{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T13:51:26Z","timestamp":1789480286115,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,5,29]],"date-time":"2023-05-29T00:00:00Z","timestamp":1685318400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cold agglutinin disease (CAD) is a rare, autoimmune, classical complement pathway (CP)\u2010mediated hemolytic anemia. Sutimlimab selectively inhibits C1s of the C1 complex, preventing CP activation while leaving the alternative and lectin pathways intact. In Part A (26\u2009weeks) of the open\u2010label, single\u2010arm, Phase 3 CARDINAL study in patients with CAD and a recent history of transfusion, sutimlimab demonstrated rapid effects on hemolysis and anemia. Results of the CARDINAL study Part B (2\u2010year extension) study, described herein, demonstrated that sutimlimab sustains improvements in hemolysis, anemia, and quality of life over a median of 144\u2009weeks of treatment. Mean last\u2010available on\u2010treatment values in Part B were improved from baseline for hemoglobin (12.2\u2009g\/dL on\u2010treatment versus 8.6\u2009g\/dL at baseline), bilirubin (16.5\u2009\u03bcmol\/L on\u2010treatment versus 52.1\u2009\u03bcmol\/L at baseline), and FACIT\u2010Fatigue scores (40.5 on\u2010treatment versus 32.4 at baseline). In the 9\u2010week follow\u2010up period after sutimlimab cessation, CP inhibition was reversed, and hemolytic markers and fatigue scores approached pre\u2010sutimlimab values. Overall, sutimlimab was generally well tolerated in Part B. All 22 patients experienced \u22651 treatment\u2010emergent adverse event (TEAE); 12 (54.5%) patients experienced \u22651 serious TEAE, including seven (31.8%) with \u22651 serious infection. Three patients discontinued due to a TEAE. No patients developed systemic lupus erythematosus or meningococcal infections. After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. In conclusion, the CARDINAL 2\u2010year results provide evidence of sustained sutimlimab effects for CAD management, but that disease activity reoccurs after treatment cessation. NCT03347396. Registered November 20, 2017.<\/jats:p>","DOI":"10.1002\/ajh.26965","type":"journal-article","created":{"date-parts":[[2023,5,29]],"date-time":"2023-05-29T14:10:10Z","timestamp":1685369410000},"page":"1246-1253","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Sustained inhibition of complement C1s with sutimlimab over 2\u2009years in patients with cold agglutinin disease"],"prefix":"10.1002","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4414-7699","authenticated-orcid":false,"given":"Alexander","family":"R\u00f6th","sequence":"first","affiliation":[{"name":"Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen University of Duisburg\u2010Essen  Essen 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