Burkhard Franz Leeb

• MD, PhD
• Owner at Rheumatological office

Background The safety profile of Janus kinase inhibitors (JAKi), particularly concerning infection risks, remains a critical concern in patients with rheumatoid arthritis (RA). Initial pivotal trials and subsequent safety trials[1] showed increased incidences of opportunistic infections and herpes zoster (HZ). However, real-world data on the incide...

Objectives Machine learning models can support an individualized approach in the choice of bDMARDs. We developed prediction models for 5 different bDMARDs using machine learning methods based on patient data derived from the Austrian Biologics Registry (BioReg). Methods Data from 1397 patients and 19 variables with at least 100 treat-to-target (t2...

Background In a clinical trial setting, patients with rheumatoid arthritis (RA) taking the Janus kinase inhibitor (JAKi) tofacitinib demonstrated higher adverse events rates compared with those taking the tumour necrosis factor inhibitors (TNFi) adalimumab or etanercept. Objective Compare treatment discontinuations for adverse events (AEs) among s...

Zusammenfassung Hintergrund: Axiale Spondyloarthritis (axSpA) bringt für Patienten neben körperlicher und psychischer Beeinträchtigung oft eine verminderte gesundheitsbezogene Lebensqualität mit sich. Mit dem Krankheitsbeginn im erwerbsfähigen Alter ist vor allem das Arbeitsleben betroffen. Ziel dieser Untersuchung war es, die Auswirkungen der axSp...

Background The continuous development of biological disease modifying antirheumatic drugs (bDMARDs) in recent years has significantly improved the treatment options for patients suffering from rheumatoid arthritis. Selecting the most effective biologic remains a challenge, since therapy-response is highly individual depending on the patient history...

Objectives The expanded therapeutic arsenal in rheumatoid arthritis (RA) raises new clinical questions. The objective of this study is to compare the effectiveness of cycling Janus kinase inhibitors (JAKi) with switching to biologic disease-modifying antirheumatic drug (bDMARD) in patients with RA after failure to the first JAKi. Methods This is a...

Background: JAK-inhibitors (JAKi), recently approved in rheumatoid arthritis (RA), have changed the landscape of treatment choices. We aimed to compare the effectiveness of four current second-line therapies of RA with different modes of action, since JAKi approval, in an international collaboration of 19 registers. Methods: In this observational...

Registry data on JAK-inihibitors

A 35-year-old man is referred for further evaluation because of symmetric swelling of the sternoclavicular joints by his primary care physician. The laboratory findings are found to be unremarkable. Radiologically, avascular necrosis of the sternoclavicular joints can be ascertained. This article gives an overview of the risk factors, classificatio...

Background: Whether the safety and efficacy of Januskinase Inhibitors (JAKis) in daily routine treatment of

Background Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results. Objectives The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-m...

Abstract Introduction: Pain is highly prevalent in older persons and has a variety of causes. In geriatric patients, especially in patients with dementia, pain is often not sufficiently recognized and therefore frequently remains untreated. For the affected patient group this can have far-reaching consequences for their functional and cognitive ab...

This article describes the case of a 52-year-old patient who suddenly and unexpectedly developed severe symptoms, such as fatigue, stiffness, visual problems and signs of infection. Initially, elevated C‑reactive protein (CRP) and acute phase parameters were detected, and a therapy with nonsteroidal anti-inflammatory drugs and antibiotics was initi...

Liebe Leserinnen und Leser, das Jahr 2020 ist wahrlich ein besonderes Jahr – und wenn man schon mehr als sechs Dezennien auf diesem Planeten verbracht hat, ist die Bedeutung dieser Aussage auch richtig einzuordnen. Neben der Causa prima, die dieses Jahr aus welchen Gründen – medizinischen, soziologischen und ökonomischen – auch immer selbstverstän...

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 inad...

Zusammenfassung In Österreich wurde vergleichsweise spät im Jahre 2009, das „Biologikaregister für entzündlich rheumatische Erkrankungen e. V.“, kurz BioReg, gegründet, mit den auch in anderen Ländern verfolgten Zielen, jene PatientInnen, die mit Biologika behandelt werden, hinsichtlich Tolerabilität und Effektivität zu dokumentieren. Aus dem Verei...

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) a...

Background The goal for the treatment of rheumatoid arthritis (RA) should be remission or at last low disease activity. Using data of the Austrian biologic registry we evaluated disease activity in patients with RA and treated with biologics for more than six years. Objectives The aim of this evaluation was to elucidate long term disease activity...

Während kontrollierte Studien vor allem Informationen zu Sicherheit und Wirksamkeit von Präparaten unter bestimmten Bedingungen bei einer ausgewählten Patienten-Subgruppe liefern, können Register Sicherheits- und Wirksamkeitsdaten unter Alltagsbedingungen generieren. Registerdaten sind daher eine wertvolle Ergänzung von Studiendaten – beide zusamme...

Während kontrollierte Studien vor allem Informationen zu Sicherheit und Wirksamkeit von Präparaten unter bestimmten Bedingungen bei einer ausgewählten Patienten-Subgruppe liefern, können Register Sicherheits- und Wirksamkeitsdaten unter Alltagsbedingungen generieren. Registerdaten sind daher eine wertvolle Ergänzung von Studiendaten – beide zusamme...

Diacerein. News Guidelines for treatment optimisation

Objectives: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. Methods: The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musc...

Usually, polymyalgia rheumatica shows a rapid onset with severe and symmetric muscle pain in the shoulder girdle and the neck, less often in the pelvic girdle, accompanied by muscle tenderness. Patients suffer from continuous pain, often aggravated during physical inactivity or the night. Sometimes transient synovitis occurs without radiological si...

This book, now in an extensively updated and expanded third edition, offers important insights into polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), providing an overview of their pathophysiology, genetics, immunology, and endocrinological mechanisms but above all presenting the state of the art in diagnosis and treatment. Both PMR and...

Background Remission or at last low disease activity is the aim of drug therapy in patients with chronic inflammatory rheumatic diseases. We evaluated disease activity in patients treated with biologics and using data of the Austrian biologic registry. Objectives The aim of this evaluation was to elucidate disease activity in patients with rheumat...

Results: With respect to demographic characteristics no differences of the five TNF-blockers available in Austria could be found. The older drugs Etanercept (ETA), and Adalimumab (ADA) were the ones most frequently prescribed, while the Infliximab (IFX) prescriptions, only intravenously applicable, were in the same range as Certolizumab Pegol (CZP)...

Objective: The SF-SACRAH was developed to assess the involvement of the hand in rheumatoid arthritis (RA) and hand osteoarthritis (HOA) patients in daily clinical routines. In this pilot study, its sensitivity to change will be assessed longitudinally, and preliminary thresholds for patient relevant changes are derived. Methods: Ninety-nine outpat...

Background: Numerous beneficial health effects of unsaturated fatty acids are well known. Assuming a beneficial therapeutic effect in inflammatory diseases, we - as a novelty - intravenously administered omega-3-fatty acids to rheumatoid arthritis (RA) patients. Objectives: To evaluate the therapeutic efficacy of intravenously administered omega-3-...

The purpose of the present study was to check the validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology, and to elucidate eventual differences with respect to disease activity (DA) in patients with rheumatoid arthritis (RA) on established biological DMARDs (bDMARDs) before inclusion into the register (...

Tighter monitoring of patients is regarded one of the key approaches to improve management of rheumatoid arthritis (RA). It could be demonstrated that the patient relevant disease course is not simply the linear link between two observation points, but fluctuates significantly in up to 80% of patients surveyed three times over two months, which und...

Background The purpose of the present study was to check the validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology, and to elucidate eventual differences with respect to disease activity (DA) in patients with rheumatoid arthritis (RA) on established biological DMARDs (bDMARDs) before inclusion into the...

Background The discordance between patients and physicians in estimation of patients' global health is well known especially from RA patients. We tried to find out whether differences in global health estimation are the same in patients with different diseases using data of the Austrian biologic registry. Objectives The aim of this evaluation was...

Diacerein is a symptomatic slow-acting drug in osteoarthritis (SYSADOA) with anti-inflammatory, anti-catabolic and pro-anabolic properties on cartilage and synovial membrane. It has also recently been shown to have protective effects against subchondral bone remodelling. Following the end of the revision procedure by the Pharmacovigilance Risk Asse...

Objective: Determinants of radiographic progression in osteoarthritis (OA) are poorly understood. We investigated which features on baseline magnetic resonance imaging (MRI) acted as predictors of change in joint space width (JSW). Methods: A total of 559 men and women over the age of 50 years with clinical knee OA [Kellgren-Lawrence (KL) grade...

Background/Purpose: An Austrian multi-center study of the effect on disease activity and the safety of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus TCZ Monotherapy in patients with mild to moderate rheumatoid arthritis (RA), with inadequate response to MTX – The OPTIMISE trial (EUDRACT No. 2011-001863-39) As only limited data...

Background/Purpose: An Austrian multi-center study of the effect on disease activity and the safety of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus TCZ Monotherapy in patients with mild to moderate rheumatoid arthritis (RA), with inadequate response to MTX – The OPTIMISE trial (EUDRACT No. 2011-001863-39) As only limited data...

For decades it has been common knowledge that there is a connection between rheumatoid factor–positive and antibodies against citrullinated peptide–positive rheumatoid arthritis (RA) and smoking1. Cigarette smoking is regarded as one of the major environmental factors suggested to play a critical role in the development of a variety of disorders in...

Background BIOREG, the Austrian registry for patients (pts.) with chronic rheumatic diseases treated with biologic DMARD's, includes pts with rheumatoid arthritis (RA), spondylarthritis (SPA), psoriatic arthritis (PSA) and other diseases since 2010. Patients on biologic treatment are included irrespective of treatment duration and history. The prim...

Objectives Remission is the goal in treating RA patients. In a chronic disease like rheumatoid arthritis (RA), the patient's perspective may differ from the opinion of the treating physician. We ask our patients to rate their satisfaction with disease activity as such on a numerical scale from 1 “excellent” to 5 “failed” (PATSAT). In 3130 consecuti...

Background The Austrian BioReg registry (http://www.bioreg.at) was initiated in 2009. Patients treated with one of the nine biologics (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) approved in Austria can be included. Patients with ongoing biologic therapy as well as biologic-naïve patient...

A survey was conducted to evaluate whether a steady improvement in the quality of life of Rheumatoid Arthritis (RA) patients as frequently reported in clinical studies, does actually occur. The focus of this study laid on the personal perception of RA patients. How do patients who have been treated along accepted guidelines see the state of their h...

Background To investigate whether a modified Rheumatoid Arthritis Disease Activity Index-5 could be applied as a routine assessment tool for psoriatic arthritis (PsA) patients. Methods Ninety-seven PsA outpatients (mean age 49.78 years; age range 23–80 years; 49 male, 48 female), completed a prototype questionnaire. Tender and swollen joint counts...

Liebe Leserinnen und Leser,wieder stehen wir am Beginn eines neuen Jahres. Bisher hat jedes neue Jahr auch Veränderungen von rheuma plus gebracht, für das heurige Jahr 2015 sind derartige Veränderungen nicht in Sicht, obwohl man natürlich niemals wissen kann, was die Zukunft so bringen wird. Der redaktionelle Workflow wurde bereits 2014 entscheiden...

Providing the physician with sufficient information about the disease course can be regarded as the most important requirement for any disease assessment tool besides easy applicability and time-sparing documentation. Applying the RADAI-5 in daily routine provides the patient's view at any time completing the questionnaire. In a first study, the RA...

The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) recently reviewed data on diacerein and confirmed the safety profile established in 1997 by the French Medical Agency. To improve the benefit/risk ratio of diacerein, PRAC recommended that treatment with diacerein should be initiated by an experienced OA...

To determine how fast rheumatoid arthritis (RA) was diagnosed in a group of patients in a rural area and whether medical care and patient satisfaction were adequate in a predominantly non-urban settlement. When visiting their rheumatologist, patients with RA were asked to complete a questionnaire at home after the consultation and then return it to...