Publications

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100 Publications visible to you, out of a total of 100
[Medication treatment of rheumatoid arthritis with a history of malignancy. Epidemiological data]

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INTRODUCTION: Only insufficient data are available regarding the question whether treatment with immunosuppressants or biologicals is feasible and safe in patients with a history of malignancy. METHOD: … Literature search via PubMed, EULAR abstracts and ACR abstracts from 2013 to 2015. RESULTS: The Societe Francaise de Rhumatologie, the Canadian Rheumatology Association and the American College of Rheumatology have tried to make recommendations on this topic. Direct evidence mainly originates from data in three national registries which suggest that treatment with tumor necrosis factor (TNF) inhibitors and rituximab appears to be safe for carefully selected patients, at least if there is a longer interval between treatment with biologicals and oncological treatment. Furthermore, despite partly conflicting data all routine drugs for treating rheumatoid arthritis do not seem to show a consistently increased risk of de novo malignancies. The currently available data are presented for each drug of interest. CONCLUSION: Taking the current literature into account an attempt is made to formulate an algorithm for the medicinal treatment of patients with rheumatoid arthritis and a history of malignancy.

Authors: M. Schmalzing, A. Strangfeld, H. P. Tony

Date Published: 2016

Publication Type: Journal

[Influence of therapy on risk of cancer in rheumatoid arthritis. Pathophysiological principles]

Abstract (Expand)

The increased incidence of certain tumor entities in chronic inflammation and infections as well as the increased tumor risk under immunosuppression, illustrate the multiple and complex influences of … the immune system on tumor pathogenesis. It is therefore conceivable that immunomodulatory therapy for rheumatoid arthritis (RA) could also influence the risk of malignancies, apart from treating the underlying disease. Basic scientific research studies have identified various signal transduction pathways that are relevant for tumorigenesis and tumor defense mechanisms. This review presents the current knowledge on the effects of the immune system on the occurrence of cancer and tries, where possible, to relate it to specific treatment options.

Authors: M. J. Waldner, A. Strangfeld, M. Aringer

Date Published: 2016

Publication Type: Journal

Health-related quality of life in patients with long-standing rheumatoid arthritis in the era of biologics: data from the German biologics register RABBIT

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OBJECTIVE: To compare the 24-month course of health-related quality of life (HRQoL) in patients with long-standing RA treated with a conventional synthetic (cs) or a first, second or third biologic (b) … DMARD in daily rheumatological care. METHODS: Patients enrolled in the German biologics register RABBIT who were observed over at least 12 months were stratified according to the nth bDMARD started at enrolment. HRQoL was captured by the SF36 health survey. Within strata of sequential bDMARD therapy, we examined patients’ HRQoL at baseline and at follow-ups in comparison with the general population, the 24-month course of HRQoL of different bDMARDs and the proportion of patients exceeding the minimal detectable improvement of physical and mental health sum scores. RESULTS: All patients reported remarkably lower scores of physical and mental health than the general population at baseline and month 12. In each stratum of sequential bDMARD therapy, patients improved significantly by month 12 and remained stable until month 24. The improvement of HRQoL was not attributable to a particular bDMARD. The following proportions of patients exceeded the minimal detectable improvement of at least 17.85 Physical Component Scale scores or 22.18 Mental Component Scale score points: csDMARD (n = 1113) 31.1%/22.3%, first bDMARD (n = 1352) 39.9%/29.7%, second bDMARD (n = 730) 37.3%/26.2% and third bDMARD (n = 680) 34.2%/30.9%. CONCLUSION: Lasting improvement of both physical and mental health is achievable even for severely affected RA patients with a history of more than one bDMARD failure. Nevertheless, impairment of HRQoL in RA patients is enormous compared with the general population.

Authors: K. Gerhold, A. Richter, M. Schneider, H. J. Bergerhausen, W. Demary, A. Liebhaber, J. Listing, A. Zink, A. Strangfeld

Date Published: 2015

Publication Type: Journal

Mortality in rheumatoid arthritis: the impact of disease activity, treatment with glucocorticoids, TNFalpha inhibitors and rituximab

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OBJECTIVES: To investigate the impact of disease activity, the course of the disease, its treatment over time, comorbidities and traditional risk factors on survival. METHODS: Data of the German biologics … register RABBIT were used. Cox regression was applied to investigate the impact of time-varying covariates (disease activity as measured by the DAS28, functional capacity, treatment with glucocorticoids, biologic or synthetic disease modifying antirheumatic drugs (DMARDs)) on mortality after adjustment for age, sex, comorbid conditions and smoking. RESULTS: During 31 378 patient-years of follow-up, 463 of 8908 patients died (standardised mortality ratio: 1.49 (95% CI 1.36 to 1.63)). Patients with persistent, highly active disease (mean DAS28 > 5.1) had a significantly higher mortality risk (adjusted HR (HRadj)=2.43; (95% CI 1.64 to 3.61)) than patients with persistently low disease activity (mean DAS28 < 3.2). Poor function and treatment with glucocorticoids > 5 mg/d was significantly associated with an increased mortality, independent of disease activity. Significantly lower mortality was observed in patients treated with tumour necrosis factor alpha (TNFalpha) inhibitors (HRadj=0.64 (95% CI 0.50 to 0.81), rituximab (HRadj=0.57 (95% CI 0.39 to 0.84), or other biologics (HRadj=0.64 (95% CI 0.42 to 0.99), compared to those receiving methotrexate. To account for treatment termination in patients at risk, an HRadj for patients ever exposed to TNFalpha inhibitors or rituximab was calculated. This resulted in an HRadj of 0.77 (95% CI 0.60 to 0.97). CONCLUSIONS: Patients with long-standing high disease activity are at substantially increased risk of mortality. Effective control of disease activity decreases mortality. TNFalpha inhibitors and rituximab seem to be superior to conventional DMARDs in reducing this risk.

Authors: J. Listing, J. Kekow, B. Manger, G. R. Burmester, D. Pattloch, A. Zink, A. Strangfeld

Date Published: 2015

Publication Type: Journal

[Not Available]

Abstract

Not specified

Author: A. Strangfeld

Date Published: 2015

Publication Type: Journal

[How do register data support clinical decision-making?]

Abstract (Expand)

BACKGROUND: Patients in daily rheumatological care differ in their individual risk profiles from participants in randomized controlled trials (RCT), e.g. due to comorbidities and age. Transferring … results from RCTs into routine daily practice is therefore limited. OBJECTIVE: The aim of this study was to evaluate the contribution of observational studies for decision-making in routine rheumatology practice. MATERIAL AND METHODS: We used data from the German biologics register RABBIT which includes patients with rheumatoid arthritis (RA) when starting synthetic (s) or biologic (b) disease-modifying antirheumatic drugs (DMARD). They are observed for at least 5 years. Comorbidities and clinically relevant aspects (e.g. history of malignancies) are reported at baseline and adverse events at regular follow-up. RESULTS: Only one out of three patients treated with bDMARDs in RABBIT would have fulfilled the inclusion criteria of the respective pivotal study. Register data enabled developing a risk scoring model which evaluates the individual risk of a patient for serious infections depending on different risk factors and the respective DMARD treatment. Open online access to the score provides the possibility of risk estimation for all rheumatologists. Further results identified long-standing high disease activity as a dominant risk factor for a worsening of prevalent comorbidities. In patients with heart failure it was shown that effective treatment and control of disease activity with tumor necrosis factor (TNF) inhibitors was more likely to be protective than harmful. CONCLUSION: Observational studies contribute essentially to the assessment of individual risks of patients. The results provide valuable information to support clinical decision-making and therefore strengthen the evidence when treating patients of higher age or with existing comorbidities.

Authors: A. Strangfeld, A. Richter

Date Published: 2015

Publication Type: Journal

Sustainability of rituximab therapy in different treatment strategies: results of a 3-year followup of a German biologics register

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OBJECTIVE: To compare the approved treatment of rheumatoid arthritis using rituximab + methotrexate (RTX + MTX) versus the off-label treatment variants of RTX in monotherapy or RTX in combination with … leflunomide (RTX + LEF). METHODS: We included RTX-naive patients enrolled in the German biologics register RABBIT (Rheumatoid Arthritis: Observation of Biologic Therapy) between 2007 and 2012 (n = 907) who started treatment with RTX. Three treatment regimens (RTX + MTX, RTX + LEF, and RTX monotherapy) were analyzed regarding therapy discontinuation, dropout, RTX retreatment, and concomitant glucocorticoid therapy. Effectiveness was evaluated with linear mixed models. RESULTS: Baseline patient characteristics were similar across treatment regimens, except for poorer functional status and more comorbidities in RTX monotherapy. Average doses of glucocorticoids were lower in RTX + LEF compared to the 2 other groups. The frequency and timing of RTX retreatment (P > 0.62) as well as improvement in the Disease Activity Score in 28 joints (DAS28) over time (P > 0.15) were similar in all treatment regimens. Within the first 12 months of treatment, the DAS28 decreased by 1.5 units, and between months 12 and 36, by a further 0.4 unit equally in all groups. Nevertheless, therapy discontinuation and dropout were significantly increased on RTX monotherapy (hazard ratio [HR] 1.7 [95% confidence interval (95% CI) 1.2-2.3]), and additionally when patients were rheumatoid factor negative (HR 1.5 [95% CI 1.0-2.1]). CONCLUSION: In patients who continue therapy, RTX + LEF, RTX monotherapy, and RTX + MTX seem to be equally effective. However, given the lower adherence rates on monotherapy, this treatment option is not sufficient for all patients. Since many patients are intolerant to MTX, more licensed RTX treatment options are needed.

Authors: A. Richter, A. Strangfeld, P. Herzer, E. Wilden, A. Bussmann, J. Listing, A. Zink

Date Published: 2014

Publication Type: Journal

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