Evaluation of Changes in Skin and Joint Outcomes and Associated Treatment Changes in Psoriatic Arthritis (PsA): Experience from the Corrona PsA/SpA Registry

Objective To characterize skin severity and joint activity outcomes and associated treatment changes in patients with psoriatic arthritis (PsA) through 12 months of follow-up after enrollment in the Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. Methods Patients ≥ 18 years of age with a diagnosis of PsA and a history of psoriasis between March 21, 2013, and September 30, 2016, were enrolled (n = 647). Demographics, clinical features, and treatment characteristics were collected and stratified by skin severity and joint activity. Change in joint and skin from enrollment to the 12-month visit was classified by change in category of Clinical Disease Activity Index (CDAI) or body surface area (BSA). Tests of association evaluated the relationship between changes in therapy and changes in skin severity and joint activity. Results Patients with improvement in both joint activity and skin severity saw the largest median reduction in both CDAI and BSA, while those who worsened in both had the greatest median increase in both CDAI and BSA. The majority of PsA patients (> 50%) had no change in skin severity regardless if they had reduced therapy (50%), no therapy changes (54%), or increased therapy (56%; P = 0.5875). However, there was a significant association between changes in therapy and changes in joint activity (P < 0.001). Patients who increased therapy were more likely to have improvement in joint activity (32%) compared to patients who reduced therapy (22%) or had no therapy changes (11%). Conclusion The clinical implication for our findings suggests the assessment and incorporation of both skin and joint components may be advisable.

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FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2755 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 778-779

Author(s):

J. S. Smolen ◽

S. Siebert ◽

T. Korotaeva ◽

P. Bergmans ◽

K. De Vlam ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Activity Index ◽

Treatment Options ◽

Disease Activity Index ◽

Rapid Screening ◽

Research Support ◽

Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

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Abstract 5108: Microalbuminuria is Associated with Progression of Coronary Atherosclerosis in the Multi-Ethnic Study of Atherosclerosis (MESA)

Circulation ◽

10.1161/circ.118.suppl_18.s_1147-b ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Andrew P DeFilippis ◽

Holly J Kramer ◽

Ronit Katz ◽

Nathan Wong ◽

Alain Bertoni ◽

...

Keyword(s):

Lipid Lowering ◽

Albumin Creatinine Ratio ◽

Ethnic Study ◽

Median Increase ◽

Increased Risk ◽

History Of ◽

Relationship Of ◽

The Relationship ◽

Progression Of Atherosclerosis

Background: Microalbuminuria (MA) is associated with an increased risk of cardiovascular disease (CVD) but the mechanism by which microalbuminuria imparts this increased risk is not known. In this study we assessed the relationship between MA and the development and progression of atherosclerosis by measuring the incidence of new CAC and the progression of existing CAC in individuals free of clinical CVD. Methods : The Multi-Ethnic Study of Atherosclerosis (MESA) is a prospective cohort study of 6,814 participants free of clinical CVD at entry who underwent assessment of coronary artery calcification (CAC) by computerized tomography at baseline. Overall, 6,775 individuals had data available on urinary albumin creatinine ratio (UACR); 1,109 individuals were excluded for missing data or macroalbuminuria (UACR≥300 mg/g). Incident CAC was defined as detectable CAC at follow-up among those with CAC=0 at baseline, and absolute CAC score change among those with CAC>0 at baseline. Relative risk (RR) regression adjusted for covariates; and multivariable adjusted median regression was employed to assess the independent relationship of MA with CAC incidence and progression. Results : Of the 5,666 subjects (mean age 62±10 years, 48% males), baseline MA was seen in 424 (7%) participants, who were more likely to have CAC compared to those with normal UACR (62% vs. 48%, p<0.0001). During a mean follow-up of 2.4±0.8 years, those with MA were more likely to develop CAC (28% vs. 15%, p<0.0001) and they had a higher absolute median increase in CAC (47 vs. 29 Agatston Units, p<0.0001). After adjustment for age, gender, ethnicity, site, follow-up duration, diabetes, hypertension, smoking, family history of heart attack, total cholesterol, lipid lowering medications and body mass index; MA was associated with incident CAC (RR 1.65; 95%CI 1.41–2.48) among those with CAC=0 at baseline. Among those with CAC>0 at baseline, MA was associated with a median increase in CAC of 7.93 (95%CI 0.38 –15.47) Agatston Units in multivariable adjusted analyses (variables noted above). Conclusion : MA is independently associated with development of incident CAC and progression of CAC in an asymptomatic multi-ethnic population, and may in part explain its associated increased risk of CVD.

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Methotrexate achieves major cDAPSA response, and improvement in dactylitis and functional status in psoriatic arthritis

Rheumatology ◽

10.1093/rheumatology/key369 ◽

2018 ◽

Vol 58 (5) ◽

pp. 869-873 ◽

Cited By ~ 2

Author(s):

Sravan Kumar Appani ◽

Phani Kumar Devarasetti ◽

Rajendra Vara Prasad Irlapati ◽

Liza Rajasekhar

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Activity Index ◽

Disease Activity Index ◽

Response To Therapy ◽

Tender Joint Count ◽

Minimal Disease Activity ◽

Randomized Controlled Studies ◽

Minimal Disease

Abstract Objective Despite the widespread clinical use of MTX in PsA, data from published randomized controlled studies suggest limited efficacy. The objective of the present study was to document the efficacy of MTX. Methods This was an open-label, prospective study of patients satisfying the ClASsification criteria for Psoriatic ARthritis study (CASPAR) criteria for PsA who received MTX in doses of ⩾15 mg/week throughout the follow-up period of 9 months. Disease activity was assessed across various domains by tender and swollen joint count, physician and patient global assessment, DAS-28 ESR, Clinical Disease Activity Index for PsA (cDAPSA), Leeds Dactylitis Instrument basic, Leeds Enthesitis Index (LEI), Psoriasis Area and Severity Index (PASI), Minimal Disease Activity and HAQ (CRD Pune version) at baseline and at 3, 6 and 9 months of follow-up. Response to therapy was assessed by EULAR DAS28 ESR, Disease Activity Index for PsA (cDAPSA) response, HAQ response and PASI75. MTX dose escalation and the use of combination DMARDS were dictated by disease activity. Results A total of 73 patients were included, with mean (s.d.) age 44 (9.7) years. The mean (s.d.) dose of MTX used was 17.5 (3.8) mg/week. Seven patients received additional DMARDS (LEF/SSZ). At the end of 9 months, significant improvement (P < 0.05) was noted in the tender joint count, swollen joint count, global activity, DAS-28ESR, cDAPSA, Leeds Dactylitis Index basic, LEI, PASI and HAQ. Major cDAPSA response was achieved in 58.9% of patients. EULAR DAS28 moderate and good response was achieved in 74% and 6.8% of patients, respectively. Minimal Disease Activity was achieved in 63% of patients. A PASI75 response and HAQ response was achieved in 67.9% and 65.8% of patients, respectively. Conclusion MTX initiated at ⩾15 mg/week with targeted escalation resulted in significant improvement in the skin, joint, dactylitis, enthesitis and functional domains of PsA.

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Defining Low Disease Activity States in Psoriatic Arthritis using Novel Composite Disease Instruments

The Journal of Rheumatology ◽

10.3899/jrheum.150826 ◽

2015 ◽

Vol 43 (2) ◽

pp. 371-375 ◽

Cited By ~ 50

Author(s):

Laura C. Coates ◽

Philip S. Helliwell

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Disease Activity Score ◽

Activity Index ◽

Disease Activity Index ◽

Substantial Agreement ◽

Good Discrimination ◽

Low Disease Activity ◽

Minimal Disease ◽

The Relationship

Objective.To explore the relationship between minimal disease activity (MDA) and the low disease activity cutoffs of the Psoriatic ArthritiS Disease Activity Score (PASDAS) and the Composite Psoriatic Disease Activity Index (CPDAI).Methods.Data from the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) composite exercise (GRACE) study were used for these analyses. Alternative definitions of low disease activity were used with 6/7 and 7/7 of MDA items, and a criteria set mandating the 2 articular items and 3/5 alternate items (MDA-joints). Two reference questions were used as anchors: physician’s global opinion of MDA, and patient’s opinion on their disease control.Results.Substantial agreement was found between MDA, MDA-joints, PASDAS, and CPDAI. Compared to the 2 reference questions, the various definitions of low disease activity gave sensitivities that were generally worse than specificities, the latter being high (> 0.9) in most cases. Both PASDAS and CPDAI demonstrated good discrimination between the “low” and “high” disease activity states by all the MDA definitions. Using these data, with an MDA of 7/7 to define a very low disease cutoff, the corresponding values for PASDAS and CPDAI were 1.9 and 2, respectively.Conclusion.An MDA score of 7/7 is proposed as very low disease activity in psoriatic arthritis. Using this definition, the equivalent cutoffs for PASDAS and CPDAI are 1.9 and 2, respectively.

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Evaluating current definitions of low disease activity in psoriatic arthritis using ultrasound

Rheumatology ◽

10.1093/rheumatology/kez237 ◽

2019 ◽

Vol 58 (12) ◽

pp. 2212-2220 ◽

Cited By ~ 3

Author(s):

Philipp Bosch ◽

Rusmir Husic ◽

Anja Ficjan ◽

Judith Gretler ◽

Angelika Lackner ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Activity Index ◽

Power Doppler ◽

Disease Activity Index ◽

High Disease Activity ◽

Minimal Disease Activity ◽

Psoriatic Disease ◽

Minimal Disease

Abstract Objective To evaluate low disease activity (LDA) cut-offs in psoriatic arthritis (PsA) using ultrasound. Methods Eighty-three PsA patients underwent clinical and ultrasound examinations at two visits. LDA was assessed using the Disease Activity index for Psoriatic Arthritis (DAPSA ⩽ 14), the Psoriatic ArthritiS Disease Activity Score (PASDAS ⩽ 3.2), the Composite Psoriatic Disease Activity Index ⩽ 4, the DAS28-CRP ⩽ 2.8 and the minimal disease activity criteria. Ultrasound was performed at 68 joints and 14 entheses. Minimal ultrasound disease activity (MUDA-j/e) was defined as a Power Doppler score ⩽ 1, respectively at joints, paratendinous tissue, tendons and entheses. A global ultrasound score was calculated by summing Grey Scale and Power Doppler information (GUIS-j/e). Results LDA was present in 33.7–65.0% at baseline and in 44.3–80.6% at follow-up, depending on the criteria used. MUDA-j/e was observed in 16.9% at baseline and in 30% at follow-up. GUIS-j/e was significantly higher in patients with moderate/high disease activity vs LDA according to DAPSA and PASDAS at baseline and DAPSA, PASDAS, Composite Psoriatic Disease Activity Index and minimal disease activity at follow-up. Patients in moderate/high disease activity had MUDA-j/e in 8.1–21.4% at baseline and in 8.3–20.0% at follow-up, depending on the applied clinical composite. MUDA-j/e patients with moderate/high disease activity had higher levels of pain and pain-related items than those with LDA. Conclusion The LDA cut-offs of DAPSA, PASDAS, Composite Psoriatic Disease Activity Index, minimal disease activity, but not DAS28-CRP are capable of distinguishing between high and low ultrasound activity. Pain and pain-related items are the main reason why PsA patients without signs of ultrasound inflammation are classified with higher disease activity.

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Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-211284 ◽

2017 ◽

Vol 76 (11) ◽

pp. 1906-1910 ◽

Cited By ~ 66

Author(s):

Brigitte Michelsen ◽

Eirik Klami Kristianslund ◽

Joseph Sexton ◽

Hilde Berner Hammer ◽

Karen Minde Fagerli ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Regression Models ◽

Activity Index ◽

Disease Activity Index ◽

Depression And Anxiety ◽

Sf 36 ◽

Remission Criteria

ObjectiveTo investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up.MethodsWe included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models.ResultsBaseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score <2.6, Simplified Disease Activity Index ≤3.3, Clinical Disease Activity Index ≤2.8, ACR/EULAR Boolean and Disease Activity Index for Psoriatic Arthritis ≤4 remission after 3 and 6 months treatment in RA (p≤0.008) and partly in PsA (p from 0.001 to 0.73). Baseline depression/anxiety was associated with increased patient’s and evaluator’s global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants.ConclusionDepression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target.

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VP176 Effectiveness Of Anti-Tumor Necrosis Factor In Patients With Psoriatic Arthritis

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317004111 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 232-232

Author(s):

Michael da Silva ◽

Jéssica dos Santos ◽

Alessandra Almeida ◽

Juliana Alvares ◽

Augusto Guerra ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Tumor Necrosis Factor ◽

Disease Activity ◽

Latin American ◽

Tumor Necrosis ◽

Activity Index ◽

Disease Activity Index ◽

The Mean ◽

Necrosis Factor

INTRODUCTION:Anti-tumor necrosis factor drugs (anti-TNF) are the last line of treatment for psoriatic arthritis (PsA) in the guideline of Brazilian Public Health System (SUS). Data of effectiveness of these drugs are scarce in the Latin American population. This study evaluated the effectiveness of the anti-TNF on a cohort of patients with PA in the SUS.METHODS:PsA patients treated with anti-TNF, were included in an open prospective cohort study. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI) were used to assess the effectiveness at six months of follow-up. The anti-TNF was considered effective when the patient achieves scores of four or less measured for BASDAI or scores of ten or less for CDAI. Frequency distributions were compiled for the sociodemographic variables and mean and standard deviation (SD) was used for clinical variables. The paired Student t-test was established to evaluate the differences between baseline and 6 months evaluated for BASDAI and CDAI.RESULTS:Fifty-four patients with PsA completed six months of follow-up. The mean age of patients was 54.03 years (10.44) and the mean disease duration was 8.00 years (7.49). Furthermore, 50 percent of the patients were female, 61.1 percent white and 59.6 percent married. The most used anti-TNF was adalimumab (63.0 percent), followed by etanercept (20.4 percent) and infliximab (16.7 percent). The anti-TNF reduced disease activity measured by BASDAI and CDAI at six months of follow-up (p<.001). The percentage of patients achieving the effectiveness with anti-TNF was 61.1 percent measured by BASDAI and 53.7 percent by CDAI.CONCLUSIONS:Anti-TNF drugs demonstrated to be effective in more than half of patients at six months. This result highlighted the importance of the treatment with the anti-TNF drugs in the Brazilian population. Long-term data are needed to confirm these results.

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Impact of markers of endothelial injury and hypercoagulability on systemic lupus erythematosus

Lupus ◽

10.1177/0961203319899478 ◽

2020 ◽

Vol 29 (2) ◽

pp. 182-190

Author(s):

W Batista Cicarini ◽

R C Figueiredo Duarte ◽

K Silvestre Ferreira ◽

C de Mello Gomes Loures ◽

R Vargas Consoli ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

Endothelial Injury ◽

Control Group ◽

Systemic Lupus ◽

Low Concentrations ◽

The Relationship

We have explored the relationship between possible hemostatic changes and clinical manifestation of the systemic lupus erythematosus (SLE) as a function of greater or lesser disease activity according to Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) criteria. Endothelial injury and hypercoagulability were investigated in patients with SLE by measuring thrombomodulin (TM), D-dimer (DDi) and thrombin generation (TG) potential. A total of 90 participants were distributed into three groups: 1) women with SLE presenting with low disease activity (laSLE) (SLEDAI-2K ≤ 4), 2) women with SLE presenting with moderate to high disease activity (mhaSLE) (SLEDAI-2K > 4), and 3) a control group comprising healthy women. Levels of TM and DDi were higher both in the laSLE and mhaSLE groups compared to controls and in mhaSLE compared to the laSLE group. With respect to TG assay, lagtime and endogen thrombin potential, low concentrations of tissue factor provided the best results for discrimination among groups. Analysis of these data allow us to conclude that TM, DDi and TG are potentially useful markers for discriminating patients with very active from those with lower active disease. Higher SLE activity may cause endothelial injury, resulting in higher TG and consequently a hypercoagulability state underlying the picture of thrombosis common in this inflammatory disease.

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SAT0364 DATA TO BE COLLECTED FOR AN OPTIMAL MANAGEMENT OF AXIAL SPONDYLOARTHRITIS IN DAILY PRACTICE: PROPOSAL FROM AN EVIDENCE BASED AND CONSENSUAL APPROACHES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3588 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1129.1-1129

Author(s):

A. Baillet ◽

X. Romand ◽

A. Pfimlin ◽

M. Dalecky ◽

M. Dougados

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Activity Index ◽

Disease Activity Index ◽

Daily Practice ◽

Evidence Based ◽

Periodic Review ◽

Grade Scale

Background:Standardization of clinical practice has been proven to be effective in management of chronic diseases. This is particularly true at the time where the concept of treat to target is becoming more and more important in the field of axial spondyloarthritis (ax-SpA).Objectives:To propose a list of variables to be collected at the time of the diagnosis and over the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice.Methods:The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of axSpA via a systematic literature research, (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of the variable in a 4 grade scale from ”potentially useful” to “mandatory”, (3) a consensus on optimal timeline for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”.Results:The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Concerning the data to be collected at the time of the diagnosis and during follow-up, we proposed to differentiate the results based on a) the way of collection of the variables (e.g. questionnaires by the patient, interview by the physician, physical examination, investigations) b) the usefulness these variables in daily practice based on the opinion of the rheumatologists ” c) the optimal timeline between 2 evaluations of the variable based on the opinion of the rheumatologists. In the initial systematic review, symptoms of heart failure history of inflammatory bowel disease, psoriasis or uveitis, patient global visual analogic scale, spine radiographs, modified Schöber test, coxo-femoral rotations, swollen joint count, urine strip test, BASDAI and ASDAS global scores were considered very useful and nocturnal back pain/morning stiffness, sacro-iliac joints radiographs and CRP were considered mandatory (Figure 1). Timeline between 2 evaluations of variables to collect in the periodic review are summarized inFigure 2.Figure 1.Core sets of items to collect and report in the systematic review in axial spondyloarthritis management in daily practice ASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, BASFI=Bath Ankylosing Spondylitis Functionnal Index, BASMI=Bath Ankylosing Spondylitis Metrology Index, CRP=C Reactive Protein, CT=computerized tomography, FIRST=Fibromyalgia Rapid Screening Tool, HLA=Human Leukocyte Antigen, MRI=Magnetic resonance imaging, PET=positron emission tomography.Figure 2.Periodic review timeline of variables to collectASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, Spondylitis Metrology Index, CRP=C Reactive Protein, IBD = inflammatory bowel diseases, PRO = Patient Reported OutcomesConclusion:Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported at the time of the diagnosis and during follow-up of patients with ax-SpA in daily practice.Acknowledgments:this study has been conducted in two parts: the first one (evidence-based) was conducted thanks to a support from Abbvie France. AbbVie did not review the content or have influence on this manuscript. The second part of this initiative (consensus) has been conducted thanks to a support from the scientific non-profit organization: Association de Recherche Clinique en RhumatologieDisclosure of Interests:Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

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Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis

Scientific Reports ◽

10.1038/s41598-020-73183-0 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Maria Chiara Ditto ◽

Simone Parisi ◽

Marta Priora ◽

Silvia Sanna ◽

Clara Lisa Peroni ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Inflammatory Arthritis ◽

Health Assessment Questionnaire ◽

Activity Index ◽

Health Assessment ◽

Disease Activity Index ◽

Clinical State ◽

Assessment Questionnaire

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.

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