Effectiveness and safety of anti-TNF therapy for ankylosing spondylitis: a real-word study

Author(s):  
Pedro Ricardo Kömel Pimenta ◽  
Michael Ruberson Ribeiro da Silva ◽  
Jéssica Barreto Ribeiro dos Santos ◽  
Adriana Maria Kakehasi ◽  
Francisco de Assis Acurcio ◽  
...  

Aim: To evaluate the effectiveness and safety of anti-TNF drugs for ankylosing spondylitis. Materials & methods: A prospective cohort study was performed at a pharmacy in the Brazilian Public Health System. Effectiveness by Bath Ankylosing Spondylitis Disease Activity Index, functionality by Health Assessment Questionnaire Disability Index, quality of life by European Quality of Life Five-Dimensions and safety was assessed at 6 and 12 months of follow-up. Results: About 160 patients started the treatment with adalimumab, etanercept or infliximab. There was a statistically significant improvement in disease activity, functionality and quality of life at 6 and 12 months (p < 0.05). Conclusion: This real-world study has shown that anti-TNF drugs are effective and well tolerated for ankylosing spondylitis patients.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1954.2-1954
Author(s):  
W. Zhou ◽  
M. He ◽  
R. Zhao ◽  
C. Dong ◽  
Z. Gu

Background:Ankylosing spondylitis (AS) is a chronic inflammatory disease that mainly affects the sacroiliac joints and the spine, resulting in decline in quality of life[1,2]. Poor QoL is significantly related to high disease activity[3]. However, there is no systematic report on which prognosis indicators are affected by disease activity in AS patients.Objectives:This study aimed to evaluate the patient-reported outcome measures and health-related quality of life (HR-QoL) in AS patients defined on the basis of the Bath Spondylitis Ankylosing Disease Activity Index (BASDAI).Methods:204 AS patients were involved in this study. A serious of questionnaires were used to overall assess AS patients, which include: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), the 10 cm Visual Analog Scale (VAS), the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), the Pittsburgh Sleep Quality Index (PSQI), the Health Assessment Questionnaire-Disability Index (HAQ-DI), the Fatigue Severity Scale(FSS) and the Short Form 36 Health Survey (SF-36). Independent samples t-test, Mann–Whitney U-test, Chi-square analysis and Pearson /Spearman correlation were used to analyze the data.Results:The results demonstrated 31.4% AS patients were in active disease activity stage. Active AS patients were older, unemployed, and had less exercise therapy than stable AS patients. Besides, AS patients with active disease activity presented more severe pain(P<0.001), poor physical function(P<0.001) and spinal mobility(P<0.001). They were more anxious(P<0.001), depressed(P<0.001) and had more sleep disturbance(P=0.001). Compared with active AS patients, stable AS patients had more leukocytes(P=0.040), lymphocytes(P=0.002), erythrocytes(P=0.001) and hemoglobin(P<0.001). Active disease activity had a significant impact on all dimensions of quality of life in AS patients(P<0.001).Conclusion:These findings suggested that medical personnel should pay more attention to active AS patients and make effective interventions to improve quality of life.References:[1]Exarchou S, Lindstrom U, Askling J, Eriksson JK, Forsblad-d’Elia H, Neovius M, Turesson C, Kristensen LE, Jacobsson LT (2015) The prevalence of clinically diagnosed ankylosing spondylitis and its clinical manifestations: a nationwide register study. Arthritis research & therapy 17:118. doi:10.1186/s13075-015-0627-0[2]Qian Q, Xu X, He H, Ji H, Zhang H, Ding Y, Dai SM, Zou Y, Zhu Q, Yang C, Ye S, Jiang L, Tang JP, Tong Q, He D, Zhao D, Li Y, Ma Y, Zhou J, Yuan Z, Zhang J, Jin L, Zhou X, Reveille JD, Zou H, Wang J (2017) Clinical patterns and characteristics of ankylosing spondylitis in China. Clinical rheumatology 36 (7):1561-1568. doi:10.1007/s10067-017-3660-3[3]Huang JC, Qian BP, Qiu Y, Wang B, Yu Y, Zhu ZZ, Hu J, Qu Z (2017) Quality of life and correlation with clinical and radiographic variables in patients with ankylosing spondylitis: a retrospective case series study. BMC musculoskeletal disorders 18 (1):352. doi:10.1186/s12891-017-1711-1Acknowledgments:Thanks to all the authors for their efforts and thanks to all members of the Department of Rheumatology of Affiliated Hospital of Nantong University for their helpfulness in the acquisition of data.Disclosure of Interests:None declared


2020 ◽  
Author(s):  
Pelin Oktayoglu ◽  
Nuriye Mete ◽  
Mehmet Caglayan

Abstract Objectives Defensins are a family of antimicrobial peptides. Elevated levels of human neutrophil peptides (HNP 1–3) are seen in blood samples of patients with inflammatory bowel disease (IBD) and in many rheumatic diseases. It has been suggested that they may play a significant role in the progression and pathogenesis of these diseases. Therefore, we aimed to investigate the levels of HNP 1–3 in sera of patients with ankylosing spondylitis (AS) and its association with disease activity and other clinical features of AS. Methods A total of 36 patients, who met the Modified New York Criteria for AS, and 50 healthy controls (HCs) were included in this study. The Bath AS Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS) were used to assess disease activity. The Bath AS Radiology Index (BASRI) was used to assess radiological damage. Spinal and hip measurements were determined by the Bath AS Metrology Index (BASMI). An AS Quality of Life (ASQoL) questionnaire was administered to assess the disease-related quality of life. Serum HNP 1–3 levels were determined using the ELISA kit. Results Mean serum HNP 1–3 levels were significantly higher in patients with AS (287.01±201.307 vs. 152.09±43.75 pg/ml) compared with HCs (p=0.001). HNP 1–3 levels did not correlate with BASDAI (p=0.519), ASDAS-CRP (p=0.424), BASRI (p=0.280), BASMI (p=0.168), ASQoL (p=0.307), ESR (p=0.706) and CRP (p=0.157) values. Conclusion Elevated serum levels of HNP 1–3 may play an important role in the pathogenetic mechanisms of AS. This result may give us an opportunity to develop new treatment strategies considering the role of these peptides in the pathogenetic mechanisms of AS.


Author(s):  
Ersin Bestaş ◽  
Ümit Dündar ◽  
Tülay Köken ◽  
Buğra Koca ◽  
Hilal Yeşil

Objectives: This study aims to compare the effects of balneotherapy, water-based exercise (WBE), and land-based exercise (LBE) on disease activity, symptoms, sleep quality, quality of life, and serum sclerostin level (SSL) in patients with ankylosing spondylitis (AS). Patients and methods: Between January 2019 and January 2020, a total of 60 patients (35 males, 25 females; mean age: 40.9±11.2 years; range, 18 to 55 years) who were diagnosed with AS were randomly divided into the balneotherapy (n=20), WBE (n=20), and LBE (n=20) groups (20 sessions of treatment in groups of five to six patients). The patients were evaluated before treatment and at 4 and 12 weeks using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP), Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), Ankylosing Spondylitis Quality of Life (ASQoL) Scale, Fatigue Severity Scale (FSS), and Pittsburg Sleep Quality Index (PSQI), and SSL were measured. Results: Statistically significant improvements in the BASDAI, BASFI, MASES, BASMI, ASQoL, FSS, and ASDAS-CRP scores were observed in all groups at 4 and 12 weeks of follow-up (p<0.05). A significant improvement in sleep latency was seen in the balneotherapy and WBE groups. Changes in SSL were not statistically significant in any group (p>0.05). Conclusion: Balneotherapy, WBE, and LBE are effective in the treatment of AS, and the beneficial effects may last for at least 12 weeks.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1438.2-1438
Author(s):  
V. Boyadzhieva ◽  
N. Stoilov ◽  
E. Kurteva ◽  
R. Stoilov

Background:Assessment of disease activity and quality of life are one of the main indicators for determining the effectiveness of treatment with disease-modifying antirheumatic drugs. In recent years, a new group has entered the market - target synthetic DMARDS, which prove their effectiveness in treating RA comparable to that of biological products.Objectives:The aim of this study is to evaluate the disease activity and quality of life of patients with rheumatoid arthritis (RA) treated with biological agents in comparison with Tofacitinib (real life data from Bulgarian population) and determine whether or not the benefits of different therapies were sustained over a follow up period of 1 year.Methods:164 patients were selected with a mean age 55.34 ± 16SD years, meeting the 1987 ACR and /or ACR/ EULAR (2010) classification criteria for Rheumatoid arthritis (RA). Patients were arranged according to treatment regimens: Tocilizumab (TCL) 30 patients, Certolizumab (CZP) 16, Golimumab (GOL) 22, Etanercept (ETN) 20, Adalimumab (ADA) 20, Rituximab (RTX) 16, Infliximab (INF) 20, Tofacitinib (TOF) 20. Disease activity and quality of life was the primary concern. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month’s thereafter. CRP was used to measure the inflammatory process.DAS28-CRP, clinical disease activity index (CDAI) and simplified disease activity index (SDAI)were calculated. On baseline all of the patients’ groups had severe disease activity (mean DAS28-CRP > 5.2, mean CDAI > 22, mean SDAI > 26. The quality of life was evaluated via EQ-5D.All of the patients were on stable therapy according to the inclusion criteria, and didn’t interrupt any of the medications including biological or target synthetic treatment.Results:Significant clinical improvement and statistically significant reduction in disease activity were observed in patients treated with bDMARDS and tsDMARDS within 6 months (p <0.005) of treatment and after 12 months of follow-up (p=0.039). The mean value of DAS28-CRP after one year follow up showed an non-inferior effect of Tofacitnib (3.04± 0.81) in comparison to biological treatment (TCL: 3.07 ± 0.73; CZP: 3.06 ± 0.65; GOL: 2.49 ± 0.76; ETN: 2.85 ± 0.55; ADA: 3.15 ± 0.82; RTX: 2.90 ± 0.70; INF: 3.14; ± 0.61; TOF: 3.04± 0.81). An improvement was also observed for the 6 to 12 months of follow-up as we did not detect a significant difference in the activity of the disease assessed by CDAI among the different drug groups.The mean values showing the change of the SDAI over the study period also outline comparable profiles. All of the treatment groups achieved a rapid reduction in disease activity that continued to decrease through the 6 and 12 months period, respectively, as supported by changes in SDAI.The quality of life evaluated with EQ-5D revealed significant improvement on the 6-th month of follow up as well as after 12th month (p<0.005) without significant difference between the observed groups.Conclusion:Real-life data show that patients on biological treatment as well as those on Tofacitinib therapy achieve a significant decrease in disease activity after one year of follow-up. This gives us reason to accept the importance of non-inferior effect of jak-inhibitors and their place in treatment of Rheumatoid arthritis.Disclosure of Interests:Vladimira Boyadzhieva: None declared, Nikolay Stoilov: None declared, Ekaterina Kurteva: None declared, Rumen Stoilov Grant/research support from: R-Pharm


2019 ◽  
Vol 46 (10) ◽  
pp. 1277-1283 ◽  
Author(s):  
John D. Reveille ◽  
Atul Deodhar ◽  
Paul H. Caldron ◽  
Anna Dudek ◽  
Diane D. Harrison ◽  
...  

Objective.Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year.Methods.A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively.Results.The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: −2.7 and −2.6; ASQoL: −5.5 and −5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE.Conclusion.Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.


2021 ◽  
pp. jrheum.201440
Author(s):  
Rubén Queiro ◽  
Sara Alonso-Castro ◽  
Mercedes Alperi

We have read with great interest the recent editorial published in The Journal by Dr. Kiltz, et al, referring to the possibility of using the Spondyloarthritis international Society Health Index (ASAS HI) as an all-in-one in the assessment of axial spondyloarthritis (axSpA)1. AxSpA has been evaluated over the years with different tools that have tried to determine the degree of activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)/Ankylosing Spondylitis Disease Activity Score (ASDAS)], functional limitations (Bath Ankylosing Spondylitis Functional Index), mobility restrictions (Bath Ankylosing Spondylitis Metrology Index), structural damage accumulated over time (Bath Ankylosing Spondylitis Radiology Index/modified Stoke Ankylosing Spondylitis Spinal Score), or quality of life (Ankylosing Spondylitis Quality of Life scale) of these patients.


2013 ◽  
Vol 40 (10) ◽  
pp. 1719-1725 ◽  
Author(s):  
Sueli Carneiro ◽  
Adriana Bortoluzzo ◽  
Celio Gonçalves ◽  
José Antonio Braga da Silva ◽  
Antonio C. Ximenes ◽  
...  

Objective.To analyze the clinical effect of enthesitis in a large Brazilian cohort of patients with spondyloarthritis (SpA).Methods.A common protocol of investigation was prospectively applied to 1505 patients with SpA in 29 centers in Brazil. Clinical and demographic variables and disease indexes were investigated. The Maastricht Ankylosing Spondylitis Enthesitis Score was used to investigate the enthesitis component. Ankylosing spondylitis was the most frequent disease in the group (65.4%). Others were psoriatic arthritis (18.4%), undifferentiated SpA (6.7%), reactive arthritis (3.3%), and enteropathic arthritis (3.2%).Results.At least 1 affected enthesis was observed in 54% of the patients with SpA, with a mean of 2.12 ± 2.98 entheses affected. According to the clinical presentation, enthesitis was significantly more frequent in patients with axial + peripheral joint involvement compared to isolated axial or peripheral involvement (p < 0.001). There was a statistical association between the presence of enthesites and axial symptoms (buttock pain, cervical pain, and hip pain), and peripheral symptoms (lower limb arthritis, number of painful and swollen joints; p < 0.05). Patients with enthesitis also presented higher mean scores of Bath Ankylosing Spondylitis Functional Index (BASFI; p < 0.001), Bath Ankylosing Spondylitis Disease Activity Index (p < 0.001), and Ankylosing Spondylitis Quality of Life (ASQoL; p < 0.001). Multivariate logistic regression showed that BASFI (p < 0.0001; OR 74.839), ASQoL (p = 0.0001; OR 14.645), and Achilles tendonitis (p = 0.0059; OR 7.593) were associated with work incapacity.Conclusion.The clinical presence of enthesitis in this large cohort of patients with SpA was frequent and was associated with a significant increase in disease activity and decline in functional capacity and quality of life.


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


2021 ◽  
Vol 10 (10) ◽  
pp. 2137
Author(s):  
Ning-Sheng Lai ◽  
Ming-Chi Lu ◽  
Hsiu-Hua Chang ◽  
Hui-Chin Lo ◽  
Chia-Wen Hsu ◽  
...  

Background and Aim: The aim of this study was to compare the correlation of a recently developed systemic lupus erythematosus disease activity score (SLE-DAS) with the SLE disease activity index 2000 (SLEDAI-2K) with the Lupus Quality of Life questionnaire (LupusQoL) in Taiwanese patients with SLE. Methods: A cross-sectional study was conducted in a regional teaching hospital in Taiwan from April to August 2019. Adult patients with a clinician-confirmed diagnosis of SLE based on the 1997 American College of Rheumatology revised criteria or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria were recruited. SLE disease activity was measured with both SLEDAI-2K and SLE-DAS. Disease-specific quality of life was assessed using the LupusQoL. Results: Of the 333 patients with SLE in this study, 90.4% were female and 40% were between the ages of 20 and 39 years. The median SLEDAI-2K score was 4.00 (interquartile range [IQR] 2.00–7.50) and the median SLE-DAS score was 2.08 (IQR 1.12–8.24) in our patients with SLE. After adjusting for sex and age intervals, both SLEDAI-2k and SLE-DAS were significantly and inversely associated with all eight domains of LupusQoL. The magnitudes of the mean absolute error, root mean square error, Akaike Information Criterion, Bayesian Information Criterion, and coefficient of determination were comparable between SLEDAI-2K and SLE-DAS. Conclusions: There were no clear differences in the use of SLE-DAS over SLEDAI-2K in assessing HRQoL in patients with SLE. We suggest that, in this aspect, both SLEDAI-2K and SLE-DAS are effective tools for measuring disease activity in patients with SLE.


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.


Sign in / Sign up

Export Citation Format

Share Document