Objective To analyse healthcare utilization, loss of productivity, and disease activity in relation to presence of anti-citrullinated protein antibodies (ACPAs). Method In total, 447 ACPA-positive and 224 ACPA-negative patients from two early rheumatoid arthritis cohorts, recruited 1996-1998 (cohort 1) and 2006-2009 (cohort 2), were followed during 3 years. Data on disease activity were collected, and patients reported healthcare utilization and days lost from work. Disease activity, healthcare costs, and loss of productivity were compared between ACPA groups. Linear regression was performed, controlling for confounders. Results Healthcare costs did not differ significantly by ACPA status (EUR 3214 for vs EUR 2174 for ACPA-positive vs ACPA-negative patients in cohort 1, ns; EUR 4150 vs EUR 3820 in cohort 2, ns). Corresponding values for loss of productivity were EUR 9148 vs EUR 7916 (ns) and EUR 5857 vs EUR 5995 (ns). Total prescription of traditional disease-modifying anti-rheumatic drugs was higher in cohort 2 than in cohort 1. Methotrexate prescription was higher in ACPA-positive patients, but biologics did not differ significantly between ACPA groups. Disease activity was significantly more improved in cohort 2, but there was no difference in achieving remission in relation to ACPA status. In cohort 1, 25% of ACPA-positive patients were in remission vs 31% of ACPA-negative (ns) and in cohort 2, 55% vs 60% (ns). Conclusions With increasing drug treatment for both ACPA-positive and ACPA-negative patients, outcome in ACPA-positive was no more severe than in ACPA-negative patients. Healthcare costs and loss of productivity were similar in the two groups.

Objective: To evaluate changes in healthcare utilization, costs, and disease activity from 1996 to 2011 for patients with early rheumatoid arthritis (RA).Method: Two cohorts of patients with early RA, included in 1996-1998 (T1) and 2006-2009 (T2), were followed regularly. Healthcare utilization, costs, and disease activity were compared between cohorts during 2years after diagnosis.Results: Disease activity was significantly improved in T2 vs T1. Drug costs increased in T2 vs T1 (EUR 911 vs EUR 535, respectively; p=0.017), and costs for RA-related hospitalization decreased. More than 90% in T2 were prescribed disease-modifying anti-rheumatic drugs (DMARDs) at inclusion compared to 50% in T1. At 2year follow-up, levels were still amp;gt;90% in T2, while corresponding values in T1 were just above 70%. Comparing T2 to T1, total direct costs were slightly higher in T2 (EUR 3941 vs EUR 3364, respectively; ns), sick leave decreased (EUR 3511 vs EUR 5672; p=0.025), while disability pension increased slightly (EUR 4889 vs EUR 4244; ns), but total indirect costs remained unchanged (EUR 8400 vs EUR 9916; ns). Total direct and indirect costs did not differ between the cohorts (EUR 12342 in T2 vs EUR 13280 in T1; ns), and loss of productivity still represented the largest component of total costs.Conclusion: T2 patients were prescribed DMARDs earlier and more aggressively than T1 patients. Stable and better improvements in disease activity, function, and quality of life were achieved in T2 compared to T1. There was a shift within the components in direct costs and indirect costs, but total costs remained essentially unchanged.

The aim of the present study was to calculate non-medical costs during year 1 after diagnosis in two cohorts of patients with early rheumatoid arthritis enrolled 1996–1998 and 2006–2009. Clinical data were collected regularly in both cohorts. Besides information about healthcare utilization and days lost from work, patients reported non-medical costs for aids/devices, transportation, formal and informal care. Formal care was valued as full labour cost for official home help (€42.80/h) and informal care from relatives and friends as opportunity cost of leisure time, corresponding to 35% of labour cost (€15/h). In both cohorts, only 2% used formal care, while more than 50% used informal care. Prescription of aids/devices was more frequent in cohort 2 and more women than men needed aids/devices. Help with transportation was also more common in cohort 2. Women in both cohorts needed more informal care than men, especially with personal care and household issues. Adjusting for covariates in regression models, female sex remained associated with higher costs in both cohorts. Non-medical costs in cohort 2 were €1892, €1575 constituting informal care, corresponding to 83% of non-medical costs. Total non-medical costs constituted 25% of total direct costs and 11% of total direct and indirect costs. Informal care accounted for the largest part of non-medical costs and women had higher costs than men. Despite established social welfare system, it is obvious that family and friends, to a large extent, are involved in informal care of patients with early RA, and this may underestimate the total burden of the disease.

Sjukdomsaktivitet, funktionsförmåga samt direkta och indirekta kostnader har analyserats i två kohorter av patienter med nydebuterad (≤ 1 år) reumatoid artrit (RA).

Den första kohorten med 320 patienter (T1) rekryterades 1996–1998 och den andra med 463 patienter (T2) rekryterades 2006–2009. Patienterna har följts regelbundet avseende kliniska och laboratoriemedicinska variabler och har fortlöpande i hälsoekonomienkäter registrerat all sjukvårdskonsumtion och antal dagar med sjukskrivning/sjukersättning samt rapporterat livskvalitet med EQ-5D och EQ-VAS.

OBJECTIVES:

To calculate total costs during the first year after diagnosis in 463 patients with early rheumatoid arthritis (RA) included during 2006-09 (T2) and compare the results with a similar cohort included in 1996-98 (T1).

METHOD:

Clinical and laboratory data were collected regularly in both cohorts, and patients completed biannual questionnaires reporting health care utilization and number of days lost from work.

RESULTS:

Disease activity was similar in both cohorts T1 and T2 at inclusion. Significant improvements were seen during the first year in both cohorts but were more pronounced in T2. Outpatient care increased and hospitalization decreased in T2 compared with T1. Almost 3% of patients had surgery in both cohorts, but in T2, only women had surgery. Drug costs were higher in T2 than in T1 (EUR 689 vs. EUR 435). In T2, 12% of drug costs were direct costs and 4% were total costs. The corresponding values for T1 were 9% and 3%. In T1, 50% were prescribed disease-modifying anti-rheumatic drugs (DMARDs) at inclusion, compared to T2, where prescription was > 90%. Direct costs were EUR 5716 in T2 and EUR 4674 in T1. Costs for sick leave were lower in T2 than in T1 (EUR 5490 vs. EUR 9055) but disability pensions were higher (EUR 4152 vs. EUR 2139), resulting in unchanged total costs. In T1, direct costs comprised 29% and indirect costs 71% of the total costs. The corresponding values for T2 were 37% and 63%.

CONCLUSIONS:

The earlier and more aggressive treatment of RA with traditional DMARDs in T2 resulted in better outcomes compared to T1. Direct costs were higher in T2, partly offset by decreased sick leave, but total costs remained unchanged.

Objectives: To compare baseline sociodemographic characteristics in two rheumatoid arthritis (RA) cohorts enrolled 10 years apart, and to examine differences with respect to the general population. Method: Clinical and sociodemographic data were collected in 320 early RA patients during 1996-98 (TIRA-1) and 467 patients in 2006-09 (TIRA-2). Multivariate logistic regression tests were performed and intercohort comparisons were related to general population data, obtained from official databases. Results: TIRA-2 patients were older than TIRA-1 (58 vs. 56 years). Women (both cohorts, 67%) were younger than men in TIRA-1 (55 vs. 59 years) and in TIRA-2 (57 vs. 61 years). Disease activity was similar but TIRA-2 women scored worse pain and worse on the HAQ. Approximately 73% were cohabiting, in both cohorts and in the general population. Education was higher in TIRA-2 than in TIRA-2 but still lower than in the general population. Women had consistently higher education than men. Education was associated with age, younger patients having higher education. In both cohorts, lower education was associated with increased disability pension and increased sick leave. Sick leave was lower in TIRA-2 than in TIRA-1 (37% vs. 50%) but disability pension was higher (16% vs. 10%). In TIRA-1, 9% of women had disability pension compared with 17% in TIRA-2. A similar decrease in sick leave and an increase in disability pension were also seen in the general population. Older age and a higher HAQ score were associated with increased sick leave and being in the TIRA-2 cohort was associated with decreased sick leave. Conclusions: TIRA-2 patients were slightly older, better educated, had lower sick leave and higher disability pension than those in TIRA-1. Similar changes were seen simultaneously in the general population. Belonging to the TIRA-2 cohort was associated with decreased sick leave, indicating that societal changes are of importance.

Objective: In Sweden, reports indicate surprisingly large regional variation in prescription of biological drugs, despite a growing number of clinical studies describing their beneficial effects and guidelines by professional organizations and agencies. Our objective was to ascertain whether there is also variation between individual rheumatologists in prescribing biologics to patients with rheumatoid arthritis (RA) and to evaluate reasons for treatment choices.

Methods: Ten hypothetical patient cases were constructed and presented to 26 rheumatologists in five regions in Sweden. The cases were based on actual cases and were thoroughly elaborated by a senior rheumatologist and pre-tested in a pilot study. The respondents were asked whether they would treat the patients with a biological agent (YES/NO) and to explain their decisions.

Results: The response rate was 26/105; 25%. Treatment choices varied considerably between the rheumatologists, some prescribing biologics to 9/10 patients and others to 2/10. In five of the ten hypothetical cases, approximately half of the respondents would prescribe biologics. No regions with particularly high or low prescription were identified. Both the decision to prescribe biologics, as well as not to prescribe, were mainly motivated by medical reasons. Some rheumatologists also referred to lifestyle-related factors or social function of the patient.

Conclusion: The choice of initiation of biologics varied substantially among rheumatologists presented with hypothetical patient cases, and there were also disparities between rheumatologists practising at the same clinic. Treatment choices were primarily motivated by medical reasons. This situation raises concerns about a lack of consensus in RA treatment strategies.

Objective. The prescription of biologic drugs for rheumatoid arthritis (RA) patients has varied considerably across different regions. Previous studies have shown physician preferences to be an important determinant in the decision to select biologic disease-modifying antirheumatic drugs (bDMARDs) rather than nonbiologic, synthetic DMARDs (sDMARDs) alone. The aim of this study was to test the hypothesis that physician preferences are an important determinant for prescribing bDMARDs for RA patients in Sweden. Methods. Using data from the Swedish Rheumatology Quality Register, we identified 4,010 RA patients who were not prescribed bDMARDs during the period 2008-2012, but who, on at least 1 occasion, had an sDMARD prescription and changed treatment for the first time to either a new sDMARD or a bDMARD. Physician preference for the use of bDMARDs was calculated using data on each physicians prescriptions during the study period. The relationship between prescription of a bDMARD and physician preference, controlling for patient characteristics, disease activity, and the physicians local context was evaluated using multivariate logistic regression. Results. When adjusting for patient characteristics, disease activity, and the physicians local context, physician preference was an important predictor for prescription of bDMARDs. Compared with patients of a physician in the lowest preference tertile, patients of physicians in the highest and middle tertiles had an odds ratio for receiving bDMARDs of 2.8 (95% confidence interval [95% CI] 2.13-3.68) and 1.28 (95% CI 1.05-1.57), respectively. Conclusion. Physician preference is an important determinant for prescribing bDMARDs.

Objectives. The objectives of this study were to analyse the total socio-economic impact of RA in Sweden during the period 1990–2010 and to analyse possible changes in costs during this period. The period was deliberately chosen to cover 10 years before and 10 years after the introduction of biologic drugs.

Methods. A prevalence-based cost-of-illness study was conducted based on data from national and regional registries.

Results. There was a decrease in the utilization of RA-related inpatient care as well as sick leave and disability pension during 1990–2010 in Sweden. Total costs for RA are presented in current prices as well as inflation-adjusted with the consumer price index (CPI) and a healthcare price index. The total fixed cost of RA was €454 million in 1990, adjusted to the price level of 2010 with the CPI. This cost increased to €600 million in 2010 and the increase was mainly due to the substantially increasing costs for pharmaceuticals. Of the total costs, drug costs increased from 3% to 33% between 1990 and 2010. Consequently the portion of total costs accounting for indirect costs for RA is lowered from 75% in 1990 to 58% in 2010.

Conclusion. By inflation adjusting with the CPI, which is reasonable from a societal perspective, there was a 32% increase in the total fixed cost of RA between 1990 and 2010. This suggests that decreased hospitalization and indirect costs have not fallen enough to offset the increasing cost of drug treatment.

Objectives: To calculate total costs over 6 years after diagnosis of early rheumatoid arthritis (RA).

Method: In the longitudinal prospective multicentre TIRA study, 239 patients from seven units, diagnosed in 1996–98, reported regularly on health-care utilization and the number of days lost from work. Costs were obtained from official databases and calculated using unit costs (Swedish kronor, SEK) from 2001. Indirect costs were calculated using the human capital approach (HCA). Costs were inflation adjusted to Euro June 2012, using the Swedish Consumer Price Index and the exchange rate of June 2012. Statistical analyses were based on linear mixed models (LMMs) for changes over time.

Results: The mean total cost per patient was EUR 14 768 in year 1, increasing to EUR 18 438 in year 6. Outpatient visits and hospitalization decreased but costs for surgery increased from EUR 92/patient in year 1 to EUR 444/patient in year 6. Drug costs increased from EUR 429/patient to EUR 2214/patient, mainly because of the introduction of biologics. In year 1, drugs made up for 10% of direct costs, and increased to 49% in year 6. Sick leave decreased during the first years but disability pensions increased, resulting in unchanged indirect costs. Over the following years, disability pensions increased further and indirect costs increased from EUR 10 284 in year 1 to EUR 13 874 in year 6. LMM analyses showed that indirect costs were unchanged whereas direct costs, after an initial fall, increased over the following years, leading to increasing total costs.

Conclusions: In the 6 years after diagnosis of early RA, drug costs were partially offset by decreasing outpatient visits but indirect costs remained unchanged and total costs increased.

Background: The introduction of biological drugs involved a fundamental change in the treatment of rheumatoid arthritis (RA). The extent to which biological drugs are prescribed to RA patients in different regions in Sweden varies greatly. Previous research has indicated that differences in health care practice at the regional level might obscure differences at the individual level. The objective of this study is to explore what influences individual rheumatologists decisions when prescribing biological drugs. Method: Semi-structured interviews, utilizing closed-and open-ended questions, were conducted with senior rheumatologists, selected through a mix of random and purposive sampling. The interview questions consisted of two parts, with a "parallel mixed method" approach. In the first and main part, open-ended exploratory questions were posed about factors influencing prescription. In the second part, the rheumatologists were asked to rate predefined factors that might influence their prescription decisions. The Consolidated Framework for Implementation Research (CFIR) was used as a conceptual framework for data collection and analysis. Results: Twenty-six rheumatologists were interviewed. A constellation of various factors and their interaction influenced rheumatologists prescribing decisions, including the individual rheumatologists experiences and perceptions of the evidence, the structure of the department including responsibility for costs, peer pressure, political and administrative influences, and participation in clinical trials. The patient as an actor emerged as an important factor. Hence, factors both at organizational and individual levels influenced the prescribing of biological drugs. The factors should not be seen as individual influences but were described as influencing prescription in an interactive, nonlinear way. Conclusions: Potential factors explaining differences in prescription practice are experience and perception of the evidence on the individual level and the structure of the department and participation in clinical trials on the organizational level. The influence of patient attitudes and preferences and interpretation of scientific evidence seemed to be somewhat contradictory in the qualitative responses as compared to the quantitative rating, and this needs further exploration. An implication of the present study is that in addition to scientific knowledge, attempts to influence prescription behavior need to be multifactorial and account for interactions of factors between different actors.

Slutsats Sjukvårdens andel av BNP ligger väsentligen oförändrad samtidigt som dyrare behandlingsmöjligheter introduceras på marknaden. Detta skapar ett behov av att fasa ut ineffektiva tekniker samt att motivera om nya metoder är kostnadseffektiva och om de ska subventioneras av samhället. Hälsoekonomiska studier får således en allt större betydelse och det är oerhört viktigt att kunna tolka dessa analyser utifrån hur data använts och på vilket sätt data har analyserats. Det är också alldeles nödvändigt att relatera effekter och nytta av en specifik intervention/teknik till förändringar i samhället. Exempelvis kan sjukskrivning och sjukersättning/förtidspension vara ett effektmått på nyttan av en specifik insats, men kan i lika hög grad spegla effekter av konjunkturläge, arbetslöshet och förändringar i sjukförsäkringssystemet. Detta bör således alltid tas med i beräkningen, eftersom dessa variabler samvearierar i mycket hög grad.

Purpose: To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson’s disease (PD).

Method: Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility).

Results: Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed.

Conclusions: In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD.

Implications for Rehabilitation

• The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD.

• The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation.

• Most measurements were feasible except for Timed-Up-and-Go.

OBJECTIVE: To compare women and men regarding course of disease activity and disability over 8 years from diagnosis of recent onset rheumatoid arthritis (RA). PATIENTS AND METHODS: 149 patients were followed for 8 years from RA diagnosis (1996-98) regarding 28-joint count disease activity score (DAS28), pain (visual analogue scale, VAS), grip force, Grip Ability Test (GAT), Signals of Functional Impairment (SOFI hand, upper/lower extremity), walking speed, activity limitation (Health Assessment Questionnaire, HAQ) and prescribed disease-modifying anti-rheumatic drugs (DMARDs). RESULTS: Disease activity pattern over time was similar in women and men, showing improvement during the first year and thereafter a stable situation during 6 years. However, at the 7- and 8-year follow-ups deterioration was seen with a less favourable course in women. HAQ did not differ between sexes at diagnosis, but at all follow-ups women had significantly higher scores than men. Women also had lower grip force and lower walking speed, but higher upper extremity mobility. DMARD prescription was similar for both sexes. Over eight years, disease duration, sex, biologics, grip force, SOFI-hand and pain intensity together explained 43% of the variation in DAS, while grip force, SOFI-lower, GAT and pain intensity could together explain 55% of variations in HAQ. CONCLUSIONS: Disease activity was fairly well managed, but disability gradually deteriorated. Despite similar medication, women had more disability than men. The discrepancy between disease activity and disability indicates unmet needs for multi-professional interventions to prevent progressing disability and patients at risk for disability need to be identified early in the process. © 2012 by the American College of Rheumatology.

Minskad incidens av förtidspension/sjukersättning på grund av RA sammanfaller i tid med nya behandlingsstrategier, men samtidigt ses motsvarande minskning av FP i populationen hos patienter med alla diagnoser. Rådande politiska och samhällsekonomiska förutsättningar har mycket stor betydelse för nivå av förtidspension/sjukersättning och kan påverka patienter med olika diagnoser på olika sätt. Detta bör beaktas vid analyser av arbetsförmåga i relation till effekt av behandling.

Objective. To explore the incidence of disability pension (DP) due to RA as an estimation of permanent work disability before and after introduction of biologic drugs. less thanbrgreater than less thanbrgreater thanMethods. The annual incidence of DP was derived from the Swedish National Social Insurance Register and rates of DP due to RA were compared with the total amount of new DPs. less thanbrgreater than less thanbrgreater thanResults.The incidence of DP due to RA has decreased over recent years, coinciding with earlier and more aggressive treatment with DMARDs and biologics. A similar declining incidence of DP was simultaneously seen in patients with all diagnoses in the general population. The decrease in DPs was, however, larger for RA and was evident even before introduction of biologics. In 1990, the proportion of DPs caused by RA was 1.9% out of total amount of DPs, decreasing to 1.5% in 2000 and to 1% in 2009. This may reflect effects of treatment, but may also be due to changing political policies as well as changes in age structure, increasing educational level and less physically demanding jobs. less thanbrgreater than less thanbrgreater thanConclusion. The decrease in DPs due to RA coincides with new treatment strategies as well as with decreasing levels of DPs in patients with all diagnoses. Prevailing political and economic conditions have a large impact on permanent work disability and may affect patients with various diagnoses in different ways. To determine if the decline is a true effect of better treatment, there is a need for further investigations, taking possible confounding factors into account.

Methods. Three-hundred and twenty patients with early (1 year) RA were assessed at regular intervals. Clinical and laboratory data were collected and patients reported health-care utilization and number of days lost from work. At 3-month follow-up, patients were divided into two groups according to disease activity, using DAS-28 with a cut-off level at 3.2. Direct and indirect costs and EuroQol-5D over the following 4 years were compared between the groups. Multivariate regression models were used to control for possible covariates. Results. Three months after diagnosis, a DAS-28 level of epsilon 3.2 was associated with high direct and indirect costs over the following 4 years. Patients with DAS-28 epsilon 3.2 at 3-month follow-up had more visits to physician, physiotherapist, occupational therapist and nurse, higher drug costs, more days in hospital and more extensive surgery compared with patients with 3-month DAS-28 less than 3.2. Number of days lost from work due to sick leave and permanent work disability was also higher in this group. The effect of disease activity on health-related quality of life was highly significant. In regression models, DAS-28 at 3-month follow-up was significantly associated with costs over the following years. Conclusions. Three months after diagnosis, DAS-28 is an important prognostic marker regarding health-care utilization and costs. Achieving remission or low disease activity 3 months after diagnosis is likely to decrease morbidity, increase quality of life and save costs for the patient and for society over the following years.

Background: Previous studies have reported that disability is strongly associated with disease activity in rheumatoid arthritis (RA) and disability at time of diagnosis has also proved to be a consistent predictor of disability over time.Objectives: To investigate the course of disease activity and disability over 8 years in early RA and to analyse differences between women and men.Methods: 149 patients with disease duration <1 year were included in the Swedish early RA-cohort "TIRA". Patients were followed prospectively for 8 years from the time of diagnosis. Disease activity was assessed by DAS28. Disability was measured by pain (VAS), grip force (Grippit), 'grip ability test' (GAT), range of motion in hand, upper and lower extremity (SOFI), walking speed and Health Assessment Questionnaire (HAQ). Changes over time and differences between women and men were evaluated.Results: Disease activity decreased over time from inclusion to the 8-year follow-up for both women and men. Disability as measured by SOFI (hand, upper and lower extremity) and walking time was improved during the first year after diagnosis but at the 7 and 8 year follow-up, the level of disability was comparable to the level at inclusion. Pain, grip force and GAT were also improved during the first years but thereafter remained stable. HAQ scores were similar in men and women at inclusion. After initial improvement, HAQ remained at a stable level in men, while scores for women deteriorated from year 2 onwards and had reached back to baseline levels at 8 year follow-up. More disability in women than men was also seen in grip force whereas men had more disability than women in SOFI upper extremity. There were no significant differences between women and men in disease activity or disability as measured by VAS pain, GAT, SOFI hand or SOFI lower extremity during the 8-year follow-up.Conclusion: Although disease activity was well managed, disability deteriorated over 8 years with a less favourable course in women than men. Besides controlling disease activity, there is accordingly a need for regular assessments to detect and prevent progressing disability in RA-patients, not only in the early phase of disease, but also over the following years

Denna rapport är framtagen i ett samarbete mellan CMT, Reumakliniken i Östergötland och Avdelningen för Reumatologi vid IKE, Hälsouniversitetet i Linköping och har finansierats med hjälp av Landstinget i Östergötland och Forskningsrådet i Sydvästra Sjukvårdsregionen (FORSS).

Det övergripande syftet med TIRA-projektet (Tidiga Insatser vid Reumatoid Artrit) var att ställa diagnos tidigt och starta multiprofessionell behandling på specialistenhet. Modern handläggning av RA (ledgångsreumatism) innebär snabbt ställd diagnos, snabbt insatt potent bromsmedicin och strukturerad uppföljning. Detta arbetssätt utvecklades i TIRA-studien och har haft stor betydelse för omhändertagandet av nyinsjuknade patienter med reumatisk sjukdom. TIRA studien har också skapat ett nätverk för kunskapsutveckling inom hela sydvästra sjukvårdsregionen samt Södermanlands och Örebro län. En stor databas för forskning har skapats och arbetet har resulterat i 16 originalartiklar i vetenskapliga tidskrifter. Fem avhandlingar har hittills skrivits med utgångspunkt från TIRA-data. Data har också exporterats till det nationella Svenska RA-registret.

Sedan TIRA-studien startade, har behandlingsstrategierna ändrats avsevärt. I början av 2000-talet introducerades s.k. biologiska läkemedel, framför allt TNFblockerare och 10 år efter start av TIRA-1 har nu TIRA-2 studien startat.

Upplägget är i allt väsentligt detsamma och TIRA-1 kohorten kommer därvid att utgöra ett unikt referensmaterial, såväl till hälsoekonomiska data som till sjukdomsutveckling för patienter i den nya studien. Denna rapport omfattar TIRA-1 studien och redovisar sjukdomsförlopp och hälsoekonomiska konsekvenser av sjukdomen och dess behandling. Många personer har varit delaktiga i studien och vi vill främst tacka Thomas Skogh, Reumakliniken Universitetssjukhuset i Linköping och alla medarbetare på de 10 medverkande reumatologenheterna. Vi vill också tacka Jan Persson som är medarbetare i TIRA projektet och har bidragit med värdefulla synpunkter. Ett extra varmt tack riktas till alla 320 patienter som deltagit i undersökningar och noggrant fyllt i enkäter under flera år.

Linköping november 2007-11-27

Eva Hallert, Magnus Husberg, Andrea Schmidt, Dick Jonsson

Objective. To calculate direct and indirect costs and to studydisease activity and functional ability over 3 yr in early rheumatoidarthritis (RA).

Methods. Three hundred and three patients with early (≤1 yr)RA were recruited during a period of 27 months (1996–1998).Data were recorded during 3 yr to assess disease activity, functionalability, medication, health-care utilization and days lost fromwork.

Results. Within 3 months, improvements were seen regarding allrecorded variables assessing disease activity and functionalability, but 15% had sustained high or moderate disease activitythroughout the study period. Indirect costs exceeded directcosts in all 3 yr. The average direct costs were € 3704 (US$3297) in year 1 and € 2652 (US$ 2360) in year 3. All costs decreased,except those for medication and surgery. Compared with men,women had more ambulatory care visits and used more complementarymedicine. The indirect costs were € 8871 (US$ 7895) in year 1and remained essentially unchanged; this was similar for bothsexes. Almost 50% were on sick leave or early retirement atinclusion. Sick leave decreased but was offset by an increasein early retirement. The 14 patients who eventually receivedTNF inhibitors incurred higher costs even before prescriptionof anti-TNF therapy.

Conclusion. Disease activity and functional ability improvedwithin 3 months after diagnosis of early RA. Direct costs decreased,except for medication and surgery. Indirect costs remained unchanged.Fifteen per cent of the patients had high or moderate diseaseactivity in all 3 yr, indicating a need for more aggressiveearly anti-rheumatic therapy.

Rheumatoid arthritis (RA) is a major cause of progressive joint damage and disability, and is associated with decline in quality of life, reduced ability to work and increased health care utilisation. The economic consequences of the disease are substantial for the individuals and their families and for the society as a whole. This thesis describes a 5-year follow up of 320 patients with early RA, enrolled between January 1996 and April 1998 in the Swedish multi-centre inception cohort TIRA (early interventions in rheumatoid arthritis). Health status, function and costs were investigated. Predictors of high costs were calculated, and an algorithm was constructed to predict future need for TNFinhibitor treatment in patients not responding to traditional disease-modifying antirheumatic drugs (DMARDs). Clinical and laboratory data, measures of functional capacity and self-reported assessments were collected regularly. In addition, patients completed biannual/annual questionnaires concerning all health care utilisation and days lost from work due to the disease. Within 3 months, improvements were seen regarding all variables assessing disease activity and functional ability, but 15% of the patients had sustained high or moderate disease activity throughout the study period. The scores of ‘health assessment questionnaire’ (HAQ) were similar for men and women at baseline, but had a less favourable course in women, who also had DMARDs more frequently prescribed.

Ambulatory care accounted for 76% of the direct costs during the first year. Women had more ambulatory care visits and higher usage of complementary medicine compared to men. Men ≥65 years had low costs compared to younger men and compared to women of all ages. In multiple logistic regression tests, HAQ, high levels of IgM-class rheumatoid factor (RF), and poor hand function increased the odds of incurring high direct costs. Poor hand function and pain increased the odds of incurring high indirect costs.

Indirect costs exceeded direct costs all three years. The average direct costs were €3,704 (US$ 3,297) year 1 and €2,652 (US$ 2,360) year 3. All costs decreased over the years, except those for medication and surgery. The indirect costs were €8,871 (US$ 7,895) year 1 and remained essentially unchanged, similarly for both sexes. More than 50% were on sick leave or early retirement at inclusion. Sick leave decreased but was offset by increase in early retirement. 14 patients (5%) were prescribed TNF-inhibitors at the 3- year follow up, thus increasing drug costs substantially. However, they incurred higher costs even before prescription of anti-TNF therapy.

At the 5-year follow-up (2001-2003), 31 patients (12%) were prescribed TNFinhibitors. Baseline values of erythrocyte sedimentation rate, C-reactive protein, anti-CCP antibodies and morning stiffness were significantly higher in this group. These patients were also to a larger extent RF-positive and carriers of the ‘shared epitope’ (SE). Anti-TNF treated patients were significantly younger and more often women. For men, a predictive model was constructed using baseline data including SE+ and IgA-RF >100 U/L and anti-CCP >240 U/L yielding a specificity of 98% and a sensitivity of 71%. For women, disease activity score (DAS28) at the 3-month follow-up proved to be a better predictor, and the final model comprised SE+ and 3-month DAS28>5.2, giving a specificity of 95% and a sensitivity of 59%.

Objective. To calculate direct and indirect costs in early rheumatoid arthritis (RA) and to characterize patients generating high and low costs respectively.

Methods. Two hundred and ninety-seven patients with recent-onset (≤12 months) RA were recruited. Clinical/laboratory data and 'health assessment questionnaire' (HAQ) were registered at inclusion and after 3, 6 and 12 months. After 6 and 12 months, the patients completed a questionnaire concerning health-care utilization and days lost from work. A cut-off point for direct costs was set at 34 000 Swedish kronor (3675) defining one-third of the patients as a high-cost group and two-thirds as low-cost group. Indirect costs were calculated for patients aged <65 yr.

Results. Two hundred and eleven patients completed the HAQ on both occasions. Indirect costs exceeded direct costs by a factor of 2.3. Sixty three per cent experienced work disability during the first year and were identified as the 'high-indirect-cost group'. Indirect costs accounted for >70% of total costs. Direct costs included ambulatory health care (76%), hospitalization (12%) and medication (9%). Men aged ≥65 yr had low costs compared with younger men and women of all ages. In multiple logistic regression tests, HAQ, high levels of IgM rheumatoid factor (IgM RF) and poor hand function increased the odds of entering the high-direct-cost group, and poor hand function and pain increased the odds of entering the high-indirect-cost group.

Conclusions. Substantial costs were incurred during the first year after diagnosis of early RA, mainly due to work disability. Indirect costs were two to three times higher than direct costs. High levels of IgM RF, high HAQ score, poor hand function and pain increased the odds of entering high-cost groups.

Objective: To describe the course of recent onset rheumatoidarthritis (RA) and to compare consequences of the disease inmen and women.

Methods: 284 patients with recent onset RA were followed upprospectively for two years from the time of diagnosis. Measuresof disease activity (for example, 28 joint disease activityscore (DAS28), C reactive protein, morning stiffness, physician’sglobal assessment) and function outcome (for example, rangeof movement, hand function, walking time) were determined. Thepatients’ self reported assessment of functional capacity(Health Assessment Questionnaire (HAQ)) and grading of wellbeingand pain (visual analogue scale) were registered. Changes overtime and differences between men and women were evaluated.

Results: Improvements were seen for all variables within thefirst three months. Disease activity then remained unchanged.Function variables followed the same pattern during the firstyear, but then tended to worsen. HAQ scores were similar atbaseline, but significantly worse in women than in men at theone and two year follow ups.

Conclusions: Disease activity was well managed and had improvedsubstantially after two years, whereas function seemed slowlyto deteriorate. Although disease variables were similar formen and women, functional ability (HAQ) had a less favourablecourse in women.