Cost-effectiveness of monoclonal antibody and maternal immunization against respiratory syncytial virus (RSV) in infants: Evaluation for six European countries.

BACKGROUND: Respiratory syncytial virus (RSV) imposes a substantial burden on pediatric hospital capacity in Europe. Promising prophylactic interventions against RSV including monoclonal antibodies (mAb) and maternal immunizations (MI) are close to licensure. Therefore, we aimed to evaluate the cost-effectiveness of potential mAb and MI interventions against RSV in infants, for six European countries. METHODS: We used a static cohort model to compare costs and health effects of four intervention programs to no program and to each other: year-round MI, year-round mAb, seasonal mAb (October to April), and seasonal mAb plus a catch-up program in October. Input parameters were obtained from national registries and literature. Influential input parameters were identified with the expected value of partial perfect information and extensive scenario analyses (including the impact of interventions on wheezing and asthma). RESULTS: From the health care payer perspective, and at a price of €50 per dose (mAb and MI), seasonal mAb plus catch-up was cost-saving in Scotland, and cost-effective for willingness-to-pay (WTP) values ≥€20,000 (England, Finland) or €30,000 (Denmark) per quality adjusted life-year (QALY) gained for all scenarios considered, except when using ICD-10 based hospitalization data. For the Netherlands, seasonal mAb was preferred (WTP value: €30,000-€90,000) for most scenarios. For Veneto region (Italy), either seasonal mAb with or without catch-up or MI was preferred, depending on the scenario and WTP value. From a full societal perspective (including leisure time lost), the seasonal mAb plus catch-up program was cost-saving for all countries except the Netherlands. CONCLUSION: The choice between a MI or mAb program depends on the level and duration of protection, price, availability, and feasibility of such programs, which should be based on the latest available evidence. Future research should focus on measuring accurately age-specific RSV-attributable hospitalizations in very young children.

Age-Specific Estimates of Respiratory Syncytial Virus-Associated Hospitalizations in 6 European Countries: A Time Series Analysis.

BACKGROUND: Knowledge on age-specific hospitalizations associated with RSV infection is limited due to limited testing, especially in older children and adults in whom RSV infections are not expected to be severe. Burden estimates based on RSV coding of hospital admissions are known to underestimate the burden of RSV. We aimed to provide robust and reliable age-specific burden estimates of RSV-associated hospital admissions based on data on respiratory infections from national health registers and laboratory-confirmed cases of RSV. METHODS: We conducted multiseason regression analysis of weekly hospitalizations with respiratory infection and weekly laboratory-confirmed cases of RSV and influenza as covariates, based on national health registers and laboratory databases across 6 European countries. The burden of RSV-associated hospitalizations was estimated by age group, clinical diagnosis, and presence of underlying medical conditions. RESULTS: Across the 6 European countries, hospitalizations of children with respiratory infections were clearly associated with RSV, with associated proportions ranging from 28% to 60% in children younger than 3 months and we found substantial proportions of admissions to hospital with respiratory infections associated with RSV in children younger than 3 years. Associated proportions were highest among hospitalizations with ICD-10 codes of "bronchitis and bronchiolitis." In all 6 countries, annual incidence of RSV-associated hospitalizations was >40 per 1000 persons in the age group 0-2 months. In age group 1-2 years the incidence rate ranged from 1.3 to 10.5 hospitalizations per 1000. Adults older than 85 years had hospitalizations with respiratory infection associated to RSV in all 6 countries although incidence rates were low. CONCLUSIONS: Our findings highlight the substantial proportion of RSV infections among hospital admissions across different ages and may help public health professionals and policy makers when planning prevention and control strategies. In addition, our findings provide valuable insights for health care professionals attending to both children and adults presenting with symptoms of viral respiratory infections.

Epidemiology of invasive meningococcal disease and sequelae in the United Kingdom during the period 2008 to 2017 - a secondary database analysis.

BACKGROUND: Invasive meningococcal disease (IMD) causes high fatality in untreated patients alongside long-term sequelae in 20% survivors. For a comprehensive assessment of epidemiology, an analysis of these sequelae is required. This study aims to investigate the epidemiology of disease between 2008 and 2017 including a description of the sequelae, through the analysis of data collected from the UK Clinical Practice Research Datalink (CPRD) linked with data from the Hospital Episode Statistics (HES), and Office for National Statistics (ONS) mortality registry data. METHODS: This was a 10-year retrospective observational cohort study designed to describe the incidence, case-fatality rate (CFR) and occurrence of sequelae due to meningococcal disease, in the UK between 2007 and 2017 using data from the UK CPRD-HES-ONS. Cases were identified and matched on age, gender, date of diagnosis of IMD and followed-up-time with a control group without IMD. Demographics, clinical characteristics, mortality, and IMD-related sequelae were examined for IMD cases and compared with matched controls for a more comprehensive assessment. RESULTS: The study analysed 640 IMD patients with majority of the cases diagnosed (76.9%) in a hospital setting. Age-group analysis showed a decrease in the incidence rate of IMD in patients aged <1 year (30.4 - 7.5%) and an increase in those >50 years (10.4 - 27.8%). CFR was slightly higher among females, toddlers, and adults >50 years. No significant change in CFR was observed over study period. Case-control study showed a higher number of IMD sequelae among cases compared to age- and gender-matched controls, especially in those ≥ 50 years. CONCLUSION: The study showed that, despite a relatively low incidence rate, IMD is responsible for a high CFR, namely in older age groups and by a high number of IMD sequelae. The study showed that leveraging data from existing databases can be used to complement surveillance data in truly assessing the epidemiology of IMD. Despite the availability of routine vaccination programs, IMD still poses a significant burden in the healthcare system of the UK. Optimization of vaccination programs may be required to reduce the disease burden.

Respiratory Syncytial Virus-Associated Hospital Admissions and Bed Days in Children <5 Years of Age in 7 European Countries.

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infections (RTIs) in young children. High-quality country-specific estimates of bed days and length of stay (LOS) show the population burden of RSV-RTI on secondary care services and the burden among patients, and can be used to inform RSV immunization implementation decisions. METHODS: We estimated the hospital burden of RSV-associated RTI (RSV-RTI) in children under 5 years in 7 European countries (Finland, Denmark, Norway, Scotland, England, the Netherlands, and Italy) using routinely collected hospital databases during 2001-2018. We described RSV-RTI admission rates during the first year of life by birth month and assessed their correlation with RSV seasonality in 5 of the countries (except for England and Italy). We estimated average annual numbers and rates of bed days for RSV-RTI and other-pathogen RTI, as well as the hospital LOS. RESULTS: We found that infants born 2 months before the peak month of RSV epidemics more frequently had the highest RSV-RTI hospital admission rate. RSV-RTI hospital episodes accounted for 9.9-21.2 bed days per 1000 children aged <5 years annually, with the median (interquartile range) LOS ranging from 2 days (0.5-4 days) to 4 days (2-6 days) between countries. Between 70% and 89% of these bed days were in infants aged <1 year, representing 40.3 (95% confidence interval [CI], 40.1-40.4) to 91.2 (95% CI, 90.6-91.8) bed days per 1000 infants annually. The number of bed days for RSV-RTI was higher than that for RTIs associated with other pathogens in infants aged <1 year, especially in those <6 months. CONCLUSIONS: RSV disease prevention therapies (monoclonal antibodies and maternal vaccines) for infants could help prevent a substantial number of bed days due to RSV-RTI. "High-risk" birth months should be considered when developing RSV immunization schedules. Variation in LOS between countries might reflect differences in hospital care practices.

Incidence of respiratory syncytial virus related health care utilization in the United States.

BACKGROUND: Respiratory Syncytial Virus (RSV) is one of the most frequent causes of acute respiratory infection worldwide. Understanding age-specific health care utilization is necessary to guide effective prevention strategies. This retrospective database analysis assessed the incidence rates of RSV-related health care utilization in the USA over a 7-year period. METHODS: Episodes of RSV were identified in the Truven Health MarketScan® Commercial Claims and Encounters database between 2008 and 2014 using ICD-9-CM codes for pneumonia, bronchiolitis and RSV (480-486, 487.0, 466.1, 491.2, 079.6). Annual RSV-related health care utilization was calculated for the total population, by age group (<1, 1, 2-4, 5-17, 18-49, 50-64, 65-74, 75-84 and ≥85 years) and the proportion of cases for each setting (hospitalization, outpatient, or emergency department [ED] / urgent care [UC]). RESULTS: Over the 7-year study period, the mean rate of all RSV-associated health care utilization was 2.4 per 1000 person-years, with mean rates ranging from 2.0 to 2.6). The highest rate was seen in infants aged <1 year (mean 79.0 per 1000 over the 7-year period), which decreased with increasing age in the range 2-49 years before increasing with age in older adults (mean rate 8.1 per 1000 over the 7-year period in those ≥85 years). Of all RSV cases, 82% were reported in an outpatient setting, 11% in the ED/UC and 7% were hospitalized. CONCLUSIONS: The annual RSV-related healthcare utilization rates were substantial, especially in infants and young children. These results underscore the need to accelerate the development of RSV prevention strategies to reduce the healthcare burden of RSV.

Respiratory Syncytial Virus-Associated Hospital Admissions in Children Younger Than 5 Years in 7 European Countries Using Routinely Collected Datasets.

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of respiratory tract infection (RTI) in young children. Registries provide opportunities to explore RSV epidemiology and burden. METHODS: We explored routinely collected hospital data on RSV in children aged < 5 years in 7 European countries. We compare RSV-associated admission rates, age, seasonality, and time trends between countries. RESULTS: We found similar age distributions of RSV-associated hospital admissions in each country, with the highest burden in children < 1 years old and peak at age 1 month. Average annual rates of RTI admission were 41.3-112.0 per 1000 children aged < 1 year and 8.6-22.3 per 1000 children aged < 1 year. In children aged < 5 years, 57%-72% of RTI admissions with specified causal pathogen were coded as RSV, with 62%-87% of pathogen-coded admissions in children < 1 year coded as RSV. CONCLUSIONS: Our results demonstrate the benefits and limitations of using linked routinely collected data to explore epidemiology and burden of RSV. Our future work will use these data to generate estimates of RSV burden using time-series modelling methodology, to inform policymaking and regulatory decisions regarding RSV immunization strategy and monitor the impact of future vaccines.

Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis.

BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of acute lower respiratory infection (ALRI) in young children aged <5 years. METHODS: We aimed to identify the global inpatient and outpatient cost of management of RSV-ALRI in young children to assist health policy makers in making decisions related to resource allocation for interventions to reduce severe morbidity and mortality from RSV in this age group. We searched 3 electronic databases including Global Health, Medline, and EMBASE for studies reporting cost data on RSV management in children under 60 months from 2000 to 2017. Unpublished data on the management cost of RSV episodes were collected through collaboration with an international working group (RSV GEN) and claim databases. RESULTS: We identified 41 studies reporting data from year 1987 to 2017, mainly from Europe, North America, and Australia, covering the management of a total of 365 828 RSV disease episodes. The average cost per episode was €3452 (95% confidence interval [CI], 3265-3639) and €299 (95% CI, 295-303) for inpatient and outpatient management without follow-up, and it increased to €8591(95% CI, 8489-8692) and €2191 (95% CI, 2190-2192), respectively, with follow-up to 2 years after the initial event. CONCLUSIONS: Known risk factors (early and late preterm birth, congenital heart disease, chronic lung disease, intensive care unit admission, and ventilator use) were associated with €4160 (95% CI, 3237-5082) increased cost of hospitalization. The global cost of inpatient and outpatient RSV ALRI management in young children in 2017 was estimated to be approximately €4.82 billion (95% CI, 3.47-7.93), 65% of these in developing countries and 55% of global costs accounted for by hospitalization. We have demonstrated that RSV imposed a substantial economic burden on health systems, governments, and the society.

Trends in healthcare utilization and costs associated with pneumonia in the United States during 2008-2014.

BACKGROUND: Pneumonia is the leading cause of morbidity and mortality worldwide. Pneumococcal conjugate vaccines have reduced the burden of pneumonia, but data on the current burden of pneumonia and its impact on the healthcare system are needed to inform the development and use of new vaccines and other preventive measures. METHODS: We retrospectively analyzed the frequency of pneumonia in the US during 2008-2014 using data from the MarketScan® Commercial Claims and Encounters database. Frequencies of healthcare utilization related to the index pneumonia episode were calculated using the annual number of enrolled person-years (PY) as the denominator and the number of individuals with pneumonia as the numerator. Pneumonia-associated costs were calculated as mean payment per episode during the 2 years from 2013 to 2014. RESULTS: The overall annual healthcare utilization rate for pneumonia was 15.1 per 1000 PY and decreased slightly from 2008 to 2014 (from 15.4 to 13.5 per 1000 PY). Most pneumonia-related healthcare utilization was due to office/outpatient visits (10.3 per 1000 PY; 68.3%). Emergency department/urgent care visits (2.5 per 1000 PY; 16.9%) and hospitalizations (2.2 per 1000 PY; 14.8%) contributed less. Pneumonia-related healthcare utilization was highest in children < 5 years (rate per 1000 PY = 29.7 for < 1 year, 47.9 for 1 year, and 39.5 for 2-4 years) and adults > 65 years (45.0 per 1000 PY). The mean cost per pneumonia episode (95% confidence interval) was US$429.1 ($424.8-$433.4) for office/outpatient visits, $1126.9 ($1119.5-$1134.3) for emergency department/urgent care visits, and $10,962.5 ($10,822.8-$11,102.2) for hospitalization. CONCLUSIONS: The burden of pneumonia on the US healthcare system remains substantial. The results presented here can help guide new vaccination strategies and other preventive interventions for reducing the remaining burden of pneumonia.

Correction to: Development and application of a questionnaire to assess patient beliefs in rheumatoid arthritis and axial spondyloarthritis.

The original version of this article was revised due to a retrospective Open Access order.

Development and application of a questionnaire to assess patient beliefs in rheumatoid arthritis and axial spondyloarthritis.

Misinterpretation of patient beliefs may complicate shared decision-making in rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). The objective of this study was to develop a questionnaire to assess patients' beliefs about their disease and its treatment, and to identify patient characteristics associated with these beliefs. All beliefs reported by > 5% of 50 patients in a previous study were reformulated with a partnering patient organization into statements with which participants could rate their agreement on a scale of 0-10 (totally disagree to totally agree). The resulting Questionnaire for Arthritis Dialogue (QuAD) was made available to patients with RA or axSpA. A score ≥ 7 was considered a strongly held belief. Associations between patient characteristics and individual lifestyle beliefs were assessed using multiple logistic regression. The 21-item QuAD was completed by 672 patients (432 RA, 240 axSpA; mean [±SD] age 54.2 [± 14.2]; 63.7% female). The most widely held beliefs were related to uncertainty about progression (n = 354, 54.0%), heredity (n = 309, 47.8%), and flare triggers (n = 283, 42.7%). The unwarranted belief that physical activity is deleterious to disease activity was associated with markers of psychological distress and lower educational levels. The beliefs of patients with RA or axSpA about their disease are wide-ranging. Since these may be unwarranted and may lead to inappropriate behaviors, physicians should discuss these beliefs with their patients. The QuAD may facilitate this dialogue, and may also be useful in population studies to standardize the assessment and evolution of beliefs over time. People with long-term inflammatory conditions such as rheumatoid arthritis (RA; inflammation of the joints) and axial spondyloarthritis (axSpA; inflammation of the spine) may hold a number of beliefs about their disease, including some that are not supported by current scientific evidence (e.g., "I think that my disease was triggered by a vaccination"). Some beliefs, especially those relating to the role of lifestyle factors (such as exercise, diet, smoking, and drinking alcohol), may encourage people living with severe diseases to change their behavior in a way that has an effect on their disease. Within this project, we developed a questionnaire to identify the most common beliefs held by people living with RA or axSpA, which is called the "Questionnaire for Arthritis Dialogue (QuAD)." We also examined whether certain characteristics (or traits) of people living with RA or axSpA are linked to beliefs not currently supported by scientific evidence. A total of 672 people living with RA or axSpA in France were asked to complete the questionnaire (QuAD). The questionnaire included 21 opinion statements that they scored from 0 (totally disagree) to 10 (totally agree). A score of more than 7 was interpreted to mean that the person significantly agreed with the opinion. Based on the responses to specific opinion statements in the questionnaire, we were able to identify possible links between beliefs that are not supported by scientific evidence (e.g., "I think that flare-ups of my disease are triggered by physical effort"), and characteristics of people living with severe diseases. Our findings suggested that beliefs about lifestyle and inflammatory diseases varied from person to person, were sometimes inconsistent (the most widely held beliefs were sometimes contradictory), and were often not supported by scientific evidence. The belief that physical activity had negative effects on the disease was linked to poor education and psychological issues (such as anxiety and helplessness). People living with axSpA were more likely to believe their disease was a result of their genetic make-up, whereas those with RA more often believed their disease was caused by emotional issues. People living with axSpA were also more likely to believe that physical activity could be beneficial for their disease, and less likely to believe that their disease was caused by smoking. Our results suggest that doctors need to discuss with their patients how they might believe lifestyle is associated with their disease. This will help to dispel any unnecessary concerns, and to encourage their patients to take up healthy lifestyles and habits that are beneficial for their disease management. It may also be beneficial for health care providers to discuss the beliefs identified in this study during educational programs about inflammatory diseases, for the benefit of people living with RA or axSpA.

Trends in healthcare utilization and costs associated with acute otitis media in the United States during 2008-2014.

BACKGROUND: Acute otitis media (AOM) is the most common cause of pediatric medical visits and antibiotic prescriptions worldwide, but its current impact on the US healthcare system is not clear. The aim of this study was to investigate changes in the incidence of AOM from 2008, just before 13-valent pneumococcal conjugate vaccine was introduced, to 2014 using US insurance records in the Truven MarketScan® database. The study also examined the costs associated with index AOM events during the two most recent years for which data were available (2013-2014). METHODS: AOM cases in the MarketScan database during 2008-2014 were identified using ICD9 diagnosis codes 381.xx and 382.xx. Incidence rates of healthcare utilization related to the index AOM episode were calculated using the annual number of enrolled person-years as the denominator and the number of individuals with AOM as the numerator. AOM-associated costs were calculated as the mean payment per episode during the 2 years from 2013 to 2014. RESULTS: The overall annual rate of AOM-related healthcare utilization was 60.5 per 1000 person-years and changed little from 2008 to 2014 (range, 58.4-62.6). Most of this was due to office/outpatient visits (55.7 [range, 52.0-58.8] per 1000 person-years). Emergency department/urgent care visits (4.7 [range 3.7-6.3] per 1000 person-years) and hospitalization (0.0 [range, 0.0-0.1] per 1000 person-years) contributed little. The rate of AOM-related healthcare utilization per 1000 person-years was highest in the youngest children and declined with age (474.3 for < 1 year, 503.9 for 1 year, 316.3 for 2-4 years, 94.9 for 5-17 years, 33.1 for 18-49 years, 28.6 for 50-64 years, 23.7 for 65-74 years, 20.2 for 75-84 years, and 16.1 for ≥85 years). The mean cost per AOM episode in 2013-2014 (95% confidence interval) was $199.0 (198.4-199.6) for office or outpatient visits, $329.6 (328.2-331.0) for emergency department/urgent care visits, and $1592.9 (1422.0-1763.8) for hospitalization. CONCLUSIONS: In the US, AOM-associated healthcare utilization and costs remain substantial. More effective preventive measures such as new vaccines are needed to reduce the burden of AOM.

Healthcare resource use and economic burden attributable to respiratory syncytial virus in the United States: a claims database analysis.

BACKGROUND: Despite several studies that have estimated the economic impact of Respiratory Syncytial Virus (RSV) in infants, limited data are available on healthcare resource use and costs attributable to RSV across age groups. The aim of this study was to quantify age-specific RSV-related healthcare resource use and costs on the US healthcare system. METHODS: This retrospective case-control study identified patients aged ≥1 year with an RSV event in the Truven Health Marketscan® Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases between August 31, 2012 and August 1, 2013. RSV patients were matched 1:1 with non-RSV controls for age, gender, region, healthcare plan and index date (n = 11,432 in each group). Stratified analyses for healthcare resource use and costs were conducted by age groups. RSV-attributable resource use and costs were assessed based on the incremental differences between RSV cases and controls using multivariate analysis. RESULTS: RSV patients had a higher healthcare resource use (hospital stays, emergency room/urgent care visits, ambulatory visits and outpatient visits) than non-RSV matched controls for all age groups (all p < 0.0001), particularly in the elderly age groups with RSV (1.9 to 3 days length of stay, 0.4 to 0.5 more ER/UC visits, 0.7 to 2.7 more ambulatory visits, 12.1 to 18.6 more outpatient visits and 9.5 to 14.6 more prescriptions than elderly in the control groups). The incremental difference in adjusted mean annual costs between RSV and non-RSV controls was higher in elderly (≥65; $12,030 to $23,194) than in those aged < 65 years ($2251 to $5391). Among children, adjusted costs attributable to RSV were higher in children aged 5-17 years ($3192), than those 1-4 years ($2251 to $2521). CONCLUSIONS: Our findings showed a substantial annual RSV-attributable healthcare resource use and costs in the US across age groups, with the highest burden in those aged ≥65 years. These data can be used in cost-effectiveness analyses, and may be useful for policymakers to guide future RSV vaccination and other prevention programs.

RAS mutation testing in patients with metastatic colorectal cancer in French clinical practice: A status report in 2014.

BACKGROUND: RAS (NRAS + KRAS) mutation testing is required in addition to simple KRAS testing prior to initiating anti-epidermal-growth-factor-receptor (EGFR) antibodies (MAb) as in metastatic colorectal cancer (mCRC). AIMS: To assess prescription and implementation rates of RAS/KRAS mutation testing. To describe the RAS/KRAS mutation test procedure and its impact on therapeutic strategy. PATIENTS AND METHODS: Observational retrospective study conducted from June to September 2014 in all consecutive patients with newly diagnosed mCRC. RESULTS: Data from 375 patients (male: 57.8%; mean age, 65.7 ±â€¯11.7 years) were analysed. RAS/KRAS mutation testing was prescribed in 90.1% of patients (338/375). The test was prescribed within 1 month around mCRC diagnosis and prior to first-line therapy in 73.1% (242/331) and 85.4% (280/328) of patients, respectively. Time from test request to receipt of results was 24.6 ±â€¯17.2 days. 59.7% of patients (190/318) had a mutation, mainly KRAS (47.9%; 152/317). Anti-EGFR MAb was prescribed in 90.9% of RAS-wild-type cases (60/66), consistent with the goal of genotyping-testing in this population. CONCLUSION: In 2014, RAS genotyping-testing in addition to KRAS testing was routinely prescribed and performed in mCRC patients in France. Time to receive results remains long and must be reduced so as to match clinical practice.

Development and psychometric validation of a patient-reported outcome measure to assess fears in rheumatoid arthritis and axial spondyloarthritis: the Fear Assessment in Inflammatory Rheumatic diseases (FAIR) questionnaire.

OBJECTIVES: To develop and validate an outcome measure for assessing fears in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). METHODS: Fears were identified in a qualitative study, and reformulated as assertions with which participants could rate their agreement (on a 0-10 numeric rating scale). A cross-sectional validation study was performed including patients diagnosed with RA or axSpA. Redundant items (correlation >0.65) were excluded. Internal consistency (Cronbach's α) and factorial structure (principal component analysis) were assessed. Patients were classified into fear levels (cluster analysis). Associations between patient variables and fear levels were evaluated using multiple logistic regression. RESULTS: 672 patients were included in the validation study (432 RA, 240 axSpA); most had moderate disease activity and were prescribed biologics. The final questionnaire included 10 questions with high internal consistency (α: 0.89) and a single dimension. Mean scores (±SD) were 51.2 (±25.4) in RA and 60.5 (±22.9) in axSpA. Groups of patients with high (17.2%), moderate (41.1%) and low (41.7%) fear scores were identified. High fear scores were associated with high Arthritis Helplessness Index scores (OR 6.85, 95% CI (3.95 to 11.87)); high Hospital Anxiety and Depression Scale anxiety (OR 5.80, 95% CI (1.19 to 4.22)) and depression (OR 2.37, 95% CI (1.29 to 4.37)) scores; low education level (OR 3.48, 95% CI (1.37 to 8.83)); and high perceived disease activity (OR 2.36, 95% CI (1.10 to 5.04)). CONCLUSIONS: Overall, 17.2% of patients had high fear scores, although disease was often well controlled. High fear scores were associated with psychological distress. This questionnaire could be useful both in routine practice and clinical trials.