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- van Assen, S., et al.
(författare)
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EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases
- 2011
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Ingår i: Annals of the Rheumatic Diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 70:3, s. 414-422
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To develop evidence-based European League Against Rheumatism (EULAR) recommendations for vaccination in patients with autoimmune inflammatory rheumatic diseases (AIIRD). Methods A EULAR task force was composed of experts representing 11 European countries, consisting of eight rheumatologists, four clinical immunologists, one rheumatologist/clinical immunologist, one infectious disease physician, one nephrologist, one paediatrician/rheumatologist and one clinical epidemiologist. Key questions were formulated and the eligible spectrum of AIIRD, immunosuppressive drugs and vaccines were defined in order to perform a systematic literature review. A search was made of Medline from 1966 to October 2009 as well as abstracts from the EULAR meetings of 2008 and 2009 and the American College of Rheumatology (ACR) meetings of 2007 and 2008. Evidence was graded in categories I-IV, the strength of recommendations was graded in categories A-D and Delphi voting was applied to determine the level of agreement between the experts of the task force. Results Eight key questions and 13 recommendations addressing vaccination in patients with AIIRD were formulated. The strength of each recommendation was determined. Delphi voting revealed a very high level of agreement with the recommendations among the experts of the task force. Finally, a research agenda was proposed. Conclusion Recommendations for vaccination in patients with AIIRD based on the currently available evidence and expert opinion were formulated. More research is needed, particularly regarding the incidence of vaccine-preventable infectious diseases and the safety of vaccination in patients with AIIRD.
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- van Assen, S., et al.
(författare)
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Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: A systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases
- 2011
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Ingår i: Autoimmunity Reviews. - : Elsevier BV. - 1873-0183 .- 1568-9972. ; 10:6, s. 341-352
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Forskningsöversikt (refereegranskat)abstract
- Objectives: To present the systematic literature review (SLR), which formed the basis for the European League Against Rheumatism (EULAR) evidence-based recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD). Methods: AIIRD, vaccines and immunomodulating drugs, as well as eight key questions were defined by the multidisciplinary expert committee commissioned by EULAR for developing the recommendations. A SLR was performed using MedLine through October 2009 and including data from meta-analyses, systematic reviews, randomized trials, and observational studies, excluding case series with participants. Articles in English and regarding patients years of age, were eligible. Results: Several vaccine-preventable infections (VPI) occur more often in AIIRD-patients and most vaccines are efficacious in AIIRD-patients, even when treated with immunomodulating agents, except rituximab. There does not appear to be an increase in vaccination-related harms in vaccinated patients with AIIRD in comparison with unvaccinated patients with AIIRD. However, these studies are underpowered and therefore not conclusive. Conclusion: Based on the current evidence from the literature, recommendations for vaccination in patients with AIIRD were made. However, more research is needed in particular regarding incidence of VPI, harms of vaccination and the influence of (new and established) immunomodulating agents on vaccination efficacy. (C) 2011 Elsevier B.V. All rights reserved.
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- Berthold, E., et al.
(författare)
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Tumour necrosis factor-α/etanercept complexes in serum predict long-term efficacy of etanercept treatment in seronegative rheumatoid arthritis
- 2018
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Ingår i: Scandinavian Journal of Rheumatology. - : Informa UK Limited. - 0300-9742 .- 1502-7732. ; 47:1, s. 22-26
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To study whether serum levels of tumour necrosis factor-α (TNF-α), free or bound to etanercept, in biological-naïve adults with rheumatoid arthritis (RA) could predict the long-term efficacy of etanercept, measured as drug survival. Method: We identified 145 biological-naïve patients with RA starting treatment with etanercept at the Department of Rheumatology, Skåne University Hospital (1999–2008), of whom 16 had seronegative and 129 seropositive RA. TNF-α in serum was quantified using enzyme-linked immunosorbent assay in samples from the onset of treatment and at 6 week follow-up. Drug survival time was used to evaluate the long-term efficacy of etanercept. Results: Levels of TNF-α were significantly increased at follow-up compared to at the start. At the 6 week follow-up, circulating TNF-α mainly comprised TNF-α in complex with etanercept. Longer drug survival time correlated with increased TNF-α at 6 week follow-up in the patients with seronegative RA, but not in the seropositive patients. Conclusion: We demonstrated that levels of circulating TNF-α increased in almost all individuals after initiation of treatment with etanercept and that this increase mainly comprised TNF-α in complex with etanercept. More importantly, this increase may predict drug survival in adults with seronegative, but not seropositive, RA and suggests that measuring TNF-α/etanercept complexes in serum may be relevant in patients with seronegative RA.
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- Kobelt, Gisela, et al.
(författare)
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Costs and outcomes for patients with rheumatoid arthritis treated with biological drugs in Sweden: a model based on registry data
- 2009
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Ingår i: Scandinavian Journal of Rheumatology. - : Informa UK Limited. - 1502-7732 .- 0300-9742. ; 38:6, s. 409-418
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To design an economic model describing the costs and outcomes for patients treated with tumour necrosis factor alpha ( TNF alpha) inhibitors for rheumatoid arthritis ( RA) in current clinical practice in Sweden, to be used as a tool to estimate cost- effectiveness of the next generation of treatments. Methods: The model was constructed as a discrete event simulation ( DES) model analysed at patient level. It contains treatment and outcome data for 1903 patients followed in the RA registry for biological drugs in southern Sweden between 1999 and 2007 [ the Southern Swedish Arthritis Treatment Group ( SSATG) Register]. Resource consumption was based on a survey of 1027 patients in the same region. Costs and quality- adjusted life years ( QALYs) are presented for 10 ( 5) years, for patients with the mean characteristics at treatment start in SSATG [ Health Assessment Questionnaire ( HAQ) score 1.33, disease duration 12.1 years, age 55 years], but also for patients with more or less severe disease. Cost and outcomes ( QALYs) are discounted with 3%. Results: The 10- year costs in the base case amount to USD336 000 ( SD USD 64 000) or EUR 223 000, with a total of 4.4 QALYs. Over 5 years, the costs amount to USD 208 000 or EUR 138 000 and QALYs to 2.5. The results were most sensitive to HAQ level at treatment start, but also to underlying disease progression, age, and disease duration. Starting treatment at a lower HAQ level ( 0.85) reduces costs by 10% and increases QALYs by 20%. Conclusion: This analysis is based on the longest available follow- up for patients treated with TNF alpha inhibitors and provides an opportunity to explore treatment strategies when new therapies become available using actual clinical practice data.
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- Olofsson, Tor, et al.
(författare)
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Predictors of work disability after start of anti-TNF therapy in a national cohort of Swedish patients with rheumatoid arthritis: does early anti-TNF therapy bring patients back to work?
- 2017
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Ingår i: Annals of the Rheumatic Diseases. - : BMJ. - 0003-4967 .- 1468-2060. ; 76:7, s. 1245-1252
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To examine predictors of work ability gain and loss after anti-tumour necrosis factor (TNF) start, respectively, in working-age patients with rheumatoid arthritis (RA) with a special focus on disease duration. Methods Patients with RA, aged 19-62 years, starting their first TNF inhibitor 2006-2009 with full work ability (0 sick leave/disability pension days during 3 months before bio-start; n=1048) or no work ability (90 days; n=753) were identified in the Swedish biologics register (Anti-Rheumatic Treatment In Sweden, ARTIS) and sick leave/disability pension days retrieved from the Social Insurance Agency. Outcome was defined as work ability gain >= 50% for patients without work ability at bio-start and work ability loss >= 50% for patients with full work ability, and survival analyses conducted. Baseline predictors including disease duration, age, sex, education level, employment, Health Assessment Questionnaire, Disease Activity Score 28 and relevant comorbidities were estimated using Cox regression. Results During 3 years after anti-TNF start, the probability of regaining work ability for totally work-disabled patients was 35% for those with disease duration <5 years and 14% for disease duration >= 5 years (adjusted HR 2.1 (95% CI 1.4 to 3.2)). For patients with full work ability at bio-start, disease duration did not predict work ability loss. Baseline disability pension was also a strong predictor of work ability gain after treatment start. Conclusions A substantial proportion of work-disabled patients with RA who start anti-TNF therapy regain work ability. Those initiating treatment within 5 years of symptom onset have a more than doubled 3-year probability of regaining work ability compared with later treatment starts. This effect seems largely due to the impact of disease duration on disability pension status.
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- Svenson, M., et al.
(författare)
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Monitoring patients treated with anti-TNF- biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies
- 2007
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Ingår i: Rheumatology. - : Oxford University Press (OUP). - 1462-0332 .- 1462-0324. ; 46:12, s. 1828-1834
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Tidskriftsartikel (refereegranskat)abstract
- Objectives. Infliximab is an anti-tumour necrosis factor-alpha (TNF-alpha) mousehuman IgG1/k antibody used to treat patients with rheumatoid arthritis (RA) and other inflammatory diseases. Unfortunately, response failure and side-effects due to immunogenicity of the drug are not rare. In this study, we have compared different methods of assessing drug levels and anti-infliximab antibodies (Abs) and analysed the character of these Abs in sera of RA patients treated with infliximab for 1.5-18 months. Methods. Functional serum infliximab levels and anti-infliximab Abs were measured by fluid-phase RIAs using I-125-labelled ligands in combination with molecular size and affinity chromatography, and immune complex precipitation. Results. Anti-infliximab Abs were predominantly IgG, 36% being IgG4, and half the immune complexes were lambda-light-chain-positive. Ab titres were associated with inhibition of TNF binding to the drug, and low trough levels of infliximab were most frequent in anti-infliximab Ab-positive sera. Cross-binding to two other anti-TNF drugs was not observed. Detection of anti-infliximab Abs by solid-phase RIA using cross-binding of plastic-fixed and soluble infliximab exhibited low sensitivity and the data were inconsistent with results obtained from binding of the Abs to soluble infliximab. Conclusions. Specific and neutralizing anti-infliximab antibodies develop in RA patients treated with infliximab, and that low trough levels of functional infliximab are associated with the presence of such antibodies. The most sensitive antibody assay involved binding to soluble and intact infliximab. Assessments of bioavailability and immunogenicity of anti-TNF biologicals may be used to optimize dose regimens and prevent prolonged use of inadequate therapy.
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