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Papers by Francesca Bartoli

Research paper thumbnail of Efficacy and Safety of Filgotinib in Rheumatoid Arthritis Patients Aged over and under 65 Years (ENANTIA-65)

Journal of personalized medicine, Jul 2, 2024

Research paper thumbnail of Risk of malignancy and biologic therapy in rheumatic inflammatory diseases: A single-center experience

Rheumatology and Immunology Research, Dec 1, 2020

Research paper thumbnail of Baricitinib in the treatment of rheumatoid arthritis: clinical and ultrasound evaluation of a real-life single-centre experience

Therapeutic Advances in Musculoskeletal Disease, 2021

Research paper thumbnail of Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Clinical Rheumatology, Jun 8, 2020

Research paper thumbnail of Sirukumab for the treatment of rheumatoid arthritis: update on sirukumab, 2018

Expert Review of Clinical Immunology, Jul 3, 2018

Research paper thumbnail of Persistence of remission after lengthening of golimumab in inflammatory joint diseases

Clinical and Experimental Rheumatology, Feb 6, 2022

Research paper thumbnail of The challenge of pet therapy in systemic sclerosis: evidence for an impact on pain, anxiety, neuroticism and social interaction

Clinical and experimental rheumatology, 2018

OBJECTIVES The aim of our study was to evaluate the effect of animal-assisted intervention (AAI),... more OBJECTIVES The aim of our study was to evaluate the effect of animal-assisted intervention (AAI), a complementary support to traditional therapies focused on the interaction between animals and human beings, in improving psychological trait, anxiety and pain in a cohort of systemic sclerosis (SSc) patients. METHODS 42 SSc patients, undergoing iloprost intravenous infusion, were divided in three groups: 1) 14 patients submitted to 20 AAI sessions; 2) 14 patients engaged in alternative social activity (control group 1 - C1); and 3) 14 patients without any alternative activity (control group 2 - C2). All patients underwent Visual Analog Scale (VAS), the State-anxiety (STAI-S) and emotional faces at the beginning (s0) and at the end (s1) of each single session, while General Anxiety State-Trait Anxiety Inventory (STAI-T), Beck Depression Inventory (BDI), Social Interaction Anxiety Scale (SIAS), Eysenck Personality Questionnaire-Revised (EPQ-R), the Social Phobia Scale (SPS), the Toronto...

Research paper thumbnail of Treatment of ulcers in systemic sclerosis

Research paper thumbnail of AB1060 Bisphosphonate intravenous allows a rapid contrast of pain in complex regional pain syndrome (CRPS)

Annals of the Rheumatic Diseases, 2013

ABSTRACT Background The treatment of CRPS remains controversial, but multidisciplinary and interd... more ABSTRACT Background The treatment of CRPS remains controversial, but multidisciplinary and interdisciplinary approaches seem to be inevitable to prevent long-standing or permanent disability (1). Bisphosphonates, apart from their antiresorptive activity, could also have other properties through a specific analgesic or anti-inflammatory effect.Bisphosphonate therapy has been shown to be effective in single cases of CRPS (2). Objectives to evaluate the efficacyof intravenous compared with intramuscular bisphosphonates in reducing pain in patients with CRPS. Methods 14 patients (one male and 13 females; mean age 64.3±8 years) diagnosed with CRPS of carpal and metacarpals bones (confirmed by clinical and MRI) from two weeks, were treated with non-steroidal anti-inflammatory drugs (NSAID), supplemental calcium and Vitamin D, physical therapy and clodronate. Seven patients were treated with iv (Group A) and seven with im clodronate (Group B) for 2 weeks. Then all patients were subjected to im clodronate 100 mg/weekly for 3 months. Pain scales (VAS 0-100) and joint examination were performed before, after one week and after 3 months of clodronate therapy. Results pain was 92.7±12 mm in group A and 91±7.5 mm in group B, before starting clodronate (t0). Clodronate reduces pain significantly (p=0.0001) in both groups after one week of therapy, but reduction of pain was significantly higher (p=0.0001) in patients treated with iv clodronate (VAS 21.8±7 mm in group A vs 48.2±9.1 mm in group B). After 3months, nostatistical significant difference (p=0.7) in painwas found. Rapid reduction of pain in group A is associated also to a rapid reductionof hyperhidrosis, edema and joint stiffness after one week of therapy.No adverse effects were reported during therapy. Conclusions Iv clodronate achieves a rapid reduction of pain compared to im formulation, in patients with CRPS. Early intervention and reduction of pain is also associated with a rapid clinical improvement that might help in the prevention of long-standing disability. Disclosure of Interest None Declared

Research paper thumbnail of FRI0395 Digital ulcers as a "sentinel" sign for early internal organ involvement in very early systemic sclerosis: evidence from a single vedoss/eustar centre

Annals of the Rheumatic Diseases, 2013

Objectives Evaluation of the presence of digital lesions [1] in patients with diagnosis of very e... more Objectives Evaluation of the presence of digital lesions [1] in patients with diagnosis of very early systemic sclerosis (VEDOSS) [2] and of their correlation with clinical, laboratory and imaging parameters. Methods 110 VEDOSS patients were investigated for presence of digital pitting scar, calcinosis, digital ulcers (DUs), necrosis or gangrene, nailfold videocapillaroscopic abnormalities, disease specific autoantibodies (anti-centromere and anti-topoisomerase I) and internal organ involvement (chest HRCT, pulmonary function tests with DLCO evaluation, oesophagealmanometry, Holter ECG, cardiac Doppler US, renal arteries Doppler US) [3]. Results 4 patients reported a history of digital pitting scars, 16 patients presented active DU and 14/16 also reported a history of previous DUs. Other 9 patients reported a history of DUs only. Both the history and the presence of DUs showed statistically significant correlation with esophageal manometry only (analyzed through IBM SPSS Statistics version 19, using Spearman’s Rho test:ρ=0,681 &ρ=0,633 respectively, p < 0,05). Clustering patients according to the presence of internal organ involvement, DUs were observed in VEDOSS patients with internal organ involvementbut not in those without organ involvement. Image/graph Conclusions DUs are already present in VEDOSS patients and correlate with esophageal involvement [4]. DU may be considered as a sentinel sign for the presence of early organ involvement, meaning the evolution from thevery early to the early phase of systemic sclerosis [5]. References Amanzi L et al. Digital ulcers in scleroderma:staging, characteristics and sub-setting through observation of 1614 digital lesions. Rheumatology (Oxford).2010 ;49:1374-82. Avouac J et al, “Preliminary criteria for the very early diagnosis of systemic sclerosis: results of a Delphi Consensus Study from EULAR Scleroderma Trials and Research Group”, Ann Rheum Dis. 2011 Mar;70:476-81. Czirjak L, Matucci Cerinic M: Beyond Raynaud’s phenomenon hides a very early systemic sclerosis: the assessment of organ involvement is always mandatory. Rheumatology 2011;50:250-1 Lepri G et al: Evidence for Esophageal and anorectal involvement in patients with very early diagnosis of systemic sclerosis (VEDOSS):report from a single EUSTAR centre. (Submitted) Matucci Cerinic M et al: Very early versus early disease: the evolving definition of the many faces of Systemic Sclerosis Ann Rheum Dis; 2012 Nov 23 Disclosure of Interest: None Declared

Research paper thumbnail of THU0195 Incidence of Infliximab (IFX) Infusion Reactions with and Without Premedication

Annals of the Rheumatic Diseases, 2013

ABSTRACT Background Some patients may experience adverse drug reactions (ADR) during infusion wit... more ABSTRACT Background Some patients may experience adverse drug reactions (ADR) during infusion with IFX and this could be due to immunogenicity. Objectives To evaluate the incidence of infusion reactions in rheumatoid arthritis (RA) patients, seronegative spondiloarthritis (SpA) and psoriatic arthritis (PsA) receiving IFX with and without premedication Methods The charts of 75 patients treated with infliximab from 2000 to 2012 were reviewed. From 2001 to 2006 patients did not receive any medication before IFX, while from 2007 to 2011 patients received premedication with paracetamole (500 mg) and iv with esomeprazole 40 mg iv, hydrocortisone 5 mg/Kg, clorfenamine 10 mg. From 2011 on, premedication was modified as follows: paracetamole 500 mg, Hydroxizine 25 mg and iv ranitidine 50 mg, 6-methilprednisolone 100 mg. Results From 2001 to 2006 when premedication was not yet used, 21/75 (28%) patients had infusional reactions to IFX. From 2007 to 2011 9/67 (13.4%) patients had infusional reactions after introduction of corticosteroids and antihistamines premedication. Moreover, 1/57 patient (1.7%) had infusional reaction in the last two years using premedication with 6-methilprednisolone iv and ranitidine iv. The number of infusion reactions was significantly lower using premedication with corticosteroids and antihistamines (p &lt;0.05). The incidence of infusional reactions was significantly reduced (p &lt;0.05) with paracetamole, hydroxyzine and 6-metilprednisolone 100 mg and ranitidine iv before IFX treatment. No one anaphylactic reactions was observed. Conclusions In our experience, the combination of drugs in a premedication protocol with paracetamole, hydroxyzine, 6-methilprednisolone and ranitidine iv reduced significantly the number and severity of infusional reactions to IFX. References Disclosure of Interest None Declared

Research paper thumbnail of The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

Therapeutic Advances in Musculoskeletal Disease, 2020

Research paper thumbnail of AB0281 SAFETY and Retention Rate After Switching from Etanercept Originator (Etn) to Etanercept Biosimilar (SB4) in Inflammatory Joint Diseases: Data from Real Life

Annals of the Rheumatic Diseases, 2020

SB4 in now commonly used in the treatment of inflammatory joint diseases, with evidence of effica... more SB4 in now commonly used in the treatment of inflammatory joint diseases, with evidence of efficacy and persistence up to 12 months from switching in both randomized controlled trials in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS).we investigated the safety and retention rate of SB4 at 6, 12 and 18 months after switching from ETN in two rheumatology departments in our region.adult patients with RA, PsA, AS, Juvenile Idiopathic Arthritis (JIA) and other rheumatic diseases treated with ETN for at least 6 months, switched to SB4 in stable clinical conditions, were eligible for this retrospective evaluation. Data on adverse events (in particular infectious events), loss of efficacy (articular, cutaneous, ocular or intestinal disease re-activation) and persistence on treatment were collected since latest available follow-up. Retention rate, reason for discontinuation and subsequent management data were collected at 6, 12, 18 months.220 patients (1...

Research paper thumbnail of Flow-Mediated Vasodilation and Carotid Intima-Media Thickness in Systemic Sclerosis

Annals of the New York Academy of Sciences, 2007

Increased evidence suggests an accelerated macrovascular disease in systemic sclerosis (SSc). Bra... more Increased evidence suggests an accelerated macrovascular disease in systemic sclerosis (SSc). Brachial artery flow-mediated vasodilation (FMD) and carotid intima-media thickness (IMT) are two indicators of subclinic cardiovascular disease and are frequently used as surrogate measures of subclinic atherosclerosis. The aim of this study was to evaluate macrovascular involvement in SSc. We studied 35 SSc patients (6 males and 29 females; 11 with diffuse and 24 with limited disease) and 20 healthy controls. Brachial artery FMD was assessed by method described by Celermajer in all patients and 13 control subjects. IMT was measured using high-resolution B-mode ultrasonography in patients and controls. Traditional risk factors for atherosclerosis (hypertension, dyslipidemia, and smoke) were also assessed. FMD was significantly impaired (3.41% +/- 4.56% versus 7.66% +/- 4.24%; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.037) and IMT was significantly elevated compared with healthy controls (0.93 +/- 0.29 mm versus 0.77 +/- 0.13 mm; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.005). FMD was not significantly different in SSc with increased IMT compared with those with normal IMT). No correlation was found between risk factors for atherosclerosis and the impairment of FMD or IMT in SSc patients. The impairment of endothelial function and structural changes of large vessels are evident in SSc, but do not seem associated with traditional risk factors for atherosclerosis. Prospective studies including also clinical outcomes are needed to assess the features and significance of macrovacular involvement in SSc.

Research paper thumbnail of Intravenous immunoglobulins reduce skin thickness in systemic sclerosis: evidence from Systematic Literature Review and from real life experience

Autoimmunity Reviews, 2021

INTRODUCTION Intravenous immunoglobulins (IVIG) are a new therapeutic approach in systemic sclero... more INTRODUCTION Intravenous immunoglobulins (IVIG) are a new therapeutic approach in systemic sclerosis SSc. An immunomodulatory and antifibrotic activity has been postulated. IVIG are generally well tolerated and have only rare side effects. Our retrospective study focused its attention on SSc, an autoimmune connective tissue disease, characterized by several complications which has a significant impact on patient's quality of life. The pathophysiology comprises fibrotic, vascular and immunological aspects. AIM The aim of this study was to verify the effectiveness of IVIG on SSc skin involvement. Moreover, a systematic review of the literature (SLR) of the results obtained to date on the use of Intravenous immunoglobulin (IVIG) in SSc has been also performed. PATIENTS AND METHODS The data of 24 patients (21 women, 3 male) with refractory diffuse SSc skin involvement were evaluated (mean age was 52.13 years). IVIG infusion at a dosage of 2 g/Kg body weight for 4 consecutive days/month, was started between 2002 and 2019. Skin involvement was evaluated with the modified Rodnan Skin Score (mRSS) before therapy and then again after 6 and 12 months. To perform the SLR, the PubMed, Medline, Embase, and Web of Science database were searched from 1990 to 2020 (keywords: IVIG, systemic sclerosis). Three assessors (E.A., C.B. & M.M.C) identified the criteria to scan all papers. RESULTS From the total SLR (106 results), 17 papers were identified after the separation of the clinical cases from the studies (total number of treated patients 183). The studies were classified according to the organ involvement considered in each study, as well as the prescribed dose (high or low doses), and the therapeutic regimens. In the selected papers, the organs mainly involved were the skin, the gastrointestinal, the joint and the cardiovascular systems. Only in one case, plasmapheresis was associated to IVIG. All papers reported significant reduction of the skin involvement, although generally the strength of the works was limited the lack of control cases or by the low number of patients involved. From the real life experience, a statistically significant reduction of mRSS was obtained at 6 months follow-up (average value of -6.61 ± 5.2, p < 0.001), and it was further maintained with a significant stabilization after 12-months (-11.45 ± 9.63, p < 0.002). DISCUSSION This SLR and the data of the retrospective study suggest that IVIG may improve skin involvement reducing mRSS in particular in those patients that were refractory to other standard of care therapies and represents a therapeutic option in patients with concomitant myositis. The literature review revealed encouraging perspectives on the use of this therapy, given the effectiveness found in the selected works.

Research paper thumbnail of AB0256 BARICITINIB (Bari) Versus Biologics Impact on Steroid Tapering in Rheumatoid Arthritis (Ra)

Annals of the Rheumatic Diseases, 2021

Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDM... more Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDMARDs) are recommended to control RA disease activity, pain and steroid use. Following randomized clinical trials (RCTs) and their post-hoc analyses, the Janus Kinase Inhibitor tsDMARDs BARI was superior to reference bDMARD Adalimumab in reducing disease activity, pain and functional disability. In addition, BARI monotherapy also determined more significant pain reduction and functional improvement when compared to Tocilizumab monotherapy (3).Objectives:to confirm RCT results in a real-life clinical setting, with focus on disease activity, pain, functional disability and steroid tapering, when comparing BARI to bDMARDs for the treatment of active RA.Methods:RA patients starting BARI or a bDMARD for active RA were retrospectively evaluated from June 2019 to June 2020. Disease activity (DAS28CRP, SDAI, CDAI), pain visual analogic scale (pain_VAS), functional disability (HAQ) assessments and...

Research paper thumbnail of Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

Medical and non-medical switching strategies have been adopted in Europe in the last few years. W... more Medical and non-medical switching strategies have been adopted in Europe in the last few years. We aimed to investigate persistence on treatment with a SB5 Adalimumab (SB5) biosimilar after switching from Adalimumab (ADA) originator among patients with inflammatory rheumatic musculoskeletal diseases (iRMD), identifying possible predictors of drug interruption and describing adverse events. iRMD patients previously switched to SB5 after at least 6 months of ADA were enrolled. Data on concomitant medications, disease flares, and persistence on SB5 up to the last available follow up were collected retrospectively. Kaplan–Meier and Cox regression models were used. A total of 172 patients (106 females, ADA duration 5.8 ± 3.8 years) were enrolled, including 34 rheumatoid arthritis, 59 psoriatic arthritis, and 61 axial spondyloarthritis patients. In a 10 ± 3 months follow up, 65 (37.8%) patients presented with adverse events, with 46 (26.7%) showing a clinically defined disease flare (no d...

Research paper thumbnail of Baricitinib in the treatment of rheumatoid arthritis: clinical and ultrasound evaluation of a real-life single-centre experience

Therapeutic Advances in Musculoskeletal Disease

Background: Ultrasound (US) is useful in monitoring RA patients, with the US7 score allowing grey... more Background: Ultrasound (US) is useful in monitoring RA patients, with the US7 score allowing grey-scale and power-Doppler (PD) semi-quantitative evaluation of synovitis and teno-synovitis. We evaluated real-life efficacy and safety of Baricitinib, an oral selective JAK1-2 inhibitor, in RA patients using clinical, clinimetric, and US assessments. Methods: Disease activity score in 28 joints calculated with C-reactive protein (DAS28-CRP), disease activity score in 28 joints calculated with erythrocyte sedimentation rate (DAS28-ESR), clinical disease activity index (CDAI), simplified disease activity index (SDAI), visual analogue scale (VAS)-pain, health assessment questionnaire (HAQ), COCHIN scale, adverse events (AE), concomitant medications, laboratory parameters, and US7 were performed/recorded at baseline, 1, 3, and 6 months in RA patients starting Baricitinib. Responder/non-responder status was determined according to the EULAR Response Criteria at 3 months. SDAI clinical remissi...

Research paper thumbnail of The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

Therapeutic Advances in Musculoskeletal Disease

Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumat... more Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN dur...

Research paper thumbnail of Effect of Dysmetabolisms and Comorbidities on the Efficacy and Safety of Biological Therapy in Chronic Inflammatory Joint Diseases

Journal of Clinical Medicine

In the present study we evaluated how systemic arterial hypertension (SAH), dyslipidemia and diab... more In the present study we evaluated how systemic arterial hypertension (SAH), dyslipidemia and diabetes mellitus influence the efficacy, safety and retention rate of biological disease-modifying anti-rheumatic drug (bDMARD) treatment in rheumatic musculoskeletal disorders (RMDs). The charts of RMD patients treated with the first-line bDMARD were reviewed, collecting data on safety, efficacy and comorbidities at prescription (baseline, BL), after 6 months (6M) and at last observation on bDMARD (last observation time, LoT). In 383 RMD patients, a higher rate of adverse events at 6M (p = 0.0402) and at LoT (p = 0.0462) was present in dyslipidemic patients. Patients who developed dyslipidemia or SAH during bDMARD treatment had similar results (dyslipidemia p = 0.0007; SAH p = 0.0319) with a longer bDMARD retention as well (dyslipidemia p < 0.0001; SAH p < 0.0001). SAH patients on angiotensin converting enzyme inhibitors (ACEis) or angiotensin-II receptor blockers (ARBs) continued bD...

Research paper thumbnail of Efficacy and Safety of Filgotinib in Rheumatoid Arthritis Patients Aged over and under 65 Years (ENANTIA-65)

Journal of personalized medicine, Jul 2, 2024

Research paper thumbnail of Risk of malignancy and biologic therapy in rheumatic inflammatory diseases: A single-center experience

Rheumatology and Immunology Research, Dec 1, 2020

Research paper thumbnail of Baricitinib in the treatment of rheumatoid arthritis: clinical and ultrasound evaluation of a real-life single-centre experience

Therapeutic Advances in Musculoskeletal Disease, 2021

Research paper thumbnail of Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Clinical Rheumatology, Jun 8, 2020

Research paper thumbnail of Sirukumab for the treatment of rheumatoid arthritis: update on sirukumab, 2018

Expert Review of Clinical Immunology, Jul 3, 2018

Research paper thumbnail of Persistence of remission after lengthening of golimumab in inflammatory joint diseases

Clinical and Experimental Rheumatology, Feb 6, 2022

Research paper thumbnail of The challenge of pet therapy in systemic sclerosis: evidence for an impact on pain, anxiety, neuroticism and social interaction

Clinical and experimental rheumatology, 2018

OBJECTIVES The aim of our study was to evaluate the effect of animal-assisted intervention (AAI),... more OBJECTIVES The aim of our study was to evaluate the effect of animal-assisted intervention (AAI), a complementary support to traditional therapies focused on the interaction between animals and human beings, in improving psychological trait, anxiety and pain in a cohort of systemic sclerosis (SSc) patients. METHODS 42 SSc patients, undergoing iloprost intravenous infusion, were divided in three groups: 1) 14 patients submitted to 20 AAI sessions; 2) 14 patients engaged in alternative social activity (control group 1 - C1); and 3) 14 patients without any alternative activity (control group 2 - C2). All patients underwent Visual Analog Scale (VAS), the State-anxiety (STAI-S) and emotional faces at the beginning (s0) and at the end (s1) of each single session, while General Anxiety State-Trait Anxiety Inventory (STAI-T), Beck Depression Inventory (BDI), Social Interaction Anxiety Scale (SIAS), Eysenck Personality Questionnaire-Revised (EPQ-R), the Social Phobia Scale (SPS), the Toronto...

Research paper thumbnail of Treatment of ulcers in systemic sclerosis

Research paper thumbnail of AB1060 Bisphosphonate intravenous allows a rapid contrast of pain in complex regional pain syndrome (CRPS)

Annals of the Rheumatic Diseases, 2013

ABSTRACT Background The treatment of CRPS remains controversial, but multidisciplinary and interd... more ABSTRACT Background The treatment of CRPS remains controversial, but multidisciplinary and interdisciplinary approaches seem to be inevitable to prevent long-standing or permanent disability (1). Bisphosphonates, apart from their antiresorptive activity, could also have other properties through a specific analgesic or anti-inflammatory effect.Bisphosphonate therapy has been shown to be effective in single cases of CRPS (2). Objectives to evaluate the efficacyof intravenous compared with intramuscular bisphosphonates in reducing pain in patients with CRPS. Methods 14 patients (one male and 13 females; mean age 64.3±8 years) diagnosed with CRPS of carpal and metacarpals bones (confirmed by clinical and MRI) from two weeks, were treated with non-steroidal anti-inflammatory drugs (NSAID), supplemental calcium and Vitamin D, physical therapy and clodronate. Seven patients were treated with iv (Group A) and seven with im clodronate (Group B) for 2 weeks. Then all patients were subjected to im clodronate 100 mg/weekly for 3 months. Pain scales (VAS 0-100) and joint examination were performed before, after one week and after 3 months of clodronate therapy. Results pain was 92.7±12 mm in group A and 91±7.5 mm in group B, before starting clodronate (t0). Clodronate reduces pain significantly (p=0.0001) in both groups after one week of therapy, but reduction of pain was significantly higher (p=0.0001) in patients treated with iv clodronate (VAS 21.8±7 mm in group A vs 48.2±9.1 mm in group B). After 3months, nostatistical significant difference (p=0.7) in painwas found. Rapid reduction of pain in group A is associated also to a rapid reductionof hyperhidrosis, edema and joint stiffness after one week of therapy.No adverse effects were reported during therapy. Conclusions Iv clodronate achieves a rapid reduction of pain compared to im formulation, in patients with CRPS. Early intervention and reduction of pain is also associated with a rapid clinical improvement that might help in the prevention of long-standing disability. Disclosure of Interest None Declared

Research paper thumbnail of FRI0395 Digital ulcers as a "sentinel" sign for early internal organ involvement in very early systemic sclerosis: evidence from a single vedoss/eustar centre

Annals of the Rheumatic Diseases, 2013

Objectives Evaluation of the presence of digital lesions [1] in patients with diagnosis of very e... more Objectives Evaluation of the presence of digital lesions [1] in patients with diagnosis of very early systemic sclerosis (VEDOSS) [2] and of their correlation with clinical, laboratory and imaging parameters. Methods 110 VEDOSS patients were investigated for presence of digital pitting scar, calcinosis, digital ulcers (DUs), necrosis or gangrene, nailfold videocapillaroscopic abnormalities, disease specific autoantibodies (anti-centromere and anti-topoisomerase I) and internal organ involvement (chest HRCT, pulmonary function tests with DLCO evaluation, oesophagealmanometry, Holter ECG, cardiac Doppler US, renal arteries Doppler US) [3]. Results 4 patients reported a history of digital pitting scars, 16 patients presented active DU and 14/16 also reported a history of previous DUs. Other 9 patients reported a history of DUs only. Both the history and the presence of DUs showed statistically significant correlation with esophageal manometry only (analyzed through IBM SPSS Statistics version 19, using Spearman’s Rho test:ρ=0,681 &ρ=0,633 respectively, p < 0,05). Clustering patients according to the presence of internal organ involvement, DUs were observed in VEDOSS patients with internal organ involvementbut not in those without organ involvement. Image/graph Conclusions DUs are already present in VEDOSS patients and correlate with esophageal involvement [4]. DU may be considered as a sentinel sign for the presence of early organ involvement, meaning the evolution from thevery early to the early phase of systemic sclerosis [5]. References Amanzi L et al. Digital ulcers in scleroderma:staging, characteristics and sub-setting through observation of 1614 digital lesions. Rheumatology (Oxford).2010 ;49:1374-82. Avouac J et al, “Preliminary criteria for the very early diagnosis of systemic sclerosis: results of a Delphi Consensus Study from EULAR Scleroderma Trials and Research Group”, Ann Rheum Dis. 2011 Mar;70:476-81. Czirjak L, Matucci Cerinic M: Beyond Raynaud’s phenomenon hides a very early systemic sclerosis: the assessment of organ involvement is always mandatory. Rheumatology 2011;50:250-1 Lepri G et al: Evidence for Esophageal and anorectal involvement in patients with very early diagnosis of systemic sclerosis (VEDOSS):report from a single EUSTAR centre. (Submitted) Matucci Cerinic M et al: Very early versus early disease: the evolving definition of the many faces of Systemic Sclerosis Ann Rheum Dis; 2012 Nov 23 Disclosure of Interest: None Declared

Research paper thumbnail of THU0195 Incidence of Infliximab (IFX) Infusion Reactions with and Without Premedication

Annals of the Rheumatic Diseases, 2013

ABSTRACT Background Some patients may experience adverse drug reactions (ADR) during infusion wit... more ABSTRACT Background Some patients may experience adverse drug reactions (ADR) during infusion with IFX and this could be due to immunogenicity. Objectives To evaluate the incidence of infusion reactions in rheumatoid arthritis (RA) patients, seronegative spondiloarthritis (SpA) and psoriatic arthritis (PsA) receiving IFX with and without premedication Methods The charts of 75 patients treated with infliximab from 2000 to 2012 were reviewed. From 2001 to 2006 patients did not receive any medication before IFX, while from 2007 to 2011 patients received premedication with paracetamole (500 mg) and iv with esomeprazole 40 mg iv, hydrocortisone 5 mg/Kg, clorfenamine 10 mg. From 2011 on, premedication was modified as follows: paracetamole 500 mg, Hydroxizine 25 mg and iv ranitidine 50 mg, 6-methilprednisolone 100 mg. Results From 2001 to 2006 when premedication was not yet used, 21/75 (28%) patients had infusional reactions to IFX. From 2007 to 2011 9/67 (13.4%) patients had infusional reactions after introduction of corticosteroids and antihistamines premedication. Moreover, 1/57 patient (1.7%) had infusional reaction in the last two years using premedication with 6-methilprednisolone iv and ranitidine iv. The number of infusion reactions was significantly lower using premedication with corticosteroids and antihistamines (p &lt;0.05). The incidence of infusional reactions was significantly reduced (p &lt;0.05) with paracetamole, hydroxyzine and 6-metilprednisolone 100 mg and ranitidine iv before IFX treatment. No one anaphylactic reactions was observed. Conclusions In our experience, the combination of drugs in a premedication protocol with paracetamole, hydroxyzine, 6-methilprednisolone and ranitidine iv reduced significantly the number and severity of infusional reactions to IFX. References Disclosure of Interest None Declared

Research paper thumbnail of The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

Therapeutic Advances in Musculoskeletal Disease, 2020

Research paper thumbnail of AB0281 SAFETY and Retention Rate After Switching from Etanercept Originator (Etn) to Etanercept Biosimilar (SB4) in Inflammatory Joint Diseases: Data from Real Life

Annals of the Rheumatic Diseases, 2020

SB4 in now commonly used in the treatment of inflammatory joint diseases, with evidence of effica... more SB4 in now commonly used in the treatment of inflammatory joint diseases, with evidence of efficacy and persistence up to 12 months from switching in both randomized controlled trials in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS).we investigated the safety and retention rate of SB4 at 6, 12 and 18 months after switching from ETN in two rheumatology departments in our region.adult patients with RA, PsA, AS, Juvenile Idiopathic Arthritis (JIA) and other rheumatic diseases treated with ETN for at least 6 months, switched to SB4 in stable clinical conditions, were eligible for this retrospective evaluation. Data on adverse events (in particular infectious events), loss of efficacy (articular, cutaneous, ocular or intestinal disease re-activation) and persistence on treatment were collected since latest available follow-up. Retention rate, reason for discontinuation and subsequent management data were collected at 6, 12, 18 months.220 patients (1...

Research paper thumbnail of Flow-Mediated Vasodilation and Carotid Intima-Media Thickness in Systemic Sclerosis

Annals of the New York Academy of Sciences, 2007

Increased evidence suggests an accelerated macrovascular disease in systemic sclerosis (SSc). Bra... more Increased evidence suggests an accelerated macrovascular disease in systemic sclerosis (SSc). Brachial artery flow-mediated vasodilation (FMD) and carotid intima-media thickness (IMT) are two indicators of subclinic cardiovascular disease and are frequently used as surrogate measures of subclinic atherosclerosis. The aim of this study was to evaluate macrovascular involvement in SSc. We studied 35 SSc patients (6 males and 29 females; 11 with diffuse and 24 with limited disease) and 20 healthy controls. Brachial artery FMD was assessed by method described by Celermajer in all patients and 13 control subjects. IMT was measured using high-resolution B-mode ultrasonography in patients and controls. Traditional risk factors for atherosclerosis (hypertension, dyslipidemia, and smoke) were also assessed. FMD was significantly impaired (3.41% +/- 4.56% versus 7.66% +/- 4.24%; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.037) and IMT was significantly elevated compared with healthy controls (0.93 +/- 0.29 mm versus 0.77 +/- 0.13 mm; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.005). FMD was not significantly different in SSc with increased IMT compared with those with normal IMT). No correlation was found between risk factors for atherosclerosis and the impairment of FMD or IMT in SSc patients. The impairment of endothelial function and structural changes of large vessels are evident in SSc, but do not seem associated with traditional risk factors for atherosclerosis. Prospective studies including also clinical outcomes are needed to assess the features and significance of macrovacular involvement in SSc.

Research paper thumbnail of Intravenous immunoglobulins reduce skin thickness in systemic sclerosis: evidence from Systematic Literature Review and from real life experience

Autoimmunity Reviews, 2021

INTRODUCTION Intravenous immunoglobulins (IVIG) are a new therapeutic approach in systemic sclero... more INTRODUCTION Intravenous immunoglobulins (IVIG) are a new therapeutic approach in systemic sclerosis SSc. An immunomodulatory and antifibrotic activity has been postulated. IVIG are generally well tolerated and have only rare side effects. Our retrospective study focused its attention on SSc, an autoimmune connective tissue disease, characterized by several complications which has a significant impact on patient's quality of life. The pathophysiology comprises fibrotic, vascular and immunological aspects. AIM The aim of this study was to verify the effectiveness of IVIG on SSc skin involvement. Moreover, a systematic review of the literature (SLR) of the results obtained to date on the use of Intravenous immunoglobulin (IVIG) in SSc has been also performed. PATIENTS AND METHODS The data of 24 patients (21 women, 3 male) with refractory diffuse SSc skin involvement were evaluated (mean age was 52.13 years). IVIG infusion at a dosage of 2 g/Kg body weight for 4 consecutive days/month, was started between 2002 and 2019. Skin involvement was evaluated with the modified Rodnan Skin Score (mRSS) before therapy and then again after 6 and 12 months. To perform the SLR, the PubMed, Medline, Embase, and Web of Science database were searched from 1990 to 2020 (keywords: IVIG, systemic sclerosis). Three assessors (E.A., C.B. & M.M.C) identified the criteria to scan all papers. RESULTS From the total SLR (106 results), 17 papers were identified after the separation of the clinical cases from the studies (total number of treated patients 183). The studies were classified according to the organ involvement considered in each study, as well as the prescribed dose (high or low doses), and the therapeutic regimens. In the selected papers, the organs mainly involved were the skin, the gastrointestinal, the joint and the cardiovascular systems. Only in one case, plasmapheresis was associated to IVIG. All papers reported significant reduction of the skin involvement, although generally the strength of the works was limited the lack of control cases or by the low number of patients involved. From the real life experience, a statistically significant reduction of mRSS was obtained at 6 months follow-up (average value of -6.61 ± 5.2, p < 0.001), and it was further maintained with a significant stabilization after 12-months (-11.45 ± 9.63, p < 0.002). DISCUSSION This SLR and the data of the retrospective study suggest that IVIG may improve skin involvement reducing mRSS in particular in those patients that were refractory to other standard of care therapies and represents a therapeutic option in patients with concomitant myositis. The literature review revealed encouraging perspectives on the use of this therapy, given the effectiveness found in the selected works.

Research paper thumbnail of AB0256 BARICITINIB (Bari) Versus Biologics Impact on Steroid Tapering in Rheumatoid Arthritis (Ra)

Annals of the Rheumatic Diseases, 2021

Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDM... more Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDMARDs) are recommended to control RA disease activity, pain and steroid use. Following randomized clinical trials (RCTs) and their post-hoc analyses, the Janus Kinase Inhibitor tsDMARDs BARI was superior to reference bDMARD Adalimumab in reducing disease activity, pain and functional disability. In addition, BARI monotherapy also determined more significant pain reduction and functional improvement when compared to Tocilizumab monotherapy (3).Objectives:to confirm RCT results in a real-life clinical setting, with focus on disease activity, pain, functional disability and steroid tapering, when comparing BARI to bDMARDs for the treatment of active RA.Methods:RA patients starting BARI or a bDMARD for active RA were retrospectively evaluated from June 2019 to June 2020. Disease activity (DAS28CRP, SDAI, CDAI), pain visual analogic scale (pain_VAS), functional disability (HAQ) assessments and...

Research paper thumbnail of Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

Medical and non-medical switching strategies have been adopted in Europe in the last few years. W... more Medical and non-medical switching strategies have been adopted in Europe in the last few years. We aimed to investigate persistence on treatment with a SB5 Adalimumab (SB5) biosimilar after switching from Adalimumab (ADA) originator among patients with inflammatory rheumatic musculoskeletal diseases (iRMD), identifying possible predictors of drug interruption and describing adverse events. iRMD patients previously switched to SB5 after at least 6 months of ADA were enrolled. Data on concomitant medications, disease flares, and persistence on SB5 up to the last available follow up were collected retrospectively. Kaplan–Meier and Cox regression models were used. A total of 172 patients (106 females, ADA duration 5.8 ± 3.8 years) were enrolled, including 34 rheumatoid arthritis, 59 psoriatic arthritis, and 61 axial spondyloarthritis patients. In a 10 ± 3 months follow up, 65 (37.8%) patients presented with adverse events, with 46 (26.7%) showing a clinically defined disease flare (no d...

Research paper thumbnail of Baricitinib in the treatment of rheumatoid arthritis: clinical and ultrasound evaluation of a real-life single-centre experience

Therapeutic Advances in Musculoskeletal Disease

Background: Ultrasound (US) is useful in monitoring RA patients, with the US7 score allowing grey... more Background: Ultrasound (US) is useful in monitoring RA patients, with the US7 score allowing grey-scale and power-Doppler (PD) semi-quantitative evaluation of synovitis and teno-synovitis. We evaluated real-life efficacy and safety of Baricitinib, an oral selective JAK1-2 inhibitor, in RA patients using clinical, clinimetric, and US assessments. Methods: Disease activity score in 28 joints calculated with C-reactive protein (DAS28-CRP), disease activity score in 28 joints calculated with erythrocyte sedimentation rate (DAS28-ESR), clinical disease activity index (CDAI), simplified disease activity index (SDAI), visual analogue scale (VAS)-pain, health assessment questionnaire (HAQ), COCHIN scale, adverse events (AE), concomitant medications, laboratory parameters, and US7 were performed/recorded at baseline, 1, 3, and 6 months in RA patients starting Baricitinib. Responder/non-responder status was determined according to the EULAR Response Criteria at 3 months. SDAI clinical remissi...

Research paper thumbnail of The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

Therapeutic Advances in Musculoskeletal Disease

Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumat... more Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN dur...

Research paper thumbnail of Effect of Dysmetabolisms and Comorbidities on the Efficacy and Safety of Biological Therapy in Chronic Inflammatory Joint Diseases

Journal of Clinical Medicine

In the present study we evaluated how systemic arterial hypertension (SAH), dyslipidemia and diab... more In the present study we evaluated how systemic arterial hypertension (SAH), dyslipidemia and diabetes mellitus influence the efficacy, safety and retention rate of biological disease-modifying anti-rheumatic drug (bDMARD) treatment in rheumatic musculoskeletal disorders (RMDs). The charts of RMD patients treated with the first-line bDMARD were reviewed, collecting data on safety, efficacy and comorbidities at prescription (baseline, BL), after 6 months (6M) and at last observation on bDMARD (last observation time, LoT). In 383 RMD patients, a higher rate of adverse events at 6M (p = 0.0402) and at LoT (p = 0.0462) was present in dyslipidemic patients. Patients who developed dyslipidemia or SAH during bDMARD treatment had similar results (dyslipidemia p = 0.0007; SAH p = 0.0319) with a longer bDMARD retention as well (dyslipidemia p < 0.0001; SAH p < 0.0001). SAH patients on angiotensin converting enzyme inhibitors (ACEis) or angiotensin-II receptor blockers (ARBs) continued bD...