Evidence map›Paper›PMID 30510080›Full record

Trial reportBlood2019

Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study.

Jong Wook Lee, Flore Sicre de Fontbrune, Lily Wong Lee Lee, Viviani Pessoa, Sandra Gualandro, Wolfgang Füreder, Vadim Ptushkin, Scott T Rottinghaus, Lori Volles, Lori Shafner and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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 NCT02946463 (A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria), which is not on this map. Cited by 244 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
244citing papers in PubMed, 6 pooled it
11.5field-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.

NCT02946463 phase3completednot on this map

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

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2016 to 2023Enrolled272ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)ArmsRavulizumab, Eculizumab
3 · Its place in the literature

Who cites it

244 citing papers in PubMed, 6 syntheses or guidelines pooled it, 389 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 9 countries.

Jong Wook LeeDepartment of Hematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0003-2949-4166
Flore Sicre de FontbruneHematology Transplant Unit, Hôpital Saint-Louis, Paris, France.ORCID 0000-0003-2000-1556
Lily Wong Lee LeeHematology Unit, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia.
Viviani PessoaHematology, Hemorio, Rio de Janeiro, Brazil.
Sandra GualandroDepartment of Haematology, University of São Paulo Medical School, São Paulo, Brazil.
Wolfgang FürederDivision of Hematology & Hemostaseology, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.
Vadim PtushkinOutpatient Department for Hematology, Oncology and Chemotherapy, S. P. Botkin Hospital, Moscow, Russia.
Scott T RottinghausAlexion Pharmaceuticals, Inc, Boston, MA.
Lori VollesAlexion Pharmaceuticals, Inc, Boston, MA.
Lori ShafnerAlexion Pharmaceuticals, Inc, Boston, MA.
Rasha AguzziAlexion Pharmaceuticals, Inc, Boston, MA.
Rajendra PradhanAlexion Pharmaceuticals, Inc, Boston, MA.
Hubert SchrezenmeierInstitute of Transfusion Medicine, University of Ulm, Ulm, Germany.
Anita HillDepartment of Haematology, Leeds Teaching Hospitals, Leeds, United Kingdom.
Alexion Pharmaceuticals (United States) · USBotkin Hospital · RUHemorio · BRHôpital Saint-Louis · FRLeeds Teaching Hospitals NHS Trust · GBMedical University of Vienna · ATQueen Elizabeth Hospital · MYThe Catholic University of Korea Seoul St. Mary's Hospital · KRUniversidade de São Paulo · BRUniversität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ravulizumab (ALXN1210), a new complement C5 inhibitor, provides immediate, complete, and sustained C5 inhibition. This phase 3, open-label study assessed the noninferiority of ravulizumab to eculizumab in complement inhibitor-naive adults with paroxysmal nocturnal hemoglobinuria (PNH). Patients with lactate dehydrogenase (LDH) ≥1.5 times the upper limit of normal and at least 1 PNH symptom were randomized 1:1 to receive ravulizumab or eculizumab for 183 days (N = 246). Coprimary efficacy end points were proportion of patients remaining transfusion-free and LDH normalization. Secondary end points were percent change from baseline in LDH, change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score, proportion of patients with breakthrough hemolysis, stabilized hemoglobin, and change in serum free C5. Ravulizumab was noninferior to eculizumab for both coprimary and all key secondary end points (

Indexed as

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

Identifiers

PMID30510080
PMCPMC6367644
OpenAlexW2903198260

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.