Evidence map›Paper›PMID 39535306›Full record

Trial reportEuropean journal of haematology2025

Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH): Pooled Results From the Phase 3 COMMODORE Studies.

Alexander Röth, Rong Fu, Guangsheng He, Hazzaa Alzahrani, Sheng-Chieh Chou, Yosr Hicheri, Maciej Kaźmierczak, Viviane Lacorte Recova, Michihiro Uchiyama, Ana-Maria Vladareanu and 8 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT04432584 phase3active not recruitingnot on this map

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamic and Efficacy of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2027Enrolled190ConditionsParoxysmal Nocturnal HemoglobinuriaArmsCrovalimab, Eculizumab
NCT04434092 phase3active not recruitingnot on this map

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2027Enrolled210ConditionsParoxysmal Nocturnal HemoglobinuriaArmsCrovalimab, Eculizumab
NCT04654468 phase3active not recruitingnot on this map

A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

TypeinterventionalSponsorHoffmann-La RocheRan2021 to 2027Enrolled51ConditionsParoxysmal Nocturnal HemoglobinuriaArmsCrovalimab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Alexander RöthDepartment of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.ORCID https://orcid.org/0000-0003-4414-7699
Rong FuDepartment of Hematology, Tianjin Medical University General Hospital, Tianjin, People's Republic of China.ORCID https://orcid.org/0000-0002-9928-9224
Guangsheng HeDepartment of Hematology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.ORCID https://orcid.org/0000-0002-3944-5897
Hazzaa AlzahraniKing Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia.
Sheng-Chieh ChouDivision of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Yosr HicheriDepartment of Hematology, Institut Paoli-Calmettes, Marseille, France.
Maciej KaźmierczakDepartment of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poznań, Poland.
Viviane Lacorte RecovaChronos Clinical Research, Brasília-DF, Brazil.
Michihiro UchiyamaDepartment of Hematology, Suwa Red Cross Hospital, Nagano, Japan.
Ana-Maria VladareanuDepartment of Hematology, Bucharest Emergency University Hospital, Bucharest, Romania.
Leigh BeveridgeGenentech, Inc., South San Francisco, California, USA.
Simon BuatoisF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Muriel BuriF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Nicolo CompagnoF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Dayu ShiRoche Product Development, Shanghai, People's Republic of China.
Nadiesh BalachandranF. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.
Sasha SreckovicGenentech, Inc., South San Francisco, California, USA.
Phillip ScheinbergDivision of Hematology, Hospital A Beneficência Portuguesa, São Paulo, Brazil.

Funding

F. Hoffmann-La Roche
6 · The paper itself

Abstract

objectivesTo evaluate the tolerability of crovalimab versus eculizumab in C5 inhibitor (C5i)-naive and -experienced patients with PNH from COMMODORE 2, 3 and 1 (NCT04434092, NCT04654468 and NCT04432584).

methodsPooled safety data were assessed in the total crovalimab and eculizumab populations and by C5i-naive versus C5i-switched status in patients receiving crovalimab. Analyses include 6.5 months of additional follow-up from the COMMODORE 2 and 1 primary analyses.

resultsCOMMODORE safety data (crovalimab, 393 patients [naive, 192 patients; switched, 201 patients]; eculizumab, 111 patients) were analysed. The total patient years (PY) were 503.9 and 51.1 in the total crovalimab and eculizumab populations, respectively, with 471 and 581 adverse events (AEs) per 100 PY. Serious infection rates were 8.9 and 13.7 AEs per 100 PY, respectively; no meningococcal infections were reported. Fatal AEs occurred in eight (2%) patients receiving crovalimab (naive, six patients; switched, two patients) and one (1%) receiving eculizumab, all treatment unrelated. In C5i-switched patients, 39 (19%) had transient immune complex reactions (risk when switching between C5i and crovalimab); the majority were Grades 1-2 arthralgia and rash, and 16 (8%) had Grade 3 events.

conclusionsCrovalimab's safety profile was consistent with eculizumab's and was generally comparable between C5i-naive and C5i-switched patients.

Indexed as

Antibodies, Monoclonal, HumanizedHemoglobinuria, ParoxysmalAdultAgedComplement Inactivating AgentsFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedComplement Inactivating Agentseculizumabcomplement C5complement inhibitorparoxysmal nocturnal haemoglobinuriasafety

Identifiers

PMID39535306
PMCPMC11707819

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.