scholarly journals O08 Development and validation of a new tool to assess inflammatory foot disease activity in RA: the Rheumatoid Arthritis Foot Disease Activity Index

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Anika Hoque
Keyword(s):  
Rheumatoid Arthritis ◽  
Construct Validity ◽  
Disease Activity ◽  
Internal Consistency ◽  
Content Validity ◽  
Activity Index ◽  
A Priori ◽  
Disease Activity Index ◽  
Das 28 ◽  
Foot Disease

Abstract Background Rheumatoid arthritis (RA) commonly affects the feet, resulting in pain, walking difficulties, and disability. Omission of foot joints from the disease activity score-28 (DAS-28) may lead to underestimation of foot disease and suboptimal medical and non-medical management. Therefore, the overall objective of this study is to evaluate the measurement properties of the Rheumatoid Arthritis Foot Disease Activity Index-5 (RADAI-F5), a newly developed 5-item (0-10 numerical rating scale) patient-reported outcome measure (PROM) with a summary score (0-10) for measuring foot disease activity in people with RA. Methods Participants with RA recruited from NHS rheumatology outpatient clinics completed the RADAI-F5, a self-modified Rheumatoid Arthritis Disease Activity Index (mRADAI-5) which is a self-reported measure of global disease activity, the Foot function index (FFI), Foot Impact Scale impairment/footwear (FIS-IF) and activity/participation (FIS-AP) subscales. DAS-28 was also recorded for each participant whenever possible. Participants completed RADAI-F5 again at 1 week to allow evaluation of 1-week reproducibility. Construct validity was evaluated using Spearman’s rho to test a priori hypotheses for expected strength of associations between the RADAI-F5 and the alternative disease activity and foot-related disability scales at baseline. Internal consistency was evaluated using Cronbach’s alpha. One-week reproducibility was evaluated using the intraclass correlation coefficient (ICC), 90% smallest detectable change (SDC90), and 95% limits of agreement (LOA). Content validity was evaluated using 5-point Likert scales for readability and relevance. Results Of 142 respondents, 103 were female and 36 were males with a mean (SD) age of 55 years (12.5) and mean (SD) RA disease duration of 39 months (70.4). Mean (SD, range) RADAI-F5 scores for the sample were 5.02 (2.47, 9.2). Associations were largely consistent with a priori hypotheses for construct validity. Strong associations were observed between the RADAI-F5 and MRADAI-5 (0.789, CI 0.73-0.85), the FFI (0.713, CI 0.62-0.79) and FIS-IS (0.695, CI 0.66-0.82) (p < 0.001). Moderate associations were observed with the FFI-AP (0.478, p < 0.001, CI 0.37-0.63). A weak association was observed between the RADAI-F5 and the DAS-28 (0.379, p < 0.001, CI 0.26-0.57). The RADAI-F5 demonstrated high internal consistency (Cronbach’s Alpha=0.82), and floor and ceiling effects were both absent. The RADAI-F5 demonstrated good reproducibility (ICC=0.868, p < 0.001, CI 0.80-0.91) and the value for SDC90 was 2.26. The upper and lower bounds for 95% LOA were -2.57 to 2.80, with 97% of scores observed within these bounds. Content validity was confirmed with 82% and 84% of participants rating the instrument as relevant and easy to understand respectively. The median time for completion was 5 minutes. Conclusion The RADAI-F5 is a highly valid and reliable PROM for measuring foot disease activity in RA patients. Furthermore, the RADAI-F5 appears to be feasible for use in clinical practice and can be used as an adjunct to the DAS28 to measure foot disease activity. Disclosures A. Hoque: Grants/research support; Stipend from Versus Arthritis to complete the Versus Arthritis MSK internship 2019 at Glasgow Caledonian University.

THU0620-HPR MEASUREMENT OF LOW DISEASE ACTIVITY USING THE CLINICAL DISEASE ACTIVITY INDEX (CDAI) VERSUS THE DISEASE ACTIVITY SCORE 28 (DAS 28): IMPACT OF INFLAMMATION MARKERS ON THE COMPARATIVE EFFECTIVENESS OF BIOLOGICS FOR THE TREATMENT OF RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 553.1-553
Author(s):  
K. Janke ◽  
K. Biester ◽  
D. Krause ◽  
B. Richter ◽  
C. Schürmann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Comparative Effectiveness ◽  
Inflammatory Markers ◽  
Activity Index ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Acute Phase Reactants ◽  
Das 28 ◽  
Effectiveness Studies

Background:Biologics for the treatment of rheumatoid arthritis (RA) have different modes of action to target auto-inflammatory processes causing the signs and symptoms of the disease. Different biologics may thus have different effects on inflammatory markers. For instance, previous studies have shown that the interleukin-6-inhibitor tocilizumab (TOC) decreases the level of acute phase reactants (APRs) [1]. Such direct effects on inflammatory markers may lead to an overestimation of clinical response if disease activity is measured via scores including inflammatory markers, such as the Disease Activity Score 28 (DAS 28). The detected changes in disease activity may not adequately reflect the clinical improvement of signs and symptoms.Objectives:In our study, we compared biologics with each other using two different disease activity scores: the DAS 28 including APRs and the clinical disease activity index (CDAI) excluding APRs. The aim of this study was to assess whether the use of the two different scores affects comparative effectiveness studies on biologics for the treatment of RA.Methods:We compared results on the comparative effectiveness of biologics using the corresponding thresholds for low disease activity (LDA) for the DAS 28 (< 3.2) and the CDAI (≤ 10). We performed two separate network meta-analyses (NMAs) after a thorough step-by-step evaluation of the similarity, homogeneity and consistency assumptions of the patient populations and the study data.Our study formed part of a systematic review (including NMAs) that was largely based on clinical study reports and re-analyses of LDA using individual patient data provided by sponsors for studies conducted up to 2017. Thus, the analyses include hitherto unknown data on LDA analysed by means of the CDAI, especially data from older studies. An extensive comparison of DAS 28 and CDAI in different patient populations was possible.Results:For all analysed patient populations, comparisons of TOC versus other biologics yielded remarkable results: advantages for TOC were found in NMAs using the DAS 28, which were not confirmed in NMAs using the CDAI. For methotrexate (MTX)-naïve patients, using the DAS 28, TOC showed a greater benefit than abatacept (ABA), certolizumab pegol (CZP), and etanercept (ETA), which was not confirmed by the CDAI. In contrast, TOC showed less benefit than adalimumab (ADA) and ETA. For patients after MTX failure and using the DAS 28, TOC showed a greater benefit than ABA, ADA, anakinra (ANA), ETA, golimumab (GOL), and infliximab (INF). With the exception of ANA, these advantages were not confirmed by the CDAI. Similar differences between DAS 28 and CDAI were shown in patients treated with biologics in monotherapy or after failure of biologics.Conclusion:In comparative effectiveness studies of biologics, the assessment of LDA using the DAS 28 instead of the CDAI leads to a consistent overestimation of the benefit of TOC in all patient populations, regardless of pre-treatment or combined therapy with MTX. The inclusion of APRs in disease activity scores may thus introduce bias. A score excluding inflammatory markers should therefore be used to ensure valid results.References:[1]Smolen JS, Aletaha D. Interleukin-6 receptor inhibition with tocilizumab and attainment of disease remission in rheumatoid arthritis: the role of acute-phase reactants. Arthritis Rheum 2011; 63(1): 43-52.Disclosure of Interests:Kirsten Janke: None declared, Katharina Biester: None declared, Dietmar Krause Grant/research support from: Pfizer and AbbVie (Abbott), Bernd Richter: None declared, Christoph Schürmann: None declared, Katharina Hirsch: None declared, Beate Wieseler: None declared

scholarly journals An observational study on Assessment of disease activity in Rheumatoid Arthritis patients using Patient based Disease Activity Score 2 (PDAS 2)

2021 ◽  
Author(s):  
Harpreet Singh ◽  
Somdatta Giri ◽  
Hemant Kumar ◽  
Pratibha Yonzone ◽  
Mahima Khatkar
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Index ◽  
Statistical Significance ◽  
Disease Activity Index ◽  
Activity Score ◽  
P Value ◽  
Internal Reliability ◽  
Das 28

Abstract Objective To assess the utility of Patient Based Disease Activity Score 2 (PDAS 2) in assessing the disease activity in Rheumatoid arthritis (RA). Methods A prospective cohort study was conducted on 80 patients of RA. The demographic and clinical characteristics of the patients were recorded. They were assessed for disease activity using “Disease Activity Score 28” (DAS 28), “Clinical Disease Activity Index” (CDAI) and PDAS 2 score at baseline (M0), at 2 months (M2) and at 4 months(M4) while they were on treatment. Data was analyzed for correlation of PDAS-2 with other scores and internal reliability. P < 0.05 was considered for statistical significance. Results The mean age was 40.13\(\pm\) 11.74 years with 70 females and 10 males. There was significant reduction in DAS28, CDAI and PDAS 2 score over 4 month follow up (all scores’ p values < 0.001). Internal reliability (as assessed by Cronbach’s Alpha) of PDAS 2 was 0.578. PDAS 2 showed significant correlation with DAS28 at M0, M2 and M4 (r = 0.792, 0.757 and 0.669 respectively, p value < 0.001) and CDAI (r = 0.861, 0.832 and 0.695 respectively, p value < 0.001). Overall there was a significant agreement between DAS 28 and PDAS 2 (K = 0.788,p < 0.001) and between CDAI and PDAS 2 (K = 0.766,p < 0.001). Conclusion PDAS-2 score can be routinely used in the clinical practice owing to its correlation with DAS-28/CDAI and because of the advantage that it assessed the patients’ daily living activities.

scholarly journals Repeatability and Reliability of the Rheumatoid Arthritis Foot Disease Activity Index in Spanish Patients: A Transcultural Adaptation

Biology ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 30
Author(s):  
Eva María Martínez-Jiménez ◽  
Héctor Pereiro-Buceta ◽  
Patricia Palomo-López ◽  
Emmanuel Navarro-Flores ◽  
Ana María Jiménez-Cebrián ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Joint Stiffness ◽  
Disease Activity Index ◽  
Spanish Version ◽  
Foot Health ◽  
Retest Reliability ◽  
Rheumatoid Arthritis Disease ◽  
Foot Disease

Background: The Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5) questionnaire, based on five questions, is used to assess the severity of rheumatoid arthritis disease in the foot. Nowadays, RADAI-F5 has been validated in different languages; however a Spanish version was lacking. Therefore, the purpose of this research was to translate and validate the Spanish version (RADAI-F5-es). Methods: A cross-cultural translation of the RADAI-F5 questionnaire was performed from English to Spanish. To validate its use, 50 subjects with rheumatoid arthritis who responded to the translated questionnaire two times in an interval of less than 3 months were selected in order to verify the psychometric properties. Results: Excellent agreement between the two versions according to the Cronbach’s α was shown. Five domains with regards to arthritis activity in foot joint tenderness and swelling, foot arthritis pain, general foot health and joint stiffness were added together to obtain the total score. Excellent retest reliability was shown for the total score. Test/retest reliability was excellent for joint stiffness on awakening and foot arthritis pain domains. There were no significant differences among any domains (p > 0.05). There were no statistically significant differences (p = 0.000) for the mean ± standard deviations (SD) between pre- and post-tests (98.09 ± 15.42) [93.75–102.43] and 97.96 ± 13.88 [94.5–101.86] points, respectively). Bland–Altman plots or clinically pertinent variations were not statistically significantly different. Conclusions: The RADAI-F5-es is considered a valid and strong tool with adequate repeatability in the Spanish community.

scholarly journals Relationship Between Disease Activity and Hearing Loss in Rheumatoid Arthritis Patients A Case Control Study

2016 ◽  
Vol 3 (1) ◽  
pp. 1-5
Author(s):  
Ilham Rkain ◽  
Hanan Rkain ◽  
Ilham Bouaddi ◽  
Taoufik Dakka ◽  
Najia Hajjaj-Hassouni ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Hearing Loss ◽  
Disease Activity ◽  
Hearing Impairment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Healthy Controls ◽  
Female Sex ◽  
Das 28 ◽  
Otoscopic Examination

Objectives Rheumatoid arthritis (RA) is well known to affect many different organ systems. Previous work suggests that this includes the auditory system. The objectives of this work are to evaluate the pattern of hearing impairment in patients with rheumatoid arthritis and also to examine the possible associations between hearing impairment and related RA features especially disease activity. Materials and methods Thirty RA patients (mean age of 44.5 ± 9.9 years; female sex (90%)) and 17 healthy controls (mean age of 41.5±9.1 years; female sex (76.4%)) were included in our study. The 2 groups were matched for age and sex (p>0.05). Otoscopic examination was normal in all participants. No subject of the 2 groups has had any abnormalities at otoscopic examination. Hearing impairment was evaluated by pure tone audiometry and tympanometry including the static compliance, middle ear pressure, stapedial reflex threshold test. In all patients the clinical features, laboratory data, X-rays, disease activity index-DAS 28 were performed. Results Hearing loss was more prevalent in RA patients compared to healthy controls (56.7 vs 11.8%; p=0.005). RA patients have conductive, sensorineural and mixed hearing loss in respectively 43.4, 3.3 and 10 % of cases. Association analysis between hearing characteristics and remission in RA patients shows that RA patients in remission have significantly lower mean hearing thresholds (12.8±5.2dB vs 18.8±6.9 dB ; p=0.04). Conclusion This study suggests that hearing loss risk is higher in RA patients and seems to be associated to disease duration. Hearing loss in RA was directly proportional to the disease activity index-DAS 28. Audiological evaluation must be performed periodically to identify possible audiological damage

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

Effect of Remission Definition on Healthcare Cost Savings Estimates for Patients with Rheumatoid Arthritis Treated with Biologic Therapies

2014 ◽  
Vol 41 (8) ◽  
pp. 1600-1606 ◽  
Author(s):  
Cheryl Barnabe ◽  
Nguyen Xuan Thanh ◽  
Arto Ohinmaa ◽  
Joanne Homik ◽  
Susan G. Barr ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Healthcare Cost ◽  
Activity Index ◽  
Cost Savings ◽  
Disease Activity Index ◽  
Disease Status ◽  
Point Estimate ◽  
Sustained Remission ◽  
American College Of Rheumatology

Objective.Sustained remission in rheumatoid arthritis (RA) results in healthcare utilization cost savings. We evaluated the variation in estimates of savings when different definitions of remission [2011 American College of Rheumatology/European League Against Rheumatism Boolean Definition, Simplified Disease Activity Index (SDAI) ≤ 3.3, Clinical Disease Activity Index (CDAI) ≤ 2.8, and Disease Activity Score-28 (DAS28) ≤ 2.6] are applied.Methods.The annual mean healthcare service utilization costs were estimated from provincial physician billing claims, outpatient visits, and hospitalizations, with linkage to clinical data from the Alberta Biologics Pharmacosurveillance Program (ABioPharm). Cost savings in patients who had a 1-year continuous period of remission were compared to those who did not, using 4 definitions of remission.Results.In 1086 patients, sustained remission rates were 16.1% for DAS28, 8.8% for Boolean, 5.5% for CDAI, and 4.2% for SDAI. The estimated mean annual healthcare cost savings per patient achieving remission (relative to not) were SDAI $1928 (95% CI 592, 3264), DAS28 $1676 (95% CI 987, 2365), and Boolean $1259 (95% CI 417, 2100). The annual savings by CDAI remission per patient were not significant at $423 (95% CI −1757, 2602). For patients in DAS28, Boolean, and SDAI remission, savings were seen both in costs directly related to RA and its comorbidities, and in costs for non-RA-related conditions.Conclusion.The magnitude of the healthcare cost savings varies according to the remission definition used in classifying patient disease status. The highest point estimate for cost savings was observed in patients attaining SDAI remission and the least with the CDAI; confidence intervals for these estimates do overlap. Future pharmacoeconomic analyses should employ all response definitions in assessing the influence of treatment.

scholarly journals Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

2015 ◽  
Vol 42 (7) ◽  
pp. 1090-1098 ◽  
Author(s):  
Leslie R. Harrold ◽  
George W. Reed ◽  
Ashwini Shewade ◽  
Robert Magner ◽  
Katherine C. Saunders ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Effectiveness ◽  
High Disease Activity ◽  
Low Disease Activity ◽  
Logistic Regression Models ◽  
Lower Baseline ◽  
Previously Treated

Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

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