the Boolean 2.0 criteria classifies more patients as achieving remission and increases the agreement with index‐based remission criteria without jeopardizing predictive value for radiographic or functional outcomes. This revised Boolean definition and the previously provisionally endorsed index‐based criteria were endorsed by ACR and EULAR.

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“…Речь идет о «показателях, оцениваемых самим пациентом» (ПОП, в англоязычной литературе -PRO, patient reported outcomes). К ним относятся боль, нарушение функции, утомляемость (усталость), нарушение сна, депрессия и тревога, а также интегральный показатель самочувствия -общая оценка активности заболевания пациентом (ООАЗП) [21,22]. Необходимо отметить, что определение ПОП проводилось далеко не во всех исследованиях ГИБП и иJAK.…”

Section: патогенетическая терапия ра и качество жизниunclassified

Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

Karateev¹,

Лила

Panevin³

et al. 2022

Naučno-praktičeskaâ revmatologiâ

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One of the main tasks of modern complex therapy of rheumatoid arthritis (RA) is to improve the quality of life of patients. To do this, it is necessary not only to achieve remission or low activity, but also to successfully control the main, most painful, manifestations of the disease. Therefore, when evaluating the results of RA treatment, the dynamics of not only standard indices (DAS28 (Disease Activity Score 28), CDAI (Clinical Disease Activity Index), SDAI (Simplified Disease Activity Index)), but also the so-called “patient reported outcomes” (PRO) – a patient’s global assessment of disease activity (PGA), pain, functional disorders and fatigue.This review examines the effect of one of the main classes of anti–rheumatic drugs - biological disease-modifying antirheumatic drugs (bDMARDs) on the PROs. The results of a series of randomized controlled trials are presented, in which changes in PROs were studied using various tumor necrosis factor α (TNF-α) inhibitors, abatacept T-lymphocyte co-stimulation inhibitor, rituximab CD20 inhibitor and interleukin (IL) 6 inhibitors.The use of bDMARDs in combination with methotrexate (MTX) provides a reduction in PGA and pain by 50-60%, functional disorders according to HAQ (Health Assessment Questionnaire) and fatigue according to FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) – by 15-30%. B DMARDs monotherapy (with the exception of the effect of tocilizumab on HAQ) does not exceed MTX monotherapy in its effect on PROs. Monotherapy with tocilizumab provides more favorable dynamics of PGA and pain than monotherapy with TNF-α inhibitors. An important advantage of IL-6 inhibitors is the rapid achievement of a clinical effect, which is noted already in the first 2 weeks after the first administration of the drug.

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

Cited by 8 publications

References 16 publications

American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision

American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision

American College of Rheumatology/EULAR Remission Criteria for Rheumatoid Arthritis: 2022 Revision

Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

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