scholarly journals Predictor of the Simplified Disease Activity Index 50 (SDAI 50) at Month 3 of bDMARD Treatment in Patients with Long-Established Rheumatoid Arthritis

2017 ◽  
Vol 11 (1) ◽  
pp. 106-112 ◽  
Author(s):  
Yusuke Miwa ◽  
Mayu Saito ◽  
Hidekazu Furuya ◽  
Ryo Yanai ◽  
Tsuyoshi Kasama

Objectives:The Simplified Disease Activity Index (SDAI) 50 has good agreement with European League Against Rheumatism (EULAR) response measures for early Rheumatoid Arthritis (RA). There have been reports on early RA, but not on long-established RA. In this study, we analysed the relationships between various baseline factors and SDAI 50 after three months of treatment with biological disease-modifying antirheumatic drugs (bDMARDs) to determine the prognostic factors for long-established RA.Methods:Subjects were 260 RA patients who had been treated with bDMARDs for 3 months. The following characteristics were investigated: Patient backgrounds, the erythrocyte sedimentation rate (ESR), C-reactive protein and serum matrix metalloproteinase-3 levels, SDAI scores, and health assessment questionnaire disability index and short form-36 scores. As a primary outcome index, the SDAI response was defined as a 50% reduction in the SDAI score between baseline and 3 months (SDAI 50).Results:Baseline values of disease duration (odds ratio: 0.942, 95% CI: 0.902-0.984), smoking history (odds ratio: 2.272, 1.064-4.850), 28-tender joint count (odds ratio: 0.899, 0.827-0.977), evaluator's global assessment (odds ratio: 1.029, 1.012-1.047) and ESR (odds ratio: 1.015, 1.001-1.030) were determined to be significant factors based on logistic regression analysis.Conclusion:Our study demonstrated that RA patients with shorter disease duration, no smoking, and higher RA disease activity are more likely to achieve SDAI 50 through bDMARD treatment.

2014 ◽  
Vol 41 (8) ◽  
pp. 1607-1613 ◽  
Author(s):  
Cheryl Barnabe ◽  
Joanne Homik ◽  
Susan G. Barr ◽  
Liam Martin ◽  
Walter P. Maksymowych

Objective.Predictors of remission in rheumatoid arthritis (RA) have been defined in cross-sectional analyses using the 28-joint Disease Activity Score (DAS28), but not with newer composite disease activity measures or using the more clinically relevant state of sustained remission. We have evaluated predictors of remission using cross-sectional and longitudinal durations of disease state, and by applying additional definitions of remission [American College of Rheumatology/European League Against Rheumatism Boolean, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI)].Methods.Individuals in the Alberta Biologics Pharmacosurveillance Program were classified for the presence of remission (point and/or sustained > 1 yr) by each of the 4 definitions. Multivariate models were constructed including all available variables in the dataset and refined to optimize model fit and predictive ability to calculate OR for remission.Results.Nonsmoking status independently predicted point remission by all definitions (OR range 1.20–2.71). Minority ethnicity decreased odds of remission by DAS28 (OR 0.13) and CDAI (OR 0.09) definitions. Male sex was associated with DAS28 remission (OR 2.85), whereas higher baseline physician global (OR 0.67) and erythrocyte sedimentation rate values (OR 0.98) decreased odds of DAS28 remission. Higher baseline patient global score (OR 0.77) and swollen joint counts (OR 0.93) were negative predictors for CDAI remission. Higher baseline Health Assessment Questionnaire (OR 0.62) reduced odds for remission by the SDAI definition, and educational attainment increased these odds (OR 2.13). Sustained remission was negatively predicted by baseline physician global for the DAS28 (OR 0.80), and higher tender joint count (OR 0.96) for the CDAI.Conclusion.We demonstrate the influence of duration of remission state and remission definition on defining independent predictors for remission in RA requiring anti-tumor necrosis factor therapy. These predictors offer improved applicability for modern rheumatology practice.


Author(s):  
A. V. Rudenko ◽  
T. D. Tyabut ◽  
A. E. Buglova ◽  
G. A. Babak ◽  
P. M. Morozik ◽  
...  

Vitamin D deficiency is an important environmental risk factor that influences the prevalence and severity of several autoimmune diseases, including rheumatoid arthritis (RA). The aim of this study was to determine the incidence of vitamin D insufficiency and deficiency in patients with RA, to establish the relationship between serum vitamin D levels and indicators of disease activity. 156 patients with RA were included in the study, mean age 60.2 ± 13.9 years. Assessment of clinical status was performed, serum concentrations of rheumatoid factor (RF), C-reactive protein (CRP), total vitamin D (25(OH)D), antibodies to cyclic citrullinated peptide (ACCP) were determined. RA disease activity was evaluated using DAS28 (disease activity score), SDAI (Simplified Disease Activity Index) и CDAI (Clinical Disease Activity Index) scores. Average levels of 25(OH)D in the surveyed sample were 25.2 ± 13.2 ng/ml. The results of the study indicate a high prevalence of vitamin D deficiency in patients with RA. Normal indicators of vitamin D, its insufficiency and deficiency were observed in 47 (30.3 %), 45 (28.7 %) and 64 (40.7 %) patients, respectively. Low level of serum 25(OH)D was associated with higher indices of RA activity according to DAS28, SDAI and CDAI, as well as with greater tender joint count. Vitamin D should be prescribed as an adjunctive therapy in patients with active RA due to its potential immunomodulatory effect, as well as for the prevention and treatment of bone metabolism disorders.


2019 ◽  
Vol 78 (12) ◽  
pp. 1609-1615 ◽  
Author(s):  
Daniel Aletaha ◽  
Jen-fue Maa ◽  
Su Chen ◽  
Sung-Hwan Park ◽  
Dave Nicholls ◽  
...  

ObjectivesTo determine if disease duration and number of prior disease-modifying antirheumatic drugs (DMARDs) affect response to therapy in patients with established rheumatoid arthritis (RA).MethodsAssociations between disease duration or number of prior DMARDs and response to therapy were assessed using data from two randomised controlled trials in patients with established RA (mean duration, 11 years) receiving adalimumab+methotrexate. Response to therapy was assessed at week 24 using disease activity outcomes, including 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)), Simplified Disease Activity Index (SDAI) and Health Assessment Questionnaire Disability Index (HAQ-DI), and proportions of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses.ResultsIn the larger study (N=207), a greater number of prior DMARDs (>2 vs 0–1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24. RA duration of >10 years versus <1 year was associated with higher HAQ-DI scores (1.1 vs 0.7) at week 24, but results on DAS28(CRP) and SDAI were mixed. A greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates at week 24. Data from the second trial (N=67) generally confirmed these findings.ConclusionsNumber of prior DMARDs and disease duration affect responses to therapy in patients with established RA. Furthermore, number of prior DMARDs, regardless of disease duration, has a limiting effect on the potential response to adalimumab therapy.


2013 ◽  
Vol 40 (4) ◽  
pp. 386-393 ◽  
Author(s):  
Isabel Castrejón ◽  
Maxime Dougados ◽  
Bernard Combe ◽  
Francis Guillemin ◽  
Bruno Fautrel ◽  
...  

Objective.To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test.Methods.The ESPOIR early RA cohort of 813 French patients recruited in 2002–2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed — Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: “RAPID3R” (RAPID3 ≤ 3.0); “RAPID3R+SJ1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint); “RAPID3R+SJ1+D1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); “RAPID3R+SJ0” (RAPID3 ≤ 3.0, 0 swollen joints); and “RAPID3R+SJ0+D1” (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed.Results.Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%–94.7%, kappa 0.67–0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%–85.8%, kappa 0.46–0.55).Conclusion.Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.


2019 ◽  
Vol 78 (11) ◽  
pp. 1454-1462 ◽  
Author(s):  
Roy M Fleischmann ◽  
Mark C Genovese ◽  
Jeffrey V Enejosa ◽  
Eduardo Mysler ◽  
Louis Bessette ◽  
...  

BackgroundIn SELECT-COMPARE, a randomised double-blind study, upadacitinib 15 mg once daily was superior to placebo or adalimumab on background methotrexate (MTX) for treating rheumatoid arthritis signs and symptoms and inhibited radiographical progression versus placebo at 26 weeks. Here we report 48-week safety and efficacy in patients who continued their original medication or were rescued to the alternative medication for insufficient response.MethodsPatients on MTX received upadacitinib 15 mg, placebo or adalimumab for 48 weeks. Rescue without washout, from placebo or adalimumab to upadacitinib or upadacitinib to adalimumab occurred if patients had <20% improvement in tender joint count (TJC) or swollen joint count (SJC) (weeks 14/18/22) or Clinical Disease Activity Index (CDAI) >10 (week 26); remaining placebo patients were switched to upadacitinib at week 26. Efficacy was analysed by randomised group (non-responder imputation), as well as separately for rescued patients (as observed). Treatment-emergent adverse events per 100 patient-years were summarised.ResultsConsistent with responses through week 26, from weeks 26 to 48, responses by randomised group including low disease activity, clinical remission and improvements in pain and function remained superior for upadacitinib versus adalimumab; radiographical progression remained lower for upadacitinib versus placebo (linear extrapolation). Although both switch groups responded, a higher proportion of patients rescued to upadacitinib from adalimumab achieved CDAI ≤10 at 6 months postswitch versus patients rescued from upadacitinib to adalimumab. Safety at week 48 was comparable to week 26.ConclusionUpadacitinib+MTX demonstrated superior clinical and functional responses versus adalimumab+MTX and maintained inhibition of structural damage versus placebo+MTX through week 48. Patients with an insufficient response to adalimumab or upadacitinib safely achieved clinically meaningful responses after switching to the alternative medication without washout.


2018 ◽  
Vol 46 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Rudolf Puchner ◽  
Judith Sautner ◽  
Johann Gruber ◽  
Elia Bragagna ◽  
Andrea Trenkler ◽  
...  

Objective.To evaluate the effect of rheumatoid arthritis (RA) on impairing women’s sexuality regarding motivation, activity, and satisfaction, and to assess the correlation of disease-related physical impairment within sexual functioning.Methods.An anonymous survey among women with RA and healthy controls (HC) using standardized questionnaires, predominantly the Changes in Sexual Functioning Questionnaire-short form (CSFQ-14). In addition, disease activity, depression, and disability were evaluated.Results.There were 319 questionnaires distributed to patients and 306 to HC. Of these, 235 patient questionnaires (73.7%) and 180 HC questionnaires (58.8%) were returned, of which 203 and 169 were completed, respectively. Of the patients with RA, 47.8% had a total CSFQ-14 score of ≤ 41, indicating female sexual dysfunction (FSD), as compared to 14.2% of HC (p < 0.0001). The median CSFQ-14 score was lower in patients with RA [42 points, interquartile range (IQR) 36–48] than in HC (49 points, IQR 44–54; p < 0.0001), resulting in an OR of 5.53 (95% CI 3.19–9.57; p < 0.0001). After adjustment for confounders, given a higher mean age of patients (55.2 ± 11.3 yrs) than HC (47.4 ± 11.8 yrs; p < 0.0001), the OR for FSD in patients with RA was still 3.04 (95% CI 1.61–5.75; p = 0.001). Neither the Health Assessment Questionnaire–Disability Index nor the Clinical Disease Activity Index was associated with FSD after adjustment.Conclusion.FSD apparently is highly prevalent in female patients with RA, affects all subdomains of sexual function, and is most likely underestimated in daily clinical practice. Of note, FSD could not be linked to disability or RA disease activity.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Juan Zhao ◽  
Wei Zhou ◽  
Yangfeng Wu ◽  
Ping Ji ◽  
Li Yang ◽  
...  

Abstract Background Tumor necrosis factor α inhibitors (TNFi) is effective for rheumatoid arthritis (RA) patients who fail to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Because of high cost, the discontinuation is common but often lead to disease relapse. The study aims to investigate, if the combination therapy of csDMARDs is more effective in reducing disease relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi and MTX. Methods It will be a two-stage trial. In the first stage, all RA patients who failed to csDMARDs treatment [disease activity score 28 (DAS28)-CRP > 3.2] will receive MTX plus TNFi for no more than 12 weeks. Patients achieving DAS28-CRP < 3.2 during the first stage will be randomized into three groups at 1:1:1 ratio: (A) add hydroxychloroquine (HCQ) and sulfasalazine (SSZ) for the first 12 weeks and then remove TNFi but continue other treatments for the next 48 weeks; (B) maintain TNFi + MTX for 60 weeks; and (C) maintain TNFi + MTX for the first 12 weeks and then remove TNFi but continue MTX monotherapy for the next 48 weeks. The primary outcome will be disease relapse (DAS28-CRP increases by at least 0.6 and > 3.2). Secondary outcomes will include the incremental cost per reducing 1 case of relapse; patient reported intolerance to the treatment; adverse events; change of mean disease activity measured by DAS28, clinical disease activity index (CDAI) and simplified disease activity index (SDAI); the proportion of modified Sharp score increase < 0.3; ultrasound-detected remission in hands; Health Assessment Questionnaire Disability Index (HAQ-DI) and health related quality of life [the five-level EuroQol-5D (EQ-5D-5L) and short form-6D (SF-6D)]. Discussion The aim of this trail will be to seek effective treatment options of preventing relapse of RA. The results of the current study may provide an instructive recommendation for more economical application of TNFi treatment in RA. Trial registration NCT, NCT02320630. Registered on 16 December 2014. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=3&cx=-jg9qo2.


2021 ◽  
pp. annrheumdis-2021-220853
Author(s):  
Dafne Capelusnik ◽  
Daniel Aletaha

ObjectiveTo perform a comprehensive analysis on predictors of achieving disease activity outcomes by change, response and state measures.MethodsWe used data from three rheumatoid arthritis (RA) trials (one for main analysis, two for validation) to analyse the effect of patient and disease characteristics, core set measure and composite indices on the achievement of different outcomes: response outcomes (% of patients achieving a relative response margin); state outcomes (remission or low disease activity, LDA) and change outcomes (numerical change on metric scales).ResultsWe included patients from the ASPIRE trial (for analysis) and from the ATTRACT and GO-BEFORE trials (for validation). While lower disease activity components at baseline—except acute phase reactants—were associated with achievement of state outcomes (such as LDA by the Simplified Disease Activity Index, SDAI), higher baseline values were associated with change outcomes (such as SDAI absolute change). A multivariate analysis of the identified predictors of state outcomes identified best prediction by a combination of shorter disease duration, male gender and lower disease activity. For prediction of response, no consistently significant predictors were found, again, with exception of C reactive protein, for which higher levels at baseline were associated with better responses.ConclusionPrediction of treatment success is limited in RA. Particularly in early RA, prediction of state targets can be achieved by lower baseline levels of diseases activity. Gender and disease duration may improve the predictability of state targets. In clinical trials, included populations and choice of outcomes can be coordinated to maximise efficiency from these studies.


2018 ◽  
Vol 8 (3) ◽  
pp. 90-94
Author(s):  
Quang Luc Nguyen ◽  
Hoang Thanh Van Nguyen ◽  
Hoang Minh Nguyen

Background and aims: Assessments of disease activity in rheumatoid arthritis plays an important role in determining treatment plans and patient response to treatment. The aims of this study was to describe the power Doppler ultrasound features of wrist joints in patients with rheumatoid arthritis and evaluate role of power Doppler ultrasoundin assessing disease activity in patients withrheumatoid arthritis. Material and method: This present study included 30patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria, who were admitted in the period July 2017 to April 2018 in Department of Nephrology and Rheumatology, Hue Central Hospital. All patients were physical examination, laboratory investigations, assessment disease activity score in 28 joints using CRP (DAS28-CRP), clinical disease activity index (CDAI), simplified disease activity index (SDAI). Grey scale ultrasound and power Doppler ultrasound were used to assess synovitis, effusion and tenosynovitis and synovial vascularity of 60 wrist joints. Power Doppler was graded using a validated semiquantitative scroring system, which consists of scale of 0-3. Result: Twenty-seven wrist joints (45.0%) had synovitis in grey scale ultrasound. Thirty-seven wrist joints (61.7%) had a power doppler signal, 18.3% had grade 1 (low), 21.7% had grade 2 (moderate) and 21.7% had grade 3 (high). Level of angiogenesis in PDUS with semiquantitative scroring systemweresignificantly correlated with tender joint count, swollen joint count, global VAS, CRP and CDAI, SDAI, DAS28-CRP. Conclusions: Power Doppler ultrasound of wrist joints could be used as a non-invasive and feasible method to assessing disease activity in patients with rheumatoid arthritis. Key words: rheumatoid arthritis, power Doppler ultrasound


Reumatismo ◽  
2015 ◽  
Vol 67 (2) ◽  
Author(s):  
E. Cipriano ◽  
F. Ceccarelli ◽  
L. Massaro ◽  
F. R. Spinelli ◽  
C. Alessandri ◽  
...  

Joint involvement is a common manifestation in systemic lupus erythematosus (SLE). According to the SLE disease activity index 2000 (SLEDAI-2K), joint involvement is present in case of ≥2 joints with pain and signs of inflammation. However this definition could fail to catch all the various features of joint involvement. Alternatively the Swollen to Tender joint Ratio (STR) could be used. This new index, which was originally proposed for rheumatoid arthritis (RA) patients, is based on the count of 28 swollen and tender joints. Our study is, therefore, aimed to assess joint involvement in a SLE cohort using the STR. SLE patients with joint symptoms (≥1 tender joint) were enrolled over a period of one month. Disease activity was assessed by SLEDAI-2K. We performed the swollen and tender joint count (0-28) and calculated the STR. Depending on the STR, SLE patients were grouped into three categories of disease activity: low (STR1.0). We also calculated the disease activity score based on a 28-joint count and the erythrocyte sedimentation rate (DAS28-ESR). We enrolled 100 SLE patients [F/M 95/5, mean±standard deviation (SD) age 46.3±10.6 years, mean±SD disease duration 147.1±103.8 months]. The median of tender and swollen joints was 4 (IQR 7) and 1 (IQR 2.5), respectively. The median STR value was 0.03 (IQR 0.6). According to the STR, disease activity was low in 70 patients, moderate in 23 and high in 7. A significant correlation was identified between STR values and DAS28 (r=0.33, p=0.001). The present study suggests a correlation between STR and DAS28, allowing an easier and faster assessment of joint involvement with the former index.


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