scholarly journals Trajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001372
Author(s):  
Sella Aarrestad Provan ◽  
Brigitte Michelsen ◽  
Joseph Sexton ◽  
Tillmann Uhlig ◽  
Hilde Berner Hammer
Keyword(s):  
Rheumatoid Arthritis ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Logistic Regression Models ◽  
Patient Reported ◽  
Biologic Dmard ◽  
Clinically Significant

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with RA initiating bDMARDs were assessed at 0, 1, 2, 3, 6 and 12 months. Swollen and tender joint counts, patient reported outcomes (PROMs), blood samples and ultrasound examinations were collected at each time point. Fatigue was assessed by the fatigue Numeric Rating Scale (0–10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Clinically significant fatigue was predefined as fatigue ≥4. Three trajectories of interest were defined according to level of RAID fatigue: no fatigue (≤3 at 5/6 visits), improved fatigue (≥4 at start, but ≤3 at follow-up) and continued fatigue (≥4 at 5/6 visits). Baseline variables were compared between groups by bivariate analyses, and logistic regression models were used to explore baseline predictors of continued vs improved fatigue.ResultsThe majority of patients starting bDMARD therapy followed one of three fatigue trajectories, (no fatigue; n=61, improved; n=33 and continued fatigue; n=53). Patients with continued fatigue were more likely to be anti–citrullinated protein antibody and/or rheumatoid factor positive and had higher baseline PROMs compared to the other groups, while there were no differences between the groups for variables of inflammation including. Patient global, tender joint count and anxiety were predictors for the continued fatigue trajectory.DiscussionA trajectory of continued fatigue was determined by PROMs and not by inflammatory RA disease activity.

MRI in early rheumatoid arthritis: synovitis and bone marrow oedema are independent predictors of subsequent radiographic progression

2010 ◽  
Vol 70 (3) ◽  
pp. 428-433 ◽  
Author(s):  
Pernille Bøyesen ◽  
Espen A Haavardsholm ◽  
Mikkel Østergaard ◽  
Désirée van der Heijde ◽  
Sølve Sesseng ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Bone Marrow ◽  
Early Rheumatoid Arthritis ◽  
Radiographic Progression ◽  
Bone Marrow Oedema ◽  
Tender Joint Count ◽  
X Rays ◽  
Tender Joint ◽  
Reactive Protein

ObjectivesTo determine whether MRI and conventional (clinical and laboratory) measures of inflammation can predict 3-year radiographic changes measured by the van der Heijde Sharp score in patients with early rheumatoid arthritis (RA).Methods55 patients with RA with disease duration <1 year participated in this 3-year follow-up study. Patients were evaluated at baseline, 3, 6, 12 and 36 months by swollen and tender joint count, disease activity score based on 28-joint count, erythrocyte sedimentation rate (ESR), C reactive protein, MRI measures of synovitis, bone marrow oedema and tenosynovitis of the dominant wrist, as well as conventional x-rays of the hands and wrists.ResultsAll measures of inflammation decreased during the follow-up period. ESR, MRI synovitis and MRI bone marrow oedema were independent predictors of 3-year radiographic progression adjusted for age, sex and anti-citrullinated protein antibodies. The 1-year cumulative measures of MRI synovitis and bone marrow oedema provided an improved explanation of variation (adjusted R2) in radiographic change compared with the baseline MRI values (adjusted R2=0.32 and 0.20 vs 0.11 and 0.04, respectively).ConclusionsBoth baseline and 1-year cumulative measures of MRI synovitis and bone marrow oedema independently predicted 3-year radiographic progression. These results confirm that MRI synovitis and MRI bone marrow oedema precede radiographic progression in patients with early RA.

scholarly journals Anticollagen type II antibodies are associated with an acute onset rheumatoid arthritis phenotype and prognosticate lower degree of inflammation during 5 years follow-up

2017 ◽  
Vol 76 (9) ◽  
pp. 1529-1536 ◽  
Author(s):  
Vivek Anand Manivel ◽  
Mohammed Mullazehi ◽  
Leonid Padyukov ◽  
Helga Westerlind ◽  
Lars Klareskog ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Assessment ◽  
Human Leukocyte ◽  
Tender Joint Count ◽  
Type Ii ◽  
Clinical Genetic ◽  
Double Positive ◽  
Tender Joint ◽  
Quality Register

ObjectiveAntifibrillar collagen type II (anti-CII) antibody-positive patients with rheumatoid arthritis (RA) have early but not late signs of increased inflammation and joint erosions. We wanted to replicate this in a large RA cohort, and to relate to human leukocyte antigen (HLA)-DRB1* alleles.MethodsAnti-CII and anti-cyclic citrullinated peptide (CCP)2 were measured at baseline in 773 patients with RA from the Swedish Epidemiological Investigation in Rheumatoid Arthritis (EIRA) study with clinical follow-up data from the Swedish Rheumatology Quality Register (SRQ) registry, and 1476 with HLA-DRB1* information. Comparisons were done concerning C reactive protein (CRP), erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), Disease Activity Score encompassing 28 joints based on ESR (DAS28), DAS28CRP, pain-Visual Analogue Scale (VAS), global-VAS and Health Assessment Questionnaire Score (HAQ) at eight occasions during 5 years, and association with HLA-DRB1* alleles.ResultsAnti-CII associated with elevated CRP, ESR, SJC, DAS28 and DAS28CRP at diagnosis and up to 6 months, whereas anti-CCP2 associated with SJC and DAS28 from 6 months to 5 years, but not earlier. The anti-CII-associated phenotype was strong, and predominated in anti-CII/anti-CCP2 double-positive patients. Anti-CII was associated with improvements in CRP, ESR, SJC, TJC and DAS28, whereas anti-CCP2 was associated with deteriorations in SJC and DAS28 over time. Anti-CII-positive patients achieved European League Against Rheumatism good or moderate response more often than negative patients. Anti-CII was positively associated with HLA-DRB1*01 and HLA-DRB1*03, with significant interaction, and double-positive individuals had >14 times higher mean anti-CII levels than HLA double negatives. Whereas smoking was associated with elevated anti-CCP2 levels, smokers had lower anti-CII levels.ConclusionsAnti-CII seropositive RA represents a distinct phenotype, in many respects representing the converse to the clinical, genetic and smoking associations described for anticitrullinated protein peptide autoantibodies. Although not diagnostically useful, early anti-CII determinations predict favourable inflammatory outcome in RA.

scholarly journals Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission

2021 ◽  
Author(s):  
Hilde Berner Hammer ◽  
Inger Marie Jensen Hansen ◽  
Pentti Järvinen ◽  
Marjatta Leirisalo-Repo ◽  
Michael Ziegelasch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Laboratory ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Tender Joint ◽  
Subjective Assessments ◽  
Patient Reported ◽  
Changes Over Time ◽  
Tender Joint Counts

Abstract Objectives Since subjective variables may reduce remission by composite disease activity scores (CDAS), the main objectives were to explore whether rheumatoid arthritis (RA) patients with mainly tender versuss mainly swollen joints had differences in patient reported outcome measures (PROMs), clinical or ultrasound assessments as well as in achieving remission defined by CDAS or ultrasound. Methods In a Nordic multicentre study, RA patients initiating tocilizumab were assessed by PROMs, clinical, laboratory and ultrasound assessments (36 joints, 4 tendons) at baseline, 4, 12 and 24 weeks. Remission was defined according to CDAI/Boolean or no Doppler activity present. Tender-Swollen joint differences (TSJD) were calculated. Statistics exploring changes over time/differences between groups included Wilcoxon, Mann–Whitney, Kruskal-Wallis and Spearman. Results 110 patients were included (mean (SD) age 55.6 (12.1) years, RA duration 8.7 (9.5) years). All PROMs, clinical, laboratory and ultrasound scores decreased during follow-up (p &lt; 0.001). During follow-up, tender joint counts were primarily correlated with PROMs (r = 0.24–0.56 (p &lt; 0.05–0.001)), and swollen joint counts with ultrasound synovitis scores (r = 0.33–0.72 (p &lt; 0.05–0.001)). At 24 weeks patients with TSJD &gt; 0 had higher PROMs and CDAI (p &lt; 0.05–0.001) but lower ultrasound synovitis scores (p &lt; 0.05). Remission by CDAI/Boolean was seen in 26–34% and by Doppler 53%, but only 2–3% of patients with TSJD &gt; 0 achieved CDAI/Boolean remission. Conclusion Patients with more tender than swollen joints scored higher on subjective assessments but had less ultrasound synovitis. They seldom achieved CDAS remission despite many being in Doppler remission. If patients with predominantly tender joints do not reach CDAS remission, objective assessments of inflammation should be performed. Clinical trial identifier ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02046616

Radial Osteotomy for Kienböck Disease: Clinical and Radiological Comparison between Younger and Older Patients

2021 ◽  
Vol 26 (03) ◽  
pp. 410-416
Author(s):  
Michiro Yamamoto ◽  
Masahiro Tatebe ◽  
Yasunobu Nakagawa ◽  
Shigeru Kurimoto ◽  
Katsuyuki Iwatsuki ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Clinical Improvement ◽  
Older Patients ◽  
Rating Scale ◽  
Clinical Results ◽  
Numeric Rating Scale ◽  
Patient Reported ◽  
Kienböck Disease ◽  
Disease Stages

Background: The usefulness of radial osteotomy for older patients remains unclear. The purpose of this study was to compare the clinical and radiological outcomes of radial osteotomy with volar locking plate between younger and older patients with Kienböck disease stages II to IIIB. Methods: This was a retrospective comparative study of 21 consecutive patients treated at our department. Lichtman’s classification was used for staging, and four patients had stage II, six patients had stage IIIA, and 11 patients had stage IIIB disease. We divided them into two groups to compare the radiological and clinical results between younger (younger than 40 years) and older patients. The mean follow-up periods in the younger and older groups were 4 and 3.6 years, respectively. For radiological assessment, we evaluated the carpal height ratio (CHR), Stahl index, and union of the fractured lunate. For clinical assessment, we examined the range of motion of the wrist, grip strength, numeric rating scale (NRS) for pain, and the patient-reported Hand20 score preoperatively and at the final follow-up. Results: There were 12 patients in the younger group with a mean age of 23 years (range, 12–37 years), and 9 in the older group with a mean age of 56 years (range, 40–74 years). There were no intra- and post-operative complications in either group. Radiological improvement, including CHR, Stahl index, and union of the fractured lunate, was more common in the younger group than in the older one, as was the case for clinical improvement. However, even in the older group, significant clinical improvement, including the range of motion of the wrist, NRS for pain, and the Hand20 score, was seen postoperatively. Conclusions: Radial osteotomy appears to be a safe and reliable option in older symptomatic patients with Kienböck disease stages II to IIIB.

scholarly journals P211 Indirect measurement of central sensitisation as a predictor of response to different drug treatments in patients with inflammatory arthritis in a UK clinical cohort

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Stephanie Santos-Paulo ◽  
Andrew R Segerdahl ◽  
Samuel Hawley ◽  
Raashid A Luqmani ◽  
Irene Tracey ◽  
...  
Keyword(s):  
Disease Activity ◽  
Demographic Data ◽  
Indirect Measurement ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Central Sensitisation ◽  
Logistic Regression Models ◽  
Unit Increase ◽  
Drug Regimens

Abstract Background Rheumatoid arthritis (RA) is a common, painful and disabling condition. Despite effective treatment of inflammation, many patients continue to experience ongoing pain. Central sensitisation could explain this apparent discordance, but at current is not routinely assessed in clinical practice. Previous studies have used the non-inflammatory components of Disease Activity Score-28 (DAS28-CRP) to derive novel, indirect indicators of central sensitisation. The aim of this study was to investigate whether DAS28-derived indices could be used to predict response to drug therapy in a clinical dataset. Methods This retrospective observational cohort study of patients with RA used NHS data collected prospectively from February 2016 to June 2018 from the Rheumatology Assessment Database in Oxford (Rhadio). The study received necessary ethical clearance from the NHS Health Research Authority (IRAS number: 246029). Baseline clinical and demographic data were extracted the following potential indirect indicators of centrally mediated pain were calculated: tender-swollen joint count difference (TJC-SJC difference), swollen to tender joint count ratio (STR), and DAS28-P, a measure of the non-inflammatory proportion of DAS28-CRP. The DAS28-P measure used herein includes CRP rather than ESR and is multiplied by 100 for ease of interpretation. Individual disease outcomes at follow-up were calculated according to European League Against Rheumatism (EULAR) criteria and multivariate logistic regression models including age, gender, treatment duration and drug regimens were generated to assess the relationship between potential baseline pain indicators and EULAR outcome at follow-up. Results We included data from 2,176 patients with RA.The majority were female (71.4%) with a median age of 64.8 (IQR= 53.6 to 73.3) years. The largest proportion of patients were classified as being in clinical remission at baseline, though there was considerable heterogeneity in the symptomatic profiles of patients within any given disease activity classification. 872 patients had valid follow-up data at ≥ three months post-baseline visit. Patients undergoing treatment escalation had significantly decreased DAS28-P scores at ≥ three months follow-up compared to baseline, while no significant change was observed in patients on stable therapy. Regression analyses showed that the three indirect indices of central sensitisation were positive predictors of treatment outcome. A unit increase in any one of TJC-SJC difference, STR or DAS28-P at baseline significantly increased the odds of a patient achieving at least a moderate EULAR response at follow-up, even when confounding factors were controlled for (DAS28-P: OR = 1.062 (95% CI: 1.050, 1.075) p &lt; 0.0005; STR: OR = 2.746 (95% CI: 1.466, 5.146) p = 0.002; TJC-SJC difference: OR = 1.101 (95% CI: 1.055, 1.150) p &lt; 0.0005). Conclusion The overall DAS28-CRP score is sensitive to fluctuations of different disease components including inflammation, pain and general health. Novel DAS28-CRP-derived indices can highlight the frequently observed discordance between the inflammatory and non-inflammatory components of the DAS28-CRP score. Disclosures S. Santos-Paulo None. A.R. Segerdahl None. S. Hawley None. R.A. Luqmani None. I. Tracey None. A. Soni None.

scholarly journals The Effect of Socioeconomic Class and Immigrant Status on Disease Activity in Rheumatoid Arthritis: Data from BARFOT, a Multi-Centre Study of Early RA

2013 ◽  
Vol 7 (1) ◽  
pp. 105-111 ◽  
Author(s):  
Maria L.E. Andersson ◽  
Stefan Bergman ◽  
Maria K. Söderlin
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Tender Joint Count ◽  
Immigrant Status ◽  
Tender Joint ◽  
Eular Response ◽  
Multi Centre Study ◽  
Socioeconomic Class ◽  
Early Ra

Background:There have been no reports on the effect of immigrant status and socioeconomic status on outcome in rheumatoid arthritis (RA) in Sweden.Methods:Between 1992 and 2006, 2,800 patients were included in the BARFOT study on early RA in Sweden. Disease Activity Score 28 joints (DAS28), Health Assessment Questionnaire (HAQ), treatment and European League Against Rheumatism (EULAR) response criteria were registered. In 2010, 1,430 patients completed a questionnaire enquiring about demographics and lifestyle factors.Results:One hundred and thirty-nine of the 1,430 patients (9.7%) were immigrants. At baseline immigrants had higher mean HAQ (1.2 vs 0.97 for non-immigrants, p=0.001), DAS28 (5.6 vs 5.2, p=0.000), visual analog scale (VAS) pain (56 mm vs 45 mm, p=0.000), VAS global health (53 mm vs 44 mm, p=0.000) and tender joint count (TJC) (10 vs 8, p=0.000). These differences persisted for up to 2 years of follow-up (for HAQ, for up to 8 years of follow-up). Immigrant status did not have any effect on swollen joint count (SJC), ESR, CRP or EULAR response. Socioeconomic class did not have any effect on treatment or outcome.Conclusions:Immigrants scored worse in pain, function and TJC for up to 2 years of follow-up, but they did not differ from non-immigrants in objective measures of inflammation or EULAR outcome. This could be due to different perceptions of health and pain and/or the stress of immigration. Socioeconomic class had no effect on treatment or outcome, and this could be due to the relatively egalitarian society in Sweden.

scholarly journals Comorbidities in Patients with Rheumatoid Arthritis and Their Association with Patient-reported Outcomes: Results of Claims Data Linked to Questionnaire Survey

2019 ◽  
Vol 46 (6) ◽  
pp. 564-571 ◽  
Author(s):  
Andres Luque Ramos ◽  
Imke Redeker ◽  
Falk Hoffmann ◽  
Johanna Callhoff ◽  
Angela Zink ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
International Classification Of Diseases ◽  
Population Based ◽  
World Health ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Patient Reported ◽  
Icd 10

Objective.To investigate the prevalence of comorbidities in a population-based cohort of persons with rheumatoid arthritis (RA) compared to matched controls and to examine their association with patient-reported outcomes in a survey sample.Methods.Data of 96,921 persons with RA [International Classification of Diseases, 10th ed (ICD-10) M05/M06] and 484,605 age- and sex-matched controls without RA of a German statutory health fund were studied regarding 26 selected comorbidities (ICD-10). A self-reported questionnaire, comprising joint counts [(tender joint count (TJC), swollen joint count (SJC)], functional status (Hannover Functional Ability Questionnaire), effect of the disease (Rheumatoid Arthritis Impact of Disease), and well-being (World Health Organization 5-item Well-Being Index; WHO-5) was sent to a random sample of 6193 persons with RA, of whom 3184 responded. For respondents who confirmed their RA (n = 2535), associations between comorbidities and patient-reported outcomes were analyzed by multivariable linear regression.Results.Compared to controls, all investigated comorbidities were more frequent in persons with RA (mean age 63 yrs, 80% female). In addition to cardiovascular risk factors, the most common were osteoarthritis (44% vs 21%), depression (32% vs 20%), and osteoporosis (26% vs 9%). Among the survey respondents, 87% of those with 0–1 comorbidity but only 77% of those with ≥ 8 comorbidities were treated by rheumatologists. Increasing numbers of comorbidities were associated with poorer values for TJC, SJC, function, and WHO-5.Conclusion.Compared to a matched population, persons with RA present with increased prevalence of numerous comorbidities. Patients with RA and multimorbidity are at risk of insufficient rheumatological care and poorer patient-reported outcomes.

scholarly journals Fatigue is associated with disease activity in some, but not all, patients living with rheumatoid arthritis: disentangling “between-person” and “within-person” associations

2022 ◽  
Vol 6 (1) ◽  
Author(s):  
Grada A. Versteeg ◽  
Peter M. ten Klooster ◽  
Mart A. F. J. van de Laar
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Repeated Measures ◽  
Rating Scale ◽  
Pragmatic Trial ◽  
Tender Joint Count ◽  
Markers Of Inflammation ◽  
Patient Reported ◽  
Fatigue Severity ◽  
Over Time

Abstract Background Previous research has shown an unclear and inconsistent association between fatigue and disease activity in patients with rheumatoid arthritis (RA). The aim of this study was to explore differences in “between-person” and “within-person” associations between disease activity parameters and fatigue severity in patients with established RA. Methods Baseline and 3-monthly follow-up data up to one-year were used from 531 patients with established RA randomized to stopping (versus continuing) tumor necrosis factor inhibitor treatment enrolled in a large pragmatic trial. Between- and within-patient associations between different indicators of disease activity (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], swollen and tender joint count [ SJC and TJC], visual analog scale general health [VAS-GH]) and patient-reported fatigue severity (Bristol RA Fatigue Numerical Rating Scale) were disaggregated and estimated using person-mean centering in combination with repeated measures linear mixed modelling. Results Overall, different indices of disease activity were weakly to moderately associated with fatigue severity over time (β’s from 0.121 for SJC to 0.352 for VAS-GH, all p’s < 0.0001). Objective markers of inflammation (CRP, ESR and SJC) were associated weakly with fatigue within patients over time (β’s: 0.104–0.142, p’s < 0.0001), but not between patients. The subjective TJC and VAS-GH were significantly associated with fatigue both within and between patients, but with substantially stronger associations at the between-patient level (β’s: 0.217–0.515, p’s < 0.0001). Within-person associations varied widely for individual patients for all components of disease activity. Conclusion Associations between fatigue and disease activity vary largely for different patients and the pattern of between-person versus within-person associations appears different for objective versus subjective components of disease activity. The current findings explain the inconsistent results of previous research, illustrates the relevance of statistically distinguishing between different types of association in research on the relation between disease activity and fatigue and additionally suggest a need for a more personalized approach to fatigue in RA patients. Trial registration Netherlands trial register, Number NTR3112.

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

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.

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

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