scholarly journals THE VALUE OF THE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE (ASDAS) IN EVALUATING DISEASE ACTIVITY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS

2015 ◽  
Vol 24 (3) ◽  
pp. 173-180
Author(s):  
Laura Muntean ◽  
◽  
Madalina Valeanu ◽  
Andreea Lungu ◽  
Ioana Felea ◽  
...  

Aim. To evaluate the clinical value of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in assessing disease activity in axial SpA patients in comparison with conventional clinical measures of disease activity in daily clinical practice. Patients and methods. Eighty-five patients with axial SpA were included in a cross-sectional study. Disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity (BASDAI) score, ASDAS score with C-reactive protein (ASDAS-CRP), ASDAS score with erythrocyte sedimentation rate (ASDAS-ESR), patient’s global assessment of disease activity (PtGA), CRP and ESR, while physical function was evaluated by the Bath Ankylosing Spondylitis Functional Index (BASFI). The correlation between different markers of disease activity and functional capacity and ASDAS scores were determined. Patients were grouped into high and low disease activity states according to PtGA scores, CRP levels and BASDAI scores. We compared the discriminating ability of the two ASDAS versions and the conventional clinical measures of disease activity in differentiating between patients with high and low disease activity by using standardized mean differences and receiver operating characteristic (ROC) curve analysis. Results. ASDAS-CRP and ASDAS-ESR showed good correlation with BASDAI (r = 0.84 and 0.72, respectively), PtGA (r = 0.82 and 0.74, respectively), and BASFI (r = 0.74 and 0.70, espectively). Moderate correlations were seen between the two ASDAS versions and ESR and CRP (r ranged from 0.43 to 0.70). The ASDAS versions had higher discriminating capacities as compared to conventional patient-reported measures (BASDAI and PtGA) and objective markers of disease activity (CRP and ESR). The ASDAS-CRP performed better than ASDAS-ESR. Both ASDAS versions and BASDAI had high areas under the curve (AUC) according to PtGA and CRP levels (AUC ranged from 0.66 to 0.92, all p < 0.01). The calculated cut-offs for discriminating between disease activity states in our axSpA patients were relatively similar to the Assessment of Spondyloarthritis International Society (ASAS) endorsed cut-offs. Conclusions. ASDAS versions had higher discriminating ability in patients with axSpA in terms of high and low disease activity states than conventional measures. These findings suggest that ASDAS is a valid and reliable assessment tool for axial SpA patients in daily clinical practice.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 342.1-342
Author(s):  
F. Proft ◽  
J. Schally ◽  
H. C. Brandt ◽  
J. Brandt-Juergens ◽  
G. R. Burmester ◽  
...  

Background:According to international recommendations, the Ankylosing Spondylitis Disease Activity Score (ASDAS) is the preferred score for assessing disease activity in axial spondyloarthritis (axSpA) [1]. However, routine determination of C-reactive protein (CRP) to calculate ASDAS values takes hours to days. This limits the use of ASDAS in clinical routine and clinical trials and hinders the implementation of treat-to-target approaches in axSpA. Whereas quick quantitative CRP (qCRP) tests allow CRP assessment within a few minutes. In a pilot project the performance of qCRP-based ASDAS assessment (ASDAS-qCRP) was already investigated in a single center study of 50 newly diagnosed, bDMARD-naïve axSpA patients with promising results [2].Objectives:To validate the ASDAS-qCRP in a prospective, multicenter study of axSpA patients in a typical axSpA cohort with an appropriate sample size.Methods:The study was conducted in five centers in Germany. Consecutive adult (≥ 18 years) axSpA patients were included. In addition to a rheumatological assessment, including patient reported outcomes (PROs), routine CRP and erythrocyte sedimentation rate (ESR) were measured in the local labs. Additionally, a qCRP testing with the „QuikRead go instrument“ (Aidian Oy, Finland) was performed at the study center (measurement range 0.5 - 200 mg/l for hematocrit concentrations of 40 – 45%). Statistical analysis included descriptive statistics, cross tabulation and weighted Cohen´s kappa comparing disease activity categories, Bland-Altman plots and intraclass correlation coefficient (ICC) for ASDAS-CRP and ASDAS-qCRP.Results:In this study 251 axSpA patients were included between January and September 2020 (mean age: 38.4 years; mean disease duration: 6.2 years, 159 patients (63.3%) were male, 211 (84.1%) HLA-B27 positive and 195 (77.7%) were classified as radiographic axSpA). 143 patients (57.0%) were treated with bDMARDs. CRP and qCRP showed mean values of 2.12 and 2.17 mg/l, respectively. With the ASDAS-qCRP, 242 patients (96.4%) were assigned to the same disease activity category as compared to the ASDAS based on the conventional lab CRP measurement (Table 1). Weighted Cohen´s kappa was 0.966 (95%CI: 0.943; 0.988). ICC for ASDAS-CRP- and ASDAS-qCRP-values was 0.997 (95%CI: 0.994; 0.999). The agreement of ASDAS-qCRP and ASDAS-CRP is shown in a Bland-Altman plot (Figure 1).Table 1.Disease activity categories by ASDAS-qCRP vs. ASDAS-CRPASDAS-qCRP (n = 251)Inactive Disease(< 1.3)Low Disease Activity (1.3 - < 2.1)High Disease Activity (2.1 - 3.5)Very high Disease Activity (> 3.5)ASDAS-CRPInactive Disease(< 1.3)56 (22.3%)2 (0.8%)Low Disease Activity (1.3 - < 2.1)62 (24.7%)7 (2.8%)High Disease Activity (2.1 - 3.5)97 (38.6%)Very high Disease Activity (> 3.5)27 (10.8%)The fields highlighted in red indicate that disease activity categories do not match.ASDAS = Ankylosing Spondylitis Disease Activity Score, CRP = C-reactive protein, qCRP = quick quantitative CRPConclusion:The ASDAS-qCRP and ASDAS-CRP showed an almost perfect agreement on the assignment to disease activity categories (96%) with the important advantage of time. With ASDAS-qCRP, rheumatologists could base their clinical decision-making on a disease activity measurement by using a composite score immediately. ASDAS-qCRP, therefore, can be integrated in clinical routine and clinical trials in the future and may facilitate implementation of the treat-to-target concept in axial SpA.References:[1]Smolen JS, et al. Ann Rheum Dis. 2018 Jan; 77(1):3-17.[2]Proft F, et al. Joint Bone Spine. 2019 Jul 29.Figure 1.Bland-Altman plot for ASDAS-qCRP and ASDAS-CRPAcknowledgements:The authors would like to deeply thank Braun T, Doerwald C, Deter N, Höppner C, Lackinger J, Lorenz C, Lunkwitz K, Mandt B, Sron S and Zernicke J for their practical support and coordinating the study.Funding statement: The AQUA study was supported by an unrestricted research grant from Novartis. Testing kits were provided free of charge from Aidian Oy, Finland.Disclosure of Interests:None declared


2011 ◽  
Vol 38 (7) ◽  
pp. 1502-1506 ◽  
Author(s):  
PEDRO M.M.C. MACHADO ◽  
ROBERT B.M. LANDEWÉ ◽  
DÉSIRÉE M. van der HEIJDE

The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in ankylosing spondylitis (AS). Criteria for disease activity states and improvement scores are important for use in clinical practice, observational studies, and clinical trials, and have been proposed by the Assessment of SpondyloArthritis international Society (ASAS). At OMERACT 10, our aim was to obtain endorsement from OMERACT for the ASDAS disease activity states and response criteria proposed by the ASAS membership. This article summarizes the associated discussions, the scientific basis of the validation process, and the results from the voting sessions, and identifies areas for research using the ASDAS. OMERACT participants agreed with the selection of cutoff values, which now have the combined endorsement of ASAS and OMERACT and are ready to be used in clinical practice and in research settings.


2020 ◽  
Vol 79 (4) ◽  
pp. 453-459 ◽  
Author(s):  
Sofia Ramiro ◽  
Robert BM Landewé ◽  
Désirée van der Heijde ◽  
Alexandre Sepriano ◽  
Oliver FitzGerald ◽  
...  

ObjectivesTo investigate whether following a treat-to-target (T2T)-strategy in daily clinical practice leads to more patients with rheumatoid arthritis (RA) meeting the remission target.MethodsRA patients from 10 countries starting/changing conventional synthetic or biological disease-modifying anti-rheumatic drugs were assessed for disease activity every 3 months for 2 years (RA BIODAM (BIOmarkers of joint DAMage) cohort). Per visit was decided whether a patient was treated according to a T2T-strategy with 44-joint disease activity score (DAS44) remission (DAS44 <1.6) as the target. Sustained T2T was defined as T2T followed in ≥2 consecutive visits. The main outcome was the achievement of DAS44 remission at the subsequent 3-month visit. Other outcomes were remission according to 28-joint disease activity score-erythrocyte sedimentation rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definitions. The association between T2T and remission was tested in generalised estimating equations models.ResultsIn total 4356 visits of 571 patients (mean (SD) age: 56 (13) years, 78% female) were included. Appropriate application of T2T was found in 59% of the visits. T2T (vs no T2T) did not yield a higher likelihood of DAS44 remission 3 months later (OR (95% CI): 1.03 (0.92 to 1.16)), but sustained T2T resulted in an increased likelihood of achieving DAS44 remission (OR: 1.19 (1.03 to 1.39)). Similar results were seen with DAS28-ESR remission. For more stringent definitions (CDAI, SDAI and ACR/EULAR Boolean remission), T2T was consistently positively associated with remission (OR range: 1.16 to 1.29), and sustained T2T had a more pronounced effect on remission (OR range: 1.49 to 1.52).ConclusionIn daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher rates of remission.


2020 ◽  
Vol 58 (3) ◽  
pp. 268-275
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
E. E. Gubar ◽  
P. L. Karpova ◽  
T. V. Korotaeva

Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying anti-rheumatic drug (DMARD) tofacitinib (TOFA; Yakvinus®) in patients with active psoriatic arthritis (PsA) at 12 and 24 weeks after starting treatment. To define the place of TOFA in the therapy of PsA patients. Subjects and methods. Examinations were made in 41 patients (17 men and 24 women) with active PsA and an insufficient response to previous treatment with synthetic DMARDs and/or biological agents (BA). Before starting therapy, the median disease activity for psoriatic arthritis (DAPSA) and disease activity score (DAS28) were 44.2 [37.8; 55.3] and 5.5 [4.7; 6.1], respectively. TOFA tablets were prescribed at a dose of 5 mg twice daily for 24 weeks with possible dose escalation to 10 mg twice daily after 12 weeks. At the beginning of the investigation, at 12 and 24 weeks, the investigators assessed disease activity and TOFA therapy efficiency of according to DAPSA, DAS28 and minimal disease activity (MDA) criteria: tender joint count ≤1, swollen joint count ≤1, a psoriasis area severity index (PASI) ≤1 or body surface area (BSA) ≤3%, pain intensity ≤15 mm, patient global assessment ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, and enthesitis ≤1. They also determined the number of patients who had achieved remission (DAPSA ≤4, DAS28 score <2.6), low disease activity (DAPSA 5-14, ≤2.6, DAS28 <3.2) or MDA (5 out of the 7 criteria) during TOFA therapy at 24-week follow-up. The safety of therapy was evaluated by analyzing the drug-induced adverse events (AE): the frequency, severity and time of their occurrence were studied. Results and discussion. At 24 weeks after initiation of TOFA therapy, there was a significant decrease of median DAPSA and DAS28 values as compared to baseline, to 11 [4.3; 17.3] and 2.6 [1.7; 3.4] respectively. The median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) also significantly decreased from 6 [4.2; 7] and 3.8 [2.8; 4.4] to 1.4 [0.6; 3.2] and 1.5 [1; 2.1] respectively. The median BSA was significantly reduced from 3 [1; 5] to 0.5 [0.1; 2]. At 24 weeks after initiation of TOFA therapy, DAPSA and DAS28 low disease activity/remission were achieved by 38.5/23.1% and 17.9/53.9% of patients, respectively. Fifteen (38.5%) patients achieved MDA. 38 (92.7%) of the 41 patients completed a full TOFA therapy cycle. Two patients dropped out of the investigation due to ineffective therapy and one due to AE (diarrhea occurring up to 10 times daily, headache, elevated blood pressure, and lacrimation). At 24 weeks, 14 (34.2%) patients reported to have AE. The most common AE noted in 7 (17.1%) patients were infections: acute respiratory viral infection (n=3), fever (n=2), and folliculitis (n=2). In addition, two patients had diarrhea and two had headache. Conclusion. TOFA is an effective drug for the treatment of PsA patients with moderate or high inflammatory activity, has a significant effect on all clinical manifestations of PsA and has a satisfactory safety profile.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 179.2-180
Author(s):  
L. Saraiva ◽  
A. R. Cunha ◽  
D. Jesus ◽  
J. A. P. Da Silva ◽  
A. Doria ◽  
...  

Background:In the management of patients with Systemic Lupus Erythematosus (SLE), it is of utmost importance to accurately identify lupus flares. There is a conceptual consensus definition of lupus flares [1]; however, the instruments used to identify flares in clinical trials, such as the SELENA Flare Index (SFI) are too cumbersome to apply in daily clinical practice. The SLE disease activity score (SLE-DAS) is a validated continuous measure of disease activity with higher sensitivity to change and validity in predicting damage accrual when compared to SLEDAI-2K. SLE-DAS is quickly scored with its online calculator. An increase in SLE-DAS ≥1.72 was validated as a clinically meaningful worsening of SLE disease activity. [2]Objectives:To compare the performance of SLE-DAS, classic SFI (c-SFI), revised SFI (r-SFI) and SLEDAI-2K in the identification of lupus flares in a real-life clinical setting.Methods:We included patients with SLE fulfilling classification criteria [ACR (1997) and/or SLICC and/or EULAR/ACR], followed at an academic lupus clinic from January 2017 to June 2020, and presenting with lupus low disease activity score (LLDAS) at baseline.Flares occurring after baseline were identified as fulfillment of the conceptual definition of flare, as assessed by the senior lupus expert at time of each outpatient visit. For each flare event, we evaluated the fulfillment of flare criteria according to c-SFI, r-SFI, SLEDAI-2K (score increase ≥4 points from baseline), and SLE-DAS (score increase ≥1.72 from baseline). As control visits without flare, we considered the first visit after baseline, where we assessed the four tools, excluding those where a flare was identified by the gold-standard expert evaluation. Sensitivity and specificity of the four flare tools were estimated and McNemar’s test applied to assess differences with the gold-standard flare definition. The inter-instrument agreement with the gold-standard was assessed through Cohen’s Kappa.Results:We included 297 patients (female: 86.2%; mean age: 48.9±14.6 years, mean disease duration: 12.5±9.0 years). At baseline, all patients were in LLDAS, receiving ongoing antimalarials, immunosuppressants, and/or glucocorticoids in 91.0%, 43.8% and 33.6%, respectively. During follow-up, 22.2% developed flares. The analysis included 92 flares [musculoskeletal (40.2%); renal (23.9%), mucocutaneous (18.5%), haematological (5.9%), serositis (3.3%); multisystemic (8.7%)], with increase or change of treatment in 80.4% of these episodes, and 292 visits without flare considered as control.There was no statistically significant difference between either SLE-DAS flare or c-SFI and the gold-standard expert flare definition (p=0.41 and p=0.82, respectively), while r-SFI and SLEDAI-2K flare were different from the gold-standard (Table 1). There was a strong agreement between SLE-DAS flare, c-SFI, r-SFI and the expert definition (Cohen’s kappa, Table 1).Table 1.Performance of the flare tools for the gold-standard flare definition.Sensitivity (%)Specificity (%)McNemar’s§§Kappa§SLE-DAS flare90.195.0n.s.0.836c-SFI flare91.196.5n.s.0.869r-SFI flare93.492.9p<0.010.820SLEDAI-2K flare51.698.6p<0.00010.590§§ McNemar’s test: significant difference from gold-standard if p<0.05; § Cohen’s kappa agreement (0-1) with the gold-standard flare definition; n.s.: non-significantConclusion:The c-SFI and SLE-DAS showed the best performance in identifying SLE flares. The SLE-DAS flare definition is easier to apply and hence might be considered as an optimal tool to be used in daily clinical practice.References:[1]Ruperto N, Hanrahan LM, Alarcón GS, et al. International consensus for a definition of disease flare in lupus. Lupus. 2011;20(5):453-62.[2]Jesus D, Matos A, Henriques C, et al. Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity. Ann Rheum Dis 2019; 78:365-71.Disclosure of Interests:None declared.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lucie Nekvindová ◽  
Jiří Vencovský ◽  
Karel Pavelka ◽  
Pavel Horák ◽  
Zlatuše Křístková ◽  
...  

Abstract Background Treat-to-target (T2T) is a widely accepted strategy for patients with rheumatoid arthritis (RA). It recommends attaining a goal of at least low disease activity (LDA) within 6 months; otherwise, the current therapy should be modified. We aimed to investigate whether switching a first-line targeted therapy (TT) in patients not reaching LDA within 6 months leads to a higher probability of meeting LDA at the 12-month visit in daily clinical practice using data from Czech registry ATTRA. Methods We included patients with RA starting the first-line TT from 1 January 2012 to 31 January 2017 with at least 1-year follow-up. We created four mutually exclusive cohorts based on (1) switching to another TT within the first year and (2) reaching a treatment target (DAS28-ESR ≤ 3.2) at the 6-month visit. The primary outcome was the comparison of odds for reaching remission (REM) or LDA at the 12-month visit between patients switching and not switching TT after not reaching treatment target at 6 months. Before using logistic regression to estimate the odds ratio, we employed the propensity score to match patients at the 6-month visit. Results A total of 1275 patients were eligible for the analysis. Sixty-two patients switched within the first 5 months of the treatment before evaluating treatment response at the 6-month visit (C1); 598 patients reached the treatment target within 6 months of therapy (C2); 124 patients did not reach treatment response at 6-month visit and switched to another therapy (C3), and 491 patients continued with the same treatment despite not reaching LDA at the 6-month visit (C4). We matched 75 patients from cohort C3 and 75 patients from C4 using the propensity score. Patients following the T2T principle (C3) showed 2.8 (95% CI 1.4–5.8; p = 0.005) times increased likelihood of achieving REM/LDA at the 12-month visit compared to patients not following the T2T strategy (C4). Conclusions In daily clinical practice, the application of the T2T strategy is underused. Switching TT after not reaching REM/LDA within the first 6 months leads to a higher probability of achieving REM/LDA in RA patients at the 12-month visit.


2017 ◽  
Vol 28 (3) ◽  
pp. 542-549 ◽  
Author(s):  
Sara Monti ◽  
Monica Todoerti ◽  
Veronica Codullo ◽  
Ennio Giulio Favalli ◽  
Martina Biggioggero ◽  
...  

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