scholarly journals Flares in Rheumatoid Arthritis Patients with Low Disease Activity: Predictability and Association with Worse Clinical Outcomes

2018 ◽  
Vol 45 (11) ◽  
pp. 1515-1521 ◽  
Author(s):  
Katie Bechman ◽  
Lieke Tweehuysen ◽  
Toby Garrood ◽  
David L. Scott ◽  
Andrew P. Cope ◽  
...  

Objective.To investigate predictors of flare in rheumatoid arthritis (RA) patients with low disease activity (LDA) and to evaluate the effect of flare on 12-month clinical outcomes.Methods.Patients with RA who were taking disease-modifying antirheumatic drugs and had a stable 28-joint count Disease Activity Score (DAS28) < 3.2 were eligible for inclusion. At baseline and every 3 months, clinical (DAS28), functional [Health Assessment Questionnaire–Disability Index (HAQ-DI), EQ-5D, Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-F), Medical Outcomes Study Short Form-36 (SF-36)], serum biomarkers [multibiomarker disease activity (MBDA) score, calprotectin, CXCL10], and imaging data were collected. Flare was defined as an increase in DAS28 compared with baseline of > 1.2, or > 0.6 if concurrent DAS28 ≥ 3.2. Cox regression analyses were used to identify baseline predictors of flare. Biomarkers were cross-sectionally correlated at time of flare. Linear regressions were performed to compare clinical outcomes after 1 year.Results.Of 152 patients, 46 (30%) experienced a flare. Functional disability at baseline was associated with flare: HAQ-DI had an unadjusted HR 1.82 (95% CI 1.20–2.72) and EQ-5D had HR 0.20 (95% CI 0.07–0.57). In multivariate analyses, only HAQ-DI remained a significant independent predictor of flare (HR 1.76, 95% CI 1.05–2.93). At time of flare, DAS28 and its components significantly correlated with MBDA and calprotectin, but correlation coefficients were low at 0.52 and 0.49, respectively. Two-thirds of flares were not associated with a rise in biomarkers. Patients who flared had significantly worse outcomes at 12 months (HAQ-DI, EQ-5D, FACIT-F, SF-36, and radiographic progression).Conclusion.Flares occur frequently in RA patients with LDA and are associated with worse disease activity, quality of life, and radiographic progression. Higher baseline HAQ-DI was modestly predictive of flare, while biomarker correlation at the time of flare suggests a noninflammatory component in a majority of events.

2009 ◽  
Vol 36 (3) ◽  
pp. 522-531 ◽  
Author(s):  
EDWARD KEYSTONE ◽  
BRUCE FREUNDLICH ◽  
MICHAEL SCHIFF ◽  
JUAN LI ◽  
MICHELE HOOPER

Objective.This analysis examined clinical and radiographic responses to methotrexate (MTX), etanercept (ETN), and combination ETN and MTX in patients with moderate versus severe rheumatoid arthritis (RA) in both early and late disease.Methods.Data from the Trial of Etanercept and Methotrexate With Radiographic Patient Outcomes (TEMPO) and the Early Rheumatoid Arthritis trials were used. Patients were classified with moderate or severe RA based on Disease Activity Score including 28-joint count (DAS28). Outcomes included DAS28 remission, DAS28 low disease activity, Health Assessment Questionnaire (HAQ), American College of Rheumatology (ACR) scores, Total Sharp Score (TSS) progression, no radiographic progression (annualized change in TSS ≥ 0), change from baseline in TSS, and the change in TSS for patients who had radiographic progression (TSS > 0).Results.Patients with moderate disease generally achieved better clinical outcomes than patients with severe disease, including significant differences in DAS28 remission, low disease activity, and HAQ ≤0.5 at Month 12. Patients with baseline severe disease had higher ACR and DAS responses than patients with moderate disease.Conclusion.Patients with severe RA disease activity achieved substantial clinical improvement with high-dose MTX and/or ETN treatment, but patients with moderate disease were more likely to reach a lower disease activity state. These findings were independent of disease duration. The results support the opportunity for excellent clinical outcomes, particularly with combination therapy, in patients with moderate RA.


RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000955 ◽  
Author(s):  
Manuel Francisco Ugarte-Gil ◽  
Guillermo J Pons-Estel ◽  
Luis M Vila ◽  
Gerald McGwin ◽  
Graciela S Alarcón

AimsTo determine whether the proportion of time systemic lupus erythematosus patients achieve remission/low disease activity state (LDAS) is associated with a better quality of life (QoL).Patients and methodsPatients from a well-established multiethnic, multicentre US cohort were included: remission: Systemic Lupus Activity Measure (SLAM) score=0, prednisone≤5 mg/day and no immunosuppressants); LDAS not in remission, SLAM score≤3, prednisone≤7.5 mg/day, no immunosuppressants; the combined proportion of time patients were in these states was the independent variable. The endpoints were the Physical and Mental Components Summary measures (PCS and MCS, respectively) and the individual subscales of the Short Form (SF)-36 at the last visit. Linear regression was used to estimate the association between the proportion of follow-up time in remission/LDAS and the SF-36 measures with and without adjustment for possible confounders.ResultsFour hundred and eighty-three patients were included. The per cent of time on remission/LDAS was associated with better QoL after adjusting for potential confounders; for the PCS the parameter estimate was 9.47 (p<0.0001), for the MCS 5.89 (p=0.0027), and for the subscales they ranged between 7.51 (p=0.0495) for mental health and 31.79 (p<0.0001) for role physical.ConclusionsThe per cent of time lupus patients stay on remission/LDAS is associated with a better QoL as measured by SF-36.


2013 ◽  
Vol 41 (2) ◽  
pp. 398-406 ◽  
Author(s):  
Frédérique Gandjbakhch ◽  
Espen A. Haavardsholm ◽  
Philip G. Conaghan ◽  
Bo Ejbjerg ◽  
Violaine Foltz ◽  
...  

Objective.To assess the predictive value of magnetic resonance imaging (MRI)-detected subclinical inflammation for subsequent radiographic progression in a longitudinal study of patients with rheumatoid arthritis (RA) in clinical remission or low disease activity (LDA), and to determine cutoffs for an MRI inflammatory activity acceptable state in RA in which radiographic progression rarely occurs.Methods.Patients with RA in clinical remission [28-joint Disease Activity Score-C-reactive protein (DAS28-CRP) < 2.6, n = 185] or LDA state (2.6 ≤ DAS28-CRP < 3.2, n = 69) with longitudinal MRI and radiographic data were included from 5 cohorts (4 international centers). MRI were assessed according to the Outcome Measures in Rheumatology (OMERACT) RA MRI scoring system (RAMRIS). Statistical analyses included an underlying conditional logistic regression model stratified per cohort, with radiographic progression as dependent variable.Results.A total of 254 patients were included in the multivariate analyses. At baseline, synovitis was observed in 95% and osteitis in 49% of patients. Radiographic progression was observed in 60 patients (24%). RAMRIS synovitis was the only independent predictive factor in multivariate analysis. ROC analysis identified a cutoff value for baseline RAMRIS synovitis score of 5 (maximum possible score 21). Rheumatoid factor (RF) status yielded a significant interaction with synovitis (p value = 0.044). RF-positive patients with a RAMRIS synovitis score of > 5 vs ≤ 5, had an OR of 4.4 (95% CI 1.72–11.4) for radiographic progression.Conclusion.High MRI synovitis score predicts radiographic progression in patients in clinical remission/LDA. A cutoff point for determining an MRI inflammatory activity acceptable state based on the RAMRIS synovitis score was established. Incorporating MRI in future remission criteria should be considered.


Author(s):  
Selena Márcia Dubois Mendes ◽  
Bárbara Liliane Lôbo Queiroz ◽  
Larissa Vieira Santana ◽  
Abrahão Fontes Baptista ◽  
Mittermayer Barreto Santiago ◽  
...  

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disease with impact on increasing the morbidity and mortality rates. Different levels of disease activity (LDA) have been established, however, its impact on pain and quality of life have yet to be been evidenced. The aim of this study was to evaluate the relationship of different levels of disease activity on the painful profile and quality of life (QOL) of patients diagnosed with RA. This was a cross-sectional study, conducted in RA patients attending an Educational Outpatient Care Service in Salvador, Bahia, Brazil. The LDA was defined according to values of Erythrocyte Sedimentation Rate (ESR), Visual Analog Scale (VAS), and number of swollen and sore joints, according to the Disease Activity Score in 28 joints (DAS28). Types of pain were assessed using the Douleur Neuropathique en 4 questions (DN4). To evaluate QOL, the Short Form (36) Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) were applied. The association between LDA, QOL and painful profile was verified using One Way-ANOVA and Bonferroni correction post-test. A high LAD was observed in 67.7% of the 96 patients  evaluated in this study. Pain sensation was reported by 94.8 % of participants with 40.6 % reporting it as nociceptive and 80.2% as intense. It was also observed that the higher LAD found the higher was the pain intensity reported (p=0.001) and lower QOL scores (p<0.001). Although the LDA did not correlate with the type of pain (p=0.611), it was correlated with the total score obtained in the QOL from the HAQ (p=0.001). The greatest impact on QOL evaluated through the SF-36 were physical (p<0.001) and functional capacity (p<0.001). In conclusion, RA patients who had high LDA reported more severe pain perception and obtained the lowest scores in the assessment of quality of life.


Author(s):  
Leticia Breda e Vasconcelos ◽  
Tais Freire Galvao

This systematic review assesses the effectiveness and safety of reducing the dose of biological drugs in patients with rheumatoid arthritis at low disease activity, compared to standard dose treatment. Clinical outcomes data were collected and summarized in meta-analysis of standardized mean difference or relative risk. Most outcomes were non-significant.


2020 ◽  
Vol 9 (10) ◽  
pp. 3219
Author(s):  
Yoon-Jeong Oh ◽  
Ki Won Moon

Using nationwide cohort data, this study evaluated predictors of flares in patients with rheumatoid arthritis (RA) who exhibit low disease activity (LDA) and the effects of flares on clinical outcomes. The Korean Observational Study Network for Arthritis (KORONA) registry is a nationwide Korean RA-specific cohort registry that collects data annually from 5.077 patients, with RA in 23 centers across South Korea. This study used data from 1.717 patients with RA who exhibited LDA [28–joint disease activity score (DAS28) < 3.2] at enrollment. Flares were defined as an increase in DAS28, compared with the previous value of > 1.2 or > 0.6, if the concurrent DAS28 was ≥ 3.2. Cox regression analysis was used to identify baseline predictors of flares. Of the 1.717 patients with RA, 566 (33.0%) experienced flares during the 2-year study period. An analysis of baseline characteristics of flare and non-flare groups revealed that more women and non-smokers were present in the flare group than in the non-flare group; the flare group also had higher scores on physician’s and patient’s pain and fatigue visual analogue scales (VAS) and the health assessment questionnaire (HAQ). In a multivariate analysis, physician’s VAS score, hemoglobin level, and HAQ score were significant predictors of flares. A high physician’s VAS score, low hemoglobin, and high HAQ score at baseline were significant predictors of flares in patients with RA who exhibited LDA.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1063.1-1063
Author(s):  
M. Brahem ◽  
M. Hassayoun ◽  
H. Hachfi ◽  
R. Sarraj ◽  
M. Ardhaoui ◽  
...  

Background:The assessment of health-related quality-of-life (HRQoL) in rheumatoid arthritis (RA) is becoming a common tool in clinical practice. The medical outcomes survey short form 36 (SF- 36) is one of the most widely used tools for measuring HRQoL in RA as well as the HAQ scale.Objectives:The aim of our study is to evaluate the impact of the RA in the quality of life (QoL) of our patients using the SF-36 and the HAQ questionnaires.Methods:This is a cross-sectional study during a period of the year 2020, including 70 patients followed in the department of Rheumatology in Mahdia, Tunisia. All patients were diagnosed with RA based in ACR 1987/EULAR 2010. We evaluated for each patient, the mean global scale and the eight domains of SF-36 (physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), a social functioning (SF), role emotional (RE) and mental health (MH)), scored from 0 (worst) to 100 (best).Results:Our study included 70 patients (59 females/11males) with an age ranged from 21 to 76 years. The mean age was 54 ± 12 years. The mean duration of the disease was 11 ± 10 years [1-40]. The mean number of tender joints was 9.7 ±9.4 and swollen joints were 4.2 ±6.1. The mean disease activity score (DAS28) was 4.6 ±1.9 [1.2-8.4]. The mean HAQ score was 1.5±1.3, 47.1% of patients had specific joint deformations, 82.9% had radiologic involvement and 31.4% had osteoporosis. The biologic analysis showed that the mean ESR was 46.7 ± 30.5 and the CRP was 15.8 ±23.3. Rheumatoid factors were positive in 42.9% of cases, the ACPA were positive in 50% of cases. 84.3% of RA patients were treated by methotrexate, 4.3% were treated by salazopyrin and 11.4% were treated by biologic treatments.The SF-36 global score was 50.4 ± 26.3 [15.3-92.8]. 46 patients (65.7% of cases) had impaired QoL (SF-36<66.7). The means of different domains (PF, RP, BP, GH, VT, SF, RE, MH) were respectively 51; 41.4; 51.4; 50; 51.2; 57.7; 41.9; 59.2. The most severely impacted domains were the RP and RE.Our study showed a significant correlation between the SF-36 global score and the number of tender joints (p=0.002), the DAS28 (p=0.017) and the HAQ(p=0.000).Conclusion:Our study showed that 65.7% of RA patients presented impaired QoL (SF-36<66.7), which is associated with high disease activity. So it’s important to jugulate the disease, in order to ameliorate the quality of life of our patients.References:[1]Matcham, F., Scott, IC, Rayner, L., Hotopf, M., Kingsley, GH, Norton, S.,… Steer, S. (2014). L’impact de la polyarthrite rhumatoïde sur la qualité de vie évalué à l’aide du SF-36: une revue systématique et une méta-analyse. Séminaires sur l’arthrite et les rhumatismes, 44 (2), 123-130. doi: 10.1016 / j.semarthrit.2014.05.001.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 886.2-886
Author(s):  
C. Bingham ◽  
S. Kafka ◽  
S. Black ◽  
S. Xu ◽  
W. Langholff ◽  
...  

Background:Use of patient-reported outcomes (PROs) to assess health-related quality of life in clinical practice, research studies, and clinical trials in rheumatoid arthritis (RA) remains an ongoing area of research. SF-36 is commonly used in RA trials but is not feasible for routine use in clinical practice settings. ThePatientReportedOutcomesMeasurementInformationSystem (PROMIS) may address this gap but has not been widely assessed in RA patients starting therapy in a real-world comparative effectiveness study, nor examined in that setting in relation to the SF36 and Clinical Disease Activity Index (CDAI).Objectives:To assess validity of PROMIS based on Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in Rheumatoid Arthritis (AWARE), an ongoing Phase 4 study providing real-world assessment of IV tumor necrosis factor inhibitor (TNFi) medications in RA patients.Methods:AWARE is a prospective, non-interventional, 3-year study conducted at 88 US sites. RA patients were enrolled when initiating TNFi treatment. Treatment decisions were made by treating rheumatologists. We report baseline PROMIS-29 (7 domains and pain intensity), PROMIS Pain Interference (PI) Short Form (SF) 6b (PI6b) and PROMIS Fatigue (F) Short Form 7a (F7a), domain T-Scores, and SF-36 subdomain and Component Scores (CS) in AWARE patients. Here we report baseline data obtained from the final 1-year AWARE dataset. Correlations between PROMIS measures and comparable SF-36 component scores were calculated using Pearson correlations. Data is shown as mean ± standard deviation (SD).Results:At baseline, mean CDAI of all patients (n=1262) was 32.3±15.6, with 70.4% in high disease activity (HDA, CDAI>22), 22.8% in moderate disease activity (MDA, CDAI: >10 and ≤22), 6.1% in low disease activity (LDA, CDAI: >2.8 and ≤10), and 0.7% in remission (CDAI ≤2.8). Mean PROMIS scores were >0.5 SD worse than population means for Physical Function (PF, 38.1±6.84), PI (63.4±7.68), F (58.8±9.95), Sleep Disturbance (55.1±8.68); and Ability to Participate in Social Roles/Activities (PSRA, 43.4±8.58). Baseline Depression and Anxiety were within 0.5 SD of population T-scores. PI6b, F7a, and P29 domain T-scores correlated with the comparable SF-36 subdomain and component scores (r’s >0.58), except sleep for which no comparable SF-36 element was applicable. Examples include: P6b (r=-0.80) and P29-PI (0.81) with SF-36 Bodily Pain; F7a (-0.77) and P29-F (-0.77) with SF-36 Vitality; P29-PF with SF-36 PF (0.77), Role-Physical (0.69), and Physical CS (0.73); P29 Anxiety with SF-36 Mental Health (-0.72), Role-Emotional (-0.56), Mental CS (-0.70); and P29-PRSA with SF-36-Social Functioning (0.71). Mean PROMIS-29 T-scores (except Anxiety and Sleep Disturbance) among patients with HDA were significantly different from patients with MDA, LDA or remission (p < 0.001 for all). Further, mean PROMIS T-scores of PF, F, PSRA, PI, Pain Intensity, PI6b and P7a among patients with MDA were significantly different from patients with more or less active RA (by CDAI category).Conclusion:Analysis of baseline results from a large cohort of RA patients indicates high correlations between individual P29 domain T-scores and SF-36 component scores, as well as categorical CDAI, providing strong evidence of PROMIS construct validity in a real-world population of RA patients.Disclosure of Interests:Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB


2015 ◽  
Vol 9 (1) ◽  
pp. 51-56 ◽  
Author(s):  
Takahiro Tokunaga ◽  
Yusuke Miwa ◽  
Airi Nishimi ◽  
Shinichiro Nishimi ◽  
Mayu Saito ◽  
...  

Objective : Sex-specific medicine has attracted attention in recent years, but no report on rheumatoid arthritis (RA) has examined sex differences in the effectiveness of biologics on activities of daily living (ADL), quality of life (QOL), or depressive state. Methods : The study subjects were 161 RA patients (female: 138; male: 23) attending regular doctor visits at our hospital. We compared the changes in disease activity, which was evaluated using the simplified disease activity index (SDAI), ADL (using the modified health assessment questionnaire; mHAQ), QOL (using short form-36; SF-36), and the Hamilton Depression Rating Scale (HAM-D) for RA patients between each sex over a six-month observation period while administering biologic treatment. Results : The female patients reported significant improvements in the following metrics: SDAI: from 22.1 ± 11.9 to 8.9 ± 7.8 (p < 0.001); mHAQ: from 0.46 ± 0.50 to 0.32 ± 0.45 (p < 0.001); and HAM-D: from 6.2 ± 4.8 to 3.8 ± 4.1 (p < 0.001). Moreover, all eight items of the SF-36 were significantly improved (p < 0.01). In contrast, the male patients improved on the SDAI (from 27.9 ± 11.7 to 12.7 ± 8.6 (p < 0.001)), but we did not observe significant improvements in the mHAQ or HAM-D scores or in any items on the SF-36. Conclusion : Both male and female patients with RA improved when using a biological drug. Sex differences in the improvement of depressive state were observed.


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