Literature DB >> 32024651

Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal?

Paul Studenic1, David Felson2,3, Maarten de Wit4, Farideh Alasti1, Tanja A Stamm5, Josef S Smolen1, Daniel Aletaha6.   

Abstract

OBJECTIVES: This study aimed to evaluate different patient global assessment (PGA) cut-offs required in the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission definition for their utility in rheumatoid arthritis (RA).
METHODS: We used data from six randomised controlled trials in early and established RA. We increased the threshold for the 0-10 score for PGA gradually from 1 to 3 in steps of 0.5 (Boolean1.5 to Boolean3.0) and omitted PGA completely (BooleanX) at 6 and 12 months. Agreement with the index-based (Simplified Disease Activity Index (SDAI)) remission definition was analysed using kappa, recursive partitioning (classification and regression tree (CART)) and receiver operating characteristics. The impact of achieving each definition on functional and radiographic outcomes after 1 year was explored.
RESULTS: Data from 1680 patients with early RA and 920 patients with established RA were included. The proportion of patients achieving Boolean remission increased with higher thresholds for PGA from 12.4% to 19.7% in early and 5.9% to 12.3% in established RA at 6 months. Best agreement with SDAI remission occurred at PGA cut-offs of 1.5 and 2.0, while agreement decreased with higher PGA (CART: optimal agreement at PGA≤1.6 cm; sensitivity of PGA≤1.5 95%). Changing PGA thresholds at 6 months did not affect radiographic progression at 12 months (mean ꙙsmTSS for Boolean, 1.5, 2.0, 2.5, 3.0, BooleanX: 0.35±5.4, 0.38±5.14, 0.41±5.1, 0.37±4.9, 0.34±4.9, 0.27±4.7). However, the proportion attaining HAQ≤0.5 was 90.2%, 87.9%, 85.2%, 81.1%, 80.7% and 73.1% for the respective Boolean definitions.
CONCLUSION: Increasing the PGA cut-off to 1.5 cm would provide high consistency between Boolean with the index-based remission; the integer cut-off of 2.0 cm performed similarly. © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Entities:  

Keywords:  disease activity; outcomes research; patient perspective; rheumatoid arthritis

Mesh:

Substances:

Year:  2020        PMID: 32024651     DOI: 10.1136/annrheumdis-2019-216529

Source DB:  PubMed          Journal:  Ann Rheum Dis        ISSN: 0003-4967            Impact factor:   19.103


  10 in total

Review 1.  Transforming clinical trials in rheumatology: towards patient-centric precision medicine.

Authors:  Costantino Pitzalis; Ernest H S Choy; Maya H Buch
Journal:  Nat Rev Rheumatol       Date:  2020-09-04       Impact factor: 20.543

2.  Reexamining remission definitions in rheumatoid arthritis: considering the twenty-eight-joint Disease Activity Score, C-reactive protein level and patient global assessment.

Authors:  David Felson; Diane Lacaille; Michael P LaValley; Daniel Aletaha
Journal:  RMD Open       Date:  2021-11

3.  Validity and risk of adopting PGA ≤ 2 as a remission criteria of Boolean in clinical practice in patient with rheumatoid arthritis.

Authors:  Ichiro Yoshii; Tatsumi Chijiwa; Naoya Sawada
Journal:  Sci Rep       Date:  2022-02-22       Impact factor: 4.379

4.  Inflammation and biologic therapy in patients with rheumatoid arthritis achieving versus not achieving ACR/EULAR Boolean remission in a treat-to-target study.

Authors:  Nina Paulshus Sundlisæter; Ulf Sundin; Anna-Birgitte Aga; Joseph Sexton; Hilde Berner Hammer; Till Uhlig; Tore K Kvien; Espen A Haavardsholm; Siri Lillegraven
Journal:  RMD Open       Date:  2022-01

5.  Reexamining Remission Definitions in Rheumatoid Arthritis: Considering Disease Activity Score in 28 Joints, C-Reactive Protein, and Patient Global Assessment.

Authors:  David T Felson; Diane Lacaille; Michael P LaValley; Daniel Aletaha
Journal:  ACR Open Rheumatol       Date:  2021-11-16

6.  Correspondence on "Re-examining remission definitions in rheumatoid arthritis: considering the 28-Joint Disease Activity Score, C-reactive protein level and patient global assessment" by Felson et al.

Authors:  Ricardo J O Ferreira; Paco M J Welsing; Johannes W G Jacobs; Laure Gossec; Mwidimi Ndosi; Pedro M Machado; Désirée van der Heijde; José A P da Silva
Journal:  ACR Open Rheumatol       Date:  2022-01-28

7.  Overtreatment in rheumatoid arthritis: are there reasons for concern?

Authors:  Ricardo J O Ferreira; Laure Gossec; Jose Antonio Pereira da Silva
Journal:  RMD Open       Date:  2022-09

8.  Remission or Not Remission, That's the Question: Shedding Light on Remission and the Impact of Objective and Subjective Measures Reflecting Disease Activity in Rheumatoid Arthritis.

Authors:  Alen Brkic; Katarzyna Łosińska; Are Hugo Pripp; Mariusz Korkosz; Glenn Haugeberg
Journal:  Rheumatol Ther       Date:  2022-09-21

9.  Limiting factors to Boolean remission differ between autoantibody-positive and -negative patients in early rheumatoid arthritis.

Authors:  Serena Bugatti; Ludovico De Stefano; Antonio Manzo; Garifallia Sakellariou; Blerina Xoxi; Carlomaurizio Montecucco
Journal:  Ther Adv Musculoskelet Dis       Date:  2021-05-22       Impact factor: 5.346

Review 10.  Patient-Reported Outcomes in Systemic Lupus Erythematosus. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring?

Authors:  Ioannis Parodis; Paul Studenic
Journal:  J Clin Med       Date:  2022-01-11       Impact factor: 4.241

  10 in total

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