Early Remission Is a Realistic Target in a Majority of Patients with DMARD-naive Rheumatoid Arthritis

2016 ◽  
Vol 43 (4) ◽  
pp. 699-706 ◽  
Author(s):  
Tuomas Rannio ◽  
Juha Asikainen ◽  
Arto Kokko ◽  
Pekka Hannonen ◽  
Tuulikki Sokka
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Joint Disease ◽  
Treat To Target ◽  
Sustained Remission ◽  
Duration Of Symptoms ◽  
Erosive Disease ◽  
Rheumatology Clinic ◽  
Patient Reported ◽  
Remission Rates

Objective.We analyzed remission rates at 3 and 12 months in patients with rheumatoid arthritis (RA) who were naive for disease-modifying antirheumatic drugs (DMARD) and who were treated in a Finnish rheumatology clinic from 2008 to 2011. We compared remission rates and drug treatments between patients with RA and patients with undifferentiated arthritis (UA).Methods.Data from all DMARD-naive RA and UA patients from the healthcare district were collected using software that includes demographic and clinical characteristics, disease activity, medications, and patient-reported outcomes. Our rheumatology clinic applies the treat-to-target principle, electronic monitoring of patients, and multidisciplinary care.Results.Out of 409 patients, 406 had data for classification by the 2010 RA criteria of the American College of Rheumatology/European League Against Rheumatism. A total of 68% were female, and mean age (SD) was 58 (16) years. Respectively, 56%, 60%, and 68% were positive for anticyclic citrullinated peptide antibodies (anti-CCP), rheumatoid factor (RF), and RF/anti-CCP, and 19% had erosive disease. The median (interquartile range) duration of symptoms was 6 (4–12) months. A total of 310 were classified as RA and 96 as UA. The patients with UA were younger, had better functional status and lower disease activity, and were more often seronegative than the patients with RA. The 28-joint Disease Activity Score (3 variables) remission rates of RA and UA patients at 3 months were 67% and 58% (p = 0.13), and at 12 months, 71% and 79%, respectively (p = 0.16). Sustained remission was observed in 57%/56% of RA/UA patients. Patients with RA used more conventional synthetic DMARD combinations than did patients with UA. None used biological DMARD at 3 months, and only 2.7%/1.1% of the patients (RA/UA) used them at 12 months (p = 0.36).Conclusion.Remarkably high remission rates are achievable in real-world DMARD-naive patients with RA or UA.

scholarly journals Sex-related differences in clinical characteristics and comorbidities and their impact on clinical outcome in Korean patients with rheumatoid arthritis

2020 ◽  
Author(s):  
Seunghwan Shin ◽  
Eun Hye Park ◽  
Eun Ha Kang ◽  
Yun Jong Lee ◽  
Yeong Wook Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Outcome ◽  
Disease Activity ◽  
Clinical Remission ◽  
Clinical Characteristics ◽  
Sustained Remission ◽  
Erosive Disease ◽  
Korean Patients ◽  
Patient Reported ◽  
Active Disease

Abstract Backgrounds: Rheumatoid arthritis (RA) is more prevalent in women and prior studies have reported several epidemiologic differences between sex and low achievement of remission in women RA. However, these sex differences across various populations remain incompletely understood. This study aimed to elucidate sex-related differences in clinical characteristics and their potential impact on clinical outcome in a large Korean cohort of patients with RA. Methods In total, 5,376 RA patients from the KORean Observational study Network for Arthritis (KORONA) database were examined at baseline and for 3 consecutive years using the disease activity score 28 (DAS28), health assessment questionnaire (HAQ), and health-related outcomes. Within a subgroup with active disease (DAS28 ≥ 3.2) at baseline, sex impacts on clinical outcome during a 3-year period were analyzed using generalized estimating equation (GEE) models. The sex effect on achieving clinical remission was analyzed using Cox-proportional hazard regression. Results At baseline, women (n = 4,574) were younger and had more erosive disease and longer disease duration than men (n = 802) with significantly higher scores in DAS28, HAQ, and patient-reported outcomes. The prevalence of interstitial lung disease, cardiovascular disease, and diabetes in men was significantly higher than that of women. In a RA subgroup with active disease at baseline, a GEE analysis demonstrated that sex significantly influenced the rate of change of DAS28 (p = 0.035) over time. In that group, men are associated with achieving DAS28 sustained remission as well as point remission (both p < 0.001). Conclusion Most comorbidities were more prevalent in men than in women among Korean patients with RA. However, for RA-related clinical outcomes, the longitudinal change in disease activity and the rate of achieving clinical remission were found to be worse in women RA. Therefore, sex-related differences should be considered when managing RA patients.

scholarly journals FRI0020 CLINICAL TREATMENT RESPONSE STILL DOES NOT MATCH PATIENT REPORTED IMPROVEMENT, EVEN IN EARLY RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Sustained Remission ◽  
Research Support ◽  
Early Ra ◽  
Severity Scores ◽  
Patient Reported ◽  
Over Time

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

scholarly journals Patient-reported Outcomes as Predictors of Change in Disease Activity and Disability in Early Rheumatoid Arthritis: Results from the Yorkshire Early Arthritis Register

2017 ◽  
Vol 44 (9) ◽  
pp. 1331-1340 ◽  
Author(s):  
Sarah Twigg ◽  
Elizabeth M.A. Hensor ◽  
Paul Emery ◽  
Alan Tennant ◽  
Ann W. Morgan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Multilevel Models ◽  
Early Arthritis ◽  
Joint Disease ◽  
Symptom Duration ◽  
Rates Of Change ◽  
Patient Reported ◽  
Predictors Of Change

Objective.To assess patient-reported variables as predictors of change in disease activity and disability in early rheumatoid arthritis (RA).Methods.Cases were recruited to the Yorkshire Early Arthritis Register (YEAR) between 1997 and 2009 (n = 1415). Predictors of the 28-joint Disease Activity Score (DAS28) and the Health Assessment Questionnaire-Disability Index (HAQ-DI) at baseline and change over 12 months were identified using multilevel models. Baseline predictors were sex, age, symptom duration, autoantibody status, pain and fatigue visual analog scales (VAS), duration of early morning stiffness (EMS), DAS28, and HAQ-DI.Results.Rates of change were slower in women than men: DAS28 fell by 0.19 and 0.17 units/month, and HAQ-DI by 0.028 and 0.023 units/month in men and women, respectively. Baseline pain and EMS had small effects on rates of change, whereas fatigue VAS was only associated with DAS28 and HAQ-DI at baseline. In patients recruited up to 2002, DAS28 reduced more quickly in those with greater pain at baseline (by 0.01 units/mo of DAS28 per cm pain VAS, p = 0.024); in patients recruited after 2002, the effect for pain was stronger (by 0.01 units/mo, p = 0.087). DAS28 reduction was greater with longer EMS. In both cohorts, fall in HAQ-DI (p = 0.006) was greater in patients with longer EMS duration, but pain and fatigue were not significant predictors of change in HAQ-DI.Conclusion.Patient-reported fatigue, pain, and stiffness at baseline are of limited value for the prediction of RA change in disease activity (DAS28) and activity limitation (HAQ-DI).

scholarly journals Is treat-to-target really working in rheumatoid arthritis? a longitudinal analysis of a cohort of patients treated in daily practice (RA BIODAM)

2020 ◽  
Vol 79 (4) ◽  
pp. 453-459 ◽  
Author(s):  
Sofia Ramiro ◽  
Robert BM Landewé ◽  
Désirée van der Heijde ◽  
Alexandre Sepriano ◽  
Oliver FitzGerald ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Index ◽  
Disease Activity Index ◽  
Daily Clinical Practice ◽  
Joint Disease ◽  
Activity Score ◽  
Treat To Target

ObjectivesTo investigate whether following a treat-to-target (T2T)-strategy in daily clinical practice leads to more patients with rheumatoid arthritis (RA) meeting the remission target.MethodsRA patients from 10 countries starting/changing conventional synthetic or biological disease-modifying anti-rheumatic drugs were assessed for disease activity every 3 months for 2 years (RA BIODAM (BIOmarkers of joint DAMage) cohort). Per visit was decided whether a patient was treated according to a T2T-strategy with 44-joint disease activity score (DAS44) remission (DAS44 <1.6) as the target. Sustained T2T was defined as T2T followed in ≥2 consecutive visits. The main outcome was the achievement of DAS44 remission at the subsequent 3-month visit. Other outcomes were remission according to 28-joint disease activity score-erythrocyte sedimentation rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definitions. The association between T2T and remission was tested in generalised estimating equations models.ResultsIn total 4356 visits of 571 patients (mean (SD) age: 56 (13) years, 78% female) were included. Appropriate application of T2T was found in 59% of the visits. T2T (vs no T2T) did not yield a higher likelihood of DAS44 remission 3 months later (OR (95% CI): 1.03 (0.92 to 1.16)), but sustained T2T resulted in an increased likelihood of achieving DAS44 remission (OR: 1.19 (1.03 to 1.39)). Similar results were seen with DAS28-ESR remission. For more stringent definitions (CDAI, SDAI and ACR/EULAR Boolean remission), T2T was consistently positively associated with remission (OR range: 1.16 to 1.29), and sustained T2T had a more pronounced effect on remission (OR range: 1.49 to 1.52).ConclusionIn daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher rates of remission.

scholarly journals Comparative analyses of responsiveness between the Rheumatoid Arthritis Impact of Disease score, other patient-reported outcomes and disease activity measures: secondary analyses from the ARCTIC study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000754 ◽  
Author(s):  
Karen Holten ◽  
Joseph Sexton ◽  
Tore K Kvien ◽  
Anna-Birgitte Aga ◽  
Espen A Haavardsholm
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inflammatory Markers ◽  
Disease Duration ◽  
Treat To Target ◽  
Patient Reported ◽  
Short Disease Duration ◽  
Activity Measures ◽  
The Mean ◽  
Disease Activity Measures

ObjectiveTo evaluate the responsiveness of the Rheumatoid Arthritis Impact of Disease (RAID) score compared with other patient-reported outcome measures (PROMs), inflammatory markers and clinical disease activity measures in patients with early rheumatoid arthritis (RA).MethodsDisease-modifying antirheumatic drug–naïve patients with RA with short disease duration were included in the treat-to-target ARCTIC trial and followed for 24 months. The responsiveness of the RAID score was evaluated using standardised response mean (SRM) and relative efficiency (RE) with respect to tender joints by Ritchie Articular Index (RAI). SRMs and REs were also calculated for other PROMs, inflammatory markers and clinical outcome measures. An SRM with value above 0.80 was considered high.Results230 patients with RA were included. The mean±SD symptom duration was 7.1±5.4 months and the baseline mean±SD  RAID score was 4.49±2.14. At 3 months of follow-up, the mean±SD change score for RAID was −2.25±1.98  and the SRM (95%  CI) −1.13 (−1.33 to −0.96). The RAID score showed high responsiveness both at 3 and 6 months (SRM≥0.80) and was more sensitive in detecting change than the reference, tender joints assessed by RAI.ConclusionsThe RAID score proved to be highly responsive to change in patients with RA with short disease duration who followed a treat-to-target strategy. The RAID score was more efficient in detecting change than the reference (RAI) as well as most other PROMs.

scholarly journals Barriers to treatment optimization and achievement of patients’ goals: perspectives from people living with rheumatoid arthritis enrolled in the ArthritisPower registry

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Kelly Gavigan ◽  
W. Benjamin Nowell ◽  
Mylene S. Serna ◽  
Jeffrey L. Stark ◽  
Mohamed Yassine ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Online Survey ◽  
Treatment Decisions ◽  
Treat To Target ◽  
Measurement Information ◽  
Treatment Goals ◽  
Barriers To Treatment ◽  
Treatment Optimization ◽  
Patient Reported

Abstract Background Few studies have investigated patients’ own treatment goals in rheumatoid arthritis (RA). The objective of this real-world, cross-sectional study of US patients with RA was to identify factors that patients believed influenced their physician’s treatment decisions. Secondary objectives included reasons patients tolerated sub-optimal disease control and their perceived barriers to treatment optimization. Methods Eligible participants were enrolled in the ArthritisPower registry, ≥ 19 years, had physician-diagnosed RA, unchanged treatment within 3 months of baseline, prior/current disease-modifying antirheumatic drug treatment (DMARDs), and computer/smartphone access. In December 2017, participants completed Patient-Reported Outcomes Measurement Information System-Computerized Adaptive Tests (PROMIS-CAT) for pain interference, fatigue, sleep disturbance, and physical function. Routine Assessment of Patient Index Data 3 (RAPID3) provided disease activity scores (0–30). Participants completed an online survey on barriers to treatment optimization, including self-perception of disease compared to RAPID3/PROMIS scores. Results A total of 249 participants met inclusion criteria and completed the survey. Mean age (SD) was 52 (11) years, and the majority were female (92%) with high RAPID3 disease activity (175/249 [70%]; median score 18). The main reason participants did not change treatment was their physician’s recommendation (66%; n = 32). Of participants with high RAPID3 disease activity, 66 (38%) were offered a treatment change; 19 (29%) of whom declined the change. Most participants who intensified treatment did so because their symptoms had remained severe or worsened (51%; n = 33); only 16 (25%) participants intensified because they had not reached a specified treatment goal. Among participants who self-reported their disease activity as “none/low” or “medium” (n = 202; 81% of cohort), most still had RAPID3 high disease activity (137/202 [68%]; score > 12). Most PROMIS scores showed moderate agreement with participants’ self-assessment of health status, in contrast to RAPID3 (weighted kappa: 0.05 [95% CI − 0.01, 0.11]). Conclusions Most participants trusted their rheumatologist’s treatment decisions and prioritized their physician’s treatment goals over their own. Patients should be encouraged to share their treatment goals/expectations with their rheumatologist, in line with the treat-to-target approach. RAPID3 may be inappropriate for setting patient-centric treatment goals given the poor agreement with self-reported disease activity; most PROMIS scores showed better alignment with patients’ own assessments.

The Effect of Different Remission Definitions on Identification of Predictors of Both Point and Sustained Remission in Rheumatoid Arthritis Treated with Anti-TNF Therapy

2014 ◽  
Vol 41 (8) ◽  
pp. 1607-1613 ◽  
Author(s):  
Cheryl Barnabe ◽  
Joanne Homik ◽  
Susan G. Barr ◽  
Liam Martin ◽  
Walter P. Maksymowych
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Joint Disease ◽  
Tender Joint Count ◽  
Sustained Remission ◽  
Tender Joint ◽  
Cross Sectional ◽  
Das28 Remission

Objective.Predictors of remission in rheumatoid arthritis (RA) have been defined in cross-sectional analyses using the 28-joint Disease Activity Score (DAS28), but not with newer composite disease activity measures or using the more clinically relevant state of sustained remission. We have evaluated predictors of remission using cross-sectional and longitudinal durations of disease state, and by applying additional definitions of remission [American College of Rheumatology/European League Against Rheumatism Boolean, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI)].Methods.Individuals in the Alberta Biologics Pharmacosurveillance Program were classified for the presence of remission (point and/or sustained > 1 yr) by each of the 4 definitions. Multivariate models were constructed including all available variables in the dataset and refined to optimize model fit and predictive ability to calculate OR for remission.Results.Nonsmoking status independently predicted point remission by all definitions (OR range 1.20–2.71). Minority ethnicity decreased odds of remission by DAS28 (OR 0.13) and CDAI (OR 0.09) definitions. Male sex was associated with DAS28 remission (OR 2.85), whereas higher baseline physician global (OR 0.67) and erythrocyte sedimentation rate values (OR 0.98) decreased odds of DAS28 remission. Higher baseline patient global score (OR 0.77) and swollen joint counts (OR 0.93) were negative predictors for CDAI remission. Higher baseline Health Assessment Questionnaire (OR 0.62) reduced odds for remission by the SDAI definition, and educational attainment increased these odds (OR 2.13). Sustained remission was negatively predicted by baseline physician global for the DAS28 (OR 0.80), and higher tender joint count (OR 0.96) for the CDAI.Conclusion.We demonstrate the influence of duration of remission state and remission definition on defining independent predictors for remission in RA requiring anti-tumor necrosis factor therapy. These predictors offer improved applicability for modern rheumatology practice.

scholarly journals Is Tightly Controlled Disease Activity Possible with Online Patient-reported Outcomes?

2014 ◽  
Vol 41 (4) ◽  
pp. 640-647 ◽  
Author(s):  
Margot J. Walter ◽  
S.H. Mohd Din ◽  
Johanna M. Hazes ◽  
E. Lesaffre ◽  
P.J. Barendregt ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Cross Validation ◽  
Activity Index ◽  
Joint Modeling ◽  
Joint Disease ◽  
Rheumatoid Arthritis Disease ◽  
Patient Reported ◽  
Over Time

Objective.To evaluate the performance of patient-reported outcomes (PRO) as primary indices for identification and prediction of a 28-joint Disease Activity Score (DAS28) > 3.2 among patients with rheumatoid arthritis (RA).Methods.Patients with RA completed monthly online PRO [Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI), visual analog scale (VAS) fatigue] and were clinically assessed every 3 months using the DAS28. Simple descriptive statistics, logistic regression, and the Bayesian joint modeling approach were used to analyze the data. The Bayesian joint model combines the scores and changes in the scores of 3 PRO to predict a DAS28 > 3.2 at the subsequent timepoint.Results.A group of 159 patients with RA participated. Stratified summaries of the PRO by DAS28 categories at baseline provided incremental values of the PRO for more active disease. However, on an individual level, the DAS28 and the PRO fluctuated over time. The prediction of subsequent DAS score by a single instrument at single timepoints resulted in moderate sensitivity and specificity. Using the intercept and slope of the combined PRO of the first 3 measurements to predict the DAS28 state at 3 months resulted in a sensitivity of 0.81 and a specificity of 0.92. After 10-fold cross validation, the model had a sensitivity of 0.61 and specificity of 0.75 to identify patients with a DAS28 > 3.2.Conclusion.PRO showed fluctuating levels of disease activity over time, while on a group level disease activity stayed the same. Using the changes in RADAI, HAQ, and VAS fatigue over time to predict future DAS28 > 3.2 resulted in moderate performance after the internal cross-validation of the model (sensitivity 0.61, specificity 0.75).

The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis

2016 ◽  
Vol 43 (7) ◽  
pp. 1268-1277 ◽  
Author(s):  
Piotr Wiland ◽  
Jean Dudler ◽  
Douglas Veale ◽  
Hasan Tahir ◽  
Ron Pedersen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Group Versus ◽  
Treatment Withdrawal ◽  
Joint Disease ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Patient Reported

Objective.An analysis of a clinical trial to assess the effects of treatment reduction and withdrawal on patient-reported outcomes (PRO) in patients with early, moderate to severe rheumatoid arthritis (RA) who achieved 28-joint Disease Activity Score (DAS28) low disease activity (LDA) or remission with etanercept (ETN) plus methotrexate (MTX) therapy.Methods.During treatment induction, patients received open-label ETN 50 mg weekly plus MTX for 52 weeks. In the reduced-treatment phase, patients with DAS28-erythrocyte sedimentation rate (ESR) ≤ 3.2 at Week 39 and DAS28-ESR < 2.6 at Week 52 in the open-label phase were randomized to double-blind treatment with ETN 25 mg plus MTX, MTX, or placebo (PBO) for 39 weeks (weeks 0–39). In the third phase, patients who achieved DAS28 remission (DAS28-ESR < 2.6) or LDA (2.6 ≤ DAS28-ESR ≤ 3.2) at Week 39 in the double-blind phase had all treatment withdrawn and were observed for an additional 26 weeks (weeks 39–65).Results.Of the 306 patients enrolled, 193 were randomized in the double-blind phase and 131 participated in the treatment-withdrawal phase. After reduction or withdrawal of ETN 50 mg/MTX, patients reduced to ETN 25 mg/MTX experienced slight, nonsignificant declines in the majority of PRO measures, whereas switching to PBO or MTX alone caused significant declines. Presenteeism and activity impairment scores were significantly better in the ETN reduced-dose group versus MTX monotherapy and PBO at Week 39 (p ≤ 0.05).Conclusion.In patients with early RA who achieved remission while receiving full-dose ETN/MTX, continuing combination therapy at a lower dose did not cause a significant worsening of PRO response, but switching to MTX alone or PBO did.ClinicalTrials.govidentifier:NCT00913458.

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