scholarly journals P127 Treating rheumatoid arthritis patients with moderate disease activity: an analysis of the upadacitinib SELECT Phase III randomised studies

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Phillip G Conaghan ◽  
Karel Pavelka ◽  
Song-Chou Hsieh ◽  
Terri-Leigh Bonnington ◽  
Toby C Kent ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Phase Iii ◽  
Integrated Analysis ◽  
Inadequate Response ◽  
Mixed Effect ◽  
Advisory Boards ◽  
Moderate Disease ◽  
Patient Reported ◽  
Moderate Disease Activity

Abstract Background/Aims  Some health systems restrict use of advanced therapies for rheumatoid arthritis (RA) to patients with high disease activity (DAS28>5.1). Upadacitinib (UPA), a selective JAK inhibitor, has demonstrated significant improvement in patients with moderate-to-severe RA. We aimed to explore the efficacy and safety of UPA in RA patients with moderate disease activity. Methods  This was a post-hoc, subgroup analysis from three phase 3 registrational trials evaluating once daily UPA 15mg versus placebo (PBO) in patients with moderate (DAS28(CRP)>3.2, ≤5.1) and high (DAS28(CRP)>5.1) disease activity. Patients had prior inadequate response to csDMARDs (SELECT-COMPARE and SELECT-NEXT integrated analysis) or bDMARDs (SELECT-BEYOND). Clinical and functional outcomes were analysed at the studies primary endpoint (Week12). Missing data were handled using non-responder imputation for binary endpoints and mixed-effect model repeat measurement for continuous variables. Results  Across all three studies mean baseline DAS28(CRP) was ∼4.5 and ∼6.2 in moderate and severe patients, respectively. At Week 12 significantly greater proportions of csDMARD-inadequate responder (IR) and bDMARD-IR patients receiving UPA 15 mg achieved ACR20, low disease activity (DAS28(CRP)≤3.2) and remission (DAS28(CRP)<2.6) compared to PBO in both disease severity subgroups (Table 1). Improvement in physical function assessed by Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ-DI) and pain visual analogue scale (VAS) were significantly greater with UPA 15mg vs PBO for severe csDMARDs-IR and bDMARD-IR populations and numerically greater in moderate bDMARD-IR patients. Across all IR populations higher proportions of patients with moderate disease treated with UPA 15mg achieved DAS28(CRP)≤3.2 and DAS28(CRP)<2.6 compared to those with severe disease. The safety profile of UPA in moderate and severe patients was comparable and consistent with previously published data. Conclusion  UPA 15mg was effective in improving clinical, functional, and patient reported outcomes in patients with either moderate or severe RA. P127 Table 1:Baseline characteristics and efficacy endpoints at week 12 from SELECT-NEXT, -COMPARE and -BEYONDTimepointKey EndpointscsDMARD IR (SELECT COMPARE and SELECT NEXT integrated)ModerateSevereUPA 15mg (n = 209)PBO (n = 195)UPA 15mg (n = 649)PBO (n = 671)BaselineAge (yrs; Mean ± SD)53.7 ± 12.654.5 ± 12.454.9 ± 11.654.1 ± 12.3Duration since diagnosis (yrs; Mean ± SD)7.5 ± 7.47.3 ± 6.78.0 ± 7.98.2 ± 8.2DAS28(CRP) (Mean ± SD)4.6 ± 0.44.6 ± 0.46.2 ± 0.76.1 ± 0.7HAQ-DI (Mean ± SD)1.2 ± 0.61.2 ± 0.61.7 ± 0.61.7 ± 0.6Pain VAS (0-100) (Mean ± SD)52.5 ± 21.448.4 ± 21.669.8 ± 18.268.9 ± 17.9Week 12ACR20 (% response, 95% CI)63.6 (57.1, 70.2)***33.8 (27.2, 40.5)71.2 (67.7, 74.7)***37.0 (33.3, 40.6)DAS28 (CRP) ≤3.2, (% response, 95% CI)61.7 (55.1, 68.3)***28.7 (22.4, 35.1)40.7 (36.9, 44.5)***10.3 (8.0, 12.6)DAS28 (CRP) ≤2.6, (% response, 95% CI)41.4 (34.5, 47.8)***14.9 (9.9, 19.9)25.1 (21.8, 28.5)***4.6 (3.0, 6.2)ΔHAQ-DI (mean, 95% CI)-0.43 (-0.51, -0.35)***-0.23 (-0.32, -0.15)-0.67 (-0.72, -0.61)***-0.31 (-0.36, -0.25)Δ Pain VAS (0-100) (% response, 95% CI)-25.0 (-28.6, -21.4)***-7.0, (-10.6, -3.2)-32.8 (-35.1, -30.5)***-16.1 (-18.4, -13.8)TimepointKey EndpointsbDMARD IR (SELECT-BEYOND)ModerateSevereUPA 15mg (n = 39)PBO (n = 38)UPA 15mg (n = 124)PBO (n = 128)BaselineAge (yrs; Mean ± SD)56.1 ± 11.157.7 ± 13.456.4 ± 11.557.6 ± 10.9Duration since diagnosis (yrs; Mean ± SD)13.6 ± 10.014.7 ± 9.411.9 ± 9.214.6 ± 9.3DAS28(CRP) (Mean ± SD)4.7 ± 0.34.4 ± 0.56.2 ± 0.86.2 ± 0.7HAQ-DI (Mean ± SD)1.4 ± 0.71.1 ± 0.51.8 ± 0.61.7 ± 0.6Pain VAS (0-100) (Mean ± SD)58.1 ± 22.449.8 ± 22.271.3 ±74.5 ±Week 12ACR20 (% response, 95% CI)61.5 (46.3, 76.8)*36.8 (21.5, 52.2)66.1 (57.8, 74.5)***26.6 (18.9, 34.2)DAS28 (CRP) ≤3.2, (% response, 95% CI)64.1 (49.0, 79.2)**28.9 (14.5, 43.4)36.3 (27.8, 44.8)***9.4 (4.3, 14.4)DAS28 (CRP) ≤2.6, (% response, 95% CI)43.6 (28.0, 59.2)*21.1 (8.1, 34.0)24.2 (16.7, 31.7)***6.3 (2.1, 10.4)ΔHAQ-DI (mean, 95% CI)-0.24 (-0.41, -0.07)-0.12 (-0.30, 0.05)-0.47 (-0.56, -0.37)***-0.18 (-0.28, -0.08)Δ Pain VAS (0-100) (% response, 95% CI)-16.8 (-25.4, -8.1)-5.4 (-14.3, 3.4)-28.7 (-33.5, -24.0)***-12.2 (-17.0, -7.3)*p ≤ 0.05;**p ≤ 0.01;***p ≤ 0.001 for comparison of UPA versus PBO. Disclosure  P.G. Conaghan: Other; P.C. has been a consultant or speaker for AbbVie, BMS, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer. K. Pavelka: Other; K.P. has received honoraria for consultations and lectures from AbbVie, Roche, Pfizer, MSD, Sanofi, UCB and Amgen. S. Hsieh: None. T. Bonnington: Other; T.B. is an employee at AbbVie Limited. T.C. Kent: Other; T.C. is an employee at AbbVie Limited. C.J. Edwards: Other; C.E. has received honoraria, advisory boards, speakers bureau, research support from AbbVie, BMS, Biogen, Fresenius, Gilead Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB.

scholarly journals Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5-year outcome compared to persistent low-remission status and represent a heterogeneous group

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Irini Genitsaridi ◽  
Irini Flouri ◽  
Dimitris Plexousakis ◽  
Konstantinos Marias ◽  
Kyriaki Boki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Serious Adverse Events ◽  
Term Outcome ◽  
Mixed Effect ◽  
Long Term Outcome ◽  
Moderate Disease ◽  
Moderate Disease Activity

Abstract Background The long-term outcome of rheumatoid arthritis (RA) patients who in clinical practice exhibit persistent moderate disease activity (pMDA) despite treatment with biologics has not been adequately studied. Herein, we analyzed the 5-year outcome of the pMDA group and assessed for within-group heterogeneity. Methods We included longitudinally monitored RA patients from the Hellenic Registry of Biologic Therapies with persistent (cumulative time ≥ 50% of a 5-year period) moderate (pMDA, 3.2 < DAS28 ≤ 5.1) or remission/low (pRLDA, DAS28 ≤ 3.2) disease activity. The former was further classified into persistent lower-moderate (plMDA, DAS28 < 4.2) and higher-moderate (phMDA, DAS28 ≥ 4.2) subgroups. Five-year trajectories of functionality (HAQ) were the primary outcome in comparing pRLDA versus pMDA and assessing heterogeneity within the pMDA subgroups through multivariable mixed-effect regression. We further compared serious adverse events (SAEs) occurrence between the two groups. Results We identified 295 patients with pMDA and 90 patients with pRLDA, the former group comprising of plMDA (n = 133, 45%) and phMDA (n = 162, 55%). pMDA was associated with worse 5-year functionality trajectory than pRLDA (+ 0.27 HAQ units, CI 95% + 0.22 to + 0.33; p < 0.0001), while the phMDA subgroup had worse 5-year functionality than plMDA (+ 0.26 HAQ units, CI 95% 0.18 to 0.36; p < 0.0001). Importantly, higher persistent disease activity was associated with more SAEs [pRLDA: 0.2 ± 0.48 vs pMDA: 0.5 ± 0.96, p = 0.006; plMDA: 0.32 ± 0.6 vs phMDA: 0.64 ± 1.16, p = 0.038]. Male gender (p = 0.017), lower baseline DAS28 (p < 0.001), HAQ improvement > 0.22 (p = 0.029), and lower average DAS28 during the first trimester since treatment initiation (p = 0.001) independently predicted grouping into pRLDA. Conclusions In clinical practice, RA patients with pMDA while on bDMARDs have adverse long-term outcomes compared to lower disease activity status, while heterogeneity exists within the pMDA group in terms of 5-year functionality and SAEs. Targeted studies to better characterize pMDA subgroups are needed, in order to assist clinicians in tailoring treatments.

scholarly journals Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5-years outcome compared to persistent low-remission status and represent a heterogeneous group.

2020 ◽  
Author(s):  
Irini Genitsaridi ◽  
Irini Flouri ◽  
Dimitris Plexousakis ◽  
Konstantinos Marias ◽  
Kyriaki Boki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Serious Adverse Events ◽  
Term Outcome ◽  
Mixed Effect ◽  
Long Term Outcome ◽  
Moderate Disease ◽  
Moderate Disease Activity

Abstract Background The long-term outcome of rheumatoid arthritis (RA) patients who in clinical practice exhibit persistent moderate disease activity (pMDA) despite treatment with biologics has not been adequately studied. Herein, we analyzed the 5-year outcome of the pMDA group and assessed for within-group heterogeneity. Methods We included longitudinally-monitored RA patients from the Hellenic Registry of Biologic Therapies with persistent (cumulative time ≥50% of a 5-year period) moderate (pMDA, 3.2<DAS28≤5.1) or remission/low (pRLDA, DAS28≤3.2) disease activity. The former was further classified into persistent lower-moderate (plMDA, DAS28<4.2) and higher-moderate (phMDA, DAS28≥4.2) subgroups. Five-year trajectories of functionality (HAQ) was the primary outcome in comparing pRLDA versus pMDA and assessing heterogeneity within the pMDA subgroups through multivariable mixed-effect regression. We further compared serious adverse events (SAEs) occurrence between the two groups.Results We identified 295 patients with pMDA and 90 patients with pRLDA, the former group comprising of plMDA (n=133, 45%) and phMDA (n=162, 55%). pMDA was associated with worse 5-year functionality trajectory than pRLDA (+0.27 HAQ units, CI 95% +0.22 to +0.33; p<0.0001), while the phMDA subgroup had worse 5-year functionality than plMDA (+0.26 HAQ units, CI 95% 0.18 to 0.36; p<0.0001). Importantly, higher persistent disease activity was associated with more SAEs [pRLDA: 0.2±0.48 vs pMDA: 0.5±0.96, p=0.006; plMDA: 0.32 ±0.6 vs phMDA: 0.64 ±1.16, p=0.038)]. Male gender (p=0.017), lower baseline DAS28 (p<0.001), HAQ improvement >0.22 (p=0.029) and lower average DAS28 during the first trimester since treatment initiation (p=0.001), independently predicted grouping into pRLDA. Conclusions In clinical practice, RA patients with pMDA while on bDMARDs have adverse long-term outcomes compared to lower disease activity status, while heterogeneity exists within the pMDA group in terms of 5-year functionality and SAEs. Targeted studies to better characterize pMDA subgroups are needed, in order to assist clinicians in tailoring treatments.

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 CORRELATION STUDY OF DISEASE ACTIVITY SCORE AND SERUM CARTILAGE OLIGOMERIC MATRIX PROTEINLEVELS OF RHEUMATOID ARTHRITIS PATIENTS IN BANDUNG, INDONESIA

2016 ◽  
Vol 10 (1) ◽  
pp. 290
Author(s):  
Nyi Mekar Saptarini ◽  
Dainar Eka Pratiwi ◽  
Ellin Febrina ◽  
Marlia Singgih Wibowo ◽  
Tutus Gusdinar
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Matrix Protein ◽  
Disease Activity Score ◽  
Correlation Study ◽  
Activity Score ◽  
Rheumatology Clinic ◽  
Das 28 ◽  
Moderate Disease ◽  
Moderate Disease Activity

ABSTRACTObjective: This study was designed to determine the correlation between Disease Activity Score (DAS 28) and the serum Cartilage Oligomeric MatrixProtein (COMP) levels in Indonesian Rheumatoid Arthritis (RA) patients. Methods: The subjects were patients who visit the rheumatology clinic at one governmental hospital in Bandung, Indonesia. DAS was determinedby the QxMD Software based on erythrocyte sedimentation rate, and serum COMP levels were determined by enzyme-linked immunosorbent assay.Statistical analysis was conducted with IBM SPSS Statistics 23. Results: DAS 28 value was 3.36 ± 0.16 which indicates the moderate disease activity. Serum COMP levels were 843.80 ± 35.79 ng/ml in RA patientsand 830.00 ± 48.92 ng/ml in normal controls. Conclusion: There is no correlation between DAS 28 and serum COMP levels in RA patients (p = 0.496 and rho = 0.129). Keywords: Autoimmune disease, Rheumatoid arthritis monitoring, Cartilage oligomeric matrix protein, Disease activity score 28

scholarly journals Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial

2016 ◽  
Vol 76 (5) ◽  
pp. 840-847 ◽  
Author(s):  
Gerd R Burmester ◽  
Yong Lin ◽  
Rahul Patel ◽  
Janet van Adelsberg ◽  
Erin K Mangan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Active Rheumatoid Arthritis ◽  
Activity Index ◽  
Joint Disease ◽  
Phase Iii ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
End Point

ObjectivesTo compare efficacy and safety of sarilumab monotherapy with adalimumab monotherapy in patients with active rheumatoid arthritis (RA) who should not continue treatment with methotrexate (MTX) due to intolerance or inadequate response.MethodsMONARCH was a randomised, active-controlled, double-blind, double-dummy, phase III superiority trial. Patients received sarilumab (200 mg every 2 weeks (q2w)) or adalimumab (40 mg q2w) monotherapy for 24 weeks. The primary end point was change from baseline in 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) at week 24.ResultsSarilumab was superior to adalimumab in the primary end point of change from baseline in DAS28-ESR (−3.28 vs −2.20; p<0.0001). Sarilumab-treated patients achieved significantly higher American College of Rheumatology 20/50/70 response rates (sarilumab: 71.7%/45.7%/23.4%; adalimumab: 58.4%/29.7%/11.9%; all p≤0.0074) and had significantly greater improvement in Health Assessment Questionnaire-Disability Index (p=0.0037). Importantly, at week 24, more patients receiving sarilumab compared with adalimumab achieved Clinical Disease Activity Index remission (7.1% vs 2.7%; nominal p=0.0468) and low disease activity (41.8% vs 24.9%; nominal p=0.0005, supplemental analysis). Adverse events occurred in 63.6% (adalimumab) and 64.1% (sarilumab) of patients, the most common being neutropenia and injection site reactions (sarilumab) and headache and worsening RA (adalimumab). Incidences of infections (sarilumab: 28.8%; adalimumab: 27.7%) and serious infections (1.1%, both groups) were similar, despite neutropenia differences.ConclusionsSarilumab monotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment. The safety profiles of both therapies were consistent with anticipated class effects.Trial registration numberNCT02332590.

scholarly journals Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies

2017 ◽  
Vol 45 (2) ◽  
pp. 177-187 ◽  
Author(s):  
Christina Charles-Schoeman ◽  
Désirée van der Heijde ◽  
Gerd R. Burmester ◽  
Peter Nash ◽  
Cristiano A.F. Zerbini ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Radiographic Progression ◽  
Activity Index ◽  
Disease Activity Index ◽  
Response Rates ◽  
Phase Iii ◽  
Inadequate Response ◽  
Link Type ◽  
Phase Iii Studies

Objective.Tofacitinib has been investigated for the treatment of rheumatoid arthritis (RA) in phase III studies in which concomitant glucocorticoids (GC) were allowed. We analyzed the effect of GC use on efficacy outcomes in patients with RA receiving tofacitinib and/or methotrexate (MTX) or conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in these studies.Methods.Our posthoc analysis included data from 6 phase III studies (NCT01039688; NCT00814307; NCT00847613; NCT00853385; NCT00856544; NCT00960440). MTX-naive patients or patients with inadequate response to csDMARD or biological DMARD received tofacitinib 5 or 10 mg twice daily alone or with csDMARD, with or without concomitant GC. Patients receiving GC (≤ 10 mg/day prednisone or equivalent) before enrollment maintained a stable dose throughout. Endpoints included the American College of Rheumatology (ACR) 20/50/70 response rates, rates of Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA; CDAI ≤ 10) and remission (CDAI ≤ 2.8), and changes from baseline in CDAI, 28-joint count Disease Activity Score (DAS28-4)–erythrocyte sedimentation rate (ESR), Health Assessment Questionnaire–Disability Index (HAQ-DI), pain visual analog scale (VAS), and modified total Sharp score.Results.Of 3200 tofacitinib-treated patients, 1258 (39.3%) received tofacitinib monotherapy and 1942 (60.7%) received tofacitinib plus csDMARD; 1767 (55.2%) received concomitant GC. ACR20/50/70 response rates, rates of CDAI LDA and remission, and improvements in CDAI, DAS28-4-ESR, HAQ-DI, and pain VAS with tofacitinib were generally similar with or without GC in monotherapy and combination therapy studies. GC use did not appear to affect radiographic progression in tofacitinib-treated MTX-naive patients. MTX plus GC appeared to inhibit radiographic progression to a numerically greater degree than MTX alone.Conclusion.Concomitant use of GC with tofacitinib did not appear to affect clinical or radiographic efficacy. MTX plus GC showed a trend to inhibit radiographic progression to a greater degree than MTX alone.

scholarly journals Absence of Fibrosis and Inflammation by Cardiac Magnetic Resonance Imaging in Rheumatoid Arthritis Patients with Low to Moderate Disease Activity

2018 ◽  
Vol 45 (8) ◽  
pp. 1078-1084 ◽  
Author(s):  
William Bradham ◽  
Michelle J. Ormseth ◽  
Comfort Elumogo ◽  
Srikanth Palanisamy ◽  
Chia-Ying Liu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Magnetic Resonance Imaging ◽  
Heart Failure ◽  
Cardiac Magnetic Resonance ◽  
Disease Activity ◽  
T1 Mapping ◽  
Cardiac Structure ◽  
Resonance Imaging ◽  
Moderate Disease ◽  
Moderate Disease Activity

Objective.The prevalence of heart failure is increased 2-fold in patients with rheumatoid arthritis (RA); this is not explained by ischemic heart disease or other risk factors for heart failure. We hypothesized that in patients with RA without known heart disease, cardiac magnetic resonance imaging (cMRI) would detect altered cardiac structure, function, and fibrosis.Methods.We performed 1.5-T cMRI in 59 patients with RA and 56 controls frequency-matched for age, race, and sex, and compared cMRI indices of structure, function, and fibrosis [late gadolinium enhancement (LGE), native T1 mapping, and extracellular volume (ECV)] using Mann-Whitney U tests and linear regression, adjusting for age, race, and sex.Results.Most patients with RA had low to moderate disease activity [28-joint count Disease Activity Score–C-reactive protein median 3.16, interquartile range (IQR) 2.03–4.05], and 49% were receiving anti-tumor necrosis factor agents. Left ventricular (LV) mass, LV end-diastolic and -systolic volumes indexed to body surface area, and LV ejection fraction and left atrial size were not altered in RA compared to controls (all p > 0.05). Measures of fibrosis were not increased in RA: LGE was present in 2 patients with RA and 1 control subject; native T1 mapping was similar comparing RA and control subjects, and ECV (median, IQR) was lower (26.6%, 24.7–28.5%) in patients with RA compared to control subjects (27.5%, 25.4–30.4%, p = 0.03).Conclusion.cMRI measures of cardiac structure and function were not significantly altered, and measures of fibrosis were similar or lower in RA patients with low to moderate disease activity compared to a matched control group.

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