Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases.

INTRODUCTION: ABP 501 was an adalimumab (ADA) biosimilar approved for treating immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In this retrospective study, we aimed to examine the treatment patterns of ABP 501 among patients with these IMIDs using German and French pharmacy claims databases. METHODS: Patients with RA, PsA, or AS who initiated ABP 501 between October 2018 and March 2020 and were observed continuously for ≥ 365 days both before and after ABP 501 initiation were included. Descriptive analyses of persistence and switch after ABP 501 discontinuation were conducted and reported for each disease cohort by prior use of ADA products (patients naïve to ADA or patients experienced with ADA). RESULTS: Median (95% confidence interval) persistence on ABP 501 was 9.4 (8.6-10.3), 10.2 (9.0-11.7), and 12.1 (11.0-13.1) months in German patients, and 11.7 (9.9-13.3), 7.1 (5.8-8.4), and 10.8 (9.6-11.9) months in French patients for RA, PsA, and AS, respectively. For patients who switched from ABP 501 to another targeted therapy during the first 12 months of follow-up, switching patterns varied between patients naïve to ADA and patients experienced with ADA in both Germany and France, with patients naïve to ADA switching most frequently to other targeted therapies including non-ADA tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, or Janus Kinase inhibitor (JAKi) and patients experienced with ADA switching most frequently back to ADA reference product (RP). CONCLUSIONS: Across three rheumatologic diseases, about half of patients persisted on ABP 501 at the end of 12 months after treatment initiation in both Germany and France. Patients experienced with ADA were more likely to switch back to ADA RP, regardless of indication and country, suggesting a possible nocebo effect. Future studies are warranted to understand reasons of discontinuation and switching.

Treatment persistence and switching patterns of ABP 501 in European patients with inflammatory bowel disease.

Background: Approval of the adalimumab (ADA) biosimilar ABP 501 for inflammatory bowel disease (IBD) indications was based on the principle of extrapolation, without indication-specific clinical trial data. Objectives: To evaluate the real-world treatment patterns of ABP 501 in patients with IBD. Design: Retrospective analysis of pharmacy claims data from Germany and France. Methods: Continuously insured adult IBD patients who initiated ABP 501 between October 2018 and March 2020 were included. Treatment persistence, adherence, and post-ABP 501 switching patterns were evaluated for two mutually exclusive groups: ADA-naïve patients (i.e. no baseline use of ADA products) and ADA-experienced patients (i.e. previously treated with ADA products). Results: A total of 3362 German patients and 733 French patients were included, with 54.4% and 65.3% being ADA-naïve patients, respectively. Median persistence (95% CI) on ABP 501 was 10.9 months (9.8-11.6) in ADA-naïve patients and 14.2 months (12.7-15.2) in ADA-experienced patients in Germany; for the French cohort, ADA-naïve and -experienced patients had median persistence of 12.8 months (10.2-14.7) and 11.5 months (8.8-14.4), respectively. During the first 12 months of ABP 501 initiation, 53.7% of German patients and 51.0% of French patients were adherent to the therapy. About 20% of patients in both countries switched from ABP 501 to another targeted therapy. In the German cohort, ADA-naïve patients most frequently switched to non-tumor necrosis factor inhibitor biologics, but ADA-experienced patients most commonly switched to reference product (RP); in the French cohort, patients most often switched to RP regardless of prior exposure to ADA products. Conclusion: About 50% of patients persisted on and were adherent to ABP 501 therapy during the first 12 months after treatment initiation in two large European countries. Post-ABP 501, switching patterns varied between countries, indicating diversified treatment practices warranting further research on reason(s) for switching and potential overall treatment outcomes.

Trends and characteristics of attempted and completed suicides reported to general practitioners before vs during the COVID-19 pandemic in France: Data from a nationwide monitoring system, 2010-2022.

BACKGROUND: Most studies published to date have investigated the impact of the COVID-19 pandemic on suicidal acts using hospital data. Trends from primary care in a country such as France are crucial, as individuals may not consult hospital services after suicide attempts (SAs) but rather see their general practitioner (GP). OBJECTIVES: We aimed to evaluate whether the incidence and characteristics of SAs and completed suicides (CSs) reported to French GPs were different during the COVID-19 pandemic than those of before. METHODS AND FINDINGS: We conducted a retrospective observational study using data from a nationwide monitoring system, the French Sentinel Network (FSN). All SAs and CSs reported by GPs to the FSN from January 1, 2010, to March 10, 2022 were included. The annual incidence rates (IRs) and the characteristics of SAs and CSs during the pandemic (March 11, 2020, to March 10, 2022) were compared to those of before. In total, 687 SAs and 169 CSs were included. The IRs remained stable for SAs and CSs before and during the pandemic (overlap in confidence intervals). The mean IRs were 52 (95%CI = 44; 57) per 100,000 inhabitants for SAs during the pandemic versus 47 [36; 57] during the pre-pandemic period (p = 0.49), and 5 (95%CI = 2; 9) for CSs versus 11 [6; 16] (p = 0.30). During the pandemic, SA were slightly different from those before in terms of age and occupational status (young/students and older/retirees over-represented), history of consultation and expression of suicidal ideas to GP (more frequent), and CS in terms of occupational status (students over-represented) (p<0.05). CONCLUSION: The COVID-19 pandemic had no major effect on the overall incidence of SAs and CSs reported to French GPs. However, more suicidal acts were reported among younger and older individuals. Suicidal patients and GPs have adapted by improving the expression of suicidal ideas.

Effects of the COVID-19 pandemic on head lice and scabies infestation dynamics: a population-based study in France.

BACKGROUND: Lockdowns and physical distancing have dramatically limited the circulation of SARS-CoV-2 and other common communicable infections. However, little is known about their impact on head lice and scabies. AIM: To assess the impact of the 2020 French National lockdowns (17 March-11 May 2020, and 30 October-15 December 2020) and physical distancing recommendations (from February 2020) on the dynamics of head lice and scabies infestations. METHODS: The weekly sales of topical head lice treatments, topical scabies treatments and oral ivermectin were extracted from the database of the healthcare science company IQVIA (60% of all French retail pharmacies) and analysed over a 5-year period (March 2016-December 2020). A periodic regression model was fitted to drug sales before the COVID-19 period (2016-2019) and extrapolated to compare the observed sales in 2020 to the expected sales. RESULTS: A decrease of the sales of tracer topical treatments for head lice and scabies was observed from March 2020, synchronously with the first French national lockdown. For the period March-December 2020, the mean reduction in observed vs. expected sales for head lice and scabies topical treatments was 44% and 14%, respectively. By contrast, although there was an observed decrease in oral ivermectin sales after March 2020, it was much lower (4%), probably because of studies reporting the potential positive effects of this drug on COVID-19 infection. CONCLUSION: COVID-19 lockdown and physical distancing reduce circulation of head lice and scabies in France. Further studies are needed to assess the long-term impact of these social behaviour changes.

Common communicable diseases in the general population in France during the COVID-19 pandemic.

In France, social distancing measures have been adopted to contain the spread of COVID-19, culminating in national Lockdowns. The use of hand washing, hydro-alcoholic rubs and mask-wearing also increased over time. As these measures are likely to impact the transmission of many communicable diseases, we studied the changes in common infectious diseases incidence in France during the first year of COVID-19 circulation. We examined the weekly incidence of acute gastroenteritis, chickenpox, acute respiratory infections and bronchiolitis reported in general practitioner networks since January 2016. We obtained search engine query volume for French terms related to these diseases and sales data for relevant drugs over the same period. A periodic regression model was fit to disease incidence, drug sales and search query volume before the COVID-19 period and extrapolated afterwards. We compared the expected values with observations made in 2020. During the first lockdown period, incidence dropped by 67% for gastroenteritis, by 79% for bronchiolitis, by 49% for acute respiratory infection and 90% for chickenpox compared to the past years. Reductions with respect to the expected incidence reflected the strength of implemented measures. Incidence in children was impacted the most. Reduction in primary care consultations dropped during a short period at the beginning of the first lockdown period but remained more than 95% of the expected value afterwards. In primary care, the large decrease in reported gastroenteritis, chickenpox or bronchiolitis observed during the period where many barrier measures were implemented imply that the circulation of common viruses was reduced and informs on the overall effect of these measures.

Immunotherapy with grass pollen tablets reduces medication dispensing for allergic rhinitis and asthma: A retrospective database study in France.

BACKGROUND: Moderate-to-severe allergic rhinitis (AR) may increase the risk of developing or worsening asthma, whereas treatment of AR with subcutaneously or sublingual allergen immunotherapy (SLIT) may slow this progression. METHODS: In a retrospective real-world analysis, prescription fulfilment data were gathered from French retail pharmacies between 1 March 2012 and 31 December 2016. Using linear regression analyses, patients having received at least two prescriptions of grass pollen SLIT tablets over at least 2 successive years were compared with control patients having received symptomatic medications only. RESULTS: A total of 1099 SLIT patients and 27 475 control patients were included in the main analysis. With regard to symptomatic AR medication dispensing, we observed a 50% decrease in the pre-index/follow-up ratio in the SLIT group, a 30% increase in the control group without age matching (P < 0.0001 vs SLIT) and a 20% increase in the control group with age matching (P < 0.0001 vs SLIT). During the follow-up, 11 (1.8%) and 782 (5.3%) patients initiated asthma treatment in the SLIT and control groups, respectively. The relative risk of medication dispensing for new asthma was lower in the SLIT group (by 62.5% [29.1%-80.1%] without age matching (P = 0.0025) and by 63.7% [31.5%-80.7%] with age matching; P = 0.0018). SLIT was also associated with slower progression of asthma medication dispensing during the follow-up period, relative to the control group (regression coefficient: -0.58 [-0.74 to 0.42] without age matching (P < 0.0001) and -0.61 [-0.76 to -0.46] with age matching; P < 0.0001). CONCLUSION: Prescription of grass pollen SLIT tablets reduced the dispensing of AR and asthma medications in real life.

Do intra-articular hyaluronic acid injections delay total knee replacement in patients with osteoarthritis - A Cox model analysis.

OBJECTIVES: This study aimed to describe patients treated for knee osteoarthritis between 2006 and 2013 in France and to compare the delay from diagnosis to total knee replacement between patients who received intra-articular hyaluronic acid injections and those who did not receive the injections. A second objective was to compare direct medical costs for ambulatory care between treatment groups. MATERIALS AND METHODS: Patients were selected from a representative sample of the real world administrative claims database using an algorithm developed by experts from the scientific committee of the study. Data were matched with the medico-administrative database for hospital care. A Cox proportional hazards model was stratified for the treatment group and adjusted for available socio-demographic and medical covariates to compare restricted mean survival times at different time points (1, 3, 5 and 7.5 years) between groups. Costs were expressed in 2013 euros. RESULTS: A total of 14,782 patients were treated for knee osteoarthritis (67% women; mean age = 68 years). Among this population, 1,662 patients had total knee replacement (11.2%). At each time point, restricted mean survival time without total knee replacement was significantly higher (p-values<0.001) for hyaluronic acid group, from +51 to +217 days at 1 and 7.5 years, respectively. For the year preceding total knee replacement, the means for total direct medical costs were similar between groups, €744 vs €805 for treatment and control groups, respectively, (p-value = 0.104). Intra-articular injections accounted for less than 10% of the total costs. CONCLUSION: This is the first retrospective longitudinal study involving knee osteoarthritis patients using medico-administrative databases in France. The results support the effectiveness of hyaluronic acid injections in delaying total knee replacement and show that patients treated with hyaluronic acid have similar direct medical costs for ambulatory care compared to patients treated with corticosteroids only.

Quality of Life in Patients Suffering from Active Exudative Age-Related Macular Degeneration: The EQUADE Study.

PURPOSE: Age-related macular degeneration (AMD) is the main cause of visual loss in the elderly population. With the use of anti-vascular endothelial growth factor, the visual outcomes of exudative AMD patients have been improved. This study was aimed at assessing the quality of life (QoL) of exudative AMD patients treated with ranibizumab and at determining its drivers in a real-life setting. METHODS: We performed a national, cross-sectional, observational survey based on questionnaires sent to members of French associations relative to AMD between December 2012 and March 2013. Patients suffering from exudative AMD with at least one intravitreal injection of ranibizumab within the last 6 months were included. Demographics, AMD characteristics, visual acuity (VA) and past and ongoing treatments were collected. The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) was self-administered. A multivariate model was used to identify QoL drivers. RESULTS: 416 questionnaires fulfilled the complete criteria for both QoL and cost analyses. The mean age of exudative AMD patients was 78.0 years and bilateral involvement was reported in 60.4%. The overall mean QoL score was 53.4. Mental health, driving and role difficulties were the most widely affected domains. After bivariate analyses, long-term illness status, worse VA and higher number of unpaid aids were associated with worse QoL, with odds ratios of 2.4, 5.2 and 11.6, respectively. The mean cost per year and per patient was 1,741 EUR. The main components of costs were aids and services and the purchase of visual equipment. CONCLUSIONS: The main predictors of QoL in exudative AMD patients treated with ranibizumab are VA outcomes, home healthcare and social services provided to the patients.

The daily cost of ICU patients: A micro-costing study in 23 French Intensive Care Units.

OBJECTIVES: To estimate the daily cost of intensive care unit (ICU) stays via micro-costing. METHODS: A multicentre, prospective, observational, cost analysis study was carried out among 21 out of 23 French ICUs randomly selected from French National Hospitals. Each ICU randomly enrolled 5 admitted adult patients with a simplified acute physiology II score ≥ 15 and with at least one major intensive care medical procedure. All health-care human resources used by each patient over a 24-hour period were recorded, as well as all medications, laboratory analyses, investigations, tests, consumables and administrative expenses. All resource costs were estimated from the hospital's perspective (reference year 2009) based on unitary cost data. RESULTS: One hundred and four patients were included (mean age: 62.3 ± 14.9 years, mean SAPS II: 51.5 ± 16.1, mean SOFA on the study day: 6.9 ± 4.3). Over 24 hours, 29 to 186 interventions per patient were performed by different caregivers, leading to a mean total time spent for patient care of 13:32 ± 05:00 h. The total daily cost per patient was € 1425 ± € 520 (95% CI = € 1323 to € 1526). ICU human resources represented 43% of total daily cost. Patient-dependent expenses (€ 842 ± € 521) represented 59% of the total daily cost. The total daily cost was correlated with the daily SOFA score (r = 0.271, P = 0.006) and the bedside-time given by caregivers (r = 0.716, P < 0.0001). CONCLUSION: The average cost of one day of ICU care in French National Hospitals is strongly correlated with the duration of bedside-care carried out by human resources.

EQOFIX: a combined economic and quality-of-life study of hemophilia B treatments in France.

BACKGROUND: EQOFIX is a medicoeconomic study that analyzed the health-related quality of life (HRQoL) and costs of care of the moderate and severe forms of hemophilia B, treated on demand or by prophylaxis with either plasma-derived Factor IX (pdFIX) or recombinant FIX (rFIX). STUDY DESIGN AND METHODS: The primary objectives were evaluations of the impact of hemophilia B on HRQoL and of the costs associated with its management. The secondary objectives were evaluations of the clinical efficacy and costs of care of pdFIX and rFIX. In this observational study we included and followed for 1 year severe and moderate hemophilia B patients without inhibitor. HRQoL was evaluated through generic and disease-specific questionnaires. Information on the health resources consumed was collected every 3 months. RESULTS: The EQOFIX cohort was composed of 155 patients, including 51 children and 104 adults, with 114 having severe disease and 41 having moderate disease. The regimens were prophylactic for 61 and on demand for 94. Altogether, 78 were treated with rFIX and 77 with pdFIX. There was no difference in the QoL between the pdFIX and rFIX treatments. The extra cost of prophylaxis was €22,605 per bleeding event prevented. The consumption of FIX was 1.4-fold higher for the patients treated with rFIX than for the patients treated with pdFIX. CONCLUSION: Our findings in a cohort composed of 25% of the French population of moderate and severe hemophilia B patients show, with similar clinical and HRQoL results, that treatment with rFIX is more expensive than treatment with pdFIX.

Gastroesophageal reflux disease: impact on work productivity and daily-life activities of daytime workers. A French cross-sectional study.

BACKGROUND: Few studies have evaluated the impact of gastroesophageal reflux disease symptoms on work productivity and no French data are available. AIM: To compare the impact of typical symptoms of nocturnal vs diurnal gastroesophageal reflux disease on work productivity and daily activities. METHODS: A French prospective, multicenter, observational study was performed in primary care setting. Patient characteristics, symptomatology and treatment were reported. Work productivity loss was assessed using the work productivity and activity impairment questionnaire, predictors were identified using multivariate regression models, and estimated cost was calculated. RESULTS: 716 eligible patients (mean age: 46.3 years) were included by 407 physicians. Nocturnal symptoms were reported in 50.8% of patients and exclusively diurnal symptoms in 49.2%. Mean work productivity and daily activities decreased by 31.4% and 32.6%, respectively (both p<0.001). Work productivity was influenced by symptom intensity, diurnal symptoms occurrence, regurgitation and diurnal sleepiness. The mean associated cost per patient/week (€313) was higher in patients with diurnal symptoms (without (€346) or with nocturnal (€312) symptoms) than in patients with exclusive nocturnal symptoms (€253) (p<0.001). CONCLUSION: Gastroesophageal reflux disease incurs high work productivity loss especially in patients with diurnal symptoms. Further medico-economic analyses are needed to estimate the cost effectiveness ratio according to therapeutic strategies.

Daily costs of prostaglandin analogues as monotherapy or in fixed combinations with timolol, in Denmark, Finland, Germany and Sweden.

BACKGROUND: To compare the daily costs of 3 prostaglandin analogues (bimatoprost, latanoprost, travoprost), alone, and associated with timolol in 4 European countries (Denmark, Finland, Germany, and Sweden). METHODS: Six glaucoma products were sampled by buying 5 bottles from 1 suburban pharmacy in each of the 4 countries. Drops were weighed by a single operator at 1 site according to standardized procedures. Residual drops were then counted. Unit bottle costs were estimated from tariff lists. Eye-drop weights were entered into a nested analysis of variance comprising drug, instillation day, country, the interaction, and a sample factor nested within the country factor. Effectiveness was represented by treatment failure rates estimated from a meta-analysis and a general practitioner survey. RESULTS: Every drug bottle contained sufficient drops to treat 1 patient for 28/31 days. Drop-size heterogeneity between countries was observed for bimatoprost and bimatoprost/timolol. Mean travoprost and travoprost/timolol drop-sizes were the smallest, and drop-counts per bottle were the lowest for latanoprost, or latanoprost/timolol. In all 4 countries annual costs were least for travoprost and travoprost/timolol. CONCLUSIONS: On taking into account drug costs and effectiveness, travoprost and travoprost/timolol were cheaper and more effective than latanoprost and latanoprost/timolol and were cheaper than bimatoprost and bimatoprost/timolol.