Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin (hf-SCIg) for inflammatory myositis: a multicenter retrospective real-world observational study.

Background: Subcutaneous immunoglobulin (SCIg) is a promising alternative to intravenous Ig (IVIg) for the treatment of idiopathic inflammatory myositis (IIM), thanks to its more favorable safety profile, reduced costs, and lower impact on patients' quality of life. We assessed the short- and long-term effectiveness and safety of recombinant human hyaluronidase-facilitated SCIg (hf-SCIg) in patients with IIM treated at different referral centers in Italy.

Methods: A multicenter, retrospective, real-life cohort study was conducted on consecutive adult patients diagnosed with IIM according to the EULAR/ACR criteria, treated with hf-SCIg for remission induction or maintenance.

Beyond the Plate: Patient Perspectives on Diet and Daily Life with Crohn's Disease-A National Survey.

Crohn's disease (CD) is a chronic inflammatory bowel disease that significantly affects patients' quality of life. Nutrition is increasingly recognized as a modifiable factor influencing disease activity and symptom management. Despite growing interest, structured dietary guidelines for CD are lacking, and patients often rely on personal experience or fragmented advice.

Treatment targets in IBD: is it time for new strategies?

Inflammatory bowel diseases' traditional management focused primarily on symptom control, often failing to prevent long-term complications such as disease progression, disabilities, hospitalizations and surgeries. The introduction of biologics and small molecules has revolutionized IBD management, enhancing inflammation control. A pivotal advance in this field is represented by the Treat-to-Target approach, which prioritizes the achievement of specific goals like endoscopic remission and biomarker normalization, thus moving beyond symptomatic relief.

Positioning Guselkumab in The Treatment Algorithm of Patients with Crohn's Disease.

Guselkumab, a selective interleukin-23 (IL-23) inhibitor, has emerged as a promising biologic therapy for the management of patients with moderate-to-severe Crohn's disease (CD) and has been recently approved for its treatment. Unlike conventional therapies, guselkumab offers a different mechanism of action by selectively inhibiting IL-23, a key cytokine implicated in the pathogenesis of CD. IL-23 drives intestinal inflammation through activation of the Th17 cell pathway and other immune processes, positioning IL-23 inhibition as a critical therapeutic approach.

Opinion of the Italian Association of Myology on Ataluren for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy.

The Italian Duchenne muscular dystrophy expert clinicians, gathered in the Italian Association of Myology (AIM), intend to express a position against the suspension of the Marketing Authorization of ataluren (Translarna) for the treatment of nonsense mutation Duchenne muscular dystrophy. The marketing authorization has been recently withdrawn by the European Commission following a recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency. This negative recommendation was based on the fact that three randomized controlled trials of ataluren in nonsense mutation Duchenne muscular dystrophy (007, 020, and 041) have failed to show statistically significant differencs in favor of the treatment in the selected primary outcomes for each individual study, i.

Association of circulating levels of anti-CarP antibodies with disease activity, disability and radiological damage in rheumatoid arthritis patients: an open-label, observational study.

Autoantibodies directed against carbamylated proteins (anti-CarP) have been recently identified as predictors for RA development. The aim of this study was to determine the positivity of anti-CarP antibodies in a real-life cohort of RA patients and their association with radiological damage, disability and disease activity. In this open-label, observational, cross-sectional study 69 RA patients and 16 healthy controls (HC) were recruited.

Therapeutic adherence in inflammatory bowel disease: User guide from a multidisciplinary modified Delphi consensus.

Background: Therapeutic non-adherence can significantly impair the quality of life of patients affected by inflammatory bowel disease (IBD), leading to worse treatment outcomes, more frequent hospitalizations, and increased healthcare expenses. Identifying and enhancing treatment adherence is a key goal in managing IBD.

Aim: To establish a consensus on the definition of therapeutic adherence, determination of risk factors, and identify patients with IBD at higher risk of non-adherence.

Deucravacitinib in patients with inflammatory bowel disease: 12-week efficacy and safety results from 3 randomized phase 2 studies in Crohn's disease and ulcerative colitis.

Background And Aims: Tyrosine kinase 2 is a downstream intracellular mediator of interleukin-23 signaling, which has a key role in the pathogenesis of inflammatory bowel disease. Deucravacitinib is a novel, oral, selective, allosteric tyrosine kinase 2 inhibitor currently approved for the treatment of adults with moderate to severe plaque psoriasis.

Methods: Here we describe 3 randomized, double-blind, placebo-controlled phase 2 studies of deucravacitinib in patients with moderately to severely active Crohn's disease (LATTICE-CD [NCT03599622]) or ulcerative colitis (LATTICE-UC [NCT03934216] and IM011-127 [NCT04613518]).

Symptom Resolution and Meaningful Improvement in Quality of Life With Risankizumab in Patients With Ulcerative Colitis: Post Hoc Analysis of the Randomized INSPIRE and COMMAND Studies.

Introduction: Patients with ulcerative colitis (UC) experience disruptive symptoms that can impair quality of life (QoL). This study examined the effect of risankizumab (RZB) induction and maintenance treatment on symptom resolution and health-related QoL (HRQoL) outcomes.

Methods: For the 12-week induction, patients were randomized to intravenous (IV) RZB 1,200 mg (RZB1200) or placebo (PBO).

Target trial emulation to evaluate the effect of immune-related adverse events on outcomes in metastatic urothelial cancer.

Background: Immune checkpoint inhibitors (ICIs) are an important therapeutic pillar in metastatic urothelial carcinoma (mUC). The occurrence of immune-related adverse events (irAEs) appears to be associated with improved outcomes in observational studies. However, these associations are likely affected by immortal time bias and do not represent causal effects.

Multiple Ileal and Colonic Stenoses: Is It Always Crohn's Disease?

A 62-year-old woman presented with multiple ileal and colonic stenoses, initially suspected to be Crohn's disease. Despite unremarkable endoscopic biopsies, surgery was performed due to clinical deterioration, and histological analysis confirmed the presence of metastatic breast cancer. This case highlights the importance of considering metastatic disease in the differential diagnosis of gastrointestinal (GI) strictures, particularly when inflammatory bowel disease markers are inconclusive or marginal.

Raising the bar in ulcerative colitis management.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by growing incidence and prevalence around the world in the last few decades. The range of available existing treatment and strategies for its management is being implemented. Given the introduction of newly developed molecules and the lack of specific guidelines, drug positioning may represent a tough clinical challenge.

ARE WE READY FOR MULTIPLE SWITCHES BETWEEN REFERENCE PRODUCTS AND BIOSIMILARS?

Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment.

RANO 2.0 criteria: concepts applicable to the neuroradiologist's clinical practice.

Purpose Of Review: The Response Assessment in Neuro-Oncology (RANO) 2.0 criteria aim at improving the standardization and reliability of treatment response assessment in clinical trials studying central nervous system (CNS) gliomas. This review presents the evidence supporting RANO 2.

Proportion of inflammatory bowel diseases patients with suboptimal disease control in daily clinical practice-Real-world evidence from the inflammatory bowel diseases-podcast study.

Background: Crohn's disease and ulcerative colitis (UC) are inflammatory bowel diseases (IBD) characterized by a progressive nature of the disease resulting in subsequent intestinal damage, limited efficacy of current treatments and suboptimal disease management and a significant burden for patients.

Objectives: The IBD-PODCAST study aims to estimate the proportion of Crohn's disease and UC patients with suboptimal disease control (SDC) in a real-world setting.

Methods: A non-interventional and cross-sectional study was conducted across 103 sites in 10 countries (Austria, Belgium, Canada, Germany, Greece, Italy, Portugal, Spain, Turkey, and UK).

Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey.

: The treatment of patients with mild-to-moderate ulcerative colitis (UC) is challenging. Although there are commonly used guidelines, therapy optimization is not standardized. We conducted a survey to investigate the management and treatment of patients with mild-to-moderate UC.

Evaluating the pharmacokinetics of upadacitinib for the treatment of moderate-to-severe Crohn's disease.

Introduction: Janus kinases (JAK) are enzymes involved in signaling pathways that activate the immune system. Upadacitinib, an oral small molecule, is the first JAK inhibitor approved by FDA and EMA for the treatment of moderately to severely active Crohn's disease (CD), following successful phase II and III trials. Compared to other JAK inhibitors, upadacitinib has a high selectivity toward JAK1.

MMX mesalamine in ulcerative colitis: Major advantages towards classical mesalamine formulations.

Medical therapy is the cornerstone of ulcerative colitis (UC) management and aims to induce and maintain remission. In case of mild-to-moderate UC, mesalamine (5-ASA) is the first-line option. 5-ASA requires local release at the level of the inflamed mucosa to exert its therapeutic action.

TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis.

The pivotal role of TL1A in modulating immune pathways crucial for inflammatory bowel disease (IBD) and intestinal fibrosis offers a promising therapeutic target. Phase 2 trials (TUSCANY and ARTEMIS-UC) evaluating an anti-TL1A antibody show progress in expanding IBD therapeutic options. First-in-human data reveal reduced expression of genes associated with extracellular matrix remodeling and fibrosis post-anti-TL1A treatment.

Patient Preferences for Treatment Attributes in Inflammatory Bowel Disease: Results From a Large Survey Across Seven European Countries Using a Discrete Choice Experiment.

Background: Inflammatory bowel disease requires long-term treatment; therefore, understanding patient preferences is important in aiding informed treatment decision making. This study explored patients' preferences for treatment attributes of available inflammatory bowel disease therapies.

Methods: Adult patients from 7 European countries who self-reported previous/current treatment for Crohn's disease (CD) or ulcerative colitis (UC) participated in an online survey via the Carenity platform.

Addition of neoadjuvant chemotherapy to a 'quadrifecta' composite in radical cystectomy.

Objectives: To evaluate the impact of incorporating neoadjuvant chemotherapy (NAC) into the 'quadrifecta' outcomes composite for reporting outcomes of radical cystectomy (RC) creating a pentafecta score.

Patients And Methods: This is a retrospective multicentre analysis of patients treated with RC, with or without NAC, for bladder cancer between 2002 and 2023. The primary outcome was the effect of adding NAC to a quadrifecta outcomes composite on cancer-specific (CSS) and overall survival (OS).