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H Zeidler

Publications and source records attributed to H Zeidler.

At least 19 recordsLinked to original sources
PubMed2003

Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: an open, observational, extension study of a three-month, randomized, placebo-controlled trial.

OBJECTIVE: Treatment of ankylosing spondylitis (AS) with infliximab, an anti-tumor necrosis factor alpha monoclonal antibody, was shown to be efficacious in patients with active disease during a 3-month treatment period. The purpose of this study was to evaluate the efficacy and safety of infliximab treatment of AS for a 1-year period. METHODS: This study was an open, observational, extension study of a 3-month, randomized, placebo-controlled trial. All patients who had tolerated infliximab (infliximab/infliximab group) or placebo (placebo/infliximab 12-week crossover group) therapy for 3 months entered the open extension trial (n = 65). Infliximab was administered at a dosage of 5 mg/kg every 6 weeks after the induction phase (weeks 0, 2, and 6). The primary end point was a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). RESULTS: At week 54, a total of 54 of the 69 patients (78%) continued to take infliximab. The intent-to-treat primary efficacy analysis at week 54 showed that 47% of patients in the infliximab/infliximab group (95% confidence interval 31-63) and 51% of the patients in the placebo/infliximab group (95% confidence interval 36-67) achieved 50% improvement in BASDAI scores. In the analysis of those who completed the study, the mean BASDAI scores improved between weeks 0 and 54 in both treatment groups: from 6.6 to 2.4 in the infliximab/infliximab group and from 6.3 to 2.6 in the placebo/infliximab group. The dosage of nonsteroidal antiinflammatory drugs was reduced in approximately 70% of the patients. There were significant improvements in measures of functioning, metrologic parameters, and quality of life. Between weeks 12 and 54, a total of 4 patients had serious adverse events that were possibly related to infliximab and resulted in their discontinuing the study. CONCLUSION: Infliximab therapy in AS patients resulted in a rapid and significant improvement in BASDAI scores (>50% improvement) and a durable response for 1 year. The safety profile of infliximab in AS was comparable to that observed in the postmarketing experience for the approved indications.

Acute-Phase Proteins↗
PubMed2003

Costs of rheumatoid arthritis in Germany: a micro-costing approach based on healthcare payer's data sources.

OBJECTIVE: To develop a systematic set of German cost data in rheumatoid arthritis (RA) based solely on valid healthcare payer's cost data sources. METHODS: Retrospectively one year cost data of 338 patients with RA were generated and analysed. The cost data were derived from a major statutory health insurance plan ("Allgemeine Ortskrankenkasse Niedersachsen") and the regional physicians' association ("Kassenärztliche Vereinigung Niedersachsen"). The recently published matrix of cost domains in RA was applied to structure the analysis. Descriptive statistics were used to analyse the data. RESULTS: The total direct costs for the 338 patients during one year (third quarter 2000 to second quarter 2001) were euro 3815 per patient-year. RA related direct costs were euro 2312 per patient-year. Outpatient costs accounted for 73.7%, inpatient costs for 24.0%, and other disease related costs for 2.3% of RA related direct costs. Outpatients cost drivers were RA related drugs (euro 1019 per patient-year), physician visits (euro 323 per patient-year), diagnostic and therapeutic procedures and tests (euro 185 per patient-year), and devices and aids (euro;168 per patient-year). 98 patients were retired prematurely owing to RA related work disability and incurred costs of euro;8358 per retired patient-year. 96 patients were gainfully employed and incurred sick leave costs of euro 2835 per employed patient-year. CONCLUSION: Micro-costing based on healthcare payer's data provides a relatively conservative albeit highly accurate estimate of costs in RA. Both RA related and non-RA related costs must be taken into account. In gainfully employed patients and in patients who receive RA related retirement payments productivity costs exceed direct costs.

Adult↗
PubMed2002

Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial.

UNLABELLED: BACKGROUND Treatment options for patients with ankylosing spondylitis are few. We aimed to assess the effectiveness of infliximab, an antibody to tumour necrosis factor (TNF)-alpha, in treatment of such patients. METHODS: In this 12-week placebo-controlled multicentre study, we randomly assigned 35 patients with active ankylosing spondylitis to intravenous infliximab (5 mg/kg) and 35 to placebo at weeks 0, 2, and 6. One patient in the infliximab group was withdrawn from the study. Our primary outcome was regression of disease activity of at least 50%. To assess response, we used validated clinical criteria from the ankylosing spondylitis assessment working group, including disease activity (BASDAI), functional indices (BASFI), metrology (BASMI), and quality of life (short form 36). Analyses were done by intention to treat. FINDINGS: 18 (53%) of 34 patients on infliximab had a regression of disease activity at week 12 of at least 50% compared with three (9%) of 35 on placebo (difference 44% [95% CI 23-61], p<0.0001). Function and quality of life also improved significantly on infliximab but not on placebo (p<0.0001 and p<0.0001, respectively). Treatment with infliximab was generally well tolerated, but three patients had to stop treatment because of systemic tuberculosis, allergic granulomatosis of the lung, or mild leucopenia. INTERPRETATION: Our results show that treatment with infliximab is effective in patients with active ankylosing spondylitis. Since there are some potentially serious adverse effects, we recommend that this treatment mainly be used in co-operation with rheumatological centres.

Adult↗
PubMed2002

[New aspects of bacteriological pathogen diagnosis in rheumatic diseases].

Microbiological diagnosis for rheumatic diseases is increasingly used as part of the diagnostic work-up in rheumatological practice due to growing knowledge about bacteria-induced rheumatic diseases. This review's focus lies on rheumatic diseases, which in contrast to septic-infectious arthritis, are characterized by the inability to culture bacteria from the inflammed joint. These reactive arthritides occur after primary extraarticular bacterial infection. The etiological diagnosis of reactive arthritis is based on the detection of a previous or ongoing bacterial infection. Diagnosis is performed by serology or direct detection of the bacterial organism or parts thereof at the site of entry and recently by molecularbiology-based detection of the bacteria in the inflamed joint. This review reflects the current diagnostic approaches and formulates diagnostic algorithms for specific and well-directed microbiological diagnosis.

Algorithms↗
PubMed2002

[Health economics research in the area of chronic polyarthritis].

Costs of illness are of major economic relevance in rheumatoid arthritis (RA) as in other chronic diseases. Overall costs of 15,000 Euro/year: 10,000 Euro indirect costs, and 5000 Euro direct costs are estimated, respectively. A further detailed analysis of direct costs underlines that inpatient care (50%) is the most prominent cost driver. Medication costs are also evaluated in detail since they are expected to gain importance with the introduction of the more expensive biologicals. While annual costs for regular disease modifying drugs (DMARDs) vary from 160 to 5000 Euro per patient, costs for the new biologicals amount up to 20,000 Euro (100-125% of the current estimated overall costs). For a comparison of different therapeutic strategies, costs are related to effectiveness in cost-effectiveness analyses. Based on present clinical trials, the ratios of medication costs and response according to the ACR 20-criteria of various DMARDs and biologicals are compared. The most cost-effective medication is sulfasalzine, followed by methotrexate, and leflunomide. Combining etanercept and methotrexate is preferable to methotrexate monotherapy and the combination of infliximab and methotrexate. This review shows that important economic issues in RA have already been addressed by applying cost-of-illness analyses and cost-effectiveness analyses. However, the knowledge about cost-effective therapeutic options is still scarce. Thus, primary data will have to be obtained using standardized approaches. These economic findings can be taken into account in the development of disease-management recommendations for RA-therapy.

Antirheumatic Agents↗
PubMed2002

[Preface].

Explore the source record for details and available documents.

Biomedical Research↗
PubMed2002

Nodular fasciitis, erythema migrans, and oligoarthritis: manifestations of Lyme borreliosis caused by Borrelia afzelii.

We describe a 35-year old patient with nodular fasciitis, erythema migrans, and gonarthritis four months after a bite of a Borrelia afzelii infected tick. The Borrelia afzelii infection was identified by a polymerase chain reaction and direct sequencing of the amplification product. Borrelia-specific DNA was also detectable in nodular fasciitis tissue. We therefore conclude that Borrelia afzelii can be a causative agent of nodular fasciitis and Lyme arthritis in a highly endemic region of Northern Germany.

Adult↗
PubMed2001

Efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis: a six-week controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug.

OBJECTIVE: To evaluate the short-term efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis (AS). METHODS: The study was a 6-week randomized, double-blind, placebo-controlled trial with 3 treatment arms: placebo, ketoprofen 100 mg twice daily, and celecoxib 100 mg twice daily. Patients who had AS according to the modified New York criteria, without peripheral synovitis and with active disease (pain > or =40 mm on a 100-mm visual analog scale [VAS] and an increase in pain of at least 30% after nonsteroidal antiinflammatory drug withdrawal) were eligible for study. Primary outcome measures were change in pain intensity (VAS) and change in functional impairment (Bath Ankylosing Spondylitis Functional Index [BASFI]). RESULTS: Of the 246 randomized patients, 76 were allocated to receive placebo, 90 ketoprofen, and 80 celecoxib. There were no statistically significant differences between treatment groups at study entry. During the 6 weeks of the study, the decrease in pain and functional impairment was greater in the active treatment groups than in the placebo group, with a trend in favor of celecoxib when the 2 active treatments were compared. The mean changes were -13 mm, -21 mm, and -27 mm (P = 0.006) for pain and 1, -6, and -12 (P = 0.0008) for BASFI score in the placebo, ketoprofen, and celecoxib groups, respectively. During treatment, the number of patients reporting epigastric pain was 6 (8%), 13 (14%), and 10 (13%) in the placebo, ketoprofen, and celecoxib groups, respectively. CONCLUSION: The results of this study confirm the clinically relevant antiinflammatory effect of celecoxib at a 200-mg daily dosage, with significant improvement of both pain and function in patients with AS.

Adult↗
PubMed2001

Indirect medical costs in early rheumatoid arthritis: composition of and changes in indirect costs within the first three years of disease.

OBJECTIVE: To investigate 1) the magnitude of indirect costs, 2) changes in cost components, and 3) correlations between changes in cost and social, clinical, and occupational variables within the first 3 years of rheumatoid arthritis (RA). METHODS: We evaluated the indirect costs per person-year in 133 consecutive gainfully employed out-patients with early RA, in a prospective multicenter followup study. Costs due to RA-related sick leave, work disability, and other work loss were assessed using the human capital approach. Variables associated with reduction in lost productivity were tested by multivariate logistic regression analysis. RESULTS: Mean +/- SEM annual indirect costs were $11,750 +/- 1,120 per person. During the 3-year period of observation, a marked reduction in the costs associated with sick leave was seen, which exceeded the increase in costs due to work disability and other work loss. This phenomenon resulted in an overall reduction in indirect costs of 21%. The final logistic regression model of reduced loss of productivity included 3 variables: no problems with standing (odds ratio [OR] 7.1), no problems with working speed (OR 4.1), and no problems with outdoor work (OR 3.1). CONCLUSION: High indirect costs in early RA were demonstrated. An overall decrease of costs can be seen in the first 3 years, due to the reduction in sick leave. Since the absence of problems due to strenuous working conditions was found to be associated with a reduction in indirect costs, it is assumed that early intensified vocational rehabilitation, apart from controlling disease activity by adequate treatment, might help to reduce indirect costs.

Arthritis, Rheumatoid↗
PubMed2001

Chlamydia and Borrelia DNA in synovial fluid of patients with early undifferentiated oligoarthritis: results of a prospective study.

OBJECTIVE: More than 50% of patients with synovitis involving 1-4 joints remain classified as having undifferentiated oligoarthritis (UOA) after 1 year of disease. The clinical presentation is often similar to that of reactive arthritis (ReA) and other spondylarthropathies or to Lyme arthritis. We therefore determined how often Chlamydia trachomatis (Ct) and Borrelia burgdorferi (Bb) can be identified in patients with UOA, by using an extensive laboratory approach. METHODS: We prospectively studied 52 patients with UOA who presented at an early synovitis clinic in a region highly endemic for Lyme disease. Patients were examined by standardized clinical and immunoserologic procedures. Synovial fluid was screened for the presence of Ct and Bb DNA by polymerase chain reaction (PCR). Urine was tested for Ct DNA by ligase chain reaction, and serum was tested for Ct antibodies by enzyme-linked immunosorbent assay and Bb antibodies by hemagglutination test and Western blotting. PCR results in the UOA patients were compared with the results in cohorts of patients with definite rheumatoid arthritis (RA), Lyme arthritis, and Chlamydia-induced arthritis (CIA). RESULTS: In the synovial fluid of 9 of 52 patients with UOA (17%), we found Ct DNA, and in 6 of the 52 patients (12%), Bb DNA was found. The frequency of bacteria-specific DNA was 50% (7 of 14) in CIA patients and 69% (11 of 16) in patients with Lyme arthritis. No Bb or Ct DNA was found in the synovial fluid of the 31 RA patients. CONCLUSION: With optimized PCR protocols, it is possible to detect considerable levels of Bb and Ct DNA in the synovial fluid of patients with UOA. Although the presence of bacterial DNA does not unequivocally prove its etiologic significance, we suggest that at least one-third of patients with UOA may have a form of ReA that involves asymptomatic primary infection.

Adolescent↗
PubMed2001

[Combined basic therapeutic drugs. From individual hope to targeted use].

Accumulating evidence suggests that treatment of rheumatoid arthritis (RA) with two or more disease-modifying antirheumatic drugs (DMARDs) is more efficient than single agent therapy. Randomized clinical trials demonstrated the efficacy of various combinations such as methotrexate plus sulfasalazine plus hydroxychloroquine, methotrexate plus ciclosporine or methotrexate plus infliximab, respectively. In contrast to these data, however, most German rheumatologists use combination therapy in a small percentage of patients with active RA. Thus, consensus criteria should be defined when and how to use combination therapy in the treatment of active disease. We suggest that combination therapy should be started if active disease is still present after three months of treatment with a single standard DMARD, mostly methotrexate, plus low dose prednisolone and that combination DMARD therapy should be used before TNF blocking agents.

Antirheumatic Agents↗