scholarly journals AB0206 DESCRIPTION AND FOLLOW-UP OF RHEUMATOID ARTHRITIS PATIENTS WHO STOPPED B/TSDMARD THERAPY, STRATIFIED BY CESSATION REASON

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1128.1-1128
Author(s):  
T. Burkard ◽  
E. Vallejo-Yagüe ◽  
T. Hügle ◽  
A. Finckh ◽  
A. M. Burden

Background:Biologic or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARD) may be stopped for several reasons such as non-response, adverse events, remission, or other reasons (e.g. major surgery). Understanding the reasons and consequences of b/tsDMARD therapy cessation may contribute towards therapy decision guidance. Moreover, identifying patient characteristics leading to the re-start of b/tsDMARD therapy may guide decision-making as to which patients should remain on continuous b/tsDMARD therapy versus who may potentially stop b/tsDMARD therapy.Objectives:To describe and follow rheumatoid arthritis (RA) patients who stopped b/tsDMARD therapy, stratified by cessation reason.Methods:We conducted a descriptive cohort study among adult RA patients in the longitudinal Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) between 1997 and 2019. RA patients who stopped their first b/tsDMARD therapy were eligible, with therapy stop date defining cohort entry. We followed all eligible patients from cohort entry until b/tsDMARD re-start (the outcome) or censoring due to end of patient record. All analyses were carried out stratified by cessation reason (non-response, adverse events, remission, other reasons, unknown reasons). We described patient characteristics (demographics, lifestyle factors, clinical information, other medication use, relevant comorbidities) at cohort entry. Furthermore, we estimated Kaplan Meier curves to describe differences in cumulative incidences of b/tsDMARD re-start. Finally, we assessed patient characteristics at b/tsDMARD re-start and compared them with those at cohort entry.Results:Among 2559 eligible RA patients, the majority stopped their b/tsDMARD due to non-response (982, 38%), followed by adverse events (475, 19%), other reasons (445, 17%), unknown reasons (444, 17%), and remission (213, 8%). Mean age at b/tsDMARD stop was around 56.2 years except in patients who stopped due to remission (mean age of 58.1 years). The majority of patients were women (78%), stopping due to an adverse event had the highest proportion of women (84%), stopping due to remission had the lowest proportion of women (70%). Compared to patients who stopped b/tsDMARD therapy due to non-response or adverse events, patients who stopped due to remission were generally more physically active, better educated, less likely to have a family history of rheumatic diseases, and had shorter median disease duration. A total of 2086 patients (82%) re-started b/tsDMARD therapy during follow-up. Of these, the majority did so after stopping due to non-response (94%), followed by adverse events (82%), unknown reasons (79%), other reasons (74%), and remission (47%). The median cumulative incidence of re-starting b/tsDMARD therapy was shortest after non-response (30 days), followed by unknown reasons (31 days), adverse events (94 days), other reasons (212 days), and remission (1597 days). The population who stopped b/tsDMARD therapy due to remission or other reasons yielded increased RA disease activity and an increase in proportions of women, cardiac diseases, degenerative joint disease, other auto-immune diseases, and of patients with family history of rheumatic diseases at the date of b/tsDMARD re-start. However, among patients who stopped b/tsDMARD therapy due to non-response or adverse events, patient characteristics at b/tsDMARD re-start were unchanged compared to those at b/tsDMARD stop.Conclusion:Observed differences in patient characteristics at b/tsDMARD stop may yield insight into why the patient was not responding, had an adverse event, or achieved remission. Observed changes in patient characteristics from the date of b/tsDMARD stop to re-start identified which ones may lead to a worsening of RA activity in the absence of b/tsDMARD therapy.Acknowledgements:We would like to thank Dr. Almut Scherer, Monika Hebeisen, and Eleftherios Papagiannoulis from SCQM for providing the data and answering questions thereto. A list of rheumatology offices and hospitals that are contributing to the SCQM registries can be found on www.scqm.ch/institutions. The SCQM is financially supported by pharmaceutical industries and donors. A list of financial supporters can be found on www.scqm.ch/sponsors.Disclosure of Interests:Theresa Burkard: None declared, Enriqueta Vallejo-Yagüe: None declared, Thomas Hügle Consultant of: Pfizer, Abbvie, Novartis, Grant/research support from: GSK, Jansen, Pfizer, Abbvie, Novartis, Roche, MSD, Sanofi, BMS, Eli Lilly, UCB, Axel Finckh Speakers bureau: Pfizer, Eli-Lilly, Paid instructor for: Pfizer, Eli-Lilly, Consultant of: Pfizer, BMS, Novartis, Grant/research support from: AbbVie, AB2Bio, BMS, Gilead, Pfizer, Viatris, Andrea Michelle Burden: None declared

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Ahmad A Sherbini ◽  
James M Gwinnutt ◽  
Kimme L Hyrich ◽  
Suzanne M M Verstappen ◽  

Abstract Background/Aims  Methotrexate (MTX) is the most common treatment for rheumatoid arthritis (RA). The prevalence of adverse events (AEs) associated with MTX treatment for RA have been studied extensively, but there are limited data on the predictors of these AEs. This study aims to summarise the prevalence rates of MTX AEs, including gastrointestinal (GI), neurological, mucocutaneous, and elevated alanine transaminase (ALT) enzyme, and to identify baseline demographic and clinical predictors of these AEs. Methods  The Rheumatoid Arthritis Medication Study (RAMS) is a UK multi-centre prospective cohort study of patients with RA starting MTX for the first time. Relevant demographic, medication, clinical and disease related data were collected at baseline. AEs were reported at six and twelve months follow-ups. The prevalence rates of AEs were calculated based on the proportions of patients who reported having had an AE within one year of follow-up. The associations between candidate baseline predictors and AEs were assessed using multivariable logistic regression. Results  A total of 2,089 patients were included with a mean age of 58.4 (standard deviation: 13.5) years, 1390 (66.5%) were women. 1,814 and 1,579 patients completed the 6 and 12 months follow-up visits, respectively. The prevalence rates of the AEs within one year of follow-up were: GI = 777 (40.6%), mucocutaneous = 441 (23.1%), neurological = 487 (25.5%), elevated ALT (> upper limit of normal [ULN]) = 286 (15.5%). Younger age and being a woman were associated with increased risk of GI AEs, (age: OR 0.97 per year increase in age, 95% CI 0.98, 1.00; male sex: OR 0.58 vs female, 95% CI 0.46, 0.74) (Table 1). Higher baseline Health Assessment Questionnaire (HAQ) score was an independent predictor of GI, mucocutaneous, and neurological AEs. Furthermore, having ALT >1xULN at baseline or history of diabetes was associated with increased risk of subsequent ALT elevation during the study follow-up. Conclusion  In patients with RA starting MTX, GI AEs were the most commonly reported AEs during the first year of follow-up. The identified predictors of AEs may facilitate discussions between clinicians and patients prior to commencing MTX, and may lead to increased adherence and consequently improved effectiveness. Disclosure  A.A. Sherbini: None. J.M. Gwinnutt: Grants/research support; BMS. K.L. Hyrich: Member of speakers’ bureau; Abbvie. Grants/research support; Pfizer, UCB, BMS. S.M.M. Verstappen: Consultancies; Celltrion. Member of speakers’ bureau; Pfizer. Grants/research support; BMS.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1755.3-1755
Author(s):  
S. Mizuki ◽  
T. Kai ◽  
K. Mishima ◽  
H. Ikeuchi ◽  
K. Oryoji

Background:Denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor kappa B ligand, which inhibits osteoclast differentiation, activation and survival, not only increases bone mineral density but also inhibits the progression of bone erosion in patients with rheumatoid arthritis (RA)1-3). Therefore, denosumab have been preferably prescribed for patients with RA recently. The persistence with denosumab, which is administered subcutaneously once every 6 months, was reported higher than with oral bisphosphonates4), and in the prospective cohort studies, the persistence rate for one year was reported to be 82-95%5-6). However, there have been no report about the persistence in patients with RA treated with denosumab, moreover the reasons for discontinuation of denosumab.Objectives:The aims of this single center retrospective cohort study were 1) to assess the persistence with denosumab in a routine clinical setting and 2) to identify the reasons of discontinuation in patients with RA. And we also reviewed the clinical outcomes of osteonecrosis of the jaw in patients with RA during denosumab treatment.Methods:The present study is based on databases from our hospital, which include age, gender, date of injection of denosumab, as well as information on patients’ characteristics. Patients were included in this study when denosumab were newly started at our department during the period from June 1, 2013 and September 30, 2017. In this study, persistence was defined as patients with an interval between injections of no longer than 6 months plus 8 weeks. Patients were followed until censoring (death, transferring to another hospital) or the end of the study (August 3, 2018).We investigated reasons for the discontinuation of denosumab. Major reasons for the discontinuation of denosumab were classified as adverse event, anxiety over adverse events, patient’s transfer or request, doctor’s careless lack of refilling an injection, and other reason.We identified patients who had been diagnosed as osteonecrosis of the jaw, and demographic, pharmacological, and clinical data were collected from medical records.Results:One hundred and seventy-five patients were identified. Kaplan–Meier analysis showed a slow decline of persistence after initiating denosumab therapy, dropping to 80.4 and 61.9 % after 1 and 2 years of follow-up. When analyzing the reason of discontinuation as adverse events, the persistence rate of denosumab was at 89.4, and 79.4% at 1, and 2 years of follow-up, respectively.During 2-year period, 72 patients discontinued denosumab. A total of 27 adverse events occurred, of which five events were osteonecrosis of the jaw. The other reasons for adverse event included death in four, fracture in three, and so on. Six patients discontinued due to anxiety over dental adverse event. Thirteen patients were in doctor’s careless lack of refilling an injectionAll five patients who were diagnosed as osteonecrosis of the jaw had received the treatment with prednisolone, and four were treated with biologic drugs. All patients stopped denosumab and switched to other drugs including teriparatide. All patients underwent surgical curettages of necrotic bone and cured.Conclusion:Persistence of denosumab in patients with RA is comparable to that in postmenopausal women with osteoporosis. Dental screening and care should be important to continue denosumab treatment.References:[1]Cohen SB.Arthritis Rheum. 2008;58:1299–1309.[2]Takeuchi T.Ann Rheum Dis. 2019;78:899–907.[3]Ebina K.Osteoporos Int. 2018;29:1627–1636.[4]Hadji P.Osteoporos Int. 2016;27:2967–2978.[5]Silverman SL.Arch Osteoporos. 2018;13:85. doi:10.1007/s11657-018-0491-z[6]Hadji P.Osteoporos Int. 2015;26:2479–2489.Disclosure of Interests:Shinichi Mizuki Speakers bureau: AbbVie, Asahi Kasei, Chugai, Eli Lilly, Janssen, Mitsubishi Tanabe, Ono, Tatsuya Kai: None declared, Koji Mishima: None declared, Hiroko Ikeuchi: None declared, Kensuke Oryoji: None declared


2021 ◽  
pp. 036354652110117
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Alice Baroncini ◽  
Jörg Eschweiler ◽  
Markus Tingart ◽  
...  

Background: Femoroacetabular impingement (FAI) is a major cause of hip pain in young adults and athletes. Surgical treatment of FAI is recommended in cases of failed nonoperative treatment that have the typical clinical and radiographic findings. At present, the role of risk factors for revision surgery and progression to total hip arthroplasty (THA) in patients with FAI is still unclear. Purpose: To investigate the possible association between (1) rate of revision and progression to THA and (2) patient characteristics, type of lesion, family history of hip disease, type of intervention, radiographic parameters, physical examination, and pre- and postoperative scores. Study Design: Systematic review; Level of evidence, 4. Methods: The present systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. In October 2020, the main online databases were accessed. All articles concerning surgical correction for selected patients with FAI were accessed. Patient characteristics, type of intervention, radiographic parameters, physical examination, and pre- and postoperative scores were assessed. The outcomes of interest were the possible association between these variables and the rate of revision and subsequent progression to THA using a multivariate analysis through the Pearson product-moment correlation coefficient. Results: Data from 99 studies (9357 procedures) were collected. The median follow-up was 30.9 months (interquartile range, 24.0-45.0). The mean ± SD age was 33.4 ± 9.3 years; mean body mass index (BMI), 24.8 ± 4.8; percentage right side, 55.8% ± 8.0%; and percentage female sex, 47.5% ± 20.4%. The overall rate of revision was 5.29% (351 of 6641 patients), while the rate of subsequent progression to THA was 3.78% (263 of 6966 patients). Labral debridement ( P < .0001), preoperative acetabular index ( P = .01), and BMI ( P = .03) all showed evidence of a statistically positive association with increased rates of THA. No other statistically significant associations were found between patient characteristics, type of lesion, family history of hip disease, type of intervention, radiographic parameters, physical examination, or pre- and postoperative scores and the rate of revision and/or progression to THA. Conclusion: Although surgical procedures to treat FAI led to satisfactory outcomes, there was a revision rate of 5.29% in the 9357 procedures in the present systematic review. The rate of progression to THA after a median follow-up of 30 months was 3.78%. Patients who have a higher BMI and/or have a pathologic acetabular index and/or undergo labral debridement during correction of FAI are more at risk for a subsequent THA. We advocate additional education of this patient population in terms of expected outcomes and suggest surgical labral repair instead of debridement if needed.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1892.3-1892
Author(s):  
K. Thomas ◽  
A. Lazarini ◽  
E. Kaltsonoudis ◽  
A. Drosos ◽  
A. Repa ◽  
...  

Background:Despite the increased incidence of influenza infection in rheumatoid arthritis (RA) patients, vaccination coverage has been shown to be suboptimal. Prospective data regarding the current rate and predictors of influenza vaccination adherence in RA patients are limited.Objectives:To calculate the current rate and predictors of influenza vaccination in a real-life, prospective, longitudinal RA cohort.Methods:Data regarding demographics, disease characteristics, treatments and co-morbidities from a multi-center, longitudinal cohort of Greek RA patients were collected at baseline and ~ 3 years later. Disease and patient characteristics were compared between patients with at least one influenza vaccine administration and non-vaccinated ones, during the 3 year follow-up period.Results:From a cohort of 1,569 RA patients, 1,406 with available vaccination data at baseline and 3 years later (mean interval: 2.9 years) were included; (women: 80.4%, mean age: 61.8 years, mean disease duration: 9.7 years, RF and/or anti-CCP positive: 50.4%, mean DAS-28 = 3.33, mean HAQ: 0.44, bDMARD use: 44.8%). At baseline, 54.2% of patients reported influenza vaccination in the past (31.8% during the previous season), while during the 3 year follow-up period, 81% had ≥1 influenza vaccinations (p=<0.001). Patients who received ≥1 influenza vaccine were older (63.5 vs. 54.7 years, p<0.001), were more likely to be seropositive (59.2% vs. 45.2%, p<0.001), had higher HAQ (0.46 vs. 0.36, p=0.02) and BMI (27.7 vs. 26.9, p=0.02) at baseline, more likely to be treated with bDMARDs (46.8% vs. 36.4%, p<0.001) and more likely to have chronic lung disease (9.7% vs. 5.3%, p=0.02), dyslipidemia (36.4% vs. 24.2%, p<0.001), hypertension (46.1% vs. 29.2%, p<0.001) and to report vaccination against influenza the previous season before baseline evaluation (34.9% vs. 18.2%, p<0.001). By multivariate analysis, history of influenza vaccination during the last season before baseline (OR=1.87, CI: 1.27-2.74, p=0.001), bDMARD treatment (OR=1.51, CI: 1.07-2.13, p=0.018) and age (OR=1.05, CI: 1.04-1.06, p<0.001) were independent predictors of influenza vaccination.Conclusion:In this ongoing, longitudinal, prospective, real-life RA cohort study, a significant increase in the influenza vaccination coverage was noted (from 53% to 81%). Influenza vaccination was independently associated with recent history of influenza vaccination, older age, and bDMARD treatment.Acknowledgments:Supported by grants from the Greek Rheumatology Society and Professional Association of Rheumatologists.Disclosure of Interests:Konstantinos Thomas: None declared, Argyro Lazarini: None declared, Evripidis Kaltsonoudis: None declared, Alexandros Drosos: None declared, ARGYRO REPA: None declared, Prodromos Sidiropoulos: None declared, Kalliopi Fragkiadaki: None declared, Maria Tektonidou Grant/research support from: AbbVie, MSD, Novartis and Pfizer, Consultant of: AbbVie, MSD, Novartis and Pfizer, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Panagiota Tsatsani: None declared, Sousana Gazi: None declared, Pelagia Katsimbri: None declared, Dimitrios Boumpas: None declared, Evangelia Argyriou: None declared, Kyriaki Boki: None declared, Gerasimos Evangelatos: None declared, Alexios Iliopoulos: None declared, Konstantina Karagianni: None declared, Lazaros Sakkas: None declared, Konstantinos Melissaropoulos: None declared, Panagiotis Georgiou: None declared, Eleftheria Grika: None declared, PANAYIOTIS VLACHOYIANNOPOULOS: None declared, Theodoros Dimitroulas: None declared, Alexandros Garyfallos Grant/research support from: MSD, Aenorasis SA, Speakers bureau: MSD, Novartis, gsk, Constantinos Georganas: None declared, Periklis Vounotrypidis: None declared, Konstantinos Ntelis: None declared, Maria Areti: None declared, George D Kitas: None declared, Dimitrios Vassilopoulos: None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1004.2-1005
Author(s):  
D. Krause ◽  
A. Mai ◽  
N. Timmesfeld ◽  
U. Trampisch ◽  
R. Klaassen-Mielke ◽  
...  

Background:Rheumatoid arthritis (RA) is a chronic inflammatory joint disease potentially leading to disability, impaired functioning, and premature death. Most treatment strategies include the early use of disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX) which is considered as an established ‘anchor’ therapy. Since it takes some weeks until MTX shows clinical efficacy, glucocorticoids (GC) are widely used for bridging.Objectives:The aim of the study “Comparison of the efficacy and safety of two starting dosages of prednisolone in early active RA” (CORRA) is to compare the efficacy and safety of two standard GC bridging schedules vs. placebo in addition to MTX, following a treat-to-target regimen, in early RA.Methods:CORRA is an investigator-initiated, randomised, multi-center, double-blind, placebo-controlled trial. Adult RA patients who were eligible for inclusion in the trial if they had a disease duration of less than 3 years and moderate or high disease activity were recruited in one hospital and 18 rheumatology practices in Germany. Patients were randomised (1:1:1) to receive 60 mg or 10 mg prednisolone (Pred) orally once daily (tapered down to 5 mg Pred within 8 weeks) or placebo. The duration of the intervention was 12 weeks, followed by an open observational phase for another 40 weeks. All patients were also treated with MTX (usually starting with 15mg/week followed by a treat-to target scheme). The primary efficacy endpoint was the progression of the radiographic joint damage after one year compared to baseline as determined by the van der Heijde modification of the Sharp score (SHS). Patients, physicians and readers of radiographs were unaware of the treatment assignments. For the comparison of the two GC groups, a non-inferiority margin of 1.3 points of the SHS was set. This trial was registered at ClinicalTrials.gov, numberNCT02000336.Results:Between February 2014 and February 2017, 395 patients were included in the trial, 381 of which had sufficient data also of follow-up visits. A total of 129 patients were assigned to the 60 mg Pred group, 124 to 10 mg Pred and 128 to the placebo group. At baseline, mean age was 58 years, 58% were female, 55% were rheumatoid factor and 52% ACPA positive. The mean number of swollen joints was 12.8 out of 28, mean ESR was 33.6 mm/h, mean CRP 2.2 mg/dL, mean DAS 28 6.0. Radiographic damage was 4.9 as measured by the SHS. In the 60 mg, 10 mg Pred group and in the placebo group, the DAS 28 was 2.6, 3.1, 4.5 at week 4 (p<0.001), 3.1, 2.8, 3.6 at week 12 (p<0.001), and 2.7, 2.6, 2.8 at week 52 (p=0.411), respectively. After 12 months the radiographic progression could be determined in 375 patients. In the 60 mg, 10 mg Pred group, and in the placebo group, the mean progression after 1 year was 1.0, 1.0, 1.1 for the total SHS and 0.5, 0.6, 0.7 for the erosion score of the SHS, respectively. Statistical analysis showed non-inferiority of the 10 mg Pred and of the placebo group in comparison to the 60 mg Pred group. Regarding safety issues, there were 10, 5, 6 serious adverse events and 31, 16, 20 adverse events in the MedDRA system organ class “infections and infestations” for the 60 mg Pred, 10 mg Pred, and the placebo group, respectively.Conclusion:The bridging schedule starting with 60 mg Pred reduced disease activity better than the 10 mg schedule or placebo only for a short time. The primary outcome structural damage was non-inferior in the 10 mg Pred and the placebo group in comparison to the 60 mg Pred group. Initial advantages of the higher dose may have been compromised by the long follow-up with the possible escalation of therapy due to the treat-to-target regimen.Disclosure of Interests:Dietmar Krause Grant/research support from: Pfizer and AbbVie (Abbott), Anna Mai: None declared, Nina Timmesfeld: None declared, Ulrike Trampisch: None declared, Renate Klaassen-Mielke: None declared, Henrik Rudolf: None declared, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Elmar Schmitz: None declared, Claas Fendler: None declared, Claudia Klink: None declared, Stephanie Boeddeker: None declared, Ertan Saracbasi: None declared, Jochen Christoph: None declared, Manfred Igelmann: None declared, Hans Juergen Menne: None declared, Albert Schmid: None declared, Hans J Trampisch: None declared, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma


Kardiologiia ◽  
2021 ◽  
Vol 61 (1) ◽  
pp. 12-21
Author(s):  
O. A. Fomicheva ◽  
T. V. Popkova ◽  
L. B. Krougly ◽  
E. V. Gerasimova ◽  
D. S. Novikova ◽  
...  

Aim      To determine in a prospective study factors of progressive atherosclerotic lesion of blood vessels in patients with rheumatoid arthritis (RA).Material and methods  This prospective study included 124 patients with RA and suspected ischemic heart disease (IHD) and 30 patients with IHD (comparison group) aged 58 [52; 63] years. On enrollment to the study and at 3 years of follow-up, all patients underwent clinical and instrumental examination according to European and Russian guidelines for diagnosis and treatment of stable IHD (2013), including coronography as indicated. For all RA patients of the comparison group, risk factors (RF) were evaluated, including arterial hypertension, smoking, excessive body weight, family history of cardiovascular diseases (CVD), diabetes mellitus, and dyslipidemia. The following laboratory data were evaluated: blood count; biochemistry, including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), rheumatoid factor (RhF), cyclic citrullinated peptide antibodies, and high-sensitivity C-reactive protein (hsCRP). Proinflammatory cytokines, including interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF- α), were measured in RA patients once, at 3 years of follow-up.Results Incidence of FRs for CVD was similar in RA patients and in the comparison group. Median RA duration before inclusion into the study was 11 years, and median DAS28 index score was 3.8. Incidence of dyslipidemia due to increased TC, LDL-C, and HDL-C was higher for RA patients at baseline. The LDL-C goal (<1.8 mmol/l) was achieved only in 3 (10 %) patients of the comparison group and 10 (8 %) RA patients. RA patients had higher levels of the inflammation indexes, hsCRP (0.75 mg/dl vs. 0.16 mg/dl; p<0.05) and erythrocyte sedimentation rate (ESR) (15 mm/h vs. 11.5 mm/h; p<0.05). In the RA group at baseline, atherosclerotic plaques with carotid artery (CTA) stenosis of 20% or more were found in 94 (77 %) patients; in 3 of them, CA stenosis was >50%. Patients with RA frequently had unchanged or slightly changed coronary arteries (CA) (47% of patients), and less frequently they had hemodynamically significant multi-arterial coronary atherosclerotic lesions (7 % vs. 57 % of patients in comparison group). At 37.5 months, 21 (23 %) of 94 RA patients had progressive atherosclerosis in CA and/or CTA; 12 (13 %) RA patients had only progressive CA atherosclerosis; 7 (8 %) had only progressive CTA atherosclerosis; and 2 (2 %) had simultaneous progression of CA and CTA atherosclerosis. Two groups of RA patients were formed, with the progression of atherosclerosis (n=21) and without the progression of atherosclerosis (n=69). RFs for the development/progression of atherosclerosis in RA patients included smoking, family history of CVD, and duration of the disease. Levels of lipids did not differ. Levels of proinflammatory cytokines (IL-1β, IL-6, TNF-α) were higher in RA patients with progressive atherosclerosis. No effects of the anti-rheumatic therapy on the progression of atherosclerosis were observed.Conclusion      Progression of atherosclerosis in RA remains in disease with low and moderate activity during the anti-rheumatic and hypolipidemic treatment. The development of atherosclerosis in RA is determined by lipid, inflammatory, and immune disorders.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1955.1-1956
Author(s):  
T. Santiago ◽  
M. Voshaar ◽  
M. De Wit ◽  
P. Carvalho ◽  
M. Boers ◽  
...  

Background:The Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis Study (GLORIA) is an international investigator-initiated pragmatic randomized trial designed to study the effects of low-dose glucocorticoids (GCs) in elderly patients with Rheumatoid Arthritis (RA).The research team is also committed to promote a better understanding of the risks and benefits of these drugs among health professionals and patients. In order to achieve these goals, it is important to assess the current ideas and concerns of patients regarding GCs.Objectives:To evaluate the current patient perspective on the efficacy and risks of GCs in RA patients who are or have been treated with GCs.Methods:Patients with RA completed an online survey (with 5 closed questions regarding efficacy and safety) presented in their native language. RA patients were recruited through a variety of patient organizations representing three continents. Patients were invited to participate through national patient organizations. In the USA, patients were also invited to participate through MediGuard.org. Participants were asked for their level of agreement on a 5-point Likert scale.Results:1344 RA patients with exposure to GCs, from Brazil, USA, UK, Portugal, Netherlands, Germany and 24 other countries** participated: 89% female, mean age (SD) 52 (14) years and mean disease duration 13 (11) years. The majority of participants (84%) had ≥10 years of education. The duration of GCs exposure was 1.6 (4.2) years. The majority of participants had read articles or pamphlets on the benefits or harms of GC therapy.Regarding GCs efficacy (table 1), high levels of endorsement were found: about 2/3 of patients considered that GCs as very useful in their case, more than half considered that GCs were effective even at low doses, and agreed that GC improved RA symptoms within days.Regarding safety (table 1), 1/3 of the participants reported having suffered some form of serious adverse events (AEs) due to GCs, and 9% perceived this as “life-threatening. Adverse events had a serious impact on quality of life, according to about 1/3 of the respondents.Conclusion:Patients with RA exposed to GC report a strong conviction that GCs are very useful and effective for the treatment of their RA, even at low doses. This is accompanied by an important prevalence of serious AEs. Understanding the patient perspective can improve shared decision-making between patient and rheumatologist.Funding statement:This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634886.Disclosure of Interests:Tânia Santiago: None declared, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Pedro Carvalho: None declared, Maarten Boers: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi., José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 54.1-54
Author(s):  
S. Benamar ◽  
C. Lukas ◽  
C. Daien ◽  
C. Gaujoux-Viala ◽  
L. Gossec ◽  
...  

Background:Polypharmacy is steadily increasing in patients with rheumatoid arthritis (RA). They may interfere with treatment response and the occurrence of serious adverse events. Medications taken by a patient may reflect active comorbidities, whereas comorbidity indices usually used include past or current diseases.Objectives:To evaluate whether polypharmarcy is associated with treatment response and adverse events in an early RA cohort and to establish whether polypharmacy could represent a substitute of comorbidities.Methods:We used data from the French cohort ESPOIR, including 813 patients with early onset arthritis. Patients included the current study had to start their first disease modifying anti-rheumatic drug (DMARD) within 24 months of inclusion in the cohort. Disease activity data were collected at one, five and ten years from the initiation of the first DMARD. For each patient, treatments were collected at baseline and at five years. Medications count included all specialties other than background RA therapy, analgesics/NSAIDs and topicals. Polypharmacy was defined as a categorical variable based on the median and tertiles of distribution in the cohort. Treatment response was assessed by achieving DAS28 ESR remission (REM) at 1 year, 5 years and 10 years from the initiation of the first DMARD. The occurrence of severe adverse events (SAE) was measured by the occurrence of severe infection, hospitalization, or death during the 10-year follow-up. The association between patient’s characteristics and achievement of REM and occurrence of SAE were tested in univariate analysis. A logistic regression model was used to evaluate associations between polypharmacy and REM at 1 year, 5 years and 10 years (we used baseline polypharmacy for the 1-year analysis and five years polypharmacy for the 5- and 10-years analyses). Multivariate adjustment was made for age, sex, BMI, duration of disease, initial DAS28 ESR, initial HAQ, smoking status, rheumatic disease comorbidity index (RDCI).Results:The proportion of patients who achieved REM one year after the initiation of the first DMARD was 32.1% in the polypharmacy according to the median group (patients taken ≥2 medication) versus 67.9% in the non-polypharmacy group (p=0.07). At 5 years after the first DMARD, the proportion of patients with REM was 45.0% in the polypharmacy group versus 56.3% in the non-polypharmacy group (p=0.03). At 10 years the proportion of patients with REM was 32.5% in the polypharmacy group versus 67.5% (p=0.06). Patients who take greater or equal to 2 medications had a 40% lower probability of achieving REM (OR = 0.60 [0.38-0.94] p = 0.03) at 5 years from the first DMARD (if RDCI index was not included in the model). At 10 years, patients receiving multiple medications had a 43% lower probability of achieving REM (OR = 0.57 [0.34-0.94] p = 0.02). SAE incidence was 61 per 1000 patient-years. For patients who developed SAE all causes 71.4% where in the polypharmacy group versus 57.8% were in the non-polypharmacy group (p = 0.03; univariate analysis). These results are no longer significant after adjustment for comorbidities indices.Conclusion:In this early RA cohort, polypharmacy is associated with a poorer treatment response and increased risk of adverse events. Polypharmacy may represent a good substitute of comorbidities for epidemiological studies.Acknowledgements:We are grateful to Nathalie Rincheval (Montpellier) who did expert monitoring and data management and all theinvestigators who recruited and followed the patients (F. Berenbaum, Paris-Saint Antoine; MC. Boissier, Paris-Bobigny; A. Cantagrel, Toulouse; B. Combe, Montpellier; M. Dougados, Paris-Cochin; P. Fardellone and P. Boumier, Amiens; B. Fautrel, Paris-La Pitié; RM. Flipo, Lille; Ph. Goupille, Tours; F. Liote, Paris- Lariboisière; O. Vittecoq, Rouen; X. Mariette, Paris-Bicêtre; P. Dieude, Paris Bichat; A. Saraux, Brest; T. Schaeverbeke, Bordeaux; and J. Sibilia, Strasbourg).The work reported on in the manuscript did not benefit from any financial support. The ESPOIR cohort is sponsored by the French Society for Rheumatology. An unrestricted grant from Merck Sharp and Dohme (MSD) was allocated for the first 5 years. Two additional grants from INSERM were obtained to support part of the biological database. Pfizer, Abbvie, Lilly and more recently Fresenius and Biogen also supported the ESPOIR cohort.Disclosure of Interests:Soraya Benamar: None declared, Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Claire Daien Speakers bureau: AbbVie, Abivax, BMS, MSD, Roche, Chugai, Novartis, Pfizer, Sandoz, Lilly, Consultant of: AbbVie, Abivax, BMS, MSD, Roche, Chugai, Novartis, Pfizer, Sandoz, Lilly, Cécile Gaujoux-Viala Speakers bureau: Abbvie, BMS, Celgene, Janssen, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi, Roche-Chugai, UCB, Consultant of: Abbvie, BMS, Celgene, Janssen, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi, Roche-Chugai, UCB, Grant/research support from: Pfizer, Laure Gossec Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis et UCB, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis et UCB, Anne-Christine Rat Speakers bureau: Pfizer, Lilly, Consultant of: Pfizer, Lilly, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi;, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi;, Grant/research support from: Novartis, Pfizer, and Roche-Chugai., Jacques Morel Speakers bureau: Abbvie, BMS, Lilly, Médac, MSD, Nordic Pharma, Pfizer, UCB, Consultant of: Abbvie, BMS, Lilly, Médac, MSD, Nordic Pharma, Pfizer, UCB, Grant/research support from: BMS, Pfizer


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  

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


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Malika A Swar ◽  
Marwan Bukhari

Abstract Background/Aims  Osteoporosis (OP) is an extra-articular manifestation of rheumatoid arthritis (RA) that leads to increased fracture susceptibility due to a variety of reasons including immobility and cytokine driven bone loss. Bone loss in other populations has well documented risk factors. It is unknown whether bone loss in RA predominantly affects the femoral neck or the spine. This study aimed to identify independent predictors of low bone mineral density (BMD) in patients RA at the lumbar spine and the femoral neck. Methods  This was a retrospective observational cohort study using patients with Rheumatoid arthritis attending for a regional dual X-ray absorptiometry (DEXA) scan at the Royal Lancaster Infirmary between 2004 and 2014. BMD in L1-L4 in the spine and in the femoral neck were recorded. The risk factors investigated were steroid use, family history of osteoporosis, smoking, alcohol abuse, BMI, gender, previous fragility fracture, number of FRAX(tm) risk factors and age. Univariate and Multivariate regression analysis models were fitted to explore bone loss at these sites using BMD in g/cm2 as a dependant variable. . Results  1,527 patients were included in the analysis, 1,207 (79%) were female. Mean age was 64.34 years (SD11.6). mean BMI was 27.32kg/cm2 (SD 5.570) 858 (56.2%) had some steroid exposure . 169(11.1%) had family history of osteoporosis. fragility fracture history found in 406 (26.6%). 621 (40.7%) were current or ex smokers . There was a median of 3 OP risk factors (IQR 1,3) The performance of the models is shown in table one below. Different risk factors appeared to influence the BMD at different sites and the cumulative risk factors influenced BMD in the spine. None of the traditional risk factors predicted poor bone loss well in this cohort. P129 Table 1:result of the regression modelsCharacteristicB femoral neck95% CIpB spine95%CIpAge at scan-0.004-0.005,-0.003&lt;0.01-0.0005-0.002,0.00050.292Sex-0.094-0.113,-0.075&lt;0.01-0.101-0.129,-0.072&lt;0.01BMI (mg/m2)0.0080.008,0.0101&lt;0.010.01130.019,0.013&lt;0.01Fragility fracture-0.024-0.055,0.0060.12-0.0138-0.060,0.0320.559Smoking0.007-0.022,0.0350.650.0286-0.015,0.0720.20Alcohol0.011-0.033,0.0 5560.620.0544-0.013,0.1120.11Family history of OP0.012-0.021,0.0450.470.0158-0.034,0.0650.53Number of risk factors-0.015-0.039,0.0080.21-0.039-0.075,-0.0030.03steroids0.004-0.023,0.0320.030.027-0.015,0.0690.21 Conclusion  This study has shown that predictors of low BMD in the spine and hip are different and less influential than expected in this cohort with RA . As the FRAX(tm) tool only uses the femoral neck, this might underestimate the fracture risk in this population. Further work looking at individual areas is ongoing. Disclosure  M.A. Swar: None. M. Bukhari: None.


Sign in / Sign up

Export Citation Format

Share Document