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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 venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths.Keywords: mesotherapy, intradermal therapy, research plan

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 medication. At the first week, all parameters examined indicated improvement that was maintained until the end of follow-up. One day after the first and second injection, patients reported a slight increase in pain VAS score, which was not statistically significant, and the pain resolved after 1 day. All patients successfully restarted playing after the first injection within 3.1±2.0 days and kept playing after the second injection following our indication (1 day of break).Conclusion: The use of a medium-molecular weight hyaluronic acid in football players affected by knee osteoarthritis seems efficacious and safe and resulted, in our experience, a stable improvement of symptoms; moreover, it allowed a rapid restart of sports activity. Larger studies on larger populations are needed to confirm these findings. Keywords: sports, hyaluronic acid, intra-articular, injection, football, trauma

LS Martin-Martin,1 F Giovannangeli,2 E Bizzi,2 U Massafra,2 E Ballanti,2 M Cassol,3 A Migliore2 1Department of Internal Medicine, Regina Apostolorum Hospital, 2Operative Unit of Rheumatology, 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome, Italy Background: Biologic agents are currently the strongest immunosuppressive drugs able to induce remission in rheumatoid arthritis (RA). One of the objectives of the medical scientific community now is how to maintain remission or low disease activity (LDA). The aim of this trial is to evaluate the contribution of low-dose sequential kinetic activation (SKA) IL-4, IL-10, and anti-IL-1 antibodies (10 fg/mL) in patients affected by RA in maintaining LDA or remission obtained after biological therapy. Method: This is a randomized, open, active-controlled, prospective, Phase IV trial. Disease activity score (DAS28), clinical disease activity index, simplified disease activity index, erythrocyte sedimentation rate and C-reactive protein levels, global health assessment, and pain visual analog scale were evaluated at baseline visit and then every 3 months together with an assessment of side effects till 12 months. Thirty-nine RA patients were enrolled and randomized to continue disease-modifying antirheumatic drugs (DMARDs) therapy or to receive a combination of SKA low-dose cytokines formulated in concentration of 10 fg/mL orally administered at a dose of 20 drops/d for 12 consecutive months. Results: The rate of maintenance of LDA at 12 months was superior in the group treated with low-dose cytokines compared with patients treated with DMARDs, 66.7% and 42.1%, respectively; however, the difference between the groups was not statistically significant. No side effects were reported in both groups. Conclusion: This is the first study using a combination of three low-dose cytokines in RA, after data published on psoriasis. These data suggest that the use of a combination of low-dose SKA cytokines may be an opportunity to explore in the management of RA. Keywords: RA, low-dose cytokines, low-dose antibodies, SKA, biological agents, low disease activity

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

OBJECTIVE: Psoriasis and psoriatic arthritis (PsA) are closely linked to cancer, as supported by the literature. Systemic treatments for psoriasis and PsA, namely non-biological disease-modifying anti-rheumatic drugs (DMARDs), have been associated with increased cancer risk in both conditions. New, more effective biological DMARDs (bDMARDs) do not seem to be associated with higher overall cancer risk compared to those not receiving bDMARDs, opening up possibilities for treating patients with previous or ongoing oncological disease alongside psoriasis and PsA. However, limited literature exists on treating PsA patients with cancer with bDMARDs. This study aims to assess the safety of secukinumab, a bDMARD, in patients with PsA and concurrent cancer. Here, we describe a case series of four patients with PsA treated with bDMARD secukinumab and review the literature on the subject. CASE SERIES: We assessed the laboratory parameters and clinical characteristics of 4 patients with PsA treated with the bDMARD secukinumab and followed up until 30 months. Three patients had oncological disease in remission, while one had active neoplasia. No cancer progression was observed during the treatment of these patients with secukinumab. CONCLUSIONS: In conclusion, our case series, consisting of four PsA patients with concurrent neoplasia treated with secukinumab, showed no evidence of cancer progression and represents the first case of PsA described in the literature treated during active oncological disease, lending support to the safety of secukinumab for the treatment of patients with PsA and concomitant neoplasia. [ABSTRACT FROM AUTHOR]

Background. Intradermal therapy (mesotherapy) is a technique used to inject drugs into the surface layer of the skin. The intradermal micro deposit allows to modulate the kinetics of drugs, slowing down its absorption and prolonging the local mechanism of action. This technique is applied in the treatment of some forms of localized pain when a systemic drug-saving effect is useful, when it is necessary to synergize with other pharmacological or non-pharmacological therapies, when other therapies have failed or cannot be used. Aim. The purpose of our study was to evaluate the effect of a mixture with respect to its lower concentration. We also wanted to evaluate the number of sessions needed to reach the therapeutic goal (50% reduction in pain from baseline) in patients with acute or chronic neck pain. Method. We analyzed retrospectively data from 62 patients with cervicobrachial pain treated with intradermal drugs. Group A received a mixture of drugs; group B received half the dose of drugs. Results. Patients who received a lower concentration of drugs achieved similar results to those who received a higher dose. The therapeutic goal was achieved on average with 3.5 + 1.7 sessions on a weekly basis (min 1; max 9). Subjects in group A required 4±1.7 treatments (min 1; max 9), while subjects in group B required 3±1.5 treatments (min 1; max 7). Conclusions. Our study confirms that even a lower dose of drugs can induce a clinically useful result. This study confirms that the useful effect of mesotherapy is only partly due to the pharmacological action. Further randomized prospective studies are needed to standardize the technique in the various pain syndromes, but it is recommended to follow the guidelines of the Italian Society of Mesotherapy to ensure patients receive appropriate treatment. [ABSTRACT FROM AUTHOR]

OBJECTIVE: A review of network meta-analysis to assess efficacy and safety of biologics for the treatment of psoriatic arthritis (PsA). MATERIALS AND METHODS: A systematic search was conducted on electronic databases to identify Bayesian meta-analysis reporting clinical parameters of efficacy, safety and cost-effectiveness of biologics that are approved for the treatment of PsA patients. RESULTS: We identified 19 studies and included them for review. There is insufficient statistical evidence to demonstrate clear differences in effectiveness between available biologic agents for PsA due to many differences in methods and clinical parameters reported in the studies. Old biologics are reported to be safe. CONCLUSIONS: New molecules approved for the treatment of PsA appear promising treatments but further comparative studies methodologically well-conducted are necessary. It is also necessary to follow strictly international recommendations to conduct NMA to better help physicians and decision-makers in making appropriate decisions. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Even though in recent years significant improvements have been made in the management of patients with rheumatoid arthritis due to the introduction of biologic agents, it is still difficult to identify the most effective and safest available treatment. The choice and comparison between biological agents are a challenge, for only limited head-tohead clinical studies are available. The aim of this manuscript is to review the published network meta-analysis (NMA) to gain a better understanding of efficacy and safety of biological agents and small molecules in the management of RA patients. MATERIALS AND METHODS: We used MEDLINE and EMBASE to identify network meta- analyses from 2008 to June 2019 comparing efficacy and safety of licensed biological agents and tsDMARDS at the approved dosages using predefined text words related to the topic. The following scenarios have been investigated: patients not responding to csDMARD (cDMARDs - IR); csDMARD naïve patients; patients not responding to biologics (bDMARDs - IR); patients in biological monotherapy. RESULTS: On the basis of the data present in the literature, we are able to hypothesize some trends of response in terms of efficacy in different subsets of patients, for example patients in monotherapy, bDMARds unresponsive patients, and Methotrexate-naive patients. The differences of the results presented in many works are due to the different inclusion criteria used in the studies, the type of biologics agent used in each study (according to the available molecules in the different years of publication), as well as differences in the methodology of NMA and in the presentation of the data. CONCLUSIONS: We suggest that the next NMA follows the indications suggested by the Professional Society for Health Economics and Outcomes Research (ISPOR) so that the results are comparable and comprehensible. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Several studies on knee osteoarthritis suggest that the intra-articular administration of hyaluronic acid products may be a relevant option in the management of patients with persistent pain. The aim of this study is to report the data of efficacy of US-guided HyalOne®/Hyalubrix® 60 injections in a large population of patients with hip osteoarthritis, repeated at least 2 times per year for up to seven years. PATIENTS AND METHODS: This is a prospective, post-marketing, cohort study. Data were collected from the ANTIAGE registry. Values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments were evaluated every six months from the baseline to the end of the follow-up, seven years later. The inclusion criteria were: age ≥18 years, symptomatic hip osteoarthritis of at least 1-year duration, and up to 84 months of follow-up. All the patients received hyaluronic acid injections at least every six months, using ultrasound guidance to ensure accurate placement. RESULTS: 1022 patients were included in the study. The patients were categorized by age classes, gender, and body mass index (BMI). All the groups show a statistically significant reduction at all time points compared to baseline values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments. There are slight differences in the subgroups of overweighted, obese and over 70 years patients. CONCLUSIONS: Our study supports the clinical efficacy and safety of HyalOne®/Hyalubrix®60 in patients affected by osteoarthritis. This is the first study, reporting on a large cohort of patients in different categories with a long follow-up on seven years. The data confirm the proper use of ultrasound-guided viscosupplementation (VS) as background therapy in the management of hip osteoarthritis. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We developed a standardized technique for ultrasound guided intra-articular injection of the hip joint with the purpose of extending routine intra-articular injection of hyaluronans and steroids to the hip, as commonly used in the knee. In this article we report the safety of this technique in an extended series of patients. PATIENTS AND METHODS: Patients were injected supine with an anterosuperior approach under ultrasound guidance. The Us probe is applied with a target device for biopsy. RESULTS: The standardised technique was used to inject 1906 patients with 4002 injections of hyaluronan products over a four-year period. The treatment was well tolerated with few, and exclusively local, side effects. CONCLUSIONS: The administrat ion of hyaluronans under ultrasound-guided intra-articular injection is a safe technique for treatment of rheumatic diseases of the hip. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Bisphosphonates are considered as a first-line therapy for the prevention and treatment of osteoporosis, showing in double-blind, randomized, controlled trials a significant reduction of incidence of new vertebral fractures compared to placebo. Recently also, Denosumab has been shown to reduce the appearance of new vertebral fractures by blocking RANK. There are not head to head comparative studies between the above mentioned drugs. Mixed treatment comparison, an extension of traditional meta-analysis, is able to compare simultaneously several drugs across a range producing a synthetic evidence of efficacy and a range of probability as to the best treatment. OBJECTIVES: The aim of this study is to simultaneously compare alendronate, risedronate, ibandronate, zolendronate and denosumab in the prevention of OP vertebral fractures in a Bayesian meta-analysis for assessing indirect comparisons. MATERIALS AND METHODS: A search for randomized controlled trials involving alendronate, risedronate, ibandronate, zolendronate and denosumab was conducted using several databases. Randomized controlled trials (RCTs) with a double blind treatment period of at least 3 years were included. Men and Glucorticoid Induced osteoporosis, RCTs having as primary or secondary endpoints continuous values as body mineral density (BMD) and studies comparing different dosing regimens of the same agent, which are not used in clinical practice, were excluded. Only fully published reports were considered. RESULTS: A total of 9 RCTs were identified providing data on 31,393 participants. Zolendronate had the highest probability (52%) of being the most effective treatment towards placebo, followed by denosumab (46% probability), ibandronate and then alendronate and risedronate against placebo. CONCLUSIONS: Although the mixed treatment comparisons among alendronate, risedronate, ibandronate, zolendronate and denosumab did not show a statistically significant difference, this analysis suggests that zolendronate, compared to placebo, is expected to provide the highest rate of reduction in vertebral fractures affecting osteoporosis affected patients. [ABSTRACT FROM AUTHOR]

Abstract Introduction: There is scarce data available on intra-articular hyaluronan's ability to modify the progression of osteoarthritis (OA). Objective: The purpose of this retrospective pilot study was to assess the impact of treatment with hylan G-F 20 on progression to total hip replacement (THR) in patients with symptomatic hip OA. Research design and methods: The records of patients presenting with symptomatic hip OA and treated with hylan G-F 20 were analysed. Endpoints were the number of THRs performed and the survival time (in months) between commencement of treatment and THR, if performed. Endpoints were evaluated for the entire study population and for those sub-groups of patients which were, or were not, defined as candidates for THR prior to intra-articular treatment. Predictive factors of progression to THR were also assessed. Results: A total of 850 patients' records were evaluated and 224 patients' data were included in the study and evaluated. Eighty-four patients (37.5%) progressed to THR, 206 patients (92.0%) achieved 12 months survival, 170 patients (75.9%) achieved 24 months survival, and 69 patients (30.8%) achieved 5 years survival. Mean survival time was 36 months. Classification as a THR candidate, Lequesne score, ultrasound pattern and the presence of diabetes were predictive factors for progression to THR. Conclusions: These results suggest that hylan G-F 20 could be included in the management of symptomatic hip OA before recommendation for THR, particularly in patients presenting with milder symptoms, or in patients where, due to comorbidities or personal choice, THR is not a feasible option. Limitations of this study include the retrospective study design and the lack of a control group to determine any placebo effect of hylan G-F 20. Further prospective studies are therefore needed to corroborate these results. [ABSTRACT FROM AUTHOR]

Introduction: Rheumatoid arthritis (RA) is characterized by the formation in the joints of an inflammatory tissue, which causes the appearance of localized erosions on the margins of the joints. The molecular mechanism that causes the bone erosion is multifactorial. Inflammatory cytokines imbalance and OPG-RANK-L system are involved. Objective of the Study: The aim of the study is to evaluate the possibility of inducing healing or reduction in the number of erosions in Rheumatoid Arthritis patients treated with anti- TNF-alpha adding Teriparatide (PTH1-34) to standard treatment with anti-TNF. Patients and Methods: Twenty adult patients with active RA diagnosed according to American Rheumatism Association (ARA) criteria at least 6 months before study begin were enrolled. Only patients affected by established RA (6 to 18 months from symptoms beginning) were recruited. Eligible patients were randomized to receive a standard dosage of etanercept (50 mg/week) or etanercept at same dosage with an addition of teriparatide (20 mg). Evaluation of eventual healing of arthritic erosions by magnetic resonance imaging was performed at time zero and then at twelve months. The following evaluation was assessed at baseline and after 12 months according to the Outcome Measures in Rheumatology Clinical Trials (OMERACT) definitions: number of erosion and presence or absence of synovitis, effusion and bone oedema. A comparative examination of quantitative and qualitative assessment of each parameter was applied. Plain radiographs of the hands were obtained at baseline and 52 weeks. Radiographs were scored blindly using the van der Heijde modification of the Sharp method. Safety of each treatment was evaluated by means of the adverse events (AES) evaluation and report. Results: There were no significant differences in baseline characteristics between the groups. The study did not achieve its primary endpoint of healing erosions. In the active arm no healing of erosions was found. At 52 weeks, there were no new MRI erosions in two arms. Bone oedema scores were significantly improved at 52 weeks in favour of both treatments versus baseline scores, without inter-groups differences. X-ray patterns were unchanged in all patients of both groups. No new erosions or previous erosions' healing were observed. No AEs were reported. Patients from both groups demonstrated a significant reduction in the DAS 28 scores at 52 weeks (p < 0.005) if compared with baseline values. Conclusions: These data confirm rapid control of inflammation and MRI damage benefits after Etanercept administration without a significant improvement in MRI findings after concomitant addition of teriparatide. Even though these results could seem to suggest to avoid the simultaneous use of these two drugs to treat RA erosions, further studies might be suggested to asses if sequential administration of an anabolic agent such as Teriparatide, after achieving clinical remission, may be able to improve bone damage. [ABSTRACT FROM AUTHOR]

Abstract Purpose: The recent development of compounds with anabolic action on bone have increased the range of therapeutic options for the treatment of osteoporosis and the prevention of fractures. Two major PTH analogs, the synthetic full-length 1-84 PTH molecule and the recombinant 1-34 N-terminal fragment (teriparatide), are available for the treatment of osteoporosis in many countries. There have bee no comparative trials on the bone anabolic effects of these compounds. Materials and methods: In this study we applied a mixed treatment comparison (MTC) to compare the efficacy of teriparatide versus PTH 1-84 for the prevention of vertebral and non-vertebral fractures in women with severe osteoporosis. With this approach the relative treatment effect of one intervention over another can be obtained in the absence of head-to-head comparison. Among the candidate papers selected for analysis, two randomized controlled trials investigating the effects of teriparatide and PTH 1-84 met the selection criteria and underwent MTC analysis. Results: Based on a fixed-effect MTC model analysis of data from two RCTs, teriparatide (20 ug/day) showed a 70% and 94% probability of being the best treatment for the prevention of vertebral and non-vertebral fractures, respectively. Together with a lack of statistical significance, this study has additional limitations. Some differences in trial procedures and populations exist; another limitation concerns the impossibility of carrying out a randomized-effect model MTC, due to sample exiguity. Furthermore, in order to consider unknown or unmeasured differences of covariates across trials, a random-effects approach would be preferred in order to assess the presence of heterogeneity across comparisons. In contrast, in our analysis a fixed-effect MTC model only was used. Conclusions: Teriparatide is expected to provide a greater efficacy over PTH 1-84 with both vertebral and non-vertebral fracture prevention in postmenopausal women with severe osteoporosis. [ABSTRACT FROM AUTHOR]

The aim of this prospective observational study is to assess the efficacy and safety profile of intra-articular Sinovial® Forte 1.6% administered under ultrasound-guidance in a large cohort of patients affected by symptomatic hip osteoarthritis (OA). Patients with symptomatic hip OA referred to our clinic in 2008-2010 received one 4 ml (2 vials) intra-articular injection of Sinovial® Forte 1.6% under ultrasound guidance. Patients were followed-up every 3 months for a total of 6 months and were offered an optional, additional injection at the 3-month follow-up visit if clinically justified. At each visit, pain scores [0-10 Yisual Analogue Scale (pain VAS)],Lequesne index scores and NSAID intake were recorded. Adverse events (AEs) were recorded throughout the study. An effect size of 30% and 50% reduction in Lequesne index and Pain VAS scores was evaluated for each patient to ascertain the number of patients achieving partial remission of symptoms and functional impairment by the use of intra-articular hyaluronic acid in hip osteoarthritis. One hundred and fourteen patients completed the 6-month follow-up and received a total of 142 injections. A statistically significant reduction in Lequesne index scores, VAS pain scores and NSAID consumption was observed at all time-points (p < 0.05). No systemic, severe or even moderate side effects were observed. Only 7 patients reported mild local reaction at the injection site, consisting of mild pain and localized warmth, which resolved spontaneously without any additional medication. This study provides evidence of the efficacy and tolerability of Sinovial® Forte 1.6% in the treatment of patients affected by symptomatic hip OA. Sinovial® Forte may also offer economical benefits, owing to the reduction in NSAID consumption associated with this treatment. The percentage of patients achieving the effect size of 30% and 50% reduction in Lequesne index and pain VAS scores encourages the use of intra-articular hyaluronic acid in patients with hip osteoarthritis. [ABSTRACT FROM AUTHOR]

Hip osteoarthritis represents a statistically relevant problem in clinical practice; previous reports showed different efficacy and safety profiles for intra-articular use of hyaluronic acid in hip osteoarthritis-affected patients, and in this sense, to add evidence to this topic, data regarding safety and efficacy of ultrasound-guided viscosupplementation are reported in order to establish whether such a therapeutic tool may represent a valid option. This study investigates the safety and efficacy profiles of ultrasound-guided intra-articular injections of Jointex® in hip osteoarthritis affected patients. This is a prospective multicentric study carried out in public hospitals. Adult outpatients suffering from symptomatic hip OA (Kellgren and Lawrence Grade 2, 3 or 4) were injected with one syringe of 4 ml (2 vials) of Jointex® under ultrasound guidance, repeated after six months; when clinically necessary an adjunctive injection was performed. Patients' characteristics, such as gender, age, weight, height and BMI, smoking habit, unilateral or bilateral hip OA, radiological grade for hip OA following Kellgren-Lawrence grading and duration of disease, were evaluated. Patients were assessed at baseline and at every control visit and injection time for Lequesne index as primary endpoint, pain (evaluated by VAS) and NSAID consumption (number of days patients assumed NSAID in the last month) both as secondary endpoint. A total of 180 patients entered the study, all of whom received at least one IA US-guided injection of Jointex® into the hip joint. A total of 36 drop outs were registered, and both distribution and causes of drop out were recorded. A total of 389 injections were carried out, as 18 patients were affected by bilateral hip OA and 7 patients affected by monolateral hip OA required one more injection for symptomatic relief in respect to other patients. Scores obtained for primary as well as secondary study endpoints reached statistical significance when compared with scores obtained at baseline visit. Lequesne index mean scores obtained at each control visit, when compared with baseline mean value, were significantly different (p<0.001 for all control visits vs baseline). Similarly, results obtained for secondary endpoints, such as Pain VAS and NSAID consumption, when compared with results obtained at the baseline visit, showed a statistical significance (p<0.001 for all control visits vs baseline). We also evaluated how many patients reached an improvement in Lequesne algo-functional index of at least 70% at 6- and 12-month control visits: a percentage of 21.23% of patients attending the 6-month control visit showed such improvement, while at the 12-month control the percentage was 20%. No local or systemic infectious adverse events were reported during the whole follow-up time. Twenty-seven patients out of 180 reported a transient discomfort in the treated hip for 1–3 days after injection that regressed spontaneously or with paracetamol 1 g two or three times a day. No systemic adverse events were observed. Intra-articular administration of Jointex® in hip OA-affected patients seems to be an efficacious and safe therapeutic option. [ABSTRACT FROM AUTHOR]

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) consumption is strictly related to a high gastrointestinal and cardiovascular mortality and morbidity rate. Osteoarthritis Research Society International (OARSI) recommendations in patients with symptomatic hip or knee OA stated that NSAIDs should be used at the lowest effective dose but their long-term use should be avoided if possible. OARSI guidelines for the treatment of the hip OA include the use of viscosupplementation, which aims to restore physiological and rheological features of the synovial fluid. Objective: Aim of this multicentric, open and retrospective study is to investigate if NSAID consumption may be reduced by the use of ultrasound-guided intra-articular injection of several hyaluronic acid (HA) products in hip joint administered in patients affected by symptomatic hip OA. Materials and Methods: Patients affected by mono or bilateral symptomatic hip OA according to American Rheumatology Association (ARA) criteria, radiological OA graded II-IV (Kellgren and Lawrence) entered the study and were administered with ultrasound-guided intra-articular injection of hyaluronic acid products. As a primary endpoint, consumption of NSAIDs was evaluated by recording the number of days a month (range 0-30) the patient had used NSAID during the previous month, reported at each visit during the 24 months follow-up period. Secondary endpoints included further analysis for subgroups of patients categorized for Lequesne index score, Kellgren-Lawrence score, pain visual analogue scale (VAS) score, ultrasound pattern, age, hyaluronic acid used. Results: 2343 patients entered the study. Regarding primary endpoint, the consumption of NSAIDs was reduced of 48.2% at the third month when compared with baseline values. This sparing effect increased at 12th and 24th month with a reduction respectively of 50% and 61% in comparison to baseline values. These differences were statistically significant. Conclusions: These data point out that intra-articular hyaluronan preparations provide OA pain relief and reduce NSAIDs consumption in a large cohort of patients for a long period of follow-up. Multiple courses of viscosupplementation (vs) are required to maintain low dose of NSAID consumption over time. NSAIDs consumption is strictly related to an high gastrointestinal and cardiovascular mortality and morbidity rate, instead HA intra-articular treatment is well tolerated and is associated with a low incidence of adverse effects. For these reasons further studies evaluating cost-effectiveness and cost-utility of VS in the management of hip OA are required. [ABSTRACT FROM AUTHOR]

Introduction: Sacroiliac joint (SIJ) represents a difficult location for local therapies, as intra-articular injections may be hard to execute, especially in particular conditions such as chronic inflammatory diseases. How-evewr, in selected patients, local therapies may be considered. Some recent studies demonstrated the feasibility of ultrasound (US)-guided injection of SIJ, but still a complete explanation and definition of the technique is needed. Materials and Methods: Seven patients, four males and 3 females, affected by mono or bilateral sacroiliitis entered the study. Each patient received 40 mg of acetonide triamcinolone for each SIJ, intra articular (IA) US-guided injection. The technical originality proposed in this study consists in the spinal needle insertion in the middle of the cranial long side of the linear transducer with an orientation of about 10°, determining shorter needle insertion for reaching joint space and consequently probably granting lesser pain and traumatism for patients. Results: A total of 22 injections was performed. The longer follow-up time obtained was 18 months in 3 patients. All patients reached at least a 6 month follow-up. All patients reported an amelioration in pain that lasted for at least 6 months. No systemic adverse events were reported or observed. Complete visualization of SIJ and of needle placement was performed by US imaging, while compound proper injection was also visualized by Color-Doppler US imaging. Discussion: Actually, sacroiliac joint intra-articular injections are often performed under fluoroscopy or Computerized Tomography guidance. Such techniques present several limitations, especially for repeated injections, such as the use of ionizing radiations, the need of a contrast agent and the direct and indirect costs connected. US guidance in IA SIJ injections may represent an easily repeatable imaging technique for needle placement and a precious tool for detecting inflammatory activity of the joint. [ABSTRACT FROM AUTHOR]

Inflammatory chronic diseases involving joints together with other organs are usually treated with a systemic approach. In a few cases, where arthritis is not responsive to traditional treatments, an intra-articular (I.A.) therapy could be useful. Furthermore, patients not eligible for systemic therapy with anti-TNF or other DMARDs, as well as patients with an initial arthritis with the involvement of a single joint, such as the knee or hip joint, could use the I.A. injection therapy. In this article we report our experience with five patients affected by rheumatic inflammatory diseases, not responding to traditional systemic DMARDs-based therapies or not eligible for systemic use of biological response modifiers who underwent ultrasound-guided I.A. injection of Infliximab. Three of 5 patients showed a positive and long-lasting response to treatment with local infliximab. Safety profile was good according to literature data. Moreover, in this article we review the literature on this therapeutic approach. This is the first report of I.A. use of Infliximab in the hip joint. [ABSTRACT FROM AUTHOR]

Introduction: Young adult hip osteoarthritis (OA) is a noteworthy problem, although rarer than the elderly form of the disease, causing limitations in social and working activities and prospects. Treatment options are scarce and surgical procedures, frequently necessary, imply the major drawback of revising the prostheses periodically, whereas chronic non-steroidal anti-inflammatory drugs (NSAID) consumption may provoke side effects. To explore alternative options to both surgery and long-term NSAID use, especially in the case of young patients, viscosupplementation seems to appear as an appropriate tool to relieve pain, ameliorate the function and delay surgery. Aim of the Study: In this study we tackle the issue of the use of hyaluronic acid (HA) injections in young adults with symptomatic hip OA. Results and Conclusions: These data, collected from 78 young patients, show that viscosupplementation is a safe procedure, and may provide significant relief from pain and functional recovery. Larger controlled studies are needed to establish otpimal treatment strategies and clinical factors predictive of treatment response. [ABSTRACT FROM AUTHOR]

Introduction: In autoimmune disorders (ADs), if Hepatitis C Virus (HCV) is present, immunosuppressive treatment could increase virus replication. Cyclosporine A (CsA), in standard therapeutic doses, has been proven able to inhibit HCV cyclophilin in vitro. Therefore CsA could improve the therapy of HCV patients with ADs. Aim: In these patients, we started an open pilot study to evaluate the safety of 3 mg/kg CsA and the ability to reduce steroid therapy. Patients and Methods: Five females and 1 male were recruited; mean age 66 ± 8 years, mean disease duration 13 ± 5 years. Three patients are affected by Psoriasic Arthritis, 1 by Rheumatoid Arthritis, 1 by Sjögren Syndrome, and 1 by Myasthenia Gravis. None of them had chronic active hepatitis. HCV genotypes were type 2 (in 3 cases) and type 1 (in 3 cases). Patients were treated with 3 mg/kg of CsA for a period of time ranging from 6 to 12 months. The starting mean dose of prednisone was 12.5 mg/day. Liver function tests were checked monthly and serum HCV-RNA load was checked by RT-PCR before and 2 months into the therapy. Results: The prednisone dose was reduced from 12.5 mg/day to 7.5 mg/day. The aminotransferases levels were unchanged after 6 months. In patients with low HCV-RNA levels before treatment, no modifications of viral load were observed, whereas patients with increased levels at onset showed mild reduction 2 months into the treatment. Conclusions: Immunosuppressive treatment of ADs patients with HCV infection can be safely provided with the integration of CsA. [ABSTRACT FROM AUTHOR]

We report the case of a 59 years old woman affected by lung and joint sarcoidosis, secondary Sjogren's syndrome refractory to common disease-modifying antirheumatic drugs (DMARDs) that regressed with infliximab and methotrexate. 99mTc-HYNIC- TOC scintigraphy was useful in diagnosis, choice of treatment and follow-up. [ABSTRACT FROM AUTHOR]