Publications

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216 Publications visible to you, out of a total of 216
Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study: comparison of patients according to their eligibility for major randomized clinical trials

Abstract (Expand)

OBJECTIVE: Randomized clinical trials (RCTs) evaluate the efficacy of treatments in selected groups of patients defined by strict inclusion criteria. The value of these trials in predicting therapeutic … effectiveness in "real world" patients is limited. This observational cohort study was designed to complement the knowledge obtained in RCTs by evaluating the effectiveness of tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) according to their eligibility for the major trials. METHODS: Using the data from the German biologics register Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT [in German]), we investigated how many of the RA patients who were treated with a TNF inhibitor (infliximab, etanercept, or adalimumab) would have been eligible for the major clinical trials that led to approval of the drugs. In addition, therapeutic effectiveness was compared in the eligible and ineligible patients using the American College of Rheumatology 20% (ACR20) and 50% (ACR50) improvement response criteria. RESULTS: Only 21-33% of the patients in the RABBIT register would have been eligible for the major trials. In these patients, the ACR20 and ACR50 improvement responses, indicating therapeutic effectiveness, were comparable with the response rates in the published trials. ACR response rates were lower in those patients considered ineligible for the trials; however, absolute improvement was similar to that in eligible patients. Ineligible patients had lower baseline disease activity, more comorbidity, and lower functional status. CONCLUSION: RCT cohorts reflect only a minor proportion of the patients treated with biologic agents in routine care. In the clinic setting, the indications for treatment with biologic agents are not identical to the inclusion criteria for trials. Despite the smaller relative improvement achieved in these patients with longstanding, severe RA who would not fulfill the inclusion criteria of a major trial, the majority of such patients would nevertheless benefit from biologic therapy.

Authors: A. Zink, A. Strangfeld, M. Schneider, P. Herzer, F. Hierse, M. Stoyanova-Scholz, S. Wassenberg, A. Kapelle, J. Listing

Date Published: 2006

Publication Type: Journal

Employment across chronic inflammatory rheumatic diseases and comparison with the general population

Abstract (Expand)

OBJECTIVE: To compare labor force participation across chronic inflammatory rheumatic diseases in order to assess the influence of the disease, disease duration, sex, education, and labor market … conditions on employment. METHODS: Data from the German rheumatological database on outpatients of working age (20-59 yrs) between 1993 and 2001 were analyzed. The patients had rheumatoid arthritis (RA; n = 26,071), ankylosing spondylitis (AS; n = 5564), psoriatic arthritis (PsA; n = 6041), systemic lupus erythematosus (SLE; n = 4603), systemic sclerosis (SSc; n = 802), or Wegener’s granulomatosis (WG; n = 385). Using population data, standardized employment ratios (SER) and part-time employment ratios of observed versus expected cases with 95% CI were calculated by means of indirect standardization for age and year of documentation. RESULTS: Across all diseases the overall employment rates were significantly lower than in the general population. Significant differences in SER were found between the diseases. The lowest SER of 0.76 to 0.81 (1.0 = population) were found in patients with RA, SLE, SSc, and WG. Higher SER were seen in AS (0.94) and PsA (0.92). In patients with a disease duration > 10 years the relative risk of being employed compared to RA, was 1.42 for AS, 1.26 for PsA, and 1.15, 1.03, 0.62 for PsA, SLE, SSc and WG, respectively. Comparing areas with low and high unemployment rates, a highly significant influence of labor market conditions on the SER was observed. The SER were significantly lower in patients with < 10 years of school education. CONCLUSION: Differences between employment rates in the population and the rates for the diseases under study are smaller than assumed by most clinical studies, especially in AS and PsA. However, these differences increase with longer disease duration. Specific measures to prevent patients from losing their job are needed, especially in areas with overall high unemployment.

Authors: W. Mau, J. Listing, D. Huscher, H. Zeidler, A. Zink

Date Published: 2005

Publication Type: Journal

Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data

Abstract (Expand)

OBJECTIVES: Implementation of the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) coding system presents challenges for using administrative data. … Recognizing this, we conducted a multistep process to develop ICD-10 coding algorithms to define Charlson and Elixhauser comorbidities in administrative data and assess the performance of the resulting algorithms. METHODS: ICD-10 coding algorithms were developed by "translation" of the ICD-9-CM codes constituting Deyo’s (for Charlson comorbidities) and Elixhauser’s coding algorithms and by physicians’ assessment of the face-validity of selected ICD-10 codes. The process of carefully developing ICD-10 algorithms also produced modified and enhanced ICD-9-CM coding algorithms for the Charlson and Elixhauser comorbidities. We then used data on in-patients aged 18 years and older in ICD-9-CM and ICD-10 administrative hospital discharge data from a Canadian health region to assess the comorbidity frequencies and mortality prediction achieved by the original ICD-9-CM algorithms, the enhanced ICD-9-CM algorithms, and the new ICD-10 coding algorithms. RESULTS: Among 56,585 patients in the ICD-9-CM data and 58,805 patients in the ICD-10 data, frequencies of the 17 Charlson comorbidities and the 30 Elixhauser comorbidities remained generally similar across algorithms. The new ICD-10 and enhanced ICD-9-CM coding algorithms either matched or outperformed the original Deyo and Elixhauser ICD-9-CM coding algorithms in predicting in-hospital mortality. The C-statistic was 0.842 for Deyo’s ICD-9-CM coding algorithm, 0.860 for the ICD-10 coding algorithm, and 0.859 for the enhanced ICD-9-CM coding algorithm, 0.868 for the original Elixhauser ICD-9-CM coding algorithm, 0.870 for the ICD-10 coding algorithm and 0.878 for the enhanced ICD-9-CM coding algorithm. CONCLUSIONS: These newly developed ICD-10 and ICD-9-CM comorbidity coding algorithms produce similar estimates of comorbidity prevalence in administrative data, and may outperform existing ICD-9-CM coding algorithms.

Authors: H. Quan, V. Sundararajan, P. Halfon, A. Fong, B. Burnand, J. C. Luthi, L. D. Saunders, C. A. Beck, T. E. Feasby, W. A. Ghali

Date Published: 2005

Publication Type: Journal

[Prescription of glucocorticoids by rheumatologists in patients with rheumatoid arthritis in Germany]

Abstract (Expand)

Systemic GCs are among the most important therapeutic options in modern rheumatology. Due to their fast clinical effects and their high anti-inflammatory potential, they are indispensable in a large … number of cases. This applies despite the well-known spectrum of adverse events and despite limited evidence from randomized clinical trials. In this situation, the results of observational studies gain additional importance. They provide information on therapeutic decisions of rheumatologists concerning GC therapy and their combination with other drugs as well as concerning the prevention of adverse events such as GC induced osteoporosis. The data gathered in the national database of the German Collaborative Arthritis Centers show that at the time of documentation 60% of all RA patients were under therapy with GCs, 85% of these were treated with a dosage of up to 7.5 mg/d. GCs are especially frequently used in combination with new or highly potent DMARDs. This underlines that rheumatologists take activity and severity into account in deciding both about GCs and DMARDs. However, there is high practice variation regarding the frequency of GC use among the rheumatological facilities which demonstrates the lack of good evidence.Rheumatologists are aware of various patient risks when prescribing GCs and adapt their therapies to these risks. Two thirds of all patients under GCs were receiving therapy for the prevention or treatment of osteoporosis at documentation, high risk groups such as women over 50 even more frequently. The data emphasize the high importance of GCs in modern rheumatology.

Authors: K. Thiele, F. Buttgereit, D. Huscher, A. Zink, Rheumazentren Arbeitsgemeinschaft Regionaler Kooperativer

Date Published: 2005

Publication Type: Journal

Current use of glucocorticoids in patients with rheumatoid arthritis in Germany

Abstract (Expand)

OBJECTIVE: To describe the current use of glucocorticoids in German patients with rheumatoid arthritis (RA). METHODS: We analyzed clinical and patient-derived data from 10,068 outpatients with RA from … the national database of the German Collaborative Arthritis Centres for the year 2001 collected by more than 80 rheumatologists in hospitals and private practices. RESULTS: Systemic glucocorticoid therapy was prescribed for 60% of all patients with RA in rheumatologic care. The proportion of patients receiving systemic glucocorticoids in addition to disease-modifying antirheumatic drug (DMARD) therapy ranged from 53% to 81% of the patients for the various DMARDs. Glucocorticoid therapy was administered more often in combination with tumor necrosis factor inhibitors (81%), cyclosporin A (80%), or leflunomide (77%) than with more traditional DMARDs such as methotrexate (63%) or sulfasalazine (55%). Regarding the prevention and treatment of osteoporosis, 63% of patients taking systemic glucocorticoids were also receiving some type of osteoporosis therapy, as opposed to only 26% of those not taking glucocorticoids. CONCLUSION: Glucocorticoids play a pivotal role in the management of RA. This is reflected in the extensive use of low-dose glucocorticoids by German rheumatologists. Even if highly effective DMARDs are prescribed, they are accompanied by glucocorticoids, at least in the initial phase. High-dose glucocorticoids are prescribed for only a small proportion of the patients. There is increasing awareness of the risk of osteoporosis in long-term glucocorticoid treatment, demonstrated by the fact that osteoporosis medication is prescribed for a large proportion of patients taking glucocorticoids.

Authors: K. Thiele, F. Buttgereit, D. Huscher, A. Zink, Centres German Collaborative Arthritis

Date Published: 2005

Publication Type: Journal

Infections in patients with rheumatoid arthritis treated with biologic agents

Abstract (Expand)

OBJECTIVE: To estimate the incidence rates of serious and nonserious infections in patients with rheumatoid arthritis (RA) who start treatment with a biologic agent, and to compare these rates with … those in patients with RA who receive conventional treatment. METHODS: Patients enrolled in the German biologics register between May 2001 and September 2003 were included. Treating rheumatologists assessed adverse events and serious adverse events. All adverse events and serious adverse events experienced within 12 months after study entry were analyzed. Propensity score methods were applied to estimate which part of a rate increase was likely to be attributable to differences in patient characteristics. RESULTS: Data were available for 512 patients receiving etanercept, 346 patients receiving infliximab, 70 patients receiving anakinra, and 601 control patients treated with disease-modifying antirheumatic drugs. The total number of adverse events per 100 patient-years was 22.6 (95% confidence interval [95% CI] 18.7-27.2) among patients receiving etanercept, 28.3 (95% CI 23.1-34.7) among patients receiving infliximab, and 6.8 (95% CI 5.0-9.4) among controls (P < 0.0001). Significant differences in the rate of serious adverse events were also observed. For patients receiving etanercept, those receiving infliximab, and controls, the total numbers of serious adverse events per 100 patient-years were 6.4 (95% CI 4.5-9.1), 6.2 (95% CI 4.0-9.5), and 2.3 (95% CI 1.3-3.9), respectively (P = 0.0016). After adjusting for differences in the case patient mix, the relative risks of serious adverse events were 2.2 (95% CI 0.9-5.4) for patients receiving etanercept and 2.1 (95% CI 0.8-5.5) for patients receiving infliximab, compared with controls. CONCLUSION: Patients treated with biologic agents have a higher a priori risk of infection. However, our data suggest that this risk is increased by treatment with tumor necrosis factor inhibitors.

Authors: J. Listing, A. Strangfeld, S. Kary, R. Rau, U. von Hinueber, M. Stoyanova-Scholz, E. Gromnica-Ihle, C. Antoni, P. Herzer, J. Kekow, M. Schneider, A. Zink

Date Published: 2005

Publication Type: Journal

Health care and burden of illness in systemic lupus erythematosus compared to rheumatoid arthritis: results from the National Database of the German Collaborative Arthritis Centres

Abstract (Expand)

During the past 20 years, outcome studies in the rheumatic diseases have, on the one hand, given increasing evidence of the unfavourable long-term prognosis of rheumatoid arthritis (RA) and on the other … hand determined continuous improvement of prognosis in systemic lupus erythematosus (SLE). The aim of the study was to investigate how this translates into the current spectrum of patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) seen by rheumatologists in Germany and to compare aspects of the burden of disease, disease outcomes and treatment between these two important rheumatic diseases using a large clinical database. Current health care was analysed with data from the German rheumatological database of 10 068 patients with RA and 1248 patients with SLE seen by rheumatologists in 2001. In addition, of a total of 3546 patients with SLE and 24 969 patients with RA seen at the German Collaborative Arthritis Centres between 1994 and 2001, 3465 cases of SLE were matched by age, sex, disease duration and referral status with a corresponding RA case. There were considerable differences in treatment of patients before referral to a rheumatologist and in rheumatologic care. In 2001, patients with SLE were treated by their rheumatologists mainly with antimalarials (AM, 37%), azathioprine (29%) and nonselective NSAIDs (16%). Of them, 61% received at least one immunosuppressive drug (including AM) plus glucocorticoids. In RA, methotrexate was the predominant medication (63%), and 56% received at least one immunosuppressive drug plus glucocorticoids. Matched pairs analysis showed that SLE patients with a short disease duration were almost equally burdened by pain, functional limitations and reduced health status as RA patients. After a disease duration of >10 years, however, patients with RA showed poorer outcomes than those with SLE: RA patients reported significantly more often severe pain (30% in RA versus 17% in SLE) and poor global health status (52 versus 38%), and their disease activity as well as severity was rated higher by the rheumatologists. In conclusion, comparing large groups of RA and SLE patients we found a similar burden in early but not in late disease. Taking into account limitations as to the generalizability of the results (recruitment in rheumatologic care, cross-sectional data, underestimation of SLE-specific outcomes), the discrepancy between the high increase in disease-related negative outcomes with longer disease duration in RA but not in SLE indicates a better long-term prognosis in SLE concerning the items observed. The great disparity in treatment intensity between rheumatologists and nonrheumatologists shows that the involvement of a specialist is needed equally in both diseases.

Authors: A. Zink, R. Fischer-Betz, K. Thiele, J. Listing, D. Huscher, E. Gromnica-Ihle, C. Specker, M. Schneider, Centers German Collaborative Arthritis

Date Published: 2004

Publication Type: Journal

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