Evidence map›Paper›PMID 40978458›Full record

ArticleTherapeutic advances in hematology2025

Managing transient immune complex reactions in patients with paroxysmal nocturnal hemoglobinuria: clinical observations from the COMMODORE 1 and 2 studies.

Austin G Kulasekararaj, Jun-Ichi Nishimura, Alexander Röth, Leigh Beveridge, Simon Buatois, Muriel Buri, Nicolo Compagno, Yves Luder, Sasha Sreckovic, Phillip Scheinberg

2 registry-linked trialsAbstract read
In one paragraph

Article in Therapeutic advances in hematology, 2025. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Austin G KulasekararajDepartment of Haematological Medicine, King's College Hospital, Denmark Hill, London SE5 9RS, UKNational Institute for Health Research and Wellcome King's Clinical Research Facility and King's College London, Denmark Hill, London SE5 9RS, UK.ORCID https://orcid.org/0000-0003-3180-3570
Jun-Ichi NishimuraDepartment of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan.
Alexander RöthDepartment of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Leigh BeveridgeGenentech, Inc., South San Francisco, CA, 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.
Yves LuderF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Sasha SreckovicGenentech, Inc., South San Francisco, CA, USA.
Phillip ScheinbergDivision of Hematology, Hospital A Beneficência Portuguesa, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Crovalimab is a novel C5 inhibitor that enables rapid and sustained C5 inhibition with every 4-week subcutaneous maintenance dosing, with the possibility for self-administration. When switching from another C5 inhibitor (binds to a different epitope than crovalimab) to crovalimab and vice versa, transient immune complexes will form and may cause transient immune complex reactions (TICRs). Objectives: To assess TICR occurrence, manifestation, and management in patients with paroxysmal nocturnal hemoglobinuria (PNH) who switched from another C5 inhibitor to crovalimab. Design: COMMODORE 1 and 2 randomized C5 inhibitor-experienced and -naïve patients, respectively, to receive crovalimab or eculizumab. The COMMODORE 1 nonrandomized, descriptive cohort included patients who previously received ravulizumab or approved or higher-than-approved doses of eculizumab. Methods: Pooled data of patients who switched from eculizumab or ravulizumab to crovalimab were evaluated for TICR incidence and severity. TICR treatments and TICR durations were assessed by severity. Results: This descriptive analysis included 201 patients who switched from eculizumab ( Conclusion: Pooled COMMODORE 1 and 2 data show that TICRs from switching between C5 inhibitors were generally mild to moderate and resolved with appropriate treatment. These results further confirm that crovalimab is well tolerated in patients with PNH. Trial registration: NCT04432584; NCT04434092.

Indexed as

C5 inhibitorsclinical observationscrovalimabeculizumabparoxysmal nocturnal hemoglobinuriaravulizumabswitchtransient immune complextransient immune complex reactionstype III hypersensitivity reactions

Identifiers

PMID40978458
PMCPMC12444074

What OpenQuestion holds

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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 OpenQuestion graph.