Early clinical response predicts low disease activity at one year in rheumatoid arthritis patients on treatment with certolizumab in real-life settings. An appraisal of the Italian registry GISEA

2016 ◽  
Vol 83 (6) ◽  
pp. 721-725 ◽  
Author(s):  
Florenzo Iannone ◽  
Giorgio Carlino ◽  
Antonio Marchesoni ◽  
Piercarlo Sarzi-Puttini ◽  
Roberto Gorla ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Real Life ◽  
Low Disease Activity ◽  
One Year

scholarly journals FRI0127 Suppression of radiographic progression after gradual methotrexate tapering in patients with rheumatoid arthritis patients maintaining low disease activity - Prospective multicenter study-

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 645.1-645
Author(s):  
K. Katayama ◽  
K. Yujiro ◽  
T. Okubo ◽  
R. Fukai ◽  
T. Sato ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Joint Destruction ◽  
Reduction Rate ◽  
Bone Destruction ◽  
High Response ◽  
Continuation Rate ◽  
Low Disease Activity ◽  
One Year ◽  
Response Group

Background:Many studies have been reported to reduce/discontinue Biologics in the treatment of rheumatoid arthritis (RA). In contrast, study for tapering methotrexate (MTX) has been limited (1,2).Objectives:We prospectively examined whether bone destruction will progress at 48 weeks after tapering or discontinuing MTX (UMIN000028875).Methods:The subjects were RA patients who have maintained low disease activity or lower for 24 weeks or more in DAS28-CRP after MTX administration. Patients having PDUS Grade 2 or 3 per site by bilateral hand ultrasonography (26 area) were excluded in this study owing to risk for joint destruction. The joint destruction was evaluated by the joint X-ray evaluation by modified total Sharp scoring (mTSS) at 1 year after the start of tapering MTX. Evaluation of clinical disease activities, severe adverse events, the continuation rate during MTX tapering were also evaluated. According to tapering response, prognostic factor for good response for tapering, joint destruction was determined. Predictors for successful tapering MTX and progression of bone destruction were determined. Statistical analysis was performed by t-test or Wilcoxon rank sum test using SAS .13.2 software.Results:The subjects were 79 (16 males, 63 females). Age average 60.9 years, disease duration 4 years 4 months, MTX dose 8.43 mg / w, DAS28-CRP 1.52, DMARDs (24.3%), ACPA 192.7 U / ml (70.5%), RF 55.6 IU / ml (65.4%).MTX was tapered from an average of 8.43 mg / w before study to 5.46 mg / w one year later. In the treatment evaluation, DAS28-CRP increased from 1.52 to 1.84. 89.7% of subjects did not progress joint damage. Other disease activities significantly increased (Table 1). The one-year continuation rate was 78.2%. Since tapering effects were varied widely, we divided patients into three groups; Flared group (N=14, initial MTX dose 8.71mg/w, final MTX dose 8.42mg/w), Low response group (N=31, final MTX reduction rate< 50%, initial MTX dose 8.93mg/w, final MTX dose 6.22mg/w), High response group (N=34, final MTX reduction rate≥ 50%, initial MTX dose 8.5mg/w, final MTX dose 3.15mg/w)(Table 2).Higher RF value at baseline and higher MTX dose at 3M, 6M were predictors of whether a subject was in Low response group or High Response group. Higher RF value and mTSS at baseline and higher MTX dose at 6M were predictors whether a subject was in Flared group or High response group. Lower age was predictor of whether a subject was in Flared group or Low responder group. Finally, mean ΔmTSS /y in Flared group (0.36) was not significantly higher than in low response group (0.07) and in high response group (0.01).Table 1Table 2.Predictors for successful tapering MTX and progression of bone destructionConclusion:Patients with MTX-administered low disease activity and finger joint echo PDUS grade 1 satisfy almost no joint destruction even after MTX reduction. For tapering, predictors may be helpful for maintaining patient’s satisfaction.References:[1]Baker KF, Skelton AJ, Lendrem DW et al. Predicting drug-free remission in rheumatoid arthritis: A prospective interventional cohort study. J. Autoimmunity. 2019;105: 102298.[2]Lillegraven S, Sundlisater N, Aga A et al. Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial. American College of Rheumatology. 2019; Abstract L08.Disclosure of Interests:None declared

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

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

scholarly journals POS0455 EFFECT OF ANTI-Ro/SSA ANTIBODIES FOR TREATMENT RESPONSE TO METHOTREXATE IN RHEUMATOID ARTHRITIS: A RETROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 458.1-458
Author(s):  
R. Yokochi ◽  
H. Tamai ◽  
T. Kido ◽  
Y. Yagyu ◽  
D. Waki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Activity ◽  
Clinical Response ◽  
Logistic Regression Analysis ◽  
Age At Onset ◽  
Treat To Target ◽  
Low Disease Activity ◽  
Target Strategy

Background:Several previous observational studies have suggested that patients with anti-Ro/SSA antibody-positive rheumatoid arthritis (RA) may respond poorly to treatment, including tumor necrosis factor inhibitors1. However, its influence on methotrexate (MTX) treatment, which is the anchor drug of treat-to-target strategy in RA treatment, remains unclear.Objectives:We compared the clinical response to MTX in both anti-Ro/SSA antibody-positive and -negative patients with MTX-naiive RA and investigated the reasons for the difference in response.Methods:We recruited 210 consecutive patients with RA who were newly started on MTX in this retrospective cohort study. The effect of the presence of anti-Ro/SSA antibodies on achieving low disease activity (LDA) of DAS28-CRP at six months after initiating MTX was investigated by using logistic regression analysis. CDAI, SDAI, concomitant using DMARDs and painkillers, patient’s and evaluator’s VAS, tender joint counts, and swollen joint counts at six months were also compared between the anti-Ro/SSA-positive patients and -negative patients. Missing data were imputed by using multiple imputations before multivariate analysis.Results:32 anti-Ro/SSA antibody-positive patients and 178 anti-Ro/SSA antibody-negative patients were included. The rate of achieving DAS28-LDA at six months was significantly lower in the anti-Ro/SSA antibody-positive patients than those in the anti-Ro/SSA antibody-negative patients (56.2% versus 75.8%, P=0.03). in the logistic regression analysis, the presence of anti-Ro/SSA antibodies was an independent negative predictor for achieving DAS-28-LDA at six months (OR:0.431, 95%CI: 0.190-0.978, P=0.044) (Table1). Anti-Ro/SSA antibody-positive patients had significantly higher patient’s VAS at six months (median [IQR]: 22 [15-41] vs 19 [5-30], P=0.038), and prescribed NSAIDs (37.5% vs 18.0%, P=0.018). CDAI and SDAI after six months were not significantly different between the group.Conclusion:The presence of anti-Ro/SSA antibodies might be one of the predictive factors for the insufficient response to treat to target strategy in RA treatment. Residual pain was suspected as one of the mechanisms contributing to the lesser clinical response of MTX in anti-Ro antibody-positive RA.References:[1]Ran Matsudaira wt al. J Rheumatol 2011;38(11):2346-54Table 1.Logistic regression analysis for the rate of achieving DAS28 low disease activity at six months.Risk factor Odds ratio95%CIP valueAge at onset0.9930.968-1.0180.586Sex (woman)0.6430.300-1.3840.258RF-positive1.9620.853-4.5110.112ACPA-positive0.5520.225-1.3510.192Anti-Ro/SSA antibody-positive0.4310.190-0.9780.044Disclosure of Interests:None declared

scholarly journals Effectiveness, Tolerability, and Safety of Tofacitinib in Rheumatoid Arthritis: A Retrospective Analysis of Real-World Data from the St. Gallen and Aarau Cohorts

2019 ◽  
Vol 8 (10) ◽  
pp. 1548 ◽  
Author(s):  
Mueller ◽  
Hasler ◽  
Popp ◽  
Mattow ◽  
Durmisi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Liver Enzymes ◽  
Real Life ◽  
Gastrointestinal Symptoms ◽  
Janus Kinase ◽  
Secondary Outcome ◽  
Low Disease Activity

: Introduction: Tofacitinib is an oral JAK inhibitor indicated for the treatment of rheumatoid arthritis (RA). The efficacy and safety of tofacitinib have been shown in several randomized clinical trials. The study presented here aimed to assess the clinical tolerability and effectiveness of tofacitinib among RA patients in real life. Methods: Consecutive patients between January 2015 and April 2017 with RA who fulfilled the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria were included in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5 mg bid. The primary objective was to analyze the safety of tofacitinib in a real-life cohort. Safety was assessed by the reasons to stop tofacitinib during follow up and changes of liver enzymes, hemoglobin, and creatinine. The secondary outcome was to analyze the frequency of and time to achieve low disease activity (LDA) and remission as defined by 28 joint count disease activity score (DAS28). Results: A total of 144 patients were treated with tofacitinib. A total of 84.9% of patients were pre-exposed to at least one biological agent. The average DAS28 at the initiation of tofacitinib was 4.43. A total of 50.0% of patients were positive for rheumatoid factor and 49.0% for ACPA. The mean follow up was 1.22 years (range 10d–3.7a) after initiation of tofacitinib treatment. A total of 94 (64.4%) patients remained on tofacitinib during follow-up. The average time to stop tofacitinib was 190.0 days. Reasons to stop tofacitinib were: insufficient response (n = 23), gastrointestinal symptoms (n = 18), infection (n = 5), myalgia (n = 2), remission (n = 2), headache (n = 2), cough, blue finger syndrome, intolerance, heartburn, psoriasis, and increased liver enzymes (all n = 1). Increased alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) > 2× upper limit of normal (ULN) were detected in 3.3% and 4.4% of patients, respectively. Hemoglobin decrease of >10% was detected in 15.1% of the patients and decreased lymphocytes <500/μL in 3.4%. An increase of creatinine >20% was detected in 9.4% of patients. A total of 62.9% and 50.0% of the patients achieved low disease activity (LDA) or remission after a median of 319 and 645 days, respectively. These rates were significantly higher in patients naïve to biologic agents as compared to patients pre-exposed to biologics (LDA: naïve 100% 92 d, pre-exposed 57.0% 434 d, p ≤ 0.001; remission: naïve 86.7% 132 d, pre-exposed 44.1%, 692 d, p = 0.001). Conclusions: Tofacitinib is a safe and effective treatment option for patients with RA. Tofacitinib may induce high rates of LDA and remission in patients with active disease, even after the use of one or more biologics, though the rate appeared higher in patients naïve to biologics. Tofacitinib may be a valuable option in a treat-to-target approach. Our data demonstrate that Janus kinase (JAK) inhibitors are safe and efficacious in real life patients.

scholarly journals Clinical Response Within 12 Weeks as a Predictor of Future Low Disease Activity in Patients with Early RA: Results from the TEAR Trial

2013 ◽  
Vol 40 (5) ◽  
pp. 572-578 ◽  
Author(s):  
Jeffrey R. Curtis ◽  
Theresa McVie ◽  
Ted R. Mikuls ◽  
Richard J. Reynolds ◽  
Iris Navarro-Millán ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Model Building ◽  
Prediction Models ◽  
Characteristic Curve ◽  
Prediction Rule ◽  
Low Disease Activity ◽  
Derivation Cohort ◽  
Early Ra

Objective.Rapidly predicting future outcomes based on short-term clinical response would be helpful to optimize rheumatoid arthritis (RA) management in early disease. Our aim was to derive and validate a clinical prediction rule to predict low disease activity (LDA) at 1 year among patients participating in the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial escalating RA therapy by adding either etanercept or sulfasalazine + hydroxychloroquine [triple therapy (TT)] after 6 months of methotrexate (MTX) therapy.Methods.Eligible subjects included in the derivation cohort (used for model building, n = 186) were participants with moderate or higher disease activity [Disease Activity Score 28-erythrocyte sedimentation rate (DAS-ESR) > 3.2] despite 24 weeks of MTX monotherapy who added either etanercept or sulfasalazine + hydroxychloroquine. Clinical characteristics measured within the next 12 weeks were used to predict LDA 1 year later using multivariable logistic regression. Validation was performed in the cohort of TEAR patients randomized to initially receive either MTX + etanercept or TT.Results.The derivation cohort yielded 3 prediction models of varying complexity that included age, DAS28 at various timepoints, body mass index, and ESR (area under the receiver-operator characteristic curve up to 0.83). Accuracy of the prediction models ranged between 80% and 95% in both derivation and validation cohorts, depending on the complexity of the model and the cutpoints chosen for response and nonresponse. About 80% of patients could be predicted to be responders or nonresponders at Week 12.Conclusion.Clinical data collected early after starting or escalating disease-modifying antirheumatic drug/biologic treatment could accurately predict LDA at 1 year in patients with early RA. For patients predicted to be nonresponders, treatment could be changed at 12 weeks to optimize outcomes.

AB0315 RETENTION RATE OF ABATACEPT MONOTHERAPY IN AN ITALIAN MULTICENTRIC RHEUMATOID ARTHRITIS COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1456.1-1457
Author(s):  
D. Iacono ◽  
I. Pantano ◽  
D. Birra ◽  
G. Scalise ◽  
M. A. Coscia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Median Duration ◽  
Retention Rate ◽  
Real Life ◽  
Physician Global Assessment ◽  
Low Disease Activity ◽  
Baseline Activity ◽  
Disease Modifying

Background:EULAR recommendations focus the importance of Methotrexate (MTX) therapy as a key element in the treatment of patients with Rheumatoid Arthritis (RA), alone as first line therapy and in combination with biological Disease Modifying Anti-rheumatic Drug (bDMARDs). Abatacept (CTLA4-Ig) in Europe is approved for the treatment of moderate to severe active RA in combination with MTX. Several patients, however, discontinue MTX for intolerance, side effects or contraindications, and real-life data demonstrate how, even in patients receiving therapy with MTX, compliance could be suboptimal. The only data on the use of abatacept in monotherapy come from the ORA-Registry, where a worse performance is observed in monotherapy patients.Objectives:To evaluate a multicenter cohort of RA patients treated with Abatacept in patients underwent combined MTX therapy vs monotherapy.Methods:We retrospectively evaluated RA patients, referring to 2 Italian rheumatology centers, treated with Abatacept monotherapy or in combination with MTX. We compared both persistence in therapy and the rate of remission/low disease activity according to Clinical Disease Activity Index (CDAI) between the 2 groups.Results:We enrolled 147 patients, out of them 66 patients were on monotherapy with Abatacept due to intolerance or controindications and 81 in therapy with Abatacept plus MTX. The two cohorts appeared homogeneous in age, gender, disease duration and baseline activity indexes, with the only difference being higher baseline Physician Global assessment (PhGA) values in monotherapy patients. During the follow-up (median duration 24±14 months), the retention rate of Abatacept treatment was 71.2% in MTX patients (median duration 27–15.6 months) and 62.1% in monotherapy patients (median duration 25.2–17.5; p=ns). No differences between the two groups in terms of retention rate, low-disease activity and CDAI remission (log rank p=ns), Breslow p=ns) were detected.Conclusion:In patients with RA with intolerance or contraindication to MTX use, Abatacept monotherapy could be an efficient and safe option even in the long term follow-up.References:[1]Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry.Truchetet ME et al. Arthritis Res Ther. 2016 Mar 30;18:72.Disclosure of Interests:DANIELA IACONO Speakers bureau: PFIZER, BRISTOL MAYERS SQUIBB, SANOFI, Ilenia Pantano: None declared, domenico birra: None declared, GIUSEPPE SCALISE: None declared, Melania Alessia Coscia: None declared, VALENTINA MESSINITI: None declared, Gabriella Loi: None declared, Anna Merchionda: None declared, Paolo Moscato: None declared, francesco ciccia Grant/research support from: pfizer, novartis, roche, Consultant of: pfizer, novartis, lilly, abbvie, Speakers bureau: pfizer, novartis, lilly, abbvie

scholarly journals AB0278 REAL LIFE EXPERIENCE OF DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS TREATED WITH BIOLOGICAL DMARDS VERSUS TOFACITINIB.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1438.2-1438
Author(s):  
V. Boyadzhieva ◽  
N. Stoilov ◽  
E. Kurteva ◽  
R. Stoilov
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Real Life ◽  
Disease Activity Index ◽  
Significant Difference ◽  
One Year

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

scholarly journals OP0156-HPR COST EFFECTIVENESS OF TELE-HEALTH FOLLOW-UP IN RHEUMATOID ARTHRITIS BASED ON A NON-INFERIORITY RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 98.2-99
Author(s):  
A. De Thurah ◽  
C. Skovsgaard ◽  
T. Maribo ◽  
N. H. Hjøllund ◽  
M. Kruse
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Disease Activity ◽  
Social Care ◽  
Control Group ◽  
Low Disease Activity ◽  
Health And Social Care ◽  
One Year ◽  
Care Costs

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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