Dr Burkhard Leeb, MD, - State Hospital Stockerau - Primarius Privat Dozent

Dr Burkhard Leeb

MD,

State Hospital Stockerau

Primarius Privat Dozent

Stockerau | Austria

Main Specialties: Internal Medicine, Rheumatology

ORCID logohttps://orcid.org/0000-0002-2368-5036


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Dr Burkhard Leeb, MD, - State Hospital Stockerau - Primarius Privat Dozent

Dr Burkhard Leeb

MD,

Introduction

Dr. Burkhard F. Leeb was born in Vienna in 1956, achieved his MD in 1981 and received his specialization in Internal Medicine in 1989, and in Rheumatology in 1994, respectively He was appointed director of the newly established center for rheumatology, Lower Austria, at Stockerau Hospital in 1999. In collaboration with his co-workers he was able to establish this institution in Austrian rheumatology within a relative short time period. Aside this occupation Dr. Leeb had the honor to serve as president of the Austrian society for rheumatology and rehabilitation between 2008 and 2010, as well as a member and also as co-convenor of several EULAR task-forces, amongst them the ones for osteoarthritis and gout. In 2010 he earned his postdoctoral lecture qualification from the Medical University of Graz, Austria. Since 2009 Burkhard Leeb serves as the chairman of the Austrian Registry for Biologics in the treatment of rheumatic diseases, BioReg. Currently he is also lecturer on rheumatology at the Karl Landsteiner University of Health Sciences, Krems, Austria. From February 2018 to March 2019 he is on a sabbatical year from his directorship.
Up to date Dr. Leeb has published more than 150 articles in peer reviewed journals, and in books, amongst them meta-analyses on chondroitin sulfate, and diacerein, EULAR response criteria for polymyalgia rheumatica, and a respective disease activity score. His main scientific interests are arthritides, polymyalgia rheumatica, as well as osteoarthritis and gout, above all the questions along with disease activity assessment and individualized patient treatment.


Primary Affiliation: State Hospital Stockerau - Stockerau , Austria

Specialties:

Research Interests:


View Dr Burkhard Leeb’s Resume / CV

Education

Jun 1994
Lainz Hospital, Center for Rheumatology
MD, consultant
Specialization in Rheumatology
Sep 1989
Lainz Hospital, 2 nd Dept. of Medicine
MD, resident
Specialization in Internal Medicine

Experience

Sep 2016
Roche Scientific Award
Nov 2009
Wyeth Scientific Award

Austrian Society for Rheumatology and Rehabilitation
Nov 2007
2nd Wyeth Scientific Award

Austrian Society for Rheumatology and Rehabilitation
Nov 2006
1st Wyeth Scientific Award

Austrian Society for Rheumatology and Rehabilitation,
Jun 2005
2nd Scientific Award

Medical Society of Lower Austria,

Publications

83Publications

1899Reads

273Profile Views

37PubMed Central Citations

A Plea for Patient Centered Treatment-Isn’t Individualized Therapy the Highest Precept?

Rheumatology (Sunnyvale), Vol.9 Iss.1 No:1000251

Rheumatology Current Research

Rheumatology: Current ResearchISSN: 2161-1149Rheumatology: Current Research Commentary A Plea for Patient Centered Treatment-Isn’t Individualized Therapy the Highest Precept? Leeb BF1,2,3 1Karl Landsteiner Institute for Clinical Rheumatology, A-2020 Hollabrunn, Babogasse 20, Austria; 2Department of Medicine, Center for Rheumatology Lower Austria, State Hospital Stockerau, Austria; 3Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria COMMENTARY The actual European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) recommendations for management of rheumatoid arthritis (RA) very much focus on early treatment and the application of the treat-to-target (T2T) principle. In fact, T2T can be regarded a common place as to set and pursue goals since ever is of course essential in any aspect of curative medicine; nobody expects physicians to behave like blind persons in a dark forest. If T2T, although, is understood in the way that the treatment goal to achieve is a certain number on a scale, as it may be required by some originators, you may better forget about, as your patients will only have little understanding for this approach. Apparently the more the physicians lack clinical expertise they think to be in the need of such cloistered proposals. Thus, in clinical routine the compliance with these recommendations appears to be rather poor, it remains am apparently theoretic framework, which meaningful application particularly depends upon the physician’s personal expertise. Keywords: Rheumatoid arthritis; Rheumatic diseases; Inflammatory Of course, the ultimate goal of any therapeutic initiative should be healing, if possible, or remission, which, in case of inflammatory rheumatic diseases, is defined as the absence of signs and symptoms of a significant inflammatory disease activity [1-8]. The T2T recommendations very much focus on reduction of measurable inflammatory activity, prevention of destruction and reduction of mortality. Unquestionably each of these points appears to be outstandingly important. This way of looking at things, though, must be regarded a very much physician created one as patients apparently have particularly different ideas about a situation which comes near health. In fact, patients rate pain reduction, improvement of functionality, health related quality of life, as well as independence similarly vital as inflammatory activity expressed by CRP and/or the joint counts, if not of higher importance [9-11]. By the way, what patients with rheumatic diseases consider necessary to feel in good health has never been interrogated, why?These different expectations and wishes lead to a significant discordance between and physicians’ and patients’ perceptions of Rheumatoid Arthritis’ disease activity changes [10]. And, this begs the question whether patients’ and physicians’ treatment goals can be regarded the same? Or, in other words, whether and why physicians should be justified to establish treatment goals for their customers? Where take physicians the arrogance to define boundaries, where diseased individual have to feel well? Moreover, if the physician is affected by the disease himself, experience tells us, that there may be some problems in patient management originating from too less distance to the patient’s problems and increased physician’s self-efficacy. The prerequisite for patient centered treatment as expressed by the respective recommendations is based on “Shared Decision-Making” (SDM) and consideration of patient wishes with respect to the treatment of choice [12]. This approach’s application means that therapeutic decisions are taken by physicians and patients together on the basis of the best disposable knowledge, including patient preferences. But, what does “shared decision” mean in clinical routine. Which aspects of the disease are to be shared between physician and patient? The physician’s position is to provide the patient with all his theoretical knowledge regarding the course of the disease and the respective treatment possibilities, additionally with his expertise derived from a hopefully large number of patients. Patients may give physicians information about their individual experiences with the disease and medications. However pain, anxiety about the future, functional deficiencies, reduced social and professional participation as well as dependence are of course indivisible for the affected individual. Isn’t it, therefore, not a very physician focused euphemism to speak of shared decision? Isn’t it the case, that after this shared decision was taken, the patient remains alone with all the disease and therapy consequences? Amongst them one of the most important ones may be the incapability to make plans for the near future despite apparently optimal management according to the recommendations [13]. Wouldn’t it be the normal situation that a patient takes his decision autonomously after optimal advice by his physician in order to guarantee a patient centered individualized treatment? Such a scenario would enable patients to take responsibility for themselves, as in reality, only the patient and his family environment has to master all the problems deriving from the disease. This trend to individualized therapy fortunately is growing throughout the last years. Patients’ opinions more and more become the basis of therapeutic decisions and management plans [14,15]. The era of patronizing patient guidance is going to come to an end, although a high degree of resistance can be observed with old fashioned rheumatologists. Rheumatic diseases affect many aspects of a patient's life. Patient-reported outcomes (PROs) provide valuable information on how patients feel with regards to a health condition and the therapy received [16]. Thus, also for the necessary documentation these instruments are the ones of choice, carrying the advantage to mirror the individual’s thoughts and feelings as well as other aspects of the disease, such as fatigue, pain etc. [17] In contrast, all composite indexes weigh the patient’s global assessment lower, far inferior to the joint counts, which are in fact physician-dependent, and sometimes inferior to the acute phase reactants [18]. That is why, all the composite indexes utilized do not grant patients’ wishes, beliefs, fears, coping mechanisms or morbid-gains a prominent status. [18]. Patients, assessing the T2T approach, judged the pronounced focus on body functions and structure scanty [19]. This result is no big surprise, as T2T is based on study results on the group level. The situation with a patient crowd in front of your office expressing their intention of an improvement of their average disease activity regardless of the individual disease activity sounds curious, however, exactly resembles what T2T means in a stricter sense. Additionally, a physician led systematic literature review revealed unsatisfactory treatment results with respect to pain, physical, social, and mental functioning as well as professional participation and sexual functionality [20]. Obviously, each of these aspects of daily life, and the more the combination of them, may heavily interfere with patients’ wellbeing, and should be worth to be in the centre of therapeutic efforts [20]. On the one hand the satisfying aspects of the rheumatologists’ work, namely patient interaction, alleviation of pain, preserving functionality, only become reality in case of engagement in the individual case. On the other hand, we are increasingly confronted with recommendations for almost all aspects of professional and daily life. This does not necessarily mean a contradiction, if the recommendations are applied as aids, and not as absolute allegations. In this way they may help to ease the rheumatologist s life and improve patient care. The prerequisites, however, constitute a responsible dealing with and serious consideration about the respective recommendation and its applicability for the individual situation. In that respect treating patients to target should mean to achieve the best possible individual outcome and not to achieve a simple numerical value. REFERENCES 1. Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960-977. 2.Singh JA, Saag KG, Bridges SL Jr, Tindall E, Miller AS, McAlindon T, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis.Arthritis Rheumatol. 2016;68(1):1-26.3. Bergstra SA, Allaart CF. What is the optimal target for treat-to-target strategies in rheumatoid arthritis? Curr Opin Rheumatol. 2018;30(3):282-287.4. Haraoui B, Smolen JS, Aletaha D, Durez P, Emery P, Fonseca JE, et al. Treating rheumatoid arthritis to target: multinational recommendations assessment questionnaire. Treat to target taskforce. Ann Rheum Dis. 2011;70(11):1999-2002. 5. Leeb BF. Individualized rheumatoid arthritis patient care means more than achieving a number. J Rheum Dis Treat. 1(1):007. 6. Gvozdenovic E, Allaart CF, Ferraccioli G, Smolen JS, Huizinga TW, Landewé R, et al. When rheumatologists report that they agree with a guideline, does this mean that they practise theguideline in clinical practice? Results of the International Recommendation Implementation Study (IRIS). RMD Open. 2016;28:2(1):e000221.7. Leeb BF. Persönliche Expertise noch gefragt? Rheuma Plus. 2018;17(4):107. 8. Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016;75(1):3-15. 9.Khan NA, Spencer HJ, Abda E, Toloza S, Yamanaka H, Sokka T, et al. Determinants of discordance in patients' and physicians' rating of rheumatoid arthritis disease activity. Arthritis Care Res. 2012;64(2):206-214. 10. Leeb BF, Sautner J, Leeb BA, Fassl C, Rintelen B. Lack of agreement between the patient’s and physician’s perception of rheumatoid arthritis’ disease activity changes. Scand J Rheumatol. 2006;35(6):441-446. 11.Alten R, Krüger K, Rellecke, J, Roche JS, Behmer O, Schiffhorst G, et al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016;10:2217-2228. 12. Stacey D, Légaré F, Col NF, Lyddiatt A, Thomson R, Trevena L, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;28(1)1:CD001431. 13. Puchner R, Brezinschek HP, Fritz J, Puchner SE, Benke AS, Leeb BF, et al. Is the state of health of rheumatoid arthritis patients receiving adequate treatment, predictable?-Results of a survey. BMC Musculoskelet Disord. 2015;16:109. 14. Fautrel B, Alten R, Kirkham B, Holzkaemper T, Fakhouri W, Taylor PC, et al. Call for action: how to improve use of patientreported outcomes to guide clinical decision making in rheumatoid arthritis. Rheumatol Int. 2018;38:(6)935-947. 15. Leeb BF. Should physicians' consider patient perception for modulating treatment? Rheumatology (Oxford). 2016;55(11): 1919-1920. 16. Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J,Valderas J, et al. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018;2:42. 17. Leeb BF, Haindl PM, Maktari A, Nothnagl T, Rintelen B. Patient centered rheumatoid arthritis activity assessment by a modified RADAI. J Rheumatol. 2008;35(7):1294-1299. 18. Leeb BF, Sautner J, Mai HTH, Haindl PM, Deutsch C, Rintelen B. A comparison of patient questionnaires and composite indexes in routine care of rheumatoid arthritis patients. Joint Bone Spine. 2009;76(6):658-664. 19. Barton JL, Imboden J, Graf J, Glidden D, Yelin EH, Schillinger D. Patient-physician discordance in assessments of global disease severity in rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010;62(6):857-864. 20. Taylor PC, Moore A, Vasilescu R, Alvir J, Tarallo M. A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective. Rheumatol Int. 2016;36(5):685-695. Rheumatology (Sunnyvale), Vol.9 Iss.1 No:1000251

View Article
September 2019
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Optimise: An Austrian Multicentre Study on the Effectiveness and Safety of Tocilizumab in Combination with Methotrexate versus Tocilizumab for Mild/Moderate Rheumatoid Arthritis and an Inadequate Response to Methotrexate

J Rheum Dis Treat 5:074. doi.org/10.23937/2469-5726/1510074

Journal of Rheumatic Diseases and Treatment

Abstract Background As data on the efficacy of biologics in patients with mild/moderate rheumatoid arthritis are limited, this study was performed to assess the efficacy and safety of tocilizumab plus methotrexate versus tocilizumab monotherapy on disease activity. Methods Seventy-seven patients with mild/moderate rheumatoid arthritis and an inadequate response (Disease Activity Score 28 > 3.2) to methotrexate were initially enrolled (mean Disease Activity Score 28 3.91 +/- 0.54) and received three infusions of tocilizumab 8 mg/kg every 4 weeks plus methotrexate. Subjects achieving a good/moderate European League Against Rheumatism response after three months of open-label treatment were randomised to Group A (tocilizumab plus methotrexate) or Group B (tocilizumab plus placebo methotrexate). The primary endpoint was the Disease Activity Score 28 change from week 12 to 24. The secondary endpoints included the proportion of patients achieving remission according to the Disease Activity Score 28 and various disease activity indices at week 24. Results Sixty-five patients were included in the blinded trial phase. At week 12, the mean Disease Activity Score 28 was 1.51 in Group A (n = 32) and 1.72 in Group B (n = 33). The Disease Activity Score 28 difference between the groups was not statistically significant (p = 0.19). No substantial differences were seen with regard to the secondary endpoints. Conclusions Additional tocilizumab treatment led to improvement in patients with mild/moderate rheumatoid arthritis. The study results give no indication that the combination of Tocilizumab with Methotrexate induces a better outcome (preserving the level of disease activity achieved at week 12) in comparison with Tocilizumab monotherapy in patients corresponding to those included into the study. Keywords Mild to moderate rheumatoid arthritis, Inadequate methotrexate response, Tocilizumab Abbreviations AE: Adverse Events; ANCOVA: Analysis of Covariance; CDAI: Clinical Disease Activity Index; CERTAIN: Certolizumab Pegol in the Treatment of RA: Remission Induction and Maintenance in Patients with LDA; CI: Confidence Interval; CZP: Certolizumab; DAS28: Disease Activity Score 28; DMARD: Disease-Modifying Anti-Rheumatic Drug; ETA: Etanercept; EULAR: European League Against Rheumatism; HAQ-DI: Health Assessment Questionnaire Disability Index; IL-6: Interleukin-6; ITT: Intention-To-Treat; LOCF: Last Observation Carried Forward; MTX: Methotrexate; PP: Per-Protocol; PRO: Patient-Reported Outcome; RA: Rheumatoid Arthritis; RADAI-5: Rheumatoid Arthritis Disease Activity Index-5; SA: Safety Analysis; SDAI: Simplified Disease Activity Index; SF-12v1: 12-Item Short Form Health Survey; TCZ: Tocilizumab; TNF-α: Tumour Necrosis Factor Alpha; TSQM: Treatment Satisfaction Questionnaire for Medication; VAS: Visual Analogue Scale Background Over the last decades, there have been major advances in the treatment of rheumatoid arthritis (RA) [1]. While early diagnosis and treatment of the disease have added to improved outcomes, biologic agents also provide improved efficacy in an additional number of patients compared to traditional treatments [2]. However, despite these advances, approximately 30 to 40% of patients fail to achieve an acceptable clinical response or to tolerate the new agents [3]. Disease-modifying anti-rheumatic drugs (DMARDs) – the cornerstone of RA treatment throughout all stages of the disease – maintain or improve physical function and retard radiographic joint damage. For many subjects, however, treatment remains limited by toxicity and/or ineffectiveness [4,5]. During the last fifteen years, biologic compounds that target tumour necrosis factor alpha (TNF-α), B-cells or T-cells have been used successfully to treat RA. Still, a considerable percentage of patients fail to respond to these therapies [6,7]. Overall, there is an obvious medical need for more effective treatments for RA based on a precise understanding of the underlying pathophysiology of the course of the disease. A different therapeutic approach, namely targeting interleukin-6 (IL-6), constitutes the application of tocilizumab (TCZ) - an anti-IL-6 receptor antibody – which has been approved for the treatment of moderate to severe RA [8]. Inhibiting the entire receptor complex prevents IL-6 signal transduction to inflammatory mediators that summon B and T cells. Tocilizumab has a nonlinear pharmacokinetic profile [9]. TCZ has been shown to be more efficacious than methotrexate (MTX) alone in some clinical trials and therefore may offer an alternative, applied as monotherapy, for patients who have experienced intolerability to MTX as well as inadequate clinical response to biologic or non-biologic DMARDs [10]. It has been demonstrated to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX. Clinical efficacy and safety studies with TCZ have been conducted or are ongoing in various disease areas, including adult-onset RA, systemic-onset juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis [11,12]. While the efficacy and safety of biologic DMARDs in general, and TCZ in combination with DMARDs in particular, has been established in moderate to severe RA, only sporadic data are available in patients with mild to moderate RA for some biologic DMARDs [13,14]. Very recently results of a meta-analysis revealed that TCZ as compared to Tumor Necrosis Factor-inhibitors, may be associated with a reduced risk of major cardiovascular events (MACEs), whereas csDMARDs like MTX may be associated with an increased risk of MACEs and particularly stroke. This finding may be related to TCZ's regulatory capability with respect to serum levels of chemerin and adiponectin in RA patients, independently of the disease treatment response [15,16]. Against this background, the present OPTIMISE trial was intended to recruit subjects with mild to moderate RA to study the efficacy and safety of TCZ in patients with less severe disease. The primary objective of this study was thus to assess the efficacy and safety of TCZ in combination with MTX versus TCZ monotherapy to preserve therapeutic response in such subjects and to determine the contribution of MTX by comparing TCZ plus MTX versus TCZ alone in patients who had previously been treated with combined TCZ plus MTX. Methods The OPTIMISE study was conducted as a local, open-label, phase IIIb trial followed by a randomised, double-blind, placebo-controlled, parallel-group study. The study was conducted according to the guidelines of the Declaration of Helsinki and Good Clinical Practice. The investigators were trained according to the Sponsor's applicable standard operating procedures. The study protocol was approved by the Ethics Committee of Lower Austria (GS4-EK-14/025-2011), and all patients provided written informed consent prior to any study procedures. Patients One hundred and twelve patients (80 female/29 male/3 missing data), ≥ 18 years of age, ≤ 150 kg of body weight, with mild to moderate active RA of more than one year duration (or radiologic evidence of RA if diagnosis of RA < 1 year) who were currently experiencing an inadequate response (Disease Activity Score 28 [DAS28] ≤ 4.5 and > 2.6) to a stable dose of MTX therapy (15-25 mg/wk) were screened for eligibility. Thirty-five were excluded prior to treatment, the majority of them for screening failures (n = 26). Subsequently, 77 patients, including 12 who were not randomised, received three infusions of TCZ (8 mg/kg) IV every four weeks plus background MTX at the accustomed dose. Table 1 shows the baseline data for these patients. Table 1: Baseline data (Safety Analysis population; n = 77). View Table 1 Patients having achieved at least a moderate European League Against Rheumatism (EULAR) response [13] after three TCZ infusions were enrolled into the blinded study phase. These 65 subjects (84.4%; 51 female/14 male; mean age 57.5 +/- 11.3 years) were stratified according to age (< 40 years, 40-65 years, > 65 years) and gender in addition to the achievement of good or moderate EULAR response Figure 1. Figure 1: Primary disposition of patients (open-label phase).EULAR: European League Against Rheumatism; MTX: Methotrexate; TCZ: Tocilizumab.View Figure 1 Patients randomized to Group A (n = 32) received TCZ 8 mg/kg IV every four weeks plus MTX (15 to 25 mg weekly as in the starting phase), whereas patients randomized to Group B (n = 33) received TCZ 8 mg/kg IV every four weeks plus placebo MTX-Tablets. In order to minimise potential MTX toxicity, all subjects received at least 5 mg oral folic acid weekly for the entire duration of the treatment period. Stable non-steroidal anti-inflammatory drug and oral corticosteroid (≤ 10 mg/d prednisone or equivalent) doses were continued during the trial. Patients who failed to achieve a good or moderate EULAR response after three months of treatment were excluded from the study and treated according to the investigators' discretion. The first patient was enrolled on January 17, 2012, and the last patient/last visit was performed on February 13, 2014. Study objectives The overall goal of the trial was to assess the effect on disease activity of TCZ plus MTX versus TCZ monotherapy in patients with mild to moderate RA. Therefore, the change in the DAS28 score including the erythrocyte sedimentation rate [17] from week 12 (time of randomisation) to week 24 was chosen as the primary endpoint (Figure 2). Figure 2: Study design.BL: Baseline; DAS28: Disease Activity Score 28; EULAR: European League Against Rheumatism; MTX: Methotrexate; TCZ: Tocilizumab.View Figure 2 The following patient-reported outcomes (PROs) were recorded: Patients' global assessment of disease activity (VAS), HAQ-DI [18], SF-12v1 [19], RADAI-5 [20], VAS fatigue, VAS pain, and TSQM [21]. The patient global assessment of disease activity contributed to the efficacy endpoints DAS28, SDAI and CDAI [14,22]. The VAS fatigue, HAQ-DI and SF-12v1 were used to assess any improvements in physical and mental health. The TSQM was used to assess the patients' satisfaction with their current treatment. Paper-based PRO questionnaires were administered to the subjects and the resulting PRO data were entered on the electronic case report forms by data management. The secondary objectives were the following: • Proportion of patients who achieved DAS28 remission [14] at 24 weeks (DAS28 < 2.6) • Proportion of patients who achieved Clinical Disease Activity Index (CDAI) remission [22] (CDAI < 2.8) at 24 weeks • Proportion of patients who achieved Simplified Disease Activity Index (SDAI) remission [22] (SDAI < 3.3) at 24 weeks • Proportion of patients who achieved Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) remission [20] (RADAI-5 score ranging from 0 to 1.4) at 24 weeks • Improvement in physical and mental health according to the Health Assessment Questionnaire Disability Index (HAQ-DI) [18], the 12-Item Short Form Health Survey (SF-12v1) [19], and the Visual Analogue Scales for fatigue (VAS fatigue) and pain (VAS pain) • Incidence of adverse events (AEs) and serious AEs during the study period • Patients' satisfaction with treatments according to the Treatment Satisfaction Questionnaire for Medication (TSQM) [21] For safety reasons, laboratory parameters were determined every four weeks, the normal values were applied according to Austrian Society of Quality Assurance norms. All laboratory analyses were performed by the local laboratories at the study sites, except those of matrix metalloproteinase-3 which were performed at the Medical University of Graz. Statistics Three populations were statistically analysed: • Safety analysis (SA) population: Patients who had been given an ID and at least one dose of study medication in the open-label phase; • Intention-to-treat (ITT) population: Patients randomised to either treatment arm if at least one dose of study medication was administered after randomisation; • Per-protocol (PP) population: The subset of ITT patients who completed the study without any major protocol violations. Missing DAS28 values after randomisation were replaced by applying the last observation carried forward (LOCF) principle. Other types of missing data were not imputed. The randomised study had a confirmatory status (two parallel groups: Group A = TCZ plus MTX vs. Group B = TCZ plus placebo). The primary efficacy analysis tested the null hypothesis that there is no difference in DAS28 change from week 12 to week 24 between the two groups against the alternative that there is a difference at the 5% significance level. A sample size estimation assuming a difference in means of 0.5 DAS28 change from week 12 to week 24 between Group A and Group B and a common standard deviation of 0.95 resulted in a need for 60 patients in each group (type I error = 5% two-sided, type II error = 19%). Considering a 20% drop-out rate before randomisation (especially by not achieving a good or moderate EULAR response at week 12), 150 patients were to be enrolled. All data sets of continuous variables were checked for normal distribution (Kolmogorov-Smirnov test with Lilliefors significance correction, type I error = 5%) and for variance homogeneity (Levene test, type I error = 5%). For group comparisons of continuous variables, the t-test was used if normality and variance homogeneity could be assumed. Welch's t-test was used if normality and no variance homogeneity could be assumed. Otherwise, the exact Mann-Whitney U test was used. Categorical variables were compared with Fisher's exact test or the exact chi-square test. According to the nature of the data sets, group comparison of the primary endpoint (DAS28 change from week 12 to week 24) was performed with the t-test. Due to a substantial difference in the DAS28 at week 12, a parametric analysis of covariance (ANCOVA) with the baseline DAS28 as covariate complemented the statistical approach. The type I error was not adjusted for multiple testing. Therefore, all results of inferential statistics are descriptive only, except for hypothesis testing for the primary endpoint. Statistical analysis was performed using the open-source R statistical software package, version 3.1.1 (The R Foundation for Statistical Computing, Vienna, Austria). Results Study population A total of 62 of the 65 patients who had been included in the double-blind phase of the trial (the ITT population) finally completed the study. There was a total of 31 protocol violations after randomisation - the most frequently being violations of inclusion/exclusion criteria and including three dropouts - which led to an exclusion of 22 subjects from the ITT population. No substantial differences were identified between the groups in the ITT population with respect to their demographic data (age at screening, gender). At baseline (time of randomisation), substantial differences were seen in TSQM side-effects and TSQM convenience (see Table 1), which were obviously due to premedication among the inadequate responders to MTX. Efficacy Primary endpoint The ITT population was used for the primary efficacy analysis (ITT analysis). Sixty-five patients achieved a moderate (n = 6) or good EULAR response (n = 59) at week 12 (ITT population). In these patients, the mean DAS28 at week 12, the time of randomisation, amounted to 1.51 in Group A (n = 32) and 1.72 in Group B (n = 33), respectively. The numerical change in the DAS28 score from week 12 to week 24 was not statistically significant, but slightly positive in Group A and slightly negative in Group B, respectively (0.17 ± 0.83 vs. -0.16 ± 1.13; 95% confidence interval [CI] for the difference: -0.16 - 0.82). The null hypothesis that no difference in DAS28 change can be seen from week 12 to week 24 between the two treatment groups was not falsified (p = 0.19; ANCOVA: p = 0.30). In addition, the analysis of the PP population provided very similar results (0.12 ± 0.87 vs. -0.19 ± 0.97; 95% CI for the difference, -0.26 - 0.89; p = 0.28; ANCOVA: p = 0.33). Secondary endpoints As to the secondary endpoints – i.e. the proportion of patients in remission, improvement of function, mental health and satisfaction with treatment – no pronounced differences were seen between the MTX- or placebo-treated patients. In general, most of the secondary endpoints showed a very slight tendency towards better results in Group B (the placebo group). No new signals were detected regarding tolerability (see Table 2 and Figure 3). Figure 3: Course of the RA indexes and PROs during the study. CDAI: Clinical Disease Activity Index; DAS28: Disease Activity Score 28; M-HAQ: Modified Health Assessment Questionnaire; MTX: Methotrexate; PRO: Patient-reported outcome; RA: Rheumatoid arthritis; RADAI-5: Rheumatoid Arthritis Disease Activity Index 5; TCZ: Tocilizumab.View Figure 3 Table 2: Secondary endpoints (ITT population, n = 65). View Table 2 Safety Seven serious AEs were reported in the SA population (Group A: 2, Group B: 5), which comprises all patients having received at least a single dose of TCZ (n = 77). Substantial differences in common AEs were seen only with respect to "blood and lymphatic system disorders" (Group A: 14, Group B: 6; p = 0.033) and "investigations" (Group A: 14, Group B: 24; p = 0.024). The other most frequent AEs were 44 "infections and infestations" (Group A: 20, Group B: 22, not randomised: 2) and 20 "gastrointestinal disorders" (Group A: 6, Group B: 12, not randomised: 2). No death occurred during the entire study. In either treatment group, one serious AE with a possible relationship to one of the investigational drugs was reported: one possible relationship with MTX for an alanine transaminase elevation in Group A and one possible relationship with both compounds (TCZ, MTX) for a urinary tract infection in Group B, which was the only serious AE leading to study termination in this particular patient (see Table 3). Table 3: AEs in treatment groups during the blinded phase of treatment. View Table 3 Discussion A plethora of clinical studies and also meta-analyses has addressed the safety and efficacy of biologic DMARDs of any type in patients with highly active RA [7]. In fact, their benefits for patients are beyond any doubt. Although persistently moderately active RA is known to not constitute a benign disease [23], only sporadic reports have dealt with RA patients in the low or moderate disease activity range [11,12,24]. It is well known that lower disease activity, negative rheumatoid factor, shorter disease duration, younger age, etc., constitute predictors of advantageous treatment outcome, the disease activity level being amongst the strongest. Yet if the only reasons not to apply the unquestionably costly biologic compounds to possibly less affected patients are economic, is it then justified to deprive such patients of this type of treatment? One prerequisite to reply to such issues is to affirm each drug's efficacy and safety. Regarding TCZ, in particular, another question can be regarded as topical as the previous one. TCZ monotherapy has been shown to be more effective than MTX alone; therefore, it is interesting to explore whether co-medication with MTX is necessary to maintain favourable treatment response [24]. Considering this background, the OPTIMISE trial should redound to a more clearly evidence-based application of TCZ. This trial was performed as an Austrian country-wide study including 14 centres and reflecting daily clinical routine. In fact, a higher degree of homogeneity with respect to patients and their social circumstances can be assumed in comparison with two international multicentre trials: the PRESERVE study investigating Etanercept (ETA) and the Certolizumab Pegol in the Treatment of RA: Remission Induction and Maintenance in Patients with LDA (CERTAIN) trial investigating Certolizumab (CZP) in the respective RA subgroups [12,13]. Comparing the baseline date of the three trials, the subjects in OPTIMISE were older and less severely diseased, as expressed by the DAS28 and HAQ-DI values [12,13], while the gender distribution appears to be similar, indicating that the patients in the OPTIMISE trial more closely matched those originally intended to be studied. As with the two TNF-α inhibitors applied in the PRESERVE and CERTAIN studies, a high number of patients responded to TCZ treatment within 12 weeks: A EULAR response was recorded in 84.4% overall, of whom 91% achieved a good response. Although this part of the trial was performed in an open manner, the high percentage of EULAR responses gives a robust indication of the efficacy of TCZ as an additional medication to primarily ineffective MTX in RA patients with moderate or low disease activity. As expressed by the composite indexes, the week-24 remission rates in the OPTIMISE trial were considerably higher than with ETA or CZP [12,13] and, interestingly, numerically higher in the TCZ monotherapy group. Additionally, the relevance of this improvement is underlined by the fact that the courses of composite indices and PROs parallel each other to a very high degree, indicating that the benefit is not only arithmetic, but that the subjects indeed experienced that benefit. Also, the percentage of patients in remission as expressed by the RADAI-5 was in the range of the CDAI remission. This can be considered remarkable with TCZ, as it relativizes the discussion about the advantage IL-6 blockers may have if acute phase reactants are components of indices. It had been anticipated that TCZ treatment would lead to significant improvements if added to ineffective MTX [24]. However, the question whether the combination of TCZ with MTX would perform better than TCZ monotherapy in maintaining treatment response seemed to be of even greater interest. At any rate, our study design – TCZ plus MTX in the open-label phase followed by MTX cessation - served to rule out placebo effects, as only responders were finally included in the blinded phase of the investigation. No substantial differences were seen when comparing the DAS28 and other index values at week 12 and week 24, no matter whether MTX was co-administered with TCZ or placebo. Not only disease activity in a stricter sense, but also quality of life, as expressed by the SF-12, and satisfaction with treatment was shown to be similar, and independent of MTX co-medication. These findings can be seen in line with previous results indicating a favourable efficacy of TCZ over MTX, and no additional benefit of the combination in patients with RA, which seems to be a unique feature of IL-6 blockers, and TCZ in particular, compared to other biologic DMARDs, such as TNF blockers and co-stimulation blockers. Finally, the achievement of the primary study objective offers another perspective for the applicability of TCZ monotherapy in RA patients. No new signals were detected with respect to safety, which can be regarded of particular importance in a less severely diseased patient population. Fortunately, no death and only seven serious AEs occurred during the course of the trial. Three of them, namely elevation of liver enzymes, urinary tract infection and stroke, were possibly attributed to the study drugs. The majority of AEs were mild infections and infestations, as expected, blood pattern changes and gastrointestinal disturbances, none of which resulted in a withdrawal of the study drugs. Our data showed a slight tendency towards a better outcome for the patients in the group receiving TCZ alone without MTX. Although the final sample size in the study was considerably lower than initially planned in the protocol (65 actually enrolled vs. 150 planned patients), it is very unlikely that superiority of TCZ plus MTX would have been shown with the full sample size of 150. Considering the current 95% CI of the DAS28 group difference between week 12 and 24 of -0.16 - 0.82 favouring TCZ and placebo, the statistical likelihood of a clinically meaningful DAS28 difference of > 0.6 according to the EULAR recommendations in favour of the TCZ plus MTX regimen can be considered far below 5%. The non-inferiority (however not statistically proven) of the TCZ regimen without MTX is also supported by the findings in the secondary endpoints, as they show results in line with those of the primary endpoints. Conclusions In summary, this two-phase trial consisting of an open-label and a double-blind phase was successful in achieving its objectives. On the one hand, the efficacy of TCZ in RA patients with low or moderate disease activity was demonstrated. On the other hand, the primary objective - the equivalence of TCZ monotherapy and the combination with MTX in maintaining treatment response – could be demonstrated. Are there practical consequences to be drawn from this study? First, if financial issues are not the primary maxim physicians act on, biologic DMARDs constitute the possibility to optimise the treatment regime in RA patients who fail to achieve a low level of disease activity. Second, TCZ monotherapy was shown to be as efficacious as the TCZ-MTX combination in maintaining beneficial treatment response, which should be considered in the presence of long-term therapy and drug reduction plans, but also if MTX proves intolerable. Third, RA patients at moderate disease activity do not seem to be at a greater risk if TCZ therapy is initiated, indicating a favourable risk-benefit ratio for the application of this treatment regime. In conclusion, additional TCZ treatment led to improvements in patients with mild to moderate RA and an inadequate response to MTX. TCZ monotherapy was seen not less effective than the combination with MTX to preserve the level of disease activity achieved at week 12. However, the uncertainty of the results is still large enough to allow speculation on even very small positive, though clinically negligible, effects of the combination. Availability of Data and Material The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Authors' Contributions BFL, RL, PF, MH, OZ, UR, WS and WBG made substantial contributions to study conception and design, as well as to data acquisition, analysis and interpretation. BFL, RL, PF, UR and WS drafted the article, and MH, OZ and WBG revised it critically for important intellectual content. All authors gave approval of the version of the article to be published. Disclosure The abstract of this paper was presented at the 2015 ACR/ARHP Annual Meeting in San Francisco as a conference talk with interim findings. The abstract (No. 1039) was published in Arthritis Rheumatol. 2015; 67 (suppl 10). Ethics Approval and Consent to Participate The study protocol was approved by the Ethics Committee of Lower Austria (GS4-EK-14/025-2011), and all patients provided written informed consent prior to any study procedures. Consent for Publication Not applicable. Competing Interests BFL has received research grants from Celltrion, Schering-Plough, Wyeth, Roche, MSD, Centocor, Abbott, Amgen, Aesca, as well as honoraria not exceeding EUR 5,000 each from Centocor, Abbott, Amgen, Aesca, UCB, Roche, MSD, Celltrion, GSK Schering-Plough, Wyeth, Pfizer, BMS, Jannssen-Cilag, Eli-Lilly, Novartis, Sandoz, Gebro and Celgene. WBG has neither competing interests nor any personal or financial interest regarding this publication. He has received speaker fees for educational lectures from all major companies in the field not exceeding EUR 10,000 per year. UR is an employee of Roche Austria GmbH. All other authors have not declared any competing interests. Funding Trial registration: ClinicalTrials.gov identifier: NCT01587989. This work was supported by Roche Austria GmbH, Vienna, Austria. Acknowledgements The authors gratefully acknowledge their co-investigators' as well as their medical writer's invaluable contributions to the OPTIMISE trial: Elke Böttcher (Vienna), Hans-Peter Brezinschek (Graz), Hans Bröll (Vienna), Ludwig Erlacher (Vienna), Peter Knoflach (Wels-Grieskirchen), Wolfgang Kranewitter (Wels-Grieskirchen), Andrea Leeb (Hollabrunn), Herwig Pieringer (Linz), Franz Rainer (Graz-Eggenberg), Martin Reinwein (Hollabrunn), Judith Sautner (Stockerau), Clemens Scheinecker (Vienna), Josef S. Smolen (Vienna), Ulrike Stuby (Linz), Jeannette Wolf (Vienna), Jochen Zwerina (Vienna) and Karl Thomanek (Vienna, medical writer). References Mahmood S, Lesuis N, van Tuyl LH, van Riel P, Landewé R (2015) Quality in rheumatoid arthritis care. Best Pract Res Clin Rheumatol 29: 664-679. Amarilyo G, Furst DE, Woo JM, Li W, Bliddal H, et al. (2016) Agreements and discrepancies between FDA reports and journal papers on biologic agents approved for rheumatoid arthritis: a meta-research project. PLoS One 11: e0147556. Woodworth TG, den Broeder AA (2015) Treating to target in established rheumatoid arthritis: challenges and opportunities in an era of novel targeted therapies and biosimilars. Best Pract Res Clin Rheumatol 29: 543-549. Souto A, Maneiro JR, Gómez-Reino JJ (2016) Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and meta-analysis of drug registries and health care databases. Rheumatology (Oxford) 55: 523-534. Ramiro S, Gaujoux-Viala C, Nam JL, Smolen JS, Buch M, et al. (2014) Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 73: 529-535. Leeb BF, Böttcher E, Brezinschek HP, Czerwenka C, Herold M, et al. (2010) The use of tumour necrosis factor alpha-blockers in daily routine: an Austrian consensus project. Clin Rheumatol 29: 167-174. Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, et al. (2014) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 73: 492-509. Bongartz T (2008) Tocilizumab for rheumatoid and juvenile idiopathic arthritis. Lancet 371: 961-963. Sebba A (2008) Tocilizumab: the first interleukin-6-receptor inhibitor. Am J Health Syst Pharm 65: 1413-1418. Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, et al. (2010) Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 69: 88-96. Mima T, Nishimoto N (2009) Clinical value of blocking IL-6 receptor. Curr Opin Rheumatol 21: 224-230. Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, et al. (2013) Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet 381: 918-929. Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, et al. (2015) Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis 74: 843-850. Van Gestel AM, Prevoo ML, van't Hof MA, van Rijswijk MH, van de Putte LB, et al. (1996) Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism criteria. Arthritis Rheum 39: 34-40. Singh S, Fumery M, Singh AG, Singh N, Prokop LJ, et al. (2019) Comparative Risk of Cardiovascular Events with Biologic and Synthetic Disease-Modifying Anti-Rheumatic Drugs in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-analysis. Arthritis Care Res (Hoboken). Fioravanti A, Tenti S, Bacarelli MR, Damiani A, Li Gobbi F, et al. (2019) Tocilizumab modulates serum levels of adiponectin and chemerin in patients with rheumatoid arthritis: potential cardiovascular protective role of IL-6 inhibition. Clin Exp Rheumatol 37: 293-300. Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, et al. (1995) Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 38: 44-48. Pope JE, Khanna D, Norrie D, Ouimet JM (2009) The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol 36: 254-259. Gandhi SK, Salmon JW, Zhao SZ, Lambert BL, Gore PR, et al. (2001) Psychometric evaluation of the 12-item short-form health survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials. Clin Ther 23: 1080-1098. Rintelen B, Haindl PM, Sautner J, Leeb BA, Deutsch C, et al. (2009) The rheumatoid arthritis disease activity index-5 in daily use. Proposal for disease activity categories. J Rheumatol 36: 918-924. Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, et al. (2013) Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis 72: 43-50. Mierau M, Schoels M, Gonda G, Fuchs J, Aletaha D, et al. (2007) Assessing remission in clinical practice. Rheumatology (Oxford) 46: 975-979. Jobanputra P, Maggs F, Deeming A, Carruthers D, Rankin E, et al. (2012) A randomised efficacy and discontinuation study of etanercept versus adalimumab (RED SEA) for rheumatoid arthritis: a pragmatic, unblinded, non-inferiority study of first TNF inhibitor use: outcomes over 2 years. BMJ Open 2: e001395. Hobbs K, Deodhar A, Wang B, Bitman B, Nussbaum J, et al. (2015) Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy. Springerplus 4: 113.

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August 2019
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Biologika-Therapien in Österreich. Daten aus dem Österreichischen Biologika-Register BioReg

Akt Rheumatol DOI: 10.1055/a-0584-5830

Aktuelle Rheumatologie

The Austrian Registry for Biologicals in the Treatment of Inflammatory Rheumatic Diseases, BioReg, was founded in 2009, which is relatively late compared to other countries. As elsewhere, the registry aims to document tolerability and efficacy. BioReg was founded as a non-profit association, which implies that the inclusion of patients is voluntary, as in the German RABBIT registry. At the end of May 2017, a total of 2,132 patients had been included in the data base, of whom 1,157 patients suffered from rheumatoid arthritis (RA), 497 from spondylitis ankylosans (SpA), 401 from psoriatic arthritis (PsA), and 77 from other rheumatic diseases (SERE). In comparison to European colleagues, rheumatologists in Austria initiate bDMARDs in RA patients at high moderate disease activity. Functionality of patients under biological treatment can be preserved, which of course exerts a positive impact on working ability. No unusual adverse events were observed; the reported side effects are the expected ones, well known from clinical trials. The prescription rates for the single compounds are comparable with those reported in the German RABBIT registry, and the retention rates are generally similar. Registries such as BioReg show the hidden normal situation for the treatment of patients with inflammatory rheumatic diseases, and specifically contribute to quality management.

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June 2018
19 Reads

The Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis: An Austrian NonInterventional Study.

Am J Arthritis Res. 2018; 2(1): 1012.

American Journal of Arthritis Research

Tocilizumab (TCZ) has variously been approved in combination with Methotrexate for the treatment of Rheumatoid Arthritis (RA) in adults. The objectives of this Non-Interventional Study (NIS) were to assess the efficacy and safety of TCZ in routine clinical use. Clinical response to TCZ was evaluated by collecting Disease Activity Score 28 (DAS28) and other efficacy parameters. The number and type of Adverse Events (AEs) and concomitant medication were documented. The median treatment duration was 52 weeks. The efficacy and safety analyses included 590 patients, 97.8% of whom had been pretreated with disease-modifying anti-rheumatic drugs. DAS28 scores were available for 484 patients, of whom 67.98% experienced disease remission and 83.06% low disease activity at any time during treatment. AEs were reported for 21.02% of the patients, with 10% serious events. The results confirm that TCZ is efficacious and well tolerated in routine use for the treatment of RA. As the results of this NIS are in line with existing data, a reevaluation of the risk-benefit balance of TCZ for the treatment of RA does not seem necessary.

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June 2018
17 Reads

Comments on Alegría and Irarrázaval (2017): Is diacerein an alternative for the treatment of osteoarthritis?

Authors:
Burkhard Leeb

Medwave 2018 Apr 12;18(2):e7193. Epub 2018 Apr 12.

Second Department of Medicine, Competence Centre for Rheumatology Lower Austria, Federal State Clinical Center Stockerau, Landstrasse 18, 2000 Stockerau, Austria; Private office: A-2020 Hollabrunn, Babogasse 20. Email:

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April 2018
15 Reads

Patient Reported Outcomes Compared to Composite Indexes in Routine Disease Activity Assessment of Rheumatoid Arthritis.

Authors:
Leeb BF

Am J Arthritis Res. 2017; 1(1): 1005.

American Journal of Arthritis Research

Editorial, no abstract available

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July 2017
17 Reads

RADAI-5 and electronic monitoring tools.

Clin Exp Rheumatol 2016 Sep-Oct;34(5 Suppl 101):S5-S10. Epub 2016 Oct 18.

2nd Dept. of Medicine, Center for Rheumatology Lower Austria, Karl Landsteiner Institute for Clinical Rheumatology, State Hospital Stockerau, Austria.

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February 2017
10 Reads
1 Citation
2.724 Impact Factor

The Short Form Score for the Assessment and Quantification of Chronic Rheumatic Affections of the Hands in Daily Clinical Routines-Its Sensitivity to Change and Preliminary Patient Relevant Variation Values: A Pilot Study.

Front Med (Lausanne) 2017 27;4. Epub 2017 Jan 27.

Second Department of Medicine, Center for Rheumatology, State Hospital Stockerau, Stockerau, Austria; Karl Landsteiner Institute for Clinical Rheumatology, Stockerau, Austria; Department for Rheumatology and Immunology, Medical University of Graz, Graz, Austria.

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http://dx.doi.org/10.3389/fmed.2017.00006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5269615PMC
January 2017
35 Reads

Should physicians' consider patient perception for modulating treatment?

Authors:
Burkhard F Leeb

Rheumatology (Oxford) 2016 11 21;55(11):1919-1920. Epub 2016 Jun 21.

2 Department of Medicine, Centre for Rheumatology, Lower Austria, State Hospital Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, Stockerau

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http://dx.doi.org/10.1093/rheumatology/kew254DOI Listing
November 2016
10 Reads
4.475 Impact Factor

Erratum to: Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria.

BMC Musculoskelet Disord 2016 10 3;17(1):412. Epub 2016 Oct 3.

Lower Austrian State Hospital Stockerau, 2nd Department for internal medicine, Lower Austrian Center for Rheumatology, Landstrasse 18, Stockerau, 2000, Austria.

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http://dx.doi.org/10.1186/s12891-016-1270-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5048649PMC
October 2016
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1.898 Impact Factor

Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria.

BMC Musculoskelet Disord 2016 08 22;17(1):358. Epub 2016 Aug 22.

Lower Austrian State Hospital Stockerau, 2nd Department for internal medicine, Lower Austrian Center for Rheumatology, Landstrasse 18, Stockerau, 2000, Austria.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994324PMC
August 2016
13 Reads
2 Citations
1.898 Impact Factor

Smoking - Does It Affect Rheumatoid Arthritis Activity? Does It Matter?

J Rheumatol 2015 Jul;42(7):1072-4

2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Stockerau; Karl Landsteiner Institute for Clinical Rheumatology, Stockerau, Austria.

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July 2015
12 Reads
3.187 Impact Factor

Is the state of health of rheumatoid arthritis patients receiving adequate treatment, predictable? - Results of a survey.

BMC Musculoskelet Disord 2015 May 6;16:109. Epub 2015 May 6.

Rheumatology and Immunology Division, Department of Internal Medicine, Medical University of Graz, Graz, Austria.

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http://dx.doi.org/10.1186/s12891-015-0567-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4427952PMC
May 2015
66 Reads
1.898 Impact Factor

Patient-centered psoriatic arthritis (PsA) activity assessment by Stockerau Activity Score for Psoriatic Arthritis (SASPA).

BMC Musculoskelet Disord 2015 Apr 1;16:73. Epub 2015 Apr 1.

2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Stockerau, Karl Landsteiner Institute for Clinical Rheumatology, Landstrasse 18, A-2000, Stockerau, Austria.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393861PMC
April 2015
23 Reads
1.898 Impact Factor

Quality of care of rural rheumatoid arthritis patients in Austria.

Wien Klin Wochenschr 2014 Jun 28;126(11-12):360-7. Epub 2014 Mar 28.

Rheumatologist in private practice, Freiung 19, 4600, Wels, Austria,

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June 2014
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[Austrian 3e-recommendations for diagnosis and management of gout 2013].

Wien Klin Wochenschr 2014 Feb 3;126(3-4):79-89. Epub 2013 Dec 3.

State Hospital Stockerau, 2nd Medical Department,Lower Austrian Centre for Rheumatology, Karl Landsteiner Institute for Clin. Rheumatology, Landstraße 18, 2000, Stockerau, Österreich,

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February 2014
15 Reads
0.791 Impact Factor

Rituximab as effective treatment in a case of severe subcutaneous nodulosis in rheumatoid arthritis.

Rheumatology (Oxford) 2013 Aug 16;52(8):1535-7. Epub 2013 Jan 16.

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August 2013
8 Reads
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Remission in rheumatoid arthritis: a comparison of the 2 newly proposed ACR/EULAR remission criteria with the rheumatoid arthritis disease activity index-5, a patient self-report disease activity index.

J Rheumatol 2013 Apr 1;40(4):394-400. Epub 2013 Feb 1.

Lower Austrian State Hospital Stockerau, Second Department for Internal Medicine, Lower Austrian Centre for Rheumatology, Stockerau, Austria.

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April 2013
13 Reads
3.187 Impact Factor

Rituximab in psoriatic arthritis: an exploratory evaluation.

Ann Rheum Dis 2012 Nov 24;71(11):1868-71. Epub 2012 Jul 24.

Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, Vienna A-1090, Austria.

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November 2012
47 Reads
10.377 Impact Factor

A comparison of the modified score for the assessment of chronic rheumatoid affections of the hands and the australian/canadian osteoarthritis hand index in hand osteoarthritis patients.

Int J Rheumatol 2009 10;2009:249096. Epub 2009 Feb 10.

Lower Austrian Centre for Rheumatology, 2nd Department of Medicine, State Hospital Weinviertel Stockerau, 2000 Stockerau, Austria.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2809330PMC
July 2011
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International position paper on febuxostat.

Clin Rheumatol 2010 Aug 17;29(8):835-40. Epub 2010 Apr 17.

Department of Rheumatology, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.

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August 2010
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10 Citations
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The use of tumour necrosis factor alpha-blockers in daily routine. An Austrian consensus project.

Clin Rheumatol 2010 Feb 11;29(2):167-74. Epub 2009 Nov 11.

Karl Landsteiner-Institute for Clinical Rheumatology, First and Second Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Stockerau, Landstrasse 18, Stockerau, 2000, Austria.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2797412PMC
February 2010
32 Reads
1.774 Impact Factor

A comparison of patient questionnaires and composite indexes in routine care of rheumatoid arthritis patients.

Joint Bone Spine 2009 Dec;76(6):658-64

1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, State Hospital Stockerau, Karl Landsteiner-Institute for Clinical Rheumatology, Landstrasse 18, A-2000 Stockerau, Austria.

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December 2009
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2.901 Impact Factor

The rheumatoid arthritis disease activity index-5 in daily use. Proposal for disease activity categories.

J Rheumatol 2009 May 30;36(5):918-24. Epub 2009 Mar 30.

1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austrian State Hospital, Stockerau, Austria.

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May 2009
339 Reads
3.187 Impact Factor

Hotel-based rheumatology, and more.

Authors:
Burkhard F Leeb

J Rheumatol 2009 Feb;36(2):455-6; author reply 456-7

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February 2009
10 Reads
1 Citation
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[Austrian expert opinion on the standard for expert assessment of course of illness in patients with chronic polyarthritis (rheumatoid arthritis)].

Wien Klin Wochenschr 2008 ;120(7-8):234-41

Klinische Abteilung für Rheumatologie, Medizinische Universität Wien, Wien, Austria.

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September 2008
25 Reads
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Patient-centered rheumatoid arthritis disease activity assessment by a modified RADAI.

J Rheumatol 2008 Jul 15;35(7):1294-9. Epub 2008 May 15.

1st and 2nd Department of Medicine, Center for Rheumatology, Lower Austria, Austria.

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July 2008
6 Reads
11 Citations
3.187 Impact Factor

Immunization of patients with rheumatoid arthritis with antitumor necrosis factor alpha therapy and methotrexate.

Curr Opin Rheumatol 2008 May;20(3):295-9

Division of Rheumatology, Department of Internal Medicine, Medical University Graz, Graz, Austria.

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May 2008
16 Reads
4.886 Impact Factor

On "Effectiveness of nonpharmacological and nonsurgical interventions..." Moe et al. Phys Ther. 2008;88: 1716-1727.

Phys Ther 2008 Mar;88(3):407-8; author reply 408

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March 2008
8 Reads
2.526 Impact Factor

Disease activity score-28 values differ considerably depending on patient's pain perception and sex.

J Rheumatol 2007 Dec 1;34(12):2382-7. Epub 2007 Nov 1.

2nd Department of Medicine, Center for Rheumatology, State Hospital Korneuburg-Stockerau, Karl Landsteiner Institute for Clinical Rheumatology; A-2000 Stockerau, Landstrasse 18, Austria.

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December 2007
11 Reads
3.187 Impact Factor

The polymyalgia rheumatica activity score in daily use: proposal for a definition of remission.

Arthritis Rheum 2007 Jun;57(5):810-5

Lower Austrian Center for Rheumatology, State Hospital Stockerau, Stockerau, Austria.

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http://www.researchgate.net/profile/Burkhard_Leeb/publicatio
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http://ard.bmj.com/content/early/2008/05/13/ard.2008.088526.
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http://dx.doi.org/10.1002/art.22771DOI Listing
June 2007
20 Reads
7.764 Impact Factor

The Disease Activity Score in 28 joints in rheumatoid arthritis and psoriatic arthritis patients.

Arthritis Rheum 2007 Mar;57(2):256-60

HUMANIS Klinikum Lower Austria, Lower Austrian Center for Rheumatology, Karl Landsteiner-Institute for Clinical Rheumatology, Stockerau, Austria.

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http://dx.doi.org/10.1002/art.22531DOI Listing
March 2007
8 Reads
7.764 Impact Factor

Diagnosis, differential diagnosis and treatment of polymyalgia rheumatica.

Drugs Aging 2006 ;23(5):391-402

1st and 2nd Department of Medicine, Centre for Rheumatology, Humanisklinikum Lower Austria, Stockerau, Landstrasse, Austria.

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http://dx.doi.org/10.2165/00002512-200623050-00003DOI Listing
December 2006
12 Reads
2.838 Impact Factor

Should physicians manipulate their assessment tools? No, they shouldn't!

Authors:
Burkhard F Leeb

J Rheumatol 2006 Nov;33(11):2359-60; author reply 2360-1

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November 2006
13 Reads
3.187 Impact Factor

A meta-analysis of controlled clinical studies with diacerein in the treatment of osteoarthritis.

Arch Intern Med 2006 Sep;166(17):1899-906

Second Department of Medicine, Lower Austrian Centre for Rheumatology, Humanis Klinikum Stockerau, Stockerau, Austria.

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http://dx.doi.org/10.1001/archinte.166.17.1899DOI Listing
September 2006
16 Reads
17.333 Impact Factor

Leflunomide/chloroquin combination therapy in rheumatoid arthritis: a pilot study.

Clin Rheumatol 2006 Jul 4;25(4):557-9. Epub 2006 Jan 4.

Second Department of Medicine, HUMANIS Klinikum Lower Austria, Lower Austrian Center for Rheumatology, A-2000, Stockerau, Landstrasse 18, Austria.

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http://dx.doi.org/10.1007/s10067-005-0149-2DOI Listing
July 2006
8 Reads
1.774 Impact Factor

Intravenous application of omega-3 fatty acids in a patient with active spondylarthropathy--a case report.

Clin Rheumatol 2006 Jul 12;25(4):577-8. Epub 2005 Oct 12.

Second Department of Medicine, Humanisklinikum Lower Austria, Lower Austrian Center for Rheumatology, Stockerau, Landstrasse 18, A-2000, Stockerau, Austria.

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http://dx.doi.org/10.1007/s10067-005-0027-yDOI Listing
July 2006
9 Reads
1.774 Impact Factor

Intravenous application of omega-3 fatty acids in patients with active rheumatoid arthritis. The ORA-1 trial. An open pilot study.

Lipids 2006 Jan;41(1):29-34

Second Department of Medicine, Lower Austrian Center for Rheumatology, Humanisklinikum Lower Austria, Stockerau, Austria.

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http://dx.doi.org/10.1007/11745-006-5066-xDOI Listing
January 2006
16 Reads
1.854 Impact Factor

Expression of resistance markers to methotrexate predicts clinical improvement in patients with rheumatoid arthritis.

Ann Rheum Dis 2005 Apr 2;64(4):564-8. Epub 2004 Sep 2.

Second Department of Medicine, Lainz Hospital, Wolkersbergenstr 1, A-1130 Vienna, Austria.

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http://dx.doi.org/10.1136/ard.2003.014985DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755459PMC
April 2005
4 Reads
10.377 Impact Factor

The patient's perspective and rheumatoid arthritis disease activity indexes.

Rheumatology (Oxford) 2005 Mar 30;44(3):360-5. Epub 2004 Nov 30.

Second Department of Medicine, Humanisklinikum Lower Austria, Lower Austrian Center for Rheumatology, Stockerau, Austria.

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http://dx.doi.org/10.1093/rheumatology/keh484DOI Listing
March 2005
15 Reads
4.475 Impact Factor

Disease activity measurement of rheumatoid arthritis: Comparison of the simplified disease activity index (SDAI) and the disease activity score including 28 joints (DAS28) in daily routine.

Arthritis Rheum 2005 Feb;53(1):56-60

Humanisklinikum Lower Austria, Lower Austrian Center for Rheumatology, Stockerau, Austria.

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http://dx.doi.org/10.1002/art.20923DOI Listing
February 2005
16 Reads
7.764 Impact Factor

The DAS28 in rheumatoid arthritis and fibromyalgia patients.

Rheumatology (Oxford) 2004 Dec 13;43(12):1504-7. Epub 2004 Jul 13.

Second Department of Medicine, HUMANIS Klinikum Lower Austria, Lower Austrian Center for Rheumatology, A-2000 Stockerau, Landstrasse 18, Austria.

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http://dx.doi.org/10.1093/rheumatology/keh322DOI Listing
December 2004
9 Reads
4.475 Impact Factor

Development of the M-SACRAH, a modified, shortened version of SACRAH (Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands).

Rheumatology (Oxford) 2004 Nov 10;43(11):1409-13. Epub 2004 Aug 10.

Second Department of Medicine, Landstrasse 18, Humanis Klinikum, Stockerau, Lower Austrian Centre for Rheumatology, A-2000.

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http://dx.doi.org/10.1093/rheumatology/keh360DOI Listing
November 2004
11 Reads
4.475 Impact Factor

A disease activity score for polymyalgia rheumatica.

Authors:
B F Leeb H A Bird

Ann Rheum Dis 2004 Oct;63(10):1279-83

2nd Department of Medicine, Lower Austrian Centre for Rheumatology, Endocrinology, Humanisklinikum Lower Austria, A-2000 Stockerau, Landstrasse 18, Austria.

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http://dx.doi.org/10.1136/ard.2003.011379DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754762PMC
October 2004
17 Reads
10.377 Impact Factor

[Treatment of osteoarthritis of the knee joint. Efficacy and tolerance to acemetacin slow release in comparison to celecoxib].

Orthopade 2004 Sep;33(9):1032-41

II. Medizinische Abteilung, NO-Zentrum für Rheumatologie, Humanis-Klinikum Niederösterreich, Landstrasse 18, 2000 Stockerau, Austria.

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http://dx.doi.org/10.1007/s00132-004-0670-zDOI Listing
September 2004
11 Reads
0.665 Impact Factor

[Rheumatology--a dynamic discipline].

Authors:
Burkhard F Leeb

Wien Med Wochenschr 2003 ;153(13-14):290

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http://dx.doi.org/10.1046/j.1563-258x.2003.03033.xDOI Listing
January 2004
10 Reads

[Biologicals in treatment of rheumatoid arthritis and other inflammatory arthropathies].

Wien Med Wochenschr 2003 ;153(13-14):304-8

II. Medizinischen Abteilung, NO Zentrum für Rheumatologie, Humanisklinikum Niederösterreich, Landstrasse 18, A-2000 Stockerau.

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http://dx.doi.org/10.1046/j.1563-258x.2003.03036.xDOI Listing
January 2004
30 Reads

SACRAH: a score for assessment and quantification of chronic rheumatic affections of the hands.

Rheumatology (Oxford) 2003 Oct 30;42(10):1173-8. Epub 2003 May 30.

Second Department of Medicine, Humanisklinikum Lower Austria, Lower Austrian Center for Rheumatology, Stockerau.

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http://dx.doi.org/10.1093/rheumatology/keg319DOI Listing
October 2003
7 Reads
4.475 Impact Factor

Expression of folylpolyglutamyl synthetase predicts poor response to methotrexate therapy in patients with rheumatoid arthritis.

Clin Exp Rheumatol 2003 Jan-Feb;21(1):27-32

Division of Oncology, Department of Internal Medicine I, University of Vienna, Vienna, Austria.

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June 2003
8 Reads
2.724 Impact Factor

Management of knee osteoarthritis.

Authors:
B F Leeb

Ann Rheum Dis 2001 Oct;60(10):984

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1753391PMC
http://dx.doi.org/10.1136/ard.60.10.984DOI Listing
October 2001
10 Reads
10.377 Impact Factor

[Anti-TNF-alpha therapy as a new option in treatment of rheumatoid arthritis?].

Authors:
B F Leeb J Sautner

Wien Med Wochenschr 1999 ;149(19-20):554-7

Niederösterreichischen Zentrum für Rheumatologie am a. ö. Krankenhaus Stockerau.

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May 2000
9 Reads

A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis.

J Rheumatol 2000 Jan;27(1):205-11

Lower Austrian Center for Rheumatology, Stockerau Hospital, Austria.

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January 2000
11 Reads
3.187 Impact Factor

T cell derived cytokines in psoriatic arthritis synovial fluids.

Ann Rheum Dis 1998 Nov;57(11):691-3

Ludwig Boltzmann Institute of Rheumatology and Balneology, Vienna-Oberlaa, Austria.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1752505PMC
http://dx.doi.org/10.1136/ard.57.11.691DOI Listing
November 1998
15 Reads
10.377 Impact Factor

Early arthritis therapy: rationale and current approach.

J Rheumatol Suppl 1998 Jul;53:13-9

Department of Internal Medicine III, University of Vienna, Austria.

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July 1998
8 Reads

Upregulation of cytokine receptors sTNF-R55, sTNF-R75, and sIL-2R in psoriatic arthritis synovial fluid.

J Rheumatol 1998 Jan;25(1):105-10

Ludwig Boltzmann Institute of Rheumatology, Vienna-Oberlaa, Austria.

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January 1998
9 Reads
3.187 Impact Factor

[Results of a multicenter study of chondroitin sulfate (Condrosulf) use in arthroses of the finger, knee and hip joints].

Wien Med Wochenschr 1996 ;146(24):609-14

Facharztpraxis für Innere Medizin-Rheumatologie, Hollabrunn.

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April 1997
23 Reads

Highly increased levels of tumor necrosis factor-alpha and other proinflammatory cytokines in psoriatic arthritis synovial fluid.

J Rheumatol 1997 Mar;24(3):518-23

Ludwig Boltzmann Institute of Rheumatology, Vienna-Oberlaa, Austria.

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March 1997
11 Reads
3.187 Impact Factor

Low serum hyaluronan in psoriatic arthritis patients in comparison to rheumatoid arthritis patients.

Clin Exp Rheumatol 1996 Jul-Aug;14(4):381-6

Ludwig Boltzmann Institute of Rheumatology and Balneology, Vienna-Oberlaa, Austria.

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January 1997
8 Reads
2.724 Impact Factor

[Diagnosis and therapy of chronic polyarthritis].

Radiologe 1996 Aug;36(8):657-62

II. Medizinische Abteilung, Krankenhaus der Stadt Wien-Lainz, Wien.

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http://dx.doi.org/10.1007/s001170050124DOI Listing
August 1996
8 Reads
0.414 Impact Factor

Folic acid and cyanocobalamin levels in serum and erythrocytes during low-dose methotrexate therapy of rheumatoid arthritis and psoriatic arthritis patients.

Clin Exp Rheumatol 1995 Jul-Aug;13(4):459-63

Second Dept. of Medicine, Lainz Hospital, Vienna, Austria.

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December 1995
6 Reads
2.724 Impact Factor

Rheumatoid arthritis of the craniocervical region by MR imaging: detection and characterization.

AJR Am J Roentgenol 1995 Sep;165(3):585-92

Department of Radiology, Krankenhaus Lainz, Vienna, Austria.

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http://dx.doi.org/10.2214/ajr.165.3.7645475DOI Listing
September 1995
9 Reads
2.731 Impact Factor

Diagnostic use of office-based ultrasound. Baker's cyst of the right knee joint.

Arthritis Rheum 1995 Jun;38(6):859-61

Second Department of Medicine, Lainz Hospital, Vienna, Austria.

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http://dx.doi.org/10.1002/art.1780380621DOI Listing
June 1995
12 Reads
7.764 Impact Factor

Should folate supplementation be routinely recommended for older patients receiving methotrexate?

Authors:
B F Leeb

Drugs Aging 1994 Nov;5(5):319-22

2nd Department of Medicine, Center for Rheumatic Diseases, Lainz Hospital, Vienna, Austria.

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http://dx.doi.org/10.2165/00002512-199405050-00001DOI Listing
November 1994
5 Reads
2.838 Impact Factor

High free and latent collagenase activity in psoriatic arthritis synovial fluids.

Br J Rheumatol 1994 Aug;33(8):702-6

Ludwig Boltzmann Institute of Rheumatology and Balneology, Vienna-Oberlaa, Austria.

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http://dx.doi.org/10.1093/rheumatology/33.8.702DOI Listing
August 1994
8 Reads

[Topical felbinac in therapy of athletic injuries].

Authors:
B Leeb

Fortschr Med 1994 Feb;112(6):77-80

II. Medizinische Abteilung, Krankenhaus Lainz, Wien.

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February 1994
13 Reads

[Blood cell concentration of methotrexate in long-term therapy of inflammatory rheumatic diseases].

Acta Med Austriaca 1988 ;15(5):140-4

II. Medizinischen Abteilung, Zentrum für Diagnostik und Therapie rheumatischer Erkrankungen, Krankenhauses der Stadt Wien-Lainz.

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March 1989
10 Reads

Top co-authors

Bernhard Rintelen
Bernhard Rintelen

Karl Landsteiner-Institute for Clinical Rheumatology

22
Judith Sautner
Judith Sautner

State Hospital Stockerau

13
Thomas Nothnagl
Thomas Nothnagl

Stockerau State Hospital

7
Manfred Herold
Manfred Herold

Medical University of Innsbruck

7
Rudolf Puchner
Rudolf Puchner

Outpatient Clinic for Internal Medicine

5
Pia M Haindl
Pia M Haindl

Karl Landsteiner Institute for Clinical Rheumatology; A-2000 Stockerau

5
Anca I Catrina
Anca I Catrina

Karolinska Institutet

3
Christopher J Edwards
Christopher J Edwards

Southampton General Hospital

3