Assessment of discordance of treatment satisfaction between patients with rheumatoid arthritis in low disease activity or in remission and their treating physicians: A cross-sectional survey

Abstract Objectives Only few observational studies have investigated the actual effectiveness of switching to biosimilars in daily clinical practice in unselected patients. The objective of this study was to examine the maintenance of effect and safety after a hospital-wide switch for economic reasons from adalimumab originator Humira® to biosimilar Amgevita® in real-world rheumatoid arthritis (RA) patients and patient satisfaction with the switch. Methods A single centre retrospective observational study of RA patients on the course of their disease activity (DAS28, ESR and CRP), health-related quality of life (SF-36) and functional disability (HAQ-DI) before and up to one year after the switch, supplemented with a cross-sectional survey on satisfaction and experienced side effects approximately 18 months after the switch. Treatment outcomes were analysed with linear mixed modelling and generalized estimation equations. Results On November 1st 2018, 239 rheumatology patients switched to the adalimumab biosimilar. Of 52 RA patients who met the inclusion criteria sufficient data were available. Disease activity levels, the proportion of patients in remission (DAS28 < 2.6), and SF-36 and HAQ-DI scores did not significantly change from before the switch. 38 of the 52 analysed patients returned the questionnaire. Overall, patients were satisfied with the switch. Three patients (7.9%) stopped the biosimilar due to side effects. Conclusion Switching to the adalimumab biosimilar did not result in increased disease activity or worse patient-reported outcomes over an observation period of 9 to 12 months. Also, there was no apparent evidence of increased side effects. Patients themselves were mostly satisfied with the switching experience.

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Management and Comorbidities in Middle-European Patients with Rheumatoid Arthritis: A Retrospective, Cross-sectional Comparison with COMORA Data

The Open Rheumatology Journal ◽

10.2174/1874312901913010094 ◽

2019 ◽

Vol 13 (1) ◽

pp. 94-97

Author(s):

Myroslav Levytskyi ◽

Sarah Maier ◽

Michael Schirmer

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Outpatient Service ◽

Treat To Target ◽

Cross Sectional ◽

Low Disease Activity ◽

Frequent Use ◽

Co Morbidity ◽

International Data ◽

Service Data

Objective: To assess disease-specific characteristics and comorbidities in consecutive Middle-European Rheumatoid Arthritis (RA) patients, and to compare results with international data. Methods: Cross-sectional retrospective analysis of consecutive RA patients from a Middle-European outpatient service. Data are compared to those of the international “Co-morbidity in Rheumatoid Arthritis” (COMORA) cohort. Results: 80 RA patients with mean disease duration of 10.6 ± 8.3 years were enrolled within 5 months. Age was 62 ± 13 years and 75% were female. The Middle-European cohort showed slightly lower disease activity than the Austrian COMORA subcohort. 88.8% of all Middle-European RA patients were in remission or had low disease activity. Despite comparable disease characteristics, the percentage of patients ever treated with biological disease-modifying antirheumatic drugs (bDMARDs) was lower in the middle-European cohort (36.3%) than in the Austrian subcohort of COMORA (59%), but similar to the international COMORA cohort (39%). More smokers were in the Austrian COMORA subcohort (48.0) than in the Middle-European (22.5%) and the COMORA cohort (13%). Hypertension (38.8%) and osteoporosis (30.0%) were the most frequent comorbidities. Conclusion: Comparison of RA patients from this Middle-European cohort with the Austrian COMORA subcohort showed less frequent use of bDMARDs during disease course – probably according to the local referral structure. 88.8% of the Middle-European RA-patients achieved the treat-to target-aim of remission or low disease activity.

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Evaluation of Serum Calprotectin Level and Disease Activity in Patients with Rheumatoid Arthritis

Current Rheumatology Reviews ◽

10.2174/1573397115666190122113221 ◽

2019 ◽

Vol 15 (4) ◽

pp. 316-320

Author(s):

Mir Amir Aghdashi ◽

Seyedmostafa Seyedmardani ◽

Sholeh Ghasemi ◽

Zohre Khodamoradi

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Inflammatory Arthritis ◽

Unknown Etiology ◽

Tender Joint Count ◽

Serum Samples ◽

Tender Joint ◽

Cross Sectional ◽

Calprotectin Level ◽

Remission Phase

Background: Rheumatoid Arthritis (RA) is the most common type of chronic inflammatory arthritis with unknown etiology marked by a symmetric, peripheral polyarthritis. Calprotectin also can be used as a biomarker of disease activity in inflammatory arthritis and other autoimmune diseases. Objective: In this study, we evaluated the association between serum calprotectin level and severity of RA activity. Methods: A cross-sectional study was conducted on 44 RA patients with disease flare-up. Serum samples were obtained from all patients to measure calprotectin, ESR, CRP prior to starting the treatment and after treatment period in the remission phase. Based on Disease Activity Score 28 (DAS28), disease activity was calculated. Results: Of 44 RA patients, 9(20.5%) were male and 35(79.5%) were female. The mean age of our cases was 53±1.6 years. Seventeen (38.6%) patients had moderate DAS28 and 27(61.4%) had high DAS28. The average level of calprotectin in the flare-up phase was 347.12±203.60 ng/ml and 188.04±23.58 ng/ml in the remission phase. We did not find any significant association between calprotectin and tender joint count (TJC; P=0.22), swollen joint count (SJC; P=0.87), and general health (GH; P=0.59), whereas significant associations were found between the calprotectin level and ESR (p=0.001) and DAS28 (p=0.02). The average calprotectin level in moderate DAS28 (275.21±217.96 ng/ml) was significantly lower than that in high DAS28 (392.4±183.88 ng/ml) (p=0.05). Conclusion: We showed that the serum level of calprotectin can be a useful and reliable biomarker in RA activity and its severity. It also can predict treatment response.

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FRI0076 Low Disease Activity or DAS-Remission as Treatment Target in Early Rheumatoid Arthritis Patients

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-eular.2715 ◽

2016 ◽

Vol 75 (Suppl 2) ◽

pp. 454.1-454

Author(s):

G. Akdemir ◽

I.M. Markusse ◽

A.A. Schouffoer ◽

P.B. de Sonnaville ◽

B.A. Grillet ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Early Rheumatoid Arthritis ◽

Treatment Target ◽

Low Disease Activity

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FRI0127 Suppression of radiographic progression after gradual methotrexate tapering in patients with rheumatoid arthritis patients maintaining low disease activity - Prospective multicenter study-

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1415 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 645.1-645

Author(s):

K. Katayama ◽

K. Yujiro ◽

T. Okubo ◽

R. Fukai ◽

T. Sato ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Joint Destruction ◽

Reduction Rate ◽

Bone Destruction ◽

High Response ◽

Continuation Rate ◽

Low Disease Activity ◽

One Year ◽

Response Group

Background:Many studies have been reported to reduce/discontinue Biologics in the treatment of rheumatoid arthritis (RA). In contrast, study for tapering methotrexate (MTX) has been limited (1,2).Objectives:We prospectively examined whether bone destruction will progress at 48 weeks after tapering or discontinuing MTX (UMIN000028875).Methods:The subjects were RA patients who have maintained low disease activity or lower for 24 weeks or more in DAS28-CRP after MTX administration. Patients having PDUS Grade 2 or 3 per site by bilateral hand ultrasonography (26 area) were excluded in this study owing to risk for joint destruction. The joint destruction was evaluated by the joint X-ray evaluation by modified total Sharp scoring (mTSS) at 1 year after the start of tapering MTX. Evaluation of clinical disease activities, severe adverse events, the continuation rate during MTX tapering were also evaluated. According to tapering response, prognostic factor for good response for tapering, joint destruction was determined. Predictors for successful tapering MTX and progression of bone destruction were determined. Statistical analysis was performed by t-test or Wilcoxon rank sum test using SAS .13.2 software.Results:The subjects were 79 (16 males, 63 females). Age average 60.9 years, disease duration 4 years 4 months, MTX dose 8.43 mg / w, DAS28-CRP 1.52, DMARDs (24.3%), ACPA 192.7 U / ml (70.5%), RF 55.6 IU / ml (65.4%).MTX was tapered from an average of 8.43 mg / w before study to 5.46 mg / w one year later. In the treatment evaluation, DAS28-CRP increased from 1.52 to 1.84. 89.7% of subjects did not progress joint damage. Other disease activities significantly increased (Table 1). The one-year continuation rate was 78.2%. Since tapering effects were varied widely, we divided patients into three groups; Flared group (N=14, initial MTX dose 8.71mg/w, final MTX dose 8.42mg/w), Low response group (N=31, final MTX reduction rate< 50%, initial MTX dose 8.93mg/w, final MTX dose 6.22mg/w), High response group (N=34, final MTX reduction rate≥ 50%, initial MTX dose 8.5mg/w, final MTX dose 3.15mg/w)(Table 2).Higher RF value at baseline and higher MTX dose at 3M, 6M were predictors of whether a subject was in Low response group or High Response group. Higher RF value and mTSS at baseline and higher MTX dose at 6M were predictors whether a subject was in Flared group or High response group. Lower age was predictor of whether a subject was in Flared group or Low responder group. Finally, mean ΔmTSS /y in Flared group (0.36) was not significantly higher than in low response group (0.07) and in high response group (0.01).Table 1Table 2.Predictors for successful tapering MTX and progression of bone destructionConclusion:Patients with MTX-administered low disease activity and finger joint echo PDUS grade 1 satisfy almost no joint destruction even after MTX reduction. For tapering, predictors may be helpful for maintaining patient’s satisfaction.References:[1]Baker KF, Skelton AJ, Lendrem DW et al. Predicting drug-free remission in rheumatoid arthritis: A prospective interventional cohort study. J. Autoimmunity. 2019;105: 102298.[2]Lillegraven S, Sundlisater N, Aga A et al. Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial. American College of Rheumatology. 2019; Abstract L08.Disclosure of Interests:None declared

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POS0733 REAL-LIFE PHYSICAL ACTIVITY IN SLE PATIENTS: ASSOCIATIONS WITH FATIGUE AND QUALITY OF SLEEP

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1775 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 617.1-617

Author(s):

H. Wohland ◽

N. Leuchten ◽

M. Aringer

Keyword(s):

Physical Activity ◽

Sleep Quality ◽

Disease Activity ◽

Lupus Erythematosus ◽

Real Life ◽

Survey Study ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Fatigue Score ◽

The Mean

Background:Fatigue is among the top complaints of patients with systemic lupus erythematosus (SLE), but only in part associated with SLE disease activity. Physical activity can help to reduce fatigue and should therefore be recommended to SLE patients. Vice versa, fatigue may arguably lead to reduced physical activity.Objectives:To investigate the extent of physical activity and the perception of fatigue and sleep quality in patients with SLE.Methods:Starting in February 2019, SLE patients were invited to participate in a cross-sectional survey study of fatigue and physical exercise during their routine outpatient clinic visits. Participants filled out a ten-page paper questionnaire focused on physical activity. To evaluate fatigue, we primarily used a 10 cm visual analogue scale (0-100 mm, with 100 meaning most fatigued), but also the FACIT fatigue score (range 0-52). Sleep quality was estimated using grades from 1 (excellent) to 6 (extremely poor).Results:93 SLE patients took part in the study. All patients fulfilled the European League Against Rheumatism/ American College of Rheumatology (EULAR/ACR) 2019 classification criteria for SLE. 91% of the patients were female. Their mean (SD) age was 45.5 (14.3) years and their mean disease duration 12.1 (9.4) years. The mean BMI was 25.2 (5.6). Of all patients, 7.5% had a diagnosis of (secondary) fibromyalgia. The mean fatigue VAS was 32 (27) mm and the mean FACIT fatigue score 35.7 (10.3). As expected, fatigue by VAS and FACIT was correlated (Spearman r=-0.61, p<0.0001). The mean SLEDAI was 1 (1) with a range of 0 to 6. Median glucocorticoid doses were 2 mg prednisolone equivalent, with a range from 0 to 10 mg.Out of 66 patients in payed jobs, 64 (97%) reported details on their working space. One person (2%) worked in a predominanty standing position, 37 (58%) worked in essentially sedentary jobs and 26 (40%) were in positions where they were mildly physically active in part. The mean fatigue VAS was 31 (24) mm for patients with partly active jobs and 27 (30) mm for those in sedentary jobs. Sleep was graded 2.9 (0.9) by those with active and 3.1 (1.3) by those with sedentary jobs.Half of the patients (51%) reported more than one physical recreational activity. 44 (47%) were walking and for five persons (5%) this was the only form of activity. Cycling was reported by 19 patients (20%), 18 of whom also practiced other activities. For transport, 52 (56%) in part chose active modes, such as walking and cycling. Patients who reported any of the above activities showed a mean fatigue VAS of 28 (25) mm, compared to 36 (28) mm in the patient group without a reported activity. Sleep quality was very similar: 3.1 (1.2) and 3.2 (1.1) for more active and more passive patients, respectively.65 (70%) patients regularly practiced sports. Of these, 39 (60%) practiced one kind of sport, 15 (23%) two, 7 (11%) three, and 2 (3%) each four and five kinds of sports. Fatigue VAS of patients practicing sports was 27 (25) mm versus 43 (28) in those who did not (p=0.0075). Sleep quality was 2.9 (1.1) in the sports cohort and 3.5 (1.1) in the no-sports cohort (p=0.0244).Conclusion:A majority of SLE patients in remission or low to moderate disease activity regularly practiced sports, and those doing so reported lesser fatigue and better sleep quality. The absolute values on the fatigue VAS were in a moderate range that made fatigue as the main cause of not performing sports rather unlikely for most patients.Disclosure of Interests:Helena Wohland: None declared, Nicolai Leuchten Speakers bureau: AbbVie, Janssen, Novartis, Roche, UCB, Consultant of: AbbVie, Janssen, Novartis, Roche, Martin Aringer Speakers bureau: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, Chugai, Gilead, GSK, HEXAL, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, GSK, Lilly, MSD, Roche, Sanofi, UCB

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The sFlt-1 to PlGF Ratio in Pregnant Women with Rheumatoid Arthritis: Impact of Disease Activity and Sulfasalazine Use

Rheumatology ◽

10.1093/rheumatology/keab372 ◽

2021 ◽

Author(s):

Rugina I Neuman ◽

Hieronymus T W Smeele ◽

A H Jan Danser ◽

Radboud J E M Dolhain ◽

Willy Visser

Keyword(s):

Rheumatoid Arthritis ◽

Cohort Study ◽

Disease Activity ◽

Pregnant Women ◽

Gestational Age ◽

Third Trimester ◽

Low Disease Activity ◽

The Third ◽

Observational Prospective Cohort Study ◽

Plgf Ratio

Abstract Objectives An elevated sFlt-1/PlGF-ratio has been validated as a significant predictor of preeclampsia, but has not been established in women with rheumatoid arthritis (RA). We explored whether the sFlt-1/PlGF-ratio could be altered due to disease activity in RA, and could be applied in this population to predict preeclampsia. Since sulfasalazine has been suggested to improve the angiogenic imbalance in preeclampsia, we also aimed to examine whether sulfasalazine could affect sFlt-1 or PlGF levels. Methods Making use of a nationwide, observational, prospective cohort study on pregnant women with RA, sFlt-1 and PlGF were measured in the third trimester. A total of 221 women, aged 21–42 years, were included, with a median gestational age of 30 + 3 weeks. Results No differences in sFlt-1 or PlGF were observed between women with high, intermediate or low disease activity (p= 0.07 and p= 0.41), whereas sFlt-1 and PlGF did not correlate with DAS28-CRP score (r=-0.01 and r=-0.05, respectively). Four (2%) women with a sFlt-1/PlGF-ratio ≤38 developed preeclampsia in comparison to three (43%) women with a ratio > 38, corresponding to a negative predictive value of 98.1%. Sulfasalazine users (n = 57) did not show altered levels of sFlt-1 or PlGF in comparison to non-sulfasalazine users (n = 164, p= 0.91 and p= 0.11). Conclusion Our study shows that in pregnant women with RA, the sFlt-1/PlGF-ratio is not altered due to disease activity and a cut-off ≤38 can be used to exclude preeclampsia. Additionally, sulfasalazine use did not affect sFlt-1 or PlGF levels in this population.

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How to Define Boolean Low Disease Activity in Rheumatoid Arthritis: Experience from a Large Real-world Cohort

Rheumatology and Therapy ◽

10.1007/s40744-020-00270-z ◽

2020 ◽

Author(s):

Wenhui Xie ◽

Guangtao Li ◽

Hong Huang ◽

Zhuoli Zhang

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Real World ◽

Low Disease Activity

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SAT0082 FRAX AND DAS IN MOROCCAN RHEUMATOID ARTHRITIS PATIENTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4467 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 975.1-975

Author(s):

H. Azzouzi ◽

O. Lamkhanat ◽

I. Linda

Keyword(s):

Rheumatoid Arthritis ◽

Fracture Risk ◽

Disease Activity ◽

Descriptive Analysis ◽

Cross Sectional Study ◽

Fracture Probability ◽

Mineral Density ◽

Cross Sectional ◽

Risk Probability ◽

Fracture Assessment

Background:Rheumatoid Arthritis (RA) is one of the risk factors for the calculation of the 10 years fracture probability assessed by the FRAX tool.Objectives:The aim was to study the association of disease activity and the 10 year fracture risk probability by the FRAX tool in our RA patients and their impact on fracture prevalence.Methods:Cross-sectional study of the association FRAX and disease activity score (DAS 28 CRP) was designed. Patients with RA were included. Mean DAS was calculated for each patient adjusted on his follow-up duration. Data about patients (demographic, disease characteristics and fracture assessment) were collected. The 10 year fracture risk probability for major osteoporotic fracture was calculated with and without BMD (bone mineral density) using the FRAX tool for Morocco. Descriptive analysis and regressions were performed with SPSS.20. p<0.05 was considered significant.Results:One hundred and ninety nine RA patients were included with mean age of 55.5±12 years. Women represented 91% and 40.1% had osteoporosis. Remission was observed in 86.4% with 95.5% taking methotrexate. 17.1% had vertebral fractures. FRAX and DAS were associated (p=0.03), and both explained vertebral fracture (VF) prevalence. When adjusted on disease parameters, FRAX with and without BMD explained the vertebral prevalence (p=0.02, OR=1.09[1.01-1.19]). However, age remains the only predictor of VF when adjusted on osteoporosis factors (DAS28CRP, menopause, BMI, smoking, diabetes, gender, steroid use, HAQ) and FRAX BMD.Conclusion:Persistent disease activity was associated to high 10 year fracture risk probability calculated by the FRAX tool in RA.Disclosure of Interests:None declared

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