Investigating the Validity of the Minimal Disease Activity State for Patients with Rheumatoid Arthritis Treated with Abatacept

2009 ◽  
Vol 36 (2) ◽  
pp. 260-265 ◽  
Author(s):  
GEORGE A. WELLS ◽  
MAARTEN BOERS ◽  
TRACY LI ◽  
PETER S. TUGWELL
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Control Group ◽  
Minimal Disease Activity ◽  
The Core ◽  
Core Set ◽  
Number Of Patients ◽  
Minimal Disease ◽  
Activity State

Objective.To validate the definitions of minimal disease activity (MDA) in patients with rheumatoid arthritis (RA) and to compare abatacept to control with respect to patients attaining a state of MDA.Methods.Two randomized controlled trials comparing abatacept to control in patients with RA were considered: ATTAIN and AIM. Core set measures, Disease Activity Score 28-joint count (DAS28), and, for AIM, radiographic scores were available. The core set and DAS-based definitions for MDA were calculated and the number of patients in the treatment groups meeting the definitions was compared to determine sensitivity of the criteria to treatment differences and patient severity. The number of times achieving MDA was compared to the change in Health Assessment Questionnaire (HAQ), and for the AIM study compared to change in radiographic scores.Results.For both definitions of MDA, the change in radiographic scores showed a continual decrease in progression the more often a patient was in MDA. The change in HAQ, for both studies, showed a similar consistent improvement — the longer a patient was in MDA, then the better the HAQ score. Significantly more patients in the abatacept group met the core set and DAS-based definition of MDA than in the control group.Conclusion.The presence and persistence of MDA was associated with slowing of radiographic progression and improvement in the HAQ, providing support for discriminative and predictive validity of the measure. The MDA results were consistent with other efficacy analyses indicating a treatment advantage for abatacept.

Minimal Disease Activity and Remission in Psoriatic Arthritis Patients Treated with Anti-TNF-α Drugs

2015 ◽  
Vol 43 (2) ◽  
pp. 350-355 ◽  
Author(s):  
Fabio Massimo Perrotta ◽  
Antonio Marchesoni ◽  
Ennio Lubrano
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Joint Disease ◽  
Practice Setting ◽  
Minimal Disease Activity ◽  
Tnf Α ◽  
Clinical Practice Setting ◽  
Minimal Disease

Objective.A state of remission is the target of therapy in chronic arthritis. The aim of the present study was to assess the rate of minimal disease activity (MDA) and remission in patients with psoriatic arthritis (PsA) treated with tumor necrosis factor (TNF-α) blockers. Disease characteristics and predictors of MDA were also evaluated.Methods.Patients fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria and treated with TNF-α blockers adalimumab, etanercept, or golimumab were enrolled and prospectively followed every 4 months for 1 year in a clinical practice setting. Patients were considered in MDA when they met at least 5/7 of the criteria previously defined. Other remission criteria evaluated were 28-joint Disease Activity Score-C-reactive protein (DAS28-CRP) < 2.6 and Disease Activity in Psoriatic Arthritis (DAPSA) score ≤ 3.3. Patients achieving MDA were compared to non-MDA to identify outcome predictor factors.Results.Of the 75 patients treated with TNF-α blockers, at baseline no patients were in MDA or had a DAPSA score ≤ 3.3, while 25 (21.3%) had a DAS28-CRP score < 2.6. Five patients (6%) discontinued treatment because of side effects or inefficacy during followup. After 12 months, MDA was achieved in 46 patients (61.3%). No difference was found among the 3 anti-TNF-α drugs. Predictors for MDA were found to be male sex, high CRP, high erythrocyte sedimentation rate, and low Health Assessment Questionnaire.Conclusion.In our prospective observational study, based on a clinical practice setting, MDA was achieved in 61.3% of patients treated with TNF-α blockers, identifying this as an achievable target for patients with PsA. Predictors of remission were also identified.

SAT0307 Treat to Target of Psoriatic Arthritis: Core Set Criteria of Minimal Disease Activity

2013 ◽  
Vol 72 (Suppl 3) ◽  
pp. A687.3-A687
Author(s):  
Y. El Miedany ◽  
M. El Gaafary ◽  
S. Youssef ◽  
I. Ahmed ◽  
A. Nasr ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Treat To Target ◽  
Minimal Disease Activity ◽  
Core Set ◽  
Minimal Disease

P-450 Effects of rheumatoid arthritis and methotrexate therapy on ovarian reserve in infertile women

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
G Vlasova ◽  
S Perminova
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Ovarian Reserve ◽  
Small Sample Size ◽  
Genetic Material ◽  
Main Group ◽  
Small Sample ◽  
Control Group ◽  
Proliferating Cells ◽  
Number Of Patients

Abstract Study question Do patients with infertility and rheumatoid arthritis (RA) treated with methotrexate (MTX) have ovarian reserve alterations? Summary answer Women with infertility and RA treated with MTX were found to have statistically significant decrease of ovarian reserve. What is known already Rheumatoid arthritis (RA) is one of the most prominent inflammatory diseases affecting women of child-bearing age [Brouwer J. et al, 2014]. RA and its treatment may interfere with the female reproductive physiology. The vast majority of patients with RA are treated with methotrexate (MTX) which is a folate antagonist that inhibits DNA synthesis. MTX, which is the anchor drug in RA, targets actively proliferating cells including the oocytes and granulosa cells which may impair the ovarian reserve [Min Tun Kyaw et al, 2020]. Study design, size, duration A prospective case-control study that enrolled 72 female patients with infertility was conducted in the 2-year time period of September 2018 to October 2020. Participants/materials, setting, methods The main group comprised 32 patients with infertility and RA; the control group consisted of 40 women with infertility only. Patients with RA were stratified into subgroups based on whether or not they received MTX. To investigate ovarian reserve measurement of serum anti-Müllerian hormone (AMH) was used. The level of AMH was evaluated concerning RA duration and activity, as well as the age at initiation of MTX therapy, dosage, and treatment duration. Main results and the role of chance The mean age of the study population was 36±3 years. The duration of RA was 4 [3;11] years. The low disease activity based on DAS28-ESR (disease activity score based on 28 joints using the erythrocyte sedimentation rate) prevailed(56.2%). In the main group 19(59.4%) women received MTX therapy. The MTX dosage was 15 [15;20]mg /wk, the duration of MTX therapy by the day of inclusion in the study was 18.7[1;15]months. The AMH level was significantly lower in the main group (2.1 n /ml vs 2.73ng /ml, p = 0.043). The number of patients with decreased ovarian reserve (AMH level&lt;1.0ng/ml) significantly prevailed in the group of patients with RA (25% vs 5%, p = 0.015). When assessing the AMH level in patients with RA who received MTX (n = 19) and patients in the control group, there was a tendency towards a decrease in the indicator in the first subgroup, but no statistically difference was found (p = 0.074). Correlation analysis of the dependence of AMH level on the patient age showed the most significant decrease in AMH in the patients with RA receiving MTX compared to the patients with RA who did not, and compared to all patients with RA regardless of the therapy received (rs=-0.563)(p &lt; 0.05). Limitations, reasons for caution The lack of statistically significant data in certain cases may be due to the small sample size. Wider implications of the findings RA and MTX administration are associated with a significant decrease in AMH levels. The age of initiation of the therapy is negatively correlated with the AMH level. In this regard, patients with already compromised reproductive function who are planning to receive MTX should be advised to preserve the genetic material. Trial registration number 567890

scholarly journals AB0226 EVALUATION OF RITUXIMAB EFFICACY WITH VARIOUS COMPOSITE MEASURES OF INFLAMMATORY ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1139.1-1139
Author(s):  
Y. Olyunin ◽  
D. Kusevich ◽  
E. Nasonov
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
High Activity ◽  
Inflammatory Activity ◽  
Tender Joint Count ◽  
Control Group ◽  
Tender Joint ◽  
Composite Indices ◽  
Number Of Patients ◽  
Target Activity

Background:Disease modifying anti-rheumatic drugs (DMARD) can provide an unbalanced effect on individual components of the inflammatory process, which in some cases leads to an insufficiently correct assessment of the patient’s status when using composite activity indices [1].Objectives:To compare the results of the rituximab (RTX) efficacy assessment in patients with rheumatoid arthritis (RA) using different composite indices of disease activity.Methods:Patients with active RA observed in 23 medical centers of the Russian Federation were included. They were randomized into 2 groups in a 2:1 ratio. In the main group methotrexate (MTX) was prescribed at 15 mg per week and RTX infusions 600 mg on days 1 and 15. Patients in the control group received MTX 15 mg per week and placebo on days 1 and 15. If after 15 weeks 20% reduction of tender joint count (TJC) and swollen joint count (SJC) was not achieved, another DMARD was prescribed.Results:159 RA patients (131 women and 18 men) were included. The mean age of patients was 51.4±11.8 years, the median duration of RA – 2.8 [0.6; 5.8] years. At baseline DAS28, SDAI and CDAI in all cases assessed disease activity as high. 6 months after RTX administration DAS28 showed remission in 9%, low, moderate and high activity activity in 7%, 47% and 37% of cases, SDAI – in 7%, 12%, 34% and 47%, CDAI – in 7%, 11%, 30% and 52%, respectively. In the control group remission, low, moderate and high activity by DAS28 were revealed in 2%, 2%, 38% and 58%, by SDAI – in 2%, 4%, 35%, 59%, by CDAI – in 2%, 6%, 29%, 63% of patients respectively. After 6 months, in patients achieved the treatment target (remission or low activity) according to DAS28, SJC in 12 cases was 0, in 3 – 1 and in 1 – 2. TJC was 0 in 9 cases and in 7 patients ranged from 1 to 14. The level of C-reactive protein (CRP) in 14 cases was within the normal range and in 2 – increased. Erythrocyte sedimentation rate (ESR) was normal in all cases. SDAI after 6 months showed the target activity in 18 patients treated with RTX. In 12 of them the SJC was 0, in 4 – 1 and in 2 – 2. In 9 cases TJC was 0, in the rest patients it varied from 2 to 5. The level of CRP was normal in 15 patients, ESR – in all patients. CDAI met the target activity in 17 patients. In 12 of them, SJC was 0, in 3 – 1, in 2 – 2. The level of CRP was normal in 14, ESR – in all patients.Conclusion:Assessment of RTX efficacy with DAS28, SDAI, and CDAI in RA provided comparable number of patients who achieved remission or low disease activity 6 months after administration of the drug. The groups of patients who reached this target level of activity by DAS28, SDAI, and CDAI did not have significant differences in the values of main measures characterizing residual inflammatory activity, including SJC, TJC, ESR, and CRP.References:[1]Bastida C, Soy D, Ruiz-Esquide V, Sanmartí R, et al. Br J Clin Pharmacol. 2019 Aug;85(8):1710-1718.Disclosure of Interests:None declared

scholarly journals AB0207 CLINICAL IMPACT OF ANTI-CARP ANTIBODIES IN RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1403.1-1404
Author(s):  
M. Markovic ◽  
B. Glisic ◽  
M. Petronijevic
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Functional Status ◽  
Joint Damage ◽  
Control Group ◽  
Antibody Concentration ◽  
Open Label ◽  
Positive Correlation ◽  
Number Of Patients ◽  
Peptide Antibodies

Background:Antibodies directed against carbamylated proteins (anti-CarP) have been recently introduced for the first time as a new biomarker in rheumatoid arthritis (RA) (1). Their presence is predictive for the development of RA (2). Anti-CarP antibodies are associated with the development of more severe forms of the disease in overall and anti-citrullinated peptide antibodies negative population of patients with RA (3). In the literature is still current the research which associate these antibodies with disease activity and functional status of patients.Objectives:This study investigated the incidence of anti-CarP positive findings in patients with RA on synthetic and biologic disease-modifying therapy (DMT) and the relationship between anti-CarP antibody status and both disability and disease activity.Methods:It was an open-label, observational, cross-sectional study. The trial included 70 patients with RA diagnosed on the basis of ACR 1987 and ACR / EULAR 2010 criteria, on treatment with synthetic and biological DMT, who attended the Clinic of Rheumatology, Military Medical Academy, from September to December 2018.The control group consisted of 18 healthy individuals. After approval of the institutional Ethical Committee and after patients have signed Informed Consent,the study was conducted. Disease activity score (DAS28) was determined for the assessment of RA activity, and the assessment of patients’ functional ability was performed using the Health assessment questionnaire disability index (HAQ-DI). Concentration of anti-CarP antibodies was determined by commercial ELISA anti-CarP quantitative sandwich immunoassay. The methods of descriptive and analytical statistics were used in statistical data processing.Results:Based on the cut-off value (5.9 ng / ml), no one in the control group had positive anti-CarP antibodies, while 34.7% of the subjects with RA were positive. The positive correlation was found between anti-CarP antibody concentration and DAS28 in all RA patients (p = 0.0003; Pearson r = 0.4829). The positive correlation was also found between anti-CarP antibody concentration and HAQ-DI in all RA patients (p = 0.0003; Pearson r = 0.4253).Conclusion:Anti-CarP antibodies were present in a significant number of patients with RA. This study demonstrated that patients with RA with higher concentrations of anti-CarP antibodies have higher disease activity and impaired functional status. It is undisputed that further and larger studies are needed to better determine the clinical significance of these antibodies.References:[1]Shi J, Knevel R et al. Autoantibodies recognizing carbamylated proteins are present in sera of patients with rheumatoid arthritis and predict joint damage. Proc Natl AcadSci U S A. 2011 Oct 18;108(42):17372-7.[2]Yee A, Webb T et al. Anti-CarP antibodies as promising marker to measure joint damage and disease activity in patients with rheumatoid arthritis. Immunol Res. 2015 Feb;61(1-2):24-30.[3]Brink M, Verheul MK et al. Anti-carbamylated protein antibodies in thepresymptomatic phase of rheumatoid arthritis, their relationship with multiple anticitrulline peptide antibodies and association with radiological damage. Arthritis Res Ther. 2015 Feb 7;17:25.Graphs 1 and 2.Correlation of anti-CarP antibody concentration with DAS28 and HAQ-DI in all RA patientsDisclosure of Interests:None declared

scholarly journals Metabolic aspects of clinical remission prediction from baseline blood gene expression in patients with rheumatoid arthritis treated with methotrexate

2019 ◽  
Vol 13 (2) ◽  
pp. 47-54
Author(s):  
E. V. Chetina ◽  
N. V. Demidova ◽  
G. A. Markova
Keyword(s):  
Rheumatoid Arthritis ◽  
Gene Expression ◽  
Disease Activity ◽  
Clinical Remission ◽  
Structural Changes ◽  
Caspase 3 ◽  
Unknown Etiology ◽  
Control Group ◽  
Healthy Individuals ◽  
Number Of Patients

Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology, which is characterized by chronic erosive arthritis (synovitis) and systemic inflammation of the viscera. Methotrexate (MTX) is the drug of choice for RA treatment. However, it is currently impossible to predict the efficacy of MTX in a particular patient; the drug fails to produce the desired effect or causes adverse reactions in a considerable number of patients. The identification of patients who are responsive to MTX could significantly improve the results of therapy.Objective: to investigate the specific features of baseline (pretreatment) expression of genes responsible for major metabolic and energy production pathways in RA patients with different disease activity and to identify the genes, the baseline expression of which could serve as a predictor for remission attainment.Patients and methods. Blood from 40 RA patients (mean age 47.5 years; mean disease duration 7.9 weeks) who had not previously received MTX and 26 healthy donors (mean age 45.1 years). All the patients had used MTX (15 mg/week) for 2 years. Clinical response was evaluated by DAS28 and the serum levels of anti-cyclic citrullinated peptide antibodies, C-reactive protein, and rheumatoid factor. Remission was diagnosed according to ACR/EULAR and DAS28 (DAS28 <2.6). Joint structural changes were radiographically evaluated. Gene expression was determined in peripheral blood cells by real-time reverse transcriptase-polymerase chain reaction. A control group consisted of 26 randomly recruited gender- and sex-matched patients without autoimmune diseases and a family history.Results and discussion. MTX treatment significantly decreased disease activity according to DAS28. At the end of the investigation, the majority of patients had moderate disease activity (3.2≤ DAS28 ≤5.1), 4 had high disease activity, while 12 attained remission (DAS28 <2.6). Gene expression analysis showed that RA patients who had achieved clinical remission after MTX therapy displayed higher baseline expression of the genes associated with glycolysis (Glut1, PKM), inflammation (TNF-α), autophagy (ULK1), apoptosis (caspase 3, p21), and hypoxia (HIF1α), compared with patients who had not attained remission and with healthy individuals. In addition, in patients who had achieved remission, the baseline expression of the CD1 gene was significantly higher than in healthy individuals, while in the remaining patients the expression of this gene was significantly lower than in the controls. While the disease activity remained high, the baseline expression of the p21, caspase 3, TGFβ1, and RUNX2 genes was significantly lower than in healthy individuals and other patients with RA.Conclusion. Remission achievement in RA patients who had not previously received MTX was associated with higher baseline (pretreatment) gene expression associated with glycolytic activity, inflammation, autophagy, apoptosis, and hypoxia compared with patients who failed to attain remission. Elevated baseline expression of the CD1 gene compared with that in healthy individuals may serve as a predictor of sensitivity to MT therapy. 

scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

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