Inflammatory hallmarks of lesser prominence in psoriatic arthritis patients starting biologics: a Nordic population-based cohort study

Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 140-146
Author(s):  
Rebekka Lund Hansen ◽  
Tanja Schoedt Jørgensen ◽  
Lene Dreyer ◽  
Merete L Hetland ◽  
Bente Glintborg ◽  
...  
Keyword(s):  
Disease Activity ◽  
Certolizumab Pegol ◽  
Strong Association ◽  
Unmet Need ◽  
Secular Trends ◽  
Nordic Countries ◽  
Tnf Inhibitor ◽  
First Line ◽  
Baseline Characteristics ◽  
Lower Disease Activity

Abstract Objectives To assess secular trends in baseline characteristics of PsA patients initiating their first or subsequent biologic DMARD (bDMARD) therapy and to explore prescription patterns and treatment rates of bDMARDs from 2006 to 2017 in the Nordic countries. Methods PsA patients registered in the Nordic rheumatology registries initiating any treatment with bDMARDs were identified. The bDMARDs were grouped as original TNF inhibitor [TNFi; adalimumab (ADA), etanercept (ETN) and infliximab (IFX)]; certolizumab pegol (CZP) and golimumab (GOL); biosimilars and ustekinumab, based on the date of release. Baseline characteristics were compared for the five countries, supplemented by secular trends with R2 calculations and point prevalence of bDMARD treatment. Results A total of 18 089 patients were identified (Denmark, 4361; Iceland, 449; Norway, 1948; Finland, 1069; Sweden, 10 262). A total of 54% of the patients were female, 34.3% of patients initiated an original TNFi, 8% CZP and GOL, 7.5% biosimilars and 0.3% ustekinumab as a first-line bDMARD. Subsequent bDMARDs were 25.2% original TNFi, 9% CZP and GOL, 12% biosimilars and 2.1% ustekinumab. From 2015 through 2017 there was a rapid uptake of biosimilars. The total of first-line bDMARD initiators with lower disease activity increased from 2006 to 2017, where an R2 close to 1 showed a strong association. Conclusion Across the Nordic countries, the number of prescribed bDMARDs increased from 2006 to 2017, indicating a previously unmet need for bDMARDs in the PsA population. In recent years, PsA patients have initiated bDMARDs with lower disease activity compared with previous years, suggesting that bDMARDs are initiated in patients with a less active inflammatory phenotype.

scholarly journals THU0378 DO COMORBIDITIES DECREASE THE FIRST TNF-INHIBITOR RETENTION AND TREATMENT RESPONSE IN AXIAL SPONDYLOARTHRITIS PATIENTS? DATA FROM TURKBIO

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 422-423
Author(s):  
Y. Erez ◽  
A. Karakas ◽  
S. B. Kocaer ◽  
T. Yüce İnel ◽  
S. Gulle ◽  
...  
Keyword(s):  
Disease Activity ◽  
Treatment Response ◽  
Axial Spondyloarthritis ◽  
Cerebrovascular Event ◽  
Tnf Inhibitor ◽  
Drug Survival ◽  
Drug Retention ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
The Impact

Background:The frequency of comorbidities has increased in spondyloarthritis patients compared to the general population. The effect of comorbidities on tumour necrosis factor alpha inhibitor (TNFi) drug retention and treatment response has not been well evaluated.Objectives:The purpose of this study to assess the impact of comorbidities on the first TNFi drug survival and treatment response in patients with axial spondyloarthritis (axSpA) registered in theTURKBIOdatabase.Methods:In this study, the frequency of comorbidities, disease activity scores at baseline and month 6 and drug retention were recorded in AxSpA patients iniating first TNFi treatment between 2011 and 2019. Kaplan Meier plot and log rank tests were used for drug survival analysis. Cox regression analysis with HR was performed to evaluate the correlation between comorbidities and drug survival.Results:There were 2428 patients with AxSpA (39.3% female) who used their first TNFi during the study period. Among them, a total of 770 (31%) had at least one comorbid disease. Hypertension was the most common comorbidity (9.7%), followed by the affective disorders (8%) and chronic lung disease (5.8%). The baseline characteristics of patients are shown in Table 1.The presence of any comorbidity did not impact the first TNFi retention (Figure 1). When comorbidities were analysed seperately, we found that only history of cerebrovascular event was negatively associated with drug retention rate (HR: 6.9, p:0.008). There was no statistically significant difference in Bath AS Disease Activity Index 50% (BASDAI50) response between patients with and without comorbidity at 6 months. Less axSpA patients with comorbidity achieved a ASDAS score ≤ 2.1 compared to patients without comorbidity at 6 months.Table 1.Baseline Characteristics of PatientsRadiographic Spondyloarthritis, n (%)2318 (95.5)Female, n(%)954 (39.3)Age, year42.2±11.8Age at diagnosis, years32.5± 11.3Age at initial TNFi, years39.4 ± 11.1Symptom duration, years9.7± 7.5Time to initial TNFi, years7±6.8HLA-B27- positivity, n (%)1144 (47.1)Smokers, n (%)1068 (44)Baseline BASDAI35.5±22.2Baseline ASDAS-CRP2.8±1.1Baseline CRP (mg/L)15.7±24.4VAS global patient46.6±28.7-Quantitative variables are presented as mean ± SD, and qualitative variables are presented as frequency and percentage-ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein VAS, visual analogue scaleConclusion:The results of this study demonstrated that the presence of previous cerebrovascular event decreased the first TNFi survival in patients with axSpA. It also suggested that comorbidities might decrease TNFi treatment response.Disclosure of Interests:None declared

Which Factors Influence Radiographic Progression During Treatment with Tumor Necrosis Factor Inhibitors in Clinical Practice? Results from 930 Patients with Rheumatoid Arthritis in the Nationwide Danish DANBIO Registry

2014 ◽  
Vol 41 (12) ◽  
pp. 2352-2360 ◽  
Author(s):  
Lykke Midtbøll Ørnbjerg ◽  
Mikkel Østergaard ◽  
Pernille Bøyesen ◽  
Niels Steen Krogh ◽  
Anja Thormann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Regression Analysis ◽  
Clinical Practice ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Radiographic Progression ◽  
Tnf Inhibitor ◽  
Baseline Characteristics ◽  
Necrosis Factor

Objective.To investigate baseline characteristics associated with radiographic progression and the effect of disease activity, drug, switching, and withdrawal on radiographic progression in tumor necrosis factor (TNF) inhibitor-naive patients with rheumatoid arthritis (RA) followed for about 2 years after anti-TNF initiation in clinical practice.Methods.DANBIO-registered patients with RA who had available radiographs (anti-TNF initiation and ∼2 yrs followup) were included. Radiographs were scored, blinded to chronology with the Sharp/van der Heijde method and linked with DANBIO data. Baseline characteristics were investigated with univariate regression and significant variables included in a multivariable logistic regression analysis with ± radiographic progression [Δ total Sharp score (TSS) > 0] as dependent variable. Effect of time-averaged C-reactive protein (CRP), 28-joint Disease Activity Score with CRP (DAS28-CRP), and treatment status at followup were investigated with univariate regression analysis.Results.The study included 930 patients. They were 75% women, 79% positive for IgM-rheumatoid factor (IgM-RF), median age was 57 yrs (range 19–88), disease duration 9 yrs (1–59), DAS28-CRP 5.0 (1.4–7.8), TSS median 15 [3–45 interquartile range (IQR)] and mean 31 (SD 40). Patients started treatment with infliximab (59%), etanercept (18%), or adalimumab (23%). At followup (median 526 days, IQR 392–735), 61% were treated with the initial anti-TNF, 29% had switched TNF inhibitor, and 10% had withdrawn. Twenty-seven percent of patients had progressed radiographically. ΔTSS was median 0.0 [0.0–0.5 IQR/mean 0.6 (SD 2.4)] units/year. Higher TSS, older age, positive IgM-RF, and concomitant prednisolone at baseline were associated with radiographic progression. Time-averaged DAS28-CRP and time-averaged CRP, but not type of TNF inhibitor, were associated with radiographic progression. Patients who stopped/switched during followup progressed more than patients who continued treatment.Conclusion.High TSS, older age, IgM-RF positivity, and concomitant prednisolone were associated with radiographic progression during 2 years of followup of 930 anti-TNF–treated patients with RA in clinical practice. High disease activity and switching/stopping anti-TNF treatment were associated with radiographic progression.

scholarly journals Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Walter P. Maksymowych ◽  
Thomas Kumke ◽  
Simone E. Auteri ◽  
Bengt Hoepken ◽  
Lars Bauer ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Clinical Response ◽  
Clinical Outcomes ◽  
Certolizumab Pegol ◽  
Sensitivity Analyses ◽  
Inactive Disease ◽  
Hla B27 ◽  
Baseline Characteristics

Abstract Background Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP). Methods C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication. Results Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified. Conclusions In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment. Trial registration ClinicalTrials.gov, NCT02552212. Registered on 15 September 2015

scholarly journals POS0896 PREDICTORS OF RESPONSE IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS RECEIVING CERTOLIZUMAB PEGOL IN THE C-AXSPAND STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 704.2-705
Author(s):  
W. P. Maksymowych ◽  
T. Kumke ◽  
S. Auteri ◽  
B. Hoepken ◽  
L. Bauer ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Predictive Factors ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Controlled Study ◽  
Hla B27 ◽  
Predictors Of Response ◽  
Baseline Characteristics

Background:Identification of predictive clinical factors of long-term treatment response in non-radiographic axial spondyloarthritis (nr-axSpA) may contribute to improved management of patients with this chronic disease. Certolizumab pegol (CZP) is currently the only FDA-approved tumour necrosis factor inhibitor (TNFi) for treatment of nr-axSpA.1Objectives:To identify whether any demographic or baseline characteristics of nr-axSpA patients from the C-axSpAnd study2 are predictive of achieving a clinical response after 1 year of CZP treatment.Methods:C-axSpAnd (NCT02552212) was a phase 3, interventional multicentre study including a 52-week double-blind, placebo-controlled period. Full study design is reported elsewhere.2 Multivariate stepwise logistic regression analysis was used to identify predictors of response for the primary efficacy variable (Ankylosing Spondylitis Disease Activity Score – major improvement [ASDAS-MI] at Week 52) and the main secondary efficacy variable (Assessment of SpondyloArthritis international Society 40% [ASAS40] at Week 52) in patients randomised to CZP 200 mg every 2 weeks (Q2W). Predictive factors used in the model included demographic and baseline characteristics, and clinical outcomes at Week 12. A p value ≤0.05 was required for forward selection into the model and p=0.1 for backward elimination from the model. Non-responder imputation was used to account for missing data or values collected after switching to open-label treatment. A sensitivity analysis was conducted to account for patients who had changes in their non-biologic background medication during the 52-week placebo-controlled period.Results:A total of 159/317 patients were randomised to CZP 200 mg Q2W and 158/317 to placebo. Predictive factors identified for Week 52 ASDAS-MI in the CZP-treated patients included being positive for both presence of sacroiliitis on MRI (MRI+) and human leukocyte antigen (HLA)-B27 (HLA-B27+), having a higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline, and having a larger Week 12 improvement in ASDAS (Figure 1A). For ASAS40 response, MRI+/HLA-B27+ was also identified as a predictor of Week 52 response, along with a lower baseline Bath AS Metrology Index (BASMI) and larger Week 12 improvements in Patient Global Assessment of Disease Activity (PtGADA) and AS Quality of Life (ASQoL; Figure 1B). Sensitivity analysis identified the same predictors for ASDAS-MI and ASAS40, with the exception of change from baseline in PtGADA as a predictor of ASAS40. Sensitivity analysis also identified achievement of Week 12 ASAS40 as a predictor of Week 52 ASAS40. In placebo-treated patients, no meaningful predictors of response at Week 52 were identified.Conclusion:Presence of sacroiliitis on MRI and HLA-B27 positivity were identified as consistent predictors of Week 52 response (ASDAS-MI and ASAS40) in nr-axSpA patients treated with CZP. To our knowledge, this is the first report from an interventional 52-week placebo-controlled study in nr-axSpA to identify objective clinical features, particularly the presence of sacroiliac joint inflammation, as being predictive of response.References:[1]Ashrafi M. Curr Opin Rheumatol 2020;32:321–9.[2]Deodhar A. Arthritis Rheumatol 2019;71:1101–11.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Walter P Maksymowych Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Boehringer, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Novartis, Pfizer, Thomas Kumke Shareholder of: UCB Pharma, Employee of: UCB Pharma, Simone Auteri Shareholder of: UCB Pharma, Employee of: UCB Pharma, Bengt Hoepken Shareholder of: UCB Pharma, Employee of: UCB Pharma, Lars Bauer Shareholder of: UCB Pharma, Employee of: UCB Pharma, Martin Rudwaleit Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, UCB Pharma

scholarly journals The Main Challenges in Systemic Lupus Erythematosus: Where Do We Stand?

2021 ◽  
Vol 10 (2) ◽  
pp. 243
Author(s):  
Matteo Piga ◽  
Laurent Arnaud
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Systemic Disease ◽  
Unmet Need ◽  
Clinical Manifestations ◽  
New Drugs ◽  
Systemic Lupus ◽  
Major Step ◽  
Damage Accrual

Systemic lupus erythematosus (SLE) is an immune-mediated multi-systemic disease characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares. Despite significant advances in the understanding of the pathophysiology and optimization of medical care, patients with SLE still have significant mortality and carry a risk of progressive organ damage accrual and reduced health-related quality of life. New tools allow earlier classification of SLE, whereas tailored early intervention and treatment strategies targeted to clinical remission or low disease activity could offer the opportunity to reduce damage, thus improving long-term outcomes. Nevertheless, the early diagnosis of SLE is still an unmet need for many patients. Further disentangling the SLE susceptibility and complex pathogenesis will allow to identify more accurate biomarkers and implement new ways to measure disease activity. This could represent a major step forward to find new trials modalities for developing new drugs, optimizing the use of currently available therapeutics and minimizing glucocorticoids. Preventing and treating comorbidities in SLE, improving the management of hard-to-treat manifestations including management of SLE during pregnancy are among the remaining major unmet needs. This review provides insights and a research agenda for the main challenges in SLE.

scholarly journals POS0619 MODELLING OF DISEASE ACTIVITY IN PATIENTS WITH INFLAMMATORY ARTHROPATHIES TREATED WITH ETANERCEPT ORIGINATOR OR BIOSIMILAR AS FIRST-LINE BIOLOGIC IN AN AUSTRALIAN REAL-WORLD DATASET

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 547.1-547
Author(s):  
C. Deakin ◽  
G. Littlejohn ◽  
H. Griffiths ◽  
T. Smith ◽  
C. Osullivan ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Data ◽  
Real World ◽  
Rank Test ◽  
P Value ◽  
Continuous Variables ◽  
Linear Quadratic ◽  
First Line ◽  
Modest Improvement ◽  
Over Time

Background:The availability of biosimilars as non-proprietary versions of established biologic disease-modifying anti-rheumatic drugs (bDMARDs) is enabling greater access for patients with rheumatic diseases to effective medications at a lower cost. Since April 2017 both the originator and a biosimilar for etanercept (trade names Enbrel and Brenzys, respectively) have been available for use in Australia.Objectives:[1]To model effectiveness of etanercept originator or biosimilar in reducing Disease Activity Score 28-joint count C reactive protein (DAS28CRP) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) treated with either drug as first-line bDMARD[2]To describe persistence on etanercept originator or biosimilar as first-line bDMARD in patients with RA, PsA or ASMethods:Clinical data were obtained from the Optimising Patient outcomes in Australian rheumatoLogy (OPAL) dataset, derived from electronic medical records. Eligible patients with RA, PsA or AS who initiated etanercept originator (n=856) or biosimilar (n=477) as first-line bDMARD between 1 April 2017 and 31 December 2020 were identified. Propensity score matching was performed to select patients on originator (n=230) or biosimilar (n=136) with similar characteristics in terms of diagnosis, disease duration, joint count, age, sex and concomitant medications. Data on clinical outcomes were recorded at 3 months after baseline, and then at 6-monthly intervals. Outcomes data that were missing at a recorded visit were imputed.Effectiveness of the originator, relative to the biosimilar, for reducing DAS28CRP over time was modelled in the matched population using linear mixed models with both random intercepts and slopes to allow for individual heterogeneity, and weighting of individuals by inverse probability of treatment weights to ensure comparability between treatment groups. Time was modelled as a combination of linear, quadratic and cubic continuous variables.Persistence on the originator or biosimilar was analysed using survival analysis (log-rank test).Results:Reduction in DAS28CRP was associated with both time and etanercept originator treatment (Table 1). The conditional R-squared for the model was 0.31. The average predicted DAS28CRP at baseline, 3 months, 6 months, 9 months and 12 months were 4.0 and 4.4, 3.1 and 3.4, 2.6 and 2.8, 2.3 and 2.6, and 2.2 and 2.4 for the originator and biosimilar, respectively, indicating a clinically meaningful effect of time for patients on either drug and an additional modest improvement for patients on the originator.Median time to 50% of patients stopping treatment was 25.5 months for the originator and 24.1 months for the biosimilar (p=0.53). An adverse event was the reason for discontinuing treatment in 33 patients (14.5%) on the originator and 18 patients (12.9%) on the biosimilar.Conclusion:Analysis using a large national real-world dataset showed treatment with either the etanercept originator or the biosimilar was associated with a reduction in DAS28CRP over time, with the originator being associated with a further modest reduction in DAS28CRP that was not clinically significant. Persistence on treatment was not different between the two drugs.Table 1.Respondent characteristics.Fixed EffectEstimate95% Confidence Intervalp-valueTime (linear)0.900.89, 0.911.5e-63Time (quadratic)1.011.00, 1.011.3e-33Time (cubic)1.001.00, 1.007.1e-23Originator0.910.86, 0.960.0013Acknowledgements:The authors acknowledge the members of OPAL Rheumatology Ltd and their patients for providing clinical data for this study, and Software4Specialists Pty Ltd for providing the Audit4 platform.Supported in part by a research grant from Investigator-Initiated Studies Program of Merck & Co Inc, Kenilworth, NJ, USA. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co Inc, Kenilworth, NJ, USA.Disclosure of Interests:Claire Deakin: None declared, Geoff Littlejohn Consultant of: Over the last 5 years Geoffrey Littlejohn has received educational grants and consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Novartis, Pfizer, Janssen, Sandoz, Sanofi and Seqirus., Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Tegan Smith: None declared, Catherine OSullivan: None declared, Paul Bird Speakers bureau: Eli Lilly, abbvie, pfizer, BMS, UCB, Gilead, Novartis

scholarly journals Plasma interferon-alpha is associated with double-positivity for autoantibodies but is not a predictor of remission in early rheumatoid arthritis—a spin-off study of the NORD-STAR randomized clinical trial

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Marit Stockfelt ◽  
Anna-Carin Lundell ◽  
Merete Lund Hetland ◽  
Mikkel Østergaard ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Disease Activity ◽  
Randomized Clinical Trial ◽  
Early Rheumatoid Arthritis ◽  
Treatment Initiation ◽  
Certolizumab Pegol ◽  
Type I ◽  
Protein Levels ◽  
Early Ra

Abstract Background The type I interferon (IFN) gene signature is present in a subgroup of patients with early rheumatoid arthritis (RA). Protein levels of IFNα have not been measured in RA and it is unknown whether they associate with clinical characteristics or treatment effect. Methods Patients with early untreated RA (n = 347) were randomized to methotrexate combined with prednisone, certolizumab-pegol, abatacept, or tocilizumab. Plasma IFNα protein levels were determined by single molecular array (Simoa) before and 24 weeks after treatment initiation and were related to demographic and clinical factors including clinical disease activity index, disease activity score in 28 joints, swollen and tender joint counts, and patient global assessment. Results IFNα protein positivity was found in 26% of the patients, and of these, 92% were double-positive for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). IFNα protein levels were reduced 24 weeks after treatment initiation, and the absolute change was similar irrespective of treatment. IFNα protein positivity was associated neither with disease activity nor with achievement of CDAI remission 24 weeks after randomization. Conclusion IFNα protein positivity is present in a subgroup of patients with early RA and associates with double-positivity for autoantibodies but not with disease activity. Pre-treatment IFNα positivity did not predict remission in any of the treatment arms, suggesting that the IFNα system is distinct from the pathways of TNF, IL-6, and T-cell activation in early RA. A spin-off study of the NORD-STAR randomized clinical trial, NCT01491815 (ClinicalTrials), registered 12/08/2011, https://clinicaltrials.gov/ct2/show/NCT01491815.

scholarly journals AB0499 PHYSICAL ACTIVITY ASSESSMENT IN TUNISIAN PATIENTS WITH SPONDYLOARTHRITIS: THE IPAQ EVALUATION

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1277.1-1277
Author(s):  
F. Majdoub ◽  
M. Sellami ◽  
S. Miladi ◽  
A. Fazaa ◽  
L. Souabni ◽  
...  
Keyword(s):  
Physical Activity ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Cross Sectional Study ◽  
Urban Setting ◽  
Tnf Inhibitor ◽  
Sectional Study ◽  
Cross Sectional ◽  
Tunisian Patients ◽  
Different Levels

Background:The occurrence of Spondyloarthritis (SpA) often conditions patients’ quality of life and hinders their well-being. Physical activity (PA) is associated with various health-related benefits among adults with chronic inflammatory rheumatism but may be insufficiently performed.Objectives:This study aimed to assess PA in patients with SpA and explore its associated factors.Methods:This is a single-center cross-sectional study, involving patients with SpA, visiting our outpatient hospital over eight weeks. Patients responded to the International Physical Activity Questionnaire-Short form (IPAQ-S).Results:Sixty patients were included (39 M/21 F) with an average age of 45.8 years [25-78]. The mean duration of SpA was 13.2 years [1-25]. About 80% of patients were from an urban setting. Sixty-three percent of patients had a professional activity, while 13.3% were retired. Twenty-nine patients (48.3%) had axial and peripheral form, 18 patients (30%) had SpA with enteropathic arthritis, 8 (13.3%) with psoriatic arthritis, 3 patients (5%) had axial spondyloarthritis, and only 2 patients (3.3%) with SAPHO-Syndrom. About 23% of patients had hip arthritis and only 5% had uveitis. Fifty-eight patients were on TNF-inhibitor (21/58 Adalimumab, 15/58 Infliximab, 14/58 Etanercept, 8/58 Golimumab). The average BASDAI was 2.7/10. The average ASDASCRP was 2.1/10. The average BASFI was 3.3/10. IPAQ results were distributed as follows: 78.3% of patients were in the « low physical activity » category, 21.7% were in the « moderate physical activity » while none of the patients were in the « high physical activity ». Patients without employment had lower levels of physical activity (29.7%) but no association was observed between those two items (p=0.082). Disease activity objectified with BASDAI was related to low physical activity (p=0.045) whereas no association was observed with ASDASCRP (p=0.870) or BASFI (p=0.056). Otherwise, TNF-inhibitor treatment was not related to different levels of PA (p=0.09).Conclusion:Tunisian patients with SpA don’t perform enough physical activity. Except for high disease activity, the different levels of PA did not appear to be explained by other disease-related variables. Thereby, physical activity should be encouraged in SpA.References:[1]Fabre, S., Molto, A., Dadoun, S. et al. Physical activity in patients with axial spondyloarthritis: a cross-sectional study of 203 patients. Rheumatol Int 36, 1711–1718 (2016).Disclosure of Interests:None declared.

scholarly journals AB0652 MACHINE LEARNING TO PREDICT EARLY TNF INHIBITOR USERS IN PATIENTS WITH ANKYLOSING SPONDYLITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1620.1-1621
Author(s):  
J. Lee ◽  
H. Kim ◽  
S. Y. Kang ◽  
S. Lee ◽  
Y. H. Eun ◽  
...  
Keyword(s):  
Machine Learning ◽  
Ankylosing Spondylitis ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Ann Model ◽  
Learning Models ◽  
Feature Importance ◽  
Importance Analysis ◽  
Baseline Characteristics ◽  
Machine Learning Models

Background:Tumor necrosis factor (TNF) inhibitors are important drugs in treating patients with ankylosing spondylitis (AS). However, they are not used as a first-line treatment for AS. There is an insufficient treatment response to the first-line treatment, non-steroidal anti-inflammatory drugs (NSAIDs), in over 40% of patients. If we can predict who will need TNF inhibitors at an earlier phase, adequate treatment can be provided at an appropriate time and potential damages can be avoided. There is no precise predictive model at present. Recently, various machine learning methods show great performances in predictions using clinical data.Objectives:We aim to generate an artificial neural network (ANN) model to predict early TNF inhibitor users in patients with ankylosing spondylitis.Methods:The baseline demographic and laboratory data of patients who visited Samsung Medical Center rheumatology clinic from Dec. 2003 to Sep. 2018 were analyzed. Patients were divided into two groups: early TNF inhibitor users treated by TNF inhibitors within six months of their follow-up (early-TNF users), and the others (non-early-TNF users). Machine learning models were formulated to predict the early-TNF users using the baseline data. Additionally, feature importance analysis was performed to delineate significant baseline characteristics.Results:The numbers of early-TNF and non-early-TNF users were 90 and 509, respectively. The best performing ANN model utilized 3 hidden layers with 50 hidden nodes each; its performance (area under curve (AUC) = 0.75) was superior to logistic regression model, support vector machine, and random forest model (AUC = 0.72, 0.65, and 0.71, respectively) in predicting early-TNF users. Feature importance analysis revealed erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and height as the top significant baseline characteristics for predicting early-TNF users. Among these characteristics, height was revealed by machine learning models but not by conventional statistical techniques.Conclusion:Our model displayed superior performance in predicting early TNF users compared with logistic regression and other machine learning models. Machine learning can be a vital tool in predicting treatment response in various rheumatologic diseases.Disclosure of Interests:None declared

scholarly journals AB0115 COMPARISON OF ULTRASOUND FINDINGS BETWEEN TNF INHIBITORS AND NON-TNF INHIBITORS AT FIRST BIOLOGICS IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1086.2-1087
Author(s):  
T. Okano ◽  
T. Koike ◽  
K. Inui ◽  
K. Mamoto ◽  
Y. Yamada ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Power Doppler ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Significant Difference ◽  
The Us ◽  
Us Findings ◽  
Improvement Ratio

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared

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