Relationship between Depression and Disease Activity in United States Veterans with Early Rheumatoid Arthritis Receiving Methotrexate

2020 ◽  
pp. jrheum.200743
Author(s):  
Alan M. Rathbun ◽  
Bryant R. England ◽  
Ted R. Mikuls ◽  
Alice S. Ryan ◽  
Jennifer L. Barton ◽  
...  

Objective Depression is common in rheumatoid arthritis (RA) patients, exacerbates disease activity, and may decrease response to first-line disease-modifying antirheumatic drugs. This study aimed to determine if depression affects disease activity among Veterans with early RA prescribed methotrexate (MTX). Methods Participants included Veterans enrolled in the Veterans Affairs Rheumatoid Arthritis registry with early RA (onset < 2 years) prescribed MTX. Depression was assessed at enrollment using International Classification of Diseases codes (296.2-296.39, 300.4, 311). Disease activity was measured using the 28 joint count disease activity score (DAS-28) and other core measures of RA disease activity. Propensity score weights were used to adjust depressed (n=48) and non-depressed (n=220) patients on baseline confounders within imputed datasets. Weighted estimating equations were used to assess standardized mean differences in disease activity between depressed and non-depressed patients at six months and one- and two-years follow-up. Results The analytic sample was composed of 268 Veterans with early RA prescribed MTX who were predominantly male (n=239; 89.2%) and older (62.7 years ± 10.6) than general population RA patients. Adjusted estimates indicated that depression was associated with significantly higher DAS-28 at six months (β=0.345; 95% CI: 0.007, 0.682) but not at one- or two-years follow-up. Also, depression was associated with significantly worse pain at six months (β=0.385; 95% CI: 0.040, 0.730) and one-year (β=0.396; 95% CI: 0.042, 0.750) follow-up. Conclusion In early RA, depression is associated with greater short-term disease activity during MTX treatment, as well as more persistent and severe pain.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 625.2-626
Author(s):  
H. Gerasimova ◽  
T. Popkova ◽  
I. Kirillova ◽  
M. Cherkasova ◽  
A. Martynova ◽  
...  

Background:N-terminal pro-brain natriuretic peptide (NT-proBNP) is a recognized predictor of congestive heart failure (CHF) and cardiovascular death. Rheumatoid arthritis (RA) patients (pts) were shown to have higher NT-proBNP concentrations than in general population, but it remains unclear, whether NT-proBNP levels are related to RA duration, activity or treatment.Objectives:To investigate the effect of interleukin 6 receptor inhibitor - tocilizumab (TCZ) and JAK inhibitor - tofacitinib (TOFA) on NT-proBNP levels in RA pts during a 12-month (m) follow-up period.Methods:The study enrolled 60pts (50women/10men) with the lack of efficacy/resistance and/or intolerance of basic anti-inflammatory drugs (DMARDs); median age was 55[42;61] years, median disease duration 55[29;120]m, with moderate to high activity (DAS28-5,1[4,6;6,1], serum positivity for rheumatoid factor (RF)(85%)/ anti-cyclic citrullinated peptide antibodies (ACCP)(80%). The study did not include RA pts with CHF and clinically overt cardiovascular disease (CVD). Twenty nine RA pts received TCZ(8mg/kg) every 4 weeks: 61% received TCZ in combination with methotrexate (MTX), 35% - with low-dose glucocorticoids (GCs). Thirty one RA pts were prescribed oral TOFA at 5 mg BID with dose escalation to 10 mg BID in 8 (26%)pts. TOFA was used in combination with MTX in 90% pts, with GCs – in 29% pts. Pts treated with TCZ and TOFA were comparable in terms of age, sex, body mass index. RA activity rates (DAS28, SDAI, ESR, CRP) were higher in pts on TCZ -therapy compared with pts treated with TOFA. Echocardiography data and NT-proBNP levels using electrochemiluminescence method Elecsys proBNP II (Roche Diagnostics, Switzerland) were obtained at baseline and after 12m.Results:Significant positive changes in major disease activity, clinical and laboratory parameters were found in RA pts after 12 m of TCZ infusion and TOFA intake: remission (DAS28<2,6) was achieved in 54% and 39% pts, low activity levels (DAS28<3,2) – in 46% and 51% pts, respectively.The NT-proBNP levels were significantly higher in RA pts than in the control group (median 69,1 (37,9;105,8) pg/mL vs 55,3 (36,6;67,3) pg/mL,p<0.05).Six pts (10%) (three in each pts group) had NT-proBNP levels over 125pg/ml, but were asymptomatic and had unremarkable echocardiography.There was a good correlation between NT-proBNP level at baseline with age (r=0,55,p<0,001), SDAI (r=0,5, h=0,01), ACCP (r=0,23,p=0,01).Decrease of median NT-proBNP levels was documented after 12m of TCZ therapy (81,5[43,0;102,0]vs41,6[25,4;64,2]pg/ml (p<0,01) and after 12m TOFA therapy (66,1[30,5;105,0]vs16,8 [5,0;81,0]pg/ml,p=0,001).After 12m of TCZ correlations of ΔNT-proBNP were established with ΔESR (R=0,43;p<0,05], ΔСRP (R=0,46;p<0,05], ΔEe left ventricle (LV) (r=0,88,p=0,03).In the group of pts treated with TOFA ΔNT-proBNP level significantly correlated with the percentage change in DAS 28 (r=0,41,p=0,038), there was no direct correlation with changes in the parameters of the LV diastolic function.Conclusion:TCZ and TOFA treatment for 12 m reduced NT-proBNP levels in RA pts without clinically manifest CVD and CHF. Falling NT-proBNP concentrations are associated with positive dynamics of RA activity (DAS 28) and inflammatory markers (CRP, ESR), therefore allowing to suggest that increased NT-proBNP levels should be considered as a component of disease activity. Correlation between ΔNT-proBNP and ΔEeLF may be indicative as possible impact of these biomarkers on the LV diastolic function’s development in RA pts.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1080-1080
Author(s):  
N. Ziade ◽  
S. Al Emadi ◽  
M. Abu Jbara ◽  
S. Saad ◽  
L. Kibbi ◽  
...  

Background:Involving the patients with rheumatoid arthritis (RA) in the assessment of their disease may increase their adherence to treatment, improve the disease outcomes and facilitate the application of telehealth. We previously reported an excellent concordance between the Disease Activity Score (DAS-28) performed by physicians and patients at the baseline visit of this prospective study (1).Objectives:To evaluate the persistence of the concordance between the physician’ and the patient’s assessment of disease activity in RA using DAS-28 after one year.Methods:At the baseline visit, patients with RA from 7 Middle Eastern Arab Countries (MEAC) were briefed about DAS-28 by their rheumatologist during a routine consultation and given smartphone access to a video in Arabic language explaining the performance of DAS-28. At 3, 6 and 12 months (± 3 months), the patients were asked to self-report DAS-28, blinded to the physician’s assessment. Concordance between the continuous DAS-28 at each visit was calculated using paired t-test numerically and the Bland-Altman method graphically. Agreement between physician- and patient-DAS categories (remission, low-, moderate- and high disease activity) was calculated at each visit using weighted kappa for category comparison. Weighted kappa of the different agreements were compared over time using their respective confidence intervals (CIs). Predictive factors of positive concordance between physician and patient-DAS were identified using binary logistic regression.Results:The study included 428 patients over a period of three years (2018 to 2020). The mean age of participants was 49.8 years, 82.5% were females, 44.3% had a university degree and the mean disease duration was 11.4 years.At baseline, the average patient-DAS was higher (4.06 (±1.52)) than the physician-DAS (3.97 (±1.52)). The mean difference was -0.09 [95%CI -0.14; -0.04] and most of the pairs were within the limit of agreement in the Bland-Altman graph, indicating a good concordance, particularly in cases of remission.During the study follow-up, 299 patients consulted for visit 2 (69.9% of the total population), 232 for visit 3 (54.2%) and 199 for visit 4 (46.5%). The weighted kappa was 0.80 [95%CI 0.76;0.85] at visit 1 and 0.79 [95%CI 0.72;0.88] at visit 4 (Figure 1 showing kappa for DAS-28, CDAI and SDAI as well). A minor numerical decrease in kappa was observed over time; however, the CIs were overlapping over the four visits and the agreement was considered stable, remaining in the excellent range. At visit 4, a positive concordance between the physician- and the patient-DAS was associated with the profession (lower in blue collar, p=0.001), the educational level (higher in high school and university, p=0.034) and the baseline physician’s DAS (higher in high disease activity, p=0.46).Conclusion:The agreement between the DAS-28 performed by the physician and by the patient was excellent at baseline and remained stable over one year. A positive concordance was associated with the profession, the educational level and the level of disease activity. The present study can help the rheumatologist make informed decisions about the patients who may be suitable for a remote evaluation of their disease activity, that can be of particular interest in the context of the COVID-19 pandemic.References:[1]Ziade N, Saad S, al Mashaleh M, et al. Perceptions of Patients with Rheumatoid Arthritis about Self-Assessment of Disease Activity after Watching an Educational Video: Qualitative Pilot Results from the Auto-DAS in Middle Eastern Arab Countries Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).Acknowledgements:The authors would like to acknowledge the patients for participating in the study and the assistants/ students/ nurses who assisted in the data collection: Dr. Fatima Abdul Majeed Al Hawaj, M. Atef Ahmed, M. Mohammad Alhusamiah, Ms Raquel De Guzman, Ms Lina Razzouk.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 112.1-112
Author(s):  
L. Brandt ◽  
H. Schulze-Koops ◽  
T. Hügle ◽  
M. J. Nissen ◽  
H. Paul ◽  
...  

Background:The therapeutic aim for rheumatoid arthritis (RA) is to control disease activity and prevent radiographic progression. Various clinical scores are utilized to describe disease activity in RA patients. The DAS28 score can define states of low disease activity (LDA) and remission. Despite achieving LDA or remission, radiographic progression may nevertheless occur. However, the rates and frequency of this occurrence have not been analyzed in detail.Objectives:To describe the frequency and rate of radiographic progression in patients with persistent LDA or remission.Methods:Analysis of RA patients from the SCQM cohort. Persistent LDA or remission were defined as DAS 28 ≤3.2 or <2.6 respectively, at two subsequent follow up time points in the database. We included patients with at least two sets of radiographs within these intervals of LDA and/or remission. Radiographic progression was measured with the Ratingen-score (range 0-190), which describes joint erosions numerically. Repair was defined as an improvement in the Ratingen score >5 points/year and progression as >2 or >5 points change in the Ratingen score within one year.Results:Among 10’141 RA patients, 4’342 episodes of remission occurred in 3’927 patients with 1’776 sets of X rays available within these episodes. Similarly, 8’136 episodes of LDA in 6’765 patients and 2’358 sets of X rays were present within these intervals. For patients in LDA or remission, rates of repair were 5.5% and 4.8%, respectively, while for radiographic progression >5 points in the Ratingen score/year were 10.3% in both groups and for >2 points change of Ratingen score/year were 27.7 and 25.4%, respectively).No differences for demographic factors or measures of disease activity, rheumatoid factor or ACPA were found comparing patients with radiographic progression or non-progression despite LDA or remission at the beginning of the episode of LDA and/or remission.Interestingly, 42.9% of patients in LDA with progression of >5 points in the Ratingen score/year were current smokers vs 29.4% among the non-progressors (X2 = 6.55, p = 0.01). This significant difference vanished when the cut-off for radiographic progression was set at >2 points yearly change in Ratingen score or in patients in remission.Conclusion:Radiographic progression despite LDA or remission are more frequent than expected. No differences in radiographic progression were found comparing LDA and remission suggesting that the goal of LDA is appropriate. Smoking seems to be an independent risk factor for radiographic progression despite LDA. Why the effect of smoking could was not demonstrated in patients in remission, remains unclear.Disclosure of Interests:Lena Brandt: None declared, Hendrik Schulze-Koops: None declared, Thomas Hügle Consultant of: GSK, Abbvie, Pfizer, Jansen, Novartis, Eli Lilly., Michael J. Nissen Consultant of: Abbvie, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Hasler paul Consultant of: Abbvie, Lilly, Rudiger Muller Consultant of: AbbVie, Novartis, Grant/research support from: Gebro


2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
Jouko Kallio ◽  
Timo Kauppila ◽  
Lasse Suominen ◽  
Anna Maria Heikkinen

Introduction. A playful competition was launched in a primary dental health care system to improve the recording of diagnoses into an electronic patient chart system and to study what diagnoses were used in primary dental care.Methods. This was a longitudinal follow-up study with public sector primary dental care practices in a Finnish city. A one-year-lasting playful competition between the dental care teams was launched and the monthly percentage of dentists’ visits with recorded diagnosis before, during, and after the intervention was recorded. The assessed diagnoses were recorded with the International Classification of Diseases (ICD-10).Results. Before the competition, the level of diagnosis recordings was practically zero. At the end of this intervention, about 25% of the visits had a recorded diagnosis. Two years after the competition, this percentage was 35% without any additional measures. The most frequent diagnoses were dental caries (K02, 38.6%), other diseases of hard tissues of teeth (K03, 14.8%), and diseases of pulp and periapical tissues (K04, 11.4%).Conclusions. Commitment to the idea that recording of diagnoses was beneficial improved the recording of dental diagnoses. However, the diagnoses obtained did not accurately reflect the reputed prevalence of oral diseases in the Finnish population.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1401.3-1401
Author(s):  
H. Bettaieb ◽  
A. Fazaa ◽  
S. Miladi ◽  
M. Sellami ◽  
O. Kmar ◽  
...  

Background:During rheumatoid arthritis (RA), initiating conventional synthetic Disease Modifying Anti-Rheumatic Drug (csDMARD) at the early stages of the disease is a mandatory condition to achieve DMARD-free sustained remission (1). Limited data studying the relationship between RA treatment delay and disease activity are available.Objectives:The aim of this study was to assess the impact of csDMARD initiation delay during RA on disease activity.Methods:This is a cross-sectional study including patients with RA (ACR/EULAR criteria).Delays were collected from patients’ interview and were represented respectively by D1, D2 and D3. D1 stands for the lag time separating the first RA symptom onset and rheumatologist consultation. D2 stands for the lag time separating the first RA symptom onset and RA diagnosis. D3 stands for lag time separating the first RA symptom onset and csDMARD initiation. Disease activity was evaluated by: Visual Analogue Scale for pain (VAS), number of tender joints, number of swollen joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and Disease Activity Score28 (DAS28).The data were analyzed with descriptive statistics, Student’s t test, chi (2) test, and Spearman correlation using the SPSS statistical package. A p value < 0.05 was considered significant.Results:The study included 100 RA patients (86 women and 14 men), with a mean age of 56.5 ± 12.4 years. The mean age at the onset of RA was 47.5 ± 12.4 years. Median D1, D2 and D3 were respectively 12 months [0-242], 15.7 months [2-252] and 18 months [2-270].Methotrextate was prescribed in 86% of cases. At RA diagnosis, the median values for the following parameters were: VAS 80 [30-100], number of tender joints 10[0-28], number of swollen joints 5 [0-17], ESR 43mm/hour [6-133], CRP 14.1 mg/l [1-120], DAS28 (ESR) 5.22 [2-7.52] and DAS28 (CRP) 4.6 [1-6.93]. After one year of follow-up, the median parameters of the disease activity were respectively: VAS 60 [0-100], number of tender joints 6[0-28], number of swollen joints 2 [0-22], ESR 32 mm/hour [2-106], CRP 7.5 mg/l [1.2-94], DAS28 (ESR) 4.1 [1.4-7.1] and DAS28 (CRP) 3.7 [1.68-6.22]. Significant positive correlation was found between delays in csDMARD initiation and DAS28 (CRP) scores over the first year (p=0.02, r=0.29).Conclusion:In this study, delays in treatment were associated with higher DAS28 (CRP) scores after one year of follow-up. Our results suggest that early identification and treatment of RA leads to improved outcomes and even improved rates of drug-free remission.References:[1]Van Nies JA, Krabben A, Schoones JW, et al. What is the evidence for the presence of a therapeutic window of opportunity in rheumatoid arthritis? A systematic literature review. Ann Rheum Dis 2014;73:861–70.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1162.2-1162
Author(s):  
E. Pogozheva ◽  
A. Karateev ◽  
V. Amirdzhanova ◽  
E. Filatova

Objectives:to evaluate the efficacy of long-term pain therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with rheumatoid arthritis (RA) with an initially moderate disease activity (DAS 28 <5,1).Methods:the study included 404 RA patients, disease duration was more than 1 year, mean DAS 28 3.7±1.6, mean age 58.6±10.0 years, 69% women, 76,7% RF “+”, 81,5% ACPA “+”. 91,2% of the patients received conventional DMARDs (methotrexate), 8,8% - biological agents. All patients received NSAIDs (aceclofenac) to control their symptoms. Тhe follow-up period was 6 months. We evaluated the dynamics of the DAS 28 index, the level of pain and patient global health on a 100- mm visual analog scale (VAS).Results:the level of pain (VAS) decreased from 63,1 ± 15,4 to 46,3± 8,3 (p=0,001) by 3 months of follow-up and up to 39,5± 11,2 (p= 0,001) by 6 months of follow-up. The patient global health (VAS) also improved from 58,2 ± 13,4 at baseline to 40,3 ± 11,2 (p=0,001) at 3 months and to 35,5 ± 9,7 (p=0,001) at 6 months of follow up. The mean DAS 28 remained within the moderate disease activity and decreased from 3,7±1,5 to 3,4 ±1,1 (p=0,01) after 3 months, and to 3,1± 0,9 (p=0,01) after 6 months.Conclusion:long-term NSAID therapy allows to control the disease activity in patients with moderate RA. This should be taken into account when planning therapy, including deciding whether to “switch” DMARDs and prescribing biological agents.Disclosure of Interests:None declared


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


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 98.2-99
Author(s):  
A. De Thurah ◽  
C. Skovsgaard ◽  
T. Maribo ◽  
N. H. Hjøllund ◽  
M. Kruse

Background:The clinical effectiveness of a patient-reported outcome (PRO) based telehealth intervention offered to rheumatoid arthritis (RA) patients with low disease activity or remission has previously been reported1. The TeRA study showed that PRO-based telehealth follow-up in RA achieved similar disease control as conventional outpatient follow-up among patients with low disease activity or remission. The degree of disease control did not differ between telehealth follow-up offered by rheumatologists or rheumatology nurses.Objectives:To compare the cost-effectiveness of PRO–based telehealth follow-up to patients with RA performed by rheumatologists or rheumatology nurses with conventional outpatient follow-up.Methods:A total of 294 patients were randomized (1:1:1) to either PRO-based telehealth follow-up carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional outpatient follow-up by physicians. Quality of life (EQ-5D) was measured at baseline and at follow-up after one year. The primary outcome was a change in the Disease Activity Score, C-reactive Protetin in 28 joints (DAS-28, CRP).The focus in the health economic evaluation was on the relation between costs and EQ-5D in the period between one year prior to and one year after the intervention. All costs were measured at the individual level and consisted of: intervention costs, health and social care costs, and productivity costs. All cost data were retrieved from Danish population-based registers. Incremental cost-effectiveness rates (ICERs) were calculated on the basis of a comparison of the development in costs and effects in the two intervention groups (separately and combined) with the control group. Bootstrap with 10,000 replications were used to access significance.Results:The difference in health and social care costs during the intervention period compared to the year before were €1,072, - €50 and €519 for the control group, the PRO-TR group and the PRO-TN respectively. Hence, the change in health and social care costs was lower for both intervention groups. The PRO-TR group had a small decrease and it was significantly lower than for the control group (p=0.0027). The difference between health and social care costs in the PRO-TN group compared to the control group was only borderline significant (p=0.067). No statistically significant differences were found in QALY’s between the three groups, all three groups experienced minor, non-significant, declines in QALY over the intervention period. ICER’s were not statistically significant but below known threshold values for the PRO-RN group (ICER=€17,121).Conclusion:It is difficult to obtain statistically significant results for cost-effectiveness in small samples. However, the results point towards a possible cost-saving impact of PRO interventions in patients with low disease activity or remission. The study was unable to conclude if PRO-TR or PRO-TN were most cost-effective. Other relevant considerations, like patient satisfaction or organisational issues, should determine the way of organizing RA disease management in these patients.References:[1]de Thurah A, Stengaard-Pedersen K, Axelsen M, et al. Tele-Health Follow-up Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial.Arthritis care & research2018;70(3): 353-60.Disclosure of Interests:Annette de Thurah Grant/research support from: Novartis (not relevant for the present study)., Speakers bureau: Lily (not relevant for the present study)., Christian Skovsgaard: None declared, Thomas Maribo: None declared, Niels Henrik Hjøllund: None declared, Marie Kruse: None declared


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