Increased Risk of Systemic Lupus Erythematosus in 29,000 Patients with Biopsy-verified Celiac Disease

Objective.To investigate a possible association between celiac disease (CD) and systemic lupus erythematosus (SLE). Case series have indicated a possible association, but population-based studies are lacking.Methods.We compared the risk of SLE in 29,048 individuals with biopsy-verified CD (villous atrophy, Marsh 3) from Sweden’s 28 pathology departments with that in 144,352 matched individuals from the general population identified through the Swedish Total Population Register. SLE was defined as having at least 2 records of SLE in the Swedish Patient Register. We used Cox regression to estimate hazard ratios (HR) for SLE.Results.During followup, 54 individuals with CD had an incident SLE. This corresponded to an HR of 3.49 (95% CI 2.48−4.90), with an absolute risk of 17/100,000 person-years and an excess risk of 12/100,000. Beyond 5 years of followup, the HR for SLE was 2.54 (95% CI 1.57−4.10). While SLE was predominantly female, we found similar risk estimates in men and women. When we restricted our outcome to individuals who also had a dispensation for a medication used in SLE, the HR was 2.43 (95% CI 1.22−4.87). The HR for having 2 records of SLE diagnoses, out of which at least 1 had occurred in a department of rheumatology, nephrology/dialysis, internal medicine, or pediatrics, was 2.87 (95% CI 1.97−4.17).Conclusion.Individuals with CD were at a 3-fold increased risk of SLE compared to the general population. Although this excess risk remained more than 5 years after CD diagnosis, absolute risks were low.

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Incidence of COVID-19 Hospitalisation in Patients with Systemic Lupus Erythematosus: A Nationwide Cohort Study from Denmark

Journal of Clinical Medicine ◽

10.3390/jcm10173842 ◽

2021 ◽

Vol 10 (17) ◽

pp. 3842

Author(s):

René Cordtz ◽

Salome Kristensen ◽

Louise Plank Holm Dalgaard ◽

Rasmus Westermann ◽

Kirsten Duch ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Cohort Study ◽

General Population ◽

Lupus Erythematosus ◽

Cox Regression ◽

Hazard Ratio ◽

Systemic Lupus ◽

Increased Risk ◽

Study Results ◽

The Impact

Background: Patients with systemic lupus erythematosus (SLE) have an increased risk of infections due to impaired immune functions, disease activity, and treatment. This study investigated the impact of having SLE on the incidence of hospitalisation with COVID-19 infection. Methods: This was a nationwide cohort study from Denmark between 1 March 2020 to 2 February 2021, based on the linkage of several nationwide registers. The adjusted incidence of COVID-19 hospitalisation was estimated for patients with SLE compared with the general population in Cox-regression models. Among SLE patients, the hazard ratio (HR) for hospitalisation was analysed as nested case-control study. Results: Sixteen of the 2533 SLE patients were hospitalised with COVID-19 infection. The age-sex adjusted rate per 1000 person years was 6.16 (95% CI 3.76–10.08) in SLE patients, and the corresponding hazard ratio was 2.54 (95% CI 1.55–4.16) compared with the matched general population group after adjustment for comorbidities. Among SLE patients, hydroxychloroquine treatment was associated with a HR for hospitalisation of 0.61 (95% CI 0.19–1.88), and 1.06 (95% CI 0.3–3.72) for glucocorticoid treatment. Conclusion: Patients with SLE were at increased risk of hospitalisation with COVID-19.

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Novel gene variants associated with cardiovascular disease in systemic lupus erythematosus and rheumatoid arthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-212614 ◽

2018 ◽

Vol 77 (7) ◽

pp. 1063-1069 ◽

Cited By ~ 8

Author(s):

Dag Leonard ◽

Elisabet Svenungsson ◽

Johanna Dahlqvist ◽

Andrei Alexsson ◽

Lisbeth Ärlestig ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Systemic Lupus Erythematosus ◽

Cardiovascular Disease ◽

General Population ◽

Lupus Erythematosus ◽

Risk Allele ◽

Snp Array ◽

Inflammatory Rheumatic Diseases ◽

Systemic Lupus ◽

Increased Risk

ObjectivesPatients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) have increased risk of cardiovascular disease (CVD). We investigated whether single nucleotide polymorphisms (SNPs) at autoimmunity risk loci were associated with CVD in SLE and RA.MethodsPatients with SLE (n=1045) were genotyped using the 200K Immunochip SNP array (Illumina). The allele frequency was compared between patients with and without different manifestations of CVD. Results were replicated in a second SLE cohort (n=1043) and in an RA cohort (n=824). We analysed publicly available genetic data from general population, performed electrophoretic mobility shift assays and measured cytokine levels and occurrence of antiphospholipid antibodies (aPLs).ResultsWe identified two new putative risk loci associated with increased risk for CVD in two SLE populations, which remained after adjustment for traditional CVD risk factors. An IL19 risk allele, rs17581834(T) was associated with stroke/myocardial infarction (MI) in SLE (OR 2.3 (1.5 to 3.4), P=8.5×10−5) and RA (OR 2.8 (1.4 to 5.6), P=3.8×10−3), meta-analysis (OR 2.5 (2.0 to 2.9), P=3.5×10−7), but not in population controls. The IL19 risk allele affected protein binding, and SLE patients with the risk allele had increased levels of plasma-IL10 (P=0.004) and aPL (P=0.01). An SRP54-AS1 risk allele, rs799454(G) was associated with stroke/transient ischaemic attack in SLE (OR 1.7 (1.3 to 2.2), P=2.5×10−5) but not in RA. The SRP54-AS1 risk allele is an expression quantitative trait locus for four genes.ConclusionsThe IL19 risk allele was associated with stroke/MI in SLE and RA, but not in the general population, indicating that shared immune pathways may be involved in the CVD pathogenesis in inflammatory rheumatic diseases.

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Mortality in patients with systemic lupus erythematosus and neuropsychiatric involvement: A retrospective analysis from a tertiary referral center in the Netherlands

Lupus ◽

10.1177/0961203320963815 ◽

2020 ◽

Vol 29 (14) ◽

pp. 1892-1901

Author(s):

Rory C Monahan ◽

Rolf Fronczek ◽

Jeroen Eikenboom ◽

Huub A M Middelkoop ◽

Liesbeth J J Beaart-van de Voorde ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

General Population ◽

The Netherlands ◽

Lupus Erythematosus ◽

Current Status ◽

Systemic Lupus ◽

Tertiary Referral ◽

Risk Of Death ◽

Increased Risk ◽

Specific Mortality

Objective We aimed to evaluate all-cause and cause-specific mortality in patients with systemic lupus erythematosus (SLE) and neuropsychiatric (NP) symptoms in the Netherlands between 2007–2018. Methods Patients visiting the tertiary referral NPSLE clinic of the Leiden University Medical Center were included. NP symptoms were attributed to SLE requiring treatment (major NPSLE) or to other and mild causes (minor/non-NPSLE). Municipal registries were checked for current status (alive/deceased). Standardized mortality ratios (SMRs) and 95% confidence intervals (CI) were calculated using data from the Dutch population. Rate ratio (RR) and 95% CI were calculated using direct standardization to compare mortality between major NPSLE and minor/non-NPSLE. Results 351 patients were included and 149 patients were classified as major NPSLE (42.5%). Compared with the general population, mortality was increased in major NPSLE (SMR 5.0 (95% CI: 2.6–8.5)) and minor/non-NPSLE patients (SMR 3.7 (95% CI: 2.2–6.0)). Compared with minor/non-NPSLE, mortality was similar in major NPSLE patients (RR: 1.0 (95% CI: 0.5–2.0)). Cause-specific mortality rates demonstrated an increased risk of death due to infections in both groups, whereas death due to cardiovascular disease was only increased in minor/non-NPSLE patients. Conclusion Mortality was increased in both major NPSLE and minor/non-NPSLE patients in comparison with the general population. There was no difference in mortality between major NPSLE and minor/non-NPSLE patients.

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FRI0556 INCREASED RISK OF MORTALITY AND CANCER IN SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM A LUPUS COHORT STUDY FROM 1998 TO 2015

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2557 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 880.1-880

Author(s):

G. Y. Ahn ◽

J. Lee ◽

J. M. Shin ◽

Y. K. Lee ◽

J. H. Kim ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

General Population ◽

Cerebrovascular Disease ◽

Lupus Erythematosus ◽

Cytotoxic Agents ◽

Mortality Data ◽

Systemic Lupus ◽

Risk Of Mortality ◽

Increased Risk ◽

Age And Sex

Background:Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune inflammatory disease with increased risk for mortality and cancers possibly because of the effects of systemic inflammation and immunodeficiency due to disease itself and/or cytotoxic agents for SLE management. Although there has been improvement in the prognosis of SLE over decades with the treatment advance including standardized treatment strategy for lupus nephritis and less cytotoxic agents, the improvement also is fixed nowadays.Objectives:In this study, we we are to investigate the mortality and cancer of SLE patients in a longitudinal SLE cohort and compare the morality ratio and incidence of cancer with general population over time.Methods:This study was conducted in Hanyang BAE lupus cohort during the period of 1998 to 2015. Mortality data and malignancy data were derived in connection with data from the Korean National Statistics Office and the Korea Central Incidence Database, respectively. The Standardized Mortality Ratio (SMR) and Standardized Incidence Ratio (SIR) was estimated yearly by dividing the observed number deaths/cancers by the expected number of deaths/cancers of age- and sex- matched general population from matched year.Results:Mortality data were available in 1284 patients and total 71 deaths were observed. The most common cause of death was SLE itself (52.1%) followed by infection (18.3%), cerebrovascular disease (8.5%) and suicide (7.0%). The total age and sex adjusted SMR was 3.4 [95% CI (Confidential Interval) 2.6-4.1]. When we conduct subgroup analysis by age, the sex-adjusted SMR was significantly increased in young and middle aged adult patients: the SMR in patients younger than 20 was 12.2, but it was not significant due to the small number of young patients (observed death 3, expected death 0.3, 95% CI 0-26.0). The adjusted SMR in patients aged 20-39, aged 40-59 and aged over 60 were 9.8 (observed death 35, expected death 4.8, 95% CI 6.5-13.0), 3.7 (observed death 24, expected death 11.5, 95% CI 2.2-5.2), and 1.0 (observed death 9, expected death 10.3, 95% CI 0.3-1.6), respectively. Compared with alive patients, died patients had more serositis and more neurologic disorder according to American College of Rheumatology classification criteria for SLE despite the shorter observational period (5.6 years vs. 9.4 years).Malignancy data were available in 1,020 patients and 56 primary cancers were diagnosed. Solid tumor was developed in 51 patient and hematologic malignancy was developed in 5 patients (3 non-Hodgkin’s lymphoma, 1 solitary plasmacytoma and 1 acute lymphoblastic leukemia). Thyroid cancer was the most common solid cancer (24 patients) followed by colorectal (5 patients), breast (4 patients), cervical cancer (4 patients) and hepatocellular carcinoma (3 patients). The total age and sex adjusted SIR was 1.1 (95% CI 0.8-1.4).Conclusion:Patients with SLE had higher risk of mortality than general population and the younger patients had the higher risk of mortality. The leading cause of death was SLE itself followed by infection and cerebrovascular disease. The risk for cancer in patient with SLE was similar with that of general population.Disclosure of Interests:None declared

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Autoimmune disorders in patients with idiopathic thrombotic thrombocytopenic purpura

Hämostaseologie ◽

10.1055/s-0037-1619783 ◽

2012 ◽

Vol 32 (S 01) ◽

pp. S86-S89 ◽

Cited By ~ 12

Author(s):

M.-L. John ◽

I. Scharrer

Keyword(s):

Systemic Lupus Erythematosus ◽

Celiac Disease ◽

General Population ◽

Thrombotic Thrombocytopenic Purpura ◽

Patient Group ◽

Lupus Erythematosus ◽

Autoimmune Disorders ◽

Prevalence Rates ◽

Systemic Lupus ◽

Thrombocytopenic Purpura

Summary76 German patients suffering from thrombotic thrombocytopenic purpura (TTP) were interrogated about the prevalence of cooccurring autoimmune disorders. In order to analyze a possible association of TTP with the questioned diseases, a comparison of prevalence rates between the patient group and the general population has been made for each disease. Results: Compared to the estimated prevalence rates, the statistical analysis revealed an unexpected high occurrence of the following disorders within the patient group: Hashimoto’s thyroiditis (23.5% within the patients compared to 0.7% within the general population, p<0.001), systemic lupus erythematosus (SLE) (6.5% in patients to 0.025% in the general population, p<0.001), immune thrombocytopenic purpura (ITP) (6.3% in patients to 0.02% in the general population, p < 0.001), psoriasis (9.4% in patients to 2.5% in the general population, p = 0.005) and celiac disease (3.1% in patients to 0.2% in the general population, p = 0.007). Conclusion: These findings confirm the mentioned tendency of autoimmune diseases to co-occur in one individual and argue once more for a genetic susceptibility in idiopathic TTP as well as in autoimmune disorders.

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Systemic Lupus Erythematosus Features in Rheumatoid Arthritis and Their Effect on Overall Mortality

The Journal of Rheumatology ◽

10.3899/jrheum.080091 ◽

2009 ◽

Vol 36 (1) ◽

pp. 50-57 ◽

Cited By ~ 23

Author(s):

MURAT ICEN ◽

PAULO J. NICOLA ◽

HILAL MARADIT-KREMERS ◽

CYNTHIA S. CROWSON ◽

TERRY M. THERNEAU ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Systemic Lupus Erythematosus ◽

Mortality Risk ◽

Lupus Erythematosus ◽

Cox Regression ◽

Systemic Lupus ◽

Risk Of Death ◽

Acr Criteria ◽

Increased Risk ◽

Overall Mortality

ObjectiveFeatures of systemic lupus erythematosus (SLE) are commonly observed in patients with rheumatoid arthritis (RA). However, their frequency and clinical significance are uncertain. We examined the frequency of SLE features in RA and their effect on overall mortality.MethodsWe assembled a population-based incidence cohort of subjects aged ≥ 18 years first diagnosed with RA [1987 American College of Rheumatology (ACR) criteria] between 1955 and 1995. Information regarding disease characteristics, therapy, comorbidities, and SLE features (1982 ACR criteria) were collected from the complete inpatient and outpatient medical records. Cox regression models were used to estimate the mortality risk associated with lupus features.ResultsThe study population comprised 603 subjects with incident RA (mean age 58 yrs, 73% women) with a mean followup time of 15 years. By 25 years after RA incidence, ≥ 4 SLE features were observed in 15.5% of the subjects with RA. After adjustment for age and sex, occurrence of ≥ 4 SLE features was associated with increased overall mortality [hazard ratio (HR) 5.54, 95% confidence interval (CI) 3.59–8.53].With further adjustment for RA characteristics, therapy, and comorbidities, the association weakened but remained statistically significant (HR 2.56, 95% CI 1.60–4.08). After adjustment for age, sex, RA characteristics, therapy, and comorbidities, thrombocytopenia (2.0, 95% CI 1.2, 3.1) and proteinuria (1.8, 95% CI 1.3, 2.6) were significantly associated with mortality.ConclusionSLE features were common in RA, given sufficient observation time. Subjects with RA who developed ≥ 4 SLE features had an increased risk of death. Proteinuria and thrombocytopenia were individually associated with an increased mortality risk.

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Increased cancer risk in patients with cutaneous lupus erythematosus and systemic lupus erythematosus compared with the general population: A Danish nationwide cohort study

Lupus ◽

10.1177/0961203321990106 ◽

2021 ◽

pp. 096120332199010

Author(s):

Rasmus Westermann ◽

Kristian Zobbe ◽

René Cordtz ◽

Jeanette H Haugaard ◽

Lene Dreyer

Keyword(s):

Systemic Lupus Erythematosus ◽

General Population ◽

Lupus Erythematosus ◽

Cutaneous Lupus Erythematosus ◽

Systemic Lupus ◽

Lung Cancers ◽

Increased Risk ◽

Specific Cancer ◽

Risk Of Cancer ◽

Cutaneous Lupus

Objectives To investigate if patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) have an increased risk of cancer compared with the general population, and furthermore to identify specific cancer types associated with increased risk. Methods This is an observational cohort study of 5310 patients with CLE or SLE identified in the Danish National Patient Register from 1 January 1995 to 31 December 2014. The cohort was followed up for cancer by linkage to the Danish Cancer Registry. Based on the age, sex, and calendar specific cancer rates of the general population of Denmark, standardised incidence ratios (SIRs) were calculated. Results The patients with CLE or SLE were followed for 40.724 person-years, each group’s average duration of follow-up being 6.9 and 8.1 years. The SIR for overall cancer (except non-melanoma skin cancer (NMSC)) was increased in patients with CLE 1.35 (95%CI 1.15 to 1.58) and patients with SLE 1.45 (95%CI 1.30 to 1.62). Both groups had high risks of hematological – including a 3–4-fold increased risk of non-Hodgkin lymphoma –, pancreatic, and lung cancers. Several cancers associated with oncogenic viruses as liver and tongue/mouth/pharynx were increased in the SLE group, while the risk of ovarian cancer was increased 2–4-fold only in the CLE group. Conclusion The overall risk of cancer was significantly increased in both patients with CLE and SLE. SIRs for hematological, pancreatic and lung cancers were elevated in both groups. Extra awareness of cancer in patients with SLE and patients with CLE should be considered.

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Association of Childhood Abuse with Incident Systemic Lupus Erythematosus in Adulthood in a Longitudinal Cohort of Women

The Journal of Rheumatology ◽

10.3899/jrheum.190009 ◽

2019 ◽

Vol 46 (12) ◽

pp. 1589-1596 ◽

Cited By ~ 3

Author(s):

Candace H. Feldman ◽

Susan Malspeis ◽

Cianna Leatherwood ◽

Laura Kubzansky ◽

Karen H. Costenbader ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Sexual Abuse ◽

Childhood Abuse ◽

Lupus Erythematosus ◽

Emotional Abuse ◽

Parental Education ◽

Cox Regression ◽

Health Study ◽

Systemic Lupus ◽

Increased Risk

Objective.Exposure to severe stressors may alter immune function and augment inflammation and cytokine release, increasing risk of autoimmune disease. We examined whether childhood abuse was associated with a heightened risk of incident systemic lupus erythematosus (SLE).Methods.Data were drawn from the Nurses’ Health Study II, a cohort of US female nurses enrolled in 1989, followed with biennial questionnaires. We measured childhood physical and emotional abuse with the Physical and Emotional Abuse Subscale of the Childhood Trauma Questionnaire and sexual abuse with the Sexual Maltreatment Scale of the Parent-Child Conflict Tactics Scale, both administered in 2001. We identified incident SLE (≥ 4 American College of Rheumatology 1997 classification criteria) through 2015. We used multivariable Cox regression models to evaluate the association between childhood abuse and SLE, accounting for potential confounders (e.g., parental education, occupation, home ownership) and mediators [e.g., depression, posttraumatic stress disorder (PTSD)].Results.Among 67,516 women, there were 94 cases of incident SLE. In adjusted models, exposure to the highest versus lowest physical and emotional abuse was associated with 2.57 times greater risk of SLE (95% CI 1.30–5.12). We found that 17% (p < 0.0001) of SLE risk associated with abuse could be explained by depression and 23% (p < 0.0001) by PTSD. We did not observe a statistically significant association with sexual abuse (HR 0.84, 95% CI 0.40–1.77, highest vs lowest exposure).Conclusion.We observed significantly increased risk of SLE among women who had experienced childhood physical and emotional abuse compared with women who had not. Exposure to childhood adversity may contribute to development of SLE.

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Improving Pneumococcal Vaccination Rates in Rheumatology Clinics

The Journal of Rheumatology ◽

10.3899/jrheum.210058 ◽

2021 ◽

pp. jrheum.210058

Author(s):

Julia G. Harris

Keyword(s):

Systemic Lupus Erythematosus ◽

General Population ◽

Lupus Erythematosus ◽

Pneumococcal Disease ◽

Pneumococcal Infection ◽

Pneumococcal Vaccination ◽

Systemic Lupus ◽

Vaccination Rates ◽

Increased Risk ◽

Invasive Pneumococcal Infection

Rheumatology patients on immunosuppression are at increased risk of invasive pneumococcal disease. There is a multitude of literature highlighting the risk of pneumococcal infection, hospitalization, and even death in patients with systemic lupus erythematosus (SLE), in whom incidence of invasive pneumococcal infection is 13 times higher than the general population. 1,2,3,4

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AB0430 MORTALITY IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND NEUROPSYCHIATRIC SYMPTOMS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.939 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1514.2-1514

Author(s):

R. Monahan ◽

R. Fronczek ◽

J. Eikenboom ◽

H. Middelkoop ◽

L. J. J. Beaart- van de Voorde ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

General Population ◽

Clinical Diagnosis ◽

Lupus Erythematosus ◽

Neuropsychiatric Symptoms ◽

Current Status ◽

Systemic Lupus ◽

Risk Of Death ◽

Increased Risk ◽

All Cause Mortality

Background:Little is known about mortality in patients with systemic lupus erythematosus (SLE) presenting with neuropsychiatric (NP) symptoms.Objectives:We aimed to evaluate all-cause and cause-specific mortality in patients with SLE and NP symptoms.Methods:All patients with the clinical diagnosis of SLE of 18 years and older that visited the tertiary referral NPSLE clinic of the Leiden University Medical Center between 2007-2018 and signed informed consent were included in this study. Patients were classified as NPSLE if NP symptoms were attributed to SLE and immunosuppressive or anticoagulant therapy was initiated, otherwise patients were classified as non-NPSLE. Municipal registries were checked for current status (alive/deceased). Electronical medical files were studied for clinical characteristics and cause of death. Standardized mortality ratios (SMRs) and 95% confidence intervals were calculated using data from the general Dutch population. In addition, a rate ratio (RR) was calculated using direct standardization to compare mortality in NPSLE with non-NPSLE patients.Results:351 patients with the clinical diagnosis of SLE were included, of which 149 patients were classified as NPSLE (42.5%). Compared with the general population, mortality was increased five times in NPSLE (SMR 5.0, 95% CI: 2.6-8.5) and nearly four times in non-NPSLE patients (SMR 3.7, 95% CI: 2.2-6.0), as shown in Table 1. Risk of death due to cardiovascular disease (CVD) was increased in non-NPSLE patients (SMR 6.2, 95% CI: 2.0-14.6) and an increased risk of death to infections was present in both NPSLE and non-NPSLE patients ((SMR 29.9, 95% CI: 3.5 – 105) and SMR 91.3 (95% CI: 18.8 – 266) respectively). However, mortality did not differ between NPSLE and non-NPSLE patients (RR 1.0, 95% CI: 0.5 – 2.0).Table 1.All-cause mortality in SLE patients presenting with neuropsychiatric symptoms attributed to SLE (NPSLE) or to other causes (non-NPSLE)NPSLE(N = 149)Non-NPSLE(N = 202)Deaths (N, %)13 (8.7)17 (8.4)Age at death (median, range)49 (32 – 79)59 (20 – 89)Follow-up time (years)9061047Crude mortality rate (per 1000 PY)14.316.2All-cause mortality*Female5.5 (2.8 – 9.6)3.4 (1.9 – 5.7)Male2.3 (0.1 - 12.8)6.2 (1.3 – 18.2)Combined5.0 (2.6 – 8.5)3.7 (2.2 – 6.0)*Standardized mortality ratio, ratio of the observed and expected number of deathsConclusion:Mortality was increased in both NPSLE and non-NPSLE patients in comparison with the general population, but there was no difference in mortality between NPSLE and non-NPSLE patients. Risk of death due to infections was increased in both groups.Disclosure of Interests:Rory Monahan: None declared, Rolf Fronczek: None declared, Jeroen Eikenboom: None declared, Huub Middelkoop: None declared, L.J.J. Beaart- van de Voorde: None declared, Gisela Terwindt: None declared, Nic van der Wee: None declared, Frits Rosendaal: None declared, Thomas Huizinga Grant/research support from: Ablynx, Bristol-Myers Squibb, Roche, Sanofi, Consultant of: Ablynx, Bristol-Myers Squibb, Roche, Sanofi, Margreet Kloppenburg: None declared, G.M. Steup-Beekman: None declared

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