Effect of Adherence to Protocolized Targeted Intensifications of Disease-modifying Antirheumatic Drugs on Treatment Outcomes in Rheumatoid Arthritis: Results from an Australian Early Arthritis Cohort

2016 ◽  
Vol 43 (9) ◽  
pp. 1643-1649 ◽  
Author(s):  
Nasir T. Wabe ◽  
Michael J. Sorich ◽  
Mihir D. Wechalekar ◽  
Leslie G. Cleland ◽  
Leah McWilliams ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Functional Outcomes ◽  
Activity Index ◽  
Remission Rate ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Treat To Target ◽  
Radiographic Outcomes ◽  
Relevant Variables

Objective.To investigate the association between adherence to treat-to-target (T2T) protocol and disease activity, functional outcomes, and radiographic outcomes in early rheumatoid arthritis (RA).Methods.Data from a longitudinal cohort of patients with early RA were used. Adherence was determined at each followup visit over 3 years according to predefined criteria. The primary endpoint was remission according to Disease Activity Score in 28 joints (DAS28) and Simplified Disease Activity Index (SDAI) criteria. Functional and radiographic outcomes measured by modified Health Assessment Questionnaire and modified total Sharp score, respectively, were secondary endpoints.Results.A total of 198 patients with 3078 clinic visits over 3 years were included in this analysis. After adjusting for relevant variables, although there was no significant association between adherence to T2T and remission rate after 1 year, the associations reached significance after 3 years for both DAS28 (OR 1.71, 95% CI 1.16–2.50; p = 0.006) and SDAI criteria (OR 1.94, 95% CI 1.06–3.56; p = 0.033). After 3 years, adherence was also associated with improvement in physical function (β=0.12, 95% CI 0.06–0.18; p < 0.0001). None of the radiographic outcomes were associated with adherence after either 1 or 3 years, although there was a trend for higher adherence to be associated with less radiographic progression at the end of the study (p = 0.061).Conclusion.Increased adherence to T2T was associated with better longterm disease activity and functional outcomes, which suggests that the benefit of a T2T protocol may be enhanced by ensuring adequate adherence.

scholarly journals Do Poor Prognostic Factors in Rheumatoid Arthritis Affect Treatment Choices and Outcomes? Analysis of a US Rheumatoid Arthritis Registry

2018 ◽  
Vol 45 (10) ◽  
pp. 1353-1360 ◽  
Author(s):  
Evo Alemao ◽  
Heather J. Litman ◽  
Sean E. Connolly ◽  
Sheila Kelly ◽  
Winnie Hua ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Prognostic Factors ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Activity Index ◽  
Functional Limitation ◽  
Disease Activity Index ◽  
Treat To Target ◽  
Work Status ◽  
Logistic Regression Models

Objective.To characterize patients with rheumatoid arthritis (RA) by number of poor prognostic factors (PPF: functional limitation, extraarticular disease, seropositivity, erosions) and evaluate treatment acceleration, clinical outcomes, and work status over 12 months by number of PPF.Methods.Using the Corrona RA registry (January 2005–December 2015), biologic-naive patients with diagnosed RA having 12-month (± 3 mos) followup were identified and categorized by PPF (0–1, 2, ≥ 3). Changes in medication, Clinical Disease Activity Index (CDAI), and work status (baseline–12 mos) were evaluated using linear and logistic regression models.Results.There were 3458 patients who met the selection criteria: 1489 (43.1%), 1214 (35.1%), and 755 (21.8%) had 0–1, 2, or ≥ 3 PPF, respectively. At baseline, patients with ≥ 3 PPF were older, and had longer RA duration and higher CDAI versus those with 0–1 PPF. In 0–1, 2, and ≥ 3 PPF groups, respectively, 20.9%, 23.2%, and 26.5% of patients received ≥ 1 biologic (p = 0.011). Biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) use was similar in patients with/without PPF (p = 0.57). After adjusting for baseline CDAI, mean (standard error) change in CDAI was −4.95 (0.24), −4.53 (0.27), and −2.52 (0.34) for 0–1, 2, and ≥ 3 PPF groups, respectively. More patients were working at baseline but not at 12-month followup in 2 (13.9%) and ≥ 3 (12.5%) versus 0–1 (7.3%) PPF group.Conclusion.Despite high disease activity and worse clinical outcomes, number of PPF did not significantly predict biologic/tsDMARD use. This may warrant reconsideration of the importance of PPF in treat-to-target approaches.

scholarly journals Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis

2020 ◽  
pp. annrheumdis-2020-218412
Author(s):  
Roy M Fleischmann ◽  
Ricardo Blanco ◽  
Stephen Hall ◽  
Glen T D Thomson ◽  
Filip E Van den Bosch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Kinase Inhibitor ◽  
Activity Index ◽  
Disease Activity Index ◽  
Initial Therapy ◽  
Janus Kinase ◽  
Treat To Target ◽  
Efficacy And Safety ◽  
Insufficient Response

ObjectivesTo evaluate efficacy and safety of immediate switch from upadacitinib to adalimumab, or vice versa, in patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy.MethodsSELECT-COMPARE randomised patients to upadacitinib 15 mg once daily (n=651), placebo (n=651) or adalimumab 40 mg every other week (n=327). A treat-to-target study design was implemented, with blinded rescue occurring prior to week 26 for patients who did not achieve at least 20% improvement in both tender and swollen joint counts (‘non-responders’) and at week 26 based on Clinical Disease Activity Index (CDAI) >10 (‘incomplete-responders’) without washout.ResultsA total of 39% (252/651) and 49% (159/327) of patients originally randomised to upadacitinib and adalimumab were rescued to the alternate therapy. In both switch groups (adalimumab to upadacitinib and vice versa) and in non-responders and incomplete-responders, improvements in disease activity were observed at 3 and 6 months following rescue. CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch. Overall, approximately 5% of rescued patients experienced worsening in disease activity at 6 months postswitch. The frequency of adverse events was similar between switch groups.ConclusionsThese observations support a treat-to-target strategy, in which patients who fail to respond initially (or do not achieve sufficient response) are switched to a therapy with an alternate mechanism of action and experience improved outcomes. No new safety findings were observed despite immediate switch without washout.

scholarly journals Clinical and ultrasound remission after 6 months of treat-to-target therapy in early rheumatoid arthritis: associations to future good radiographic and physical outcomes

2018 ◽  
Vol 77 (10) ◽  
pp. 1421-1425 ◽  
Author(s):  
Nina Paulshus Sundlisæter ◽  
Anna-Birgitte Aga ◽  
Inge Christoffer Olsen ◽  
Hilde Berner Hammer ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Radiographic Progression ◽  
Activity Index ◽  
Power Doppler ◽  
Disease Activity Index ◽  
Treat To Target ◽  
Good Outcome ◽  
Grey Scale

ObjectiveTo explore associations between remission, based on clinical and ultrasound definitions, and future good radiographic and physical outcome in early rheumatoid arthritis (RA).MethodsNewly diagnosed patients with RA followed a treat-to-target strategy incorporating ultrasound information in the Aiming for Remission in rheumatoid arthritis: a randomised trial examining the benefit of ultrasound in a Clinical TIght Control regimen (ARCTIC) trial. We defined 6-month remission according to Disease Activity Score, Disease Activity Score in 28 joints-erythrocyte sedimentation rate, American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean criteria, Simplified Disease Activity Index, Clinical Disease Activity Index and two ultrasound definitions (no power Doppler signal, grey scale score ≤2). Two outcomes were defined: no radiographic progression and good outcome (no radiographic progression+physical function≥general population median), both sustained 12–24 months. We calculated the ORs of these outcomes for the remission definitions.ResultsOf 103 patients, 42%–82% reached remission at 6 months, dependent on definition. Seventy-one per cent of patients had no radiographic progression and 37% had good outcome. An association between 6-month remission and no radiographic progression was observed for ACR/EULAR Boolean remission (44 joints, OR 3.2, 95% CI 1.2 to 8.4), ultrasound power Doppler (OR 3.6, 95% CI 1.3 to 10.0) and grey scale remission (OR 3.2, 95% CI 1.2 to 8.0). All clinical, but not ultrasound remission criteria were associated with achievement of a good outcome.ConclusionsOur data support ACR/EULAR Boolean remission based on 44 joints as the preferred treatment target in early RA. Absence of ultrasound inflammation was associated with no radiographic progression.Trial registration numberNCT01205854; Post-results.

OP129 Predictors Of Effectiveness In Patients With Rheumatoid Arthritis

2017 ◽  
Vol 33 (S1) ◽  
pp. 59-60
Author(s):  
Jéssica dos Santos ◽  
Haliton Oliveira ◽  
Francisco Acurcio Michael da Silva ◽  
Alessandra Almeida ◽  
Flávia Rodrigues ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Univariate Analysis ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Chi Square ◽  
Low Disease Activity ◽  
Gender Education

INTRODUCTION:Biological disease-modifying anti-rheumatic drugs (bDMARDs) have become firmly established in the management of patients with rheumatoid arthritis (RA), but some patients do not improve despite therapy. This study evaluated the predictors of effectiveness of the bDMARDs on a cohort of patients with rheumatoid arthritis (RA) in the Brazilian Public Health System.METHODS:RA individuals treated with bDMARDs, were included in the open prospective cohort study. The Clinical Disease Activity Index (CDAI) was used to assess the effectiveness comparing results at baseline and after 6 months of follow-up. The association between socio-demographic and clinical characteristics with the disease activity measured by the CDAI was also investigated. The bDMARDs was considered effective when the patient achieved remission or low disease activity and considered not effective when there was still moderate or high disease activity. Pearson's chi-square was applied for the univariate analysis to evaluate the association of effectiveness measured by the CDAI with the socio-demographic (gender, education, marital status and race) and clinical variables (type of drug, EuroQol (EQ)-5D and Health Assessment Questionnaire (HAQ)). Logistic regression was applied in the multivariate analysis of the variables that presented a p< .20 value during the univariate analysis.RESULTS:All 266 RA patients completed six months of follow-up. The most widely used bDMARDs was adalimumab (57.1 percent), with etanercept used by 22.2 percent, golimumab by 7.5 percent, abatacept by 4.5 percent, tocilizumab by 3.4 percent, infliximab by 2.6 percent, certolizumab by 1.5 percent, and rituximab by 1.1 percent. The bDMARDs reduced disease activity as measured by CDAI at six months of follow-up (p<.001). The percentage of patients achieving remission or low disease activity was 40.6 percent. bDMARDs were more effective in patients with better functionality (Odds Ratio, OR = 2.140 / 95 percent Confidence Interval, CI 1.219 - 3.756) at beginning of treatment and in patients who not had a previous bDMARDs (OR = 2.150 / 95 percent CI 1.144 - 4.042).CONCLUSIONS:In this real-world study, functionality and use of previous bDMARDs are predictors in patients with RA treated with bDMARDs.

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.

Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA)

2015 ◽  
Vol 75 (9) ◽  
pp. 1645-1653 ◽  
Author(s):  
K Hørslev-Petersen ◽  
M L Hetland ◽  
L M Ørnbjerg ◽  
P Junker ◽  
J Pødenphant ◽  
...  
Keyword(s):  
Disease Activity ◽  
Induction Therapy ◽  
Activity Index ◽  
Controlled Trial ◽  
Disease Activity Index ◽  
Treat To Target ◽  
American College Of Rheumatology ◽  
Radiographic Outcomes ◽  
Target Strategy ◽  
Erosive Progression

ObjectivesTo study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647).MethodsDisease-modifying antirheumatic drug (DMARD)-naive patients with eRA started methotrexate (20 mg/week) and intra-articular triamcinolone (20 mg/ml) for 2 years. In addition, they were randomised to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40 mg/every other week) (DMARD+adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine were added if disease activity persisted after 3 months. During year 2, synthetic DMARDs continued. Adalimumab was (re)initiated if active disease reoccurred. Clinical response, remission, disability, quality of life and radiographic changes were assessed.ResultsOne year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups. In the DMARD/DMARD+adalimumab groups, the median 2-year methotrexate dose was 20/20 mg/week (p=0.45), triple DMARD therapy had been initiated in 33/27 patients (p=0.49), adalimumab was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120 mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) ≤3.2 or DAS28>3.2 without swollen joints) was achieved at all visits in ≥85% of patients in year 2; remission rates were DAS28CRP<2.6:69%/66%; Clinical Disease Activity Index ≤2.8:55%/57%; Simplified Disease Activity Index <3.3:54%/49%; American College of Rheumatology/European League against Rheumatism (28 joints):44%/45% (p=0.66–1.00). Radiographic progression (Δtotal Sharp score/year) was similar 1.31/0.53 (p=0.12). Erosive progression (Δerosion score (ES)/year) was year 1:0.57/0.06 (p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (ΔES≤0) was year 1: 59%/76% (p=0.03); year 2:64%/79% (p=0.04).ConclusionsAn aggressive triamcinolone and synthetic DMARD treat-to-target strategy in eRA provided excellent 2-year clinical and radiographic disease control independent of adalimumab induction therapy. ES progression was slightly less during and following adalimumab induction therapy.Trial registration numberNCT00660647.

scholarly journals Effectiveness and Safety of Subcutaneous Abatacept in Biologic-Naïve RA Patients at Week 52: A Japanese Multicenter Investigational Study (ORIGAMI Study)

2021 ◽  
Author(s):  
Naoto Tamura ◽  
Takanori Azuma ◽  
Kenta Misaki ◽  
Rei Yamaguchi ◽  
Fuminori Hirano ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Treatment Retention ◽  
Low Disease Activity ◽  
Moderate Disease ◽  
Moderate Disease Activity

Abstract Objectives To evaluate the effectiveness and safety of abatacept over 52 weeks in biologic-naïve rheumatoid arthritis (RA) patients with moderate disease activity in the prospective, 5-year, observational study (ORIGAMI study) in Japan. Methods Abatacept 125 mg was administered subcutaneously once a week. Clinical outcomes included Simplified Disease Activity Index (SDAI) remission at Week 52 (primary endpoint), Japanese Health Assessment Questionnaire (J-HAQ), EuroQol 5-Dimension (EQ-5D), treatment retention, and safety. Results were compared with those of csDMARD controls from the ongoing Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry. Results Overall, 325 patients were enrolled, with a mean age of 66.9±12.7 years. The proportion of patients achieving SDAI remission (≤3.3) at Week 52 was 18.9% (95% CI: 14.3–23.6) and low disease activity (≤11) was 53.3% (95% CI: 47.4–59.1). A significant improvement was observed in J-HAQ and EQ-5D over 52 weeks in both the abatacept and csDMARD groups. The probability of abatacept treatment retention at Week 52 was 69.9% (95% CI: 64.7–75.5). AEs and serious AEs were reported in 50.0% and 12.1% of patients, respectively. Conclusions Abatacept significantly improved disease activity, physical disability, and quality of life for up to 52 weeks in RA patients in a real-world setting.

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 Estimation of a numerical value for joint damage-related physical disability in rheumatoid arthritis clinical trials

2009 ◽  
Vol 69 (6) ◽  
pp. 1058-1064 ◽  
Author(s):  
Josef S Smolen ◽  
Daniel Aletaha ◽  
Johannes C Grisar ◽  
Tanja A Stamm ◽  
John T Sharp
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Health Assessment ◽  
Joint Damage ◽  
Disease Activity Index ◽  
Controlled Clinical Trial ◽  
Short Term ◽  
Randomised Controlled ◽  
Radiographic Changes

BackgroundJoint damage is an important outcome in trials of rheumatoid arthritis (RA), usually assessed by Total Sharp Score (TSS). It is currently unknown how it translates numerically into disability by the Health Assessment Questionnaire (HAQ).ObjectiveTo determine the units of HAQ score corresponding to one TSS unit.MethodsA short-term observational trial of glucocorticoids in RA (the ‘BEst LIfe with Rheumatoid Arthritis’ (BELIRA) trial) was evaluated, using randomised controlled clinical trial (RCT) data for confirmation. For each trial arm HAQ, TSS and the Simplified Disease Activity Index (SDAI) were assessed. Based on the hypothesis that short-term HAQ changes will mostly be due to changes of disease activity, activity HAQ (ACT-HAQ) at end point (EP) was determined and remaining disability defined as damage related (DAM-HAQ). Using TSS at EP, the HAQ units corresponding to a TSS unit were estimated.ResultsIn BELIRA, one TSS unit corresponded to a mean of 0.017 HAQ units; to account for other causes of irreversible disability, the 25th percentile was used: 0.011 HAQ units/TSS unit. In RCT trial arms, the HAQ/TSS were similar (0.013 and 0.015 in established and early RA, respectively; 25th percentile: 0.010). The correlation between DAM-HAQEP and TSS was r=0.829. Over 5 years, damage would amount to an increase of irreversible HAQ of 0.33 on placebo, 0.13 on disease-modifying antirheumatic drugs (DMARDs) and 0.03 on TNF inhibitors+methotrexate (MTX).ConclusionAn approach to estimate the numerical relationship between HAQ and damage as 0.01 HAQ points/TSS unit is presented, although the linear relationship may not be generally valid. This allows the assessment of functional correlates of radiographic changes in trials.

scholarly journals AB0271 EFFECTIVENESS OF DULOXETINE FOR RELIEF OF THE REMNANT PAIN OF RHEUMATOID ARTHRITIS PATIENT WHOSE DISEASE ACTIVITY IS REMISSION

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1434.1-1434
Author(s):  
I. Yoshii
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Relief ◽  
Disease Activity ◽  
Clinical Remission ◽  
Health Assessment Questionnaire ◽  
Activity Index ◽  
Statistical Significance ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Assessment Questionnaire

Background:Pain control in rheumatoid arthritis (RA) patient is an important matter. When pain remains even disease activity is remission, it causes deterioration of activity in daily living (ADL) in past research. In other words, pain affects ADL independently from disease activity, namely the Health Assessment Questionnaire (HAQ) score, a most popular index of ADL for patient with RA[1]. Thus, burden of remnant pain despite clinical remission in RA is serious and pending subject.Duloxetine, a potent reuptake inhibitor of serotonin and norepinephrine, is developed for the treatment of major depressive disorder [2]. It’s effectiveness for pain relief with osteoarthritis is also widely accepted. This drug should be effective not only for chronic pain due to osteoarthritis, but also due to RA. However, effectiveness of duloxetine for remnant pain relief in patient with RA in clinical remission is still unclear.Objectives:In this study, effectiveness of duloxetine for the remnant pain despite clinical remission in patient with RA was statistically evaluated.Methods:RA patients whose pain score with visual analog scale (PS-VAS) >30mm despite Clinical Disease Activity Score (CDAI) is <2.8, were picked up for the study. These patients were divided into groups whether duloxetine was administrated (a group without duloxetine: G-C; a group with duloxetine: G-D).PS-VAS, C-reactive protein, CDAI and simplified disease activity index (SDAI), modified Health Assessment Questionnaire (mHAQ), and QOL value which is calculated from Euro-QOL 5-Dimensions (EQ-5D) were measured at the initiation of duloxetine in the G-D and at the first CDAI remission attained in the G-C, and at week 12 thereafter. Change of these indices were compared with One sample T-test for each group. Patient’s global assessment (PGA) at baseline compared to the other components of CDAI was evaluated for each group statistically with One-tailed T-test. Differences between the two groups at each moment were statistically evaluated with Mann-Whitney U-test. Statistical significance was set less than 1%. All statistical analyses were performed using StatPlus:mac®(AnalystSoft Inc., Walnut, CA, USA).Results:A total of three hundred and six patients were recruited. G-D counted sixty-eight with 18 males and 50 females, while G-C counted 238 with 57 males and 181 females. Average age were 71.3 and 71.5 for G-D and G-C, respectively, with 53.6 months for time span from baseline to initiation in the G-D. 80.8% of the patients in G-D sustained to administrate duloxetine. PGA was 0.6 and 0.5 for G-D and G-C respectively, while the other component of CDAI were below 0.3 in average for both groups and these values were significantly lower than the PGA score in both groups. PS-VAS was 46.4 and 44.0, and significantly decreased to 26.1 and 36.0 in average for G-D and G-C respectively at week 12 when compared to baseline. Reversely, the CDAI score was significantly elevated significantly from 1.16 and 1.19 to 3.25 and 4.34 for G-D and G-C respectively. PGA also significantly increased to 1.5 and 2.4 for G-D and G-C respectively. CRP and the SDAI score also demonstrated same trend significantly as the CDAI score for both groups. mHAQ decreased significantly from 0.430 and 0.495 to 0.393 and 0.487 for G-D and G-C respectively. QOL value increased from 0.800 and 0.817 to 0.811 and 0.840 for G-D and G-C respectively, however no statistical significance demonstrated in both groups.Conclusion:Duloxetine has been suggested to have effectiveness for the pain relief, for improvement of ADL, and for the contribution to QOL maintenance, however, no effect of disease activity control is expected.References:[1]Yoshii I, Chijiwa T, Sawada N. Influence of pain score measured by a visual analog scale (PS-VAS) on the Health Assessment Questionnaire Disability Index and 28-joint Disease Activity Index with C-reactive protein in rheumatoid arthritis patients. Int J Rheum Dis 2018;21:1955-61.[2]Knadler MP, Lobo E, Chappell J, Bergstrom R. Duloxetine. Clin Pharmacokinet 2011;50:281-94.Disclosure of Interests:None declared

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