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Acute inflammation is a necessary part of successful healing after musculoskeletal insult. Disruption or prolongation of this process can lead to suboptimal outcomesCitation1. Blocking pro-inflammation pathways by means of non-steroidal anti-inflammatory drugs (NSAIDs) is routinely used to manage pain and inflammationCitation2. Such treatment continues to be advocated by authors in this journalCitation3. While often symptomatically beneficial and of potential value in breaking the pain cycle and helping clinicians clarify the relative importance of inflammation in a patient’s symptoms, their use may encourage harmful pain-masking, interfere with tissue healing (homeostasis), promote chronicity and predispose to re-injuryCitation4–6. Furthermore, potentially serious side effects of NSAIDs are well establishedCitation7. There is currently much interest in the potential of moving from treatments which inhibit inflammation to those promoting resolution, a new area of scientific research termed “resolution pharmacology”Citation8. For patients who have suffered injury or are experiencing acute or acute on chronic osteoarthritis symptoms is there currently enough evidence to justify a shift in therapeutic approach towards pro-resolution strategies?, Peer Reviewed

Alberto Migliore,1 Gianfranco Gigliucci,1 Lyudmila Alekseeva,2 Raveendhara R Bannuru,3 Tomasz Blicharski,4 Demirhan Diracoglu,5 Athanasios Georgiadis,6 Hesham Hamoud,7 Natalia Martusevich,8 Marco Matucci Cerinic,9 Jan Perduk,10 Imre Szerb,11 Tomáš Trč,12 Xavier Chevalier13 1Rheumatology Unit - San Pietro Fatebenefratelli Hospital, Rome, Italy; 2Department of Metabolic Diseases of Bone and Joints, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation; 3Center for Treatment Comparison and Integrative Analysis (CTCIA) at Tufts Medical Center, Boston, MA, USA; 4Lubelskie Centrum Diagnostyczne, Świdnik, Poland; 5Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul, Turkey; 6Department of Rheumatology, University of Ioannina, Ioannina, Greece; 7Department of Rheumatology Al Azhar University, Cairo, Egypt; 8Department of Rheumatology, Belarusian State Medical University, Minsk, Belarus; 9Division of Rheumatology, University of Florence, Florence, Italy; 10Department of Musculoskeletal Medicine and Sports, Hospital KoÅ¡ice -Å aca, Kosice Saca, Slovakia; 11Semmelweis University, Department of Traumatology Uzsoki Hospital, Department of Orthopaedics&Traumatology FIFA Medical Centre of Excellence Uzsoki u.29– 41, Budapest, Hungary; 12Department of Orthopaedic Surgery, Charles University and Motol University Hospital, Prague, Czech Republic; 13Rheumatology Division, Henri-Mondor Hospital, Créteil, FranceCorrespondence: Alberto MiglioreRheumatology Unit - San Pietro Fatebenefratelli Hospital, Rome, ItalyEmail reumafbf@libero.itAbstract: Osteoarthritis (OA) is a significant cause of disability. Considering the increasing diffusion of the viscosupplementation (VS) with hyaluronic acid (HA), the International Symposium Intra Articular Treatment (ISIAT) appointed a Technical Expert Panel (TEP) to identify the criteria for successful VS with a specific HA in OA; this through a systematic literature rev

Alberto Migliore,1 Gianfranco Gigliucci,1 Raffaele Di Marzo,2 Domenico Russo,3 Massimo Mammucari4 1Department of Internal Medicine, Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome, Italy; 2Italian Society of Mesotherapy, Rome, Italy; 3“San Marco” Hospice and Palliative Care, Latina, Italy; 4Primary Care Unit ASL RM 1, Rome, ItalyCorrespondence: Alberto Migliore Email migliore.alberto60@gmail.comAbstract: This narrative review is the final output of an initiative of the SIM (Italian Society of Mesotherapy). A narrative review of scientific literature on the efficacy of fractional intradermal vaccination in comparison with full doses has been conducted for the following pathogens: influenza virus, rabies virus, poliovirus (PV), hepatitis B virus (HBV), hepatitis A virus (HAV), diphtheria-tetanus-pertussis bacterias (DTP), human papillomavirus (HPV), Japanese encephalitis virus (JE), meningococcus, varicella zoster virus (VZV) and yellow fever virus. The findings suggest that the use of the intradermal route represents a valid strategy in terms of efficacy and efficiency for influenza, rabies and HBV vaccines. Some systematic reviews on influenza vaccines suggest the absence of a substantial difference between immunogenicity induced by a fractional ID dose of up to 20% and the IM dose in healthy adults, elderly, immunocompromised patients and children. Clinical studies of remaining vaccines against other pathogens (HAV, DTP bacterias, JE, meningococcal disease, VZV, and yellow fever virus) are scarce, but promising. In the context of a COVID-19 vaccine shortage, countries should investigate if a fractional dosing scheme may help to save doses and achieve herd immunity quickly. SIM urges the scientific community and health authorities to investigate the potentiality of fractionate intradermal administration in anti-COVID-19 vaccination.Keywords: vaccination, intradermal, COVID-19, dose sparing

Massimo Mammucari,1 Teresa Paolucci,2 Domenico Russo,3 Enrica Maggiori,1 Raffaele Di Marzo,4 Alberto Migliore,5 Umberto Massafra,5 Gianpaolo Ronconi,6 Paola Emilia Ferrara,6 Fabio Gori,7 Barbara Bifarini,7 Stefano Brauneis,8 Renato Vellucci,9 Rocco Domenico Mediati,9 Bartolomeo Violo,10 Silvia Natoli,11 Carmen Pediliggieri,12 Cristiana Di Campli,12 Maria Chiara Collina12 1Primary Care Unit, ASL RM 1, Rome, Italy; 2Unit of Physical Medicine and Rehabilitation, G. D’ Annunzio University of Chieti-Pescara, Department of Oral Medical Science and Biotechnology (DSMOB), Chieti, Italy; 3“San Marco” Hospice and Palliative Care, Latina, Italy; 4Member of the Italian Society of Mesotherapy, Rome, Italy; 5Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome, Italy; 6Physical Medicine and Rehabilitation Unit, IRCCS, Catholic University of Sacred Heart, Rome, Italy; 7Section of Anaesthesia, Intensive Care, and Pain Medicine, University Hospital Santa Maria Della Misericordia, Perugia, Italy; 8Pain Centre “Enzo BorzomatI”, University Hospital of Rome “Policlinico Umberto I”, Rome, Italy; 9Anaesthesiology Department, University Hospital Careggi, Florence, Italy; 10Pain Therapy Unit, S. Spirito Nuovo Regina Margherita Hospital, Rome, Italy; 11Department of Clinical Science and Translational Medicine, Tor Vergata University, Rome, Italy; 12Department of Vascular Surgery, Limb Salvage and Diabetic Foot, IDI-IRCCS, Rome, ItalyCorrespondence: Massimo MammucariPrimary Care Unit, Local Health, ASL RM 1, Rome, 00165, ItalyTel +39-06-61560695 Email massimo.mammucari@libero.itAbstract: Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic v

Lorenzo Pradelli,1 Tiziana Sinigaglia,1 Alberto Migliore,2 Giovanni Antonio Checchia,3 Francesco Franceschi,4 Bruno Frediani,5 Florenzo Iannone,6 Emilio Romanini7 1AdRes HE&OR, Torino, Italy; 2Saint Peter Hospital, Rome, Italy; 3Hospital of Monselice, Padua, Italy; 4University Hospital of Rome, Rome, Italy; 5Hospital of Siena, Siena, Italy; 6University of Bari, Bari, Italy; 7RomaPro Center for Hip and Knee Arthroplasty, polo Sanitario San Feliciano, Rome, ItalyCorrespondence: Lorenzo Pradelli Email l.pradelli@adreshe.comAbstract: The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vo

Introduction: The administration by injection of hyaluronic acid (HA) for 3-5 weeks is effective in the treatment of patients with knee osteoarthritis (OA). Other products for intra-articular use have been recently introduced for the treatment of OA. Among these, a medical device, MD-Knee, produced by Guna S.p.A.; this study aims to estimate the cost-minimization of MD-Knee versus HA in the treatment of knee osteoarthritis. Methods and Results: We performed a cost-minimization analysis (CMA). The CMA was conducted from the perspective of the Italian National Health Service (iNHS). Only direct medical costs (MD-Knee and HA) were considered. We performed a sensitivity analysis to test the robustness of the results. The mean 6-months cost per patient was € 75,00 with MD-Knee and € 185,00 with HA. Conclusion: From the Italian National Health Service’s perspective, MD-Knee appears to be the cost-saving therapeutic option compared with HA in the treatment of patients with knee osteoarthritis. (HTA & Market Access)

Introduction: The administration by injection of hyaluronic acid (HA) for 3-5 weeks is effective in the treatment of patients with knee osteoarthritis (OA). Other products for intra-articular use have been recently introduced for the treatment of OA. Among these, a medical device, MD-Knee, produced by Guna S.p.A.; this study aims to estimate the cost-minimization of MD-Knee versus HA in the treatment of knee osteoarthritis. Methods and Results: We performed a cost-minimization analysis (CMA). The CMA was conducted from the perspective of the Italian National Health Service (iNHS). Only direct medical costs (MD-Knee and HA) were considered. We performed a sensitivity analysis to test the robustness of the results. The mean 6-months cost per patient was € 75,00 with MD-Knee and € 185,00 with HA. Conclusion: From the Italian National Health Service’s perspective, MD-Knee appears to be the cost-saving therapeutic option compared with HA in the treatment of patients with knee osteoarthritis. (HTA & Market Access)

Alberto Migliore,1 Andrea Sorbino,2 Serenella Bacciu,2 Alberto Bellelli,3 Bruno Frediani,4 Sandro Tormenta,3 Carmelo Pirri,2 Calogero Foti2 1Rheumatology, S. Pietro Fatebenefratelli Hospital, Rome, Italy; 2Physical and Rehabilitation Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Radiology, Fatebenefratelli S. Pietro Hospital, Rome, Italy; 4Research Centre of Systemic Autoinflammatory Diseases Behcet Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Centre Department of Medical Sciences Surgery and Neurosciences, University of Siena, Siena, ItalyCorrespondence: Andrea Sorbino Email a.sorbino@quaderni.bizBackground: Low back pain (LBP) is one of the most common spine diseases and represents the most frequent cause of absence from work in developed countries. Approximately 40% of chronic LBP is related to discogenic origin. The goal of the study is producing a review of literature to describe analytically the techniques of intradiscal injections.Methods: PubMed database was searched for clinical studies with the different key terms: “intradiscal”, “injection”, “steroid” “procedures”, “techniques”, “CT”, “MRI”, “fluoroscopy”, “fluoroscopic”, “guidance”, “ozone”, “ultrasound”, “images”. Only studies written in English, French, or Italian in which the intradiscal injection represents the main procedure for the low back discopathy treatment on humans were considered. We excluded the articles that do not mention this procedure; those which indicated that the intradiscal injection had happened accidentally during other treatments; those reporting the patient’s pain was determined by other causes than the discopathy (facet joint syndrome, tumor, spondylodiscitis

Alberto Migliore,1,2 Bruno Frediani,3 Gianfranco Gigliucci,1 Calogero Foti,4 Sergio Crimaldi,5 Orazio De Lucia,6 Giovanni Iolascon7 1Rheumatology Unit, S. Pietro FBF Hospital, Rome, Italy; 2Department of Internal Medicine, S. Pietro FBF Hospital, Rome, Italy; 3Medical and Surgical Science and Neuroscience Department, Rheumatology Section, University of Siena, O.U. of Osteo-Articular Diagnostic Procedures, Siena, Italy; 4Physical and Rehabilitation Medicine Department, University of Rome Tor Vergata, Rome, Italy; 5Orthopaedics and Traumatology Department, Lucca Hospital, USL Tuscany Northwest, Lucca, Italy; 6Division of Rheumatology, Gaetano Pini Institute, Milan, Italy; 7Physical and Rehabilitation Medicine Department, Napoli University, Naples, ItalyCorrespondence: Alberto MiglioreDepartment of Internal Medicine, S. Pietro FBF Hospital, Rome 00189, ItalyTel +39 049 7443620Fax +39 049 7443622Email alberto.migliore.12@outlook.itPurpose: The use of ultrasound (US) guidance has allowed hip osteoarthritis to be treated with intra-articular (IA) injections. HYMOVIS ONE (HYADD4-G) is a new hyaluronic acid (HA) derivative product with unusual characteristics, and it has been used with good results in knee osteoarthritis (OA). This study assessed the efficacy and safety of a single HYMOVIS ONE injection in patients affected by symptomatic hip OA.Patients and Methods: This post-marketing cohort study assessed data from the ANTIAGE Register. Inclusion criteria were age ≥ 40 years, symptomatic hip OA (Kellgren-Lawrence grade I–III) of ≥ 1-year duration, and ≥ 12 months follow-up. All patients received a single HYMOVIS ONE (32 mg/4 mL) injection at baseline. Values for 10-cm visual analogue scale (VAS) pain scores, the Lequesne index, and nonsteroidal anti–inflammatory drug (NSAID) consumption were evaluated at 6 and 12 months. Adverse events were also recorded.Results: The included patients (n = 198) consisted of 42.5% women, with a mea

Introduction: The administration by injection of hyaluronic acid (HA) for 3-5 weeks is effective in the treatment of patients with knee osteoarthritis (OA). Other products for intra-articular use have been recently introduced for the treatment of OA. Among these, a medical device, MD-Knee, produced by Guna S.p.A.; this study aims to estimate the cost-minimization of MD-Knee versus HA in the treatment of knee osteoarthritis. Methods and Results: We performed a cost-minimization analysis (CMA). The CMA was conducted from the perspective of the Italian National Health Service (iNHS). Only direct medical costs (MD-Knee and HA) were considered. We performed a sensitivity analysis to test the robustness of the results. The mean 6-months cost per patient was € 75,00 with MD-Knee and € 185,00 with HA. Conclusion: From the Italian National Health Service’s perspective, MD-Knee appears to be the cost-saving therapeutic option compared with HA in the treatment of patients with knee osteoarthritis. (HTA & Market Access)

Introduction: Patients’ quality of life impairment together with a heavy burden to the NHS and society are caused by chronic inflammatory diseases. Their treatment substantially improved with the advent of biological drugs (such as adalimumab), but these drugs are very expensive. At present, the patent protection of adalimumab (Humira®) has expired, and a biosimilar (Hyrimoz®) has been approved. Since the biosimilar price is expected to be lower as compared with the originator’s, the present Drug Budget Impact analysis tries to evaluate whether and how much profitable the biosimilar availability will be for the Italian NHS, in terms of cost containment (savings). Methods and results : The time horizon in the analysis model is five years. The initial overall number of patients treated with adalimumab is estimated (based on the Italian population, the disease prevalence rates, the proportion of patients under treatment and adalimumab market share) and kept constant in time. However, the model assumes that, year by year, patients in treatment with the originator will partly switch to the biosimilar (based on a prudent estimate of the uptake rate), while (due to a bolder estimate) a larger share of naïve patients will directly start with the biosimilar. Thanks to such assumptions, total number of patients treated with adalimumab (separately with the originator and with the biosimilar) is estimated, with the respective total costs. Conclusions:  According to the present analysis, the availability of the biosimilar would generate cumulated savings (in five years) as high as €260 millions for the Italian NHS.

Introduction: Patients’ quality of life impairment together with a heavy burden to the NHS and society are caused by chronic inflammatory diseases. Their treatment substantially improved with the advent of biological drugs (such as adalimumab), but these drugs are very expensive. At present, the patent protection of adalimumab (Humira®) has expired, and a biosimilar (Hyrimoz®) has been approved. Since the biosimilar price is expected to be lower as compared with the originator’s, the present Drug Budget Impact analysis tries to evaluate whether and how much profitable the biosimilar availability will be for the Italian NHS, in terms of cost containment (savings). Methods and results : The time horizon in the analysis model is five years. The initial overall number of patients treated with adalimumab is estimated (based on the Italian population, the disease prevalence rates, the proportion of patients under treatment and adalimumab market share) and kept constant in time. However, the model assumes that, year by year, patients in treatment with the originator will partly switch to the biosimilar (based on a prudent estimate of the uptake rate), while (due to a bolder estimate) a larger share of naïve patients will directly start with the biosimilar. Thanks to such assumptions, total number of patients treated with adalimumab (separately with the originator and with the biosimilar) is estimated, with the respective total costs. Conclusions:  According to the present analysis, the availability of the biosimilar would generate cumulated savings (in five years) as high as €260 millions for the Italian NHS.

Migliore A, Giannini S, Bizzi E, Massafra U, Cassol M, Abilius MJ, Boni G. Open Access Journal of Sports Medicine. 2019;10:11–15.Following publication, the authors of this article discovered an error on page 12, in Methods section, 3rd paragraph, 4th row regarding name and affiliation of hyaluronic acid applied in this study. Correct name and provenance is SINOVIAL 8 mg/mL (IBSA Farmaceutici, Italy).Read the original article

Alberto Migliore,1 Davide Integlia,2 Giuseppe Pompilio,2 Francesca Di Giuseppe,2 Cinzia Aru,2 Tray Brown31Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome, Italy; 2ISHEO Srl, Rome, Italy; 3Department of Public Health and Primary Care, University of Cambridge, Cambridge, UKPurpose: To estimate the cost-effectiveness and budget impact of viscosupplementation with one intra-articular (IA) injection of 6 mL hylan G-F 20 (Synvisc-One®,) and with three injections of 2 mL hylan G-F 20 (Synvisc®,3×2) in knee osteoarthritis (OA) patients compared with conventional support therapy (CST – eg, NSAIDs and acetaminophen) and the cost-effectiveness of one IA injection of 2 mL hylan G-F 20 (Synvisc®,1×2) in hip OA patients compared with CST from an Italian Health System perspective.Methods: The model used was a Markov model with states for stages II–IV on the Kellgren–Lawrence scale and runs on 6-month cycles over a 5-year time horizon. A 3.5% discount was applied to both costs and utilities. Direct costs were determined from the perspective of the Italian National Health Service. A one-way and probabilistic sensitivity analysis was conducted for both comparisons.Results: Hylan G-F 20 1×6 mL and hylan G-F 20 3×2 mL for knee OA were very likely to be cost-effective when compared to acetaminophen (ICER = €3,160.61 and €3,845.81 per QALY, respectively) and NSAIDs as both ICERs are below €25,000. The hip OA treatment by hylan G-F 20 1×2 mL was dominant compared to NSAIDs and very likely compared to acetaminophen. The results of the cost-effectiveness analysis were confirmed by one-way sensitivity analysis. The budget impact analysis for knee and hip OA showed a small increase in expenditure during 5 years.Conclusions: Hylan G-F 20 1×6 mL/hylan G-F 20 is a cost-effectiveness treatment compared to NSAIDs and acetaminophen in the trea

Introduction: Patients’ quality of life impairment together with a heavy burden to the NHS and society are caused by chronic inflammatory diseases. Their treatment substantially improved with the advent of biological drugs (such as adalimumab), but these drugs are very expensive. At present, the patent protection of adalimumab (Humira®) has expired, and a biosimilar (Hyrimoz®) has been approved. Since the biosimilar price is expected to be lower as compared with the originator’s, the present Drug Budget Impact analysis tries to evaluate whether and how much profitable the biosimilar availability will be for the Italian NHS, in terms of cost containment (savings). Methods and results : The time horizon in the analysis model is five years. The initial overall number of patients treated with adalimumab is estimated (based on the Italian population, the disease prevalence rates, the proportion of patients under treatment and adalimumab market share) and kept constant in time. However, the model assumes that, year by year, patients in treatment with the originator will partly switch to the biosimilar (based on a prudent estimate of the uptake rate), while (due to a bolder estimate) a larger share of naïve patients will directly start with the biosimilar. Thanks to such assumptions, total number of patients treated with adalimumab (separately with the originator and with the biosimilar) is estimated, with the respective total costs. Conclusions:  According to the present analysis, the availability of the biosimilar would generate cumulated savings (in five years) as high as €260 millions for the Italian NHS.

Alberto Migliore,1 Silvana Giannini,2 Emanuele Bizzi,1 Umberto Massafra,1 Maurizio Cassol,3 Martin Jose Michael Abilius,1 Giovanni Boni4 1Operative Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 2Department of Radiology, Villa Stuart Sport Clinic, Rome 00136, Italy; 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 4ANTIAGE Sportive Medicine Ambulatory Department (Ambulatorio di Medicina dello Sport Antiage), Foligno, Italy Objective: The aim of this study is to investigate the effect of intra-articular hyaluronic acid administration in active football players complaining of knee pain after sports activity. Efficacy and safety profiles of intra-articular hyaluronic acid and time needed for football players to recover and restart sports activity were examined.Methods: Clinical data of active football players reporting knee pain after sports activity were included in this retrospective study. All patients who received an intra-articular injection at time 0 and after 2 weeks were included in the study. Patients underwent laboratory examination, knee X-ray, ultrasound, and clinical examination before receiving the intra-articular injection. Effusions or cysts were drained before injections. Lequesne index score, pain visual analog scale (VAS) score, and patient’s global assessment score were recorded at time 0 (day of the first injection), 1 and 2 days after the first injection, at 2 weeks (day of the second injection), and at follow-up visits. Only data from patients completing the follow-up were analyzed.Results: Data from 17 patients were analyzed: 16 males and one female, of which three were professional players (two males and one female) and 14 were nonprofessional players. The mean age of patients was 39.8±11.8 years. Two patients (one male and one female) showed joint effusion. Two patients reported relevant joint pain after injection that regressed without any medicatio

Background The introduction of biological therapies has greatly improved treatment of rheumatoid arthritis (RA) and patients' quality of life. Abatacept is a biological drug that can be given every 28 days by Intravenous Infusion (IvI). IvI administration takes a short period of time and does not require pre-medications nor specific post-infusion support. These characteristics allowed the launch of the SuSTAin Program for the out-of-hospital administration of abatacept IvI. Object The main aim of this analysis was to assess the economic value generated by the SuSTAin Program for rheumatology centres and the Italian National Health Service (INHS). Methods Using the SuSTAin database and supported by a Delphi panel of eleven Italian rheumatology experts – one from each participating centre – we collected data about infusion duration and costs of IvI administration (nurse and rheumatologist)/control visit (rheumatologist). The analysis evaluated the saving generated by the SuSTAin Program for the INHS (avoided refunds by INHS to rheumatology centres) and patient's adherence to IvI administrations in the SuSTAin Program. Costs were assessed in Euros 2015. Results From December 2010 to August 2015, eleven Italian rheumatology centres adopted the SuSTAin Program and 2,856 infusions were given to 135 patients. In each centre, an infusion was shown to take approximately 123.7 minutes and a control visit 30 minutes. Based on the average hourly wage of a rheumatologist and a nurse and the time they dedicate to the infusion, the mean cost per infusion was €66.71. The potential saving for rheumatology centres amounted to €194,134, while the real saving for INHS was €32,234. Data showed a high level of patients' adherence (97%). Conclusions The SuSTAin Program represents an innovative way to support patients with RA when treated with abatacept IvI, generating measurable economic value for both rheumatology centres and INHS.

Maurizio Benucci,1 Veronica Rogai,2 Fabiola Atzeni,3 Volker Hammen,4 Piercarlo Sarzti-Puttini,3 Alberto Migliore5 1Rheumatology Unit, S.Giovanni di Dio Hospital, Florence, Italy; 2Eli Lilly Italia SpA, Sesto Fiorentino, Italy; 3Rheumatology Unit, L Sacco Hospital, Milan, Italy; 4Lilly Deutschland GmbH, Bad Homburg, Germany; 5Villa San Pietro Fatebenefratelli Hospital, Rome, Italy Abstract: This literature review examines available evidence on the current and past costs associated with rheumatoid arthritis (RA) in Italy, together with the future health-economic prospects for the disease. Studies have been conducted to date on the prevalence, or the associated costs, of RA in Italy. Although future changes in the incidence of RA are a matter of debate, the impact of RA on health care costs is expected to grow in coming decades in line with projected increases in life expectancy and in the proportion of elderly people in Italy. It has been estimated that the indirect (productivity loss and informal care) and intangible (deterioration in health-related quality of life) costs of the disease will contribute to an increase in national health service expenditure, which will correspond to 1% of the total health care costs of the nation in the near future. The introduction of biological agents for the treatment of rheumatic diseases has resulted in an increase in the direct costs of RA; however, economic analyses that exclude indirect costs will underestimate the full economic impact of RA. The effectiveness of innovative therapies in preventing disease progression and functional impairment may, over time, attenuate the cost impact of RA in terms of hospitalizations and work absenteeism. Further research is needed to develop estimates of the economic impact of different therapeutic approaches in patients with RA in Italy, in order to provide tools that can drive the choice of the most cost-effective therapeutic option while maintaining high-quality care. Keywords: rheumatoid

Background The introduction of biological therapies has greatly improved treatment of rheumatoid arthritis (RA) and patients' quality of life. Abatacept is a biological drug that can be given every 28 days by Intravenous Infusion (IvI). IvI administration takes a short period of time and does not require pre-medications nor specific post-infusion support. These characteristics allowed the launch of the SuSTAin Program for the out-of-hospital administration of abatacept IvI. Object The main aim of this analysis was to assess the economic value generated by the SuSTAin Program for rheumatology centres and the Italian National Health Service (INHS). Methods Using the SuSTAin database and supported by a Delphi panel of eleven Italian rheumatology experts – one from each participating centre – we collected data about infusion duration and costs of IvI administration (nurse and rheumatologist)/control visit (rheumatologist). The analysis evaluated the saving generated by the SuSTAin Program for the INHS (avoided refunds by INHS to rheumatology centres) and patient's adherence to IvI administrations in the SuSTAin Program. Costs were assessed in Euros 2015. Results From December 2010 to August 2015, eleven Italian rheumatology centres adopted the SuSTAin Program and 2,856 infusions were given to 135 patients. In each centre, an infusion was shown to take approximately 123.7 minutes and a control visit 30 minutes. Based on the average hourly wage of a rheumatologist and a nurse and the time they dedicate to the infusion, the mean cost per infusion was €66.71. The potential saving for rheumatology centres amounted to €194,134, while the real saving for INHS was €32,234. Data showed a high level of patients' adherence (97%). Conclusions The SuSTAin Program represents an innovative way to support patients with RA when treated with abatacept IvI, generating measurable economic value for both rheumatology centres and INHS.

Alberto Migliore,1 Emanuele Bizzi,1 Colin Gerard Egan,2 Mauro Bernardi,3 Lea Petrella4 1Rheumatology Unit, San Pietro Fatebenefratelli Hospital, Rome, 2Primula Multimedia SRL, Pisa, 3Department of Statistical Sciences, University of Padova, Padova, 4MEMOTEF Department, Sapienza University of Rome, Rome, Italy Background: Biological agents provide an important therapeutic alternative for rheumatoid arthritis patients refractory to conventional disease-modifying antirheumatic drugs. Few head-to-head comparative trials are available.Purpose: The aim of this meta-analysis was to compare the relative efficacy of different biologic agents indicated for use as monotherapy in rheumatoid arthritis.Methods: A systemic literature search was performed on electronic databases to identify articles reporting double-blind randomized controlled trials investigating the efficacy of biologic agents indicated for monotherapy. Efficacy was assessed using American College of Rheumatology (ACR) 20, 50, and 70 criteria at 16–24 weeks. Relative efficacy was estimated using Bayesian mixed-treatment comparison models. Outcome measures were expressed as odds ratio and 95% credible intervals.Results: Ten randomized controlled trials were selected for data extraction and analysis. Mixed-treatment comparison analysis revealed that tocilizumab offered 100% probability of being the best treatment for inducing an ACR20 response versus placebo, methotrexate, adalimumab, or etanercept. Likewise, for ACR50 and ACR70 outcome responses, tocilizumab had a 99.8% or 98.7% probability of being the best treatment, respectively, compared to other treatments or placebo. Tocilizumab increased the relative probability of being the best treatment (vs methotrexate) by 3.2-fold (odds ratio: 2.1–3.89) for all ACR outcomes.Conclusion: Tocilizumab offered the greatest possibility of obtaining an ACR20, ACR50, and ACR70 outcome vs other monotherapies or placebo. Keywords: biologics, meta-ana

Prisco Piscitelli,1,2 Giovanni Iolascon,3 Alberto Argentiero,2 Giovanna Chitano,2 Cosimo Neglia,2 Gemma Marcucci,1 Manuela Pulimeno,2 Marco Benvenuto,2 Santa Mundi,2 Valentina Marzo,2 Daniela Donato,4 Angelo Baggiani,4 Alberto Migliore,5 Mauro Granata,6 Francesca Gimigliano,3 Raffaele Di Blasio,7 Alessandra Gimigliano,3 Lorenzo Renzulli,7 Maria Luisa Brandi,1 Alessandro Distante,2,4 Raffaele Gimigliano3,71University of Florence, Florence Italy; 2ISBEM Research Centre, Brindisi, Italy; 3Second University of Naples, Naples, Italy; 4University of Pisa, Pisa, Italy; 5Fatebenefratelli St Peter’s Hospital, Rome, Italy; 6St Filippo Neri Hospital, Rome, Italy; 7Casa di Cura Santa Maria del Pozzo, Somma Vesuviana, ItalyObjectives: As osteoporotic fractures are becoming a major health care problem in countries characterized by an increasing number of older adults, in this study we aimed to compare the incidence and costs of hip fragility fractures in Italian elderly people versus those of major cardiovascular diseases (strokes and acute myocardial infarctions [AMI]) occurring in the whole adult population.Methods: We analyzed hospitalization records maintained at the national level by the Italian Ministry of Health for the diagnosis of hip fractures (ICD-9-CM codes 820–821), AMI (code 410), hemorrhagic (codes 430, 431, 432) and ischemic strokes (codes 433–434), and TIA (code 435) between 2001–2005. Cost analyses were based on diagnosis-related groups.Results: The incidence of hip fractures in elderly people has increased (+12.9% between 2001 and 2005), as well as that of AMI (+20.2%) and strokes (hemorrhagic: +9.6%; ischemic: +14.7) occurring in the whole adult population; conversely, hospitalization due to TIA decreased by a rate of 13.6% between 2001 and 2005. In 2005, the hospital costs across the national health care system that were associated with hip fragility fractures in the elderly were comparable to those of strokes (both hem

Alberto Migliore1, Francesca Giovannangeli1, Emanuele Bizzi1, Bruno Laganà2, Mauro Granata31Department of Rheumatology, S Pietro FBF Hospital, 2Department of Rheumatology, Second Medical School, Sapienza University, 3Rheumatology and Osteoporosis Center, San Filippo Neri Hospital, Rome, ItalyBackground: Osteoarthritis is a public health concern, particularly in modern society, and is the leading osteoarticular pathology in developed countries. The increased prevalence of osteoarthritis with aging, coupled with the aging of populations, makes osteoarthritis a high priority health care problem. Viscosupplementation is a well established treatment option in knee osteoarthritis that is included in the professional guidelines for treatment of this joint disease.Objective: This review assessed the efficacy and safety of viscosupplementation with hylan G-F 20 (Synvisc®) in the management of joint pain in knee osteoarthritis.Methods: Three databases were searched, ie, Medline (1970–2010), the Database of Abstract on Reviews and Effectiveness, and the Cochrane Database of Systematic Reviews. Reference lists of relevant articles were examined for additional references.Results: Eighteen studies were identified (six European, five Turkish, three US, two Canadian, one Swiss and one English), which reported efficacy of viscosupplementation in a total of 3689 patients undergoing viscosupplementation treatment with Synvisc for knee osteoarthritis compared with low molecular weight viscosupplementation, high molecular weight viscosupplementation, medium molecular weight viscosupplementation, placebo, corticosteroids, nonsteroidal anti-inflammatory drugs, and physical therapy.Conclusion: Synvisc viscosupplementation in the treatment of knee osteoarthritis is a safe and effective therapeutic option that could also reduce the direct and indirect costs related to this disease.Keywords: viscosupplementation, knee osteoarthritis, hyaluronic acid, hyaluronan, s

Alberto Migliore1,2, Mauro Granata31UOS of Rheumatology S. Pietro Fatebenefratelli Hospital, Rome, Italy; 2AFaR Research Center, S. Pietro, Rome, Italy; 3UOS of Rheumatology S. Filippo Neri Hospital, Rome, ItalyAbstract: Osteoarthritis is one of the leading causes of disability in the elderly. The changes in the lubricating properties of synovial fluid lead to significant pain and loss of function. More than ten years have passed from the first studies. Up till now many authors have supported intra-articular hyaluronan (HA) therapy as not only a symptom-modifying therapy but also a treatment which may significantly decrease the rate of deterioration of joint structure. In this review we report data relative to knee and hip treatment. The ongoing studies continue to further our understanding of the fundamental mechanisms that likely underlie the therapeutic benefits of this treatment but, despite recent progress, many unresolved issues require further study. Large scale double blind controlled studies must be carried out to confirm these promising data and produce meaningful guidelines.Keywords: osteoarthritis, hyaluronan, intra-articular injections, ultrasound-guided, viscosupplementation