scholarly journals AB0201 IMPACT OF TREATMENT INITIATION DELAY ON DISEASE ACTIVITY DURING RHEUMATOID ARTHRITIS

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. 900.1-900
Author(s):  
L. Diebold ◽  
T. Wirth ◽  
V. Pradel ◽  
N. Balandraud ◽  
E. Fockens ◽  
...  

Background:Among therapeutics used to treat rheumatoid arthritis (RA), Tocilizumab (TCZ) and Abatacept (ABA) are both biologic agents that can be delivered subcutaneously (SC) or intravenously (IV). During the first COVID-19 lockdown in France, all patients treated with IV TCZ or IV ABA were offered the option to switch to SC administration.Objectives:The primary aim was to assess the impact of changing the route of administration on the disease activity. The second aim was to assess whether the return to IV route at the patient’s request was associated with disease activity variation, flares, anxiety, depression and low physical activity during the lockdown.Methods:We conducted a prospective monocentric observational study. Eligibility criteria: Adult ≥ 18 years old, RA treated with IV TCZ or IV ABA with a stable dose ≥3 months, change in administration route (from IV to SC) between March 16, 2020, and April 17, 2020. The following data were collected at baseline and 6 months later (M6): demographics, RA characteristics, treatment, history of previous SC treatment, disease activity (DAS28), self-administered questionnaires on flares, RA life repercussions, physical activity, anxiety and depression (FLARE, RAID, Ricci &Gagnon, HAD).The primary outcome was the proportion of patients with a DAS28 variation>1.2 at M6. Analyses: Chi2-test for quantitative variables and Mann-Whitney test for qualitative variables. Factors associated with return to IV route identification was performed with univariate and multivariate analysis.Results:Among the 84 patients who were offered to switch their treatment route of administration, 13 refused to change their treatment. Among the 71 who switched (48 TCZ, 23 ABA), 58 had a M6 follow-up visit (13 lost of follow-up) and DAS28 was available for 49 patients at M6. Main baseline characteristics: female 81%, mean age 62.7, mean disease duration: 16.0, ACPA positive: 72.4%, mean DAS28: 2.01, previously treated with SC TCZ or ABA: 17%.At M6, the mean DAS28 variation was 0.18 ± 0.15. Ten (12.2%) patients had a DAS28 worsening>1.2 (ABA: 5/17 [29.4%] and TCZ: 5/32 [15.6%], p= 0.152) and 19 patients (32.8%) had a DAS28 worsening>0.6 (ABA: 11/17 [64.7%] and TCZ: 8/32 [25.0%], p= 0.007).At M6, 41 patients (77.4%) were back to IV route (26 TCZ, 15 ABA) at their request. The proportion of patients with a DAS28 worsening>1.2 and>0.6 in the groups return to IV versus SC maintenance were 22.5%, 42.5% versus 11.1% and 22.2% (p=0.4), respectively. The univariate analysis identified the following factors associated with the return to IV route: HAD depression score (12 vs 41, p=0.009), HAS anxiety score (12 vs 41, p=0.047) and corticosteroid use (70% vs 100%, p=0.021), in the SC maintenance vs return to IV, respectively.Conclusion:The change of administration route of TCZ and ABA during the first COVID-19 lockdown was infrequently associated with a worsening of RA disease. However, the great majority of the patients (77.4%) request to return to IV route, even without disease activity worsening. This nocebo effect was associated with higher anxiety and depression scores.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1207.2-1207
Author(s):  
A. García Fernández ◽  
A. Briones-Figueroa ◽  
L. Calvo Sanz ◽  
Á. Andreu-Suárez ◽  
J. Bachiller-Corral ◽  
...  

Background:Biological therapy (BT) has changed the treatment and perspectives of JIA patients but little is known about when is the best moment to start BT and the impact of this prompt iniciation.Objectives:To analyze the response to BT of Juvenile Idiophatic Arthritis (JIA) patients according to the time when the BT was started.Methods:A retrospective, descriptive study was conducted on JIA patients followed up in a referal hospital that started BT up to 24 months after diagnosis from 2000 to 2018. Disease activity was measured, at 2 years after diagnosis, according to Wallace criteria for remission (absence of: active arthritis, active uveitis, fever, rash or any other manifestation attributable to JIA, normal CRP and ESR, PGA indicating no active disease) for at least 6 months.Results:55 JIA patients that started BT up to 24 months from diagnosis were analyzed. 69,1% were girls with a median age at diagnosis of 8 years old IQR(3-13), median age at the start of BT of 9 years old IQR(3-13). Regarding JIA categories: 25,5% were Oligoarticular Persistent (OligP), 18,2% Systemic JIA (sJIA), 16,4% Entesitis related Arthritis (ERA), 12,7% Psoriatic Arthritis (APso) and Polyarticular RF- (PolyRF-), 5,5% Oligoarticular Extended (OligE) and Polyarticular RF+ (PolyRF+), 3,6% Undifferentiated (Und). 20% of patients had uveitis during followup. Conventional DMARD (cDMARD) was indicated in 83,6% of patients (95,7% Methotrexate) at diagnosis [median 0 months IQR(0-2,3)]. At the end of followup (2 years) only 30,9% of patients continued with cDMARDs. The main causes of discontinuation were: adverse events (46,7%), remission (36,7%). TNF inhibitors were precribed in 81,8% of patients and 18,2% of patients recieved two BT during the first 2 years from diagnosis. 54,5% of BT were indicated during the first 6 months from diagnosis, 27,3% from 7 to 12 months, 12,7% from 13 to 18 months, 5,5% from 19 to 24 months.After 2 years from diagnosis, 78,2% of patients were on remission and 21,8% active. Among patients with active disease: 75% had arthritis, 16,7% had uveitis and 8,3% had both. There were no differences regarding disease activity among patients with uveitis and neither taking cDMARDs. Regarding JIA categories: 66,7% of OligE, 57,1% of PolyRF- and 57,1% of APso patients were active at 2 years from diagnosis when compared to the other categories (p=0.004).Patients on remission at 24 months from diagnosis started sooner the BT than active patients [CI 95% (0,46-8,29) p=0,029]. The time when the BT was started was correlated to the activity at 2 years (K= 0,294 p=0,029). When the BT was prescribed after 7,5months from diagnosis it was correlated, in a COR curve, with a higher probability of active disease at 2 years (S= 0,67 E= 0,63). There was a correlation, among patients on remission at 2 years, between prompt start of BT and less time to reach remission (K= -0,345 p=0,024). Patients with active disease at 2 years, regardless of moment of BT iniciation, required more BT during follow-up (p=0,002).Conclusion:Prompt iniciation of BT was correlated with a better outcome. JIA patients that started BT early after diagnosis had a higher probability of remission after 2 years. Starting BT after 7,5 months was correlated with a higher probability of active disease at 2 years. Active disease at 24 months was correlated with persistent active disease during follow-up.Disclosure of Interests:None declared


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


2021 ◽  
Author(s):  
Bushra Shahida ◽  
Kleoniki Tsoumani ◽  
Tereza Planck ◽  
Vijayachitra Modhukur ◽  
Pernilla Asp ◽  
...  

Abstract Introduction. Treatment of Graves´ disease (GD) with radioiodine increases the risk of developing Graves´ ophthalmopathy (GO) but the link between thyroid and orbital tissue remains undefined.The aim was to investigate the relationship between GO and TRAb after treatment with radioiodine and to define the impact of risk genes.Methods. GD patients without ophthalmopathy or previous treatment with radioiodine were prospectively included at treatment with radioiodine for hyperthyroidism. A follow-up was performed one year later for registration of GO development. The study was performed at a University Hospital Clinic; referral center of all patients treated with radioiodine in the south of Sweden. The main outcome measures were development of TRAb, anti-TPO, anti-TG after three months and GO after 12 months and relationship to the genetic background (HLA, CTLA-4, CYR61).Results. Three months of radioiodine TRAb increased in two thirds of patients (p<0.0005) but not in the other third. Anti-TPO was associated with TRAb (R=0.362, p <0.0001) but not anti-TG. At follow-up one year later (n=204) 32 patients developed GO with a proportion of 70% in the group increasing in TRAb and 30 % in the group with unchanged or lower TRAb (p-value <0.0005). Patients with GO had higher levels of TRAb than patients without GO. CTLA-4 (rs231775 SNP) was significantly (p<0.005) associated with TRAb levels above the median three months after radioiodine.Conclusions. The increase in TRAb after treatment with radioiodine is associated with GO and a genetic variation in CTLA-4 is associated with higher levels of TRAb.


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.


RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000738 ◽  
Author(s):  
Janet E Pope ◽  
Mohammad Movahedi ◽  
Emmanouil Rampakakis ◽  
Angela Cesta ◽  
John S Sampalis ◽  
...  

Objective(s)This study evaluated the interaction of anticitrullinated protein antibody (ACPA) and rheumatoid factor (RF) in predicting sustained clinical response in an observational registry of patients with rheumatoid arthritis (RA) followed in routine practice.MethodsPatients with RA enrolled in the Ontario Best Practices Research Initiative registry, with ≥1 swollen joint, autoantibody information and ≥1 follow-up assessment were included. Sustained clinical remission was defined as Clinical Disease Activity Index (CDAI) ≤2.8 in at least two sequential visits separated by 3–12 months. Time to sustained remission was assessed using cumulative incidence curves and multivariate cox regression.ResultsAmong 3251 patients in the registry, 970 were included, of whom 262 (27%) were ACPAneg/RFneg, 60 (6.2%) ACPApos /RFneg, 117 (12.1%) ACPAneg/RFpos and 531 (54.7%) ACPApos /RFpos at baseline. Significant between group differences were observed in age (p=0.02), CDAI (p=0.03), tender joint count (p=0.02) and Health Assessment Questionnaire (p=0.002), with ACPApos patients being youngest with lowest disease activity and disability. No difference in biologic use was found between groups (20.2% of patients).Over a mean follow-up of 3 years, sustained remission was achieved by 43.5% of ACPApos/RFpos patients, 43.3% of ACPApos /RFneg patients, 31.6 % of ACPAneg/RFpos patients and 32.4% of ACPAneg/RFneg patients (p=0.01). Significant differences were observed in CDAI improvement based on ACPA and RF status where ACPApos/RFpos had a shorter time to achieving sustained remission (HR 1.30; 95% CI 1.01 to 1.67) and experienced significantly higher improvements compared with ACPAneg/RFneg patients.Conclusion(s)Combined ACPA and RF positivity were associated with improved and faster response to antirheumatic medications in patients with RA.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1457.2-1458
Author(s):  
W. G. Rojas Zuleta ◽  
O. J. Felipe Díaz ◽  
A. E. Pantoja Marquez ◽  
R. Giraldo ◽  
J. G. López Velandia ◽  
...  

Background:The optimization of biological agents (bDMARD), is a strategy that has proven to be cost effective and its use can reduce the risk related to drug exposure (1–3). It is included in the EULAR management guidelines and in the consensus of the Colombian Rheumatology Association.Objectives:To analyze optimization success of bDMARD therapies in patients with RA.Methods:Cohort study of RA patients in a specialized multicenter institution in Colombia, followed from January 2015 to December 2019. Patients in remission or low activity for at least 6 months with bDMARD, and with at least two consecutive medical visits, were included. Optimization types were dose decrease, application interval increments, or both. Patients who had disease reactivation (DAS28- CPR >3.2) and returned to standard dose, were considered a failure. By Kaplan-Meier analysis, the optimization failure was estimated according to bDMARD typeResults:92 patients were included, 78.26% were women, with a median age of 57 years (IQR 50-64), a disease evolution time of 15 years (IQR 10-21), a treatment of 5.6 years (IQR 2.7-8.0), and optimization of 7.75 months (IQR 3.25-15.75). The most commonly used bDMARD therapies were etanercept 36.96%, tocilizumab 30.43% and adalimumab 16.30%. 69.39% (34) were naive for biological treatment. The 53.26% (49) of patients had a follow-up time greater than 6 months.95.92% remained under optimization scheme without disease activity changes, and 4.08% of patients underwent definitive discontinuation of bDMARD, for sustained therapeutic objective. 8.16% (4) had relapses in the first 6 months after onset, of which 2 patients returned to standard doses. In survival analysis it was observed that patients who were optimized for antiTNF failed faster than the non-antiTNF, although this difference was not statistically significant (Log Rank test 0.003 p value = 0.959). Of the total patients, 28 have been optimized for 12 months or more, of these, 96.43% (27) continue in sustained remission, and 55.56% (15) received combined therapy with s synthetic DMARD (sDMARD).Figure 1.Kaplan MeierConclusion:During follow-up, most patients remain in optimization strategy. In those who continued in sustained remission, more than half received sDMARD, this suggests that their use may be a determining factor in preventing disease relapses. More studies are required to evaluate this hypothesis.References:[1]Niccoli L, Nannini C, Blandizzi C. Personalization of biologic therapy in patients with rheumatoid arthritis: Less frequently accounted choice-driving variables. Ther Clin Risk Manag. 2018;14:2097–111.[2]ASOREUMA. Asociación Colombiana de Reumatología. Consenso sobre recomendaciones para disminución y descontinuación de la terapia biológica en pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica. Rev Colomb Reumatol. 2019 Jan;26(1):11–23.[3]Cantini F, Niccoli L, Nannini C. Second-line biologic therapy optimization in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Semin Arthritis Rheum. 2017;47(2):183–92.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


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 184.2-184
Author(s):  
I. Flouri ◽  
A. Repa ◽  
N. Avgustidis ◽  
N. Kougkas ◽  
A. Eskitzis ◽  
...  

Background:Difficult-to-treat rheumatoid arthritis (D2T RA) was recently defined by a EULAR study group (1) and, as a disease category it is largely complicated and under-researched. Patient comorbidities may play a significant role in the response to therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) and in the disease classification as D2T RA.Objectives:To evaluate the impact of comorbidities [studied as total Comorbidities Count (CC) and rheumatic disease comorbidity index (RDCI)] on 6-month response to therapy with the first bDMARD in real-world clinical practice and on eventual disease designation as D2T RA.Methods:Prospective study of all RA patients who start any bDMARD in a tertiary centre University Hospital after their consent. All patient comorbidities [among a list of approximately 100 pre-specified major comorbidities] are registered by treating physicians. Response to therapy was defined as achievement of low disease activity or remission (LDA/Rem) according to simplified disease activity index (SDAI) and health assessment questionnaire (HAQ) improvement of ≥ 0.25.D2T RA patient group was defined according to the EULAR definition of D2T RA and was compared to: a/ all other patients and b/ to a sub-group of patients designated as “well-controlled RA” (follow-up ≥2 years and ≥2 visits in the last year in LDA/Rem).Logistic regression models were used to adjust for the potential confounding of age, sex, disease duration, seropositivity, number of previous synthetic DMARDs, type of 1st bDMARD initiated (TNF inhibitor vs. non-TNF inhibitor), co-administered methotrexate and corticosteroids (yes/no), baseline SDAI and HAQ and year of therapy start.Results:Analysis included 501 RA patients who received a total of 1098 bDMARD treatments. At 1st bDMARD treatment start, patients (women: 81%) had a median (IQR) age: 60 (51-68) years, disease duration: 5.4 (3-11) years, SDAI: 36 (28-46), HAQ: 1.0 (0.5-1.5), CC: 3 (2-6) και RDCI: 2 (0-3).In adjusted analyses, total comorbidity count (CC) ≤1 (vs ≥ 2) was predicting LDA/Rem at 6 months of therapy [OR (95%CI) = 4.1 (1.5-11), p=0.005], while RDCI=0 (vs. ≥ 1) was predicting HAQ improvement ≥ 0.25 [OR (95% CI) = 2.6 (1.2-6.7), p=0.046].During 2614 patient-years of follow-up, the disease in 98 patients could be classified as “D2T RA”, while 127 patients had “well-controlled RA”. Baseline independent predictors for D2T RA compared to all other patients were RDCI ≥ 1 (vs. 0) [OR = 3.3 (1.7-9.4), p = 0.024], female sex [OR =3.1 (1.01-9.5)] and age [OR = 0.97 (0.94-0.99)]. Multivariable analyses for predictors of “D2T” compared to “well-controlled” RA yielded similar results.Conclusion:In RA patients starting the first bDMARD treatment, a higher number of comorbidities at baseline is an independent predictor of lower 6-month response to therapy and final disease classification as “difficult-to-treat” RA.References:[1]Nagy G, Roodenrijs NM, Welsing PM, Kedves M, Hamar A, van der Goes MC, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis. 2021 Jan;80(1):31–5.Acknowledgements:Pancretan Health Association and Special Account for Research Grants (ELKE) – University of Crete.Disclosure of Interests:None declared.


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