Real world use of sutimlimab in patients with cold agglutinin disease: An international study

Abstract Sutimlimab has demonstrated high efficacy in increasing hemoglobin levels and reducing markers of hemolysis in patients with cold agglutinin disease (CAD) in clinical trials. However, data on its real-world use are limited. We evaluated 54 patients treated with Sutimlimab through post-trial access or compassionate use programs in Austria, France, Germany, Italy, Japan, Spain, UK, and Australia. Past medical history, CAD treatments and laboratory parameters were collected at baseline and at weeks 2, 4, 8, 12, 16, and 24, and at months 12, 18, 24, after starting sutimlimab. Response was classified as partial (Hb >10 g/dL), complete (>12 g/dL), or no response. The median age was 66 years (range 45-88) and 31 (57%) patients were females. The direct antiglobulin test (DAT) was positive for C3 alone in 35 patients, for IgG and C3 in 8, and for IgM and C3 in 10. The median CA titer was 1:1,024 (range, 1:4 to >1:25,000). CAD bone marrow infiltrate was observed in 23 patients. Prior CAD treatments (median 3, 1-4) included corticosteroids (31), rituximab (40), and rituximab–bendamustine (12). Pre-Sutimlimab complications included 8 G≥ 3 infections and 12 thrombotic events. The median number of RBC transfusions in the 6 months pre-Sutimlimab was 2 (0–18). At baseline, median Hb was 8.4 g/dL (2.9–10.8), LDH 1.6× ULN (0.8–3.6), unconjugated bilirubin 1.9 mg/dL (0.8–7.49), and reticulocytes 107×10⁹/L (10–340). Sutimlimab was administered as monotherapy (n=42) or in combination with erythropoietin (8), corticosteroids (2), or both (2). The median follow-up was 28 months (6–81). Hb increased over time: +2.0 g/dL at 2 weeks, +2.7 g/dL at 4 weeks, and +3 g/dL at 8 weeks, followed by sustained levels up to 24 months. Overall response rates (PR + CR) were 78%, 75%, 84%, 85%, 86%, 80%, 77%, 84%, and 85% at the respective timepoints. An additional 14% of patients showed an Hb increase at week 2 and 18% at week 4. All but 7 patients became transfusion-independent. Sutimlimab was discontinued in 2 patients due to lack of response, in 1 due to overt Waldenström's macroglobulinemia, and in 7 based on their own decision with maintenance of good CAD control; 13 patients had an infection (G3 in 7, 1 H. influenzae pneumonia), 1 thrombosis (DVT of basilic vein), and 8 hemolytic exacerbations. At the last follow up only one patient had died due to progressive WM with sepsis. Sutimlimab confirmed to be an effective treatment in improving anemia and resolving transfusion dependence in more than 70% patients in the real world.

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Journal
Blood
Published
2025-11-03
DOI
https://doi.org/10.1182/blood-2025-1100
Citations
1
Primary Topic
Blood groups and transfusion
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article
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1.77
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article

Real world use of sutimlimab in patients with cold agglutinin disease: An international study

Uroš Markovic, Marta Bortolotti, Joan Cid, Francesco Lanza et al.
1 citations
Blood
Blood groups and transfusion
1.77
article

Real world use of sutimlimab in patients with cold agglutinin disease: An international study

Uroš Markovic, Marta Bortolotti, Joan Cid, Francesco Lanza, Vincenzo Sammartano, Wilma Barcellini, Guillaume Moulis, George Kannourakis, Cinzia Bitetti, Carlo Visco, Francesco Versino, Antonio De Vivo, Mark Greve, Luana Fianchi, Michael Fillitz, Antonio Giovanni Solimando, Nilla Maschio, Fabrizio Vianello, Giacinto Luca Pedone, Jahanzaib Khwaja, Antonella Sau, Dorela Lame, Bruno Fattizzo, Bernd Jilma, Elisa Sambruna, Moritz Kleemiss, Nicola Tumedei, Laura Pavan, Esther Natalie Oliva, Andrea Patriarca, Marc Michel, Davide Rapezzi, Luigi Curreli, Yoshitaka Miyakawa, Ulrich Jaeger, Arbana Dizdari
article en
1 citations

Abstract

Abstract Sutimlimab has demonstrated high efficacy in increasing hemoglobin levels and reducing markers of hemolysis in patients with cold agglutinin disease (CAD) in clinical trials. However, data on its real-world use are limited. We evaluated 54 patients treated with Sutimlimab through post-trial access or compassionate use programs in Austria, France, Germany, Italy, Japan, Spain, UK, and Australia. Past medical history, CAD treatments and laboratory parameters were collected at baseline and at weeks 2, 4, 8, 12, 16, and 24, and at months 12, 18, 24, after starting sutimlimab. Response was classified as partial (Hb >10 g/dL), complete (>12 g/dL), or no response. The median age was 66 years (range 45-88) and 31 (57%) patients were females. The direct antiglobulin test (DAT) was positive for C3 alone in 35 patients, for IgG and C3 in 8, and for IgM and C3 in 10. The median CA titer was 1:1,024 (range, 1:4 to >1:25,000). CAD bone marrow infiltrate was observed in 23 patients. Prior CAD treatments (median 3, 1-4) included corticosteroids (31), rituximab (40), and rituximab–bendamustine (12). Pre-Sutimlimab complications included 8 G≥ 3 infections and 12 thrombotic events. The median number of RBC transfusions in the 6 months pre-Sutimlimab was 2 (0–18). At baseline, median Hb was 8.4 g/dL (2.9–10.8), LDH 1.6× ULN (0.8–3.6), unconjugated bilirubin 1.9 mg/dL (0.8–7.49), and reticulocytes 107×10⁹/L (10–340). Sutimlimab was administered as monotherapy (n=42) or in combination with erythropoietin (8), corticosteroids (2), or both (2). The median follow-up was 28 months (6–81). Hb increased over time: +2.0 g/dL at 2 weeks, +2.7 g/dL at 4 weeks, and +3 g/dL at 8 weeks, followed by sustained levels up to 24 months. Overall response rates (PR + CR) were 78%, 75%, 84%, 85%, 86%, 80%, 77%, 84%, and 85% at the respective timepoints. An additional 14% of patients showed an Hb increase at week 2 and 18% at week 4. All but 7 patients became transfusion-independent. Sutimlimab was discontinued in 2 patients due to lack of response, in 1 due to overt Waldenström's macroglobulinemia, and in 7 based on their own decision with maintenance of good CAD control; 13 patients had an infection (G3 in 7, 1 H. influenzae pneumonia), 1 thrombosis (DVT of basilic vein), and 8 hemolytic exacerbations. At the last follow up only one patient had died due to progressive WM with sepsis. Sutimlimab confirmed to be an effective treatment in improving anemia and resolving transfusion dependence in more than 70% patients in the real world.

BloodVol. 146(Supplement 1)
University of Verona (IT), University of Vienna (AT), Mater Health Services (AU), University of Bonn (DE), University of Padua (IT), Tokyo Medical University (JP), Université Fédérale de Toulouse Midi-Pyrénées (FR), University of Milan (IT), London North West Healthcare NHS Trust (GB), Agostino Gemelli University Polyclinic (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), University of Catania (IT), Ospedale Maggiore (IT), Toulouse School of Economics (FR), Toulouse Mathematics Institute (FR), Hanusch Hospital (AT), Sociedad Española de Trombosis y Hemostasia (ES), Istituto Nazionale di Fisica Nucleare, Sezione di Padova (IT), Ospedali Riuniti di Ancona (IT), Ospedale di Santo Spirito (IT), Azienda Unità Sanitaria Locale Della Romagna (IT), Ballarat Health Services (AU), Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo (IT), Fondazione Centro Marino Internazionale (IT), The London College (GB), Institut Mondor de Recherche Biomédicale (FR), Novamont (Italy) (IT), Istituto Nazionale per la Fisica della Materia (IT), University College London (GB), University of Bari Aldo Moro (IT), University of Reggio Calabria (IT), University of Naples Federico II (IT), Medical University of Vienna (AT), University of Bologna (IT)
Openalex Percentile: Top 11%
Blood groups and transfusion
1.77
DOIOpen Access PDFOpenAlex
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