scholarly journals Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis

2008 ◽  
Vol 68 (4) ◽  
pp. 531-535 ◽  
Author(s):  
M K de Vries ◽  
I E van der Horst-Bruinsma ◽  
M T Nurmohamed ◽  
L A Aarden ◽  
S O Stapel ◽  
...  

Background:Immunogenicity, specifically the onset of antibodies against tumour necrosis factor (TNF) blocking agents, seems to play an important role in non-response to treatment with these drugs.Objectives:To assess the relation of clinical response of ankylosing spondylitis (AS) to etanercept with etanercept levels, and the presence of antibodies to etanercept.Methods:Patients with AS were treated with etanercept 25 mg twice weekly, according to the international Assessment in Ankylosing Spondylitis (ASAS) working group consensus statement. Sera were collected at baseline and after 3 and 6 months of treatment. Clinical response was defined as a 50% improvement or as an absolute improvement of 2 points on a (0–10 scale) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. Functional etanercept levels were measured by a newly developed ELISA, measuring the binding of etanercept to TNF. Antibodies against etanercept were measured with a two-site assay and antigen binding test. Clinical data were used to correlate disease activity with serum etanercept levels.Results:In all, 53 consecutive patients were included. After 3 months of treatment 40 patients (76%) fulfilled the response criteria. Mean etanercept levels were 2.7 mg/litre and 3.0 mg/litre after 3 and 6 months respectively. Characteristics and etanercept levels of responders and non-responders were similar. No antibodies to etanercept were detected with any of the assays.Conclusion:Etanercept levels of responders and non-responders were similar and no antibodies to etanercept were detected with any of the assays. This study indicates that etanercept is much less immunogenic compared with the other TNF-blocking agents.

2007 ◽  
Vol 67 (4) ◽  
pp. 511-517 ◽  
Author(s):  
S Visvanathan ◽  
C Wagner ◽  
J C Marini ◽  
D Baker ◽  
T Gathany ◽  
...  

Objective:To evaluate the relationship between biomarker levels and disease activity and the spinal inflammation detected by magnetic resonance imaging (MRI) in patients with ankylosing spondylitis (AS).Methods:Patients with AS were randomly assigned in a 3:8 ratio to receive infusions of placebo or 5 mg/kg infliximab at weeks 0, 2, 6, 12 and 18. Sera were collected for biomarker analysis at weeks 0, 2 and 24 and were analysed for levels of interleukin-6 (IL-6), vascular endothelial growth factor (VEGF) and C-reactive protein (CRP). Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores and pre- and post-gadolinium T1 and short τ inversion recovery MRIs were collected at baseline and week 24.Results:Significantly greater reductions in IL-6, VEGF and CRP were observed at weeks 2 and 24 in the infliximab group compared with the placebo group (all p<0.001). Baseline IL-6 levels >7.38 pg/ml and CRP levels >1.5 mg/dl were associated with increased rates of clinical response after 24 weeks. Multiple regression analyses showed that reductions from baseline to week 2 in IL-6, but not CRP or VEGF, were significantly associated with reductions in MRI activity and BASDAI scores from baseline to week 24 in the infliximab group (p<0.001).Conclusions:Significant reductions in IL-6, VEGF and CRP were observed with infliximab compared with placebo. High levels of baseline IL-6 and CRP were associated with clinical response after infliximab treatment. Early reductions in IL-6 were significantly associated with improvements in disease activity and the spinal inflammation detected by MRI.


2019 ◽  
Vol 47 (1) ◽  
pp. 35-41 ◽  
Author(s):  
Jürgen Braun ◽  
Xenofon Baraliakos ◽  
Uta Kiltz ◽  
Klaus Krüger ◽  
Gerd R. Burmester ◽  
...  

Objective.International recommendations for the management of axial spondyloarthritis including ankylosing spondylitis (AS) recommend a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) level of disease activity of ≥ 4 to initiate treatment with biologics. We aimed to evaluate the level of disease activity used to initiate tumor necrosis factor inhibitor (TNFi) treatment and the level of responses to treatment based on different BASDAI cutoffs.Methods.This is a posthoc analysis of the noninterventional, prospective, GO-NICE study in the subgroup of biologic-naive AS treated with golimumab (GOL) 50 mg subcutaneously once monthly.Results.Of the 244 biologic-naive AS patients at baseline, 70.5% had a BASDAI ≥ 4 (Group 1), 14.3% had 2.8 to < 4 (Group 2), and 15.2% had even < 2.8 (Group 3). A total of 134 patients (54.9%) completed the 24-month observational period. The mean BASDAI in Groups 1, 2, and 3 was initially 5.9 ± 1.3, 3.4 ± 0.4, and 2.0 ± 0.8, decreased to 2.2 ± 2.0, 1.9 ± 1.2, and 1.0 ± 1.2 within 3 months (all p < 0.0001 vs baseline), and decreased significantly to 2.2 ± 1.7, 1.9 ± 1.7, and 1.4 ± 1.0 at Month 24 (all p < 0.005), respectively. BASDAI 50% improvement was noted in 68.8%, 44.8%, and 45.2% of patients at Month 3, and in 84.9%, 61.9%, and 55.0% at Month 24.Conclusion.TNFi treatment was initiated in almost a third of AS patients with lower disease activity states as assessed by BASDAI cutoff of ≥ 4. Patients with a BASDAI between 2.8 and < 4 appeared to benefit significantly from GOL treatment, while patients with BASDAI < 2.8 did not. This finding should lead to a reevaluation of the established BASDAI cutoff of ≥ 4.


2016 ◽  
Vol 43 (5) ◽  
pp. 918-923 ◽  
Author(s):  
Ennio Lubrano ◽  
Wendy J. Parsons ◽  
Fabio Massimo Perrotta

Objective.To assess the response to treatment, remission, and minimal disease activity (MDA) in a group of patients with predominant axial psoriatic arthritis (axPsA). Predictors of response were also evaluated.Methods.Patients fulfilling the ClASsification of Psoriatic ARthritis (CASPAR) criteria and treated with anti-tumor necrosis factor (anti-TNF) agents adalimumab, etanercept, and golimumab were enrolled and prospectively followed every 4 months for 1 year in a clinical practice setting. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 was assessed as a set of response criteria to treatment; Composite Psoriatic Disease Activity Index (CPDAI) < 4, Disease Activity Index for Psoriatic Arthritis (DAPSA) score ≤ 3.3, and partial remission (PR) were also evaluated as remission criteria. Patients were considered in MDA when they met at least 5/7 of the criteria previously defined. Patients achieving BASDAI 50, PR, and MDA were compared to identify outcome predictor factors. Concordance between the outcome measures was also performed.Results.Of the 58 patients treated with anti-TNF, at baseline no patients were in PR or MDA. No patients had a CPDAI < 4 or a DAPSA score ≤ 3.3. After 12 months, BASDAI 50 was achieved in 15/48 patients (31.2%). CPDAI < 4, DAPSA score ≤ 3.3, PR, and MDA were achieved, respectively, in 17/48 (35.4%), 11/48 (22.9%), 11/48 (22.9%), and 24/48 (50%) patients. No difference was found among the 3 anti-TNF. Predictors for MDA were male sex, young age, low disease duration, low Health Assessment Questionnaire score, and absence of enthesitis.Conclusion.This longitudinal observational study, based on a clinical practice setting, showed that remission and MDA are achievable targets in axPsA treated with anti-TNF. Predictors of remission and MDA were also identified.


2010 ◽  
Vol 37 (4) ◽  
pp. 829-834 ◽  
Author(s):  
TAMAR F. BRIONEZ ◽  
SHERVIN ASSASSI ◽  
JOHN D. REVEILLE ◽  
CHARLES GREEN ◽  
THOMAS LEARCH ◽  
...  

Objective.To investigate the role of psychological variables in self-reported disease activity in patients with ankylosing spondylitis (AS), while controlling for demographic and medical variables.Methods.Patients with AS (n = 294) meeting modified New York criteria completed psychological measures evaluating depression, resilience, active and passive coping, internality, and helplessness. Demographic, clinical, and radiologic data were also collected. Univariate and multivariate analyses were completed to determine the strength of the correlation of psychological variables with disease activity, as measured by the Bath AS Disease Activity Index (BASDAI).Results.In the multivariate regression analysis, the psychological variables contributed significantly to the variance in BASDAI scores, adding an additional 33% to the overall R-square beyond that accounted for by demographic and medical variables (combined R-square 18%). Specifically, arthritis helplessness and depression accounted for the most significant portion of the variance in BASDAI scores in the final model.Conclusion.Arthritis helplessness and depression accounted for significant variability in self-reported disease activity beyond clinical and demographic variables in patients with AS. These findings have important clinical implications in the treatment and monitoring of disease activity in AS, and suggest potential avenues of intervention.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bora Nam ◽  
Bon San Koo ◽  
Tae-Han Lee ◽  
Ji-Hui Shin ◽  
Jin-Ju Kim ◽  
...  

Abstract Background The purpose of this study was to determine the prevalence of high disease activity as measured using the Ankylosing Spondylitis Disease Activity Score (ASDAS) in ankylosing spondylitis (AS) patients who nonetheless have low Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores after anti-tumor necrosis factor (TNF) treatment. Its clinical impact on anti-TNF survival was also investigated. Methods We conducted a single-centre retrospective cohort study of AS patients having low BASDAI scores (< 4) and available ASDAS-C-reactive protein (CRP) data after 3 months of first-line anti-TNF treatment. Patients were grouped into high-ASDAS (≥ 2.1) and low-ASDAS (< 2.1) groups according to the ASDAS-CRP after 3 months of anti-TNF treatment. Their characteristics were compared. And survival analyses were carried out using Kaplan–Meier curves and log-rank test with the event being discontinuation of anti-TNF treatment due to lack/loss of efficacy. Results Among 116 AS patients with low BASDAI scores after 3 months of anti-TNF treatment, 38.8% were grouped into the high-ASDAS group. The high-ASDAS group tended to have greater disease activity after 9 months of treatment (BASDAI 2.9 ± 1.1 vs. 2.3 ± 1.4, p=0.007; ASDAS-CRP 1.8 ± 0.6 vs. 1.5 ± 0.7, p=0.079; proportion of high ASDAS-CRP 27.8% vs. 13.8%, p=0.094) and greater risk of discontinuing anti-TNF treatment due to lack/loss of efficacy than the low-ASDAS group (p=0.011). Conclusions A relatively high proportion of AS patients with low BASDAI scores had high ASDAS-CRP. These low-BASDAI/high-ASDAS-CRP patients also had a greater risk for discontinuation of anti-TNF treatment due to low/lack of efficacy than the low-ASDAS group. The use of the ASDAS-CRP alone or in addition to the BASDAI may improve the assessment of AS patients treated with anti-TNF agents.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1129.1-1129
Author(s):  
A. Baillet ◽  
X. Romand ◽  
A. Pfimlin ◽  
M. Dalecky ◽  
M. Dougados

Background:Standardization of clinical practice has been proven to be effective in management of chronic diseases. This is particularly true at the time where the concept of treat to target is becoming more and more important in the field of axial spondyloarthritis (ax-SpA).Objectives:To propose a list of variables to be collected at the time of the diagnosis and over the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice.Methods:The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of axSpA via a systematic literature research, (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of the variable in a 4 grade scale from ”potentially useful” to “mandatory”, (3) a consensus on optimal timeline for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”.Results:The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Concerning the data to be collected at the time of the diagnosis and during follow-up, we proposed to differentiate the results based on a) the way of collection of the variables (e.g. questionnaires by the patient, interview by the physician, physical examination, investigations) b) the usefulness these variables in daily practice based on the opinion of the rheumatologists ” c) the optimal timeline between 2 evaluations of the variable based on the opinion of the rheumatologists. In the initial systematic review, symptoms of heart failure history of inflammatory bowel disease, psoriasis or uveitis, patient global visual analogic scale, spine radiographs, modified Schöber test, coxo-femoral rotations, swollen joint count, urine strip test, BASDAI and ASDAS global scores were considered very useful and nocturnal back pain/morning stiffness, sacro-iliac joints radiographs and CRP were considered mandatory (Figure 1). Timeline between 2 evaluations of variables to collect in the periodic review are summarized inFigure 2.Figure 1.Core sets of items to collect and report in the systematic review in axial spondyloarthritis management in daily practice ASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, BASFI=Bath Ankylosing Spondylitis Functionnal Index, BASMI=Bath Ankylosing Spondylitis Metrology Index, CRP=C Reactive Protein, CT=computerized tomography, FIRST=Fibromyalgia Rapid Screening Tool, HLA=Human Leukocyte Antigen, MRI=Magnetic resonance imaging, PET=positron emission tomography.Figure 2.Periodic review timeline of variables to collectASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, Spondylitis Metrology Index, CRP=C Reactive Protein, IBD = inflammatory bowel diseases, PRO = Patient Reported OutcomesConclusion:Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported at the time of the diagnosis and during follow-up of patients with ax-SpA in daily practice.Acknowledgments:this study has been conducted in two parts: the first one (evidence-based) was conducted thanks to a support from Abbvie France. AbbVie did not review the content or have influence on this manuscript. The second part of this initiative (consensus) has been conducted thanks to a support from the scientific non-profit organization: Association de Recherche Clinique en RhumatologieDisclosure of Interests:Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  

Background:Axial spondyloarthritis (ax-SpA) is a chronic rheumatic disease that mainly affects men. However, the female form of ax-SpA remains insufficiently studied.Objectives:The aim of this study was to determine the clinical characteristics, the disease activity and the functional impact of female ax-SpA in comparison with male ax-SpA.Methods:This is a retrospective study including patients diagnosed with ax-SpA fulfilling the criteria of the Assessment of SpondyloArthritis international Society (ASAS) 2009.Clinical parameters, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of female and male ax-SpA.Results:Two hundred ax-SpA patients were included with 31% of female (n=62) and a mean age of 43,3 ± 11,2 years.The mean age at onset of symptoms was 31,8 ± 8,9 years for women and 25,3 ± 9,1 years for men (p <0,0001). The mean age at diagnosis was 36,4 ± 9,6 years for women and 31,7 ± 10,4 years for men (p = 0,003). Ax-SpA with juvenile onset was noted in 1,7% of women and 12,1% of men (p = 0,02). Male ax-SpA were significantly more smokers (46.8% vs 5.4%; p <0.001). The mean duration of morning stiffness was 11,3 ± 9,2 minutes for women versus 21,6 ± 19,3 minutes for men (p = 0,005).The mean ESR was 42,4 ± 29,8 mm for women and 28,3 ± 23,4 mm for men (p = 0,001). Radiographic sacroiliitis was present in 69,3% of women versus 84,7% of men (p = 0,01). The use of anti-TNF alpha was less frequent in women (29% vs 48,5%; p = 0,01).Our study didn’t found a statistically significant difference in peripheral manifestations, extraarticular manifestations, CRP, BASDAI and BASFI between the two groups.Conclusion:Female ax-SpA seems to have a better prognosis than male with older age in disease onset, less inflammation, less radiographic sacroiliitis and less use of biological treatments.References:[1]Rusman T, et al. Curr Rheumatol Rep. 2018; 20(6).[2]Siar N, et al. Curr Rheumatol Rev. 2019;Disclosure of Interests:None declared


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Maria Chiara Ditto ◽  
Simone Parisi ◽  
Marta Priora ◽  
Silvia Sanna ◽  
Clara Lisa Peroni ◽  
...  

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.


2020 ◽  
Vol 58 (5) ◽  
pp. 503-511
Author(s):  
O. A. Krichevskaya ◽  
Z. M. Gandaloeva ◽  
S. I. Glukhova ◽  
I. Yu. Skripkina ◽  
A. B. Demina ◽  
...  

Objective: Assessment of ankylosing spondylitis activity patterns during pregnancy using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score — C-Reactive Protein) disease activity indices.Materials and methods. The prospective study included 36 pregnant women with AS (modified New York AS criteria, 1984). Patients’ mean age was 31.6±4.8 years, mean age at AS onset was 21.8±10.9, and disease duration 134.9±89.3 months. The control group included 30 healthy pregnant women with no history of back pain and arthritis, their mean age was 28.2±4.5 years. In the I trimester of pregnancy 10 (33.3%) As patients experienced back pain, while in the III trimester already 15 (50%) had back pain. Throughout pregnancy, the intensity of back pain in the I, II и III trimesters based on numeric scale was on average 1.9±0.9; 2.1±1.1 and 2.1±0.8. BASDAI and ASDAS-CRP were used to measure disease activity on gestational Weeks 10–11, 20–21 and 31–32. The time of conception BASDAI score was assessed retrospectively at the 1st visit.Results and discussion. BASDAI mean values at the time of conception and I, II и III trimesters of pregnancy were: 2.3±1.9; 2.8±1.72 (p<0,05 vs month of conception); 3.2±1.9 and 3.3±2.1 respectively. Mean ASDAS-CRP in the I, II и III trimesters were 1.9±0.7; 2.3±0.9 and 2.2±0,8 respectively. There was a trend to CRP increase in the II and III trimesters vs the I: median CRP values in the I, II and III trimesters were 5.7 [1.6; 6.2], 8.0 [2.1; 9.6] and 7.9 [2.0; 9.2] mg/L, respectively. Percentages of patients with high disease activity based on BASDAI scores in the I, II and III trimesters were 30.6; 34.3 and 34.3%; based on ASDAS-CRP — 36.1; 57.5 and 53%, respectively. Throughout pregnancy, BASDAI scores were lower in the control group than in AS patients (p<0.01). However, no differences were found when comparing BASDAI values of AS patients and healthy women with back pain during pregnancy. The level of fatigue did not differ between pregnant women with AS (median 5[3; 7] and 5[3; 6]) and healthy controls (5[3; 8] and 5[4; 6]) in the I and II trimesters, while in the III trimester, fatigue in healthy pregnant women (6[4; 8]) was more pronounced than in AS patients (5[3; 6], p=0.01). Throughout pregnancy, the intensity of back pain in AS patients and healthy pregnant women with back pain did not differ (p<0.05). Median pain intensity in the I, II and III trimesters was 3[2; 4]; 4[3; 5]; 3[2; 6] and 2,5[1; 4]; 3[2; 7]; 4[2; 6], respectively. A high (rs ≥0,7) correlation of all BASDAI components with the index itself in each trimester of pregnancy, except for joint pain in the month of conception, and in the I and III trimesters was established in the group of pregnant women with AS. The control group had quite high correlation (rs >0.7) of fatigue severity with the BASDAI index in the I and II trimesters of pregnancy and moderate correlation (rs >0.53) in the III trimester; as wells as moderate (rs >0.5-0.69) correlation between back pain and BASDAIConclusion. A trend towards increasing AS activity based on BASDAI and ASDAS-CRP scores and CRP levels was established for the first half of pregnancy. Later in pregnancy these increased values failed to return to normal until the end of gestation. The percentage of AS patients with highto-moderate disease activity throughout pregnancy was lower based on BASDAI score vs based on ASDAS-CRP. Some BASDAI components (fatigue and back pain) reflect not only the activity of AS, but also changes associated with physiological pregnancy. The BASDAI index requires adaptation for use in pregnancy


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Mateusz Wojciech Romanowski ◽  
Maja Špiritović ◽  
Radosław Rutkowski ◽  
Adrian Dudek ◽  
Włodzimierz Samborski ◽  
...  

Objectives. This study aims to compare the effectiveness of deep tissue massage (DTM) and therapeutic massage (TM) in the management of ankylosing spondylitis (AS) patients. Materials and Methods. This was a small, randomized clinical pilot study. Subjects were 27 men with diagnosed AS, randomly assigned to DTM group or TM group. Subjects in each group had 10 sessions of massage. Outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), Modified Schober Test, Finger to Floor Test, chest expansion, and pain intensity of lower back. Results. There are no statistical significant differences between groups, except for BASDAI and pain intensity of lower back. Conclusions. This study suggests that massage may have clinical benefits for treating ankylosing spondylitis patients. Additional scientific research in this area is warranted.


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