Takeda (Norway)

BACKGROUND: Despite the increasing use of biologics in patients with inflammatory bowel disease (IBD), real-world data about outcomes in the era of biologics remain inconclusive. AIMS: To investigate trends in surgeries, hospitalisations and medication use in patients with IBD in a multinational, population-based cohort METHODS: We included 42,894 patients with ulcerative colitis (UC) and 24,864 with Crohn's disease (CD) who were diagnosed between 2010 and 2017 in Denmark, Norway and Sweden. We extracted data about surgeries, hospitalisations and medications from national registries and compared across countries and diagnosis years. RESULTS: Between 2010 and 2017, 2-year surgery rates were 4-7% in UC and 10-15% in CD and were stable over time. Two-year hospitalisation rates increased in Denmark (UC: 20% to 35%; CD: 27% to 32%) but were stable in Norway and Sweden (fluctuating between 33% and 37% in UC, and 46% and 52% in CD). Two-year rates of biologic use increased in both UC (7% to 16% in Denmark, 8% to 18% in Norway) and CD (22% to 26% in Denmark; 21% to 35% in Norway). Two-year rates of immunomodulator use increased in Norway (from 14% to 23% in UC; 37% to 45% in CD) and Sweden (from 41% to 52% in CD), but were stable in Denmark (between 17% and 21% in UC; 39% to 46% in CD). CONCLUSION: Between 2010 and 2017, surgery rates among Scandinavian patients with IBD remained stable, with no clear changes in hospitalisation rates despite the increasing use of immunomodulators and biologics.

PURPOSE: Patients diagnosed with advanced-stage Hodgkin lymphoma (aHL) have historically been risk-stratified using the International Prognostic Score (IPS). This study investigated if a machine learning (ML) approach could outperform existing models when it comes to predicting overall survival (OS) and progression-free survival (PFS). PATIENTS AND METHODS: This study used patient data from the Danish National Lymphoma Register for model development (development cohort). The ML model was developed using stacking, which combines several predictive survival models (Cox proportional hazard, flexible parametric model, IPS, principal component, penalized regression) into a single model, and was compared with two versions of IPS (IPS-3 and IPS-7) and the newly developed aHL international prognostic index (A-HIPI). Internal model validation was performed using nested cross-validation, and external validation was performed using patient data from the Swedish Lymphoma Register and Cancer Registry of Norway (validation cohort). RESULTS: In total, 707 and 760 patients with aHL were included in the development and validation cohorts, respectively. Examining model performance for OS in the development cohort, the concordance index (C-index) for the ML model, IPS-7, IPS-3, and A-HIPI was found to be 0.789, 0.608, 0.650, and 0.768, respectively. The corresponding estimates in the validation cohort were 0.749, 0.700, 0.663, and 0.741. For PFS, the ML model achieved the highest C-index in both cohorts (0.665 in the development cohort and 0.691 in the validation cohort). The time-varying AUCs for both the ML model and the A-HIPI were consistently higher in both cohorts compared with the IPS models within the first 5 years after diagnosis. CONCLUSION: The new prognostic model for aHL on the basis of ML techniques demonstrated a substantial improvement compared with the IPS models, but yielded a limited improvement in predictive performance compared with the A-HIPI.

Despite the global phase-out of leaded gasoline, lead poisoning is estimated to cause 5.5 million premature deaths and the loss of 765 million IQ points annually. However, the contributions of different lead exposure sources to blood lead levels (BLLs) are poorly understood. We conducted a systematic literature review using the Scopus database, examining 39 studies that attribute BLLs to specific sources of lead exposure, published since the year 2000 and with sample sizes > 100. The 39 studies were from 26 countries; 22 were from low- and middle-income countries, with an average sample size of 1003 participants. Twenty-three of the studies reported absolute BLL impacts (μg/L) from lead exposure sources, other studies reported odds ratios for elevated BLLs (> 50 or > 100 μg/L). Averaged across the studies, the BLL impacts were 42.3 μg/L from living near industrial lead pollution hotspots, 31.4 μg/L from occupational and take-home exposure, 28.0 μg/L from deteriorated paint, 19.8 μg/L from traditional medicines and cosmetics, 19.3 μg/L from foodware (glazed ceramics and melamine plates), 17.3 μg/L from smoking, 15.4 μg/L from foods, and 12.9 μg/L from geophagy. Only one of the reviewed studies assessed the BLL impact of metal cookware, and did not find a significant relationship with BLLs. However, the statistical power of the attributional studies to detect relationships with BLLs was often limited. Future studies should investigate the ingestion routes from industrial pollution, the contamination of foods and spices, BLL impacts of lead-contaminated metal cookware, and traditional medicines administered to young children and infants. • Lead exposure costs 5.5 million premature deaths and 765 million IQ points annually • Lack of data on the level of contamination of consumer products and foodstuffs • Ingestion routes for industrial lead pollution unclear, concealing health burden • Identifying sources of lead poisoning limited by statistical power and study design • Need for regulation on lead in consumer products and industrial pollution

AIM: The Health outcomes and Understanding of MyelomA multi-National Study (HUMANS) was a large-scale, retrospective study conducted across Denmark, Finland and Sweden using linked data from national registries. We describe the characteristics, treatment patterns and clinical outcomes for patients with newly diagnosed multiple myeloma (NDMM) over 2010-2018. METHODS: Patients with NDMM who received MM-specific, first-line treatments, were categorised by treatment (autologous stem cell transplantation [ASCT] or a combination chemotherapy regimen based on bortezomib, lenalidomide or melphalan-prednisolone-thalidomide). RESULTS: 11,023 patients received treatment over 2010-2018. Time between diagnosis and treatment was shortest in Denmark (0.9 months), then Sweden (2.9 months) and Finland (4.6 months). Around one third of patients underwent ASCT. Lenalidomide-based regimens were prescribed to 23-28% of patients in Denmark and Finland, versus 12% in Sweden. Patients receiving lenalidomide had the longest wait for treatment, from 3.2 months (Denmark) to 12.1 months (Sweden). Treatment persistence was highest among patients receiving melphalan-prednisolone-thalidomide (7-8 months) in Finland and Sweden and lowest among those receiving bortezomib (3.5 months) in Finland. Overall survival (OS) was longest among patients with ASCT (7-10 years). Among patients receiving chemotherapy, OS (from diagnosis/treatment initiation), varied between cohorts. In a sensitivity analysis excluding patients with smouldering MM, OS decreased for all; for patients receiving bortezomib or lenalidomide, OS from diagnosis was 40-49 and 27-54 months, respectively. CONCLUSIONS: This population-based study of patients with NDMM receiving first-line MM-specific treatment, provides real-world data on treatment patterns and outcomes to complement data from randomised clinical trials.

Abstract Background Biological therapy has been suggested to decrease surgery and hospitalisation risk in patients diagnosed with inflammatory bowel disease (IBD). During 2010 to 2016, the use of biologics in Denmark (DEN), Sweden (SWE) and Norway (NOR) increased dramatically and the time to first biologic treatment declined.1 However, the impact of increasing use of biologics on disease outcomes remains to be shown in real-life practice. In this nationwide study in three Nordic countries, we aimed to investigate trends in surgery and hospitalisation rates in IBD patients in the biological era.1 Høivik ML et al. Time to first treatment with biologic agents for Ulcerative Colitis and Crohn’s Disease across four Nordic countries: Results from the TRINordic study, Submitted to ECCO 2020. Methods A total number of 67 758 IBD patients (42 894 patients with ulcerative colitis (UC) and 24 864 Crohn’s disease (CD) diagnosed during the period from 2010 to 2017 in DEN, NOR and SWE were included using the National Patient Registries. Patients were required to have 1-year follow-up; results are limited to patients diagnosed between 2010 and 2016, inclusive. Using the unique personal identification number, individual-level information on surgery, hospitalisation and drug treatment were extracted from the National Patient Registries and the National Prescription Registries. Disease outcomes within two years after diagnosis were compared across annual cohorts. Results During 2010 to 2016, 2-year surgery rates in CD patients showed a non-significant decline from 11.9% in 2011 to 9.5% in 2016 in SWE while remaining stable in NOR and DEN (Figure 1). No temporal pattern in surgery risk was observed for UC. The proportion of CD patients being hospitalised within two years from diagnosis declined in SWE and NOR from 52.3% and 51.0% in 2011 to 47.3% and 38.5% in 2015 (p < 0.001), respectively, while hospitalisation in UC remained stable. In contrast, 2-year hospitalisation rates in DEN increased in CD from 27.0% in 2011 to 31.5% in 2016 (p = 0.045) and similarly in UC from 20.4 to 35.0% (p < 0.001), respectively (Figure 2). Conclusion No clear pattern was seen in two-year surgery and hospitalisation rates in IBD patients during 2010 to 2017 despite a concurrent increase in biological use in all countries. However, differences in treatment practices across countries might influence these findings. The impact of increased biological use on long-term outcomes in IBD remains to be shown.

Complaints of dry mouth and poor dental health are common in persons with narcolepsy. The aim of this study was to investigate whether salivary secretion is reduced in narcolepsy. Persons using tricyclic anti-depressants (TCAs) were excluded, since TCAs are known to reduce salivary secretion. Thus, two patient subgroups were studied, one on central stimulant (CS) treatment (medicated group, n = 12), and one unmedicated group (n = 8), representing all persons with narcolepsy living in the Oslo area meeting these criteria. The survey group and 20 age- and sex-matched healthy control persons without symptoms of dry mouth were examined with respect to the following parameters: unstimulated (UWS) and chewing-stimulated (SWS) whole salivary flow rates, citric-acid-stimulated parotid and submandibular flow rates, buffering effect, and number of some aciduric micro-organisms in the oral cavity. As a group, persons with narcolepsy had lower whole salivary flow rates, a lower buffering effect, and higher Candida albicans scores than the control group. When the patients were divided into the medicated and unmedicated groups, these differences were valid only for the medicated group. Whether the observed differences were effects of CS medication or reflected that these persons were more seriously affected by the disease has to be further explored.

Purpose: Linked health-care registries and high coverage in Nordic countries lend themselves well to epidemiologic research. Given its relatively high incidence in Western Europe, complexity in diagnosis, and challenges in registration, multiple myeloma (MM) was selected to compare registries in Denmark, Finland, and Sweden. Patients and Methods: Data were obtained from four archetypal registries in each country (spanning January 2005–October 2018): National Patient Registry (NPR), Prescribed Drug Registry (PDR), Cancer Registry (CR), and Cause of Death Registry. Patients newly diagnosed with MM who received MM-specific treatment were included. PDR/NPR treatment records were used to assess incident NPR cases. The registration quality of MM-specific drugs in the PDR of each country was also evaluated. Results: In Denmark, only 6% of patients in the NPR were not registered in the CR; in Sweden, it was 16.9%. No systematic differences were identified that could explain this discrepancy. In Denmark, lenalidomide and bortezomib were registered in the NPR with high coverage, but less expensive drugs typically given in combination with bortezomib were not covered in any of the registries. In Finland and Sweden, bortezomib records were not identified in the PDR, but some were in the NPR; other drugs had good coverage in the PDR. Conclusions: The registries evaluated in this study can be used to identify the MM population; however, given the gaps in MM registration in the Finnish and Swedish CRs, Danish registries provide the most comprehensive datasets for research on treatment patterns for MM. Plain Language Summary: National patient registries collect observational data on populations of patients and are often used for research. In this study, we investigated how complete the national patient registries were for Denmark, Finland and Sweden when recording the number of patients with multiple myeloma (MM; a type of bone marrow cancer) between 2005 and 2018. We also investigated the completeness in registration of given treatments during the study period in the national registries. Overall, the Danish national patient registries had the most comprehensive information on patients with MM. Registry data from Denmark could therefore be useful for conducting further research into the characteristics, treatment patterns, and outcomes of patients with MM. Keywords: incidence, prevalence, real-world evidence

Central disorders of hypersomnolence (CDH) are chronic diseases that significantly impact the lives of affected individuals. We aimed to explore the perspectives of individuals with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH), and the challenges they encounter in their daily lives and within the healthcare systems in the Nordics. Interviews with patients (N = 41) and healthcare professionals (n = 14) and a patient survey (n = 70) were conducted in 2022 in Denmark, Sweden, Finland, and Norway to develop a patient journey map that visualises the patient with CDH journey and provides insights into the difficulties faced by these individuals. The patient journey mapping approach was chosen to focus on the processes and experiences of patients, highlighting the challenges they confront. Our findings revealed that the process of receiving a CDH diagnosis, as well as subsequent misdiagnoses and treatment, can be protracted and burdensome. CDH diagnoses remain poorly understood by neurologists, general practitioners, and the public, resulting in adverse consequences, with patients reporting a mean (standard deviation [SD]) time from symptom onset to diagnosis of 8.4 (5.11) years and a mean (SD) of 5.5 (4.17) productive hours lost/day. The available non-pharmaceutical support for patients with CDH, encompassing medical, psychological, educational, and professional assistance, was insufficient. The generalisability of the findings to one specific diagnosis is limited due to the collective analysis of the CDH. These findings are invaluable for identifying disruptions in the patient with CDH journeys and for designing improved pathways for those with NT1, NT2, and IH in the future.

Biologic treatment and surgery are complementary therapies for patients with moderate-to-severe IBD. Biological treatment has been available for the last 18 years, but there is limited knowledge about treatment patterns in different age groups. The aim of this study was to describe the use of anti-TNFα therapy and IBD-related surgery in three different age groups in Norway. Data were collected from the Norwegian Patient Registry (NPR) and included information on every individual hospital treatment episode for IBD patients (ICD-10 codes K50 and K51) from 2008 to 2015. The results were calculated for patients who were first observed with an IBD diagnosis in the registry between 2010 and 2012. The patients were followed for three years after the first observed IBD diagnosis and only patients with at least two IBD-related hospital events during the three years were included. The use of anti-TNFαs (both intravenous and subcutaneous) is recorded with ATC codes for each patient in the NPR. The occurrence of first IBD-related major surgery was assessed over the same time period, based on surgery codes for resections, colectomies, strictureplasty and intestinal obstruction repair. The analysis was stratified by disease type; ulcerative colitis (UC) or Crohn’s disease (CD) and age group (0–19 years, 20–59 years, 60+ years). The study population included 8257 patients (CD: 2829 [34%]; UC: 5428 [66%]). For CD, 355 (13%), 1937 (68%) and 537 (19%) patients were aged 0–19, 20–59 and 60+ years old, respectively. For UC, corresponding patient numbers were 297 (5%), 3665 (68%) and 1466 (27%). Three years after identification, the proportion of CD patients treated with anti-TNFαs was 50.1%, 29.6% and 11.7% in those aged 0–19, 20–59 and 60+ years, respectively. For UC, the corresponding proportions were 30.0%, 12.8% and 5.5% (Figure 1). Three years after identification IBD-related surgery was performed in 7.9%, 14.1% and 16.6% of CD patients aged 0–19, 20–59 and 60+ years, respectively. For UC, the corresponding proportions were 6.7%, 4.5% and 6.6% (Figure 2). Cumulative probability of receiving anti-TNFα therapy within three years by diagnosis and age groups (%). Cumulative risk of undergoing a resection among patients with and without pCD. Both for CD and UC, there were observed differences in the proportion of anti-TNFα treated individuals and in IBD-related surgery rates between age groups.

Abstract Background The effects of polymorphisms in CYP3A4 (20230G > A), CYP3A5 (6986A > G), ABCB1 (1236C > T, 2677G > T/A, 3435C > T), ABCG2 (421C > A), and ABCC2 (-24C > T) on the area under the concentration-time curve (AUC) of osimertinib in 23 patients with non-small cell lung cancer were investigated. Methods Blood sampling was performed just prior to and at 1, 2, 4, 6, 8, 12, and 24 h after osimertinib administration at the steady-state on day 15 after beginning therapy. Results There were significant correlations of the osimertinib AUC 0-24 with age ( P = 0.038), serum albumin ( P = 0.002), and serum creatinine ( P = 0.012). Additionally, there were significant differences in the AUC 0-24 of osimertinib among the groups administered vonoprazan, histamine 2-receptor antagonists or esomeprazole, and no acid suppressants ( P = 0.021). By contrast, there were no significant differences in the AUC 0-24 of osimertinib between genotypes of CYP3A4/5 or ABC transporters. Furthermore, there were no significant differences in the AUC 0-24 of osimertinib between patients with diarrhea, skin rash, or hepatotoxicity and those without these conditions. In multivariate analysis, only serum albumin value was an independent factor predicting the AUC 0-24 of osimertinib. Conclusions Analysis of CYP3A4/5 and ABC transporter polymorphisms before osimertinib therapy may not predict the efficacy or side effects of osimertinib. However, lower serum albumin values were associated with an increase in the AUC 0 − 24 of osimertinib. After beginning osimertinib therapy, periodic measurement of serum albumin values should be performed.

Introduction Current treatment for multiple myeloma (MM), an incurable but treatment sensitive plasma cell cancer, aims to extend time to disease progression, prolong survival and improve quality of life. Nevertheless, epidemiological knowledge regarding MM treatment is mostly derived from randomized controlled trials, which are limited by strict inclusion criteria, study designs that assess drug efficacy in optimal clinical settings, and short follow-up. Current treatment options for MM are associated with complex and varying treatment-related side effect profiles. However, real-world evidence is available only for a limited selection of treatment regimens. Thus, there is a need for studies to further investigate treatment patterns in clinical settings that reflect real-world practice. The Health Outcome and Understanding of Myeloma - a multi-national real-world evidence (HUMANS) study - aimed to characterize patient characteristics, treatment patterns, and outcomes for newly diagnosed patients with MM who received first-line treatment. Here we report first results from the Danish study. Methods This population-based, retrospective, longitudinal, observational study used secondary data from the Danish Cancer Register (DCR) and National Patient Register (NPR) for patients diagnosed with MM. Patients were stratified by autologous stem cell transplantation (ASCT) and pharmacological treatment (bortezomib-based, lenalidomide-based, or other first-line therapy) and characterized using descriptive statistics. To analyse recent treatment patterns and also include patients with long duration before treatment start, eligible patients had first MM diagnosis from 2005-2016 in the NPR and DCR (diagnosis date identified from the DCR), first MM-specific treatment from 2010-2018 in the NPR, no other hematologic cancer records in the NPR and DCR, and no MM treatment before diagnosis. Treatment duration (time between start and end of treatment period, with set grace period of 60 days and assumed treatment supply of 7 and 28 days per treatment event for bortezomib and lenalidomide, respectively) and overall survival (OS) were estimated by Kaplan-Meier method. Results The study population comprised 2,451 patients with MM, of which 887 patients (36%) underwent ASCT. In the non-ASCT population (n=1564), the majority (n=838, 54%) received bortezomib as first-line treatment, 102 patients (7%) received lenalidomide, and for 631 patients (40%), first-line treatment could not be identified (referred to as the other non-ASCT cohort). Mean (standard deviation) age overall at first MM diagnosis was 68 (±11) years, and was 72 (±8), 75 (±9), 77 (±7), and 59 (±8) years in the bortezomib, lenalidomide, other non-ASCT and ASCT cohorts, respectively. A higher number of men (57%) than women were diagnosed with MM. From 2015 onwards, the proportion of patients who received lenalidomide increased, whereas for patients who received other MM specific drugs, the proportion decreased (see Table 1). The median OS (95% confidence interval [CI]) from administration of first-line treatment for the bortezomib and lenalidomide cohorts was 52.9 (46.2-58.2) and 69.3 (54.7-108.4) months, respectively. For the ASCT cohort the median OS was 117.2 (104.2-133.8) months from MM diagnosis. Patients followed a once or twice weekly regimen of bortezomib treatment, i.e. 3/4 or 7 days between treatments (Figure 1). Patients in the bortezomib cohort remained treated with a median bortezomib treatment duration of 4 months (CI 4.04-4.60) and an estimated 10% remained on treatment at 10 months. In the lenalidomide cohort, patients remained treated with a median duration of 7 months (CI 4.67-10.12) and an estimated 10% remained on treatment at 23 months (Figure 2). Conclusion In this study, we present population-based treatment patterns and outcomes for MM in Danish clinical practice. The 4 month median treatment duration of bortezomib was lower than the target treatment suggested by prior clinical trials. The differences in overall survival and treatment duration should be interpreted with caution, as patients in the different cohorts have varying baseline characteristics. Linked data from the DCR and NPR may provide real-world evidence of treatment patterns in clinical practice. Research regarding time to progression in a multiple myeloma real-world setting is warranted. Disclosures Abildgaard: Amgen: Research Funding; Takeda: Research Funding; Janssen: Research Funding; Celgene: Research Funding. Szilcz:Parexel International: Employment. Ma:Parexel International: Employment. Ørstavik:Takeda Pharmaceuticals International AG: Employment. Bent-Ennakhil:Takeda Pharmaceuticals International AG: Employment. Freilich:Parexel International: Employment. Gavini:Takeda Pharmaceuticals International AG: Employment.

Abstract Background The use of biologic therapy has increased significantly during the last decade. In 2015, one in three Crohn’s disease (CD) patients and one in five ulcerative colitis (UC) patients had received biologics within 2 years of diagnosis 1 in Denmark (DEN), Sweden (SWE) and Norway (NOR). Whether this change in treatment strategy has resulted in changes in the use of conventional drugs (5-aminosalicylates [5-ASA], immunomodulators [IM] or corticosteroids) remains unknown. An aim of this study was to investigate the use of these drugs in the biological era.1 Høivik ML et al. Time to first treatment with biologic agents for ulcerative colitis and Crohn’s disease across four Nordic countries: Results from the TRINordic study, Submitted to ECCO 2020. Methods A total of 67,758 incident IBD patients (42,894 UC, 24,864 CD) diagnosed between 2010 to 2017 were included in a nationwide cohort in DEN, NOR and SWE. Information on drug treatment was extracted from the National Patient Registries and the National Prescription Registries. Patients were required to have at least 1-year of follow-up post-diagnosis; results are limited to patients diagnosed between 2010 to 2016, inclusive. Results During 2010 to 2016, cumulative exposure to 5-ASA in CD patients at 2 years after diagnosis declined from 19.0%, 39.0% and 50.5% in 2011 to 16.3%, 31.1% and 39.6% in 2016 in DEN, NOR and SWE, respectively (p < 0.001). The opposite trend was observed in UC where 87.3–91.1% received 5-ASA within 2 years in 2015 compared with 75.8–87.3% in 2011 (p < 0.001) (Figure 1). In all countries, corticosteroid use remained stable in CD with more than half of patients receiving corticosteroids within 2 years of diagnosis. In UC, corticosteroid use within 2 years of diagnosis increased in NOR from 42.2% in 2011 to 51.6% in 2015 (p < 0.001) but remained stable in DEN and SWE (Figure 2). The use of IM within 2 years increased in CD patients in NOR and SWE from 36.5% and 40.8% in 2010 to 51.3% and 52.1% in 2015 (p < 0.001). IM were less frequently used in UC but increased similarly from 14.0% and 21.1% in 2010 to 22.5% and 26.4% in 2015 (p < 0.001). In DEN, IM use remained stable over time (Figure 3). Conclusion The use of 5-ASA declined over time in patients diagnosed with CD but increased over time in patients diagnosed with UC. Corticosteroid use remained stable in CD but increased over time in UC patients in NOR. The increasing and earlier use of biologics was accompanied by increasing use of IM in all countries. While this could suggest a more aggressive treatment approach, differences in treatment practices across countries might contribute to these findings. The impact of changes in treatment strategies on disease outcomes remains to be shown.

Abstract Background Incidence and prevalence of inflammatory bowel diseases (IBD) have been increasing for the past decades in the western world, however with an emerging trend of incidence stabilisation in recent years. There is an indication of higher IBD incidence and prevalence in northern Europe, especially in the Nordic region, compared with southern Europe. Methods This retrospective observational study collected data from the National Patient Registries and National Prescription Registries (Sweden [SWE], Norway [NOR], Denmark [DEN]) and one university hospital database (Turku, Finland [FIN]) during 2010–2017 to investigate the annual incidence and prevalence of ulcerative colitis (UC) and Crohn’s disease (CD). Patients with ≥2 ICD-10 diagnosis codes for UC (K51) or CD (K50) from 2010 or later and no K51 or K50 codes prior to 2010 were included; patients were classified according to their last code. The look-back period for SWE was until 2000, for NOR until 2008, for DEN until 1995, and for FIN until 2004. Incidence proportions highlight results through 2016, as 2017 patients had less than 1-year follow-up. Results In total, 69,876 patients were included (SWE n = 27,902, NOR n = 20,761, FIN n = 2,118, DEN n = 19,095), of which 44 367 patients were diagnosed with UC and 25,509 with CD. In 2016, the annual incidence of UC was 28 patients per 100,000 persons in NOR, 32 patients per 100,000 persons in DEN, 25 patients per 100,000 persons in SWE, and 44 patients per 100,000 in FIN. The corresponding results for the annual incidence of CD per 100,000 persons were 22 in NOR, 16 in DEN, 16 in SWE, and 21 in FIN. The prevalence per 100,000 persons of both UC and CD was the highest in DEN, followed by SWE and NOR, and lowest in FIN. Prevalence estimates increased in all four Nordic countries during 2010–2017: for UC, from 409 to 488 patients in SWE, from 256 to 428 in NOR, from 129 to 375 in FIN, and from 577 to 798 in DEN. For CD, it increased from 261 to 313 patients in SWE, from 164 to 258 in NOR, from 54 to 164 in FIN, and from 280 to 400 in DEN. Conclusion This retrospective observational study showed that during 2016, the annual incidence of UC ranged from 25–44 patients per 100,000 persons across the evaluated Nordic countries, whereas the annual incidence of CD was 16–22 patients per 100,000 persons. Prevalence of both UC and CD increased during 2010–2017 in all four countries. Estimates of UC and CD incidence and prevalence in this analysis are greater than reported in the published literature. Additional analyses are underway to further explore the impact of methodological decisions on the estimates of UC and CD annual incidence and prevalence.

Introduction Multiple myeloma (MM) is an incurable but treatment sensitive plasma cell cancer with an average survival of 2-5 years following diagnosis, depending on age and stage. Few studies report real-world data in MM, with limited estimations of incidence and prevalence. The Health Outcome and Understanding of Myeloma - a multi-national real-world evidence (HUMANS) study utilized real-world data from nationwide registers in Sweden and Denmark, with almost complete population coverage, to estimate the incidence and prevalence of MM. Methods This population-based, retrospective, observational, cohort study used linked, secondary data from national healthcare registers in Sweden (National Patient Register [NPR], Cancer Register [CR], Cause of Death [COD], and Prescription Drug Register [PDR]) and Denmark (NPR and CR) from 2005-2018. Patients with MM diagnosis recorded in the NPR and/or CR treated and untreated with MM specific drugs were included. The NPR in both countries is a hospital discharge register, in which patients receive an ICD-10 diagnosis each time they visit outpatient or inpatient care as the main reason for the hospital visit. The CR is manually reported by physicians when a cancer diagnosis is confirmed. In Denmark, the CR is automatically connected to the NPR, thereby obliging physicians to register whether a diagnosis is confirmed upon first NPR ICD-10 code registration of a cancer diagnosis. The Swedish CR requires active registration of a pathologist or treating hematologist to confirm the diagnosis. To determine the completeness of registration in each respective CR, treatments from the Swedish PDR and Danish NPR from 2010-2018 were used to assess incident NPR cases. Treated patients registered in the NPR, but not in the CR (NPR+/CR-) were compared with treated patients registered in both (NPR+/CR+) to assess any systematic reasons for lack of CR registration. Final inclusion criteria were determined for best estimate of incidence/prevalence of MM. Prevalence was defined as the number of non-deceased patients with MM recorded during each calendar year, as assessed from the COD register. Incidence and prevalence rates were calculated as the crude incident and prevalent cases, divided by the patients at risk (total population minus prevalent population) for each year and multiplied by 100,000. Results In Sweden, data for 13,523 unique patients with registered MM was collected. Of these, 4,563 and 874 fulfilled the inclusion criteria of NPR+/CR+ and NPR+/CR-, respectively. In the comparative analysis, NPR+/CR+ and NPR+/CR- patients had a similar frequency of treatment at a hematology department (57% of NPR+/CR+ and 53% of NPR+/CR- patients had ≥1 visit ), and had a similar share of patients with autologous stem cell transplant (22% for NPR+/CR+ and 18% for NPR+/CR-), and of MM pharmacological treatment type (53% for NPR+/CR+ and 47% for NPR+/CR- had ≥1 prescription of lenalidomide). Both university hospitals and general hospitals had a high share of NPR+/CR- patients. As no systematic difference was found for patients registered in the CR or not, we considered the estimate of incidence to be a sum of NPR+/CR+ treated AND untreated + NPR+/CR- treated. In Denmark, data for 6331 unique patients with registered MM were collected. Of these, 3,680 met inclusion criteria for NPR+/CR+ and 233 for NPR+/CR-. Patients registered as NPR+/CR- were 33% more commonly not visiting a hematology department versus NPR+/CR+. Thus, a systematic skew in CR misregistration could not be excluded. We propose the best estimate of incidence and prevalence of MM in Denmark to be patients registered in the NPR and CR (treated or untreated). In Sweden and Denmark, incidence and prevalence were higher in patients aged ≥70 versus <70 years, and in males versus females. Between the two countries, incidence and prevalence of MM were generally similar, with slightly higher prevalence in Sweden (vs Denmark) and incidence in Denmark (vs Sweden) in patients aged ≥ 70 years (Tables 1 and 2). Best estimates for validated incidences of MM were largely similar to those reported in the Swedish and Danish myeloma registries (Table 3). Conclusion The use of several nationwide registries with independent case registration, rigorous inclusion criteria, and careful consideration of criteria used to estimate incidence/prevalence, arguably provides improved estimates of incidence/prevalence compared with previous studies. Disclosures Abildgaard: Takeda: Research Funding; Celgene: Research Funding; Amgen: Research Funding; Janssen: Research Funding. Szilcz:Parexel International: Employment. Ma:Parexel International: Employment. Ørstavik:Takeda Pharmaceuticals International AG: Employment. Bent-Ennakhil:Takeda Pharmaceuticals International AG: Employment. Freilich:Parexel International: Employment. Gavini:Takeda Pharmaceuticals International AG: Employment.

Abstract Background Real-world data on time from diagnosis to first biologic treatment is limited for ulcerative colitis (UC) and Crohn’s disease (CD) patient populations. Methods This retrospective observational study collected data from the National Patient Registries and National Prescription Registries in Sweden (data on biologic use was only available for Stockholm [STK], Norway [NOR], Denmark [DEN]) and one university hospital database (Turku, Finland [FIN]) during 2010–2017 to investigate time from diagnosis to first biologic treatment for UC and CD. Patients with ≥2 ICD-10 diagnosis codes for UC (K51) or CD (K50) from 2010 or later were included; patients were classified according to their last code. The look-back period for SWE was until 2000, for NOR until 2008, for DEN until 1995, and for FIN until 2004. Time to first biologic was defined as the period from the first UC or CD code to first biologic record. In FIN, it was only possible to investigate infliximab (IFX). Results A total of 47,568 patients were included (STK n = 5594, NOR n = 20,761, FIN n = 2118, DEN n = 19,095). Of them, 30 397 patients had UC and 17 171 CD diagnosed during 2010–2017. Time to first biologic following diagnosis of UC or CD was decreased over time. For patients diagnosed with CD in 2015, in STK, NOR, FIN, and DEN, 30%, 35%, 25%, and 26%, respectively, received a biologic within 2 years; in 2010, the proportions were less than 10%, 20%, 5%, and 22%, respectively. FIN results may be attributed to only IFX use captured in the data sources. NOR had in most cohorts the shortest time between diagnosis and first treatment with a biologic agent, e.g. 33%, 35%, 36%, 34% and 33% of patients diagnosed with CD in 2011, 2012, 2013, 2014 and 2015, respectively, received a biologic already one month after diagnosis compared with 2%, 1%, 3%, 4% and 6%, respectively, in STK, 7%, 5%, 9%, 4% and 5%, respectively, in FIN and 3%, 10%, 28%, 12% and 23%, respectively, in DEN. Fewer UC than CD patients received biologics, but the time to first biologic was shortened to the same extent (Figure 1 and 2, respectively). In NOR, FIN and DEN, the most common biologic used was IFX for UC and CD, e.g. 18%, 14% and 15%, respectively, of UC and 35%, 17% and 35%, respectively, of CD patients diagnosed in 2015 had received IFX; in STK it was IFX for UC (8% of patients diagnosed in 2015) and adalimumab for CD (20% of patients diagnosed in 2015). Conclusion This retrospective observational study of >45 000 patients with inflammatory bowel disease in four Nordic countries showed reduced time between diagnosis and first biologic from 2010 to 2017, with the shortest time between diagnosis and first biologic in Norway. IFX was most commonly used.