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

2020 ◽  
Vol 79 (4) ◽  
pp. 445-452 ◽  
Author(s):  
Paul Studenic ◽  
David Felson ◽  
Maarten de Wit ◽  
Farideh Alasti ◽  
Tanja A Stamm ◽  
...  

ObjectivesThis 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).MethodsWe 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.ResultsData 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.ConclusionIncreasing 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.

2020 ◽  
pp. annrheumdis-2020-217171 ◽  
Author(s):  
Ricardo J O Ferreira ◽  
Paco M J Welsing ◽  
Johannes W G Jacobs ◽  
Laure Gossec ◽  
Mwidimi Ndosi ◽  
...  

ObjectivesTo determine the impact of excluding patient global assessment (PGA) from the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean remission criteria, on prediction of radiographic and functional outcome of rheumatoid arthritis (RA).MethodsMeta-analyses using individual patient data from randomised controlled trials testing the efficacy of biological agents on radiographic and functional outcomes at ≥2 years. Remission states were defined by 4 variants of the ACR/EULAR Boolean definition: (i) tender and swollen 28-joint counts (TJC28/SJC28), C reactive protein (CRP, mg/dL) and PGA (0–10=worst) all ≤1 (4V-remission); (ii) the same, except PGA >1 (4V-near-remission); (iii) 3V-remission (i and ii combined; similar to 4V, but without PGA); (iv) non-remission (TJC28 >1 and/or SJC28 >1 and/or CRP >1). The most stringent class achieved at 6 or 12 months was considered. Good radiographic (GRO) and functional outcome (GFO) were defined as no worsening (ie, change in modified total Sharp score (ΔmTSS) ≤0.5 units and ≤0.0 Health Assessment Questionnaire–Disability Index points, respectively, during the second year). The pooled probabilities of GRO and GFO for the different definitions of remission were estimated and compared.ResultsIndividual patient data (n=5792) from 11 trials were analysed. 4V-remission was achieved by 23% of patients and 4V-near-remission by 19%. The probability of GRO in the 4V-near-remission group was numerically, but non-significantly, lower than that in the 4V-remission (78 vs 81%) and significantly higher than that for non-remission (72%; difference=6%, 95% CI 2% to 10%). Applying 3V-remission could have prevented therapy escalation in 19% of all participants, at the cost of an additional 6.1%, 4.0% and 0.7% of patients having ΔmTSS >0.0, >0.5 and >5 units over 2 years, respectively. The probability of GFO (assessed in 8 trials) in 4V-near-remission (67%, 95% CI 63% to 71%) was significantly lower than in 4V-remission (78%, 74% to 81%) and similar to non-remission (69%, 66% to 72%).Conclusion4V-near-remission and 3V-remission have similar validity as the original 4V-remission definition in predicting GRO, despite expected worse prediction of GFO, while potentially reducing the risk of overtreatment. This supports further exploration of 3V-remission as the target for immunosuppressive therapy complemented by patient-oriented targets.


2021 ◽  
Author(s):  
Susan J. Bartlett ◽  
Vivian P. Bykerk ◽  
Orit Schieir ◽  
Marie-France Valois ◽  
Janet E Pope ◽  
...  

Abstract Purpose The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) is a patient-reported measure of disease activity in RA. We estimated minimal and meaningful change from the perspective of RA patients, physicians, and using a disease activity index. Methods Data were from 3- and 6-month visits of adults with early RA enrolled in the Canadian Early Arthritis Cohort. Participants completed the RA-FQ, the Patient Global Assessment of RA, and Patient Global Change Impression at consecutive visits. Rheumatologists recorded joint counts and MD Global. Clinical Disease Activity Index (CDAI) scores were computed. We compared mean RA-FQ change across categories using patients, physicians, and CDAI anchors. Results The 808 adults were mostly white (84%) women (71%) with a mean age of 55 and moderate-high disease activity (85%) at enrollment. At V2, 79% of patients classified their RA as changed; 59% were better and 20% were worse. Patients reporting they were a lot worse had a mean RA-FQ increase of 8.9 points whereas those who were a lot better had a -6.0 decrease. Minimal worsening and improvement were associated with a mean 4.7 and -1.8 change in RA-FQ, respectively, while patients rating their RA unchanged had stable scores. Physician and CDAI classified more patients as worse than patients, and minimal and meaningful RA-FQ thresholds differed by group. Conclusion Thresholds to identify meaningful change vary by anchor used. These data offer new evidence demonstrating robust psychometric properties of the RA-FQ and offer guidance about improvement or worsening, supporting its use in RA care, research and decision-making.


2021 ◽  
Author(s):  
Ichiro Yoshii ◽  
Tatsumi Chijiwa ◽  
Naoya Sawada

Abstract Validity and risk of setting patient’s global assessment (PGA) ≤ 2 as a Boolean remission criteria substituting PGA ≤ 1 in treating rheumatoid arthritis (RA) was investigatedPatients were recruited from an area cohort, of whom attained Boolean remission (Boolean-1) or near remission with PGA ≤ 2 and the rest components were ≤ 1 (Boolean-2). Simplified disease activity index (SDAI) score was compared according to the criteria variations.A total of 517 patients were studied. Mean SDAI score of patients with Boolean-1 was significantly lower than that of patients with Boolean-2 at acquisition. The trend was evident in the patients who attained Boolean-1 remission. Mean SDAI score at acquisition, 6 months after, and 1 year after of patients who attained Boolean-2 first and then Boolean-1, was significantly inferior to that of patients who attained the remissions at the same time. The mean SDAI score at month 6 in the Boolean-2 was not SDAI remission at all.We concluded that setting PGA ≤ 2 as a remission criteria may not have statistical difference in disease activity from PGA ≤ 1, however, there was an determinant risk to misread that includes patient who losses clinical remission after acquisition.


2013 ◽  
Vol 40 (8) ◽  
pp. 1254-1258 ◽  
Author(s):  
Yuko Kaneko ◽  
Harumi Kondo ◽  
Tsutomu Takeuchi

Objective.To investigate the performance of the new remission criteria for rheumatoid arthritis (RA) in daily clinical practice and the effect of possible misclassification of remission when 44 joints are assessed.Methods.Disease activity and remission rate were calculated according to the Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and a Boolean-based definition for 1402 patients with RA in Keio University Hospital. Characteristics of patients in remission were investigated, and the number of misclassified patients was determined — those classified as being in remission based on 28-joint count but as nonremission based on a 44-joint count for each definition criterion.Results.Of all patients analyzed, 46.6%, 45.9%, 41.0%, and 31.5% were classified as in remission in the DAS28, SDAI, CDAI, and Boolean definitions, respectively. Patients classified into remission based only on the DAS28 showed relatively low erythrocyte sedimentation rates but greater swollen joint counts than those classified into remission based on the other definitions. In patients classified into remission based only on the Boolean criteria, the mean physician global assessment was greater than the mean patient global assessment. Although 119 patients had ≤ 1 involved joint in the 28-joint count but > 1 in the 44-joint count, only 34 of these 119 (2.4% of all subjects) were found to have been misclassified into remission.Conclusion.In practice, about half of patients with RA can achieve clinical remission within the DAS28, SDAI, and CDAI; and one-third according to the Boolean-based definition. Patients classified in remission based on a 28-joint count may have pain and swelling in the feet, but misclassification of remission was relatively rare and was seen in only 2.4% of patients under a Boolean definition. The 28-joint count can be sufficient for assessing clinical remission based on the new remission criteria.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 508.1-508
Author(s):  
P. Mandl ◽  
P. Studenic ◽  
F. Alasti ◽  
R. Kaltenberger ◽  
A. Kerschbaumer ◽  
...  

Background:The notion that weather conditions may influence the symptoms and course of rheumatic and musculoskeletal diseases goes back to ancient times. However, despite the seemingly obvious relationship, previous studies assessing how meteorological variables affect pain and disease activity have yielded contradictory results.Objectives:To evaluate whether meteorological variables influence disease activity in patients with rheumatoid arthritis (RA).Methods:We assessed correlations between clinical measures of disease activity (pain, patient global assessment [PGA], tender- and swollen 28 joint counts [TJC and SJC]) and individual meteorological variables: temperature (temp.), effective (eff.) temperature, saturation vapor pressure (SVP), absolute humidity (AH), relative humidity (RH), dew point, vapor pressure (VP) and precipitation. Assessments documented in the Care for Rheumatoid Arthritis database of our institution were matched with these meteorological variables on a daily basis for a period of 12 years between 2005 and 2017 and analyzed utilizing generalized estimating equations. Patients with <5 visits in the study period, those with <1 visit/quarter or with no pain (VAS=0) in ≥3 consecutive visits and those living outside of the catchment area were excluded. Patients were grouped into remission or low (≤11) vs. moderate or high (>11) disease activity based on the simplified disease activity index (SDAI).Results:A total of 461 patients with an average disease duration at first visit of 5.7±7.4 years, average age of 55.3±14.5 years and a mean SDAI of 22.1±12.7 were analyzed. Among patients with moderate or high disease activity, higher temp./eff. temp. and SVP were associated with lower pain, TJC and SJC (Figure 1); on the contrary, higher RH was associated with higher pain and higher SJC. In those in remission or low disease activity, higher RH, AH, VP or dew point were associated with lower PGA. Higher precipitation was associated with lower SJC.Figure 1.Association of meteorological parameters and clinical measures of disease activity. PGA: patient’s global assessment, SDAI: simplified disease activity index, SJC: swollen joint count, TJC: tender joint count. * p≤ 0.05, ** p≤ 0.01, *** p≤ 0.001Conclusion:In this large association study of meteorological parameters with RA, both temperature and humidity parameters were modestly inversely associated with pain, TJC and SJC.Disclosure of Interests:None declared


2021 ◽  
Vol 13 ◽  
pp. 1759720X2110090
Author(s):  
Ahmad Y. Abuhelwa ◽  
David J. R. Foster ◽  
Arkady Manning-Bennett ◽  
Michael J. Sorich ◽  
Susanna Proudman ◽  
...  

Background: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease associated with increased risk of cardiovascular disease (CVD). Treatment for CVD may involve pharmacological agents that antagonise beta adrenergic receptors. These receptors may play an important role in immunology, and the effects of beta-blockers (BB) in RA is unknown. The aim of this study was to investigate the association between BB use and remission in patients with RA initiating tocilizumab +/− conventional synthetic (cs-) DMARD therapy. Methods: Data was pooled from five randomised trials investigating tocilizumab and/or csDMARD treatment in RA (primarily methotrexate). The association between BB use and remission according to the Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) was assessed by Cox proportional hazard analysis. Sensitivity analysis in patients with pre-existing CVD and an exploratory analysis of the impact of other CVD drugs were conducted. Results: Data were available from 5502 participants, 594 (10.8%) of whom were using systemic BB. BB use was associated with less frequent SDAI remission in the total [adjusted hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.57–0.87, p = 0.001] and CVD cohort [adjusted HR 0.72 (0.57–0.90, p = 0.005)]. The association was consistent between trials (interaction p = 0.44) and treatment arms (interaction p = 0.06). No significant association between remission and β1-receptor selectivity was identified ( p = 0.16), and the association was independent from other cardiovascular drug use. Similar associations between BB use and CDAI remission were observed. Conclusion: In a large, pooled cohort of RA patients initiating csDMARDs and/or tocilizumab, BB use was independently associated with less frequent remission.


2020 ◽  
pp. 1-4
Author(s):  
Louay Labban ◽  
◽  
Maysoun Kudsi ◽  

Objective: To determine if changes in depressive symptoms or anxiety lead to changes in the activity of systemic lupus erythematosus (SLE) during COVID 19 quarantine. Participants and Methods: Twenty‐eight patients with SLE were examined prospectively every 2 weeks for up to 8 weeks at the time of COVID 19 quarantine in Syria. At each assessment, (CES‐D), Anxiety Inventory, patient’s global assessment, physician global assessment, and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) were done. Results: Changes in depression and anxiety were positively correlated with simultaneous changes in the patient global assessment of SLE activity, but not with changes in the physician global assessment, SLEDAI. Depression and anxiety scores were also correlated with patient global assessments 2 weeks later, but lagged scores were not significantly associated with the patient global assessment after controlling for current depression and anxiety scores. No measure of SLE activity increased in the 2 weeks immediately after a large increase in CES‐D or State Anxiety scores. Conclusion: No evidence was found to support the hypothesis that psychological distress causes increased SLE activity.


2017 ◽  
Vol 23 (4) ◽  
pp. 189-194
Author(s):  
Doiniţa Oprea ◽  
Elena Valentina Ionescu ◽  
Liliana Elena Stanciu ◽  
Carmen Oprea ◽  
Ruxandra Badiu ◽  
...  

AbstractBackground. Rheumatoid arthritis (RA), met in the literature also as chronic evolving polyarthritis, is a chronic inflammatory disease, which typically involves the small and medium joints, with a symmetric distribution. Clinical studies shown that a proportion of patients with RA, without measurable rheumatoid factors are a distinct entity from those patients with seropositive RA. Around one third of patients with RA are seronegative for those two serological markers, the rheumatoid factors (RF) and anti-citrullinated peptide antibodies (Anti-CCP). Hands are the most frequently affected in both seropositive and seronegative RA and the first joints involved in the inflammatory process are the metacarpo-phalangeal joints, IFP joints and the radiocarpian joint. The big joints become later symptomatic, after the small joints are affected. Materials and methods: 66 patients files and the personal records of the patients consecutively admitted in the Rheumatology Department of the Clinical Emergency County Hospital Constanta. Patients from county Constanta were included in the study, with diagnosis of rheumatoid arthritis (diagnosis confirmed at least 2 years ago), including both forms (seropositive and seronegative) of the disease. The complete clinical exam was done for the patients included in the study, following the identification of the active joint disease. The mechanical status of the joint was observed by a single evaluator for each of those 66 patients with RA, with special focus on the presence of the deformities / ankyloses of the hands joints. Therefore, there were evaluated: the mobility (the number of the joints with limited movements), deformities, ankyloses (the number of the joints without mobility). The joint mobility was assessed by counting the hand joints with limited movements and the worsening of the prehension function. The presence of the following hand deformities was followed: fingers in “swan neck”, “fusiform fingers”, the thumb “in Z”, and the aspect of “hand in the shape of a camel back”. For evaluating the painful or swollen joints we used: the 28 joint index, the overall evaluation of the disease activity - by the patient (Patient Global Assessment-PGA) and by the doctor (Medical Doctor Global Assessment- MDGA), the score of disease activity DAS 28 (DAS28 - Disease Activity Score 28), the index of the clinical activity of the disease (Clinical Disease Activity Index- CDAI), as well as the simplified index of activity of the disease (Simplified Disease Activity Index-SDAI). It was determined for each patient the plasma RF and anticitrullinated peptide antibodies. Results and discussion. As expected, there is a bigger frequency of female patients in both forms of the disease (seropositive and seronegative) and regarding males the recurrence is approximate equal between those two groups. By comparing the frequency of the joint deformities at hand level between the 2 groups of patients included in the study (seropositive PR and seronegative PR), we saw a superiority of these (with all their forms) in the patients with seropositive polyarthritis. Conclusions. The clinical study done in this work is completing the data offered by the studies of some dedicated authors, who analysed the characteristic elements of rheumatoid arthritis depending on seropositivity. Our results confirm the idea that seronegative rheumatoid arthritis has a more gentle clinical evolution and is a less destructive form of disease.


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