Recordati Rare Diseases Inc. announced the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida. The company will showcase nine poster presentations featuring research advances in Castleman disease, cold agglutinin disease, and immune-related complications of CAR T-cell therapy.
Key Research Highlights
The presentations include several notable developments in rare disease research. Among the most significant is the first real-world evaluation of sutimlimab in treating patients with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Additionally, researchers will present findings on an artificial intelligence model that evaluates Castleman disease tissue samples, potentially representing a breakthrough in diagnostic capabilities.
"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."
Castleman Disease Research Portfolio
Six presentations will focus on Castleman disease research, covering various aspects from epidemiology to treatment outcomes. The studies include a retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls, conducted by researchers at Cleveland Clinic.
A 20-year cohort study from Mayo Clinic will provide comprehensive analysis of subtype-specific outcomes and management in Castleman disease. The University of Utah will present research on automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model.
Pediatric research will be represented through a study from the University of Pennsylvania's Center for Cytokine Storm Treatment & Laboratory, demonstrating that pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab treatment.
Cold Agglutinin Disease and CAR T-Cell Therapy Studies
The cold agglutinin disease research will feature a multinational, multicenter, observational, prospective cohort study examining the real-world safety of sutimlimab in patients with CAD or CAS, presented by researchers from the West German Cancer Center.
Two studies will address CAR T-cell therapy complications, including final Phase I trial results on the safety and immunomodulatory effects of siltuximab prophylaxis prior to CD19 directed chimeric antigen receptor T-cell therapy for B-cell lymphomas. A comparative study will examine siltuximab versus tocilizumab for managing CAR T-cell associated cytokine release syndrome.
Disease Background and Clinical Significance
Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. The condition's symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making accurate diagnosis challenging. Some patients with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that plays a central pathological role in the disease and may explain symptoms such as swollen lymph nodes, fever, unexplained weight loss, and night sweats.
Cold agglutinin disease is a rare type of autoimmune hemolytic anemia 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. The condition causes severe, debilitating fatigue and other clinical manifestations that significantly 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.
Company Commitment to Rare Disease Research
"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."
The research presentations reflect Recordati's ongoing commitment to advancing care for people living with rare hematologic disorders. The company operates as Recordati's dedicated business unit focused on rare diseases, with a mission to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies.
