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2. Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Author

van den Heuvel, Tim, primary, Kolassa, Ralf, additional, Keuthage, Winfried, additional, Kroeger, Jens, additional, Ré, Roseline, additional, de Portu, Simona, additional, Vorrink, Linda, additional, Shin, John, additional, Castañeda, Javier, additional, Vigersky, Robert, additional, and Cohen, Ohad, additional

Published
2023
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3. A European Cost-Utility Analysis of the MiniMedTM 780G Advanced Hybrid Closed-Loop System versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes

Author

Jendle, Johan, Buompensiere, Maria Ida, Ozdemir Saltik, Asli Zeynep, de Portu, Simona, Smith-Palmer, Jayne, Pollock, Richard, Cohen, Ohad, Jendle, Johan, Buompensiere, Maria Ida, Ozdemir Saltik, Asli Zeynep, de Portu, Simona, Smith-Palmer, Jayne, Pollock, Richard, and Cohen, Ohad

Abstract

Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. Here, a cost-utility analysis of the MiniMedTM 780G AHCL system (MM780G) versus intermittently-scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were assumed. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in healthcare costs between countries, the health economic outcomes differ. In the countries included here, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.

Published
2023
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4. Response to: Letter to the Editor with Regard to the Cost-Effectiveness of Hybrid Closed-Loop Systems Versus Multiple Daily Injections Plus Intermittently Scanned Continuous Glucose Monitoring in Type 1 Diabetes in the Netherlands

Author

MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., de Portu, Simona, de Valk, Harold W., MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., de Portu, Simona, and de Valk, Harold W.

Published
2023

5. sj-docx-1-dst-10.1177_19322968231161320 – Supplemental material for Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Author

van den Heuvel, Tim, Kolassa, Ralf, Keuthage, Winfried, Kroeger, Jens, Ré, Roseline, de Portu, Simona, Vorrink, Linda, Shin, John, Castañeda, Javier, Vigersky, Robert, and Cohen, Ohad

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-docx-1-dst-10.1177_19322968231161320 for Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring by Tim van den Heuvel, Ralf Kolassa, Winfried Keuthage, Jens Kroeger, Roseline Ré, Simona de Portu, Linda Vorrink, John Shin, Javier Castañeda, Robert Vigersky and Ohad Cohen in Journal of Diabetes Science and Technology

Published
2023
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7. Cost-Effectiveness of Hybrid Closed Loop Insulin Pumps Versus Multiple Daily Injections Plus Intermittently Scanned Glucose Monitoring in People With Type 1 Diabetes in The Netherlands

Author

MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., De Portu, Simona, de Valk, Harold W., MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., De Portu, Simona, and de Valk, Harold W.

Published
2022

9. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial

Author

MS Interne Geneeskunde, Circulatory Health, Habteab, Aklilu, Castañeda, Javier, De Valk, Harold, Choudhary, Pratik, Bosi, Emanuele, Lablanche, Sandrine, De Portu, Simona, Da Silva, Julien, Vorrink-De Groot, Linda, Shin, John, Cohen, Ohad, MS Interne Geneeskunde, Circulatory Health, Habteab, Aklilu, Castañeda, Javier, De Valk, Harold, Choudhary, Pratik, Bosi, Emanuele, Lablanche, Sandrine, De Portu, Simona, Da Silva, Julien, Vorrink-De Groot, Linda, Shin, John, and Cohen, Ohad

Published
2020

13. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Haddouche, Aini, Bellanne‐Chantelot, Christine, Rod, Anne, Fournier, Luc, Chiche, Laurence, Gautier, Jean‐Francois, Timsit, José, Laboureau, Sandrine, Chaillous, Lucy, Valero, Rene, Larger, Etienne, Jeandidier, Nathalie, Wilhelm, Jean‐Marie, Popelier, Marc, Guillausseau, Pierre‐Jean, Thivolet, Charles, Lecomte, Pierre, Benhamou, Pierre‐Yves, Reznik, Yves, Bosi, Emanuele, Choudhary, Pratik, De Valk, Harold, Lablanche, Sandrine, Castaneda, Javier, De Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine, Cohen, Ohad, Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette, Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Institut National de l'Environnement Industriel et des Risques (INERIS), Service de Chirurgie digestive [Bordeaux], CHU Bordeaux [Bordeaux], Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition, Hôpital Laennec, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Pharmacologie Endocrinienne, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université de Liège, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Dipartimento di Biologia Evoluzionistica 'Leo Pardi', Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), King's College Hospital (KCH), University Medical Center [Utrecht], Medtronic Bakken Research Center BV, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Human Computer Technology Laboratory (HCTLab), Universidad Autonoma de Madrid (UAM), Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute of Child Health, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Endocrinologie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lariboisière, Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF), Università degli Studi di Firenze [Firenze], Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Service de diabétologie - endocrinologie [Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz-Université de Franche-Comté (UFC), Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Bosi, E., Choudhary, P., de Valk, H. W., Lablanche, S., Castaneda, J., de Portu, S., Da Silva, J., Re, R., Vorrink-de Groot, L., Shin, J., Kaufman, F. R., Cohen, O., Laurenzi, A., Caretto, A., Slatterly, D., Henderson-Wilson, M., Weisnagel, S. J., Dube, M. -C., Julien, V. -E., Trevisan, R., Lepore, G., Bellante, R., Hramiak, I., Spaic, T., Driscoll, M., Borot, S., Clergeot, A., Khiat, L., Hammond, P., Ray, S., Dinning, L., Tonolo, G., Manconi, A., Ledda, M. S., de Ranitz, W., Silvius, B., Wojtusciszyn, A., Farret, A., Vriesendorp, T., Immeker-de Jong, F., van der Linden, J., Brink, H. S., Alkemade, M., Schaepelynck-Belicar, P., Galie, S., Treglia, C., Benhamou, P. -Y., Haddouche, M., Hoogma, R., Leelarathna, L., Shaju, A., and James, L.

Subjects
Adult, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, glucose, hemoglobin A1c, insulin, antidiabetic agent, 030209 endocrinology & metabolism, Low insulin, law.invention, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Type 1 diabetes, Continuous glucose monitoring, business.industry, Middle Aged, medicine.disease, Hypoglycemia, 3. Good health, Diabetes Mellitus, Type 1, Hypoglycaemia unawareness, Female, Open label, business
Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect −2·9 [95% CI −3·5 to −2·3]; p

Published
2019

14. Cost-Effectiveness Analysis of the MiniMed 670G Hybrid Closed-Loop System Versus Continuous Subcutaneous Insulin Infusion for Treatment of Type 1 Diabetes

Author

Jendle, Johan, Pöhlmann, Johannes, de Portu, Simona, Smith-Palmer, Jayne, Roze, Stéphane, Jendle, Johan, Pöhlmann, Johannes, de Portu, Simona, Smith-Palmer, Jayne, and Roze, Stéphane

Abstract

BACKGROUND: Hybrid closed-loop (HCL) systems combine continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII) to continuously self-adjust basal insulin delivery. Relative to CSII, HCL improves glycemic control and reduces the risk of hypoglycemia but has higher acquisition costs. The aim of this analysis was to assess the cost-effectiveness of the MiniMed™ 670G HCL system versus CSII in people with type 1 diabetes (T1D) in Sweden. METHODS: Cost-effectiveness analysis, from a societal perspective, was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Clinical data were sourced from a study comparing the MiniMed 670G system with CSII in people with T1D. Cost data, expressed in 2018 Swedish krona (SEK), were obtained from Swedish reference prices and published literature. RESULTS: The MiniMed 670G system was associated with a quality-adjusted life-year (QALY) gain of 1.90 but higher overall costs versus CSII, leading to an incremental cost-effectiveness ratio (ICER) of SEK 164,236 per QALY gained. Use of the HCL system resulted in a lower cumulative incidence of diabetes-related complications. Higher HCL system acquisition costs were partially offset by reduced complication costs and productivity losses. In people with T1D poorly controlled at baseline, the MiniMed 670G system was associated with 2.25 incremental QALYs versus CSII, yielding an ICER of SEK 15,830 per QALY gained. CONCLUSIONS: The MiniMed 670G system was associated with clinical benefits and quality-of-life improvements in people with T1D relative to CSII. At a willingness-to-pay threshold of SEK 300,000 per QALY gained, this HCL system likely represents a cost-effective treatment option for people with T1D in Sweden., Funding Agency:Medtronic International Trading Sarl

Published
2019
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16. Study of MiniMed 640G Insulin Pump with SmartGuard in Prevention of Low Glucose Events in Adults with Type 1 Diabetes (SMILE): Design of a Hypoglycemia Prevention Trial with Continuous Glucose Monitoring Data as Outcomes

Author

Emanuele Bosi, Harold W. de Valk, Javier Castañeda, Sandrine Lablanche, Linda Vorrink, Simona de Portu, Pratik Choudhary, Ohad Cohen, Julien Da Silva, University Medical Center [Utrecht], Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Centre Hospitalier Universitaire [Grenoble] (CHU), Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed), King's College Hospital (KCH), Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Medtronic Bakken Research Center BV, De Valk, Harold W., Lablanche, Sandrine, Bosi, Emanuele, Choudhary, Pratik, Silva, Julien Da, Castaneda, Javier, Vorrink, Linda, De Portu, Simona, and Cohen, Ohad

Subjects
Adult, Blood Glucose, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Glycated Hemoglobin A, [SDV]Life Sciences [q-bio], Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Hypoglycemia, Insulin pump therapy, 03 medical and health sciences, Low glucose, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, Prospective Studies, 030212 general & internal medicine, Continuous glucose monitoring, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, Glycated Hemoglobin, Type 1 diabetes, Hypoglycemic Agent, Sensor-integrated pump therapy, business.industry, Blood Glucose Self-Monitoring, medicine.disease, 3. Good health, Prospective Studie, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Treatment Outcome, Research Design, Insulin Infusion System, Female, business, Type 1 diabetes mellitu, Human
Abstract

Background: Sensor-integrated pump systems with low-glucose suspend (also known as threshold suspend) functions have markedly transformed the management of type 1 diabetes, but most studies to date have excluded patients at high risk of hypoglycemia. The SMILE study is investigating the efficacy of the MiniMed™ 640G insulin pump with the SmartGuard™ predictive low-glucose management (PLGM) feature in the prevention of hypoglycemia in adults with type 1 diabetes, who are at high risk of hypoglycemia. Methods: SMILE is a prospective, randomized, open-label, controlled trial being undertaken in four European countries and Canada. Following a 2-week run-in phase, eligible participants will be randomized to use either the MiniMed 640G system with continuous glucose monitoring (CGM) and the SmartGuard PLGM feature on continuously for 24 weeks (treatment arm), or the MiniMed 640G without CGM and with blinded continuous glucose measurements between weeks 10-12, 16-18, and 22-24 (control arm). The primary endpoint is the mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL (≤3.0 mmol/L) for >20 consecutive minutes. Secondary endpoints include various glycemic indices in the hypoglycemic and hyperglycemic ranges, as well as glycated hemoglobin. Data on patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction will also be collected. Conclusions: It is anticipated that the SMILE study will provide important insights into the effectiveness of SmartGuard technology in adult patients with type 1 diabetes.

Published
2018

17. Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: An extension of the Psoriatic Arthritis Cost Evaluation (PACE) study

Author

Olivieri, I., Cortesi, P. A., Portu, S., Carlo Salvarani, Cauli, A., Lubrano, E., Spadaro, A., Cantini, F., Ciampichini, R., Cutro, M. S., Mathieu, A., Matucci-Cerinic, M., Punzi, L., Scarpa, R., Mantovani, L. G., Olivieri, I, Cortesi, P, de Portu, S, Salvarani, C, Cauli, A, Lubrano, E, Spadaro, A, Cantini, F, Ciampichini, R, Cutro, M, Mathieu, A, Matucci Cerinic, M, Punzi, L, Scarpa, R, Mantovani, L, Olivieri, Ignazio, Cortesi, Paolo A., DE PORTU, Simona, Salvarani, Carlo, Cauli, Alberto, Lubrano, Ennio, Spadaro, Antonio, Cantini, Fabrizio, Ciampichini, Roberta, Cutro, Maria Stefania, Mathieu, Alessandro, Matucci Cerinic, Marco, Punzi, Leonardo, Scarpa, Raffaele, and Mantovani, LORENZO GIOVANNI

Subjects
Adult, Male, Quality of life, Time Factors, Cost, Cost-Benefit Analysis, Immunology, Anti-Inflammatory Agents, Anti-tumour necrosis factor agent, Drug Costs, Rheumatology, Immunology and Allergy, Humans, Drug Substitution, Tumor Necrosis Factor-alpha, Medicine (all), Arthritis, Psoriatic, Remission Induction, Psoriatic arthriti, Middle Aged, Costs, Female, Health Resources, Italy, Models, Economic, Quality of Life, Treatment Outcome, Anti-tumour necrosis factor agents, Psoriatic arthritis
Abstract

Objective: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs). Methods: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared. Results: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years. Conclusion: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients. © Copyright Clinical and Experimental Rheumatology 2016.

Published
2016

18. Cost-effectiveness of sensor-augmented insulin pump therapy vs continuous subcutaneous insulin infusion in patients with type 1 diabetes in the Netherlands.

Author

Roze S, Smith-Palmer J, de Portu S, Delbaere A, de Brouwer B, and de Valk HW

Abstract

Aim: The aim of this study was to perform a cost-effectiveness analysis to establish the cost-effectiveness of sensor-augmented pump therapy (SAP) with automated insulin suspension vs continuous subcutaneous insulin infusion (CSII) alone in patients with type 1 diabetes in the Netherlands., Patients and Methods: The analysis was performed using the IQVIA CORE Diabetes Model (CDM) in two different patient cohorts: one with suboptimal glycemic control at baseline (mean age 27 years, mean baseline HbA1c 8.0% [64 mmol/mol]) and the other at increased risk of hypoglycemic events (mean age 18.6 years, mean baseline HbA1c 7.5% [58 mmol/mol]). Clinical input data were sourced from published literature, and the analysis was performed from the societal perspective., Results: In patients with suboptimal baseline glycemic control, SAP improved quality-adjusted life expectancy by 1.77 quality-adjusted life years (QALYs) vs CSII (15.54 QALYs vs 13.77 QALYs) with higher lifetime costs (EUR 189,855 vs EUR 150,366), resulting in an incremental cost-effectiveness ratio (ICER) of EUR 22,325 per QALY gained. In this cohort, sensitivity analyses showed that the influence of SAP on fear of hypoglycemia (FoH) and baseline HbA1c were key drivers of results. In patients at increased risk of hypoglycemia, the gain in quality-adjusted life expectancy with SAP vs CSII was 2.16 QALYs (16.70 QALYs vs 14.53 QALYs) with higher lifetime costs (EUR 204,013 vs EUR 171,032) leading to an ICER of EUR 15,243 per QALY gained. In this patient group, findings were most sensitive to changes in assumptions relating to the incidence of severe hypoglycemic events in the CSII arm., Conclusion: For type 1 diabetes patients in the Netherlands who do not achieve target HbA1c levels or who experience frequent severe hypoglycemic events on CSII, switching to SAP is likely to be cost-effective., Competing Interests: Disclosure Funding for the analysis was provided by Medtronic International Trading Sàrl. AD and SdP are current employees of Medtronic International Trading Sàrl, which manufactures SAP devices. BdB is a current employee of Medtronic Trading NL. SR is a current employee of HEVA HEOR, which has received consulting fees from Medtronic International Trading Sàrl. JS-P is a current employee of Ossian Health Economics and Communications, which has received consulting fees from Medtronic International Trading Sàrl. HWdV has previously received consulting fees/honoraria from Medtronic International Trading Sàrl. The authors report no other conflicts of interest in this work.

Published
2019
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19. Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.

Author

Olivieri I, Cortesi PA, de Portu S, Salvarani C, Cauli A, Lubrano E, Spadaro A, Cantini F, Ciampichini R, Cutro MS, Mathieu A, Matucci-Cerinic M, Punzi L, Scarpa R, and Mantovani LG

Subjects
Adult, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic immunology, Arthritis, Psoriatic psychology, Cost-Benefit Analysis, Female, Health Resources economics, Health Resources statistics & numerical data, Humans, Italy, Male, Middle Aged, Models, Economic, Quality of Life, Remission Induction, Time Factors, Treatment Outcome, Tumor Necrosis Factor-alpha immunology, Anti-Inflammatory Agents economics, Anti-Inflammatory Agents therapeutic use, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic economics, Drug Costs, Drug Substitution economics, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

Objectives: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs)., Methods: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared., Results: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years., Conclusions: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.

Published
2016

20. Adalimumab clinical efficacy is associated with rheumatoid factor and anti-cyclic citrullinated peptide antibody titer reduction: a one-year prospective study.

Author

Atzeni F, Sarzi-Puttini P, Dell' Acqua D, de Portu S, Cecchini G, Cruini C, Carrabba M, and Meroni PL

Subjects
Adalimumab, Adult, Aged, Aged, 80 and over, Antibodies, Anticardiolipin blood, Antibodies, Monoclonal, Humanized, Arthritis, Rheumatoid blood, Arthritis, Rheumatoid immunology, Autoantibodies blood, Female, Humans, Male, Middle Aged, Prospective Studies, Reproducibility of Results, Rheumatoid Factor blood, Antibodies, Monoclonal therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Methotrexate therapeutic use
Abstract

Studies on autoantibody production in patients treated with tumor necrosis factor-alpha (TNF-alpha) inhibitors reported contradictory results. We investigated in a prospective study the efficacy of a treatment with human monoclonal anti-TNF-alpha antibody (adalimumab) in patients with rheumatoid arthritis (RA) and we evaluated the relationship between treatment efficacy and the incidence and titers of disease-associated and non-organ-specific autoantibodies. Fifty-seven patients with RA not responsive to methotrexate and treated with adalimumab were enrolled. Antinuclear, anti-double-stranded(ds)DNA, anti-extractable nuclear antigens, anti-cardiolipin (aCL), anti-beta2 glycoprotein I (anti-beta2GPI) autoantibodies, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) autoantibodies were investigated at baseline and after 6 and 12 months of follow-up. Comparable parameters were evaluated in a further 55 patients treated with methotrexate only. Treatment with adalimumab induced a significant decrease in RF and anti-CCP serum levels, and the decrease in antibody titers correlated with the clinical response to the therapy. A significant induction of antinuclear autoantibodies (ANA) and IgG/IgM anti-dsDNA autoantibodies were also found in 28% and 14.6% patients, respectively, whereas aCL and anti-beta2GPI autoantibodies were not detected in significant quantities. No association between ANA, anti-dsDNA, aCL and anti-beta2GPI autoantibodies and clinical manifestations was found. Clinical efficacy of adalimumab is associated with the decrease in RF and anti-CCP serum levels that was detected after 24 weeks and remained stable until the 48th week of treatment. Antinuclear and anti-dsDNA autoantibodies, but not anti-phospholipid autoantibodies, can be induced by adalimumab but to a lower extent than in studies with other anti-TNF blocking agents.

Published
2006
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