AB0126 METHOTREXATE MAINTENANCE THERAPY DURING THE TARGETED THERAPY ERA IN RHEUMATOID ARTHRITIS

Background:The persistence with methotrexate (MTX) at 1 year or 5 years in rheumatoid arthritis (RA) is very variable and intolerance remains the main cause of discontinuation of treatment. Changes in treatment with the strategy of adding “add-on” to a targeted therapy when the conventional DMARD becomes insufficient to optimally control the disease may decrease the maintenance MTX therapy rates, particularly for biologics with a Marketing Authorization as monotherapy.Objectives:The main objective of this study was to determine the rate of maintenance at 1 year of the combination therapy with different biologics, to compare the evaluation scores in patients receiving treatment as monotherapy (biological only) versus combination therapy with methotrexate and to analyze predictive factors for MTX maintenance therapy.Methods:We performed a descriptive study of 56 patients with RA meeting the criteria of the ACR 2010. Statistical analysis SPSS.20 Software.Results:These were 56 patients: 93% women and 7% men, mean age 46.74 years with an average duration of the disease of 14.74 years. 71.42% of patients were under corticosteroids taken for a period of 13 years with an average dose of 5.04 mg / day. BMI was highin 23.80% of patients, 30.95% had at least one associated comorbidity. The RF was positive in 61.90% and ACPA positive in 78.57% of cases. 47.62% were under MTX taken for 6.55 years with a dose of 13.03 mg / week on average: 68.75% by oral intake and 31.25% by subcutaneous intake with an average duration of setting before the switch of 8 years. 28 patients were on rituximab, 19 patients on tocilizumab and 9 patients on TNFi. 88.09% did not havenot received from bDMARD before. The mean ESR was 36.57 mm H1 and CRP was 8.56 mg / L. DAS28 at baseline was 6.81 and the current DAS 28 was 2.95 and the HAQ was 1.11. The rate of MTX maintenance therapy at 1 year was 36.84%, with rituximab, 64.28% with tocilizumab and 88% with TNFi. The comparison between the combination therapy with MTX and monotherapy groups showed a significant difference for the number of tender joints NTJ (3.5 vs 2.61), however, no significant difference concerning DAS28 value (2.98 vs 3.06), number of swollen joints NSJ (0.29 vs 0.22) and HAQ (1.09 vs 1.15). Regarding predictive factors of MTX maintenance therapy: Significant correlation was found with a high DAS 28 at baseline, however no correlation concerning the positivity of ACPA, duration of the disease, NTJ, NSJ, ESR, HAQ and the high dose of MTX. Reduction in persistence has found a significant correlation with non-naive RA of ≥ 1 bDMARD, disease activity score, type of biotherapy (antiTNF / rituximab vs Tocilizumab), young age, however no influence was found with a high BMI, HAQ, the presence of comorbidities or the withdrawal of corticosteroids. The increase in the persistence of combination therapy was associated with male gender and RF seropositivity only.Conclusion:Drug persistence is an important aspect of treatment effectiveness. For rheumatologists, knowledge of the factors that predict whether to maintain the combination therapy with methotrexate, increase or reduce the persistence is of great interest when choosing a new treatment to initiate in patients with RA.References:[1]Lavielle.M and Dougados.M. Targeted therapies in rheumatoid arthritis: Combination with conventional synthetic disease modifying antirheumatic drugs or monotherapy? Jone Bone Spine 2018;85:3-9.Disclosure of Interests:None declared

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Anti-carbamylated Protein Antibodies and Serum Level of 14-3-3 Protein for Early Detection of Rheumatoid Arthritis Patient in Correlation with Rheumatoid Factor, Anti-CCP Antibodies, Disease Activity and Joint Damage using High Frequency Musculoskeletal Ultrasound

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x07666200120111549 ◽

2020 ◽

Vol 7 (2) ◽

pp. 141-153

Author(s):

Sahar A. Ahmed ◽

Enas M. Darwish ◽

Walaa A. Attya ◽

Mai Samir ◽

Mennatallah Elsayed ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Rheumatoid Factor ◽

Disease Activity Score ◽

Joint Damage ◽

Musculoskeletal Ultrasound ◽

Activity Score ◽

Das 28 ◽

Significant Difference ◽

Hands And Feet

Background: Rheumatoid arthritis (RA) is a common progressive chronic inflammatory autoimmune disease which affects mostly small joints, causing pain, swelling, deformity, and disability. Although progress has been made in exploring RA nature, still there is a lot to know about the disease pathogenesis, diagnosis, and treatment. Aim of the Work: To investigate the role of serum anti-carbamylated protein antibodies and 14-3-3η in the diagnosis of RA compared to rheumatoid factor (RF), anti-CCP antibodies, and highfrequency musculoskeletal ultrasound used to assess the disease activity and joint damage. Methods: Serum anti-carbamylated protein antibodies and 14-3-3η were measured using ELISA in 61 RA patients and 26 normal controls. RA Disease Activity Score (DAS 28), X-ray and musculoskeletal ultrasound (hands and feet), carotid ultrasound (Intima-Media Thickness IMT) were used in assessing the RA disease. Results: Anti-carbamylated protein antibodies were significantly elevated in RA patients 4.5 (4.1- 8.9 U⁄ml) compared to the control 3.2(1.9- 4.3 U⁄ml) (p< 0.001) but 14-3-3η showed no significant difference. There was a significant positive correlation between anti-carbamylated protein antibodies, 14-3-3η levels and disease activity score assessed by DAS 28, increased IMT measured by carotid duplex, total synovitis and total erosion score were assessed by musculoskeletal ultrasound. There was no correlation between RF and anti-CCP antibodies. Anti-carbamylated protein antibodies were found to have 66.7% sensitivity and 85.2% specificity in RA diagnosis, while 14- 3-3η had 51.9% sensitivity and 72.1% specificity. Conclusion: Anti-carbamylated protein antibodies and 14-3-3η have a high sensitivity and specificity in RA diagnosis and had a correlation with the disease activity and joint damage.

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AB0655 RHEUMATOID ARTHRITIS ACTIVITY BEFORE AND AFTER COVID-19 LOCKDOWN PERIOD

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.576 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1360.1-1360

Author(s):

M. Jordhani ◽

D. Ruci ◽

F. Skana ◽

E. Memlika

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Musculoskeletal Diseases ◽

Statistical Tests ◽

Laboratory Data ◽

World Population ◽

Chronic Patients ◽

Das 28 ◽

Significant Difference ◽

Before And After

Background:The COVID-19 global pandemic has had a great impact on world population due to morbidity, mortality and restriction measures in order to stop the progression of COVID-19.Patients with rheumatic and musculoskeletic diseases, and especially rheumatoid arthritis (RA) patients, being one of the vulnerable classes of chronic patients, were recommended to follow the government’s rules1.Objectives:The aim of this study was to evaluate DAS-28-ESR in patients with rheumatoid arthritis before and after lockdown period.Methods:This is a multi-center observational study including 85 patients which were evaluated before and after lockdown for their disease activity score according to DAS-28-ESR score. They had been diagnosed with rheumatoid arthritis more than 5 years ago. A thorough physical examination was performed before and after the lockdown period. It included examination of tender and swollen joints and patient’s global health. They were completed with all required laboratory data, including erythrosedimentation rate. For a more accurate calculation, DAS-28-ESR was used in an electronic version. Patients with other inflammatory or infective diseases were excluded from the study. All data were statistically evaluated using statistical tests such as t-student test.Results:The first group (the one before lockdown) had an average DAS-28-ESR of 4.7 while after the lockdown period, the average DAS-28-ESR was 5.16.After statistically evaluating all data, it was found that there exists a significant difference between DAS-28-ESR score before and after COVID-19 lockdown (p=0.0011).Conclusion:Our study showed that lockdown period due to COVID-19 pandemic, has aggravated disease activity in patients with Rheumatoid Arthritis. This may be consequence of various causes such as physical inactivity and difficulty to follow-up or to take the medication properly.References:[1]Landewé RB, Machado PM, Kroon F, et al, EULAR provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2, Annals of the Rheumatic Diseases 2020;79:851-858.Disclosure of Interests:None declared.

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Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

Autoimmunity Highlights ◽

10.1186/s13317-021-00153-5 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Vinod Solipuram ◽

Akhila Mohan ◽

Roshniben Patel ◽

Ruoning Ni

Keyword(s):

Rheumatoid Arthritis ◽

Combination Therapy ◽

Randomized Controlled Trials ◽

Random Effect ◽

Janus Kinase ◽

Controlled Trials ◽

Randomized Controlled ◽

Increased Risk ◽

Significant Difference ◽

Risk Of Malignancy

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.

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AB1119 U9: A NOVEL CLINICALLY ORIENTED ULTRASONOGRAPHIC SCALE AS A USEFUL MARKER FOR MONITORING THERAPEUTIC RESPONSE IN RHEUMATOID ARTHRITIS (MULTI CENTERS STUDY)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2733 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1848.2-1849

Author(s):

M. A. Mortada ◽

H. Eitta ◽

R. Elmallah ◽

A. Radwan ◽

A. Elsaman

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Clinical Laboratory ◽

Pearson Correlation ◽

Response To Treatment ◽

P Value ◽

Clinical Parameters ◽

Biologic Dmards ◽

Das 28 ◽

Significant Difference

Background:Musculoskeletal Ultrasonography (MSUS) is now a widely used tool for monitoring of rheumatoid arthritis (RA). Although there are many proposed sets of composite scores, a fixed set of joints may not be an ideal tool to assess a disease like RA, which affects many joints and tendons in different presentations. In previous study (1) U9 score was proven to be correlated with disease activity parameters.Objectives:To determine whether US assessment using U9 score is useful for monitoring response to treatment for RA or not?Methods:A prospective, multicenter study were conducted in period from July 2019 to December 2019. All recruited RA patients were subjected to: Disease activity assessment by clinical disease activity indices (CDAI and DAS28 ESR). Functional status assessment by (HAQ) and ultrasonographic assessment using U9 score which include 8 joints (bilateral wrists,2ndMCP,3RDMCP and knees) plus most clinically affected joint or tendon (one joint or one tendon). Most clinically affected joints from 48 joints. Any affected tendons could be choosing. All targeted joints were evaluated according to EULAR guidlines and by EULAR/ OMERACT combined score (0-3). Targeted tendons were scored (0-3).All patients received their treatment (biologic and non biologic DMARDs) according to the decision of the treating physicians. No specific therapy is needed. CDAI and DAS28 ESR, HAQ and U9 score were repeated after 3 months to detect the response to change after receiving the therapy.Results:One hundred and forty patients (23.6% were male) with mean age 39.26±11.30 were recruited from 4 tertiary referral university hospitals.There was a significant difference (<0.001) between the first and second visits as regards clinical, laboratory and ultrasonographic parameters. DAS 28 decreased form (5.29±1.21) to (3.95±0.99), ESR decreased from (42.12±15.24) to (26.84±12.32), HAQ2 improved from (0.652±0.350) to (0.510±0.237) and U9 total US score decreased from (13.56±5.18) to (8.02±4.28).There was significant correlation between U9 ultrasonographic score and clinical parameters at both visits (table 1).Table 1.correlation between U9 ultrasonographic score and clinical parameters.U9 at 1stvisitU9 at 2ndvisitDAS-28Pearson Correlation(P value)0.806<0.0010.790<0.001CDAIPearson Correlation(P value)0.787<0.0010.773<0.001HAQPearson Correlation(P value)0.431<0.0010.317<0.001We found that the most suitable cut-off value of U9 score to predict high disease activity was 11.5 (sensitivity 85.7% and specificity 80.6%), cut off value for moderate disease activity was 5.5(sensitivity 83.2% and specificity 88%) and cut off value for low disease activity was 3.5 (sensitivity of 83.3% and specificity 57.1%). These results are summarized in the following table:Conclusion:U9 ultrasonographic score is very useful method for evaluating the monitoring the response of treatment.References:[1]Mortada, et al. Annals of the Rheumatic Diseases 2019;78:1009.Disclosure of Interests:None declared

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OP0185 RADIOGRAPHIC PROGRESSION DESPITE PERSISTENT LDA OR REMISSION IS INFLUENCED BY CURRENT SMOKING RATHER THAN THE RESPECTIVE DAS 28 LEVEL, RESULTS OF THE SWISS RHEUMATOID ARTHRITIS REGISTER (SCQM)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2557 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 112.1-112

Author(s):

L. Brandt ◽

H. Schulze-Koops ◽

T. Hügle ◽

M. J. Nissen ◽

H. Paul ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Radiographic Progression ◽

X Rays ◽

Das28 Score ◽

Das 28 ◽

Significant Difference ◽

Control Disease ◽

One Year ◽

Ratingen Score

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

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The comparative effectiveness of oral versus subcutaneous methotrexate for the treatment of early rheumatoid arthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2014-206504 ◽

2015 ◽

Vol 75 (6) ◽

pp. 1003-1008 ◽

Cited By ~ 27

Author(s):

Glen S Hazlewood ◽

J Carter Thorne ◽

Janet E Pope ◽

Daming Lin ◽

Diane Tin ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Early Rheumatoid Arthritis ◽

Comparative Effectiveness ◽

Initial Therapy ◽

First Year ◽

Sustained Remission ◽

Das 28 ◽

Significant Difference ◽

Treatment Changes ◽

Multivariable Models

ObjectiveTo determine the comparative effectiveness of oral versus subcutaneous methotrexate (MTX) as initial therapy for patients with early rheumatoid arthritis (ERA).MethodsPatients with ERA (symptoms ≤1 year) initiating MTX therapy were included from a multicentre, prospective cohort study. We compared the effectiveness between starting with oral versus subcutaneous MTX over the first year. Longitudinal multivariable models, adjusted for potential baseline and time-varying confounders, were used to compare treatment changes due to inefficacy or toxicity and treatment efficacy (Disease Activity Score-28 (DAS-28), DAS-28 remission and Health Assessment Questionnaire-Disability Index (HAQ-DI)).Results666 patients were included (417 oral MTX, 249 subcutaneous MTX). Patients prescribed subcutaneous MTX were prescribed a higher dose of MTX (mean dose over first three months 22.3 mg vs 17.2 mg/week). At 1 year, 49% of patients initially treated with subcutaneous MTX had changed treatment compared with 77% treated with oral MTX. After adjusting for potential confounders, subcutaneous MTX was associated with a lower rate of treatment failure ((HR (95% CI) 0.55 (0.39 to 0.79)). Most treatment failures were due to inefficacy with no difference in failure due to toxicity. In multivariable models, subcutaneous MTX was also associated with lower average DAS-28 scores (mean difference (−0.38 (95% CI −0.64 to −0.10)) and a small difference in DAS-28 remission (OR 1.2 (95% CI 1.1 to 1.3)). There was no significant difference in sustained remission or HAQ-DI (p values 0.43 and 0.75).ConclusionsInitial treatment with subcutaneous MTX was associated with lower rates of treatment changes, no difference in toxicity and some improvements in disease control versus oral MTX over the first year in patients with ERA.

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IL-22 and ACPA Levels and their Relationship to the Disease Activity in Rheumatoid Arthritis Patients

Open Access Journal of Microbiology & Biotechnology ◽

10.23880/oajmb-16000185 ◽

2021 ◽

Vol 6 (1) ◽

pp. 1-7

Author(s):

Khater ES

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Solid Phase ◽

Sandwich Elisa ◽

Control Group ◽

Erosive Disease ◽

Das 28 ◽

Significant Difference ◽

Hs Crp ◽

And Control

Aim: to determine ACPA IgG and IL-22 levels in RA patients and their relationship to the disease activity Place and duration of the study: A cross sectional study and prospective cohort study was performed from August 2020 to January 2021 in rheumatology outpatient clinic and laboratory of Al- Quwayiyah General hospital. Methodology: Forty five rheumatoid arthritis patients were included and 35 healthy participants free of any diseases considered as control group. The patients in this study met the American College of Rheumatology's 2010 guidelines. RA Disease activity was assessed for rheumatoid patients using DAS28 scoring. Serum samples collected from the patients and control to perform ESR, Hs-CRP, RF factors and also IL22 and ACPA IgG which were detected using sandwich ELISA and indirect solid phase enzyme immunoassay techniques respectively. Results: Out of the 45 RA patients, 34(75.6%) were females and 11(24.4%) were males aged from (28-67years) with median patient age 42 years. There was no statistically significant difference regarding age and sex between RA patients and control. Thirty (66.7%) of the 45 RA patients had low disease activity or remission, while 15 (33.3%) had moderate to extreme disease activity. Thirty two 32(71.1%) patients of the 45 RA patients had erosive disease. The level of ESR, hs-CRP and RF are increased in the patient group than control, in spite that there were significant differences in the Mean± SD among RA group and control group regarding RF, there was no significant statistical differences ESR, hs-CRP. in the study there was an increase in ACPA and IL-22 levels in patients suffering of RA; 21.52±1.29 U/ml and 71.22±10.63 pg\ml. respectively. While among control there was low serum levels; 14.06±2.01U/ml 33.25±2.41pg\ml and respectively. Significant statistical difference was observed regarding IL-22 and ACPA IgG levels among RA patients and control (P=0.038 and P=0.019 respectively). There is a significant positive relationship (positive correlation) detected between ACPA and IL-22 levels, (r=-0.810; p=0.597). The levels of IL-22 and ACPA were significantly associated with DAS 28. Their relationship was strong as the r value was 0.427 and 0.411 respectively. Conclusion: IL-22 and ACPA IgG levels were highly increased among RA patients in comparison to the control group. The IL-22 and ACPA IgG levels were strongly correlated with the rheumatoid disease activity, DAS 28. These results suggest that Il-22 can be used in association with ACPA IgG level as diagnostic and prognostic markers of rheumatoid arthritis

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Correlation Between Carotid Intima-Media Thickness and the Activity of Rheumatoid Arthritis: A 1-Year Cross-Sectional Study

Journal of the Bahrain Medical Society ◽

10.26715/jbms.3_28122018 ◽

2018 ◽

Vol 30 (3) ◽

pp. 34-41

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Intima Media Thickness ◽

Carotid Intima Media Thickness ◽

Tender Joint Count ◽

Tender Joint ◽

Media Thickness ◽

Das 28 ◽

Significant Difference ◽

The Mean

Background and objectives: Among several noninvasive techniques available, a high-resolution B-mode ultrasonography is the widely used technique to measure carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients with elevated cardiovascular risk. The present study was undertaken to explore the clinical relationship between CIMT and disease activity in patients with RA. Methods: This study involved 50 adult patients with RA. Demographic, physical, systemic, and clinical data and history of the patients were recorded. Investigations, such as erythrocyte sedimentation rate, highly sensitive C-reactive protein, renal and liver function tests, RA factor, and anticyclic citrullinated peptide antibody tests were performed. CIMT was assessed using highresolution B-mode ultrasonography and the disease severity was assessed based on disease activity score (DAS) 28. Results: The mean age of the RA patients was 49.88 ± 12.12 years with male predilection. The mean duration, mean European League Against Rheumatism (EULAR) criteria score, and mean DAS 28 score in RA patients were 3.62 ± 3.25 years, 8.10 ± 1.58, and 4.91 ± 1.11, respectively. The mean CIMT observed in RA patients was 0.94 ± 0.31 cm. Significant difference was observed in the mean CIMT values of different variables, including duration of joint pain (P = 0.007), tender joint count (P < 0.001), swollen joint count (P < 0.001), EULAR criteria score (P < 0.001), and DAS 28 score (P < 0.001). Also, CIMT correlated positively with tender joint count (r = 0.711; P < 0.001), swollen joint count (r = 0.673; P < 0.001), EULAR criteria score (r = 0.611; P < 0.001), and DAS 28 score (r = 0.729; P < 0.001). Conclusion: A strong correlation was observed between CIMT and disease activity in patients with RA. Hence, CIMT can be a useful surrogate marker for detecting atherosclerosis in patients with RA.

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Outcome of 136 Children with Advanced Lymphoblastic Lymphoma Receiving an BFM-Type Therapy with Intensified Maintenance: A Report from the Japanese Pediatric Leukemia/Lymphoma Study Group ALB-NHL03 Study

Blood ◽

10.1182/blood.v124.21.3049.3049 ◽

2014 ◽

Vol 124 (21) ◽

pp. 3049-3049

Author(s):

Shosuke Sunami ◽

Masahiro Sekimizu ◽

Tetsuya Takimoto ◽

Tetsuya Mori ◽

Tetsuo Mitsui ◽

...

Keyword(s):

Maintenance Therapy ◽

Lymphoblastic Leukemia ◽

Lymphoblastic Lymphoma ◽

High Dose ◽

Induction Phase ◽

Pediatric Leukemia ◽

Cns Disease ◽

Stage 4 ◽

Mediastinal Disease ◽

Significant Difference

Abstract BACKGROUND: Lymphoblastic lymphoma (LBL) accounts for 30% of childhood non Hodgkin’s lymphoma in Japan. From European and North American groups, favorable results have been reported, using treatment strategies for acute lymphoblastic leukemia, over 80% of event free survival rate even in advanced LBL. However there were few data on Japanese or Asian patients with LBL. Here we report final outcome of first nation-wide prospective study over one hundred cases with advanced childhood LBL from Japan. PATIENTS & METHOD: Patients with stage 3 or 4 LBL received for 9 weeks induction phase, which consisted of 7 drugs and triple IT , followed by three courses of high dose MTX(5g/m2). After high dose MTX, re-induction, early maintenance, and late maintenance phase were administered. With an attempt to intensify maintenance therapy,early maintenance was consisted by two cycles of four courses of six drugs(MTX, PSL,VCR, L-ASP, 6MP, THP#) and late maintenance was five cycles of five drugs(MTX, PSL,VCR, 6MP,AraC). We omitted local radiotherapy including prophylactic cranial radiotherapy except patient with initial central nervous system (CNS) disease. The total duration of the treatment was 24 month. RESULTS: From November 2004 to October 2010, 154 children with newly diagnosed advanced stage LBL were entered in this study. A total of 136 cases were eligible. Ages ranged from four month to 15 years, with a median of 9.07 years. Of the 136 patients, 36 were girls and 100 were boys. The distribution of clinical stage 3 and stage 4 was 82 and 54 patients respectively. 94 patients had primary mediastinal disease. 41 patients had BM disease, 31 patients had CNS disease and 8 patients had BM and CNS disease. 104 patients (76.5%) had precursor T LBL (T-LBL), 31 patients (22.8%) had precursor B LBL (B-LBL), onepatient (0.7%) had bi phenotype LBL. The follow-up time ranged from 2.8 to 94 months, with a median 58 months. For the 136 patients analyzed in this study, 5-year OS was 82.9% and 5-year EFS was 77.9%. There was no significant difference in outcome by gender (5-year EFS, male 78.2% vs. female 73.0%), or by immunophenotype (5-year EFS, B-LBL 80.7% vs. T-LBL 76.9%). Of note, the 5-year EFS for stage 3 T-LBL patients were worse than that of stage 4 T-LBL patients (70.6% vs. 88.9%, P=0.031). There were also significant difference in 5-year EFS for T-LBL patients who achieved CR and CRu at end of induction, 86.9%, and 69.7% (P=0.034), respectively.Most events were observed as mediastinum enlargement before initiation of intensified maintenance therapy. CONCLUSIONS: Our firstnationwide study provided about 80% cure rate with only one case of toxic death in childhood advanced LBL. However, our intensified maintenance therapy could not improve survival outcome. Our result also emphasize the significant difference between T-LBL stage 3 and stage 4 and might suggest the difference in ethnicity for the composition of biological subgroup in T-LBL. THP: Pirarubicin Disclosures No relevant conflicts of interest to declare.

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