Publications by authors named "Carlo Salvarani"

420 Publications

VECTOR: An algorithm for the detection of COVID-19 pneumonia from velcro-like lung sounds.

Comput Biol Med 2022 Jan 6;142:105220. Epub 2022 Jan 6.

University of Modena and Reggio Emilia, Department of Surgery, Medicine, Dentistry and Morphological Sciences with Transplant Surgery, Oncology and Regenerative Medicine Relevance, via del Pozzo 71, 42124, Modena, Italy; Rheumatology Unit, Azienda Policlinico di Modena, via del Pozzo 71, 42124, Modena, Italy. Electronic address:

The coronavirus disease 2019 (COVID-19) has severely stressed the sanitary systems of all countries in the world. One of the main issues that physicians are called to tackle is represented by the monitoring of pauci-symptomatic COVID-19 patients at home and, generally speaking, everyone the access to the hospital might or should be severely reduced. Indeed, the early detection of interstitial pneumonia is particularly relevant for the survival of these patients. Recent studies on rheumatoid arthritis and interstitial lung diseases have shown that pathological pulmonary sounds can be automatically detected by suitably developed algorithms. The scope of this preliminary work consists of proving that the pathological lung sounds evidenced in patients affected by COVID-19 pneumonia can be automatically detected as well by the same class of algorithms. In particular the software VECTOR, suitably devised for interstitial lung diseases, has been employed to process the lung sounds of 28 patient recorded in the emergency room at the university hospital of Modena (Italy) during December 2020. The performance of VECTOR has been compared with diagnostic techniques based on imaging, namely lung ultrasound, chest X-ray and high resolution computed tomography, which have been assumed as ground truth. The results have evidenced a surprising overall diagnostic accuracy of 75% even if the staff of the emergency room has not been suitably trained for lung auscultation and the parameters of the software have not been optimized to detect interstitial pneumonia. These results pave the way to a new approach for monitoring the pulmonary implication in pauci-symptomatic COVID-19 patients.
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http://dx.doi.org/10.1016/j.compbiomed.2022.105220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734059PMC
January 2022

Use of Ultrasonography to Discriminate Psoriatic Arthritis from Fibromyalgia: A Post-Hoc Analysis of the ULISSE Study.

J Clin Med 2021 Dec 29;11(1). Epub 2021 Dec 29.

Rheumatology Unit, Azienda USL-IRCCS di Reggio Emilia and Università di Modena and Reggio Emilia, 42123 Reggio Emilia, Italy.

In psoriatic arthritis (PsA) patients with concomitant chronic widespread pain, the differential diagnosis with fibromyalgia syndrome (FMS) can be challenging. We evaluated whether ultrasound (US) examination of entheseal sites can distinguish pain from (PsA) enthesitis versus FMS. PsA and FMS patients underwent clinical evaluation and gray-scale (GS; B-mode) and power Doppler (PD) US examination of the entheses. At least one enthesis with GS- and PD-mode changes was found in 90% and 59.3% of PsA patients ( = 140) and 62.7% and 35.3% of FMS patients ( = 51), respectively. GS and PD identified changes in 49.5% and 19.2% of the 840 PsA entheses and 22.5% and 7.9% of the 306 FMS entheses, respectively. Receiver operating characteristic curve analysis showed an area under the curve of 0.77 and 0.66 for B- and PD-mode, respectively, 3.5 being the best cut-off GS-score to discriminate the two conditions. Multivariate regression showed that Achilles and proximal patellar tendon enthesitis (B-mode) were strongly associated with PsA (odds ratio, ~2). Principal component analysis (B-mode) confirmed that PsA patients have a higher number of involved entheses and patterns of entheseal involvement than FMS patients. US evaluation of the entheses may help differentiate chronic widespread pain from PsA versus FMS.
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http://dx.doi.org/10.3390/jcm11010180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8745640PMC
December 2021

Infections of scleroderma digital ulcers: A single center cohort retrospective study.

Dermatol Reports 2021 Nov 5;13(3):9075. Epub 2021 Oct 5.

Scleroderma Unit, University of Modena and Reggio Emilia.

Systemic sclerosis (SSc) is a complex autoimmune and up to 50% of patients develop digital ulcers. We revised fifty consecutive patients with SSc-related digital ulcers (DUs) who referred to our Scleroderma Unit. Thirty-five of them who showed clear signs of DUs infection underwent to cutaneous swab and microbiological data collection. We performed 87 cutaneous swabs overall. DUs were recurrent in 58% of the patients and multiple in 60% of patients. Fourty-four swabs (53%) were positive for (13% Methicillin-Resistant), 9 (10%) were positive for , and then the others less frequently isolated. Nine patients (25%) needed hospitalization. Our data support a patient-tailored approached to DUs, particularly those infected. Selfhygiene and asepsis during dressing procedures are mandatory. Patient must be trained to avoid dangerous behaviors and reduce the risk of infection.
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http://dx.doi.org/10.4081/dr.2021.9075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672119PMC
November 2021

Vessel inflammation and morphological changes in patients with large vessel vasculitis: a retrospective study.

RMD Open 2022 Jan;8(1)

Unit of Rheumatology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Objective: The aim was to identify any association between imaging signs of vessel wall inflammation (positron emission tomography-CT (PET-CT) score and CT/MR wall thickening) and synchronous and subsequent vascular damage (stenoses/dilations) in patients with large vessel vasculitis (LVV).

Methods: Consecutive patients with LVV referred to a tertiary centre in 2007-2020 with baseline PET-CT and morphological imaging (CT/MR angiography) performed within 3 months were included. All available PET-CT and CT/MR scans were reviewed to assess PET-CT uptake (4-point semi-quantitative score), wall thickening, stenoses and dilations for 15 vascular segments. The associations of baseline PET score and CT/MR wall thickening with synchronous and incident stenoses/dilations at CT/MR performed 6-30 months from baseline were evaluated in per-segment and per-patient analyses. Respective areas under the receiver operating characteristic curve (AUC) were calculated.

Results: We included 100 patients with LVV (median age: 48 years, 22% males). Baseline PET score and wall thickening were strongly associated (Cuzick non-parametric test for trend across order groups (NPtrend) <0.001). The association with synchronous stenoses/dilations was weak for PET score (NPtrend=0.01) and strong for wall thickening (p<0.001). In per-patient analyses, sensitivity/specificity for ≥1 synchronous stenoses/dilations were 44%/67% for PET score ≥2 and 66.7%/60.5% for wall thickening. Subsequent CTs/MRs were available in 28 patients, with seven incident stenoses/dilations. Baseline PET score was strongly associated with incident stenoses/dilations (p=0.001), while baseline wall thickening was not (p=0.708), with AUCs for incident stenoses/dilations of 0.80 for PET score and 0.52 for wall thickening.

Conclusion: PET score and wall thickening are strongly associated, but only baseline PET score is a good predictor of incident vessel wall damage in LVV.
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http://dx.doi.org/10.1136/rmdopen-2021-001977DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734042PMC
January 2022

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials.

Rheumatol Ther 2021 Dec 30. Epub 2021 Dec 30.

Northwestern University Feinberg School of Medicine, 420 E Superior St., Chicago, IL, 60611, USA.

Introduction: This integrated analysis describes the safety profile of upadacitinib, an oral Janus kinase inhibitor, at 15 and 30 mg once daily for up to 3 years of exposure in patients with active psoriatic arthritis (PsA) who had a prior inadequate response or intolerance to ≥ 1 non-biologic or biologic disease-modifying antirheumatic drug.

Methods: Safety data were pooled and analyzed from two randomized, placebo-controlled phase 3 trials. Both trials evaluated upadacitinib 15 mg and 30 mg once daily, and one trial also evaluated adalimumab 40 mg every other week. Treatment-emergent adverse events (TEAEs) and laboratory data were summarized for four groups: pooled placebo, pooled upadacitinib 15 mg, pooled upadacitinib 30 mg, and adalimumab. TEAEs were reported as exposure-adjusted event rates (events per 100 patient-years [E/100 PY]) up to a data cut-off of June 29, 2020.

Results: A total of 2257 patients received ≥ 1 dose of upadacitinib 15 mg (N = 907) or 30 mg (N = 921) for 2504.6 PY of exposure or adalimumab (N = 429) for 549.7 PY of exposure. Upper respiratory tract infection, nasopharyngitis, and increased creatine phosphokinase (CPK) were the most common TEAEs with upadacitinib. Rates of malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs), and deaths were similar across treatment groups. Rates of herpes zoster (HZ) and opportunistic infections (OI; excluding tuberculosis, HZ, and oral candidiasis) were higher with upadacitinib versus adalimumab. Serious infection, anemia, and CPK elevations were most frequent with upadacitinib 30 mg. Potentially clinically significant laboratory abnormalities were uncommon.

Conclusions: Upadacitinib 15 mg and adalimumab had similar safety profiles with the exception of HZ and OIs, consistent with what was observed in rheumatoid arthritis. Rates of malignancies, MACEs, VTEs, and deaths were comparable among patients receiving upadacitinib and adalimumab. No new safety risks emerged with longer-term exposure to upadacitinib.

Trial Registration Numbers: SELECT-PsA 1: NCT03104400; SELECT-PsA 2: NCT03104374.
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http://dx.doi.org/10.1007/s40744-021-00410-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717827PMC
December 2021

Empowering Patients in the Therapeutic Decision-Making Process: A Glance Into Behçet's Syndrome.

Front Med (Lausanne) 2021 13;8:769870. Epub 2021 Dec 13.

Rheumatology Unit, Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa, Italy.

Behçet's syndrome (BS) represents a challenging condition, characterized by a variable spectrum of disease profile and associated with a significant limitation of the daily activities as well as a potential negative impact on relationships and psychological status. Considering also the complexity of the therapeutic management of BS, that often includes biological off-label treatments, the participation in the therapeutic decision-making process of the BS patients is essential to ensure the integration of the care process into the life of the patient. For this reason, the empowerment of BS patients represents a crucial need and the present work is aimed at fully exploring all the potential variables implicated in the BS patient empowerment, also highlighting major points to consider and concrete actions to be planned in the immediate future in order to implement a pragmatic facilitation of the patients' empowerment.
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http://dx.doi.org/10.3389/fmed.2021.769870DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8710680PMC
December 2021

Uveitis and Other Ocular Complications Following COVID-19 Vaccination.

J Clin Med 2021 Dec 19;10(24). Epub 2021 Dec 19.

Ocular Immunology Unit, Azienda USL-IRCCS, 42123 Reggio Emilia, Italy.

Coronavirus disease 2019 (COVID-19) vaccines can cause transient local and systemic post-vaccination reactions. The aim of this study was to report uveitis and other ocular complications following COVID-19 vaccination. The study included 42 eyes of 34 patients (20 females, 14 males), with a mean age of 49.8 years (range 18-83 years). The cases reported were three herpetic keratitis, two anterior scleritis, five anterior uveitis (AU), three toxoplasma retinochoroiditis, two Vogt-Koyanagi-Harada (VKH) disease reactivations, two pars planitis, two retinal vasculitis, one bilateral panuveitis in new-onset Behçet's disease, three multiple evanescent white dot syndromes (MEWDS), one acute macular neuroretinopathy (AMN), five retinal vein occlusions (RVO), one non-arteritic ischemic optic neuropathy (NAION), three activations of quiescent choroidal neovascularization (CNV) secondary to myopia or uveitis, and one central serous chorioretinopathy (CSCR). Mean time between vaccination and ocular complication onset was 9.4 days (range 1-30 days). Twenty-three cases occurred after Pfizer-BioNTech vaccination (BNT162b2 mRNA), 7 after Oxford-AstraZeneca vaccine (ChAdOx1 nCoV-19), 3 after ModernaTX vaccination (mRNA-1273), and 1 after Janssen Johnson & Johnson vaccine (Ad26.COV2). Uveitis and other ocular complications may develop after the administration of COVID-19 vaccine.
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http://dx.doi.org/10.3390/jcm10245960DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8704915PMC
December 2021

Acute exacerbation of interstitial lung disease associated with rheumatic disease.

Nat Rev Rheumatol 2021 Dec 7. Epub 2021 Dec 7.

Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.

Interstitial lung disease (ILD) is a cause of morbidity and mortality in patients with rheumatic diseases, such as connective-tissue diseases, rheumatoid arthritis and systemic vasculitis. Some patients with ILD secondary to rheumatic disease (RD-ILD) experience acute exacerbations, with sudden ILD progression and high mortality during or immediately after the exacerbation, and a very low 1-year survival rate. In the ILD subtype idiopathic pulmonary fibrosis (IPF), an acute exacerbation is defined as acute worsening or development of dyspnoea associated with new bilateral ground-glass opacities and/or consolidations at high-resolution CT, superimposed on a background pattern consistent with fibrosing ILD. However, acute exacerbation in RD-ILD (AE-RD-ILD) currently has no specific definition. The aetiology and pathogenesis of AE-RD-ILD remain unclear, but distinct triggers might include infection, mechanical stress, microaspiration and DMARD treatment. At this time, no effective evidence-based therapeutic strategies for AE-RD-ILD are available. In clinical practice, AE-RD-ILD is often empirically treated with high-dose systemic steroids and antibiotics, with or without immunosuppressive drugs. In this Review, we summarize the clinical features, diagnosis, management and prognosis of AE-RD-ILD, enabling the similarities and differences with acute exacerbation in IPF to be critically assessed.
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http://dx.doi.org/10.1038/s41584-021-00721-zDOI Listing
December 2021

Role of PD-L1 in licensing immunoregulatory function of dental pulp mesenchymal stem cells.

Stem Cell Res Ther 2021 Dec 4;12(1):598. Epub 2021 Dec 4.

Department of Surgery, Medicine Dentistry and Morphological Sciences with Interest in Transplant, University of Modena and Reggio Emilia, Modena, Italy.

Background: Dental pulp stem cells (DPSCs) are low immunogenic and hold immunomodulatory properties that, along with their well-established multi-potency, might enhance their potential application in autoimmune and inflammatory diseases. The present study focused on the ability of DPSCs to modulate the inflammatory microenvironment through PD1/PD-L1 pathway.

Methods: Inflammatory microenvironment was created in vitro by the activation of T cells isolated from healthy donors and rheumatoid arthritis (RA) patients with anti-CD3 and anti-CD28 antibodies. Direct and indirect co-cultures between DPSCs and PBMCs were carried out to evaluate the activation of immunomodulatory checkpoints in DPSCs and the inflammatory pattern in PBMCs.

Results: Our data suggest that the inflammatory stimuli trigger DPSCs immunoregulatory functions that can be exerted by both direct and indirect contact. As demonstrated by using a selective PD-L1 inhibitor, DPSCs were able to activate compensatory pathways targeting to orchestrate the inflammatory process by modulating pro-inflammatory cytokines in pre-activated T lymphocytes. The involvement of PD-L1 mechanism was also observed in autologous inflammatory status (pulpitis) and after direct exposure to pre-activated T cells from RA patients suggesting that immunomodulatory/anti-inflammatory properties are strictly related to their stemness status.

Conclusions: Our findings point out that the communication with the inflammatory microenvironment is essential in licensing their immunomodulatory properties.
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http://dx.doi.org/10.1186/s13287-021-02664-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8643194PMC
December 2021

Systemic sclerosis cutaneous expression: Management of skin fibrosis and digital ulcers.

Ann Med Surg (Lond) 2021 Nov 2;71:102984. Epub 2021 Nov 2.

Department of Rheumatology, Division of Rheumatology, University of Modena and Reggio Emilia, Policlinico of Modena, Largo Pozzo 71, 41124, Modena, Italy.

Systemic sclerosis is a connective tissue disease with cutaneous involvement. Clinical manifestations result from the balance of inflammations/autoimmunity process and fibrogenesis. Patients suffer from skin ulcers, non-ulcerative lesions including digital pitting scars, telangiectasias, subungual hyperkeratosis, abrasions, fissures, and subcutaneous calcinosis. A review about the pathophysiology of the disease, the physical examination of the patients, the instrumental assessment, and possible treatments is performed.
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http://dx.doi.org/10.1016/j.amsu.2021.102984DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8606707PMC
November 2021

Sex-related Differences in Systemic Sclerosis: A Multicenter Cross-sectional Study From the National Registry of the Italian Society for Rheumatology.

J Rheumatol 2021 Nov 15. Epub 2021 Nov 15.

This study was supported by the Italian Society for Rheumatology (SIR). R. De Angelis, MD, A.M. Risa, MD, Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona; D. Giuggioli, MD, F. Lumetti, MD, A. Spinella, MD, C. Ferri, MD, Rheumatology Unit, School of Medicine, University of Modena and Reggio Emilia, Modena; G. Bajocchi, MD, L. Magnani, MD, C. Salvarani, MD, Rheumatology Unit, S. Maria Hospital-USL, IRCCS Institute, Reggio Emilia; L. Dagna, MD, C. Campochiaro, MD, G. De Luca, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan; G. Zanframundo, MD, V. Codullo, MD, Department of Rheumatology, Policlinico San Matteo, Pavia; R. Foti, MD, E. Visalli, MD, AOU Policlinico Vittorio Emanuele, Catania; F. Cacciapaglia, MD, F. Iannone, MD, Rheumatology Unit, Department of Emergency Surgery and Organ Transplantations, University of Bari, Bari; G. Cuomo, MD, F. Masini, MD, Luigi Vanvitelli University, Naples; A. Ariani, MD, Department of Medicine, Internal Medicine and Rheumatology, Azienda Ospedaliero Universitaria di Parma, Parma; E. Rosato, MD, A. Gigante, MD, Department of Translational and Precision Medicine, Sapienza University of Rome; S. Guiducci, MD, S. Bellando-Randone, MD, Department of Rheumatology, University of Florence, Florence; F. Girelli, MD, Department of Medicine, Rheumatology Unit, Ospedale GB Morgagni-L Pierantoni, Forlì; V. Riccieri, MD, G. Pellegrino, MD, Department of Rheumatology, Sapienza University of Rome, Rome; E. Zanatta, MD, A. Doria, MD, Department of Rheumatology, University of Padua, Padova; S. Bosello, MD, Institute of Rheumatology and Affine Sciences, Division of Rheumatology, Catholic University of the Sacred Heart, Rome; I. Cavazzana, MD, F. Dall'Ara, MD, M.G. Lazzaroni, MD, Department of Rheumatology, Spedali Civili di Brescia, Brescia; F. Ingegnoli, MD, Division of Clinical Rheumatology, ASST Pini, Dept. of Clinical Sciences & Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Research Center for Environmental Health, Università degli Studi di Milano, Milan; M. De Santis, MD, E.Generali, MD, Humanitas Clinical and Research Center IRCCS, Milan; G. Murdaca, MD, S. Martino Hospital-University of Genoa, Genoa; G. Abignano, MD, G. Mennillo, MD, S. D'Angelo, MD, Department of Translational and Precision Medicine, Sapienza University of Rome; N. Romeo, MD, S. Croce e Carle Hospital, Cuneo; A. Della Rossa, MD, S. Barsotti, MD, Department of Rheumatology, University of Pisa, Pisa; M. Caminiti, MD, G. Pagano Mariano, MD, F. Calabrese, MD, Departmental Rheumatology Unit, Grande Ospedale Metropolitano, Reggio Calabria; A. Iuliano, MD, G.D. Sebastiani, MD, Rheumatology Unit, San Camillo-Forlanini Hospital, Rome; G. Ciano, MD, Local Health Department, Avellino; L. Beretta, MD, Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano, Milan; G. Bagnato, MD, Department of Clinical and Experimental Medicine, University of Messina, Messina; E. Lubrano, MD, Department of Rheumatology, University of Molise, Campobasso; I. De Andres, MD, Rheumatology Unit, Azienda Ospedaliera di Rilievo Nazionale ed Alta Specializzazione Garibaldi, Catania; A. Giollo, MD, Rheumatology Section, Department of Medicine, University of Verona, Verona; M. Saracco, MD, Rheumatology Unit, Mauriziano-Umberto I Hospital, Turin; C. Agnes, MD, San Lorenzo Hospital; E. Pigatto, MD, F. Cozzi, MD, Department of Medicine, Villa Salus Hospital, Venice; F. Furini, MD, L. Vultaggio, MD, M. Govoni, MD, Rheumatology Unit, Department of Medical Sciences, University of Ferrara and Azienda Ospedaliera-Universitaria S. Anna di Ferrara, Ferrara; S. Parisi, MD, C.L. Peroni, MD, E. Fusaro, MD, Rheumatology Unit, Città della Salute e della Scienza, Turin; D.Rozza, MS, A. Zanetti, MS, G. Carrara, MS, G. Landolfi, MS, Epidemiology Unit, Italian Society for Rheumatology, Milan; C.A. Scirè, MD, Epidemiology Unit, Italian Society for Rheumatology, Milan, and Rheumatology Unit, University of Ferrara-S. Anna Hospital, Ferrara; G. Bianchi, MD, Rheumatology Unit, Department of Musculoskeletal Sciences, Local Health Trust 3, La Colletta Hospital, Genoa; \M. Matucci-Cerinic, MD, Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, and Department of Rheumatology, University of Florence, Florence, Italy. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. R. De Angelis, MD, PhD, Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, "Carlo Urbani" Hospital, Via Aldo Moro, 25, 60035 Jesi, Ancona, Italy. Email: Accepted for publication October 27, 2021.

Objective: There is still a great deal to learn about the influence of sex in systemic sclerosis (SSc). In this respect, national registries provide large and homogeneous patient cohorts for analytical studies. We therefore investigated a wide-ranging and well-characterized SSc series with the aim of identifying sex differences in disease expression, with a special focus on demographic, clinical, and serological characteristics.

Methods: A multicenter SSc cohort of 2281 patients, including 247 men, was recruited in the Italian Systemic sclerosis PRogression INvestiGation (SPRING) registry. Demographic data, disease manifestations, serological profile, and internal organ involvement were compared.

Results: The overall female/male ratio was 8.2:1. Female/male ratios for limited cutaneous SSc, diffuse cutaneous SSc, and SSc sine scleroderma subsets were 8.7:1, 4.9:1, and 10.7:1, respectively. A shorter time from onset of Raynaud phenomenon to SSc diagnosis, an increased prevalence of the diffuse cutaneous subset, renal crisis, and digital ulcers were found in males, whereas a significantly higher percentage of sicca syndrome, serum antinuclear antibodies, antiextractable nuclear antigens, anti-La/SSB, and anticentromere protein B was detected in the female group. Males exhibited lower left ventricular ejection fraction, as well as higher prevalence of conduction blocks, arrhythmias, ground glass, and honeycombing. Moreover, forced vital capacity and total lung capacity were medially lower in men than in women. Finally, males were more frequently treated with immunosuppressive drugs.

Conclusion: Our study further supports the presence of several sex-related differences in patients with SSc. These differences were pronounced in the severity of cutaneous, peripheral vascular, and cardiopulmonary involvement for male patients, whereas an increased prevalence of sicca syndrome and a specific autoantibody profile characterized the female sex.
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http://dx.doi.org/10.3899/jrheum.210794DOI Listing
November 2021

New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension.

Rheumatology (Oxford) 2021 Oct 29. Epub 2021 Oct 29.

Genentech, South San Francisco, CA, USA.

Objective: Tocilizumab plus prednisone induces sustained glucocorticoid-free remission in patients with giant cell arteritis (GCA). However, its long-term benefits in new-onset vs relapsing disease are uncertain and the value of weekly vs every-other-week dosing has not been evaluated.

Methods: In GiACTA part 1, patients with new-onset or relapsing GCA received blinded tocilizumab weekly (TCZ QW), tocilizumab every-other-week (TCZ Q2W), or placebo for 52 weeks with a prednisone taper. In part 2 (open-label), patients were treated at investigator discretion for 104 weeks. In this analysis, patients were evaluated according to their original treatment assignments and outcomes beyond 52 weeks were assessed. Outcomes of interest included time to first flare and cumulative glucocorticoid exposure over 3 years according to baseline disease status.

Results: Part 1 enrolled 250 patients; 215 entered part 2. At baseline, 48% had new-onset disease and 52% had relapsing disease. In patients with new-onset and relapsing disease, median time to first flare in the TCZ QW group was 577 and 575 days, respectively, vs 479 and 428 days with TCZ Q2W and 179 and 224 days with placebo; median cumulative glucocorticoid dose was 3068 mg and 2191 mg with TCZ QW, 4080 mg and 2353 mg with TCZ Q2W, and 4639 mg and 6178 mg with placebo.

Conclusions: TCZ QW delays the time to flare and reduces cumulative glucocorticoid dose in patients with relapsing GCA and new-onset GCA. These data support initiating TCZ QW as part of first-line therapy in all patients with active GCA.

Trial Registration Number: ClinicalTrials.gov, NCT01791153.
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http://dx.doi.org/10.1093/rheumatology/keab780DOI Listing
October 2021

Ultrasound Effectiveness of Steroid Injection for hand Psoriatic Dactylitis: Results from a Longitudinal Observational Study.

Rheumatol Ther 2021 Dec 15;8(4):1809-1826. Epub 2021 Oct 15.

Department of Clinical Medicine and Surgery, Rheumatology Unit, University of Naples Federico II, via S. Pansini 5, 80131, Naples, Italy.

Introduction: To assess clinical and ultrasound effectiveness of steroid injection (local treatment, LT) into the digital flexor tendon sheath for the treatment of psoriatic dactylitis compared to systemic treatment (ST) alone.

Methods: In this observational, multicentre, prospective study, 88 cases of symptomatic hand dactylitis were evaluated clinically and sonographically by high-frequency ultrasound (US) probe in both greyscale (GS) and power Doppler (PD). The presence of flexor tenosynovitis (FT), soft tissue oedema (STO), peritendon extensor inflammation and synovitis was assessed (including DACtylitis glObal Sonographic-DACTOS-score) before treatment, at 1-month (T1) and 3-months (T3) follow-up. LT was proposed to all patients. Patients refusing LT were treated with oral NSAIDs. Patients continued the same baseline csDMARDs and/or corticosteroid therapy during the whole follow-up period. US response was defined for DACTOS score < 3 and US remission for DACTOS score = 0.

Results: At T3 evaluation the ST group showed a significantly higher persistence (grade > 1) of FT and STO (p < 0.001 for all) and MCP synovitis (p = 0.001). US remission was achieved only in the LT group (at T3 31% vs. 0, p < 0.001). The percentage of patients with DACTOS < 3 was significantly greater in the LT group compared with ST group, at both T1 (49% vs. 5%, p < 0.001) and T3 evaluation (76% vs. 7%, p < 0.001). In multiple conditional logistic regression analysis, the only factor associated with US remission was LT (T3 odds ratio = 41.21, p < 0.001).

Conclusions: US confirmed the effectiveness of steroid injection for dactylitis by demonstrating that it involves the resolution of extra-articular inflammation, in particular FT and STO.
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http://dx.doi.org/10.1007/s40744-021-00383-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572270PMC
December 2021

Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1.

Rheumatol Ther 2021 Dec 12;8(4):1789-1808. Epub 2021 Oct 12.

Department of Medicine, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.

Introduction: The aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1.

Methods: In this placebo- and active comparator, phase 3 randomized, controlled trial, patients received daily upadacitinib 15 or 30 mg, placebo, or adalimumab 40 mg every other week through 56 weeks. At week 24, placebo-assigned patients were rerandomized to upadacitinib 15 or 30 mg. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form 36 Health Survey (SF-36), EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment. Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID), scores ≥ normative values, and sustained clinically meaningful responses were compared between treatment groups.

Results: At weeks 12 and 24, upadacitinib treatment resulted in improvements from baseline versus placebo across all PROs as well as improvements versus adalimumab in HAQ-DI and SF-36 Physical Component Summary score (nominal p < 0.05). Improvements in PtGA, pain, and HAQ-DI were reported as early as week 2. At week 12, significantly (nominal p < 0.05) more upadacitinib- versus placebo-treated patients reported improvements ≥ MCID across all PROs including seven SF-36 domains. The proportions of upadacitinib-treated patients reporting clinically meaningful improvements at week 12 were similar to or greater than with adalimumab and sustained through week 56. Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab.

Conclusions: Upadacitinib treatment provides rapid, sustained, and clinically meaningful improvements in PROs in non-bDMARD-IR patients with PsA. SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.
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http://dx.doi.org/10.1007/s40744-021-00379-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572257PMC
December 2021

From Raynaud Phenomenon to Systemic Sclerosis in COVID-19: A Case Report.

Adv Skin Wound Care 2022 Feb;35(2):123-124

In the Rheumatology Unit, University of Modena and Reggio Emilia Medical School, Azienda Ospedaliero-Universitaria, Policlinico di Modena, Italy, Dilia Giuggioli, MD, PhD, is Associate Professor; Amelia Spinella, MD, PhD, is Medical Assistant; Marco de Pinto, MD, is Resident; Mascia Maria Teresa, MD, is Associate Professor; and Carlo Salvarani, MD, is Full Professor. The authors have disclosed no financial relationships related to this article. Submitted December 21, 2020; accepted in revised form March 15, 2021; published online ahead of print October 6, 2021.

Abstract: In 2019, the novel SARS-CoV-2 infection emerged, causing the disease called COVID-19, which primarily affects the respiratory tract and lung at alveolar and interstitial levels. Systemic sclerosis (SSc) is an autoimmune connective disease characterized by vascular abnormalities and diffuse and progressive fibrosis of the skin and internal organs. Raynaud phenomenon (RP) occurs in virtually all patients affected by SSc and, in most cases, is an onset symptom of the disease; that is, RP may appear several years before overt illness. Although the exact pathophysiologic pathways leading to RP and SSc are still unknown, several infectious agents, especially viruses, have been suggested as possible triggering factors. Here, the authors describe the first case of RP secondary to SSc following SARS-CoV-2 infection.
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http://dx.doi.org/10.1097/01.ASW.0000795240.63966.53DOI Listing
February 2022

VEXAS syndrome: a case series from a single-center cohort of Italian patients with vasculitis.

Arthritis Rheumatol 2021 Oct 5. Epub 2021 Oct 5.

Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Objectives: We used a clinically oriented phenotype-first approach to identify patients with VEXAS syndrome from a single-center cohort of Italian patients with vasculitis.

Methods: The clinical records of 147 consecutive male patients followed in our vasculitis clinic from 2013 to date were retrospectively reviewed. All patients with a diagnosis of vasculitis and inflammatory manifestations resistant to treatment, persistently elevated inflammatory markers, and hematologic abnormalities were identified. Bone marrow aspirates were reviewed for the presence of vacuoles. Sequencing of UBA1 was performed using genomic DNA from peripheral blood leukocytes or bone marrow tissue.

Results: 7 patients with vasculitis and concomitant features of VEXAS syndrome were identified. A final diagnosis of VEXAS syndrome was made in 3 of the 5 patients who underwent sequencing of UBA1 (for 1 patient it was a post-mortem diagnosis). All 3 patients had evidence of the characteristic vacuoles at bone marrow aspirate, and all 3 patients met the definite WHO criteria for myelodysplastic syndrome. Cytogenetic analysis showed a normal karyotype in all 3 patients. We report the first case of VEXAS syndrome associated with ANCA-associated vasculitis.

Conclusion: Our data emphasize the need to consider VEXAS syndrome when evaluating patients with many different forms of systemic vasculitis. The novel association between VEXAS syndrome and ANCA associated vasculitis needs further investigations.
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http://dx.doi.org/10.1002/art.41992DOI Listing
October 2021

Durable renal response and safety with add-on belimumab in patients with lupus nephritis in real-life setting (BeRLiSS-LN). Results from a large, nationwide, multicentric cohort.

J Autoimmun 2021 11 30;124:102729. Epub 2021 Sep 30.

University of di Verona, Unit of Rheumatology, Verona, Italy.

Background: Belimumab was recently approved for treatment of lupus glomerulonephritis (LN).

Aim: To evaluate renal response and its predictors in LN patients receiving belimumab in real-life.

Patients And Methods: We considered all patients fulfilling the SLEDAI-2K renal items and/or having estimated glomerular filtration rate (eGFR)≤60 ml/min/1.73 m, with positive anti-dsDNA and/or low C3/C4 enrolled in the multicentre Italian lupus cohort BeRLiSS (BElimumab in Real LIfe Setting Study), treated with monthly IV Belimumab 10 mg/kg over standard treatment. Primary efficacy renal response (PERR), defined as proteinuria ≤0.7 g/24 h, eGFR≥60 ml/min/1.73 m without rescue therapy, was considered as primary outcome. Complete renal response (CRR; proteinuria <0.5 g/24 h, eGFR≥90 ml/min/1.73 m) was considered as secondary outcome. Prevalence and predictors of PERR were evaluated at 6, 12, 24 months by multivariate logistic regression.

Results: Among the 466 SLE patients of BeRLiSS, 91 fulfilled the inclusion criteria, 79 females, median age 41.0 (33.0-47.0) years, median follow-up 22.0 (12.0-36.0) months. Sixty-four (70.3%) achieved PERR, of whom 38.4% reached CRR. Among patients achieving PERR at 6 months, 86.7% maintained response throughout the follow-up. At multivariable analysis, hypertension (OR [95%CI]: 0.28 [0.09-0.89], p = 0.032), high baseline serum creatinine (0.97 [0.95-0.99], p = 0.01) and high baseline proteinuria (0.37, [0.19-0.74], p = 0.005) negatively predicted PERR. Positive predictors of PERR at 12 and 24 months were baseline anti-Sm positivity (OR [95%CI]: 6.2 [1.21-31.7], p = 0.029; 19.8 [2.01-186.7], p = 0.009, respectively) and having achieved PERR at 6 months (14.4 [3.28-63.6]; 11.7 [2.7-48.7], p = 0.001 for both).

Conclusions: Add-on therapy with belimumab led to durable renal response in patients with LN in a real-life setting.
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http://dx.doi.org/10.1016/j.jaut.2021.102729DOI Listing
November 2021

18F-FDG PET-CT versus contrast enhanced CT for the diagnosis of fever of unknown origin.

Eur J Intern Med 2021 11 27;93:26-27. Epub 2021 Sep 27.

Rheumatology Unit, Department of Internal Medicine, Reggio Emilia, Italy; University of Modena and Reggio Emilia, Modena; Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ejim.2021.09.006DOI Listing
November 2021

Sensing Inflammation Biomarkers with Electrolyte-Gated Organic Electronic Transistors.

Adv Healthc Mater 2021 10 22;10(20):e2100955. Epub 2021 Aug 22.

Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 103, Modena, 41125, Italy.

An overview of cytokine biosensing is provided, with a focus on the opportunities provided by organic electronic platforms for monitoring these inflammation biomarkers which manifest at ultralow concentration levels in physiopathological conditions. Specifically, two of the field's state-of-the-art technologies-organic electrochemical transistors (OECTs) and electrolyte gated organic field effect transistors (EGOFETs)-and their use in sensing cytokines and other proteins associated with inflammation are a particular focus. The overview will include an introduction to current clinical and "gold standard" quantification techniques and their limitations in terms of cost, time, and required infrastructure. A critical review of recent progress with OECT- and EGOFET-based protein biosensors is presented, alongside a discussion onthe future of these technologies in the years and decades ahead. This is especially timely as the world grapples with limited healthcare diagnostics during the Coronavirus disease (COVID-19)pandemic where one of the worst-case scenarios for patients is the "cytokine storm." Clearly, low-cost point-of-care technologies provided by OECTs and EGOFETs can ease the global burden on healthcare systems and support professionals by providing unprecedented wealth of data that can help to monitor disease progression in real time.
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http://dx.doi.org/10.1002/adhm.202100955DOI Listing
October 2021

Survival and Recurrence in Vitreoretinal Lymphoma Simulating Uveitis at Presentation: The Possible Role of Combined Chemotherapy.

Ocul Immunol Inflamm 2021 Aug 11:1-9. Epub 2021 Aug 11.

Ocular Immunology Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.

To investigate the role of combined systemic and local chemotherapy in improving the survival of patients with vitreoretinal lymphoma (VRL). Patients with VRL consecutively seen from 2006 to 2020 were retrospectively reviewed; data on the presence and time of central nervous system (CNS) involvement and treatment regimen (systemic, local or combined chemotherapy) were collected. Overall survival (OS) and progression-free survival (PFS) were calculated for each group. Forty-three eyes of 22 subjects with histology-proven VRL were included. Mean time of survival was 64.8 months (SE±10.8). Twelve patients (57%) presented CNS involvement, which was significantly associated with progression (r = 0.48, P = .03) and death (r = 0.56, P = .009). The isolated primary VRL group had a 5-year OS of 80%. Combined systemic and local chemotherapy reduced the risk of death by 82% (hazard ratio 0.18[0.04- 0.85]) in the entire cohort. Combined systemic and local chemotherapy significantly improved OS but not PFS of patients affected by VRL.
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http://dx.doi.org/10.1080/09273948.2021.1962916DOI Listing
August 2021

Efficacy and safety of TNF-α antagonists and tocilizumab in Takayasu arteritis: Multicenter retrospective study of 209 patients.

Rheumatology (Oxford) 2021 Aug 7. Epub 2021 Aug 7.

Service de Médecine Interne et Immunologie Clinique Groupe Hospitalier UNEOS Metz-Vantoux, France.

Objective: To assess safety and efficacy of TNF-α antagonists and tocilizumab in patients with Takayasu arteritis (TAK).

Methods And Results: Two-hundred nine patients with TAK [median age of 29 years [7-62], and 186 (89%) females] were included. They received either TNF-α antagonists [n = 132 (63%) with 172 lines; infliximab (n = 109), adalimumab (n = 45), golimumab (n = 8), certolizumab (n = 6) and etanercept (n = 5)], or tocilizumab [n = 77 (37%) with 121 lines; intravenous and subcutaneous in 95 and 26 cases, respectively]. A complete response at 6 months was evidenced in 101/152 (66%) on TNF-α antagonists and 75/107 (70%) on tocilizumab, respectively. Age ≥ 30 years [OR = 2.09 [1.09; 3.99]] was associated with complete response, whereas vascular signs [0.26 [0.1; 0.65]], baseline prednisone ≥ 20 mg/day [0.51 [0.28; 0.93]] were negatively associated with the complete response to TNF-α antagonists or tocilizumab. During a median follow-up of 36 months, 103 relapses were noted. Supra-aortic branches and thoracic aorta involvements [HR 2.44 (1.06; 5.65) and 3.66 (1.18; 11.4), respectively], and systemic signs at baseline [HR 2.01 (1.30; 3.11)] were significantly associated with relapse. The cumulative incidence of treatment discontinuation and relapse were similar in TNFα antagonists and tocilizumab. Fifty-eight (20%) adverse effects occurred on biological-targeted therapies of whom 37 (21%) and 21 (17%), (p= 0.4) on TNF-α antagonists and tocilizumab, respectively.

Conclusion: This large multicentre study shows high efficacy of biological-targeted treatments in refractory TAK. Efficacy, relapse and drug retention rate were equivalent with TNF-α antagonists and tocilizumab.
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http://dx.doi.org/10.1093/rheumatology/keab635DOI Listing
August 2021

Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study.

Arthritis Rheumatol 2021 Aug 4. Epub 2021 Aug 4.

San Giovanni Bosco Hospital and University of Turin, Turin, Italy.

Objective: Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real-life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort.

Methods: We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015-2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of ≤4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations.

Results: Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty-five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty-two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty-four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44).

Conclusion: Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial.
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http://dx.doi.org/10.1002/art.41943DOI Listing
August 2021

The association between body mass index and fibromyalgia severity: data from a cross-sectional survey of 2339 patients.

Rheumatol Adv Pract 2021 1;5(1):rkab015. Epub 2021 Mar 1.

Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan.

Objective: Various studies have shown that overweight and obesity are central features of FM, but the real impact of a high BMI on clinical severity in patients with FM is still controversial. The aim of this study was to analyse the relationships between BMI categories and measures of symptom severity and functional impairment using data from a Web-based registry of patients with FM.

Methods: Adult patients with an ACR 2010/2011 diagnosis of FM underwent a complete physical examination and laboratory tests and were asked to complete a package of questionnaires covering their sociodemographic and treatment details, in addition to the following disease-specific questionnaires: the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status questionnaire (ModFAS) and the Polysymptomatic Distress Scale (PDS).

Results: A total of 2339 patients were recruited and divided into two weight categories, underweight/normal (U/N,  = 1127, 48.2%) and overweight/obese (O/O,  = 1212, 51.8%). The total and subscales of FIQR, ModFAS and PSD scores were significantly higher in the O/O patients, as were all the mean scores of the individual FIQR items ( < 0.001 for all).

Conclusion: Our findings demonstrate that O/O patients with FM are significantly more impaired than U/N patients in all the symptomatological and functional domains as measured using the FIQR, ModFAS and PDS, thus suggesting that being O/O has an additional effect on symptoms and function.
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http://dx.doi.org/10.1093/rap/rkab015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324026PMC
March 2021

Interstitial Lung Disease and Anti-Myeloperoxidase Antibodies: Not a Simple Association.

J Clin Med 2021 Jun 9;10(12). Epub 2021 Jun 9.

Rheumatology Unit, Azienda Ospedaliera Policlinico di Modena, University of Modena and Reggio Emilia, 41121 Modena, Italy.

Anti-neutrophil cytoplasmic antibodies (ANCA), mainly anti-myeloperoxidase (MPO) antibodies, have been frequently identified in patients with idiopathic pulmonary fibrosis (IPF). However, their role remains unclear, and only 7-23% of these patients develops clinically overt vasculitis. We aimed to investigate the clinical, serological, and radiological features and prognosis of anti-MPO-positive interstitial lung disease (ILD) patients. Fifty-eight consecutive patients firstly referred for idiopathic interstitial pneumonia and showing serological positivity of anti-MPO antibodies were retrospectively enrolled. For each patient, clinical data, lung function testing, chest high-resolution computed tomography (HRCT) pattern, and survival were recorded. Thirteen patients developed a rheumatic disease during a median follow-up of 39 months. Usual interstitial pneumonia (UIP) was the most frequent ILD pattern, significantly influencing the patients' survival. In fact, while the 52-week survival of the overall population was 71.4 ± 7.5%, significantly higher than IPF, survivals of anti-MPO patients with UIP pattern and IPF were similar. Forced vital capacity and diffusion lung capacity for CO significantly declined in 37.7 and 41.5% of cases, respectively, while disease progression at chest HRCT was observed in 45.2%. A careful clinical history and evaluation should always be performed in ILD patients with anti-MPO antibodies to quickly identify patients who are developing a systemic rheumatic disease.
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http://dx.doi.org/10.3390/jcm10122548DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8227546PMC
June 2021

Clinical and Pathological Features of Breast Cancer in Systemic Sclerosis: Results from the Sclero-Breast Study.

J Pers Med 2021 Jun 20;11(6). Epub 2021 Jun 20.

SSc Unit, Rheumatology Unit, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.

Systemic Sclerosis (SSc) is a chronic disease associated with a 1.5-fold increase in cancer risk, including lung cancer, hematological malignancies, and breast cancer (BC). This is a retrospective study aiming to explore the clinical and pathological features of BC developed by SSc patients. A total of 54.5% of patients developed BC before SSc (median interval: 5 years), whereas 45.5% of patients developed BC after SSc (median delay: 8 years). A total of 93.1% of patients were diagnosed with an early stage tumor. Among invasive carcinomas, 70.8% presented with a low Mib1, 8.3% with a tubular histotype, and 42.8% with a Luminal A-like phenotype. A total of 66.6% of patients underwent breast-conserving surgery and 55.5% RT. A total of 40% of patients developed interstitial lung disease after RT and 20% diffuse cutaneous SSc. The cause of death of the six deceased patients was PAH. A significant association was observed between the use of immunosuppressive therapy and diffuse skin extension, negative ACA, positive Anti-Scl-70, and interstitial lung disease, but not BC status. SSc patients developed BC at a good prognosis, suggesting a de-escalation strategy of cancer therapies. In particular, ionizing radiation and chemotherapeuticals should be limited to higher-risk cases. Finally, proper screening is mandatory in order to allow for early cancer detection in SSc patients.
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http://dx.doi.org/10.3390/jpm11060580DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234103PMC
June 2021

Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials.

Rheumatol Ther 2021 Sep 28;8(3):1435-1441. Epub 2021 Jun 28.

Rheumatology Department, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.

Objectives: Interstitial lung disease (ILD) occurs in up to 30% of patients with rheumatoid arthritis (RA), resulting in increased morbidity and death in the absence of proven therapies. The aim of this study is to estimate the number of incident ILD cases reported through development studies with baricitinib in patients with RA.

Methods: Estimates were based on 3770 patients with RA from eight randomized clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension study on baricitinib for which ILD was not an exclusion criterion with 12,358 patient-years of exposure (PYE).

Results: Twenty-one non-infectious cases of ILD were reported with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 PYE. Of the 21 cases, six were reported as serious and 15 as non-serious resulting in an incidence rate of 0.05 per 100 PYE and 0.12 per 100 PYE, respectively. There were also 11 cases caused by an infectious agent: seven serious (IR: 0.06 per 100 PYE) and four non-serious cases (IR: 0.03 per 100 PYE).

Conclusions: The findings of this analysis in patients with RA treated with baricitinib are consistent with a low risk to develop non-infectious ILD during baricitinib treatment, similar to that observed with other Janus kinase inhibitors.
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http://dx.doi.org/10.1007/s40744-021-00332-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380601PMC
September 2021

Incidence and prevalence of large vessel vasculitis (giant cell arteritis and Takayasu arteritis) in northern Italy: A population-based study.

Semin Arthritis Rheum 2021 08 7;51(4):786-792. Epub 2021 Jun 7.

Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy; Università di Modena e Reggio Emilia, Modena, Italy. Electronic address:

Objectives: To investigate the epidemiology of the entire spectrum of large vessel vasculitis (LVV) in a well-defined population from a Northern Italian area.

Methods: All patients with incident giant cell arteritis (GCA) diagnosed from 2005 to 2016 and all patients with incident Takayasu arteritis (TAK) diagnosed from 1998 to 2016 living in the Reggio Emilia area were identified. Only patients satisfying the modified inclusion criteria of the GiACTA trial, and the 1990 ACR classification criteria for TAK were included. The epidemiology of cranial- and LV-GCA was separately evaluated.

Results: 207 patients were diagnosed with GCA and 5 with TAK. 123 patients had cranial-GCA, 53 patients had LV-GCA, and the remaining 31 patients had overlapping features. The standardized annual incidence rate of GCA was 8.3 (95% CI 7.1, 9.4) per 100,000 population ages ≥50 years. The standardized annual incidence rate of cranial-GCA (6.1 [95% CI 5.1, 7.1] per 100,000 population ages ≥50 years) was double the rate of LV-GCA (3.4 [95% CI 2.7, 4.2]). The age-specific incidence rates were similar in the <70 and >90 years age groups, but they were higher in cranial-GCA than in LV-GCA in the age groups 70-79 and 80-89 years. The age- and sex-adjusted annual incidence rate of TAK was 0.5 (95% CI 0.1, 1.2) per 1,000,000 population.

Conclusion: Incidence of GCA is higher than previously reported by study evaluating only biopsy-proven or ACR classification criteria confirmed cases. Cranial-GCA and LV-GCA have epidemiological differences. TAK is an extremely rare disease also in Italy.
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http://dx.doi.org/10.1016/j.semarthrit.2021.06.001DOI Listing
August 2021

Fibrosing interstitial lung disease in primary Sjogren syndrome.

Joint Bone Spine 2021 Dec 9;88(6):105237. Epub 2021 Jun 9.

Rheumatology Unit, University of Modena and Reggio-Emilia, Modena, Italy.

Objectives: Interstitial lung disease (ILD) represents the main pulmonary involvement in primary Sjogren syndrome (pSS). A proportion of patients with pSS develop a progressive fibrosing form of ILD, but no data are available about the prevalence of these patterns in pSS patients. Aim of this monocentric, cross-sectional study was to investigate the prevalence of fibrosing patterns in pSS patients with ILD.

Methods: All consecutive patients fulfilling classification criteria for pSS with a new or previous diagnosis of ILD were enrolled in the study. Diagnosis of ILD was always performed by mean of HRCT and specific patterns were identified according to current classification criteria and divided in two groups according to the detection of a fibrotic pattern.

Results: Thirty-four pSS-ILD patients were enrolled in the study (males/females 3/31, median age 69.5 years, median pSS duration 47.5 months). Fibrotic pattern was detected in 52.9% of patients, namely: UIP (13 patients, 38.2%), fibrotic NSIP (4, 11.8%), fibrotic OP (1 2.9%) and group 2 (16 pts, 47.1%) including NSIP (6, 17.6%), OP (4, 11.8%), LIP (2, 5.9%) and unclassifiable (4, 11.8%). These patients were younger and with a shorter pSS duration at ILD diagnosis, in particular ILD diagnosis was prior or concurrent to pSS in 83.3% of cases compared to 62.5% in the group of nonfibrotic pattern (P<0.05).

Conclusion: Our data suggest a high prevalence of this pulmonary clinical phenotype in pSS-ILD patients. Since the course of progressive fibrosing pneumonia generally results in respiratory failure, this result could be worthy of further studies.
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http://dx.doi.org/10.1016/j.jbspin.2021.105237DOI Listing
December 2021
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