Trial reportThe New England journal of medicine2017
Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease.
2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 465 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
465citing papers in PubMed, 2 pooled it
32.7field-weighted citation impact, top 1% of its field
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.
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.
A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Sickle Cell-Related Pain Crises
Crizanlizumab for Treating COVID-19 Vasculopathy
Who cites it
465 citing papers in PubMed, 2 syntheses or guidelines pooled it, 853 citations in OpenAlex.
- Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue.Journal of clinical apheresis · 2026Guideline
- Practical guide for disease-modifying medication management of children and adolescents with sickle cell disease.Hematology. American Society of Hematology. Education Program · 2024Guideline
- Real-World Evidence of Crizanlizumab Showing Reductions in Vaso-Occlusive Crises and Opioid Usage in Sickle Cell Disease.European journal of haematology · 2025Trial
- Adding hydroxyurea to chronic transfusion therapy for sickle cell anemia reduces transfusion burden.Transfusion · 2025Trial
- Crizanlizumab for retinal vasculopathy with cerebral leukoencephalopathy in a phase II clinical study.The Journal of clinical investigation · 2024Trial
- One-year safety and efficacy of mitapivat in sickle cell disease: follow-up results of a phase 2, open-label study.Blood advances · 2023Trial
- CRISPR-Cas9 Editing of theThe New England journal of medicine · 2023Trial
- Effect of the P-Selectin Inhibitor Crizanlizumab on Survival Free of Organ Support in Patients Hospitalized for COVID-19: A Randomized Controlled Trial.Circulation · 2023Trial
- Subphenotypes of Sickle Cell Disease: A Guide to Targeting Treatment?American journal of hematology · 2026Article
- A Multicenter, Open-Label, Phase 2 Trial Comparing Crizanlizumab Combined With Standard Therapy to Standard Therapy Alone on Renal Function in Patients With Sickle Cell Nephropathy (STEADFAST).American journal of hematology · 2026Article
- EHA Guidelines on the management of children and adults with hemoglobin SC disease.HemaSphere · 2026Article
- Protein-protein interaction disruption as a next-generation antithrombotic strategy.Journal of thrombosis and thrombolysis · 2026Review
- Neutrophil Extracellular Traps in the Tumor Microenvironment: Mechanisms, Immune Regulation, and Implications for Immune Checkpoint Inhibitor Therapy.International journal of molecular sciences · 2026Review
- Base editing for precision therapeutics.Cell genomics · 2026Review
- Brain MRI and cognitive outcomes in adults with sickle cell disease treated with crizanlizumab.Blood red cells & iron · 2026Article
- Pathological P-Selectin Upregulation Promotes Retinal Ganglion Cell Degeneration Accompanied by T-Cell Recruitment in Glaucoma.Investigative ophthalmology & visual science · 2026Article
- Acute therapy with hemopexin (CSL889) resolves LPS-induced lung vaso-occlusion in sickle mice.Blood vessels, thrombosis & hemostasis · 2026Article
- P2Y12-P-selectin-mediated platelet activation in a murine model of dengue-associated thrombocytopenia.EBioMedicine · 2026Article
- Thrombocytosis and the generation of platelet-derived microparticles in the pathophysiology of sickle cell disease.British journal of haematology · 2026Review
- Retinal imaging and supervised learning predict hospitalizations and kidney and heart-lung damage in sickle cell disease.Blood advances · 2026Observational
405 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 7 institutions in 3 countries.
Kenneth I AtagaFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Abdullah KutlarFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Julie KanterFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Darla LilesFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Rodolfo CancadoFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
João FriedrischFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Troy H GuthrieFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Jennifer Knight-MaddenFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Ofelia A AlvarezFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Victor R GordeukFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Sandra GualandroFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Marina P ColellaFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Wally R SmithFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Scott A RollinsFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Jonathan W StockerFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Russell P RotherFrom the Division of Hematology-Oncology, University of North Carolina, Chapel Hill (K.I.A.), and the Division of Hematology-Oncology, East Carolina University, Greenville (D.L.) - both in North Carolina; the Sickle Cell Center, Medical College of Georgia, Augusta University, Augusta (A.K.); the Division of Pediatrics, Medical University of South Carolina, Charleston (J.K.); the Department of Hematology-Oncology, Santa Casa Medical School of São Paulo (R.C.), and the Division of Hematology, University of São Paulo (S.G.), São Paulo, the Hematology and Bone Marrow Transplantation Service, Hospital de Clínicas de Porto Alegre, Porto Alegre (J.F.), and the Hematology and Hemotherapy Center, University of Campinas, Campinas (M.P.C.) - all in Brazil; the Baptist Cancer Institute, Baptist Medical Center, Jacksonville, FL (T.H.G.); the Sickle Cell Unit, University of the West Indies, Mona, Jamaica (J.K.-M.); the Division of Pediatric Hematology-Oncology, University of Miami, Miami (O.A.A.); the Department of Medicine, University of Illinois at Chicago, Chicago (V.R.G.); the Division of General Internal Medicine, Virginia Commonwealth University Medical Center, Richmond (W.R.S.); and Selexys Pharmaceuticals, Oklahoma City (S.A.R., J.W.S., R.P.R.).
Medical University of South Carolina · USAugusta University · USBaptist Cancer Center · USUniversidade de São Paulo · BRUniversity of Illinois Chicago · USUniversity of North Carolina at Chapel Hill · USVirginia Commonwealth University Medical Center · US
Funding
Development of an Anti-P-selectin Antibody for the Treatment of Sickle Cell DiseaR44HL093893 · NHLBI · SELEXYS PHARMACEUTICALS CORPORATION · PI ROLLINS, SCOTT A · 2009 to 2014
$6.5MPhase 2 Study of SelG1 for the Treatment of Sickle Cell DiseaseR01FD004805 · FDA · SELEXYS PHARMACEUTICALS CORPORATION · PI ROLLINS, SCOTT A · 2014 to 2016
$1.1MFDA HHS R01 FD004805NHLBI NIH HHS R44 HL093893
Abstract
backgroundThe up-regulation of P-selectin in endothelial cells and platelets contributes to the cell-cell interactions that are involved in the pathogenesis of vaso-occlusion and sickle cell-related pain crises. The safety and efficacy of crizanlizumab, an antibody against the adhesion molecule P-selectin, were evaluated in patients with sickle cell disease.
methodsIn this double-blind, randomized, placebo-controlled, phase 2 trial, we assigned patients to receive low-dose crizanlizumab (2.5 mg per kilogram of body weight), high-dose crizanlizumab (5.0 mg per kilogram), or placebo, administered intravenously 14 times over a period of 52 weeks. Patients who were receiving concomitant hydroxyurea as well as those not receiving hydroxyurea were included in the study. The primary end point was the annual rate of sickle cell-related pain crises with high-dose crizanlizumab versus placebo. The annual rate of days hospitalized, the times to first and second crises, annual rates of uncomplicated crises (defined as crises other than the acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism) and the acute chest syndrome, and patient-reported outcomes were also assessed.
resultsA total of 198 patients underwent randomization at 60 sites. The median rate of crises per year was 1.63 with high-dose crizanlizumab versus 2.98 with placebo (indicating a 45.3% lower rate with high-dose crizanlizumab, P=0.01). The median time to the first crisis was significantly longer with high-dose crizanlizumab than with placebo (4.07 vs. 1.38 months, P=0.001), as was the median time to the second crisis (10.32 vs. 5.09 months, P=0.02). The median rate of uncomplicated crises per year was 1.08 with high-dose crizanlizumab, as compared with 2.91 with placebo (indicating a 62.9% lower rate with high-dose crizanlizumab, P=0.02). Adverse events that occurred in 10% or more of the patients in either active-treatment group and at a frequency that was at least twice as high as that in the placebo group were arthralgia, diarrhea, pruritus, vomiting, and chest pain.
conclusionsIn patients with sickle cell disease, crizanlizumab therapy resulted in a significantly lower rate of sickle cell-related pain crises than placebo and was associated with a low incidence of adverse events. (Funded by Selexys Pharmaceuticals and others; SUSTAIN ClinicalTrials.gov number, NCT01895361 .).
Indexed as
AdolescentAdultAnemia, Sickle CellAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHydroxyureaMaleMiddle AgedPainP-SelectinQuality of LifeYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedcrizanlizumabHydroxyureaP-Selectin
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Registered trials
NCT01895361ClinicalTrials.gov
NCT04435184ClinicalTrials.gov
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.