Recordati Rare Diseases to Share New Data at the American Society of Hematology (ASH) Meeting

Poster presentations at ASH highlight advances in the understanding and research of Castleman disease, cold agglutinin disease, B-cell lymphoma, and other hematologic conditions

BRIDGEWATER, N.J., Nov. 3, 2025 /PRNewswire/ -- Recordati Rare Diseases Inc. today announced the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67^th American Society of Hematology (ASH) Annual Meeting, which takes place December 6-9, 2025, in Orlando, Fla. In a series of nine poster presentations, Recordati researchers and independent investigators will present research detailing advances in Castleman disease (CD), cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS), and immune-related complications of CAR T-cell therapy. Highlights include a report on the development of an artificial intelligence (AI) model that evaluates CD tissue samples; an analysis of the morbidity burden and healthcare costs among patients with idiopathic multicentric Castleman disease (iMCD); the first real-world evaluation of sutimlimab in the treatment of patients with CAD or CAS; and a prospective evaluation of siltuximab in the prevention or treatment of cytokine release syndrome (CRS) after CAR T-cell therapy.

"We are particularly excited about the long-term safety data for sutimlimab in cold agglutinin disease and the growing body of research investigating the use of siltuximab in Castleman disease," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "Also notable is the poster describing an innovative, AI-based approach to lymph node analysis, which could represent a meaningful step toward earlier and more consistent diagnosis of Castleman disease, one of the most difficult hematologic conditions to diagnose accurately. Altogether, the datasets presented at ASH 2025 reflect Recordati's ongoing commitment to advancing care for people living with rare hematologic disorders."

"The ASH Annual Meeting is an important opportunity to showcase research advances in hematologic diseases, and we are pleased that the meeting organizers have accepted nine abstracts related to our therapies," said Mohamed Ladha, President and General Manager at Recordati Rare Diseases North America. "Together with our independent research partners, Recordati is at the forefront of advancing potential therapeutic solutions for people living with devastating conditions such as Castleman disease. We look forward to these data sparking further dialogue and collaboration as we continue in our efforts to improve patients' lives."

The ASH 2025 Annual Meeting will feature the following poster presentations:

Castleman Disease

Poster number: 2606
Title: Retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls (BURDEN-iMCD)
Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic 

Poster number: 3001
Title: Comprehensive analysis of subtype-specific outcomes and management in Castleman disease: a 20-year cohort study
Presenting author: Yoshito Nishimura, MD, PhD, MPH, Mayo Clinic

Poster number: 3002
Title: Automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model
Presenting author: Muir Morrison, PhD, University of Utah

Poster number: 3009
Title: Pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab
Presenting author: Bridget Austin, MS, Perelman School of Medicine, University of Pennsylvania, Center for Cytokine Storm Treatment & Laboratory

Poster number: 3006
Title: Epidemiology and clinical characteristics of idiopathic multicentric Castleman disease in Spain (ARCANA study): Prevalence cohort
Presenting author: José-Tomás Navarro, MD, PhD, Catalan Institute of Oncology, Josep Carreras Leukaemia Research Institute

Poster number: 4788
Title: Siltuximab-mediated suppression of CRP is associated with clinical response in idiopathic multicentric Castleman disease
Presenting author: Jean-Francois Rossi, MD, PhD, Université de Montpellier

Cold Agglutinin Disease (CAD)

Poster number: 6242
Title: Real-world safety of sutimlimab in patients with CAD/CAS: a multinational, multicenter, observational, prospective cohort study
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

CAR T-Cell Therapy Toxicity (including in B-Cell Lymphoma)*

Poster number: 2385
Title: Safety and immunomodulatory effects of siltuximab prophylaxis prior to standard of care CD19 directed chimeric antigen receptor T-cell (CD19.CART) therapy for B-cell lymphomas: final Phase I trial results
Presenting author: Nathan Denlinger, DO, MS, The Ohio State University Wexner Medical Center, James Comprehensive Cancer Center

Poster number: 5919
Title: Siltuximab versus tocilizumab for the management of CAR T-cell associated cytokine release syndrome
Presenting author: Mayur Narkhede, MD, University of Alabama at Birmingham

*These studies were conducted as investigator-sponsored studies without research involvement by Recordati.

About Idiopathic Multicentric Castleman Disease (iMCD)
Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a central pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats.

About Cold Agglutinin Disease (CAD)
Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients' quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30.

About Recordati Rare Diseases
Recordati Rare Diseases is Recordati's dedicated business unit focused on Rare Diseases. Recordati is an international pharmaceutical Group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas, and APAC, with over 4,500 employees.

Recordati Rare Diseases' mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis, and expand availability of treatments for people with rare diseases.

Recordati Rare Diseases Inc. is the company's U.S. corporate headquarters located in Bridgewater, NJ, with the global headquarter offices located in Milan, Italy. 

For full prescribing information, including approved indications and important safety information about marketed products, please visit: https://recordatirarediseases.us/our-products/.

SOURCE Recordati