Maternal and infant outcomes in pregnancies of women with axial spondyloarthritis compared with matched controls: results from nationwide health insurance data.

OBJECTIVES: To investigate pregnancy outcomes in women with axial spondyloarthritis (axSpA) under different pharmacological treatments in comparison with matched controls. METHODS: Using health insurance data from 2006 to 2019, pregnancy outcomes of women with axSpA were compared with those of age-matched and calendar year-matched controls without axSpA. Women with axSpA were further stratified by treatment prior to delivery and pregnancy outcomes compared. Adjusted ORs (aORs) with 95% CIs were calculated using generalised estimating equation analyses. RESULTS: A total of 1021 pregnancy outcomes in patients with axSpA were identified (928 deliveries, 80 abortions, 13 ectopic pregnancies) and compared with 10 210 pregnancy outcomes in controls (9488 deliveries, 615 abortions, 147 ectopic pregnancies). Compared with controls, women with axSpA showed higher odds of elective caesarean section (aOR 1.52; 1.25 to 1.85).Among women with axSpA, the risk of preterm birth was higher under non-steroidal anti-inflammatory drugs (NSAIDs) treatment (aOR 2.22; 1.09 to 4.52) than without any anti-inflammatory treatment. The risks of preterm birth (aOR 4.01; 1.93 to 8.34) and small-for-gestational-age (aOR 3.22; 1.34 to 7.73) were increased under NSAIDs treatment in combination with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), steroids or analgesics. Non-significant increased risks of small-for-gestational-age (aOR 1.68; 0.43 to 6.57) and preterm birth (aOR 1.56; 0.51 to 4.83) were found under biological DMARDs. CONCLUSIONS: Women with axSpA have significantly increased odds of caesarean section compared with matched controls. Risks of preterm birth and small-for-gestational-age vary by type of anti-inflammatory treatment.

Factors Associated with Survey Non-Response in a Cross-Sectional Survey of Persons with an Axial Spondyloarthritis or Osteoarthritis Claims Diagnosis.

Non-response in surveys can lead to bias, which is often difficult to investigate. The aim of this analysis was to compare factors available from claims data associated with survey non-response and to compare them among two samples. A stratified sample of 4471 persons with a diagnosis of axial spondyloarthritis (axSpA) and a sample of 8995 persons with an osteoarthritis (OA) diagnosis from a German statutory health insurance were randomly selected and sent a postal survey. The association of age, sex, medical prescriptions, specialist physician contact, influenza vaccination, hospitalization, and Elixhauser comorbidity index with the survey response was assessed. Multiple logistic regression models were used with response as the outcome. A total of 47% of the axSpA sample and 40% of the OA sample responded to the survey. In both samples, the response was highest in the 70-79-year-olds. Women in all age groups responded more often, except for the 70-79-year-olds. Rheumatologist/orthopedist contact, physical therapy prescription, and influenza vaccination were more frequent among responders. In the logistic regression models, rheumatologist/orthopedist treatment, influenza vaccination, and physical therapy were associated with a higher odds ratio for response in both samples. The prescription of biologic drugs was associated with higher response in axSpA. A high Elixhauser comorbidity index and opioid use were not relevantly associated with response. Being reimbursed for long-term care was associated with lower response-this was only significant in the OA sample. The number of quarters with a diagnosis in the survey year was associated with higher response. Similar factors were associated with non-response in the two samples. The results can help other investigators to plan sample sizes of their surveys in similar settings.

Which disease-related factors influence patients' and physicians' willingness to consider joint replacement in hip and knee OA? Results of a questionnaire survey linked to claims data.

BACKGROUND: A great heterogeneity in total joint replacement (TJR) rates has been reported for osteoarthritis (OA), most likely arising from a gap between patients' and physicians' views on the need for TJR. The purpose of this study therefore was to analyze potential cofactors which might influence the desire of patients to undergo TJR and physicians' willingness to discuss surgery with their patients. METHODS: A total of 8995 patients in Germany with a claims data diagnosis of hip or knee OA or polyarthrosis were asked to complete a questionnaire for this cross-sectional study of sociodemographic factors, indicators of current joint function (WOMAC score), willingness to undergo TJR and whether they had already discussed TJR with a physician. The overall response rate was 40%. Responders with polyarthrosis and individuals without current or chronic symptoms in the corresponding joints, pain in already replaced joints or simultaneous symptomatic hip and knee OA were excluded. We linked the survey results to claims data. Separate logistic regression models were used to assess which parameters were associated with patients' willingness to undergo TJR and physicians' discussion of surgery. RESULTS: We analyzed 478 hip OA and 932 knee OA patients. Just 17% with hip OA and 14% with knee OA were willing to undergo TJR, although 44 and 45% had already discussed surgery with their physicians. Patients' willingness was associated with higher WOMAC scores, a deterioration of symptoms over the last 2 years, and previous TJR for another joint. The discussion with a physician was influenced by the impact on personal life and previous arthroplasty. Older age (odds Ratio (OR) 1.2 per 10 years), male sex (OR 0.69 vs female), longer symptom duration (OR 1.08 per 5 years), deterioration of symptoms (OR 2.0 vs no change/improvement), a higher WOMAC score (OR 1.3 per 10% deterioration) and reduced well-being (OR 1.1 per 10% deterioration) were associated with physician discussion in knee OA patients. CONCLUSIONS: The proportion of patients willing to undergo TJR is lower than the proportion in whom physicians discuss surgery. While previous TJR seems to enhance patients' and surgeons' willingness, the influence of other cofactors is heterogeneous.

Disease Burden of Patients With Osteoarthritis: Results of a Cross-Sectional Survey Linked to Claims Data.

OBJECTIVE: Osteoarthritis (OA) is a major reason for chronic pain, stiffness, and functional limitation. This study was undertaken to analyze factors associated with the burden of OA, taking the pattern of joint involvement into account. METHODS: From a random sample of 8,995 patients with OA (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, German Modification codes M15 [polyarticular], M16 [hip], or M17 [knee]) from a German statutory health insurance database, 3,564 patients completed a survey including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Patients with knee, hip, concomitant hip and knee, or polyarticular manifestation were compared concerning pain, stiffness, function, and impact on work and personal life. Data were linked to dispensation records. The association of age, sex, body mass index (BMI), symptom duration, and the World Health Organization-5 Well-Being Index (WHO-5) with WOMAC results was assessed in multiple linear regression models. RESULTS: Patients with knee (n = 1,448), hip (n = 959), hip and knee (n = 399), or polyarthritic (n = 758) OA were included. Concomitant hip and knee OA was accompanied by the highest WOMAC values (mean 44), frequent impairment of personal life (75%), and the highest use of analgesics (52% nonsteroidal antiinflammatory drugs, 22% opioids, and 37% others). In the regression analyses, BMI per 5 units and WHO-5 per 10% worsening were associated with an increase in WOMAC values of 4-5 points, irrespective of the joint manifestations. CONCLUSION: Disease burden is high in patients with concomitant hip and knee OA and is connected with frequent prescription of analgesics. Involvement of several joints, BMI, and depressive symptoms need to be considered when using the WOMAC as an outcome instrument.

Patients with rheumatoid arthritis facing sick leave or work disability meet varying regulations: a study among rheumatologists and patients from 44 European countries.

OBJECTIVES: To describe and explore differences in formal regulations around sick leave and work disability (WD) for patients with rheumatoid arthritis (RA), as well as perceptions by rheumatologists and patients on the system's performance, across European countries. METHODS: We conducted three cross-sectional surveys in 50 European countries: one on work (re-)integration and social security (SS) system arrangements in case of sick leave and long-term WD due to RA (one rheumatologist per country), and two among approximately 15 rheumatologists and 15 patients per country on perceptions regarding SS arrangements on work participation. Differences in regulations and perceptions were compared across categories defined by gross domestic product (GDP), type of social welfare regime, European Union (EU) membership and country RA WD rates. RESULTS: Forty-four (88%) countries provided data on regulations, 33 (75%) on perceptions of rheumatologists (n=539) and 34 (77%) on perceptions of patients (n=719). While large variation was observed across all regulations across countries, no relationship was found between most of regulations or income compensation and GDP, type of SS system or rates of WD. Regarding perceptions, rheumatologists in high GDP and EU-member countries felt less confident in their role in the decision process towards WD (ß=-0.5 (95% CI -0.9 to -0.2) and ß=-0.5 (95% CI -1.0 to -0.1), respectively). The Scandinavian and Bismarckian system scored best on patients' and rheumatologists' perceptions of regulations and system performance. CONCLUSIONS: There is large heterogeneity in rules and regulations of SS systems across Europe in relation to WD of patients with RA, and it cannot be explained by existing welfare regimes, EU membership or country's wealth.

[Utilization of individual out-of-pocket health services (IGeL) in persons with osteoarthritis in Germany : Results of a survey from the PROCLAIR study]. / Inanspruchnahme von individuellen Gesundheitsleistungen (IGeL) bei Arthrose in Deutschland : Ergebnisse einer Befragung im Rahmen der PROCLAIR-Studie.

BACKGROUND: Little is known about the utilization of individual health services performed by a physician (IGeL) and the services and supplements provided outside a doctor's office (MuPaP) for osteoarthritis patients. OBJECTIVES: The aims of this study are to analyze the use of osteoarthritis-specific IGeL and MuPaP as well as predictors for their utilization. MATERIALS AND METHODS: For this cross-sectional study, claims data was used to identify all persons with hip, knee, or polyarticular osteoarthritis in 2014 (n = 657,807). A random sample (n = 8995) was sent a questionnaire about their usage of IGeL and MuPaP. Furthermore, the type of physicians conducting or recommending services was evaluated. Applying multivariable logistic regression, predictors associated with the utilization of IGeL, MuPaP, and overall individual health services were analyzed. RESULTS: After validating the data and osteoarthritis diagnosis, 2363 persons were enrolled (mean age: 65.5 years, 72% female). In the last 12 months, 39% of patients had used at least one IGeL (MuPaP: 76%), with 86% being primarily performed by orthopedists (MuPaP: 88% patient self-motivated). Knee osteoarthritis was associated with increased utilization of IGeL. Having female gender, higher income, residence in Western Germany, higher disease burden, and lower satisfaction with the healthcare system were influences on the use of overall individual health services. CONCLUSIONS: Since patients with high disease burden in particular tend to use these therapies with varying treatment success, detailed information, especially about the risks and existing evidence, should be a prerequisite for trustworthy doctor-patient relationships.

Prevalence and treatment of hip and knee osteoarthritis in people aged 60 years or older in Germany: an analysis based on health insurance claims data.

OBJECTIVE: Osteoarthritis (OA) is highly prevalent throughout the world, especially in the elderly population, and is strongly associated with patients' frailty. However, little is known about the prevalence and treatment of OA in elderly patients in routine clinical care in Germany. MATERIALS AND METHODS: As a part of Linking Patient-Reported Outcomes with CLAIms Data for Health Services Research in Rheumatology (PROCLAIR), a cross-sectional study using claims data from a large Germany statutory health insurance (BARMER) was conducted. We included people aged 60 years or older and assessed the prevalence of OA of the hip or knee, defined as having outpatient diagnoses (ICD: M16 or M17) in at least two quarters of 2014. The use of conservative treatment, including analgesics and physical therapy, and total joint replacement was studied. Analyses were stratified by age, sex, comorbidities, and level of care dependency defined by social law. RESULTS: A total of 595,754 patients (mean age: 74.9 years; 69.8% female) were diagnosed with OA (21.8%), with the highest prevalence in those between 80 and 89 years (31.0%) and in females compared to males (23.9% vs 18.3%). Prevalence decreased with increasing level of care dependency from 30.5% in patients with a low level (0/1) to 18.7% in the highest level of care dependency. A total of 63.4% of the patients with OA received analgesics, with higher use with increasing age. Physical therapy was prescribed to 43.1% of the patients, but use decreased with age. In all, 5.3% of the patients received total joint replacement in 2014. CONCLUSION: The lower frequency of coded OA with increasing level of care dependency may reflect underdiagnosis, and patients with many other medical problems seem to be at risk for inadequate recognition and treatment of their OA.

High prevalence of diabetes in patients with rheumatoid arthritis: results from a questionnaire survey linked to claims data.

Objectives: To investigate the prevalence of diabetes in patients with RA and the impact of diabetes on self-reported outcomes and health care. Methods: RA patients between the ages of 18 and 79 years were randomly selected from a nationwide statutory health insurance fund and were surveyed about rheumatological care and disease burden. Comorbid diabetes (E10-14) was analysed regarding age, sex, BMI and socioeconomic status. Disease burden, comorbidity and prescriptions were compared in RA patients with and without diabetes. Predictors of rheumatological care were identified by multivariate regression. Results: Of the 2535 RA patients, 498 (20%) had diabetes. Diabetes was more frequent in males, in older patients, in patients with a higher BMI and in those with a lower socioeconomic status. All disease outcomes were poorer in RA-diabetes patients and were mainly attributable to a higher BMI. RA-diabetes patients received less DMARDs (40% vs 48%) and had more hospital stays (41% vs 30%) than patients without diabetes (all P < 0.05). Rates of cardiovascular disease (35% vs 15%), depression (39% vs 26%) and renal failure (23% vs 8%) were higher in RA-diabetes patients (all P < 0.0001). They were less frequently treated by rheumatology specialists: 57% vs 67%; odds ratio = 0.64 (95% CI: 0.45, 0.92), after controlling for confounders. Conclusion: The prevalence of diabetes in patients with RA is high and is associated with known sociodemographic factors. More than 40% of patients with RA and diabetes were not under rheumatological care even though they reported a high disease burden, were frequently hospitalized and often presented with further comorbidities.

Rheumatologic care of nursing home residents with rheumatoid arthritis: a comparison of the year before and after nursing home admission.

The purpose of this study was to investigate health care for patients with rheumatoid arthritis (RA) before and after admission to nursing homes. Data of a German health insurance fund from persons with diagnostic codes of RA, aged ≥65 years, admitted to a nursing home between 2010 and 2014 and continuously insured 1 year before and after admission were used. The proportion of patients with ≥1 rheumatologist visit and ≥1 prescription of biologic or conventional synthetic disease-modifying antirheumatic drugs (bDMARDs or csDMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) in the year before and after admission were calculated. Predictors of rheumatologic care after admission were analyzed by multivariable logistic regression. Of 75,697 nursing home residents, 2485 (3.3%) had RA (90.5% female, mean age 83.8). Treatment by rheumatologists and prescription of antirheumatic drugs decreased significantly in the year after admission (rheumatologic visits: 17.6 to 9.1%, bDMARDs: 2.1 to 1.5%, csDMARDs: 22.5 to 16.5%, glucocorticoids: 46.5 to 43.1%, NSAIDs: 47.4 to 38.5%). 60.2% of patients in rheumatologic care received csDMARDs compared with 14.5% without rheumatologic care. Rheumatologic care before admission to a nursing home strongly predicted rheumatologic care thereafter (OR 33.8, 95%-CI 23.2-49.2). Younger age and lower care level (reflecting need of help) were also associated with a higher chance of rheumatologic care. Rheumatologic care is already infrequent in old patients with RA and further decreases after admission to a nursing home. Patients without rheumatologic care are at high risk of insufficient treatment for their RA. Admission to a nursing home further increases this risk.

The EULAR Study Group for Registers and Observational Drug Studies: comparability of the patient case mix in the European biologic disease modifying anti-rheumatic drug registers.

OBJECTIVE: Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics and collate information on the availability of potential confounders within these registers. METHODS: Baseline characteristics of patients starting their first bDMARD in an arbitrary year (2008) for the treatment of RA, including demographic and disease characteristics, bDMARD drug details and co-morbidities, were collected and compared across 14 European bDMARD registers. RESULTS: A total of 5320 patients were included. Half the registers had restricted recruitment to certain bDMARDs during the study year. All registers` collected data on age, gender, disease duration, seropositivity for IgM-RF and 28-joint DAS (DAS28). The mean DAS28 ranged from 4.2 to 6.6 and the mean HAQ from 0.8 to 1.9. Current smoking ranged from 9% to 34%. Nine registers reported co-morbidities with varying prevalence. CONCLUSION: In addition to demonstrating European-wide collaboration across rheumatology bDMARD registers, this assessment identified differences in prescribing patterns, recruitment strategies and data items collected. These differences need to be considered when applying strategies for combined analysis. The lack of a common data model across Europe calls for further work to harmonize data collection across registers.

Evolution of cost structures in rheumatoid arthritis over the past decade.

OBJECTIVE: To estimate the changes in direct and indirect costs induced by patients with rheumatoid arthritis (RA) in German rheumatology, between 2002 and 2011. To examine the impact of functional status on various cost domains. To compare the direct costs incurred by patients at working age (18-64 years) to patients at an age of retirement (≥65 years). METHODS: We analysed data from the National Database of the German Collaborative Arthritis Centres with about 3400 patients each year. Costs were calculated using fixed prices as well as annually updated cost factors. Indirect costs were calculated using the human capital as well as the friction cost approaches. RESULTS: There was a considerable increase in direct costs: from €4914 to €8206 in patients aged 18-64, and from €4100 to €6221 in those aged ≥65, attributable to increasing prescription of biologic agents (18-64 years from 5.6% to 31.2%, ≥65 years from 2.8% to 19.2%). This was accompanied by decreasing inpatient treatment expenses and indirect costs due to sick leave and work disability. The total growth of cost, on average, was €2437-2981 for patients at working age, and €2121 for patients at retirement age. CONCLUSIONS: The increase in treatment costs for RA over the last decade was associated with lower hospitalisation rates, better functional status and a lower incidence of work disability, offsetting a large proportion of risen drug costs. Since the rise in drug costs has manifested a plateau from 2009 onwards, no relevant further increase in total costs for patients with RA treated in German rheumatology is expected.

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs.

Treatment of rheumatoid arthritis (RA) may differ among rheumatologists and currently, clear and consensual international recommendations on RA treatment are not available. In this paper recommendations for the treatment of RA with synthetic and biological disease-modifying antirheumatic drugs (DMARDs) and glucocorticoids (GCs) that also account for strategic algorithms and deal with economic aspects, are described. The recommendations are based on evidence from five systematic literature reviews (SLRs) performed for synthetic DMARDs, biological DMARDs, GCs, treatment strategies and economic issues. The SLR-derived evidence was discussed and summarised as an expert opinion in the course of a Delphi-like process. Levels of evidence, strength of recommendations and levels of agreement were derived. Fifteen recommendations were developed covering an area from general aspects such as remission/low disease activity as treatment aim via the preference for methotrexate monotherapy with or without GCs vis-à-vis combination of synthetic DMARDs to the use of biological agents mainly in patients for whom synthetic DMARDs and tumour necrosis factor inhibitors had failed. Cost effectiveness of the treatments was additionally examined. These recommendations are intended to inform rheumatologists, patients and other stakeholders about a European consensus on the management of RA with DMARDs and GCs as well as strategies to reach optimal outcomes of RA, based on evidence and expert opinion.

Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis.

OBJECTIVE: To review the cost effectiveness of rheumatoid arthritis (RA) treatments and inform the clinical recommendations by the European League Against Rheumatism. METHODS: A systematic literature search and review of the health economic evidence on RA treatment options was performed. RESULTS: Despite diverse methodological approaches, health economic analyses are concordant: at onset of disease, traditional disease-modifying antirheumatic drugs (DMARDs) are cost effective-that is, treatment merits outweigh treatment costs. If DMARDs fail, therapeutic escalation with tumour necrosis factor alpha inhibitors (TNFi) is cost effective when standard dosing schemes are employed. If TNFi fail, rituximab or abatacept is cost effective. Economic evidence for switching TNFi remains sparse. CONCLUSIONS: The costly sequelae of insufficiently controlled RA justify intensive escalations of treatment in this disease. By maintaining function, patients are kept in the work process, reducing indirect costs. Quality of life is improved at an expense commonly accepted for chronic diseases. Effective control of disease activity seems to be a prudent use of societal resources.

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).

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.

Healthcare and burden of disease in psoriatic arthritis. A comparison with rheumatoid arthritis and ankylosing spondylitis.

OBJECTIVE: To compare quality of life and treatment among patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) treated by German rheumatologists. METHODS: Data for outpatients with PsA (n = 1863), RA (n = 9627), or AS (n = 1378) enrolled in the national database of the German collaborative arthritis centers in the year 2002 were analyzed. Among those with PsA, 2 subgroups with predominantly peripheral arthritis (n = 1612) and predominantly axial disease (n = 251) were distinguished. RESULTS: We found a high burden of illness in patients with PsA treated by rheumatologists. Among the 2 subgroups, those with axial PsA had worse outcomes (pain, function) than those with peripheral PsA. However, compared with RA and AS, physician ratings of disease activity and severity were lower in PsA. Concerning access to rheumatology care, there were similarities between AS and axial PsA, with very long disease duration at first visit (mean of about 6 yrs), versus RA and peripheral PsA, with shorter duration (1.6 and 2.5 yrs, respectively). A majority (84%) of patients with PsA were treated with disease modifying antirheumatic drugs. Thirty percent of the patients with PsA currently were under therapy with glucocorticoids, mainly (89%) with a dose < 7.5 mg. CONCLUSION: Patients with PsA seen in rheumatologic care have a burden of illness comparable to that of patients with RA or AS.

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

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.

Modelling cost effectiveness and cost utility of sequential DMARD therapy including leflunomide in rheumatoid arthritis in Germany: I. Selected DMARDs and patient-related costs.

OBJECTIVE: To quantify direct costs of medication and cost of illness (according to functional capacity) for patients with rheumatoid arthritis (RA) in Germany, allowing further use in a health economic evaluation of sequential therapy with disease-modifying antirheumatic drugs (DMARDs) in specialised, i.e. rheumatological, care in Germany. DESIGN AND SETTING: The analysis was conducted from the societal perspective in Germany using a modelling approach, which was based on secondary analysis of existing data and on data from a sample of 583 patients from the German rheumatological database of 1998. Functional capacity was defined by the Hannover Functional Ability Questionnaire (HFAQ) scores. Costs were calculated from resources utilised and patients' work capacity. Direct costs consisted of outpatient medical services, inpatient treatment, long-term care and rehabilitation treatment. Indirect costs incurred by sick leave and premature retirement were quantified according to the human-capital approach. MAIN OUTCOME MEASURES AND RESULTS: Average total direct costs (year 1998-2001 values) per patient per year for continuous treatment with the selected DMARDs comprising costs for drugs, monitoring and treatment of adverse drug reactions (ADRs) were highest for intramuscular gold (sodium aurothiomalate) [euro 2106 (euro 1 approximately equal to $US 0.91; average of the period from 2000 through 2001)] followed by leflunomide (euro 2010), azathioprine (euro 1878), sulfasalazine (euro 1190), oral methotrexate (euro 708), and lowest for the antimalarials chloroquine/hydroxychloroquine (euro 684). There were additional yearly costs for RA-related non-DMARD medication of euro 554 per patient, including management of ADRs. Mean cost of illness (year 1998 values) excluding medication cost amounted to euro 17,868 per RA patient per year. Annual costs increased with increasing disability, i.e. decreasing functional capacity, of RA patients from euro 6029 per patient with more than 94% of functional capacity to euro 28,509 per patient with <20% of functional capacity. In general, there was a predominance of indirect costs in each of the categories of functional capacity, ranging between 74% and 87% of total (direct and indirect) annual costs per RA patient. Annual direct costs increased from euro 811 to euro 7438 per patient with increasing disability. Inpatient treatment was the predominant component of direct costs. Patients in the worst category (<20%) of function experienced hospital costs that were 6.5 times higher than those of patients in the best category (>94%). CONCLUSIONS: On the basis of the data presented it can be concluded that the results of this investigation are typical for patients in rheumatological care in Germany and can therefore be used in a health economic analysis of different DMARD sequences aimed at changing disease progression over time.

Modelling cost effectiveness and cost utility of sequential DMARD therapy including leflunomide for rheumatoid arthritis in Germany: II. The contribution of leflunomide to efficiency.

OBJECTIVE: To estimate the 3-year incremental cost effectiveness and cost utility of introducing leflunomide into sequential therapy, consisting of the most frequently used disease-modifying antirheumatic drugs (DMARDs), for patients with rheumatoid arthritis in specialised, i.e. rheumatological, care in Germany. DESIGN AND SETTING: The analysis was conducted from the societal perspective in Germany using an existing 3-year simulation model, which was adapted to the German healthcare system after secondary analysis of relevant publications and data. DMARD sequences including leflunomide were compared with those excluding leflunomide. Costs comprised direct costs incurred by treatment and indirect costs incurred by loss of productivity (sick leave and premature retirement) of rheumatoid arthritis patients. Effectiveness parameters were given by response years gained (RYGs) according to the American College of Rheumatology (ACR) criteria for 20%, 50% and 70% improvement (ACR20/50/70RYGs) and by QALYs gained (QALYGs). Costs, effects and QALYs were discounted by 5% per annum. In the base-case analysis, average values of costs, response years and QALYs were applied. Costs were in 1998-2001 values (euro 1 approximately equal to $US 0.91, average of the period from the year 2000 through 2001). MAIN OUTCOME MEASURES AND RESULTS: After 3 years, adding leflunomide was less costly and more effective than the strategy excluding leflunomide when total (direct and indirect) costs were considered. There were savings of euro 271,777 and 8.1, 4.3, 5.1 and 4.9 ACR20RYGs, ACR50RYGs, ACR70RYGs and QALYGs per 100 patients, respectively, obtained through adding leflunomide. Focusing on direct costs, adding leflunomide was more costly and more effective compared with excluding leflunomide, with an incremental cost effectiveness of euro 5004 per ACR20RYG, euro 9535 per ACR50RYG, euro 7996 per ACR70RYG, and an incremental cost utility of euro8301 per QALYG, after 3 years. The robustness of the results was shown in comprehensive sensitivity analyses. In the analysis of extremes, different combinations of the limits of cost, effectiveness and utility parameters were investigated. Adding leflunomide to sequential DMARD therapy remained dominant in 79% of the possible cases, i.e. was less costly and more effective than the strategy excluding leflunomide. Focusing on direct costs, adding leflunomide became dominant in 29% and remained more costly and more effective in 50% of possible cases. CONCLUSIONS: Our analysis suggests, with its underlying data and assumptions, that having leflunomide as an additional option in a DMARD treatment sequence extends the time patients benefit from DMARD therapy at reasonable additional direct costs. Adding leflunomide may even be cost saving when total (direct and indirect) costs are considered. As data on DMARD effectiveness were extracted from the results of clinical trials, real-world data from observational studies would be needed to corroborate the findings of the present analysis.

[The National Database of the Regional Collaborative Rheumatic Centers as a tool for clinical epidemiology and quality assessment in rheumatology]. / Die Kerndokumentation der Regionalen Kooperativen Rheumazentren als Instrument der klinischen Epidemiologie und der Qualitätssicherung der rheumatologischen Versorgung.

The national database of the German Collaborative Arthritis Centres is a well-established tool for the observation and assessment of health care delivery to patients with rheumatic diseases in Germany. The discussion of variations in treatment practices contributes to the internal quality assessment in the participating arthritis centres. This documentation has shown deficits in primary health care including late referral to a rheumatologist, undertreatment with disease-modifying drugs and complementary therapies. In rheumatology, there is a trend towards early, intensive medical treatment including combination therapy. The frequency and length of inpatient hospital and rehabilitation treatments is decreasing, while active physiotherapy in outpatient care has been increased. Specific deficits have been identified concerning the provision of occupational therapy services and patient education.

Long-term outcome in patients with juvenile idiopathic arthritis.

OBJECTIVE: To describe the long-term outcome of juvenile idiopathic arthritis (JIA). METHODS: All patients with JIA referred to a pediatric rheumatology center between 1978 and 1988 were identified and invited to undergo an assessment. Patients with JIA from a population-based cohort from East Berlin were included. The outcome assessment considered changes in body function and structure (e.g., mortality, joint abnormalities, disease activity), activities at the individual level (Health Assessment Questionnaire), and participation in society (e.g., mobility, educational and vocational background). RESULTS: Of 260 eligible patients, 215 (83%) were evaluated. Subtypes of JIA at disease onset included oligoarthritis (40%), polyarthritis (14%), systemic arthritis (14%), psoriatic arthritis (1%), enthesitis-related arthritis (15%), and other arthritis (16%). Followup was conducted after a median of 16.5 years. No deaths occurred in this cohort. At followup, approximately half of the patients had active disease and/or changes in body structures to a variable extent. Approximately one-third of patients rated themselves as being functionally limited. Patients demonstrated good social integration: few mobility problems were reported, and the educational achievements of patients were higher and their rate of unemployment was lower compared with the age-matched population. No significant differences in outcome were found between the population-based and the referral-based cohorts. CONCLUSION: Even though approximately half of the JIA patients had more or less distinctive changes in body function and/or structure after a disease duration of >15 years, fewer than 10% were severely disabled or handicapped. Because JIA often persists into adulthood, long-term followup and care are necessary.