Showing papers by "Lorenzo G. Mantovani published in 2017"

Global, regional, and national burden of neurological disorders, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016

Abstract: Summary Background Comparable data on the global and country-specific burden of neurological disorders and their trends are crucial for health-care planning and resource allocation. The Global Burden of Diseases, Injuries, and Risk Factors (GBD) Study provides such information but does not routinely aggregate results that are of interest to clinicians specialising in neurological conditions. In this systematic analysis, we quantified the global disease burden due to neurological disorders in 2015 and its relationship with country development level. Methods We estimated global and country-specific prevalence, mortality, disability-adjusted life-years (DALYs), years of life lost (YLLs), and years lived with disability (YLDs) for various neurological disorders that in the GBD classification have been previously spread across multiple disease groupings. The more inclusive grouping of neurological disorders included stroke, meningitis, encephalitis, tetanus, Alzheimer's disease and other dementias, Parkinson's disease, epilepsy, multiple sclerosis, motor neuron disease, migraine, tension-type headache, medication overuse headache, brain and nervous system cancers, and a residual category of other neurological disorders. We also analysed results based on the Socio-demographic Index (SDI), a compound measure of income per capita, education, and fertility, to identify patterns associated with development and how countries fare against expected outcomes relative to their level of development. Findings Neurological disorders ranked as the leading cause group of DALYs in 2015 (250·7 [95% uncertainty interval (UI) 229·1 to 274·7] million, comprising 10·2% of global DALYs) and the second-leading cause group of deaths (9·4 [9·1 to 9·7] million], comprising 16·8% of global deaths). The most prevalent neurological disorders were tension-type headache (1505·9 [UI 1337·3 to 1681·6 million cases]), migraine (958·8 [872·1 to 1055·6] million), medication overuse headache (58·5 [50·8 to 67·4 million]), and Alzheimer's disease and other dementias (46·0 [40·2 to 52·7 million]). Between 1990 and 2015, the number of deaths from neurological disorders increased by 36·7%, and the number of DALYs by 7·4%. These increases occurred despite decreases in age-standardised rates of death and DALYs of 26·1% and 29·7%, respectively; stroke and communicable neurological disorders were responsible for most of these decreases. Communicable neurological disorders were the largest cause of DALYs in countries with low SDI. Stroke rates were highest at middle levels of SDI and lowest at the highest SDI. Most of the changes in DALY rates of neurological disorders with development were driven by changes in YLLs. Interpretation Neurological disorders are an important cause of disability and death worldwide. Globally, the burden of neurological disorders has increased substantially over the past 25 years because of expanding population numbers and ageing, despite substantial decreases in mortality rates from stroke and communicable neurological disorders. The number of patients who will need care by clinicians with expertise in neurological conditions will continue to grow in coming decades. Policy makers and health-care providers should be aware of these trends to provide adequate services. Funding Bill & Melinda Gates Foundation.

Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation

Abstract: Objective We studied evolving antithrombotic therapy patterns in patients with newly diagnosed non-valvular atrial fibrillation (AF) and ?1 additional stroke risk factor between 2010 and 2015. Methods 39 670 patients were prospectively enrolled in four sequential cohorts in the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF): cohort C1 (2010'2011), n=5500; C2 (20112013), n=11 662; C3 (2013-2014), n=11 462; C4 (2014- 2015), n=11 046. Baseline characteristics and antithrombotic therapy initiated at diagnosis were analysed by cohort. Results Baseline characteristics were similar across cohorts. Median CHA2DS2-VASc (cardiac failure, hypertension, age ?75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female)) score was 3 in all four cohorts. From C1 to C4, the proportion of patients on anticoagulant (AC) therapy increased by almost 15% (C1 57.4%; C4 71.1%). Use of vitamin K antagonist (VKA)±antiplatelet (AP) (C1 53.2%; C4 34.0%) and AP monotherapy (C1 30.2%; C4 16.6%) declined, while use of non-VKA oral ACs (NOACs)±AP increased (C1 4.2%; C4 37.0%). Most CHA2DS2-VASc ?2 patients received AC, and this proportion increased over time, largely driven by NOAC prescribing. NOACs were more frequently prescribed than VKAs in men, the elderly, patients of Asian ethnicity, those with dementia, or those using non-steroidal antiinflammatory drugs, and current smokers. VKA use was more common in patients with cardiac, vascular, or renal comorbidities. Conclusions Since NOACs were introduced, there has been an increase in newly diagnosed patients with AF at risk of stroke receiving guideline-recommended therapy, predominantly driven by increased use of NOACs and reduced use of VKA±AP or AP alone.

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation

Abstract: Objectives To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. Design The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA 2 DS 2 -VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Participants Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. Results The discriminatory value of the GARFIELD-AF risk model was superior to CHA 2 DS 2 -VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64–0.67), 0.64 (0.61–0.66) and 0.64 (0.61–0.68), respectively, for CHA 2 DS 2 -VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA 2 DS 2 -VASc 0 or 1 (men) and 1 or 2 (women)), the CHA 2 DS 2 -VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA 2 DS 2 -VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). Conclusions Performance of the GARFIELD-AF risk tool was superior to CHA 2 DS 2 -VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710).

Epidemiologic and Economic Burden Attributable to First Spinal Fusion Surgery: Analysis From an Italian Administrative Database.

Abstract: Study Design.Retrospective large population based-study.Objective.Assessment of the epidemiologic trends and economic burden of first spinal fusions.Summary of Background Data.No adequate data are available regarding the epidemiology of spinal fusion surgery and its economic impact in Europe.Methods

Subgroup Analysis of Patients with Cancer in XALIA: A Noninterventional Study of Rivaroxaban versus Standard Anticoagulation for VTE.

Abstract: Background The noninterventional XALIA study compared rivaroxaban with standard anticoagulation for deep vein thrombosis treatment. This substudy describes the demographics, clinical characteristics, and outcomes of the patients with cancer. Methods Therapy type, dose, and duration were at the physician's discretion. The cohorts identified were rivaroxaban (rivaroxaban alone or after heparin or fondaparinux for ≤48 hours); early switchers (rivaroxaban after heparin or fondaparinux for >48 hours to 14 days and/or a vitamin K antagonist [VKA] for 1–14 days); standard anticoagulation (heparin or fondaparinux and a VKA); low-molecular-weight heparin (LMWH) alone; and miscellaneous (other heparins, fondaparinux alone, VKA alone). Primary outcomes were major bleeding, recurrent venous thromboembolism, and all-cause mortality. Results In XALIA, 587 patients (11.4% of the XALIA cohort) were with cancer: 146 (24.9%) rivaroxaban, 30 (5.1%) early switchers, 141 (24.0%) standard anticoagulation, 223 (38.0%) LMWH, and 47 (8.0%) miscellaneous. Patients with gastrointestinal or lung cancer more commonly received LMWH than rivaroxaban; the opposite occurred in patients with breast or genitourinary cancer. Rates of primary outcome in the rivaroxaban group were as follows: major bleeding, 1.4% (n = 2); recurrent venous thromboembolism, 3.4% (n = 5); and all-cause mortality, 4.8% (n = 7). Conclusion In XALIA, physicians treated cancer-associated thrombosis with various anticoagulant regimens, most commonly LMWH. In addition, the choice of anticoagulant varied with cancer type. In rivaroxaban-treated patients, rates for the primary outcomes were low, suggesting that patients administered rivaroxaban were a good prognosis group.

Cost-effectiveness analysis of pharmacokinetic-driven prophylaxis vs. standard prophylaxis in patients with severe haemophilia A.

Abstract: The objective of this study was to assess the cost-effectiveness of pharmacokinetic-driven prophylaxis in severe haemophilia A patients. A microsimulation model was developed to evaluate the cost-effectiveness of pharmacokinetic-driven prophylaxis vs. standard prophylaxis and estimate cost, annual j

Meta-analysis on incidence of inhibitors in patients with haemophilia A treated with recombinant factor VIII products.

Abstract: Recent cohort studies showed differences in inhibitor incidence in previously untreated patients (PUPs) with haemophilia A treated with recombinant factor VIII (rFVIII) concentrates. We carried out a systematic literature search and meta-analysis for all randomized clinical trials and observational

Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling.

Abstract: Objective: To evaluate the cost-effectiveness of bariatric surgery in Italy from a third-party payer perspective over a medium-term (10 years) and a long-term (li

Direct-acting antivirals combination for elderly patients with chronic hepatitis C: A cost-effectiveness analysis.

Abstract: Background Chronic Hepatitis C (CHC) has been undertreated among elderly patients. Interferon-free treatment represents an opportunity for these patients. The aim of the study was to assess the cost-effectiveness of Directly Acting Antivirals (DAAs) in CHC elderly patients. Methods A Markov model of CHC natural history was built. The study focuses on CHC patients older than 65 years, stratified according to genotype (1/4, 2 and 3), liver fibrosis (METAVIR F1 to F4), age and frailty phenotype (robust, pre-frail and frail). DAAs combination versus no treatment was simulated for each theoretical population, assessing Life Years, Quality-Adjusted Life Years (QALYs), costs, incremental cost-effectiveness ratios (ICERs) in a lifetime time horizon and by the Healthcare System perspective. Results ICER increased with age and frailty status in all fibrosis stages. For robust F3 and F4 patients ICERs remained below the willingness-to-pay threshold (WTP) of 40.000€/QALY up to age 75 and 86 years, respectively, depending on drug price and SVR probability (sensitivity analysis). Notably, in F4 and frail subjects older than 75 years, ICER was more sensitive to non-liver related mortality rate. In elderly F1 and F2 patients, ICERs were below WTP only up to 77 years old, with wide variability among frailty phenotypes. Conclusions cost-effectiveness of DAAs treatment of elderly CHC patients is solid in those with advanced fibrosis, but it depends strongly on frailty status and age, particularly in patients with milder fibrosis stages. Accurate assessment of clinical variables, including frailty, is necessary to allocate limited resources to this special population. This article is protected by copyright. All rights reserved.

Summary report of the First International Conference on inhibitors in haemophilia A.

Abstract: Disclaimer This summary is not a full and complete recitation of the conference. It is an attempt to capture, in broad terms, the nature and the scope of the comments. The summary has been prepared in an effort to highlight key elements of the presentations in a concise format, not to replace them. Every effort has been made to avoid mischaracterisation and to present the views provided fairly. Any failure to do so is unintentional. Images are publicly available from the Speakers’ presentations published at the Conference website www.smc-media.eu/inhibitors/ and sourced to the original source when available. The Authors declare no conflicts of interest.

Sacubitril/valsartan in heart failure with reduced ejection fraction: cost and effectiveness in the Italian context.

Abstract: The use of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers and mineralocorticoid receptor antagonists (MRAs) has led to significant improvements in mortality and morbidity in patients with heart failure (HF) with reduced ejection fraction (HFrEF). However, HFrEF is still associated with high rates of morbidity and mortality, and high health care costs.1,2 Recently, a treatment option for HFrEF, sacubitril/valsartan (Entresto®; Novartis International AG; Basel, Switzerland), was approved by the US Food and Drug Administration and by the European Medicines Agency, and recommended in the new guidelines of the European Society of Cardiology and American College of Cardiology/American Heart Association as a replacement for an ACEI to further reduce the risk for HF hospitalization and death in ambulatory patients with HFrEF who remain symptomatic despite optimal treatment with an ACEI/ARB, beta-blockers and an MRA. However, the cost-effectiveness of sacubitril/valsartan has been studied mainly in US settings3–5 and few data are available for cost-effectiveness in European countries.6 Given the differences in the characteristics of the respective HFrEF populations in the USA and Europe established in the PARADIGM-HF trial7,8 and variations in the health systems, management of patients and health care costs, we performed a cost-effectiveness analysis of the use of sacubitril/valsartan in Italy, which is one of the most populated European countries. A previously published Markov model3 was used to simulate the course of HF and the impact of treatment options based on data derived from the PARADIGM-HF trial.7 Using this model, a cost-effectiveness analysis was conducted to compare treatment with sacubitril/valsartan b.i.d. in the Italian HFrEF population (Table 1). Expected clinical benefits and costs were estimated for each simulated treatment based on Italian National Health System practice and using a lifetime horizon in the base case analysis. The model estimated the costs related to the treatments (primary therapy and background therapy), costs associated with HF management (specialist evaluation and diagnostics) and hospitalizations, life years, quality-adjusted life years (QALYs) and the incremental costeffectiveness ratio (ICER). Future costs and clinical benefits were discounted at a rate of 3.5% per year. The details of the model have already been described in a previous article.3 Briefly, it is a two-state Markov model in which a patient with HFrEF has a monthly risk for surviving without further complication, becoming hospitalized or dying. Cardiovascular (CV) mortality and hospitalization for patients with HFrEF follows a Gompertz hazard function based on the PARADIGM-HF trial adjusted for the characteristics of the Italian HFrEF population (Table 1).1,3,4 The probability of non-CV mortality was derived from mortality tables for the general Italian population. In the PARADIGM-HF trial, sacubitril/valsartan was found to have higher efficacy than enalapril in reducing CV mortality and hospitalizations; these effects were applied to the model (Table 1). The model assumed that treatment effects would last until the patients discontinued the treatment or died. A probability of discontinuation of drugs during the first 10 years simulated was assumed in the model (Table 1). When sacubitril/valsartan is discontinued, patients are switched to enalapril treatment; when enalapril is discontinued, patients are switched to losartan. Only direct medical costs associated with hospitalization, pharmacological therapies and HF management were considered in the analysis (Table 1). A health-related quality of life (HRQoL) decrement was applied to the model based on data collected using the EuroQol five dimensions questionnaire (EQ-5D) in the PARADIGM-HF trial (Table 1). Sacubitril/valsartan was associated with an increment of utility value of 0.011 compared with enalapril.5 At 10 years, the base case analysis showed cumulative incidences of CV mortality of 37.2% in patients treated with enalapril and 33.8% in those treated with sacubitril/valsartan. Over the course of the entire simulation, for every 1000 patients, approximately 243 hospitalizations were avoided in those treated with sacubitril/valsartan compared with those treated with enalapril. When hospitalizations for HF diagnoses only and for HF plus other CV diagnoses were considered, the numbers of admissions avoided were 94 and 184, respectively. In the base case analysis performed with a lifetime horizon, average survival times in patients treated with sacubitril/valsartan or enalapril were 10.70 years and 10.24 years, respectively. The discounted QALYs gained and the overall discounted costs per patient were 6.16 QALYs and €35 943, respectively, in patients treated with sacubitril/valsartan, and 5.88 QALYs and €30 581, respectively, in patients treated with enalapril. The administration of sacubitril/valsartan increased overall costs, although this increase was partially offset by the reduction in hospitalization costs. Compared with enalapril, sacubitril/valsartan had an ICER of €19 487 per QALY gained, which is below the usually accepted willingness-to-pay (WTP) threshold of €40 000 per QALY gained (Figure 1). Variables with the highest impact on the ICER were the effect of sacubitril/valsartan on CV mortality and hospitalization rate, and the probability of hospitalization with enalapril. The results remained favourable for sacubitril/valsartan in all sensitivity analyses performed. The alternative scenario analysis conducted in specific subpopulations categorized according to New York Heart Association (NYHA) functional class showed that sacubitril/valsartan provided an ICER of less than €20 000 per QALY gained in both patients with NYHA class I or II status and those with NYHA class III or IV status (Figure 1). Assuming a short time horizon (10 years) in the analysis, the use of sacubitril/valsartan remained cost-effective with an ICER of €26 180 per QALY gained (Figure 1). In the probabilistic sensitivity analysis, the probability that sacubitril/valsartan would be cost-effective was >85% at a WTP threshold

Cost-effectiveness analysis of oral fentanyl formulations for breakthrough cancer pain treatment.

Abstract: Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs). Relative efficacy, resources used and unit costs data were derived from the literature and validated by clinical experts. Probabilistic and deterministic sensitivity analyses were performed. At base-case analysis, Sublingual Fentanyl Citrate (FCSL) compared to other oral formulations reported a lower patient's cost (€1,960.8) and a higher efficacy (18.7% of BTcP avoided and 0.0507 QALYs gained). The sensitivity analyses confirmed the main results in all tested scenarios, with the highest impact reported by BTcP duration and health care resources consumption parameters. Between OFFs, FCSL is the cost-effective option due to faster reduction of pain intensity. However, new research is needed to better understand the economic and epidemiologic impact of BTcP, and to collect more robust data on economic and quality of life impact of the different fentanyl formulations. Different fentanyl formulations are available to manage BTcP in cancer population. The study is the first that assesses the different impact in terms of cost and effectiveness of OFFs, providing new information to better allocate the resources available to treat BTcP and highlighting the need of better data.

Obsessive Compulsive Tic Disorder: appropriate diagnosis and treatment as key elements to improve health and rationalize use of resources

Abstract: Background: Obsessive Compulsive Tic Disorder (OCTD) has been described recently as an early onset and highly disabling endophenotype of Tic Disorder and Obsessive Compulsive Disorder. OCTD has a relevant but largely unknown clinical, social and economic burden for patients and their families. Our paper aimed to explore relevant aspects of the burden of OCTD. Methods: we conducted a literature review and a pilot study using retrospective demographic, clinical and economic data of patients with OCTD accessing the Galeazzi Hospital in Milan. Results: the literature review shows the absence of information on OCTD. From the pilot study we analysed data of 30 patients (80.0% male, 36.7% aged from 7 to 13 years, 63.3% aged from 15 to 48 years), 83.0% declared that obsessions and/or compulsions were the most important factors determining their social impairment. Adult patients refractory to drug treatment underwent Deep Brain Stimulation plus drugs. The mean clinical scores at the time of diagnosis indicated a severe condition for both tics and obsessive compulsive components. The mean time elapsed from symptoms onset to diagnosis of OCTD was 5.6 years, reaching up to 11 years in one case. Before reaching the correct diagnosis, different specialists visited the patients several times, 93.3% underwent diagnostic examinations and 86.7% took 2 or 3 different drugs. Ten patients were hospitalised and 8 had received psychotherapy. Discussion: Albeit preliminary, these results show that attention is mandatory for establishing correct diagnosis and treatment guidelines to improve health and rationally spend resources for OCTD.

The second Team Haemophilia Education Meeting, 2016, Frankfurt, Germany

Abstract: The first Team Haemophilia Education (THE) Meeting was held on 7-8 May 2015 in Amsterdam, The Netherlands. It aimed to promote the optimal care of patients with haemophilia through education of the multidisciplinary treatment team. This was achieved by reviewing the latest developments in haemophilia management, considering how these can be implemented in the clinic to improve patient care and providing a platform for networking and debate for all haemophilia treatment team members. The second THE Meeting was held on 19-20 May in Frankfurt, Germany, and participants included doctors, nurses, physiotherapists, patient representatives and data management staff from 20 different countries. Topics covered the role of the multidisciplinary team in delivering the best haemophilia care, challenges in the management of haemophilia across Europe, available clotting factor treatments, future treatments and the use of genetics in advising carriers of haemophilia. This report is a summary of the key developments in haemophilia care presented by various investigators and healthcare professionals at THE Meeting 2016.

[Use of Kovaltry® in patients with Hemophilia A: clinical and economical aspects from the pivotal clinical trials]

Abstract: Farmeconomia. Health economics and therapeutic pathways 2017; 18(1) © SEEd All rights reserved Dal punto di vista economico, il costo del trattamento del paziente emofilico è principalmente associato alla terapia farmacologica [7-9]. Il trattamento in profilassi comporta una spesa sensibilmente maggiore rispetto a quello OD, con un costo stimato in Italia che si aggira tra € 180.000-200.000 per pazienteanno [9]. Per ottimizzare la gestione farmacologica dei pazienti emofilici con le risorse disponibili è fondamentale valutare i diversi prodotti di rFVIII, dal punto di vista dell’efficacia, della sicurezza e dei dosaggi utilizzati. Negli ultimi anni sono stati studiati nuovi rFVIII caratterizzati da un miglioramento del processo produttivo e della sicurezza e/o dalla possibilità di trattamento con diversi schemi di dosaggio. Tra i nuovi rFVIII sviluppati è presente Kovaltry® (Bayer Pharma AG, octocog-alfa), un rFVIII a catena intera, formulato con saccarosio, con miglioramento delle caratteristiche di glicosilazione e sottoposto a nanofiltrazione con filtro da 20 nm [10,11]. Per confermare l’efficacia di Kovaltry® in profilassi è stata effettuata un’analisi dei trial clinici registrativi negli adulti (≥ 12 anni), mettendo a confronto i risultati con quelli di studi analoghi condotti sui nuovi rFVIII disponibili in Italia: Elocta® (Biogen Idec LiEmofilia a E trattamEnti disponibili

Nintedanib for the treatment of idiopathic pulmonary fibrosis in Italy

Abstract: To date, there are few therapeutic answers for Idiopathic pulmonary fibrosis (IPF) and only two pharmacological treatments have a marketing authorization for this disease. Recently nintedanib (Ofev®) has been authorized as a new therapeutic option and its economic profile has been evaluated by international Health Technology Assessment (HTA) bodies. IPF has important implications for everyday life of patients and their carers, negatively influencing their quality of life and bringing heavy economic burden to the NHS and to the entire society. It is, therefore important to consider these aspects for the Italian environment and to perform a pharmacoeconomic evaluation to define the efficiency of nintedanib in IPF by means of a Cost-Utility Analysis (CUA). As IPF is a chronic and progressive disease, a lifetime Markov model has been therefore developed with health states describing the patient’s condition as a combination of lung function and exacerbation history. The cohort entered in the model at different Forced Vital Capacity (FVC%) predicted health states, without exacerbation. The Clinical data used to perform this CUA were derived from clinical trials and the relative efficacy of nintedanib versus the comparator (pirfenidone) was then obtained from a Network Meta-Analysis (NMA) combining data reported in each primary study (INPULSIS 1-2 and TOMORROW trials for nintedanib, and CAPACITY and ASCEND trials for pirfenidone, respectively). At base-case, treatment with nintedanib resulted in a slightly lower estimated total cost vs pirfenidone, better safety profile and lower risk of acute exacerbations with an advantage in Quality Adjusted Life years (QALYs) gained. These results were confirmed by the sensitivity analysis. Although nintedanib appears to be a valuable option for the NHS to treat IPF patients, future data evidence, as long-term or real-life data, will help to confirm these results. [In Italian]

AB1203-HPR Comparison of quality of life of patients with rheumatoid arthritis, psoriatic arthritis and ankilosing spondilitis with treatment or prescription of biologic drugs: results from the cara study

Abstract: Background Chronic rheumatic conditions such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are associated with severe morbidity and significant impairment of patients9 health related quality of life (HRQoL). Several treatments are available but not all the patients respond positively to them. Biologic therapies such as anti-TNFα agents are shown to benefit who fail or have partial responses to standard DMARD therapy. Objectives Within a multicenter stated preferences study (CARA Study), we assessed HRQoL in patients with RA, AS and PsA, and estimated relationship of HRQOL with the different diagnoses, clinical characteristics and biological treatment experience. Methods Patients with RA, AS, or PsA, who at the time of enrollment were following a treatment (experienced) or received a first prescription (naive) of treatment with biological drugs were enrolled. Together with preferences data, clinical and HRQOL information was reported. HRQoL was assessed with the recently developed and successfully validated version of the EQ-5D-5L, which allows to obtain a description of health (in 5 domains and 5 levels of severity each), a measure (EQ-VAS) and a valuation (utility) of health. Multiple linear regression analyses were conducted to assess the association between EQ-5D VAS score and the utility with age, sex, diagnosis, treatment experience, years from symptoms onset and years from diagnosis. Results 513 patients were enrolled (mean±SD =50.0±13.6, 42.5% female). As regards the diagnosis, 33.9% had RA, 34.9% PsA and 31.2% AS. The mean±SD time from the symptoms onset was 10.8±9.4 and from the diagnosis was 8.0±8.2 years. Almost half of the patients (47.4%) were naive to the biological treatment. Patients reporting severe or extreme problems were: 7.1% in mobility, 3.6% in self-care, 10.3% in usual activities, 18.6% in pain/discomfort, 5.5% in anxiety/depression. The mean±SD of the VAS was 60.4±20.5 and of the utility was 0.773±0.116. From the regression model the VAS and utility are significantly (p Conclusions Patients naive to biological treatment have significat lower levels of HRQoL, suggesting that their current situation is not satisfactory and need to start with a more effective treatment. Disclosure of Interest L. Sinigaglia: None declared, L. Scalone: None declared, P. Sarzi-Puttini: None declared, C. Montecucco: None declared, R. Giacomelli Grant/research support from: MSD, G. Lapadula: None declared, I. Olivieri: None declared, A. Giardino Employee of: MSD Italia, G. Didoni Employee of: MSD Italia, P. Cortesi Grant/research support from: Gilead, L. Mantovani: None declared, M. Mecchia Employee of: MSD Italia

Letter to the editor: Clinical Use, Quality of Life and Cost-Effectiveness of Spinal Cord Stimulation Used to Treat Patients with Failed Back Surgery Syndrome.

Abstract: Copyright C 2017 by Korean Society of Spine Surgery This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Asian Spine Journal • pISSN 1976-1902 eISSN 1976-7846 • www.asianspinejournal.org Received May 10, 2017; Accepted 20-May 20, 2017 Corresponding author: Luciana Scalone CESP, Research Centre on Public Health, University of Milan Bicocca Via Cadore, 48, Monza I-20900, Italy Tel: +39-(0)39-2333097, Fax: +39-(0)2-700536422, E-mail: luciana.scalone@unimib.it