Updated global consensus guidelines for cold agglutinin disease (CAD), alongside post-hoc Phase 3 analysis and real-world data, supplement evidence of sutimlimab long-term safety and efficacy in CAD

Research findings and the first globally validated symptom burden tool for idiopathic Castleman disease (iMCD) advance understanding and management of Castleman disease

BRIDGEWATER, N.J., Nov. 12, 2026 /PRNewswire/ -- Recordati Rare Diseases Inc. today announced new data presentations across its rare hematology portfolio at the 68^th American Society of Hematology (ASH) Annual Meeting and Exposition, December 12-15, 2026, in New Orleans, La. Recordati researchers and independent investigators will present findings from  five studies spanning clinical research, diagnostic and disease management tools for cold agglutinin disease (CAD) and idiopathic multicentric Castleman disease (iMCD). Two additional iMCD abstracts are published in the November online supplement of Blood, the peer-reviewed journal of ASH. 

Highlights include poster presentations on CAD, a rare type of autoimmune hemolytic anemia (AIHA), including international expert consensus treatment guidelines, a post-hoc analysis of the pivotal Phase 3 sutimlimab CARDINAL and CADENZA trials in CAD, and new real-world data from the CADENCE registry. These supplement guidance for patient care, and existing evidence extending beyond the duration of clinical trials of long-term sutimlimab safety and efficacy in CAD.

In iMCD research, there will be an oral presentation on an internationally validated patient-reported outcomes scale to assess disease symptom burden over time. Additional studies explore tools to support diagnostic accuracy and consistency of iMCD, including global use of an expert-curated, disease-specific digital pathology platform. Multicentric Castleman disease commonly presents with enlarged lymph nodes in multiple regions of the body and is often misdiagnosed because it mimics other diseases.

"We are excited about the progress that will be discussed at this meeting around the diagnosis and treatment of CAD and iMCD," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "This also includes data around the long-term management of these diseases. Through collaborations with researchers worldwide, we aim to continually advance care for patients living with these conditions."

"Recordati is proud to continue our support of the American Society of Hematology Annual Meeting as we share research that reflects our commitment to patients with rare hematology and oncology disorders," said Melissa Koomey, President and General Manager of Recordati Rare Diseases North America. "We look forward to continuing our dialogue with the hematology/oncology community when we gather in December."

The ASH 2026 Annual Meeting will feature the following presentations from Recordati and external investigators:

Cold Agglutinin Disease (CAD)

Title: Multinational Expert Delphi Consensus on Diagnosis and Treatment of Cold Agglutinin Disease*
Poster number: 4633
Presenting author: Ilene C. Weitz, MD, Keck School of Medicine, University of Southern California, Los Angeles

Title: Impact of delayed dosing on hemolytic markers and complement pathway activity in the phase 3 CARDINAL and CADENZA studies of sutimlimab in cold agglutinin disease: a post-hoc analysis
Poster number: 2875
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

Title: Baseline characteristics of cold agglutinin disease/cold agglutinin syndrome patients enrolled in the international CADENCE registry
Poster number: 1113
Presenting author: Catherine M. Broome, MD, Lombardi Cancer Center, MedStar Georgetown University

Title: Updated real-world outcomes of sutimlimab in patients with cold agglutinin disease/cold agglutinin syndrome from CADENCE: a multinational, multi-center, observational, prospective cohort study
Poster number: 4634
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

Castleman Disease

Title: Idiopathic multicentric Castleman disease (iMCD) symptom burden scale (ISBUS): International development and validation of a first-ever tool for assessing symptom burden in iMCD
Oral presentation number: 462
Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic Cancer Institute
Presentation date & location: Saturday, December 12, 5:15 PM CT; Room: MCCNO - 260-262

Title: Scaling rare-disease pathology expertise: Real-world adoption of a whole-slide imaging and histologic grading platform for Castleman disease
Abstract book publication: 8612
Primary author: Robert S. Ohgami, MD, PhD, University of Utah, and ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ in Salt Lake City

Title: Divergent outcomes following treatment pauses in idiopathic multicentric Castleman disease: A registry-based case series
Abstract book publication: 6559
Primary author: Joshua Brandstadter, MD, PhD, Hospital of the University of Pennsylvania

*Triducive Partners Ltd. independently provided facilitation of the Delphi process and medical writing support. Funding was provided by Recordati Rare Disease Inc.

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 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 key 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.

INDICATION

ENJAYMO® (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS
Serious Infections Including Those Caused by Encapsulated Bacteria

• ENJAYMO, a proximal classical complement C1s inhibitor, increases susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.
• Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. 
• Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO in the two phase 3 trials. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to Klebsiella pneumoniae.  
• Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor.
• If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccine(s), administer as soon as possible.
• Vaccination does not eliminate the risk of serious encapsulated bacterial infections. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
• If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
  • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
  • Consider patients' immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

• Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 trials, 29% (19/66) of patients treated with ENJAYMO experienced infusion-related reactions. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
• Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
• Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

• Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
• In clinical trials, 4.5% (3/66) of patients developed a relapse or worsening of previously diagnosed autoimmune disease.
• Monitor ENJAYMO patients for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

• If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, eg, elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

• The most common adverse reactions in the CADENZA trial (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in the CARDINAL trial (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea

Please see full Prescribing Information.

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 around 4,700 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/.

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