Real-world biologic treatment and associated cost in patients with inflammatory bowel disease.

OBJECTIVES: This study aimed to describe biologic treatment of German inflammatory bowel disease (IBD) patients, including biologics' dosage, health care resource use, and treatment-associated cost. METHODS: In this retrospective claims data analysis, all continuously insured adult IBD patients (Crohn's disease [CD] or ulcerative colitis [UC]) who started a new therapy with an anti-tumor necrosis factor alpha (anti-TNF-α) or vedolizumab (VDZ) were included. Observation started with the date of the first prescription of index biologic therapy and lasted 12 months. RESULTS: In the database, 1248 out of 57 296 IBD patients started a biologic treatment of interest (1020 anti-TNF-α, 228 VDZ), and 837 patients were bio-naïve (773 anti-TNF-α, 64 VDZ). The mean age of bio-naïve/bio-experienced anti-TNF-α patients was 39.2/38.1 years (54.9 %/56.7 % female) and 42.6/37.8 years for VDZ patients (56.3 %/54.9 % female). The proportion of patients receiving a maintenance dosage > 150 % compared to SmPC was 15.1 % for Adalimumab, 5.2-39.0 % for Golimumab, 14.7-34.5 % for Infliximab, and 19.7 % for VDZ patients. During the maintenance phase, up to 58.8 % of patients received at least 1 prescription of any CS, and 41.7 %/47.1 % (anti-TNF-α/VDZ) were treated in a hospital due to IBD. The mean IBD-related direct health care cost per patient year was €â€Š30 246 (anti-TNF-α)/ €â€Š28 227 (VDZ) for bio-naïve patients (p = 0.288) and €â€Š34 136 (anti-TNF-α)/ €â€Š32 112 (VDZ) for bio-experienced patients (p = 0.011). CONCLUSIONS: A substantial percentage of patients receive a high biologic dosage in the maintenance phase. Despite biologic therapy, 30-40 % receive a CS therapy and/or experience at least 1 IBD-associated hospitalization within a year, possibly indicating a remaining disease activity.

Primary data, claims data, and linked data in observational research: the case of COPD in Germany.

BACKGROUND: Real-world evidence (RWE) can inform patient management decisions, but RWE studies are associated with limitations. Linkage of different RWE data types could address such limitations by enriching data and improving scientific quality. Using the example of chronic obstructive pulmonary disease (COPD) in Germany, this study assessed the value of data linkage between primary and secondary data sources for RWE. METHODS: Post hoc analysis of data from an observational RWE study, which used prospectively collected data and data from an insurance claims database to assess treatment adherence and persistence in patients with COPD in Germany. Patient-level primary data were collected from the prospective observational study (primary dataset, N = 636), and claims data from the sickness fund AOK Nordost (claims dataset, N = 74,916). Primary and claims data were linked at a patient level using insurance numbers (linked dataset). Patients in the linked dataset were indexed at date of study inclusion for primary data and matched calendar date for claims data. Agreement between primary and claims data was examined for patients in the linked dataset based on comparisons between recorded sociodemographic data at index, comorbidities (primary: any recorded; claims: pre-index), prescriptions for COPD therapies (type and date) and exacerbations in the 12-month post-index period. RESULTS: The linked dataset included primary and claims data for 536 patients. Fewer comorbid patients were reported in primary data compared with claims data (p < 0.001), with overall agreement between 63.6% (hypertension) and 90.5% (osteoporosis). Number of prescriptions for COPD therapies per patient was lower in primary versus claims data (3.7 vs 10.3 prescriptions, respectively), with only 24.5% of prescriptions recorded in both datasets. Only 11.5% of exacerbations (moderate or severe) were recorded in both datasets, with 15.5% recorded only in primary data and 73.0% recorded only in claims data. CONCLUSION: Our study highlighted discrepancies between primary and claims data capture for this population of German patients with COPD, with lower reporting of comorbidities, COPD therapy prescriptions and exacerbations in primary versus claims data. Study findings suggest that data linkage of primary and claims data could provide enrichment and be useful in fully describing COPD endpoints.

Staphylococcus aureus Infections in German Patients with Type 2 Diabetes Mellitus after Orthopedic Surgery: Incidence, Risk Factors, and Clinical and Health-Economic Outcomes.

BACKGROUND: This study assessed Staphylococcus aureus infection risk in patients with type 2 diabetes mellitus (T2DM) undergoing an orthopedic knee, hip, or spine surgery. PATIENTS AND METHODS: All patients with a diagnosis of T2DM in the period from 2010 to 2012 were identified from a German claims database. First inpatient knee, hip, or spine surgery was used as index date. Cumulative incidence of S. aureus infections was calculated for several time intervals. Risk factors were identified based on a multi-variable Cox regression analysis. A case control analysis was conducted to assess mortality, healthcare resource utilization, and healthcare costs of S. aureus. RESULTS: In total, 9,401 patients with T2DM underwent a knee, hip, or spine surgery. Mean age was 72.58 years, 63.32% were female, and 1.08% experienced an S. aureus infection in the 365-day follow-up period. The difference in all-cause direct treatment costs per patient-year between infected and non-infected patients was 24,437.50$. Mortality rates were 25.52% (S. aureus group) versus 5.22% (non-S. aureus group), based on a 365-day follow-up. CONCLUSIONS: Staphylococcus aureus is associated with a substantial healthcare burden and high mortality. Effective infection control measures should be considered to reduce post-surgical S. aureus infection risk in patients with T2DM.