National Health Care Registers Research Articles

Enhanced liver Fibrosis® test predicts liver-related outcomes in the general population

Background & AimsThe Enhanced Liver Fibrosis® (ELF) test exhibits good discriminative performance in detecting advanced liver fibrosis and in predicting liver-related outcomes in patients with specific liver diseases, but large population-based studies are missing. We analysed the predictive performance of the ELF test in a general population cohort. MethodsData were sourced from the Health 2000 study, a Finnish population-based health examination survey conducted in 2000–2001. Subjects with baseline liver disease were excluded. The ELF test was performed on blood samples collected at baseline. Data were linked with national healthcare registers for liver-related outcomes (hospitalisation, cancer, and death). ResultsThe cohort comprised 6,040 individuals (mean age 52.7. 45.6% men) with 67 liver-related outcomes during a median 13.1-year follow-up. ELF predicted liver outcomes (unadjusted hazards ratio 2.70, 95% CI 2.16–3.38). with 5- and 10-year AUCs of 0.81 (95% CI 0.71–0.91) and 0.71 (95% CI 0.63–0.79) by competing-risk methodology. The 10-year risks for liver outcomes increased from 0.5% at ELF <9.8 to 7.1% at ELF ≥11.3, being higher among men than women at any given ELF level. Among individuals with body mass index ≥30 kg/m2, diabetes, or alanine aminotransferase >40 U/L. Five-year AUCs for ELF were 0.85, 0.87, and 0.88, respectively. The predictive ability of the ELF test decreased with time: the 10-year AUCs were 0.78, 0.69, and 0.82, respectively. ConclusionsThe ELF test shows good discriminative performance in predicting liver-related outcomes in a large general population cohort and appears particularly useful for predicting 5-year outcomes in persons with risk factors. Impact and implicationsThe Enhanced Liver Fibrosis test exhibits good performance for predicting liver-related outcomes (hospitalisation, liver cancer, or liver-related death) in the general population, especially in those with risk factors.

Patient-reported outcome measures and their association to the original Strickland classification after flexor tendon repair.

The aim of this study was to examine the relationship between patient-reported outcome measures (PROMs) and the original Strickland classification after flexor tendon injuries in Zones 1 and 2. Data were collected from the Swedish national health care registry for hand surgery (HAKIR). The studied PROMs were the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) and the patient questionnaire from the HAKIR (HQ-8). Complete data of both range of motion (ROM) and PROMs were available for 215 patients at 3 months after surgery, and for 150 patients at 12 months after surgery. We found that QuickDASH values were low and similar between all groups as classified by the Strickland system at 12 months. A statistically significant difference between PROM values (for stiffness and satisfaction) was found only between the Strickland groups Fair and Good, but not between Poor and Fair or Good and Excellent. This suggests that further categorization according to the Strickland classification is less important to the patients as long as they regain 70% of their ROM.Level of evidence: III.

Pre- and perinatal exposures associated with developing pediatric-onset immune-mediated inflammatory disease: A Danish nation-wide cohort study

ObjectivesWe aimed to identify pre- and perinatal risk factors for developing pediatric-onset immune-mediated inflammatory (pIMID). MethodsThis nation-wide, cohort study included all children born in Denmark from 1994 to 2014 identified from the Danish Medical Birth registry. Individuals were followed through 2014 and cross-linked to the continuously updated national socioeconomic and healthcare registers to obtain data on pre- and perinatal exposures (maternal age, educational level, smoking, maternal IMID, parity, mode of conception and delivery, plurality, child's sex, and birth season). The primary outcome was a pIMID diagnosis (inflammatory bowel disease, autoimmune hepatitis, primary sclerosing cholangitis, juvenile idiopathic arthritis, or systemic lupus erythematosus) before 18 years of age. Risk estimates were calculated using Cox proportional hazards model and presented by hazard ratios (HR) with 95% confidence intervals (95%CI). ResultsWe included 1,350,353 children with a follow-up time of 14,158,433 person-years. Among these, 2,728 were diagnosed with a pIMID. We found a higher risk of pIMID in children born to women with a preconception IMID diagnosis (HR: 3.5 [95%CI: 2.7–4.6]), children born by Caesarean section (HR: 1.2 [95%CI: 1.0–1.3]), and among females (1.5 [95%CI: 1.4–1.6]) than among children without these characteristics. Plural pregnancies were associated with a lower risk of pIMID than single pregnancies (HR: 0.7 [95%CI: 0.6–0.9]). ConclusionsOur results indicate a high genetic burden in pIMID but also identifies intervenable risk factors, such as Cesarean section. Physicians should, keep this in mind when caring for high-risk populations and pregnant women previously diagnosed with an IMID.

Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice: results from the ARTIS programme

ObjectiveLongitudinal clinical registry-infrastructures such as Anti-Rheumatic Therapies in Sweden (ARTIS) allow simultaneous comparison of the safety of individual immunomodulatory drugs used in clinical practice, with consistent definitions of treatment cohorts,...

Infrared Thermography Compared to Standard Care in the Prevention and Care of Diabetic Foot: A Cost Analysis Utilizing Real-World Data and an Expert Panel.

Infrared thermography (IRT) is a non-invasive technology for screening and early detection of diabetic foot. Real-world data and the Delphi technique were used to assess IRT's potential effect on typical care pathways of diabetic foot and their costs in the Finnish healthcare setting. The most typical care pathways of diabetic foot were identified from national healthcare registers from 2011 to 2017. The effect of IRT in terms of avoidable care episodes was assessed by a Delphi panel including Finnish diabetic foot specialists (n=13). By combining a series of decision-analytic models, the IRT's potential effect on the costs of each pathway and their sensitivity to model assumptions were estimated. Hypothetical annual savings were estimated to be EUR ~1.7 million (EUR ~1.3 million-EUR ~2.5 million), constituting approximately 20% of the total annual care pathway costs examined. In the longer and more complex pathways, the application of IRT was estimated to result in notable savings while in the shorter pathways, IRT could increase costs. Our modeling suggests that IRT could potentially reduce costs in a Finnish healthcare setting. Given our analysis, generation of robust evidence on the effectiveness of recent IRT technologies with up-to-date protocols seems appropriate.

The association between body mass index groups and metabolic comorbidities with healthcare and medication costs: a nationwide biobank and registry study in Finland

ABSTRACT Background: The increasing prevalence of obesity imposes a significant cost burden on individuals and societies worldwide. Objective: In this nationally representative study, the association between body mass index (BMI) groups and the number of metabolic comorbidities (MetC) with total direct costs was investigated in the Finnish population. Study design, setting, and participants: The study cohort included 5,587 adults with BMI ≥18.5 kg/m2 who participated in the cross-sectional FinHealth 2017 health examination survey conducted by the Finnish Institute for Health and Welfare. Data on healthcare resource utilization (HCRU) and drug purchases were collected from national healthcare and drug registers. Main outcome measure: The primary outcome was total direct costs (costs of primary and secondary HCRU and prescription medications). Results: Class I (BMI 30.0–34.9 kg/m2) and class II – III (BMI ≥35.0 kg/m2) obesity were associated with 43% and 40% higher age- and sex-adjusted direct costs, respectively, compared with normal weight, mainly driven by a steeply increased comorbidity in the higher BMI groups. In all BMI groups combined, individuals with ≥2 MetCs comprised 39% of the total study population and 60% of the total costs. Conclusion: To manage the cost burden of obesity, treatment should be given equal consideration as other chronic diseases, and BMIs ≥30.0 kg/m2 should be considered in treatment decisions.

Direct oral anticoagulants versus warfarin in patients with non-valvular atrial fibrillation and CKD G3-G5D.

The use of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD) including dialysis is growing. Several studies have shown favorable results of DOAC compared with warfarin regarding bleeding risk but no difference in stroke protection. However, these studies had poor time in therapeutic range (TTR), in the warfarin comparison group. This was a Swedish national cohort study investigating the risk of ischemic stroke and major bleeding on DOAC compared with warfarin in patients with NVAF, glomerular filtration rate category 3-5D (G3-G5D), kidney transplant recipients excluded, between 2009 and 2018. Data extracted from high-quality national healthcare registries including the Swedish Renal Registry, AuriculA (the Swedish national quality register for AF and anticoagulation) and The Stroke Register. At enrolment, of 2453 patients 59% were treated with warfarin (mean TTR 67%) and 41% with DOAC. Overall, 693 (28.3%) had G3, 1113 (45.4%) G4, 222 (9.1%) G5 and 425 (17.3%) G5D. DOAC compared with warfarin showed lower hazard of major bleeding [hazard ratio 0.71 (95% confidence interval 0.53-0.96)] but no difference in ischemic stroke risk. Mortality was increased during DOAC treatment [1.24 (1.01-1.53)], presumably not a causal association since fewer fatal bleedings occurred on DOAC. DOAC treatment, compared with warfarin, is associated with almost 30% lower risk of bleeding in patients with NVAF and CKD G3-G5D. The stroke risk is comparable between the treatments. This is the first study comparing DOAC and well-managed warfarin (TTR 67%) in advanced CKD. Ongoing and planned randomized controlled trials need to confirm the possible benefit of DOAC.

The Stockholm-Gotland perinatal cohort-A population-based cohort including longitudinal data throughout pregnancy and the postpartum period.

Register-based reproductive and perinatal databases rarely contain detailed information from medical records or repeated measurements throughout pregnancy and delivery. This lack of enriched pregnancy and birth data led to the initiation of the Swedish Stockholm-Gotland Perinatal Cohort (SGPC). To describe the strengths of the SGPC, as well as the unique research questions that can be addressed using this cohort. The SGPC is a prospectively collected, population-based cohort that includes all births (from 22 completed gestational weeks onwards) between 1 January 2008 and 15 June 2020 in the Stockholm and Gotland regions of Sweden (335,153 singleton and 11,025 multiple pregnancies). Descriptive study. The SGPC is based on the electronic medical records of women and their infants. The medical record system is used for all antenatal clinic visits and admissions, delivery and neonatal admissions, as well as postpartum clinical visits. SGPC has been further enriched with data linkages to 10 Swedish National Health Care and Quality Registers. In contrast to other reproductive and perinatal databases available in Sweden, including the Medical Birth Register and the Pregnancy Register, SGPC contains highly detailed medical record data, including time-varying serial measurements for physiological parameters throughout pregnancy, delivery, and postpartum, for both mother and infant. These strengths have enabled studies that were previously inconceivable; the effects of serial measurements of pregnancy weight gain, changes in haemoglobin counts and blood pressure during pregnancy, fetal weight estimations by ultrasound, duration of stages and phases of labour, cervical dilatation and oxytocin use during delivery, and constructing reference curves for umbilical cord pH. The SGPC-with its rich content, repeated measurements and linkages to numerous health care and quality registers-is a unique cohort that enables high-quality perinatal studies that would otherwise not be possible.

Early start of anti-dementia medication is associated with lower health and social care costs in Alzheimer´s patients: a Finnish nationwide register study.

To evaluate the association between health and social care costs and early start of anti-dementia medication in a nationwide cohort of Finnish Alzheimer's disease (AD) patients. The cohort included 7454 Finnish AD patients who had their first AD diagnosis in 2012 and lived at home at the time of diagnosis. Data were collected retrospectively from the Finnish national health and social care registers. The primary outcome was 2-year cumulative direct costs after the incident AD diagnosis. The exploratory variable was early anti-dementia medication start (anti-dementia medication started within 3 months of the incident AD diagnosis). Sociodemographic variables, admission to 24-h care and care intensity level, as well as comorbidities were considered as adjusting variables. Of all patients, 88.9% started AD medication within 3months of diagnosis. The 2-year cumulative costs were €30,787 and €40,484 per patient for early and late starters, respectively. When adjusted for possible confounders, early start of anti-dementia medication was associated with 26.5% lower 2-year cumulative costs compared to late starters (relative cost 0.735; p < 0.001). Early diagnosis and start of anti-dementia medication is important for managing the costs of increasing number of AD patients.

Short-acting β2 -agonist use and asthma exacerbations in Swedish children: A SABINA Junior study.

In adults and adolescents with asthma, use of ≥3 short-acting β2 -agonist (SABA) canisters/year is associated with increased exacerbation risk. Whether this association is present in younger children remains unknown. In this SABA use IN Asthma (SABINA) Junior study, we assessed the association of SABA collection with exacerbation risk in the general Swedish pediatric asthma population. This population-based cohort study utilized linked data from the Swedish national healthcare registries involving patients with asthma (<18 years) treated in secondary care between 2006-2015. Exacerbation risk, by baseline SABA collection (0-2 vs. ≥3 canisters, further examined as ordinal/continuous variable) and stratified on comorbid atopic disease (allergic rhinitis, dermatitis and eczema, and food/other allergies), was assessed for 1-year follow-up using negative binomial regression. Of 219,561 patients assessed, 45.4%, 31.7%, and 26.5% of patients aged 0-5, 6-11, and 12-17 years, respectively, collected ≥3 SABA canisters during the baseline year (high use). Collection of ≥3 SABA canisters (vs. 0-2) was associated with increased exacerbation risk during follow-up (incidence rate ratios [95% confidence interval]: 1.35 [1.29-1.42], 1.22 [1.15-1.29], and 1.26 [1.19-1.34] for 0-5-, 6-11-, and 12-17-year-olds, respectively); the association persisted with SABA as a continuous variable and was stronger among patients without atopic diseases (32%-44% increased risk versus. 14%-21% for those with atopic disease across groups). High SABA use was associated with increased asthma exacerbation risk in children, particularly in those without comorbid atopic diseases, emphasizing the need for asthma medication reviews and reformative initiatives by caregivers and healthcare providers on SABA use.

Prevalence of atrial fibrillation – a comprehensive nationwide analysis in Finland

Abstract Introduction Prevalence of atrial fibrillation (AF) is strongly associated with age, and with longer life-time expectancy number of AF patients is worldwide strongly increasing. However, nationwide prevalence of AF is not known when primary care data as well is accessible. Purpose The FinACAF-study is a nationwide registry study including of all AF patients searched from all available national health care registers. To our knowledge, this is the first nationwide AF study including both primary, secondary, and tertiary health care register data. The aim of this study was to assess the prevalence of AF in unselected nationwide population in Finland. Methods In the FinACAF study we gathered data of all AF patients (hospitalizations and outpatient specialist visits and primary health care, and National Reimbursement Register) from all national health care registers from 01st January 2004 to 31st December 2018. The annual prevalence on December 31st of each year 2007–2018 was calculated as the cumulative number of patients alive with AF divided by the number of Finnish population on the last day of that year. The prevalence is presented for population ≥20 years, and with the entire population as the background population, as well as for populations ≥65 years, and ≥75 years. Results In total, 411,387 patients with the diagnosis of AF were documented during 2004–2018 in Finland. The number of adult patients with AF at the end of the study period in 2018 was 226,847, corresponding to an AF prevalence of 5.2% in the age group ≥20 years. The prevalence in the total Finnish population was 4.1%. The prevalence rates increased remarkably with increasing age and were higher in men compared to women (5.9% vs. 4.6%, p&amp;lt;0.001) in all age groups (Figure 1). The prevalence of AF in the adult population increased remarkably from 2.5% in 2007 to 5.2% in 2018 (p&amp;lt;0.001) (Figure 2). Among the population ≥65 years the prevalence in 2018 was 15.3%, and in the elderly, ≥75 years the prevalence of AF was 23.4%. Conclusions Based on comprehensive, nationwide data – also including the primary care – we observed extremely increasing prevalence of AF in the older population, as well as remarkably increasing prevalence of AF over time. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Helsinki and Uusimaa Hospital District

Association between arterial hypertension and liver outcomes using polygenic risk scores: a population-based study

Arterial hypertension (HTA) is associated with liver disease, but causality remains unclear. We investigated whether genetic predisposition to HTA is associated with liver disease in the population, and if antihypertensive medication modifies this association. Participants of the Finnish health-examination surveys, FINRISK 1992–2012 and Health 2000 (n = 33,770), were linked with national electronic healthcare registers for liver-related outcomes (K70-K77, C22.0) and with the drug reimbursement registry for new initiation of antihypertensive medication during follow-up. Genetic predisposition to HTA was defined by polygenic risk scores (PRSs). During a median 12.9-year follow-up (409,268.9 person-years), 441 liver-related outcomes occurred. In the fully-adjusted Cox-regression models, both measured systolic blood pressure and clinically defined HTA were associated with liver-related outcomes. PRSs for systolic and diastolic blood pressure were significantly associated with liver-related outcomes (HR/SD 1.19, 95% CI 1.01–1.24, and 1.12, 95% CI 1.01–1.25, respectively). In the highest quintile of the systolic blood pressure PRS, new initiation of antihypertensive medication was associated with reduced rates of liver-related outcomes (HR 0.55, 95% CI 0.31–0.97). HTA and a genetic predisposition for HTA are associated with liver-related outcomes in the population. New initiation of antihypertensive medication attenuates this association in persons with high genetic risk for HTA.

Dietary Saturated Fat and Bone Health in Young Adults: The Young Finns Cohort

Previous studies suggest that saturated fat (SFA) intake may negatively impact on bone. However, few human studies on the topic exist. Women and men aged 31–46 years from the Cardiovascular Risk in Young Finns study attended the peripheral quantitative computed tomography and ultrasound bone measurements in 2008 (n = 1884–1953, ~ 56% women). In addition, fracture diagnoses in 1980–2018 were searched for the national health care registers and 431 participants had at least one fracture. Food consumption was gathered with the 48-h dietary recall interviews and food frequency questionnaire in 1980–2007. In the present study, radial, tibial, and calcaneal bone traits, and fractures were examined relative to the long-term intake of SFA. No consistent associations were seen between bone outcomes and SFA intake that would have replicated in both women and men. The only evidence for differential distributions was seen in cortical density and cortical-to-total area ratio at the radial shaft, and speed of sound at the calcaneus, which were 0.1–0.4% higher in women in the lowest tertile of SFA intake compared with the highest tertile. In addition, among men, the odds ratio (OR) of fractures was greater in the second (OR 1.86, 95% confidence interval (CI) 1.03–3.33) and third tertile of SFA intake (OR 2.45, 95% CI 1.38–4.36) compared with the lowest tertile, independently of many risk factors of osteoporosis. In this observational study, we found no robust evidence of the associations of dietary long-term SFA intake with bone outcomes. Therefore, additional studies are needed to confirm the association of dietary SFA with bone health in humans.

Low-dose aspirin use and colorectal cancer survival in 32,195 patients-A national cohort study.

Results from previous studies indicate that use of aspirin may improve colorectal cancer (CRC) survival. The aim of this study was to assess whether use of aspirin influences overall survival or CRC-specific survival in an unselected cohort of patients diagnosed with CRC. The study was performed using the Colorectal Cancer Data Base Sweden (CRCBaSe), a mega-linkage originating from the Swedish Colorectal Cancer Register, with additional linkages to other national health care registers. All patients diagnosed with primary CRC stage I-III treated with curative surgery, aged 18-85 years at diagnosis, from 2007 through 2016 were identified. Information on low-dose aspirin use was extracted from the Swedish Prescribed Drug Register. Exposure was defined as dispensed prescription for at least 6months. Aspirin exposure was analyzed at the time of surgery (yes/no) and as a time-varying exposure during follow-up. Follow-up was restricted to a maximum 6 years, to model 5-year survival. Cox regression models were fitted to estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Adjustments were performed for sex, age, year of diagnosis, Charlson comorbidity index, hypertension, and ASA score as potential confounders. A total of 32,195 patients diagnosed with CRC were included. 6764 (21%) were exposed to aspirin at the time of CRC surgery. The median time of follow-up was 4.2 years. Aspirin use at the time of surgery was not associated with all-cause (adjusted HR=1.03, 95% CI: 0.97-1.08) nor CRC-specific mortality (adjusted HR=0.99, 95% CI: 0.91-1.07). Aspirin use during follow-up was associated with increased all-cause (adjusted HR=1.09, 95% CI: 1.04-1.15) but not CRC-specific mortality (adjusted HR=0.98, 95% CI: 0.91-1.06). A CRC-specific effect associated with aspirin was noted from approximately 3 years following surgery. In this large nation-wide cohort study there was no convincing association between aspirin use after CRC and OS or CRC-specific survival.

Use of ADHD Medication Among Danish Children and Adolescents from 2010-2020 - A Nationwide Study

IntroductionTo ensure rational drug use, there is a need to continuously monitor the use of ADHD medication among children and adolescents.ObjectivesTo describe the use of ADHD medication among Danish children and adolescents from 2010-2020.Methods Using the Danish national healthcare registries, we extracted data on filled prescriptions of ADHD medication (including methylphenidate, atomoxetine, guanfacine, dexamphetamine, and lisdexamphetamine) among children (age 6-12 years) and adolescents (age 13-17 years) between 2010-2020. We examined the annual incidence rate and prevalence proportion of ADHD drug use, and the proportion of children and adolescents having an ADHD diagnosis when initiating ADHD medication.Results From 2010-2020, the incidence followed a u-shaped trend with an incidence rate of 4.9/1,000 children and 4.4/1,000 adolescents in 2010, decreasing to 3.2/1,000 children and 3.0/1,000 adolescents in 2013, and rising to 4.9/1,000 children and 4.8/1,000 adolescents in 2020. The prevalence for children showed a similar trend, shifting from 17/1,000 in 2010, to 15/1,000 in 2016, and peaking at 19/1,000 children in 2020. However, among adolescents the prevalence increased steadily from 19/1,000 in 2010 to 29/1,000 in 2020. 67% of children and 53% of adolescents initiating ADHD medication had an ADHD diagnosis.Conclusions After an initial decline in incidence rates of ADHD medication use among Danish children and adolescents, there has been a rise in use the last five years. The same trend applied for the prevalence among children, whereas the prevalence among adolescents increased steadily over the entire period. More than half of children and adolescents initiating ADHD medication were diagnosed with ADHD.DisclosureNo significant relationships.

POS0637 SAFETY OF b/tsDMARDs FOR RA AS USED IN CLINICAL PRACTICE - RESULTS FROM THE LAST DECADE OF THE ARTIS PROGRAM

BackgroundWhile the relative efficacy of treatments can be demonstrated in relatively small studies with limited follow-up, most safety concerns are infrequent, requiring longer follow-up and larger populations. This is recognized by the regulatory framework, where data from pivotal randomized controlled trials are usually considered sufficient for demonstrating efficacy and non-toxicity, but post-approval safety studies are required for many years to fully evaluate drug-associated risks. Though such regulatory safety-studies often focus on one drug (vs. all others), clinical decision-making requires data across all available treatment options. Long-standing longitudinal clinical registries, like the Anti-Rheumatic Therapies in Sweden (ARTIS) database, thus have a key role in assessing the relative safety of b/tsDMARDs, allowing simultaneous comparison of all drugs used in clinical practice, with consistent definitions of treatment cohorts, follow-up, and outcomes.ObjectivesTo assess incidence rates of critical safety endpoints for individual b/tsDMARDs used to treat RA, updating previously published reports and including more recently introduced treatments.MethodsNationwide register-based cohort study including all RA patients in Sweden registered as starting any b/tsDMARD between Jan 1st 2010 and Dec 31st 2019, and followed until Dec 31st 2020. The incidence rates of selected outcomes, identified through national healthcare registers, were compared between individual b/tsDMARDs while adjusting for a range of potential confounders (covering demographics, RA-related characteristics and disease activity, and comorbidity) using Inverse Probability of Treatment Weighting. Probabilities were predicted by multinomial logistic regression, regressing all covariates on treatment status. Exposure time was counted from treatment start until stop (+90 days’ lag time), censored at emigration and death.ResultsThere were clear differences between patients starting individual b/tsDMARDs, in particular with TNF inhibitors more often used as a first line b/tsDMARD; sarilumab, baricitinib, and tofacitinib predominantly used later in the treatment course; rituximab used more often for older patients, and non-TNFi generally used more frequently for patients with higher disease activity or comorbidity. Expectedly, these differences translated into differences in the crude rate of safety endpoints.Several differences remained after confounder-adjustment (Table 1), including a higher rate of treatment discontinuation due to adverse events on baricitinib, tofacitinib, and sarilumab. Rituximab was associated with higher rates of several outcomes, but the confounder-adjustment markedly reduced risks and residual confounding likely explain part of the remaining increase. Baricitinib and tofacitinib were associated with higher rates of hospitalised herpes zoster, but not with similarly elevated rates of other serious infections. There were no clear differences in the rate of cardiovascular events or severe depression. Low number of events limit the comparison, in particular for sarilumab and tofacitinib.Table 1.Weighted incidence rate per 1,000 person-years of selected safety outcomes.DMARDNDiscont. due to. adverse eventACSStrokeLiver diseaseHosp. infectionHosp. Herpes zosterHosp. depressionAny hosp.All-cause mortalityETA8244456.24.51.4322.92.315610.8ADA5069465.95.61.1363.51.51669.5INF2832508.25.83.1433.22.019712.7CER2072546.47.02.5343.61.717211.0GOL1796515.96.8-322.8-15411.5ABA3254567.34.71.9362.31.617213.9RTX3990318.46.22.2413.32.419415.1TCZ2619305.75.02.1312.91.616315.7SAR271100---18--298-BARI1665693.04.21.4378.82.617316.7TOFA39282---3212.9-129-Note: Rates based on &lt;5 events set to ‘-‘.ConclusionWe found large differences in the rate of treatment discontinuations due to adverse events across b/tsDMARDs, which were not generally mirrored by corresponding differences in the rates for specific serious adverse events.ReferencesN/AAcknowledgementsARTIS has been or is currently supported by agreements with Abbvie, BMS, Eli Lilly, MSD, Pfizer, Roche, Samsung Bioepis, and Sanofi.Disclosure of InterestsThomas Frisell: None declared, Hannah Bower: None declared, Eva Baecklund: None declared, Daniela Di Giuseppe: None declared, Bénédicte Delcoigne: None declared, Nils Feltelius Employee of: NF is employed by the Medical Products Agency (MPA), which is a governmental body. The views in this abstract may not represent the views of the MPA, Helena Forsblad-d’Elia: None declared, Elisabet Lindqvist: None declared, Ulf Lindström: None declared, Johan Askling Grant/research support from: Karolinska Institutet has entered into agreements with the following companies, with JA as PI: Abbvie,BMS, Eli Lilly, Galapagos, Janssen, Pfizer, Roche, Samsung Bioepis and Sanofi.

Care pathways in atopic dermatitis: a retrospective population-based cohort study.

BackgroundAtopic dermatitis (AD) is a complex disease with variations in severity and healthcare utilization. Examining patient pathways through analyses of longitudinal patient data provides an opportunity to describe real‐world clinical patient care and evaluate healthcare access and treatment.ObjectiveTo describe longitudinal care pathways including health care management, treatment patterns and disease progression (by proxy measures) in patients with AD.Materials and methodsThis was a longitudinal observational study, which used linked data from national and regional healthcare registers in Sweden. Patients with AD were identified through diagnosis in primary or secondary care or by dispensed medications. Descriptive statistics for number of healthcare visits, type of dispensed drug class, rate of ‐ and time to ‐ referral to secondary care and treatment escalation were calculated.ResultsA total of 341 866 patients with AD distributed as 197 959 paediatric (age < 12), 36 133 adolescent (age ≥ 12‐ < 18) and 107 774 adult (age ≥ 18) patients were included in this study. Healthcare visits to primary and secondary care and dispensation of AD‐indicated treatments were more common during the year in which managed AD care was initiated. Topical corticosteroids (TCSs) and emollients were the most frequently used treatments across all age cohorts while systemic treatment was uncommon in all age cohorts. Among patients who initiated treatment with TCSs, 18.2% escalated to TCSs with higher potency following the start of managed AD care.ConclusionsWe found that healthcare contacts and use of AD‐indicated treatments were concentrated in the year during which managed AD care was initiated and decreased significantly thereafter. Since a significant proportion of patients with AD have flares and persistent AD, our results suggest that patients with AD may be monitored infrequently and are undertreated. There is a need to inform practitioners about adequate treatment options to provide individualized care, in particular for patients with persistent severe AD.

Risk factors for reoperation after flexor tendon repair: a registry study.

The aim of this study was to identify risk factors for reoperations after Zones 1 and 2 flexor tendon repairs. A multiple logistic regression model was used to identify risk factors from data collected via the Swedish national health care registry for hand surgery (HAKIR). The studied potential risk factors were age and gender, socio-economics and surgical techniques. Included were 1372 patients with injuries to 1585 fingers and follow-up of at least 12months (median 37 IQR 27-56). Tendon ruptures occurred in 80 fingers and tenolysis was required in 76 fingers. Variables that affected the risk of rupture were age >25years (p < 0.001), flexor pollicis longus tendon injuries (p < 0.001) and being male (p = 0.004). Injury to both finger flexors had an effect on both rupture (p = 0.005) and tenolysis (p < 0.001). Understanding the risk factors may provide important guidance both to surgeons and therapists when treating patients with flexor tendon injuries.Level of evidence: III.

Improved long-term outcome of patients with non-muscle invasive, low and intermediate risk bladder cancer between 1997 and 2014; a Swedish population-based study

Objective The most common form of urinary bladder cancer is the low and intermediate risk categories of stage Ta. This patient group has a high recurrence rate, but progression is rare. The aim of this study was to investigate recurrence and survival in a large population-based setting, with respect to possible prognostic factors and during different time periods. Patients and methods BladderBaSe is a database which links information from the Swedish National Register of Urinary Bladder Cancer with national healthcare and demographic registers. Between 1997 and 2014, 16,599 were diagnosed with low and intermediate risk of Ta cancer in Sweden. The times to recurrence and cancer-specific death were analysed concerning the differences in age, gender, grade, region and hospital type. For temporal analysis, we divided the material into 6-year periods. Results The mean age was 70 years and 75% were males. Low risk according to grade constituted 56%, whilst 44% had intermediate risk. With a median follow-up time of 63 months the recurrence rates were 47% and 59% for the respective categories and overall 52%. The rate was similar between the first two time periods, but became substantially lower in the most recent period. Five percent of patients died of the disease and risk category was the main prognostic variable. Conclusions The risk of recurrence decreased in the last time period. Risk category based on grade was the most important prognostic indicator for outcome.

MO758: Warfarin Treatment Quality and Outcomes in Patients with Non-Valvular Atrial Fibrillation and Chronic Kidney Disease Including Patients on Dialysis

Abstract BACKGROUND AND AIMS Warfarin has traditionally been the drug of choice for patients with atrial fibrillation and GFR &amp;lt; 30 mL/min. Observational studies have shown a lower risk of ischemic stroke with warfarin compared with no treatment, but also an increased risk of bleeding [1]. For patients on dialysis, the role of warfarin is less clear due to high bleeding risk and diverging data on stroke protection [2, 3]. Warfarin treatment quality can be calculated as time in therapeutic range (TTR). TTR ≥ 70% is considered lowering the risk of adverse events [4]. The impact of a patient’s individual TTR (iTTR) on ischemic stroke and bleeding is poorly investigated for patients with eGFR &amp;lt; 60 mL/min/1.73 m2 including patients on dialysis, and the aim is to study this further. METHOD A Swedish retrospective national cohort study investigating the risk of ischemic stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) during warfarin treatment depending on iTTR (individual time in therapeutic range). Patients included have warfarin treated NVAF, eGFR &amp;lt; 60 mL/min or on dialysis, kidney transplant recipients excluded, between 2009 and 2018. Data extracted from Swedish high quality national health-care registries including Swedish Renal Registry for GFR-category, The Stroke Register for stroke-related outcomes and Auricula—the Swedish national quality register for AF and anticoagulation for warfarin treatment periods and INR measurements. ITTR is calculated in a 90-day Window and updated at each new INR value. The impact of iTTR is tested with the Cox regression and time-dependent covariates regarding risk for ischemic stroke, major bleeding (intracranial, gastrointestinal and other) and all-cause mortality. RESULTS At enrolment of 2421 patients (29.1% female) 22.1% had G3 (eGFR 59–30 mL/min/1.73 m2) 47.4% G4 (eGFR 15–29), 10.9% G5 (eGFR &amp;lt; 15) and 19.7% G5D (on dialysis). Mean iTTR for all patients was 64% (G3 71%, G4 66%, G5 61% and G5D 55%). The number of events, time on warfarin and event rates are found in Table 1. Adjusted analysis shows that a 0.2 unit increase of iTTR lowers the risk of major bleeding for all patients, patients in G3–G5 and patients on dialysis (G5D) {hazard ratio 0.69 [95% confidence interval (95% CI) 0.61–0.78], 0.65 (0.55–0.77) and 0.78 (0.62–1.0)} (Fig. 1). Increased iTTR by 0.2 units does not seem to have a significant effect on the hazard of ischemic stroke for all patients, G3–G5 and G5D [HR 0.72 (95% CI 0.51–1.00), 0.77 (0.49–1.19) and 0.70 (0.36–1.37)]. An ITTR increase of 0.2 units lowers the risk of all-cause mortality for all patients, G3–G5 and G5D [0.62 (0.55–0.69), 0.56 (0.48–0.65) and 0.75 (0.62–0.9)]. ITTR &amp;gt; 70% compared with &amp;lt;70% lowers the risk of major bleeding and all-cause mortality in all patients [HR 0.63 (0.52, 0.76) and HR 0.52 (0.44, 0.61) but no significant effect on ischemic stroke (HR 0.61 (0.37, 1.01)]. CONCLUSION Warfarin treatment quality worsens with decreasing GFR. Higher iTTR confers a lower risk of major bleeding and death for patients with NVAF and CKD, eGFR &amp;lt; 60 including dialysis. Conclusions cannot be made regarding the effect of iTTR and ischemic stroke due to few events. Patients with NVAF and chronic kidney disease including patients on dialysis on warfarin should be closely monitored to lower the bleeding risk.