THU0040 Impact of Baseline Conventional Disease Activity Variables, Imaging Assessment of RA Activity (Joint US and MRI Synovitis Scores), MMP-3 and Calprotectin Levels on Achievement of ACR70 Response in RA Patients after Etanercept Treatment: Table 1.

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 192.1-192
Author(s):  
A. Pchelintseva ◽  
E. Panasyuk ◽  
N. Ionichenok ◽  
A. Zhornyak ◽  
A. Ilyina ◽  
...  
2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1451.3-1451
Author(s):  
K. Kraev ◽  
M. Geneva-Popova ◽  
S. Popova

Background:Biological drugs are protein derivatives that, as such, are highly immunogenic. In recent years there have been many conflicting opinions about the role of drug immunogenicity in clinical practice.Objectives:To evaluate the drug immunogenicity of TNF-alpha blocking drugs (etanercept and adalimumab) used to treat patients with rheumatoid arthritis. To determine whether their presence can alter the effect of treatment and to evaluate their role in the clinical practice of rheumatologists.Methods:121 patients with rheumatoid arthritis, as well as 31 healthy controls, similar in sex and age, were examined. They were all monitored at 0, 6, 12 and 24 months from the start of TNF-alpha blocker treatment. Demographics, vital signs, markers of inflammation such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and disease activity indices were examined at each visit, respectively. Drug-induced neutralizing antibodies, as well as drug bioavailability in patients treated with adalimumab, were examined by ELISA.Results:Drug-induced neutralizing antibodies to adalimumab were detected in 11.57% of patients at 6 month, in 17.64% of patients at 12 month, and 24.8% at 24 month. Drug-induced neutralizing antibodies to etanercept were not detected at 6 months, at 7.77% at 12 months, at 9.63% of patients at 24 months. Of the adalimumab patients who were having drug-induced antibodies, 92.59% had low drug bioavailability, while the remaining 7.41% of patients showed normal drug bioavailability despite the presence of drug-induced neutralizing antibodies. In terms of worsening of the disease activity, a positive correlation was found with the presence of drug antibodies - Pearson Correlation = 0.701, p = 0.001. Patients with poor clinical response and available drug antibodies receiving adalimumab were slightly more than those treated with etanercept at 12 and 24 months but the difference is non-significant-U = 0.527, p> 0.05 and U = 0.623, p> 0.05, respectively.Conclusion:Presence of drug-induced neutralizing antibodies in patients treated with adalimumab and etanercept has been associated with poor clinical response and worsening of the patient’s condition. Testing of drug-induced neutralizing antibodies as well as the drug bioavailability of the drug used can be used as reliable biomarkers in clinical rheumatology.References:[1]Benucci M., F.Li Gobbi, M. Meacii et al., “Antidrug antibodies against TNF-blocking agents: correlations between disese activity, hypersensitivity reactions, and different classes of immunoglobulins”, Biologics and Targets and Therapy, 2015: 9 7 -2.[2]Chen D., Y. Chen, W. Tsai et al., “ Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis”, Ann Rheum Dis. 2015 Mar; 74 (3).[3]Kalden J. and H. Schulze-Koops, “ Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment ”, Nature Reviews Rheumatology, 2017 volume 13, 707–718.[4]Wolf-Henning Boehnck, N. Brembilla, “ Immunogenicity of biological therapies: causes and consequences, ” Expert Review of Clinical Immunology, Vol 14, 2018, Issue 6, 513-523Disclosure of Interests:None declared


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.


Background: Rheumatoid arthritis (RA) is a progressive inflammatory disease affecting the joints with a marked impact upon functional capacity of the patient. The working ability of RA patients can be preserved if the disease modifying antirheumatic drug (DMARD) therapy is initiated early in the course of disease. The objective of our study was to compare the disease activity variables in DMARD-naïve seropositive rheumatoid arthritis (SPRA) and seronegative rheumatoid arthritis (SNRA) patients and to determine correlations between the disease activity variables in RA. Methods: A cross-sectional study recruited n=90 patients from Rheumatology Clinic from May 2020 to October 2020. The rheumatoid factor (RF), anti-cyclic citrullinated peptide levels (ACCP), erythrocyte sedimentation rates (ESR) were clinically measured. Disease activity variables including the tender joint count (TJC), swollen joint count (SJC), health assessment questionnaire-disability index (HAQ-DI) and disease activity score of 28 joints (DAS28) were consistently calculated. Patients were divided into seropositive RA group and seronegative RA group, based on RF and ACCP. Chi squared test and Pearson correlation were applied, p≤0.05 was considered statistically significant. Results: High HAQ-DI and DAS28-ESR scores were found in SPRA than in the SNRA patients and were statistically significant (p=0.000, p=0.054). TJ-28 and SJ-28 counts were higher in SPRA but were not statistically significant. There was a significant correlation of DAS28 with TJ-28 (r=0.816, p-value = 0.000), with SJ-28(r=0.801, p-value = 0.000) and HAQ-DI (r=0.517, p-value = 0.000). Conclusion: Evaluation of inflammatory markers and functional disability was found significant (p=0.000) in determining the disease activity compared to presence of autoantibodies in DMARD naïve RA patients. Keywords: Disease Modifying Antirheumatic Drug; Arthritis; Rheumatoid Factor; Autoimmune Diseases.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1831.1-1831
Author(s):  
V. Choida ◽  
A. V. Madenidou ◽  
D. Sen ◽  
M. Hall-Craggs ◽  
C. Ciurtin

Background:Whole body MRI (WBMRI) is an imaging technique that allows the assessment of the spine and peripheral joints in patients with inflammatory arthritis (IA) in a single examination. Depending on the protocol, it can potentially identify synovitis, enthesitis, spondyloarthritis and chronic structural changes.Objectives:To evaluate the performance of WBMRI in patients with IA for detecting inflammation compared with clinical assessments and to show changes in response to treatment.Methods:We conducted a systematic search of the electronic databases MEDLINE, EMBASE and Cochrane Library. Two authors selected independently the eligible studies, extracted the predefined data and assessed the quality using the QUADAS2 tool. Studies that reported a)disease activity scores, b)patient or physician reported outcomes or c)results from other imaging tests in IA patients who underwent WBMRI were included.Results:Fourteen studies out of 471 met our inclusion criteria. The majority of the studies were performed in Spondyloarthritis [SpA] (n=9), followed by Rheumatoid Arthritis [RA] (n=4) and Psoriatic Arthritis [PsA] patients (n=3). Nine studies provided clinical and MRI outcome measures. There was great heterogeneity in the quality of studies, disease specific outcomes reported and methodology used to compare with MRI findings. One study documented low correlation between 28 swollen/tender joint count and MRI bone marrow oedema (BME)/synovitis in RA patients, whereas another reported that 31% of MRI negative joints (other than hand joints) exhibited tenderness. In PsA, one study demonstrated correlation between 28 swollen joint count and BME (r=0.54,p=0.03). Superiority of WBMRI in the detection of synovitis and enthesitis over clinical examination was documented in two studies with SpA patients. A third study in SpA showed a ranging agreement of 49 to 100% between clinical and WBMRI enthesitis.Treatment response to biologics was assessed by WBMRI in 7 studies (5 in SpA, 2 in RA). In RA, one study showed numerical (but not statistically significant) reduction of WBMRI joint count at week 16 and 52 of Adalimumab treatment, whereas the reduction was statistically significant for the subset of patients achieving good EULAR response at week 16. The other study demonstrated a reduction in WBMRI synovitis and bone oedema scores after 1 year of anti-TNF or Tocilizumab treatment (median DAS28 score decreased from 5.1 to 2.1). A multicentre open label study reported a reduction in the number of MRI enthesitis lesions, spinal and sacroiliac joint scores at week 48, year 2 and 3 of Etanercept treatment in SpA patients. The mean BASDAI score decreased from 5.4 at baseline to 1.5 at year 2 and 2.2 at year 3. Improvement in WBMRI scores in SpA was also documented in one Adalimumab and one further Etanercept study.Conclusion:There was a variable level of correlation between clinical and WBMRI outcome measures across the included studies. The clinical significance of inflammation detected by WBMRI in some studies remains unclear. Many of the devised WBMRI scores appear to decrease after biologic treatment. Further studies are needed to determine the accuracy of WBMRI in detecting inflammation and its potential utility for clinical practice.Disclosure of Interests:Varvara Choida: None declared, Anastasia-Vasiliki Madenidou: None declared, Debajit Sen: None declared, Margaret Hall-Craggs: None declared, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences


2009 ◽  
Vol 69 (01) ◽  
pp. 138-142 ◽  
Author(s):  
F H M Prince ◽  
L M Geerdink ◽  
G J J M Borsboom ◽  
M Twilt ◽  
M A J van Rossum ◽  
...  

Objective:To evaluate changes in health-related quality of life (HRQoL) in patients with refractory juvenile idiopathic arthritis (JIA) who are being treated with etanercept.Methods:53 patients with JIA from seven Dutch centres were included. HRQoL was measured by the Childhood Health Assessment Questionnaire (CHAQ), Child Health Questionnaire (CHQ) and Health Utilities Index mark 3 (HUI3) at the start and after 3, 15 and 27 months of treatment. At the same time points the following JIA disease activity variables were collected; physician’s global assessment through the visual analogue scale (VAS), number of active and limited joints and erythrocyte sedimentation rate. A statistical method linear mixed models was used to assess outcomes over time.Results:During etanercept treatment both disease-specific and generic HRQoL outcomes improved dramatically. Significant improvements were shown after 3 months and these improvements continued at least up to 27 months of treatment. The disease-specific CHAQ, including VAS pain and wellbeing, showed a significant improvement in all domains. The generic health-profile measure CHQ improved for all the health concepts except for “family cohesion”, which was normal. The generic preference-based HUI3 showed impairment and, subsequently, significant improvement in the more specific domains (“pain”, “ambulatory”, “dexterity”). In accordance disease activity variables also improved significantly over time.Conclusion:This study shows that the HRQoL of patients with refractory JIA can be substantially improved by the use of etanercept for all aspects impaired by JIA. Information on HRQoL is crucial to understand the complete impact of etanercept treatment on patients with JIA and their families.


2021 ◽  
Vol 13 ◽  
pp. 1759720X2098770
Author(s):  
Fabian Proft ◽  
Anja Weiß ◽  
Murat Torgutalp ◽  
Mikhail Protopopov ◽  
Valeria Rios Rodriguez ◽  
...  

Aims: Long-term data on TNFi treatment in patients with axSpA is scarce. The objective of this analysis was to assess long-term clinical efficacy of etanercept in early axSpA [including both non-radiographic and radiographic axSpA forms], who participated in the long-term (until year 10) extension of the ESTHER-trial. Methods: In the previously reported ESTHER-trial, patients with early active axSpA were randomized to treatment with etanercept ( n = 40) or sulfasalazine ( n = 36) during the first year. Patients in remission discontinued their therapy and were followed up until the end of year 2; in case of remission-loss, etanercept was (re)-introduced and continued until the end of year 10. If remission was not achieved at year 1, patients continued receiving (or were switched to) etanercept for up to 10 years. Results: A total of 19 patients (12 with r-axSpA and 7 with nr-axSpA at baseline) out of the initial 76 patients (= 25%) completed year 10 of the study. In the entire group, a sustained clinical response was seen over 10 years of follow up in the as-observed analysis. Completers were significantly more often male and showed lower values of patient and physician global assessments of disease activity, Ankylosing Spondylitis Disease Activity Score (ASDAS), and Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) scores at baseline as compared with non-completers. When analyzing clinical data of the completers, mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) values were constantly below 2 and mean ASDAS below 2.1 during follow up with no statistically significant differences between the r-axSpA and nr-axSpA subgroups. A total of 39 serious adverse events were documented over the 10 years, while six of them were seen as possibly associated with the etanercept treatment, which led in five patients to treatment discontinuation. Conclusion: A sustained clinical response was observed over the 10 years of the study with comparable response and drop-out rates between r-axSpA and nr-axSpA. Etanercept was well tolerated across the entire treatment period and showed a good safety profile with no new safety signals.


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