Evidence map›Paper›PMID 30510079›Full record

Trial reportBlood2019

Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study.

Austin G Kulasekararaj, Anita Hill, Scott T Rottinghaus, Saskia Langemeijer, Richard Wells, F Ataulfo Gonzalez-Fernandez, Anna Gaya, Jong Wook Lee, Emilio Ojeda Gutierrez, Caroline I Piatek and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
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. It is linked to trial NCT03056040 (A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria), which is not on this map. Cited by 216 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 4 pooled it
12.9field-weighted citation impact, top 1% 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.

NCT03056040 phase3completednot on this map

A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2017 to 2022Enrolled202ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)ArmsRavulizumab, Eculizumab
3 · Its place in the literature

Who cites it

216 citing papers in PubMed, 4 syntheses or guidelines pooled it, 370 citations in OpenAlex.

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  4. Interventions for atypical haemolytic uraemic syndrome.The Cochrane database of systematic reviews · 2021
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156 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 11 countries.

Austin G KulasekararajDepartment of Haematological Medicine, King's College Hospital, National Institute of Health Research/Wellcome King's Clinical Research Facility, London, United Kingdom.
Anita HillDepartment of Haematology, Leeds Teaching Hospitals, Leeds, United Kingdom.
Scott T RottinghausAlexion Pharmaceuticals, Inc., Boston, MA.
Saskia LangemeijerRadboudumc, Nijmegen, The Netherlands.
Richard WellsSunnybrook Health Sciences Centre, Toronto, ON, Canada.
F Ataulfo Gonzalez-FernandezHospital Clinico Universitario San Carlos, Department of Hematology, The Clínic Institute of Haematological and Oncological Diseases, Madrid, Spain.
Anna GayaHospital Clínic de Barcelona, Barcelona, Spain.
Jong Wook LeeDepartment of Hematology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Emilio Ojeda GutierrezHospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Caroline I PiatekJane Anne Nohl Division of Hematology, Keck School of Medicine of USC, Los Angeles, CA.
Jeff SzerClinical Haematology, Royal Melbourne Hospital, Melbourne, VIC, Australia.
Antonio RisitanoHematology, Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.
Shinji NakaoHaematology/Respiratory Medicine, Faculty of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.
Eric BachmanAlexion Pharmaceuticals, Inc., Boston, MA.
Lori ShafnerAlexion Pharmaceuticals, Inc., Boston, MA.
Andrew I DamokoshAlexion Pharmaceuticals, Inc., Boston, MA.
Stephan OrtizAlexion Pharmaceuticals, Inc., Boston, MA.
Alexander RöthDepartment of Hematology, West German Cancer Center, University Hospital Essen, Essen, Germany.
Regis Peffault de LatourBone Marrow Transplantation Unit, Saint Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Alexion Pharmaceuticals (United States) · USEssen University Hospital · DEFederico II University Hospital · ITHôpital Saint-Louis · FRHospital Clínic de Barcelona · ESHospital Clínico San Carlos · ESHospital Universitario Puerta de Hierro Majadahonda · ESKanazawa University · JPKeck Hospital of USC · USKing's College Hospital · GBLeeds Teaching Hospitals NHS Trust · GBRadboud University Nijmegen · NLSeoul St. Mary's Hospital · KRSunnybrook Health Science Centre · CAThe Royal Melbourne Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for >6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (

Indexed as

Salvage TherapyAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsComplement C5Complement Inactivating AgentsDrug Resistance, NeoplasmFemaleFollow-Up StudiesHemoglobinuria, ParoxysmalHemolysisHumansMaleMiddle AgedPrognosisAntibodies, Monoclonal, HumanizedComplement C5Complement Inactivating Agentseculizumabravulizumab

Identifiers

PMID30510079
PMCPMC6368201
OpenAlexW2902552969

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.