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.

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 Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000991 ◽  
Author(s):  
Alain Saraux ◽  
René-Marc Flipo ◽  
Francis Fagnani ◽  
Jacques Massol ◽  
Gabrielle Cukierman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Certolizumab Pegol ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Low Disease Activity ◽  
Clinical Criteria ◽  
Late Treatment ◽  
Clinical Measures

ObjectiveTo evaluate the performance of clinical criteria for predicting late treatment failure in patients with early non-response to certolizumab pegol (CZP).MethodsA protocol-specified analysis of interim data from ECLAIR, a 3-year longitudinal, prospective, observational, multicentre study of patients with active rheumatoid arthritis (RA) initiating CZP treatment in France, was conducted. Clinical measures assessed were Clinical Disease Activity Index (CDAI), Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28(ESR)) and Health Assessment Questionnaire Disability Index (HAQ-DI). Early non-response was measured at 3 months (M3) and failure to achieve low disease activity (LDA) at 12 months (M12).Results574/792 enrolled patients were treated at M3. The numbers available for predictability analyses were 532 (CDAI), 434 (DAS28(ESR)) and 496 (HAQ-DI). Of the three indices evaluated, the highest predictor of non-response value was observed for the CDAI (88.8% (95% CI 81.0 to 94.1)), indicating that up to 88% of patients identified as non-responders at M3 failed to achieve LDA at M12, regardless of baseline disease severity or treatment history. The specificity for this measure was also very high (96.0%), indicating that less than 5% of patients who achieved CDAI response at M12 had not responded at M3. Similar predictability was observed for DAS28(ESR), but only in patients with high disease activity at baseline and/or those previously treated by a biological disease-modifying antirheumatic drug.ConclusionCDAI non-response at M3 is a predictor of failure to achieve the therapeutic target of LDA at M12 in patients with RA initiating treatment with CZP.

scholarly journals AB0365 COMPARISON OF SUSTAINED CLINICAL REMISSION AND/OR LOW DISEASE ACTIVITY RATE BETWEEN RAPIDLY AND GRADUALLY DE-ESCALATION OF BARICITINIB IN RHEUMATOID ARTHRITIS.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1483.2-1483
Author(s):  
M. Yamasaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Janus Kinase ◽  
Biologic Dmards ◽  
Low Disease Activity ◽  
First Line Therapy

Background:However baricitinib, an oral selective inhibitor of Janus kinase (JAK) 1 and 2, improved signs and symptoms of rheumatoid arthritis (RA), it is unknown who can taper or stop baricitinib and strategies for de-escalation.Objectives:We analyze predictors of tapering of withdrawal failure in rheumatoid arthritis (RA) patients treated with baricitinib. This study will assess and compare (1) characteristic of patients who achieve remission (REM) or low disease activity (LDA) as who can taper baricitinib and (2) two de-escalation methods, rapidly and gradually de-escalation in patients who respond first-line therapy.Methods:Cases were recruited to SHin-yokohama Arthritis REgister (SHARE) between 2015 and 2019 (n=3,674). Patients were diagnosed according to ACR/EULAR 2010 classification criteria, and treated with DMARDs which included baricitinib 2mg/day (n=154). In 154 cases, Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI), anti-CCP2 and patients clinical parameters were analyzed. Two de-escalation methods were compared in this study. In rapidly de-escalation methods, baricitinib were stopped in patients with stable REM/LDA over 12 weeks. In gradually de-escalation methods, baricitinib were decreased to 50%, 42%, 28%, 14% in order with stable REM/LDA over 12 weeks.Results:In 154 (Male25, Female129 cases, RA duration 11.4+/-8.0 years) cases, CDAI at baricitinib-start was 20.6+/-12.4 and titer of anti-CCP2 was 242.6+/-516.5 U/ml. 126 cases (81.8%) were more than 2 years of RA duration and 49 cases (31.8%) had persistency of signs and/or symptoms suggestive of inflammatory RA disease activitiy, despite prior treatment with csDMARDs and at least two biologic DMARDs. 33 cases (21.4%) were biologic DMARDs naive.(1)”Multivariate logistic regression examined the predictors to detect who can taper baricitinib” However there were no differences in duration of RA, onset age of RA, biologics and/or JAK inhibitors naïve, anti-CCP2 titer and CDAI at the start baricitinib, patients who showed decrease of CDAI at 12 weeks were correlated with achievement of remission (REM) or low disease activity (LDA) in patients treated with baricitinib (OR 0.964, 95%CI 0.934-0.996, p=0.010). ROC analysis of ΔCDAI at 12 weeks is cut-off value of -6.6 (p=0.011).(2)”Comparison of sustained REM and/or LDA rate between rapidly and gradually de-escalation of baricitinib in rheumatoid arthritis” 11 cases were tapered baricitinib with rapidly de-escalation methods and 60 patients were with gradually de-escalation. Mean times to start taper baricitinib in rapidly and gradually de-escalation group were 4.6+/-1.6 months and 5.9+/-2.2 months respectively. Gradually de-escalation methods showed less relapse rate compared with rapidly de-escalation after tapered baricitinib for 6 months (18.3% vs. 54.5%, p=0.018). There were no differences in clinical features such as anti-CCP2, CDAI and administration period of baricitinib between non-relapse and relapse patients in gradually escalation methods.Conclusion:A combination of ΔCDAI at 12 weeks and tapering baricitinib using gradually de-escalation methods may help to predict successful baricitinib deduction in RA patients with sustained clinical REM and/or LDA.References:[1]Ann Rheum Dis. 2019;78:171[2]Rheumatology. 2019;58:110[3]An Rheum Dis. 2015;74:19Disclosure of Interests:None declared

scholarly journals Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

2015 ◽  
Vol 42 (7) ◽  
pp. 1090-1098 ◽  
Author(s):  
Leslie R. Harrold ◽  
George W. Reed ◽  
Ashwini Shewade ◽  
Robert Magner ◽  
Katherine C. Saunders ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Effectiveness ◽  
High Disease Activity ◽  
Low Disease Activity ◽  
Logistic Regression Models ◽  
Lower Baseline ◽  
Previously Treated

Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

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 Relationship between shoulder ultrasound findings and disease activity in patients with rheumatoid arthritis: A pilot study

2021 ◽  
Author(s):  
Merve Akdeniz Leblebicier ◽  
Fatıma Yaman ◽  
İsmail Saraçoğlu ◽  
Vural Kavuncu ◽  
Meltem İmal Kızılkaya
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Shoulder Pain ◽  
Glenohumeral Joint ◽  
Low Disease Activity ◽  
Moderate Disease ◽  
Ultrasound Findings ◽  
History Of ◽  
Us Findings ◽  
Moderate Disease Activity

Objectives: The aim of this study was to investigate whether shoulder ultrasound (US) findings were associated with disease activity and pain level in rheumatoid arthritis (RA) patients. Patients and methods: Between April 2019 and November 2019, a total of 60 shoulders of 30 female patients with RA (mean age: 53.8±12.0 years; range, 30 to 65 years) were included. The patients were questioned about shoulder pain and their Disease Activity Score-28 (DAS28) was estimated. After clinical examination with shoulder impingement tests, both shoulders were evaluated by US. Results: Of 60 shoulders examined by shoulder US, the most common shoulder pathology was supraspinatus tendinopathy (n=33, 55%). The prevalence of subdeltoid bursitis on US was significantly higher in the group with moderate disease activity, compared to the group with low disease activity (p<0.05). There were no significant differences in the physical examination findings of patients with low and moderate disease activity. In terms of US findings, subscapularis tendinopathy, glenohumeral joint and acromioclavicular joint degeneration, and subacromial bursitis were more common in shoulders with a history of pain, compared to non-painful shoulders. Conclusion: Shoulder US may be useful for demonstrating shoulder involvement in patients with RA, independent of the presence of shoulder pain.

Effectiveness and safety of anti-TNF therapy for ankylosing spondylitis: a real-word study

2021 ◽  
Author(s):  
Pedro Ricardo Kömel Pimenta ◽  
Michael Ruberson Ribeiro da Silva ◽  
Jéssica Barreto Ribeiro dos Santos ◽  
Adriana Maria Kakehasi ◽  
Francisco de Assis Acurcio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Five Dimensions ◽  
System Effectiveness

Aim: To evaluate the effectiveness and safety of anti-TNF drugs for ankylosing spondylitis. Materials & methods: A prospective cohort study was performed at a pharmacy in the Brazilian Public Health System. Effectiveness by Bath Ankylosing Spondylitis Disease Activity Index, functionality by Health Assessment Questionnaire Disability Index, quality of life by European Quality of Life Five-Dimensions and safety was assessed at 6 and 12 months of follow-up. Results: About 160 patients started the treatment with adalimumab, etanercept or infliximab. There was a statistically significant improvement in disease activity, functionality and quality of life at 6 and 12 months (p < 0.05). Conclusion: This real-world study has shown that anti-TNF drugs are effective and well tolerated for ankylosing spondylitis patients.

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 AB0130 QUESTIONING THE USEFULNESS OF CDAI AS A MEASURE OF DISEASE ACTIVITY IN A TREAT TO TARGET PROGRAMME

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1093.2-1094
Author(s):  
C. Lally ◽  
I. Ali ◽  
C. Silke ◽  
B. Whelan ◽  
M. O’sullivan
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Early Arthritis ◽  
Clinical Disease Activity Index ◽  
Clinical Disease ◽  
Low Disease Activity ◽  
X Ray ◽  
Clinical Disease Activity

Background:Rheumatoid arthritis (RA) is a chronic autoimmune condition which if not treated can lead to joint destruction and long term disability. In RA, the concept of T2T is recommended as the appropriate method to manage early arthritis 1. It has shown promising results to achieve clinical remission (CR) or low disease activity (LDA) 2.Objectives:The objective of this study was to investigate the potential to achieve remission or LDA according to the Clinical Disease Activity Index (CDAI) for RA, during treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs) and Biologics, and the factors that affect the remission/LDA outcome.Methods:We performed an observational prospective study on patients’ data available from our Early Arthritis Cohort. All patients with newly diagnosed RA who met the American College of Rheumatology (ACR) criteria were enrolled. Patients are managed by an Advanced Nurse Practitioner (ANP) with consultant supervision. To assess their response to treatment, we used the Clinical Disease Activity Index3. Analysis was performed using SPSS.Results:Out of a total of 459 patients, 353 completed the programme. 217 patients (61.5%) were female and (136) 38.5 % were male. Mean age was 53.98 (SD 14.66). 195 patients were on monotherapy, 40 on combination DMARDs and 115 were on Biologics/Janus Kinase Inhibitors (JAK-Inh). Remission-rates in the monotherapy and combination DMARDs groups were approximately 60%, whilst the remission rate in the Biologics/JAK-Inh group was 41.7%. Amongst female patients 15.9% had erosions on X-ray at the time of diagnosis whilst the equivalent figure for male patients was 29.6%.Conclusion:An association between male gender and the likelihood of erosions on X-Ray was observed. In addition an association between final medication and outcome was observed. An increased likelihood of non-remission was noted in patients that required escalation to Biologics/JAKs. A possible explanation for the lower levels of remission seen throughout the groups is the difficulty in achieving remission under the CDAI score as compared to DAS-28.References:[1]Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Annals of the Rheumatic Diseases. 2016;75(1):3.[2]Scott IC, Ibrahim F, Panayi G, Cope AP, Garrood T, Vincent A, Scott DL, Kirkham B; TITRATE Programme Investigators. The frequency of remission and low disease activity in patients with rheumatoid arthritis, and their ability to identify people with low disability and normal quality of life. Semin Arthritis Rheum. 2019 Aug;49(1):20-26. doi: 10.1016/j.semarthrit.2018.12.006. Epub 2018 Dec 28. PMID: 30685064.Disclosure of Interests:None declared

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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