Safety and Effectiveness of Sutimlimab in Cold Agglutinin Disease: A Real‐World International Experience
Year: 2026
Type: article
Study design: Observational Study
Abstract: Sutimlimab is a monoclonal antibody against complement fraction C1s approved for the treatment of hemolytic anemia due to cold agglutinin disease (CAD). Here, we analyzed and report the largest international CAD cohort of sutimlimab-treated patients ever reported to highlight its safety and effectiveness in the real-world setting. We accrued a cohort of 57 CAD patients (median age 73.5 years, 56% females). At baseline, patients had severe to moderate anemia (median Hb 8.9 g/dL) and active hemolysis, with a substantial transfusion burden despite a median of 2 prior therapies, including corticosteroids and rituximab. After sutimlimab initiation, median Hb increased by 2 g/dL within 2 weeks and reached 12 g/dL in 4 weeks, remaining stable up to 24 months. This improvement was paralleled by an early and durable normalization of hemolytic markers. Objective responses were observed in most patients by week 2, with complete responses in approximately 50% by Week 4 and 55%-60% during long-term follow-up. Peripheral cold-induced symptoms did not improve and were associated with reduced response rates. Inadequate reticulocytosis also predicted poorer response and suggests the combination with recombinant erythropoietin. Sutimlimab was generally well tolerated. Infections were the most frequent adverse events (23%); severe infections predominantly occurred in previously rituximab-treated individuals. Hemolytic exacerbations occurred in 16% of cases, mostly due to infections. Thrombotic complications were rare. Overall, sutimlimab demonstrated rapid, durable effectiveness and a favorable safety profile in heavily pretreated real-world CAD patients.
Source: American Journal of Hematology
DOI: 10.1002/ajh.70307
Authors: Bruno Fattizzo, Elisa Sambruna, Yoshitaka Miyakawa, Marc Michel, Carlo Visco, Michael Fillitz, George Kannourakis, Maria Bruna Greve, Moritz Kleemiss, Johan Cid, Andrea Patriarca, Laura Pavan, Arbana Dizdari, Nilla Maschio, Antonella Sau, Cinzia Bitetti, Riccardo Mario Colombo, Luigi Curreli, Dorela Lame, Uros Markovic, Fabrizio Pappagallo, Giacinto Luca Pedone, Davide Rapezzi, Vincenzo Sammartano, Nicola Tumedei, Antonio Giovanni Solimando, Jalink Marit, Luana Fianchi, Jahanzaib Khwaja, Antonio De Vivo, Francesco Lanza, Fabrizio Vianello, Esther N. Oliva, Catherine Broome, Francesco Passamonti, Ulrich Jaeger, Bernd Jilma, Guillaume Moulis, Wilma Barcellini
Institutions: University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Saitama Medical University, Université Paris-Est Créteil, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Henri-Mondor, University of Verona, Hanusch Hospital, Ballarat Health Services, Azienda ospedaliera "Bianchi-Melacrino-Morelli", University Hospital Bonn, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Universitat de Barcelona, Azienda Ospedaliero Universitaria Maggiore della Carita, University of Padua, Ospedale "Santa Maria delle Croci" di Ravenna, Istituto Oncologico Veneto, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", University of Bari Aldo Moro, Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo, Federico II University Hospital, University of Naples Federico II, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, Leiden University Medical Center, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, London North West Healthcare NHS Trust, University of Bologna, Georgetown University, Medical University of Vienna, Centre Hospitalier Universitaire de Toulouse
Language: English
Topic: Blood groups and transfusion
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
Funder: Ministero della Salute
OpenAlex ID: W7154590978