Healthcare resource utilization and treatment costs of Finnish chronic inflammatory bowel disease patients treated with infliximab.

Objectives: Inflammatory bowel disease (IBD) is associated with a high economic burden to society due to its early onset and chronic character. Here, we set out to characterize healthcare resource utilization and associated costs in Crohn's disease (CD) and ulcerative colitis (UC) patients with infliximab treatment, the most widely used first-line biologic agent in Finland, in a real-world clinical setting. Methods: This was a retrospective, non-interventional single-center study. Infliximab was administered in routine care, and data were collected retrospectively from electronic health records. All adult anti-TNF naïve CD or UC patients whose infliximab treatment was initiated at the Hospital District of Southwest Finland between the years of 2014 and 2016 were included in the study. Each patient was followed-up for 12 months after the initiation of infliximab treatment. Results: A total of 155 patients were included (45 CD, 110 UC). Altogether, 60.0% (n = 27) of all CD patients and 43.6% (n = 48) of all UC patients persisted on infliximab therapy 12 months after treatment initiation. The total cost was similar for both CD and UC cohorts (CD, €10,243; UC, €10,770), infliximab treatment being the highest individual cost (60.3% of the total cost in CD; 53.4% in UC). The mean number of infliximab infusions during the 12-month follow-up was 7.0 for CD and 6.5 for UC patients. Conclusions: IBD causes a significant burden to the Finnish healthcare system. This study provides a detailed characterization of the cost landscape of IBD and contributes to optimizing treatment strategies and healthcare resource use in the biosimilar era.

Characterization of inflammatory bowel disease management by vedolizumab and concomitant treatments in real-life clinical practice.

Limited data is available on vedolizumab combination therapies in real-world clinical practice. Here, we evaluated the concomitant corticosteroid, immunosuppressive, and 5-aminosalicylic acid utilization of inflammatory bowel disease (IBD) patients treated with vedolizumab in a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centres with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) who had at least one vedolizumab infusion since it's availability in Finland were included in the study. Data were collected from medical charts at baseline (vedolizumab treatment initiation), week 14, and month 6. The majority of patients who used corticosteroids at the baseline and persisted on vedolizumab treatment for 6 months were taken off corticosteroid treatment by the 6-month time point (CD, 54.5%; UC, 69.8%). Modest corticosteroid dose reductions were observed among treatment persistent CD patients from the baseline until month 6. Corticosteroid users had less vedolizumab discontinuations due to primary ineffectiveness and more discontinuations due to adverse events than patients not using corticosteroids. Vedolizumab may have a corticosteroid sparing effect in real-world clinical practice. Concomitant corticosteroid use may lead to a lower rate of vedolizumab discontinuation due to primary ineffectiveness, but a higher discontinuation rate due to adverse events.

Effect of physical activity on pulse wave velocity in elderly subjects with normal glucose, prediabetes or Type 2 Diabetes.

Carotid-femoral pulse wave velocity ((cf)PWV) is a measure of arterial stiffness, predicting cardiovascular disease. We hypothesized that the amount of physical activity (PA) is correlated with reduced arterial stiffness in Type 2 diabetic (T2D) subjects. 570 subjects from the 1945 Oulu birth cohort were included in the analysis. (cf)PWV was determined by a non-invasive applanation tonometry. Oral glucose tolerance test was performed and LDL and HDL cholesterol analyzed. PA was registered daily with a wrist-worn acceleration meter for two weeks. (cf)PWV values in subjects with impaired glucose metabolism (IGM) and T2D were higher than in normal glycemic subjects (P < 0.001). PA, fasting and 2 h glucose and HbA1c correlated significantly with (cf)PWV, but HDL or LDL cholesterol did not. The 2 h glucose, heart rate and alcohol consumption in T2D subjects had independent effects on (cf)PWV in multiple regression analysis. T2D and IGM were significantly associated to (cf)PWV. Interestingly, lipids did not have an additional effect on (cf)PWV. Subjects walking more than 10 000 steps/day had 0.2 m/s lower (cf)PWV than those walking less than 6000 steps/day. Presence of T2D, elevated heart rate and alcohol consumption in males were associated with increased aortic stiffening in elderly subjects.

The Long-Term Footprint of Endometriosis: Population-Based Cohort Analysis Reveals Increased Pain Symptoms and Decreased Pain Tolerance at Age 46 Years.

Previous studies have shown increased pain sensitivity in fertile-aged women with endometriosis in response to mechanical stimuli. As yet, population-based studies on the association of endometriosis with pain sensation and pain symptoms in late fertile age are lacking. The main objective of this population-based cohort study was to investigate whether a history of endometriosis is associated with altered pain sensation and musculoskeletal pain symptoms at age 46 years. Our data are derived from the Northern Finland Birth Cohort 1966, which contains postal questionnaire data (72% response rate) as well as clinical data assessing pressure-pain threshold and maximal pain tolerance. The study population consisted of 284 women with endometriosis and 3,390 controls. Our results showed that at age 46 women with a history of endometriosis had a 5.3% lower pressure-pain threshold and 5.1% lower maximal pain tolerance compared with controls. The most significant contributors besides endometriosis were anxiety, depression, and current smoking status. Women with endometriosis also reported an increased number of pain sites (0 pain sites, 9.6 vs 17.9%; 5-8 pain sites, 24.8 vs 19.1%, endometriosis vs controls respectively; P < .001), and their pain was more troublesome and intense. The results were adjusted for body mass index, smoking, depressive/anxiety symptoms, education, and use of hormonal contraceptives. These unique data revealed an altered pain sensation and a greater likelihood of reporting musculoskeletal pain at age 46 years among women with a history of endometriosis. The results imply that endometriosis has a long-term footprint on affected women, thus underlying the need for psychological support and medical treatment beyond fertile age. PERSPECTIVE: This population-based cohort study showed decreased pain threshold and maximal pain tolerance in women with endometriosis in the late fertile age of 46 years. The pain was also found to be more bothersome and intense compared with controls.

ÖMPSQ-Short Score and determinants of chronic pain: cross-sectional results from a middle-aged birth cohort.

BACKGROUND: The Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) was developed to identify patients at risk of developing work disability due to pain. So far, neither the ÖMPSQ or its short version (ÖMSPQ-short) have been tested in population-based samples. AIM: We examined the associations between several well-known determinants for chronic pain and ÖMPSQ-Short Score. DESIGN: Cross-sectional study. SETTING: All measurements and tests were made at the University of Oulu. POPULATION: Subjects belonging to the Northern Finland Birth Cohort 1966 answered a questionnaire at the age of 46 years (N.=5637). METHODS: The questionnaire included the ÖMPSQ-short as well as questions about smoking, education, location, number of pain sites, and physical activity. In addition, body weight and height were measured in order to calculate the Body Mass Index. RESULTS: In multivariate logistic regression analysis, reporting 4-5 pain sites (females OR 3.4; males 3.0), ≥6 pain sites (females OR 12.4; males 7.4) and current smoking (females 1.8; males 2.6) were associated with being classified into the ÖMPSQ high risk group. In females, also obesity (OR 1.6) and less than 9 years of education (2.7) were associated with higher ÖMPSQ Score. The frequency of physical activity was not associated with the ÖMPSQ Score. CONCLUSIONS: High number of pain sites and smoking among both genders, and obesity and low education level among females is associated with higher ÖMPSQ scores. Therefore, the ÖMPSQ-short may be a working instrument for also screening the general population. CLINICAL REHABILITATION IMPACT: Results of this study may improve the detection of patients at high risk of developing work disability due to pain.

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO).

OBJECTIVES: The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients. METHODS: This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation. RESULTS: A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6. CONCLUSIONS: Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Effects of Leisure-Time Physical Activity on Vertebral Dimensions in the Northern Finland Birth Cohort 1966.

Vertebral fractures are a common burden amongst elderly and late middle aged people. Vertebral cross-sectional area (CSA) is a major determinant of vertebral strength and thus associated with vertebral fracture risk. Previous studies suggest that physical activity affects vertebral CSA. We aimed to investigate the relationship between leisure-time physical activity (LTPA) from adolescence to middle age and vertebral dimensions in adulthood. We utilized the Northern Finland Birth Cohort 1966, of which 1188 subjects had records of LTPA at 14, 31 and 46 years, and had undergone lumbar magnetic resonance imaging (MRI) at the mean age of 47 years. Using MRI data, we measured eight dimensions of the L4 vertebra. Socioeconomic status, smoking habits, height and weight were also recorded at 14, 31 and 46 years. We obtained lifetime LTPA (14-46 years of age) trajectories using latent class analysis, which resulted in three categories (active, moderately active, inactive) in both genders. Linear regression analysis was used to analyze the association between LTPA and vertebral CSA with adjustments for vertebral height, BMI, socioeconomic status and smoking. High lifetime LTPA was associated with larger vertebral CSA in women but not men. Further research is needed to investigate the factors behind the observed gender-related differences.

Lifelong Physical Activity and Cardiovascular Autonomic Function in Midlife.

PURPOSE: Physical activity (PA) associates with cardiovascular autonomic function, but the relationship with lifelong PA is unclear. We hypothesized that lifelong PA would associate with cardiovascular autonomic function in midlife. METHODS: At the age of 46 yr, the subjects of the prospective Northern Finland Birth Cohort 1966 were invited to examinations where vagally mediated heart rate variability (root mean square of the successive differences in RRi [rMSSD]) and cross-spectral baroreflex sensitivity (BRS) were analyzed from 3-min recordings of ECG and blood pressure in seated and standing positions. Three lifelong PA trajectory groups (active, semiactive, and inactive) were formed according to their self-reported frequencies of participation in PA at the ages of 14, 31, and 46 yr. Finally, 1283 men and 1779 women without cardiorespiratory diseases and diabetes had complete data on lifelong PA, covariates, and rMSSD, and 662 men and 807 women for BRS. RESULTS: In both sexes and measurement conditions, the active (P < 0.01) and semiactive groups (P < 0.05) had greater rMSSD than the inactive group, and the highest BRS was observed in the active group (ANOVA P = 0.001-0.032). In men, these differences were not significant when adjusted for 46-yr lifestyle (smoking, alcohol consumption, sleep, and sitting time), body mass index, waist-to-hip ratio, blood pressure, lipid status, and glucose status. In women, lifelong PA remained a significant independent determinant of seated and standing rMSSD and standing BRS. CONCLUSION: Higher lifelong PA was associated with better cardiovascular autonomic function in midlife. In women, this effect was independent, but in men, it seemed to be mediated by the other lifestyle and cardiometabolic factors.

Improving visual prognosis of the diabetic patients during the past 30 years based on the data of the Finnish Register of Visual Impairment.

PURPOSE: To evaluate changes in visual impairment (VI) due to diabetic retinopathy (DR) recorded in the Finnish Register of Visual Impairment (RVI) during the past 30 years. METHODS: Data from the visually impaired diabetic persons included in the RVI were analysed using three 10-year cohorts (1982-90, 1991-2000, 2001-10). Information on the age at the time of the first VI registration, severity of VI determined according to the World Health Organisation (WHO) definition, and the age at death was collected. VI due to proliferative (PDR) and non-proliferative (NPDR) DR were analysed separately. RESULTS: Data of 4080 patients whose primary cause for VI was DR were analysed. The median age at the time of notification of VI for the three cohorts was 39, 62 and 59 years in the PDR group and 71, 73 and 73 in the NPDR group, respectively. The proportion of blind persons was 42%, 22% and 15% in the PDR group and 10%, 9% and 4% in the NPDR group, respectively. The median age at death in the three cohorts was 54, 73 and 72 years in PDR group and 76, 79 and 80 years in the NPDR group, respectively. The standardized mortality ratio (SMR) compared with the general population was 8.3, 2.9 and 1.4 in persons with PDR and 3.4, 2.0 and 1.2 in those with NPDR, respectively. CONCLUSIONS: A significant change in the profile of the VI in the PDR group has taken place in Finland. It was characterized by increased age at the time of VI notification, decreased severity of VI and higher age at death. Most evidently these improvements took place in the 1990s. The profile of VI in the NPDR group has changed only modestly. Compared with the general population, SMRs improved both in NPDR and PDR groups continuously.

A genome-wide association study of body mass index across early life and childhood.

BACKGROUND: Several studies have investigated the effect of known adult body mass index (BMI) associated single nucleotide polymorphisms (SNPs) on BMI in childhood. There has been no genome-wide association study (GWAS) of BMI trajectories over childhood. METHODS: We conducted a GWAS meta-analysis of BMI trajectories from 1 to 17 years of age in 9377 children (77,967 measurements) from the Avon Longitudinal Study of Parents and Children (ALSPAC) and the Western Australian Pregnancy Cohort (Raine) Study. Genome-wide significant loci were examined in a further 3918 individuals (48,530 measurements) from Northern Finland. Linear mixed effects models with smoothing splines were used in each cohort for longitudinal modelling of BMI. RESULTS: A novel SNP, downstream from the FAM120AOS gene on chromosome 9, was detected in the meta-analysis of ALSPAC and Raine. This association was driven by a difference in BMI at 8 years (T allele of rs944990 increased BMI; PSNP = 1.52 × 10(-8)), with a modest association with change in BMI over time (PWald(Change) = 0.006). Three known adult BMI-associated loci (FTO, MC4R and ADCY3) and one childhood obesity locus (OLFM4) reached genome-wide significance (PWald < 1.13 × 10(-8)) with BMI at 8 years and/or change over time. CONCLUSIONS: This GWAS of BMI trajectories over childhood identified a novel locus that warrants further investigation. We also observed genome-wide significance with previously established obesity loci, making the novel observation that these loci affected both the level and the rate of change in BMI. We have demonstrated that the use of repeated measures data can increase power to allow detection of genetic loci with smaller sample sizes.