Evidence map›Paper›PMID 39091672›Full record

ArticleEClinicalMedicine2024

Long-term efficacy and safety of continued complement C1s inhibition with sutimlimab in cold agglutinin disease: CADENZA study Part B.

Alexander Röth, Sigbjørn Berentsen, Wilma Barcellini, Shirley D'Sa, Bernd Jilma, Marc Michel, Ilene C Weitz, Masaki Yamaguchi, Jun-Ichi Nishimura, Josephine M I Vos and 10 more

Registry-linked trialAbstract read
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In one paragraph

Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03347422 (A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03347422 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

TypeinterventionalSponsorBioverativ, a Sanofi companyRan2018 to 2021Enrolled42ConditionsCold Agglutinin DiseaseArmssutimlimab (BIVV009), placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Diagnosis and management of cold agglutinin disease.Hematology. American Society of Hematology. Education Program · 2025
    Review
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Alexander RöthDepartment of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Sigbjørn BerentsenDepartment of Research and Innovation, Haugesund Hospital, Haugesund, Norway.
Wilma BarcelliniFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Shirley D'SaUCLH Centre for Waldenström's Macroglobulinemia and Related Conditions, University College London Hospitals NHS Foundation Trust, London, UK.
Bernd JilmaDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Marc MichelHenri-Mondor University Hospital, Assistance Publique-Hôpitaux de Paris, UPEC, Créteil, France.
Ilene C WeitzKeck School of Medicine of USC, Los Angeles, CA, USA.
Masaki YamaguchiIshikawa Prefectural Central Hospital, Japan.
Jun-Ichi NishimuraOsaka University Graduate School of Medicine, Japan.
Josephine M I VosAmsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Joan CidDepartment of Hemotherapy and Hemostasis, ICMHO, IDIBAPS, Hospital Clinic, Barcelona, Catalonia, Spain.
Michael StorekSanofi, Cambridge, MA, USA.
Nancy WongSanofi, Cambridge, MA, USA.
Ronnie YooSanofi, Cambridge, MA, USA.
Deepthi JayawardeneSanofi, Cambridge, MA, USA.
Shruti SrivastavaSanofi, Bridgewater, NJ, USA.
Marek WardęckiSanofi, Warsaw, Poland.
Frank ShaferSanofi, Bridgewater, NJ, USA.
Michelle LeeSanofi, Bridgewater, NJ, USA.
Catherine M BroomeDivision of Hematology, MedStar Georgetown University Hospital, Washington, DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Cold agglutinin disease (CAD) is a rare autoimmune haemolytic anaemia mediated by the classical complement pathway (CP). Sutimlimab selectively targets complement C1s inhibiting classical CP activation. In CADENZA Part A (26-weeks), a placebo-controlled study in patients without recent transfusion history, sutimlimab reduced haemolysis, anaemia, and fatigue, and was generally well tolerated. Methods: The CADENZA study (NCT03347422) started in March 2018 (Part A) and completed in December 2021 (Part B). All patients in Part B were eligible to receive sutimlimab for up to 1 year after the last patient completed Part A. Efficacy and safety was assessed throughout Part B, until the last on-treatment visit with available assessment (LV), and after a 9-week washout. Findings: In total, 32/39 patients completed Part B; median treatment duration: 99 weeks. Similar sustained improvements in haemolysis, anaemia, and quality of life were observed in patients switching to sutimlimab and those continuing sutimlimab. Mean LV values for the combined group (ie, placebo-to-sutimlimab group and sutimlimab-to-sutimlimab group) improved from baseline for haemoglobin (≥11.0 g/dL on-treatment Interpretation: The CADENZA Part B results support the sustained efficacy and safety of sutimlimab for treatment of CAD; however, upon discontinuation disease activity reoccurs. Funding: Sanofi.

Indexed as

Autoimmune haemolytic anaemiaClassical complement pathwayCold agglutinin diseaseComplement C1sHaemolysisSutimlimab

Identifiers

PMID39091672
PMCPMC11293518

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.