FRI0277 EFFECTIVENESS OF BDMARDS IN AS AND NR-AXSPA PATIENT POPULATIONS: EXPERIENCE FROM THE CORRONA REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 725.1-726
Author(s):  
T. Hunter ◽  
T. Blachley ◽  
W. Malatestinic ◽  
L. Harrold ◽  
B. Dube ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Characteristics ◽  
Response Rates ◽  
Tender Joint Count ◽  
Research Support ◽  
Tender Joint ◽  
Clinical Registry ◽  
Modest Improvement ◽  
Asas Criteria ◽  
Patient Reported

Background:Axial spondyloarthritis (axSpA) consists of ankylosing spondylitis (AS), also referred to as radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA). AxSpA can lead to reduced mobility, pain, fatigue, and impact quality of life. While bDMARDs are available for treatment, the literature lacks studies exploring their real-world effectiveness in clinical registry patients with axSpA.Table 1.Demographic characteristics and clinical response rates of AxSpA patientsTable 2.TNFi drug survival rate results of early and late disease courseObjectives:To describe patient characteristics of bDMARD initiators among the AS and nr-axSpA populations and the effectiveness of bDMARDs at the 6-month (± 3) post-initiation follow-up (FU) visit in the Corrona PsA/SpA Registry.Methods:This study included patients aged ≥ 18 years with AS per modified NY criteria and nr-axSpA per ASAS criteria enrolled between 3/2013 and 9/2019. Concurrently diagnosed patients with PsA were excluded. Baseline characteristics, such as demographic, clinical, disease activity, treatment, and patient-reported outcomes (PRO), were collected for those initiating a bDMARD at enrollment or during FU; response rates and mean change in disease activity and PRO between initiation and 6-month FU were calculated.Results:The AS (n=179) and nr-axSpA (n=32) bDMARD initiators groups were similar at initiation for mean age (AS: 49.1 yrs, nr-axSpA: 48.9 yrs), ASDAS scores (AS: 2.9, nr-axSpA: 2.8) and patient global assessment (AS: 59.6, nr-axSpA: 60.0). The two groups were different for time from disease duration (AS 8.5 yrs, nr-axSpA, 6.6 yrs), current NSAID use (AS: 64.2%, nr-axSpA: 46.9%) and naivete to cDMARDS (AS: 70.4%, nr-axSpA: 40.6%), TNFs (AS: 47.5%, nr-axSpA: 21.9%), non-TNFs (AS: 96.1%, nr-axSpA: 93.8%) and bDMARDs (AS: 46.9%, nr-axSpA: 21.9%). Patients were similarly impacted by their condition for BASDAI (AS: 5.0, nr-axSpA, 5.6), pain (AS: 55.8, nr-axSpA, 60.8) and fatigue (AS: 51.6, nr-axSpA, 59.9), but there was an imbalance in tender joint count (AS: 2.6, nr-axSpA, 13.4).At 6-month FU, both populations experienced minimal or no change in ASDAS scores (AS: -0.3, nr-axSpA: 0.0) remaining in a high state of disease activity (ASDAS, ≥2.2). A small percent of both groups achieved ASAS20 (AS: 20.1%; nr-axSpA: 21.9%) and ASAS40 (AS: 14 %, nr-axSpA: 15.6%). Further, bDMARD initiators had minimal decreases in BASDAI (AS: -0.6, nr-axSpA: -0.8), pain (AS: -8.5, nr-axSpA: -12.2), and fatigue (AS: -5.0, nr-axSpA: -7.9) scores.Conclusion:AS and nr-axSpA bDMARD initiators had a modest improvement in outcomes at six months. Twenty percent or fewer patients achieved ASAS20 or ASAS40, with many having residual impairment based on ASDAS, BASDAI, pain, and fatigue outcomes at six months. While patients are initiating biologic agents, room for improvement exists as many are not achieving optimal treatment response of inactive (ASDAS, <1.3) or low disease activity (ASDAS, <2.1).Disclosure of Interests:Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Taylor Blachley Employee of: Corrona, LLC, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Blessing Dube Employee of: Corrona, LLC, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

scholarly journals AB0886-HPR ASSESSMENT OF SEASONAL VARIATIONS ON CHRONIC INFLAMMATORY RHEUMATISMS ACTIVITY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1466.2-1467
Author(s):  
O. Hamdi ◽  
M. Sellami ◽  
S. Miladi ◽  
A. Fazaa ◽  
L. Souabni ◽  
...  
Keyword(s):  
Disease Activity ◽  
Pain Score ◽  
Health Care Professionals ◽  
Seasonal Changes ◽  
Morning Stiffness ◽  
Cross Sectional Study ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Cross Sectional ◽  
Asas Criteria

Background:Although rheumatoid arthritis (RA) and spondyloarthritis (SA) activities have been described to vary under the influence of several factors, little is known about the influence of seasonality on the activity of chronic inflammatory rheumatisms.Objectives:To assess the influence of seasonality on the activity of chronic inflammatory rheumatisms.Methods:We conducted a cross-sectional study involving patients with RA (2010 ACR/EULAR criteria) and SA (2009 ASAS criteria). Chronic inflammatory rheumatisms activity was assessed during the summer (June-September) and winter (December-February) using clinical parameters including the Patient’s Global Assessment of disease activity (PGA), 10-cm Visual Analog Scale (VAS) pain score, morning stiffness, nocturnal awakenings, and joint count for RA (tender joint count (TJC) and swollen joint count (SJC)); biological parameters including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); disease activity scores including the SDAI, CDAI and DAS28for RA, BASDAI and ASDASCRP for SA. An analysis of variance (ANOVA) was used to assess the statistical relationship between seasonality and rheumatisms activities.Results:We enrolled 175 patients (100 RA and 75 SA) with a sex ratio of 0.5 and a mean age of 57.75 ± 10.53 years [23-83]. The mean chronic inflammatory rheumatisms duration was 12.38 ± 4.6 years. RA was erosive in 91% of cases. Rheumatoid factor and anti-citrullinated peptides antibodies were positive respectively in 84% and 85% of cases. Seventy-five percent of RA patients were on corticosteroids with a mean dose of 10.14 mg/day of prednisone equivalent and 79% of SA patients were on non-steroidal anti-inflammatory drugs. Eighty percent of our patients were treated with conventional synthetic DMARD and 44% with biological DMARD. Small joints were more affected than large joints regardless of the season in RA patients (p=0.05). The following parameters were higher in winter than in summer in RA patients: mean PGA 4.73 vs 4.64 (p=0.01); mean morning stiffness 1.6 vs 1.1 (p=0.01); mean SJC 8.7 vs 7.5 (p=0.01); mean DAS28 ESR 4.56 vs 3.99 (p= 0.05); mean DAS28 CRP 4.6 vs 3.41 (p= 0.05), mean SDAI 21.8 vs 19.5 (p= 0.05); mean CDAI 20.5 vs 18.75 (p= 0.01) and mean ESR 45.6mm/h vs 38.2 mm/h (p=0.01). As for SA, the following parameters were higher in winter than in summer: mean morning stiffness 2 vs 1.4 (p= 0.01); mean ASDASCRP 3.9 vs 3.1 (p= 0.01) and mean BASDAI 6.2 vs 4.9 (p= 0.05). However, we found no statistically significant correlation between seasonal changes and VAS pain score, nocturnal awakenings, TJC, and CRP.Conclusion:Chronic inflammatory rheumatisms activity was higher in winter. Health care professionals should take seasonal changes into account in order to improve therapeutic care.Disclosure of Interests:None declared

scholarly journals Sex-Specific Differences and How to Handle Them in Early Psoriatic Arthritis

2021 ◽  
Author(s):  
Evangelia Passia ◽  
Marijn Vis ◽  
Laura Coates ◽  
Anuska Soni ◽  
Ilja Tchetverikov ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Functional Capacity ◽  
Cohort Analysis ◽  
Treatment Strategies ◽  
Patient Characteristics ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Duration Of Symptoms ◽  
Early Psoriatic Arthritis

Abstract Objectives:The prevalence of Psoriatic Arthritis (PsA) is the same in men and women, however, the latter experience a higher burden of disease and are affected more frequently by polyarthritis. Here, we performed an early PsA cohort analysis to assess sex-related differences in demographics, disease characteristics and evolution over 1 year including applied treatment strategies. Methods:Our study is embedded in the Dutch south-west Early Psoriatic Arthritis cohoRt. We described patient characteristics and treatment decisions. For the comparison across sexes and baseline and 1 year follow up, appropriate tests depending on the distribution were used. Results:273 men and 294 women with no significant differences in age and ethnicity were included. Women reported significantly longer duration of symptoms before diagnosis and significantly higher tender joint count, a higher disease activity, higher levels of pain and lower functional capacity. Although minimal disease activity (MDA) rates increased over time for both sexes, MDA remained significantly more prevalent among men at one year (58.1% vs 35.7%, p<0.00). Initially, treatment strategies were similar in both sexes with Methotrexate being the most frequently used drug during the first year. Women received Methotrexate for a shorter period [196(93-364) vs 306(157-365), p<0.00] and therefore received a lower cumulative dose compared to men. Retention time was shorter for all DMARDs and women had a delayed start on b-DMARDs. Conclusion:After 1 year of standard-of-care treatment women didn’t surpass their baseline disadvantages. Despite the overall improvement, they still presented higher disease activity, higher levels of pain and lower functional capacity score than men. The nature of these findings may advocate a need for sex specific adjustment of treatment strategies and evaluation in early PsA patients.

scholarly journals Sex-specific differences and how to handle them in early psoriatic arthritis

2022 ◽  
Vol 24 (1) ◽  
Author(s):  
E. Passia ◽  
M. Vis ◽  
L. C. Coates ◽  
A. Soni ◽  
I. Tchetverikov ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Functional Capacity ◽  
Cohort Analysis ◽  
Treatment Strategies ◽  
Patient Characteristics ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Duration Of Symptoms ◽  
Early Psoriatic Arthritis

Abstract Objectives The prevalence of psoriatic arthritis (PsA) is the same in men and women; however, the latter experience a higher burden of disease and are affected more frequently by polyarthritis. Here, we performed an early PsA cohort analysis to assess sex-related differences in demographics, disease characteristics, and evolution over 1 year including applied treatment strategies. Methods Our study is embedded in the Dutch south-west Early Psoriatic Arthritis cohoRt. We described patient characteristics and treatment decisions. For the comparison across sexes and baseline and 1 year follow-up, appropriate tests depending on the distribution were used. Results Two hundred seventy-three men and 294 women with no significant differences in age and ethnicity were included. Women reported significantly longer duration of symptoms before diagnosis and significantly higher tender joint count, a higher disease activity, higher levels of pain, and lower functional capacity. Although minimal disease activity (MDA) rates increased over time for both sexes, MDA remained significantly more prevalent among men at 1 year (58.1% vs 35.7%, p < 0.00). Initially, treatment strategies were similar in both sexes with methotrexate being the most frequently used drug during the first year. Women received methotrexate for a shorter period [196 (93–364) vs 306 (157–365), p < 0.00] and therefore received a lower cumulative dose compared to men. Retention time was shorter for all DMARDs, and women had a delayed start on b-DMARDs. Conclusion After 1 year of standard-of-care treatment, women did not surpass their baseline disadvantages. Despite the overall improvement, they still presented higher disease activity, higher levels of pain, and lower functional capacity score than men. The nature of these findings may advocate a need for sex specific adjustment of treatment strategies and evaluation in early PsA patients.

scholarly journals FRI0599 USEFUL II: DERIVATION OF THE LUPUS ARTHRITIS AND MUSCULOSKELETAL DISEASE ACTIVITY SCORE (LAMDA) USING DATA FROM A MULTICENTRE LONGITUDINAL STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 905.2-906
Author(s):  
K. Mahmoud ◽  
A. Zayat ◽  
M. Y. MD Yusof ◽  
C. Ciurtin ◽  
C. S. Yee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Activity ◽  
Effect Size ◽  
Lasso Regression ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Becton Dickinson ◽  
Tender Joint ◽  
Patient Reported ◽  
Minimal Disease

Background:Musculoskeletal (MSK) disease is the commonest manifestation of SLE. We showed that the MSK components of the BILAG index and SLEDAI have limited sensitivity, specificity and responsiveness compared to ultrasound (US) synovitis. The USEFUL study evaluated response to glucocorticoids in SLE patients with inflammatory pain.Objectives:To develop a disease activity tool for lupus MSK manifestations that is continuous, responsive, sensitive, and correlates with US-synovitisMethods:133 patients who received depomedrone 120mg IM were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG2004 index, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS. Total US score (OMERACT-EULAR) in the hands and wrists was calculated blinded to patient and clinical assessor. Patients reported overall response using a Likert scale.The LAMDA was developed by modelling a core set of clinical variables against total US score using penalized (Lasso) regression. Responsiveness was compared between LAMDA and other variables at week 6 using effect sizes. Minimum clinically important difference (MCID) was explored using the SEM and minimal disease activity threshold using ROC.Results:The variables selected for the LAMDA score were swollen joint count, patient MSK pain VAS, physician MSK disease activity VAS and ESR. A continuous score was derived. This had a theoretical range from 0 to 26.5 based on maximum ESR of 100. The highest value observed in USEFUL was 15. LAMDA was significantly higher in patients with active US (mean (SD) 5.71 (2.67), n=78) compared to patients with normal US (3.27 (1.77), n=55; difference (95% CI) -2.45 (-3.26, -1.63), t=-5.93, p<0.001). This difference remained significant in patients with no swollen joints (difference (95% CI) -0.71 (-1.40, -0.02), t=-2.06, p=0.044).Effect size was greater for the LAMDA (0.37) than the BILAG-MSK (0.31), SLEDAI-MSK (0.27) and total US score (0.33). In patients with active US at baseline, LAMDA’s effect size was 0.42.The MCID was 0.71 and correlated with patient-reported change in pain. A threshold for minimal disease activity of 3.23 optimized sensitivity (0.77 (0.65, 0.89)) and specificity (0.80 (0.68, 0.92)) against US score >0.Conclusion:The LAMDA score is a novel continuous disease activity instrument for MSK manifestations of SLE derived from variables familiar to rheumatologists. The LAMDA score is sensitive to imaging detected synovitis without swelling and more responsive than other instruments. . LAMDA may improve the ability of clinicians to accurately determine therapeutic efficacy in clinical trials and practice. Future work will validate the LAMDA score in independent cohorts and randomized trials.Acknowledgements:This project was funded by Lupus UKDisclosure of Interests:Khaled Mahmoud: None declared, Ahmed Zayat: None declared, Md Yuzaiful Md Yusof: None declared, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences, Chee-Seng Yee: None declared, David Isenberg Consultant of: Study Investigator and Consultant to Genentech, Lee-Suan Teh: None declared, Katherine Dutton: None declared, David d’cruz Grant/research support from: GlaxoSmithKline, Nora Ng: None declared, Philip G Conaghan Consultant of: AbbVie, BMS, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GSK, Novartis, Pfizer, Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Elizabeth Hensor: None declared, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK

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 AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

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

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.

scholarly journals FRI0020 CLINICAL TREATMENT RESPONSE STILL DOES NOT MATCH PATIENT REPORTED IMPROVEMENT, EVEN IN EARLY RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Sustained Remission ◽  
Research Support ◽  
Early Ra ◽  
Severity Scores ◽  
Patient Reported ◽  
Over Time

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

scholarly journals Systematic Review and Metaanalysis of Patient Self-Report versus Trained Assessor Joint Counts in Rheumatoid Arthritis

2009 ◽  
Vol 36 (12) ◽  
pp. 2635-2641 ◽  
Author(s):  
JENNIFER L. BARTON ◽  
LINDSEY A. CRISWELL ◽  
RACHEL KAISER ◽  
YEA-HUNG CHEN ◽  
DEAN SCHILLINGER
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Self Report ◽  
Future Research ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Trained Assessor ◽  
Tender Joint Counts

Objective.Patient self-report outcomes and physician-performed joint counts are important measures of disease activity and treatment response. This metaanalysis examines the degree of concordance in joint counts between trained assessors and patients with rheumatoid arthritis (RA).Methods.Studies eligible for inclusion met the following criteria: English language; compared patient with trained assessor joint counts; peer-reviewed; and RA diagnosis determined by board-certified or board-eligible specialist or met 1987 American College of Rheumatology criteria. We searched PubMed and Embase to identify articles between 1966 and January 1, 2008. We compared measures of correlation between patients and assessors for either tender/painful or swollen joint counts. We used metaanalysis methods to calculate summary correlation estimates.Results.We retrieved 462 articles and 18 were included. Self-report joint counts were obtained by a text and/or mannequin (picture) format. The summary estimates for the Pearson correlation coefficients for tender joint counts were 0.61 (0.47 lower, 0.75 upper) and for swollen joint counts 0.44 (0.15, 0.73). Summary results for the Spearman correlation coefficients were 0.60 (0.30, 0.90) for tender joint counts and 0.54 (0.35, 0.73) for swollen joint counts.Conclusion.A self-report tender joint count has moderate to marked correlation with those performed by a trained assessor. In contrast, swollen joint counts demonstrate lower levels of correlation. Future research should explore whether integrating self-report tender joint counts into routine care can improve efficiency and quality of care, while directly involving patients in assessment of RA disease activity.

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