Evidence map›Paper›PMID 30559259›Full record

Trial reportBlood2019

Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial.

Ulrich Jäger, Shirley D'Sa, Christian Schörgenhofer, Johann Bartko, Ulla Derhaschnig, Christian Sillaber, Petra Jilma-Stohlawetz, Michael Fillitz, Thomas Schenk, Gary Patou and 4 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it, 109 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Occurrence of Cold Agglutinin Disease among Patients with Autoimmune Hemolytic Anemia: A Hungarian Single-Center Experience.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Article
  6. Article
  7. Effects of OACS applied bio materials · 2026
    Article
  8. Article
  9. Article
  10. [Cold agglutinin disease (CAD)].Innere Medizin (Heidelberg, Germany) · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. [Sjögren's syndrome combined with cold agglutinin disease: A case report].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2023
    Article
  17. Article
  18. Article
  19. Observational
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Ulrich JägerDivision of Haematology, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.
Shirley D'SaWaldenströms, POEMS and Myeloma Clinics, University College London Hospitals, National Health Service Foundation Trust & Mount Vernon Cancer Centre, London, United Kingdom.
Christian SchörgenhoferDepartment of Clinical Pharmacology and.ORCID 0000-0002-2286-1077
Johann BartkoDepartment of Clinical Pharmacology and.
Ulla DerhaschnigDepartment of Clinical Pharmacology and.
Christian SillaberDivision of Haematology, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.
Petra Jilma-StohlawetzDepartment of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
Michael FillitzDepartment of Internal Medicine, Hanusch Krankenhaus, Vienna, Austria.
Thomas SchenkDepartment of Internal Medicine, Universitätsklinikum St. Pölten, St. Pölten, Austria.
Gary PatouBioverativ, a Sanofi company, Waltham, MA; and.
Sandip PanickerBioverativ, a Sanofi company, Waltham, MA; and.ORCID 0000-0001-7901-2730
Graham C ParryBioverativ, a Sanofi company, Waltham, MA; and.
James C GilbertBand Therapeutics, LLC, Belmont, MA.
Bernd JilmaDepartment of Clinical Pharmacology and.ORCID 0000-0001-5652-7977
Medical University of Vienna · ATHanusch Hospital · ATNational Health Service · GBUniversitätsklinikum St. Pölten · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cold agglutinin disease is a difficult-to-treat autoimmune hemolytic anemia in which immunoglobulin M antibodies bind to erythrocytes and fix complement, resulting in predominantly extravascular hemolysis. This trial tested the hypothesis that the anti-C1s antibody sutimlimab would ameliorate hemolytic anemia. Ten patients with cold agglutinin disease participated in the phase 1b component of a first-in-human trial. Patients received a test dose of 10-mg/kg sutimlimab followed by a full dose of 60 mg/kg 1 to 4 days later and 3 additional weekly doses of 60 mg/kg. All infusions were well tolerated without premedication. No drug-related serious adverse events were observed. Seven of 10 patients with cold agglutinin disease responded with a hemoglobin increase >2 g/dL. Sutimlimab rapidly increased hemoglobin levels by a median of 1.6 g/dL within the first week, and by a median of 3.9 g/dL (interquartile range, 1.3-4.5 g/dL; 95% confidence interval, 2.1-4.5) within 6 weeks (

Indexed as

Severity of Illness IndexAgedAnemia, HemolyticAnemia, Hemolytic, AutoimmuneAntibodies, Monoclonal, HumanizedComplement C1sFemaleFollow-Up StudiesHemolysisHumansMaleMiddle AgedPrognosisProspective StudiesAntibodies, Monoclonal, HumanizedComplement C1ssutimlimab

Identifiers

PMID30559259
PMCPMC6396179
OpenAlexW2905576105

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.