Ten-year Followup of Infliximab Therapy in Rheumatoid Arthritis Patients with Severe, Longstanding Refractory Disease: A Cohort Study

2014 ◽  
Vol 41 (7) ◽  
pp. 1276-1281 ◽  
Author(s):  
Filip De Keyser ◽  
Joris De Kock ◽  
Hermine Leroi ◽  
Patrick Durez ◽  
René Westhovens ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Control ◽  
Health Assessment ◽  
Pain Scale ◽  
Joint Disease ◽  
Study Cohort ◽  
Patient Pain ◽  
Baseline Characteristics ◽  
Reported Data

Objective.Our study describes the 10-year followup data of the Belgian Expanded Access Program (EAP) for infliximab (IFX), which included patients with active rheumatoid arthritis who were refractory to methotrexate. The objectives of the study were to evaluate the continuation rate, reasons for discontinuation, and longterm disease control under IFX treatment, and to study baseline characteristics associated with longterm successful IFX therapy.Methods.Between February 2000 and September 2001, 511 patients were enrolled in the Belgian IFX EAP, and 507 effectively started IFX therapy. Previously reported data showed that 160 patients were still treated with IFX after 7 years of followup. We describe the therapy status, reasons for IFX discontinuation, and the level of disease activity of this subgroup after 10 years of followup. Baseline characteristics of the total EAP cohort were used to describe variables associated with longterm successful IFX treatment.Results.After 10 years of followup, 110 of the 507 patients (21.7%) were still receiving IFX treatment. In the 7-year to 10-year period, which is the focus of the current study, 16 patients were lost to followup and 34 patients discontinued IFX treatment, mainly because of loss of efficacy. Patients successfully treated with IFX for 10 years had lower baseline values for 28-joint Disease Activity Score (DAS28), patient pain scale, physician visual analog scale, and Health Assessment Questionnaire in comparison with the rest of the study cohort. The mean DAS28 level of the subgroup still taking IFX after 10 years was 2.55 ± 1.01.Conclusion.In the Belgian EAP, 21.7% of patients continued to receive maintenance IFX treatment after 10 years of followup. IFX provided good longterm disease control in these patients.

scholarly journals Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

2019 ◽  
Vol 78 (12) ◽  
pp. 1609-1615 ◽  
Author(s):  
Daniel Aletaha ◽  
Jen-fue Maa ◽  
Su Chen ◽  
Sung-Hwan Park ◽  
Dave Nicholls ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Response To Therapy ◽  
Joint Disease ◽  
Adalimumab Therapy ◽  
Disease Modifying

ObjectivesTo determine if disease duration and number of prior disease-modifying antirheumatic drugs (DMARDs) affect response to therapy in patients with established rheumatoid arthritis (RA).MethodsAssociations between disease duration or number of prior DMARDs and response to therapy were assessed using data from two randomised controlled trials in patients with established RA (mean duration, 11 years) receiving adalimumab+methotrexate. Response to therapy was assessed at week 24 using disease activity outcomes, including 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)), Simplified Disease Activity Index (SDAI) and Health Assessment Questionnaire Disability Index (HAQ-DI), and proportions of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses.ResultsIn the larger study (N=207), a greater number of prior DMARDs (>2 vs 0–1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24. RA duration of >10 years versus <1 year was associated with higher HAQ-DI scores (1.1 vs 0.7) at week 24, but results on DAS28(CRP) and SDAI were mixed. A greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates at week 24. Data from the second trial (N=67) generally confirmed these findings.ConclusionsNumber of prior DMARDs and disease duration affect responses to therapy in patients with established RA. Furthermore, number of prior DMARDs, regardless of disease duration, has a limiting effect on the potential response to adalimumab therapy.

scholarly journals Predictors of Flares in Patients with Rheumatoid Arthritis Who Exhibit Low Disease Activity: A Nationwide Cohort Study

2020 ◽  
Vol 9 (10) ◽  
pp. 3219
Author(s):  
Yoon-Jeong Oh ◽  
Ki Won Moon
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Health Assessment ◽  
Joint Disease ◽  
Low Disease Activity ◽  
Cox Regression Analysis ◽  
Vas Score ◽  
Analogue Scales ◽  
Assessment Questionnaire

Using nationwide cohort data, this study evaluated predictors of flares in patients with rheumatoid arthritis (RA) who exhibit low disease activity (LDA) and the effects of flares on clinical outcomes. The Korean Observational Study Network for Arthritis (KORONA) registry is a nationwide Korean RA-specific cohort registry that collects data annually from 5.077 patients, with RA in 23 centers across South Korea. This study used data from 1.717 patients with RA who exhibited LDA [28–joint disease activity score (DAS28) < 3.2] at enrollment. Flares were defined as an increase in DAS28, compared with the previous value of > 1.2 or > 0.6, if the concurrent DAS28 was ≥ 3.2. Cox regression analysis was used to identify baseline predictors of flares. Of the 1.717 patients with RA, 566 (33.0%) experienced flares during the 2-year study period. An analysis of baseline characteristics of flare and non-flare groups revealed that more women and non-smokers were present in the flare group than in the non-flare group; the flare group also had higher scores on physician’s and patient’s pain and fatigue visual analogue scales (VAS) and the health assessment questionnaire (HAQ). In a multivariate analysis, physician’s VAS score, hemoglobin level, and HAQ score were significant predictors of flares. A high physician’s VAS score, low hemoglobin, and high HAQ score at baseline were significant predictors of flares in patients with RA who exhibited LDA.

scholarly journals Has the Severity of Rheumatoid Arthritis at Presentation Diminished Over Time?

2014 ◽  
Vol 41 (8) ◽  
pp. 1590-1599 ◽  
Author(s):  
Janet G. Diffin ◽  
Mark Lunt ◽  
Tarnya Marshall ◽  
Jacqueline R. Chipping ◽  
Deborah P.M. Symmons ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Drug Exposure ◽  
Functional Disability ◽  
Health Assessment ◽  
Joint Disease ◽  
Symptom Duration ◽  
Recent Onset ◽  
American College Of Rheumatology ◽  
Over Time

Objective.To examine the pattern of disease severity in patients with rheumatoid arthritis (RA) at presentation to the Norfolk Arthritis Register (NOAR) over 20 years.Methods.NOAR is a primary-care–based cohort of patients with recent-onset inflammatory polyarthritis. At baseline, subjects are assessed and examined by a research nurse. The Health Assessment Questionnaire (HAQ) is administered and the DAS28 (28-joint Disease Activity Score) is calculated. Information is collected on disease-modifying antirheumatic drug exposure. In this study, patients (symptom duration of < 2 years at baseline) were grouped into 4 cohorts (Cohort 1: 1990–1994; Cohort 2: 1995–1999; Cohort 3: 2000–2004; Cohort 4: 2005–2008). The American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for RA were applied retrospectively at baseline. Regression analyses were used to examine whether calendar year of presentation to NOAR was associated with baseline HAQ and DAS28 scores. Potential confounders included age at symptom onset, sex, rheumatoid factor, and anticyclic citrullinated peptide antibody positivity.Results.A total of 1724 patients met the ACR/EULAR 2010 RA criteria at baseline. Unadjusted mean DAS28 scores decreased over time. Calendar year of presentation to NOAR was significantly associated with lower DAS28 scores over time [Y = 4.51 + (–0.56 × year) + (0.44 × year2)]. Although unadjusted median HAQ scores increased over time, calendar year of presentation to NOAR was not significantly associated with HAQ scores [Y = (1.1) + (0.023 × year) + (0.05 × year2)]. Similar results were observed in each subpopulation of patients.Conclusion.While baseline disease activity has lessened slightly over time, there has been no improvement in baseline levels of functional disability.

Differences in Predictive Factors for Sustained Clinical Remission with Abatacept Between Younger and Elderly Patients with Biologic-naive Rheumatoid Arthritis: Results from the ABROAD Study

2016 ◽  
Vol 43 (11) ◽  
pp. 1974-1983 ◽  
Author(s):  
Masahiro Sekiguchi ◽  
Takao Fujii ◽  
Kiyoshi Matsui ◽  
Kosaku Murakami ◽  
Satoshi Morita ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Elderly Patients ◽  
Disease Activity ◽  
Predictive Factors ◽  
Clinical Remission ◽  
Health Assessment ◽  
The Elderly ◽  
Joint Disease ◽  
Younger Patients ◽  
Reactive Protein

Objective.To differentiate predictive factors for sustained clinical remission between elderly and younger patients with rheumatoid arthritis (RA) receiving abatacept (ABA) as an initial biological disease-modifying antirheumatic drug.Methods.The study involved 277 biologic-naive patients with RA with high or moderate disease activity, who were treated with intravenous ABA and evaluated for 48 weeks in 43 Japanese hospitals and rheumatology clinics (the ABatacept Research Outcomes as a First-line Biological Agent in the Real WorlD study: UMIN000004651). Predictive factors associated with sustained clinical remission defined by the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) during the 24–48–week or 36–48–week periods were determined in elderly (≥ 65 yrs, n = 148) and younger patient groups (< 65 yrs, n = 129) using logistic regression analysis.Results.Clinical remission was achieved at 24 and 48 weeks in 35.1% and 36.5% of patients in the elderly group and 34.9% and 43.4% in the younger group, respectively. In elderly patients, anticitrullinated protein antibody (ACPA) positivity and a lower DAS28-CRP score were significantly associated with sustained clinical remission; however, a lower Health Assessment Questionnaire-Disability Index (HAQ-DI) score was not related to sustained clinical remission. In younger patients, lower DAS28-CRP and HAQ-DI scores were predictive factors for sustained clinical remission, whereas ACPA positivity was not a useful predictive factor for sustained clinical remission.Conclusion.Although the effectiveness of ABA in biologic-naive patients with RA was equally recognized in elderly and younger patients, the baseline clinical characteristics associated with sustained clinical remission were substantially different.

Five-year Favorable Outcome of Patients with Early Rheumatoid Arthritis in the 2000s: Data from the ESPOIR Cohort

2013 ◽  
Vol 40 (10) ◽  
pp. 1650-1657 ◽  
Author(s):  
Bernard Combe ◽  
Nathalie Rincheval ◽  
Joelle Benessiano ◽  
Francis Berenbaum ◽  
Alain Cantagrel ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Radiographic Progression ◽  
Health Assessment ◽  
Daily Practice ◽  
Joint Disease ◽  
Early Ra ◽  
American College Of Rheumatology ◽  
Biologic Dmard

Objective.To report the 5-year outcome of a large prospective cohort of patients with very early rheumatoid arthritis (RA), and to identify factors predictive of outcome.Methods.Patients were recruited if they had early arthritis of < 6 months’ duration, had a high probability of developing RA, and had never been prescribed disease-modifying antirheumatic drugs (DMARD) or steroids. Logistic regression analysis was used to determine factors that predict outcome.Results.We included 813 patients from December 2002 to April 2005. Age was 48.1 ± 12.6 years, delay before referral 103.1 ± 52.4 days, 28-joint Disease Activity Score (DAS28) 5.1 ± 1.3, Health Assessment Questionnaire (HAQ) 1.0 ± 0.7; 45.8% and 38.7% had rheumatoid factor or antibodies to cyclic citrullinated peptide (anti-CCP), respectively; 22% had hand or foot erosions; 78.5% fulfilled the American College of Rheumatology/European League Against Rheumatism criteria for RA at baseline and 93.8% during followup. At 5 years, 573 patients were evaluated. The outcome was mild for most patients: disease activity (median DAS28 = 2.5) and HAQ disability (median 0.3) were well controlled over time; 50.6% achieved DAS28 remission and 64.7% low disease activity. Radiographic progression was low (2.9 Sharp unit/year) and only a few patients required joint surgery. Nevertheless, some patients developed new comorbidities. During the 5 years, 82.7% of patients had received at least 1 DMARD (methotrexate, 65.9%), 18.3% a biological DMARD, and about 60% prednisone at least once. Anti-CCP was the best predictor of remaining in the cohort for 5 years, of prescription of synthetic or biologic DMARD, and of radiographic progression.Conclusion.The 5-year outcome of an early RA cohort in the 2000s was described. Anti-CCP was a robust predictor of outcome. The generally good 5-year outcome could be related to early referral and early effective treatment, key processes in the management of early RA in daily practice.

Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study

2016 ◽  
Vol 43 (12) ◽  
pp. 2094-2100 ◽  
Author(s):  
Nemanja Damjanov ◽  
Malgorzata Tlustochowicz ◽  
Jacob Aelion ◽  
Maria Greenwald ◽  
Annette Diehl ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
B Cells ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Statistical Significance ◽  
Health Assessment ◽  
High Sensitivity ◽  
Joint Disease ◽  
Controlled Study ◽  
Double Blind

Objective.To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA).Methods.A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate. The primary endpoint was proportion of patients achieving 20% improvement from baseline at Week 16 by American College of Rheumatology criteria (ACR20). Other outcomes included 28-joint Disease Activity Score (DAS28)–C-reactive protein (CRP), physician’s and patient’s global assessments of disease activity (PGA and PtGA, respectively) and Health Assessment Questionnaire–Disability Index (HAQ-DI). Peripheral CD19+ B cells were measured by high-sensitivity flow cytometer. Statistical significance was set at 2-sided α 0.10 level.Results.The SBI/SBI/SBI group demonstrated significant improvement in ACR20 and DAS28-CRP from Week 8 onward, sustained improvement in CRP levels from Week 12 onward, and significant improvements in PGA and PtGA in weeks 16 through 24, and in HAQ-DI at Week 24. The SBI/Pbo/Pbo and SBI/SBI/Pbo groups did not meet the primary endpoint but demonstrated improvements in several secondary endpoints. All treatment groups exhibited depletion of peripheral CD19+ B cells throughout the study. Overall, 61.5% of patients receiving SBI-087 and 55.0% of patients receiving Pbo reported adverse events.Conclusion.SBI-087 effectively depleted peripheral CD20 B cells and was well tolerated. Improvements were consistently observed in the SBI/SBI/SBI group for the majority of efficacy and quality-of-life outcomes.

scholarly journals Abatacept Plus Methotrexate Provides Incremental Clinical Benefits Versus Methotrexate Alone in Methotrexate-naive Patients with Early Rheumatoid Arthritis Who Achieve Radiographic Nonprogression

2011 ◽  
Vol 38 (11) ◽  
pp. 2362-2368 ◽  
Author(s):  
ALVIN F. WELLS ◽  
RENE WESTHOVENS ◽  
DIANE MONIZ REED ◽  
LUCIANA FANTI ◽  
JEAN-CLAUDE BECKER ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Disease Activity Score ◽  
Health Assessment ◽  
Joint Damage ◽  
Joint Disease ◽  
Activity Score ◽  
Double Blind ◽  
American College Of Rheumatology

Objective.This article reports 1-year clinical outcomes in the subgroup of patients with rheumatoid arthritis in the Abatacept study to Gauge Remission and joint damage progression in methotrexate-naive patients with Early Erosive rheumatoid arthritis (AGREE) who achieved radiographic nonprogression at the end of the double-blind phase.Methods.Patients who achieved radiographic nonprogression (change from baseline in total Sharp score ≤ 0 at 12 months) with abatacept plus methotrexate (MTX) or MTX alone were eligible for this analysis. Clinical outcomes were remission, defined by 28-joint Disease Activity Score (DAS28) using C-reactive protein (CRP), low Disease Activity Score (LDAS), American College of Rheumatology (ACR) scores, physical function (Health Assessment Questionnaire), and tender and swollen joint counts. Safety was assessed at each visit.Results.Patients in the abatacept plus MTX and MTX monotherapy groups had similar baseline characteristics and were similar to the overall study population. The proportion of patients who achieved DAS28 (CRP) remission or LDAS was greater with abatacept plus MTX vs MTX alone [43.2% vs 22.7% (p < 0.001) and 57.4% vs 40.6% (p = 0.008), respectively]. More patients receiving abatacept plus MTX achieved key ACR responses, including major clinical response (27.3% vs 11.9%; p < 0.001). Safety profiles were similar in both treatment groups.Conclusion.More MTX-naive patients with early RA who achieved radiographic nonprogression taking abatacept plus MTX also achieved DAS28 (CRP)-defined remission and LDAS compared with patients who received MTX alone, supporting the use of abatacept as a first-line biologic in combination with disease-modifying antirheumatic drugs.

Longterm Followup of Rituximab Therapy in Patients with Rheumatoid Arthritis: Results from the Belgian MabThera in Rheumatoid Arthritis Registry

2014 ◽  
Vol 41 (9) ◽  
pp. 1761-1765 ◽  
Author(s):  
Filip De Keyser ◽  
Ilse Hoffman ◽  
Patrick Durez ◽  
Marie-Joëlle Kaiser ◽  
Rene Westhovens ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Control ◽  
Daily Practice ◽  
Lower Number ◽  
Joint Disease ◽  
Patient Profile ◽  
Lower Baseline ◽  
Longterm Treatment ◽  
Set Up

Objective.Our study reports the results of the MIRA (MabThera In Rheumatoid Arthritis) registry, set up to collect data about clinical usage, patient profile, and retention of rituximab (RTX) treatment in daily clinical practice in Belgium.Methods.Patients with active rheumatoid arthritis (RA) who failed at least 1 anti-tumor necrosis factor (anti-TNF) treatment were included in our study between November 2006 and October 2011. At baseline, demographics, medication, disease history, disease activity, rheumatoid factor (RF), and anticyclic citrullinated peptide antibodies (anti-CCP) status were recorded. Evolution of the 28-joint Disease Activity Score (DAS28)-erythrocyte sedimentation rate, retreatments, and reasons for therapy stop were followed prospectively.Results.The MIRA registry included 649 patients, with mean disease duration of 12.8 ± 0.4 years and DAS28 values at inclusion of 5.85 ± 0.48. Patients received on average 2.82 ± 0.07 (range 1–9) RTX treatments, over a mean followup period of 93.1 ± 2.6 weeks. At database lock, 433 patients (66.7%) were still under RTX treatment, 182 (28.0%) had stopped treatment, and 34 (5.2%) were lost to followup. Ineffectiveness (n = 108, 59%) and safety concerns (n = 39, 22%) were the most frequent reasons for discontinuing RTX therapy. From 2006 to 2011, RTX practice patterns clearly evolved toward RTX being started in patients with a lower number of previously failed anti-TNF drugs and lower baseline DAS28 values. A lower number of previous anti-TNF drugs, and positivity for RF and anti-CCP, predicted more successful longterm treatment. RTX treatment provided adequate longterm disease control.Conclusion.In our daily practice study, RTX provided good longterm disease control and treatment retention in refractory patients with RA. Over the years, rheumatologists tended to start this treatment in patients with fewer previous anti-TNF treatments and lower disease activity.

Sleep Disturbances and Interleukin 6 Receptor Inhibition in Rheumatoid Arthritis

2011 ◽  
Vol 39 (1) ◽  
pp. 60-62 ◽  
Author(s):  
KALLIOPI FRAGIADAKI ◽  
MARIA G. TEKTONIDOU ◽  
MARIA KONSTA ◽  
GEORGE P. CHROUSOS ◽  
PETROS P. SFIKAKIS
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Quality ◽  
Disease Activity ◽  
Interleukin 6 ◽  
Daytime Sleepiness ◽  
Sleep Disturbances ◽  
Functional Disability ◽  
Health Assessment ◽  
Joint Disease ◽  
Interleukin 6 Receptor

Objective.Interleukin 6 (IL-6)-mediated interactions have been associated with sleep disturbances in healthy subjects. In this pilot study we examined whether administration of the IL-6 receptor antagonist tocilizumab in patients with rheumatoid arthritis (RA) affects sleep disturbances.Methods.Fifteen patients (13 women) with sleep disturbances at baseline received 6 monthly infusions of tocilizumab 8 mg/kg for moderately or severely active RA. Sleep quality was assessed by Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness by Epworth Sleepiness Scale, disease activity by the 28-joint Disease Activity Score-erythrocyte sedimentation rate, functional disability by Health Assessment Questionnaire Disability Index (HAQ-DI), and fatigue by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale; FFS) at baseline and first, second, third, and sixth month of treatment. Medications used before enrollment remained unchanged during followup.Results.Sleep quality improved and daytime sleepiness decreased significantly at first-month assessment (p < 0.00001 and p < 0.004, respectively, by repeated measurement analysis) compared to baseline, and these changes became more evident through 6 months. Disease activity decreased, fatigue decreased, and functional status improved significantly. Changes in PSQI score over time were not associated with the corresponding changes in DAS28-ESR (r = 0.37, p = 0.17), but correlated significantly with HAQ-DI changes (r = 0.60, p = 0.02) and marginally with changes in FFS scores (r = −0.46, p = 0.08).Conclusion.Improvement of sleep quality after tocilizumab treatment in patients with RA does not appear to directly result from decreased disease activity, further suggesting that aberrant IL-6 regulation is associated with sleep disturbances.

scholarly journals Clinical, Radiologic, and Functional Outcomes Following Methotrexate Withdrawal in Etanercept-Treated Patients with Active Early Rheumatoid Arthritis: A Subanalysis of COMET Year 2 by Week 52 DAS28 Status

2021 ◽  
Vol 15 (1) ◽  
pp. 31-38
Author(s):  
Paul Emery ◽  
Ferdinand Breedveld ◽  
Eduardo Campos-Alberto ◽  
Annette E. Szumski ◽  
Tomohiro Hirose
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Functional Outcomes ◽  
Health Assessment ◽  
Joint Disease ◽  
Low Disease Activity ◽  
Period 2 ◽  
Modified Total Sharp Score ◽  
Post Hoc

Introduction: This post-hoc analysis explored Methotrexate (MTX) withdrawal on clinical, radiographic, and functional outcomes in patients with early rheumatoid arthritis who previously received 52 weeks of Etanercept (ETN) + MTX treatment in the COMET study. Methods: Response at week 104 was analyzed based on the attainment of remission (28-joint disease activity score [DAS28] <2.6; Boolean); low disease activity (LDA; 2.6 ≤DAS28 ≤3.2); normal Health Assessment Questionnaire-Disability Index (HAQ-DI) score (≤0.5); or radiographic non-progression (change in modified Total Sharp Score ≤0.5). Results: Of 208 patients with baseline DAS28 scores at week 52, 105 received ETN + MTX and 103 received ETN over weeks 52-104 (Period 2). At week 104, rates of LDA (70% vs 67%), remission (59% vs 52%), and normal HAQ-DI (63% vs 61%) were similar in both arms; week 52 responders also had a higher response rate at week 104 irrespective of treatment during Period 2. Overall rates of radiographic non-progression were higher for ETN + MTX (90%) vs ETN (74%) at week 104; week 52 non-responders in the Period 2 ETN + MTX arm had a 21-27% higher rate vs ETN, while the treatment difference was 11-12% for week 52 responders. Conclusion: The data suggest that for responders to ETN + MTX at week 52, MTX may be safely withdrawn. For non-responders where de-escalation would not be considered, the continuation of the combination is advisable. Radiological outcome was numerically worse, but of uncertain clinical significance.

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