Roche (Finland)

BackgroundThe prevalence of vision-threatening diseases, such as age-related macular degeneration (AMD) and diabetic macular edema (DME), is likely to increase in developed countries owing to an aging population, rising life expectancy, and unfavorable lifestyle changes. Increases in the burden of vision-threatening diseases pose a challenge to the healthcare system. After the emergence of intravitreal anti-VEGF inhibitors, treatment options for neovascular AMD (nAMD), DME, retinal vein occlusion (RVO) and myopic choroidal neovascularization (myopic CNV) have increased. As this change in treatment practices has occurred over the last two decades, it is important to demonstrate changes in patient numbers and administered treatments to provide solutions for handling the workload and productivity in ophthalmology departments. In addition, the registry data landscape has evolved in Finland in recent years. Thus, understanding the possibilities and limitations of ophthalmology registries and patient information systems is required.MethodsThis study involved the secondary use of retrospectively registered data from the data warehouse of the Hospital District of Southwest Finland. Our goal was to explore how the workload of ophthalmology departments caused by intravitreal injections has evolved from 2015 to 2022.ResultsThe ophthalmology department workload increased significantly during our observation period as the total number of patients receiving intravitreal treatments for nAMD, DME, RVO, and myopic CNV increased 199.6% from 2015 to 2021. In addition, the total number of administered anti-VEGF injections increased during our observation period, but the increase rate began to subside (2019–2020: increase 23.7%, 2020–2021: increase 10.3%, 2021–2022: increase 6.7%).ConclusionSupporting the utilization of registry data is essential in evidence-based discussions evolving workload in healthcare. However, it is important to understand the limitations and the quality of the registries. Our study contributes to better understanding the Finnish registry perspective, and it demonstrates the increase in workload in ophthalmology departments caused by intravitreal injections.

BackgroundMany patients with chronic heart failure (HF) experience a reduced health status, leading to readmission after hospitalization despite receiving conventional care. Telemonitoring approaches aim to improve the early detection of HF decompensations and prevent readmissions. However, knowledge about the impact of telemonitoring on preventing readmissions and related costs remains scarce.ObjectiveThis study assessed the effectiveness of adding a telemonitoring solution to the standard of care (SOC) for the prevention of hospitalization and related costs in patients with HF in Finland.MethodsWe performed a nonrandomized pre-post telemonitoring study to estimate health care costs and resource use during 6 months on SOC followed by 6 months on SOC with a novel telemonitoring solution. The telemonitoring solution consisted of a digital platform for patient-reported symptoms and daily weight and blood pressure measurements, automatically generated alerts triggering phone calls with secondary care nurses, and rapid response to alerts by treating physicians. Telemonitoring solution data were linked to patient register data on primary care, secondary care, and hospitalization. The patient register of the Southern Savonia Social and Health Care Authority (Essote) was used. Eligible patients had at least 1 hospital admission within the last 12 months and self-reported New York Heart Association class II-IV from the central hospital in the Southern Savonia region.ResultsOut of 50 recruited patients with HF, 43 completed the study and were included in the analysis. The hospitalization-related cost decreased (49%; P=.03) from €2189 (95% CI €1384-€2994; a currency exchange rate of EUR €1=US $1.10589 is applicable) during SOC to €1114 (95% CI €425-€1803) during telemonitoring. The number of patients with at least 1 hospitalization due to HF was reduced by 70% (P=.002) from 20 (47%) out of 43patients during SOC to 6 (14%) out of 43 patients in telemonitoring. The estimated mean total health care cost per patient was €3124 (95% CI €2212-€4036) during SOC and €2104 (95% CI €1313-€2895) during telemonitoring, resulting in a 33% reduction (P=.07) in costs with telemonitoring.ConclusionsThe results suggest that the telemonitoring solution can reduce hospital-related costs for patients with HF with a recent hospital admission.

Objectives: To study the efficacy and safety of once-monthly oral ibandronate in the prevention of glucocorticoid (GC)-induced osteoporosis (GIOP) in postmenopausal women with inflammatory rheumatic diseases.Method: A randomized, double-blind, placebo-controlled, parallel-group study of 140 postmenopausal women was conducted. At baseline, the mean lumbar spine (LS) (L1–L4) bone mineral density (BMD) was normal or osteopaenic (T-score ≥ –2.0) and the patients were receiving treatment with 5–15 mg/day of prednisone equivalent. Patients were randomized 1:1 to receive either monthly oral ibandronate 150 mg or placebo for 12 months. All patients received vitamin D and calcium supplements. The primary endpoint was the relative change in mean LS BMD from baseline to 12 months.Results: Mean LS BMD increased significantly by 2.6% and 3.2% from baseline to 6 and 12 months with ibandronate compared to 0.3% and –0.1% with placebo, respectively (p < 0.001). Comparable significant mean increases were also found in trochanter, femoral neck and total hip BMDs at 12 months. Reductions in the serum levels of bone turnover markers C-terminal telopeptide of type I collagen (sCTX), N-terminal propeptide of type I procollagen (P1NP), and tartrate-resistant acid phosphatase (TRACP) were significantly more marked in the ibandronate group than in the placebo group at 1, 6, and 12 months. Adverse events (AEs) were reported at a similar frequency in both groups. A higher proportion of serious AEs (SAEs) were reported in the ibandronate group without emergence of any single SAE.Conclusions: Once-monthly oral ibandronate provides a significant increase in LS and total hip BMD with an acceptable safety profile in postmenopausal women treated with low-dose GCs for inflammatory rheumatic diseases.

9518 Background: Amplification of the HER-2/neu and topoisomerase IIα (TOP2A) genes has been linked to the effects of anthracyclines. Their role in predicting outcome of anthracycline-based adjuvant chemotherapy for breast cancer patients has remained controversial. Methods: High-risk breast cancer patients (with 5 or more positive axillary lymph nodes) were included in the present substudy of the SBG 9401 study, comparing an epirubicin-based regimen (9 courses of tailored and dose-escalated 5-fluorouracil, epirubicin and cyclophosphamide; FEC) with 3–4 courses of standard FEC followed by marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa and carboplatin (CTCb). Amplification of HER-2/neu and TOP2A were determined retrospectively on paraffin-embedded tumor tissue sections by chromogenic in situ hybridization (CISH), tissue samples were available from 396/525 (75%) patients. The primary end-point was time to recurrence of breast cancer. Results: HER-2/neu amplification, present in 32.7% of the tumors, was a strong prognostic factor for short relapse-free survival (p=0.0034), but did not predict treatment outcome in either treatment group separately. TOP2A gene amplification, present in 37% of HER-2/neu positive tumors, was associated with a statistically significantly better relapse-free survival than TOP2A non-amplified tumors in patients treated with tailored and dose-escalated FEC (HR=0.44, p=0.049). There was no such correlation seen in patients treated with standard FEC followed by the marrow-supported CTCb regimen (HR=0.95; p=0.87). TOP2A amplification was not associated with tumor size, lymph node status or hormone receptor status. Conclusions: Topoisomerase IIa gene amplification defines a subgroup of HER-2 amplified tumors patients who benefit from the tailored and dose-escalated FEC regimen, indicating that epirubicin should be given with sufficient dose intensity and total dose for a better outcome for this small subgroup. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb, Roche Finland Aventis, Bristol-Myers Squibb Hoffmann-La Roche Aventis, Lilly Oncology, Pierre Fabre, Roche

The efficacy of moclobemide (300-450 mg/day) was compared with fluoxetine (20-40 mg/day) in a double-blind, multicentre study in 209 patients with new episodes of depression selected from 612 consecutive depressed patients representative of those consulting psychiatric services in Finland. Antidepressant efficacy was assessed with the Hamilton Depression Rating Scale (HDRS), Montgomery-Asberg Depression Rating Scale and Clinical Global Impression (CGI). The Medical Outcome Study Short-form General Health Survey (SF-20) and 15D Measure of Quality of Life were used to measure effectiveness in terms of health-related quality of life. Efficacy was evident with both drug treatments, with 67% in the moclobemide group and 57% in the fluoxetine group having a reduction in HDRS of more than 50%. Similarly, 77% of the patients in the moclobemide group and 67% in the fluoxetine group were assessed on the CGI as much better or very much better after 6 weeks of treatment. The most commonly reported adverse events were nausea, other gastrointestinal symptoms, nervousness, dizziness and sleep disorders. Nausea was significantly more common in the fluoxetine group and was found especially in women. Premature terminations of treatment were 18% in the moclobemide and 21% in the fluoxetine group. A significant change for the better in quality of life was found in both treatment groups, even at week 2 but especially after 6 weeks of treatment. Improvement was not only seen in dimensions measuring depression or mental health but also in other dimensions.

Forty-six patients with Lichen sclerosus (Ls) of the vulva were treated with peroral etretinate for 3 months. The pretreatment serum levels of vitamins A and E, and selenium were measured. Etretinate therapy proved to be effective in the treatment of Ls; however, it did not affect the vitamin A status of the Ls patients. Vitamin E and selenium levels did not differ from the control values, nor did they have any prognostic value.