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Supplemental material, sj-docx-1-tab-10.1177_1759720X211033679 for Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis by Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Marco Bardelli, Lorenzo Tofani, Francesca Bartoli, Caterina Baldi, Laura Cometi, Ginevra Fiori, Francesca Nacci, Luca Cantarini, Serena Guiducci, Alberto Moggi-Pignone, Bruno Frediani and Marco Matucci-Cerinic in Therapeutic Advances in Musculoskeletal Disease

Supplemental material, sj-docx-1-tab-10.1177_1759720X211033679 for Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis by Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Marco Bardelli, Lorenzo Tofani, Francesca Bartoli, Caterina Baldi, Laura Cometi, Ginevra Fiori, Francesca Nacci, Luca Cantarini, Serena Guiducci, Alberto Moggi-Pignone, Bruno Frediani and Marco Matucci-Cerinic in Therapeutic Advances in Musculoskeletal Disease

Aim: To evaluate outcome of an accelerated radiotherapy (RT) regimen in elderly patients with an early stage non-melanoma skin cancer (NMSC). Methods: Total RT dose was 30 Gy in 5 Gy fractions in six consecutive days. Results: Thirty-one patients were enrolled. Fourteen were aged ≥80 years. Acute skin and observed late toxicity were exclusively of grade 1. Thirty patients showed a complete response (median follow-up 30 months). Two-year actuarial local control was 93.2%. The cosmetic result was mostly judged as good or excellent. Conclusions: Short-course RT in elderly NMSC patients produces >90% local control of disease.

Background Surgical procedures with an extended follow-up and therefore recognized as safe in literature are classified into 2 categories: procedures limiting the introduction of food mechanically (restrictive interventions such as adjustable gastric banding, vertical banded gastroplasty, and sleeve gastrectomy) or functionally (mini gastric bypass or gastric bypass) and procedures limiting absorption (mainly biliopancreatic diversion [BPD]). Materials and methods Seventy-nine patients who underwent postbariatric abdominoplasty to correct serious flaws resulting from weight loss surgery were included in this retrospective study. Dehiscence of the surgical wound was carefully investigated between the population previously submitted to BPD and gastric bypass. The data were analyzed by correlating the incidence of postoperative dehiscence by Fisher exact test, with a statistical significance level of P Results Among the 42 abdominoplasties after BPD, dehiscence rate was 33% (14 patients), whereas in the group of 37 patients who underwent gastric bypass, the occurrence of dehiscence was 8% (3 patients).The Fisher exact test highlighted previously performed BPD as statistically significant for the onset of postoperative dehiscence (P=0.012). Conclusions There is a great need to validate these data on large or multicentric studies. The previous bariatric surgery procedure may play a role similar to so many other widely investigated risk factors such as smoking and body mass index, and some categories of patients should require even more attention in the preoperative, intraoperative, and postoperative management.

Lipomas are the most common type of soft tissue benign tumor. They can be either isolated entities or involved in a multiple lipomatosis, which may have a familial basis or be an acquired condition.Chemotherapy and/or blood stem cell transplantation may be plausible causes of multiple lipomatosis.A 28 year-old patient was diagnosed with non-seminomatous germ cell left testicular cancer. The patient was addressed to chemotherapy and peripheral blood stem cell chemomobilization. After stem cells collection, the patient underwent autologous peripheral blood stem cell transplant.A subsequent de novo multiple lipomatosis onset developed.Although this is a preliminary study and further elaborations are needed, dermatologists and surgeons facing with multiple lipomatosis should consider previous chemotherapy and peripheral blood stem cell mobilization/transplant as possible causes of its onset.

The aim of the study is to evaluate the frequency and features of positive pathergy test (PPT) in Italy, its role in the diagnosis of Behçet's disease (BD), and any association with other BD-related manifestations. 52 BD patients, 52 patients with axial spondyloarthritis (ax-SpA), and 26 healthy controls (HCs) underwent intradermal injection of normal saline and intradermal needle soaked with fresh self-saliva. The results of pathergy tests were statistically analysed in the light of demographic, clinical, and therapeutic features of subjects enrolled. Pathergy test performed with saline resulted always negative in all groups. Skin prick test using self-saliva resulted in the occurrence of a papule in 3 (5.8%) BD patients and in 1 (1.9%) patient with ax-SpA. A ≥ 15mm erythematous area surrounding the needle prick site was observed in 22 (42.3%) BD patients, 5 (9.6%) patients with ax-SpA, and 2 (7.7%) HCs (p = 0.00002). The frequency of skin erythema was significantly more frequent in patients with BD than those with ax-SpA (p

Background: Additional prognostic factors and personalized therapeutic alternatives for vulvar squamous cell carcinoma (VSCC), especially for advanced stages with poor prognosis, are urgently needed. Objectives: To review and assess literature regarding underlying molecular mechanisms of VSCC target therapeutic and prognostic approaches. Methods: We performed a narrative literature review from the inception of the database up to January 2020 limited to English language, organizing knowledge in five main fields: extracellular and intracellular cell cycle deregulation, tumor immune microenvironment, tumor angiogenesis and hormones. Results: EGFR immunohistochemical overexpression/gene amplification, representing early events in VSCC carcinogenesis, have been correlated with a worse prognosis and led to inclusion of erlotinib in cancer guidelines. p16 expression and HPV positivity are linked to a better prognosis, while p53 overexpression is linked to a worse prognosis; thus, biomarkers could help tailoring conventional treatment and follow-up. The implications of PD-L1 positivity in reference to HPV status and prognosis are still not clear, even though pembrolizumab is part of available systemic therapies. The role of tumor angiogenesis emerges through data on microvessel density, immunohistochemical VEGF staining and evaluation of serum VEGF concentrations. Few data exist on hormonal receptor expression, even though hormonal therapy showed great manageability. Conclusions: We suggest adding p16, p53 and HPV status to routine hystopathological examination of vulvar biopsies or surgical specimens. Predictive biomarkers for anti-EGFR and anti-PD-1/PD-L1 drugs are needed. Enough preclinical data supporting anti-angiogenic target therapies in clinical trials are existing. Hormonal receptor expression deserves further investigation.

ObjectiveThe present paper describes the design, development, and implementation of the AutoInflammatory Disease Alliance (AIDA) International Registry specifically dedicated to patients with Schnitzler's syndrome.MethodsThis is a clinical physician-driven, population- and electronic-based registry implemented for the retrospective and prospective collection of real-life data from patients with Schnitzler's syndrome; the registry is based on the Research Electronic Data Capture (REDCap) tool, which is designed to collect standardized information for clinical research, and has been realized to change over time according to future scientific acquisitions and potentially communicate with other existing or future similar registries.ResultsSince its launch, 113 centers from 23 countries in 4 continents have been involved. Fifty-seven have already obtained the approval from their local Ethics Committees. The platform counts 324 users (114 Principal Investigators, 205 Site Investigators, 2 Lead Investigators, and 3 data managers) at current (April 28th, 2022). The registry collects baseline and follow-up data using 3,924 fields organized into 25 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, laboratory, instrumental exams, therapies, socioeconomic information, and healthcare access.ConclusionsThis International Registry for patients with Schnitzler's syndrome facilitates standardized data collection, enabling international collaborative projects through data sharing and dissemination of knowledge; in turn, it will shed light into many blind spots characterizing this complex autoinflammatory disorder.

The aim of this study was to develop a Delphi consensus statement between rheumatologists and radiologists for the diagnosis and monitoring of axial spondyloarthritis (axial-SpA).Following an extensive literature search to identify unmet needs and potential goals for a multidisciplinary approach, a scientific board comprising 28 Italian hospital-based rheumatologists (n=19) and radiologists (n=9) identified 8 "starting points", resulting in the development of 23 consensus statements covering issues from current practice guidelines to specific MRI protocols for the assessment of axial-SpA. Each participant anonymously expressed a level of agreement for each statement using a 5-point Likert scale (1="strongly disagree"; 5="strongly agree") via an online Delphi method.Total cumulative agreement (TCA) was defined as the sum of the percentage of response to items 4 ("agree") and 5 ("absolutely agree"). Consensus was defined as ≥80% total cumulative agreement for each statement.After the first round of voting (28 participants), positive consensus was reached for 28/31 (90.3%) statements. Statements without consensus (n=3) were discussed in a face-to-face plenary session prior to the second vote (28 participants). After the second round voting, positive consensus was attained for all 31 statements, with mean final TCA of 95.5% (range 82.1-100%).This Delphi consensus statement provides an aid to rheumatologists and radiologists for the diagnosis and monitoring of axial-SpA.