Publications

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213 Publications visible to you, out of a total of 213
Advance and unmet need of health care for patients with rheumatoid arthritis in the German population–results from the German Rheumatoid Arthritis Population Survey (GRAPS)

Abstract (Expand)

OBJECTIVES: To assess the quality of health care for RA patients in the general population of Germany. METHODS: A three-stage population survey was conducted to identify individuals with RA using a … health care access panel (18-79 years; n = 70,112). A 20-item postal screening questionnaire of musculoskeletal symptoms and diagnoses was followed by a detailed questionnaire for those who indicated the possibility of having RA. Respondents who fulfilled the modified ACR decision tree, who reported an RA diagnosis, care by a rheumatologist or the use of DMARDs were asked to participate in a clinical examination by rheumatologists who diagnosed the participants and rated the adequacy of treatment. RESULTS: RA could not be ruled out in 1177 cases, of which 643 agreed to participate in the clinical examination, which was finally attended by 317 participants. Attendees did not differ with regard to any health or treatment measure from those who did not attend. Forty-one RA patients were detected. Of them, 93% had seen a rheumatologist at least once and 63% within the last 12 months. A total of 73% had received DMARD therapy at some time and 59% were currently receiving it. An unmet need for DMARDs was discovered in 29% of the RA attendees. It pertained almost exclusively to the seronegative cases of which 29% had a need to start and 17% to increase a DMARD therapy according to the opinion of the examining rheumatologist. CONCLUSION: Health care for RA patients has improved significantly since the last German RA survey in 1989. However, DMARD prescription still does not meet clinical recommendations, specifically in RF-negative patients. Since seronegative RA is a treatable disease, this group should not be overlooked.

Authors: G. Westhoff, M. Schneider, H. Raspe, H. Zeidler, C. Runge, T. Volmer, A. Zink

Date Published: 2009

Publication Type: Journal Article

Comparative effectiveness of tumour necrosis factor alpha inhibitors in combination with either methotrexate or leflunomide

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OBJECTIVE: The objective of this study was to compare the effectiveness of a combination of tumour necrosis factor alpha (TNFalpha) inhibitors with either methotrexate or leflunomide in the treatment … of patients with rheumatoid arthritis in a real-world setting. METHODS: Data from 1769 outpatients enrolled in the German biologics register RABBIT who were treated with one of the TNFalpha inhibitors adalimumab, etanercept, or infliximab in combination with either methotrexate (n = 1375) or leflunomide (n = 394) were included in the analysis. Clinical status including disease activity as well as treatment data were documented by the treating rheumatologist at baseline and at 3, 6, 12, 18, 24, 30 and 36 months of follow-up. RESULTS: Patients treated with a combination of biologics with leflunomide had significantly higher baseline disease activity than those treated with methotrexate. The highest disease activity was found for patients treated with the combination infliximab/leflunomide. After 36 months, the discontinuation rates were 46.3%, 51.3% and 61.5% for combinations of etanercept, adalimumab and infliximab with methotrexate and 53.4%, 63.1% and 67.1% for combinations with leflunomide, respectively. European League Against Rheumatism response rates after 24 months ranged from 74% to 81% for combinations with methotrexate and 72% to 81% for combinations with leflunomide. CONCLUSION: The current clinical practice is to use methotrexate as a first choice for the combination with TNFalpha antagonists. In a number of patients methotrexate has to be replaced by another disease-modifying antirheumatic drug. Our data support the view that leflunomide is a useful alternative if methotrexate is contraindicated.

Authors: A. Strangfeld, F. Hierse, J. Kekow, U. von Hinueber, H. P. Tony, R. Dockhorn, J. Listing, A. Zink

Date Published: 2009

Publication Type: Journal Article

Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents

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CONTEXT: The risk of bacterial infection is increased in patients treated with drugs that inhibit tumor necrosis factor alpha (TNF-alpha). Little is known about the reactivation of latent viral infections … during treatment with TNF-alpha inhibitors. OBJECTIVE: To investigate whether TNF-alpha inhibitors together as a class, or separately as either monoclonal anti-TNF-alpha antibodies (adalimumab, infliximab) or a fusion protein (etanercept), are related to higher rates of herpes zoster in patients with rheumatoid arthritis. DESIGN, SETTING, AND PATIENTS: Patients were enrolled in the German biologics register RABBIT, a prospective cohort, between May 2001 and December 2006 at the initiation of treatment with infliximab, etanercept, adalimumab, or anakinra, or when they changed conventional disease-modifying antirheumatic drug (DMARD). Treatment, clinical status, and adverse events were assessed by rheumatologists at fixed points during follow-up. MAIN OUTCOME MEASURES: Hazard ratio (HR) of herpes zoster episodes following anti-TNF-alpha treatment. Study aims were to detect a clinically significant difference (HR, 2.0) between TNF-alpha inhibitors as a class compared with DMARDs and to detect an HR of at least 2.5 for each of 2 types of TNF-alpha inhibitors, the monoclonal antibodies or the fusion protein, compared with conventional DMARDs. RESULTS: Among 5040 patients receiving TNF-alpha inhibitors or conventional DMARDs, 86 episodes of herpes zoster occurred in 82 patients. Thirty-nine occurrences could be attributed to treatment with anti-TNF-alpha antibodies, 23 to etanercept, and 24 to conventional DMARDs. The crude incidence rate per 1000 patient-years was 11.1 (95% confidence interval [CI], 7.9-15.1) for the monoclonal antibodies, 8.9 (95% CI, 5.6-13.3) for etanercept, and 5.6 (95% CI, 3.6-8.3) for conventional DMARDs. Adjusted for age, rheumatoid arthritis severity, and glucocorticoid use, a significantly increased risk was observed for treatment with the monoclonal antibodies (HR, 1.82 [95% CI, 1.05-3.15]), although this risk was lower than the threshold for clinical significance. No significant associations were found for etanercept use (HR, 1.36 [95% CI, 0.73-2.55]) or for anti-TNF-alpha treatment (HR, 1.63 [95% CI, 0.97-2.74]) as a class. CONCLUSION: Treatment with monoclonal anti-TNF-alpha antibodies may be associated with increased risk of herpes zoster, but this requires further study.

Authors: A. Strangfeld, J. Listing, P. Herzer, A. Liebhaber, K. Rockwitz, C. Richter, A. Zink

Date Published: 2009

Publication Type: Journal Article

[Validation of secondary data. Strengths and limitations]

Abstract (Expand)

Medical records databases (such as the General Practice Research Database-GPRD) and administrative databases (such as German Statutory Health Insurance (SHI) claims data) are useful sources for … pharmacoepidemiology and health services research. However, these data are not primarily collected for research purposes. Validation studies are needed to examine their completeness and accuracy depending on the corresponding research question. This article reviews strategies for checks of internal consistency within the data from one SHI as well as between data from several SHIs and possibilities of internal data validation. Descriptive analyses of consistency can help to determine the integrity of data. The aim of internal validation is to separate uncertain from true cases based on information from secondary data alone or to reproduce known associations within the database. In addition external validation of secondary data is desirable using original prescriptions, medical records, hospital discharge letters and/or patient or physician interviews as a gold standard. A considerable number of external validation studies of diagnostic coding have been conducted within the GPRD. In contrast, such validation studies of German SHI claims data are mostly lacking and are urgently needed in the near future.

Authors: F. Hoffmann, F. Andersohn, K. Giersiepen, E. Scharnetzky, E. Garbe

Date Published: 2008

Publication Type: Journal Article

[Burden of illness. First routine report on socio-medical consequences of inflammatory rheumatic disease in Germany]

Abstract (Expand)

A synopsis of different socio-medical consequences of inflammatory rheumatic diseases is not yet available for Germany. Therefore, the data reported during the past decade for rheumatoid arthritis, … ankylosing spondylitis, psoriatic arthritis, systemic sclerosis, systemic lupus erythematodes, and Wegener’s granulomatosis are summarized in this article. Apart from clinical studies, relevant data sources were the national data base of the German collaborative arthritis centres, statistical figures from the compulsory health insurance and the national pension insurance scheme. Data were mainly available for sick leave and work disability showing limitations, which frequently occurred during the early course of diseases and increased with disease duration. Furthermore, different risk factors were identified. Measures to maintain continued participation in the labour force, such as part-time employment, partial work disability instead of full work disability, were not being adequately utilized. Only few data regarding the need of help and care were available. The proportion of patients in need of help and care increased with the duration of rheumatoid arthritis to more than 50% after more than 2 decades. This review presents detailed information concerning aspects of the burden of rheumatic diseases, which are frequently not adequately taken into account. They may be useful for the advice and care of individual patients as well as for decision processes concerning the health care system.

Authors: W. Mau, W. Beyer, I. Ehlebracht-Konig, M. Engel, E. Genth, B. Greitemann, W. H. Jackel, A. Zink

Date Published: 2008

Publication Type: Journal Article

Does tumor necrosis factor alpha inhibition promote or prevent heart failure in patients with rheumatoid arthritis?

Abstract (Expand)

OBJECTIVE: To determine the hazard risk of developing or worsening heart failure in rheumatoid arthritis (RA) patients treated with tumor necrosis factor alpha (TNFalpha) inhibitors. METHODS: RA patients … ages 18-75 years who started treatment with infliximab, etanercept, or adalimumab (n = 2,757), or conventional disease-modifying antirheumatic drugs (controls; n = 1,491) at the time of enrollment in a German biologics register were studied. Cox proportional hazards models were applied to investigate the influence of disease-related and treatment-specific risk factors on the incidence or worsening of heart failure. RESULTS: The 3-year incidence rates of heart failure in patients with and patients without cardiovascular disease at the start of treatment were 2.2% and 0.4%, respectively. After adjustment for traditional cardiovascular risk factors, an increased risk of developing heart failure was found in patients who had a higher 28-joint Disease Activity Score at followup (hazard ratio [HR] 1.47 [95% confidence interval 1.07-2.02], P = 0.019). A residual nonsignificant risk related to treatment with TNFalpha inhibitors remained (adjusted HR 1.66 [95% confidence interval 0.67-4.1], P = 0.28). This residual risk was balanced by the efficacy of the anti-TNF treatment. When only baseline characteristics were taken into account, the HR related to TNFalpha inhibitor treatment decreased to 0.70 (95% confidence interval 0.27-1.84). CONCLUSION: The findings of this study indicate that TNFalpha inhibitor treatment that effectively reduces the inflammatory activity of RA is more likely to be beneficial than harmful with regard to the risk of heart failure, especially if there is no concomitant therapy with glucocorticoids or cyclooxygenase 2 inhibitors. Furthermore, the data suggest that TNFalpha inhibition does not increase the risk of worsening of prevalent heart failure.

Authors: J. Listing, A. Strangfeld, J. Kekow, M. Schneider, A. Kapelle, S. Wassenberg, A. Zink

Date Published: 2008

Publication Type: Journal Article

Cost of illness in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and systemic lupus erythematosus in Germany

Abstract (Expand)

OBJECTIVE: To estimate and compare the direct and indirect costs of illness in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE), and to … evaluate the effect of sex, disease duration and functional status on the various cost domains. METHODS: Data of outpatients, aged 18-65, with rheumatoid arthritis (n = 4351), ankylosing spondylitis (n = 827), PsA (n = 908) or SLE (n = 844), who were enrolled in the national database of the German collaborative arthritis centres in 2002, were analysed. Data on healthcare consumption, out-of-pocket expenses and productivity losses were derived from doctors and patients. For the calculation of indirect costs, the human capital approach (HCA) and the friction cost approach (FCA) were applied. RESULTS: Mean direct costs amounted to 4737 euros a year in rheumatoid arthritis, 3676 euros in ankylosing spondylitis, 3156 euros in PsA and 3191 euros in SLE. By using the HCA, total costs were calculated at 15,637 euros in rheumatoid arthritis, 13,513 euros in ankylosing spondylitis, 11,075 euros in PsA and 14,411 euros in SLE, whereas with the FCA the numbers were 7899 euros, 7204 euros, 5570 euros and 6518 euros, respectively. Costs increased with disease duration and were strongly dependent on functional status. In patients with the highest disability (<50% of full function), the total costs on applying the HCA were 34,915 euros in rheumatoid arthritis, 29,647 euros in alkylosing spondylitis, 37,440 euros in PsA and 32,296 euros in SLE. CONCLUSION: The costs of illness are high in all four diseases, with a strong effect of functional status on total costs. Indirect costs differ by the factor 3, based on whether the HCA or the FCA is used.

Authors: D. Huscher, S. Merkesdal, K. Thiele, H. Zeidler, M. Schneider, A. Zink, Centres German Collaborative Arthritis

Date Published: 2006

Publication Type: Journal Article

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