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About 370 results

ALLMedicine Cold Agglutinin Disease Center

Research & Reviews  181 results

Cold agglutinin disease revisited: A multinational, observational study of 232 patients.
https://doi.org/10.1182/blood.2020005674
Blood Berentsen S, Barcellini W et. al.

May 6th, 2020 - We retrospectively studied 232 patients with cold agglutinin disease (CAD) at 24 centers in five countries. In Norway and a northern region of Italy, the study was close to being population-based. For the first time, we demonstrate 4-fold differen...

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza Study)
https://clinicaltrials.gov/ct2/show/NCT03347422

Apr 23rd, 2020 - The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglu...

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
https://clinicaltrials.gov/ct2/show/NCT03347396

Apr 23rd, 2020 - The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=) 2 gram per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood trans...

Complementopathies and precision medicine.
https://doi.org/10.1172/JCI136094
The Journal of Clinical Investigation; Gavriilaki E, Brodsky RA

Apr 20th, 2020 - The renaissance of complement diagnostics and therapeutics has introduced precision medicine into a widened field of complement-mediated diseases. In particular, complement-mediated diseases (or complementopathies) with ongoing or published clinic...

Inhibition of complement C1s in patients with cold agglutinin disease: lessons learned ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7094024
Blood Advances; Gelbenegger G, Schoergenhofer C et. al.

Mar 16th, 2020 - Cold agglutinin disease (CAD) causes predominantly extravascular hemolysis and anemia via complement activation. Sutimlimab is a novel humanized monoclonal antibody directed against classical pathway complement factor C1s. We aimed to evaluate the...

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Guidelines  1 results

FDA grants orphan drug designation to APL-2 for autoimmune hemolytic anemia
https://www.healio.com/hematology-oncology/hematology/news/online/%7B2785cd04-4008-4105-91cc-e82f5573ee6f%7D/fda-grants-orphan-drug-designation-to-apl-2-for-autoimmune-hemolytic-anemia

Feb 4th, 2019 - The FDA granted orphan drug designation to the C3 complement inhibitor APL-2 for the treatment of autoimmune hemolytic anemia. Autoimmune hemolytic anemia refers to both cold agglutinin disease and warm autoimmune hemolytic anemia, which affect a ...

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Clinicaltrials.gov  183 results

Cold agglutinin disease revisited: A multinational, observational study of 232 patients.
https://doi.org/10.1182/blood.2020005674
Blood Berentsen S, Barcellini W et. al.

May 6th, 2020 - We retrospectively studied 232 patients with cold agglutinin disease (CAD) at 24 centers in five countries. In Norway and a northern region of Italy, the study was close to being population-based. For the first time, we demonstrate 4-fold differen...

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza Study)
https://clinicaltrials.gov/ct2/show/NCT03347422

Apr 23rd, 2020 - The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglu...

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
https://clinicaltrials.gov/ct2/show/NCT03347396

Apr 23rd, 2020 - The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=) 2 gram per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood trans...

Complementopathies and precision medicine.
https://doi.org/10.1172/JCI136094
The Journal of Clinical Investigation; Gavriilaki E, Brodsky RA

Apr 20th, 2020 - The renaissance of complement diagnostics and therapeutics has introduced precision medicine into a widened field of complement-mediated diseases. In particular, complement-mediated diseases (or complementopathies) with ongoing or published clinic...

Inhibition of complement C1s in patients with cold agglutinin disease: lessons learned ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7094024
Blood Advances; Gelbenegger G, Schoergenhofer C et. al.

Mar 16th, 2020 - Cold agglutinin disease (CAD) causes predominantly extravascular hemolysis and anemia via complement activation. Sutimlimab is a novel humanized monoclonal antibody directed against classical pathway complement factor C1s. We aimed to evaluate the...

see more →

News  5 results

Sutimlimab boosts hemoglobin, quality of life in cold agglutinin disease
https://www.mdedge.com/hematology-oncology/article/214191/anemia/sutimlimab-boosts-hemoglobin-quality-life-cold-agglutinin?channel=39313
Neil Osterweil

Dec 12th, 2019 - ORLANDO – An investigational selective inhibitor of the complement pathway, sutimlimab, induced rapid and sustained benefits in patients with cold agglutinin disease, a rare autoimmune hemolytic anemia with no currently approved effective therapie.

FDA grants orphan drug designation to APL-2 for autoimmune hemolytic anemia
https://www.healio.com/hematology-oncology/hematology/news/online/%7B2785cd04-4008-4105-91cc-e82f5573ee6f%7D/fda-grants-orphan-drug-designation-to-apl-2-for-autoimmune-hemolytic-anemia

Feb 4th, 2019 - The FDA granted orphan drug designation to the C3 complement inhibitor APL-2 for the treatment of autoimmune hemolytic anemia. Autoimmune hemolytic anemia refers to both cold agglutinin disease and warm autoimmune hemolytic anemia, which affect a ...

Potential treatment on the horizon for cold agglutinin disease
https://www.mdedge.com/hematology-oncology/article/192203/anemia/potential-treatment-horizon-cold-agglutinin-disease
HT Staff

Jan 2nd, 2019 - Red blood cells In a first-in-human trial, sutimlimab rapidly halted hemolysis, corrected anemia, precluded the need for transfusion, and caused no serious adverse effects in patients with cold agglutinin disease. Sutimlimab also “induced clinical.

Drug granted orphan designation for hemolytic anemia
https://www.mdedge.com/hematology-oncology/article/188833/anemia/drug-granted-orphan-designation-hemolytic-anemia
HT Staff

Mar 1st, 2016 - Red blood cells The European Commission (EC) has granted orphan drug designation for TNT009 to treat autoimmune hemolytic anemia, including cold agglutinin disease. TNT009 is a monoclonal antibody that selectively inhibits the classical complement.

Rituximab Use and Chronic Cold Agglutinin Disease
https://www.medscape.com/viewarticle/445043

Dec 17th, 2002 - Question Do you have any knowledge about rituximab use in a patient with chronic cold agglutinin disease (a lymphoproliferative disease in which monoclonal immunoglobulin M [IgM] causes agglutination of red blood cells in response to cold)? Could ...

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