Evidence map›Paper›PMID 41566054›Full record

Observational studyAnnals of hematology2026

Real life use of ravulizumab in Italian patients with paroxysmal nocturnal hemoglobinuria: evidence from the REACTION observational study.

Anna Paola Iori, Antonio De Vivo, Eros Di Bona, Giovanni Caocci, Francesca Fioritoni, Fabio Ciceri, Eloise Beggiato, Davide Rapezzi, Angela Amendola, Amalia Figuera and 26 more

Registry-linked trialAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05274633 (Real Life Use of Ravulizumab in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria a Multicenter Observational Retrospective and Prospective Cohort Study.), which is 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.

NCT05274633 completednot on this map

Real Life Use of Ravulizumab in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria a Multicenter Observational Retrospective and Prospective Cohort Study.

TypeobservationalSponsorAlexion Pharmaceuticals, Inc.Ran2022 to 2025Enrolled120ConditionsParoxysmal Nocturnal HemoglobinuriaArmsRavulizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

36 authors.

Anna Paola IoriA.O.U. Policlinico Umberto I-Ematologia, Rome, Italy. iori@bce.uniroma1.it.
Antonio De VivoA.O.U. Policlinico Sant'Orsola-UOC Ematologia, Bologna, Italy.ORCID http://orcid.org/0000-0001-6022-0003
Eros Di BonaOspedale San Bassiano-Oncoematologia, Bassano del Grappa (Vicenza), Italy.
Giovanni CaocciOspedale Businco-Ematologia e CTMO, Cagliari, Italy.ORCID http://orcid.org/0000-0002-6585-5187
Francesca FioritoniOspedale Santo Spirito-UOC Ematologia, Pescara, Italy.
Fabio CiceriUniversità Vita-Salute San Raffaele, Milan, Italy.
Eloise BeggiatoA.O.U. Città della Salute e della Scienza-Ematologia, Turin, Italy.ORCID http://orcid.org/0000-0002-2971-7596
Davide RapezziASO Santa Croce e Carle-Ematologia, Cuneo, Italy.ORCID http://orcid.org/0009-0004-0907-2905
Angela AmendolaAOR SAN CARLO, Dipartimento Oncologico, UOC Ematologia con Centro trapianto di Midollo, Cellule staminali e terapie cellulari, Potenza, Italy.
Amalia FigueraA.O.U. Policlinico Rodolico-San Marco-Ematologia, Catania, Italy.
Carmine SelleriA.O.U. S.Giovanni di Dio e R.D'Aragona-UOC Ematologia e Trapianti Cellule Staminali Emopoietiche, Salerno, Italy.ORCID http://orcid.org/0000-0002-5861-8984
Francesco LonguA.O.U. Sassari-Ematologia, Sassari, Italy.
Bruno FattizzoFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-SC Ematologia, Milan, Italy.ORCID http://orcid.org/0000-0003-0857-8379
Alessandra TucciASST Spedali Civili-Ematologia, Brescia, Italy.ORCID http://orcid.org/0000-0003-3052-7463
Alessandro CignettiA.O. Ordine Mauriziano-SCDU Ematologia e Terapie cellulari, Turin, Italy.
Valeria AmicoAzienda Ospedaliera San Pio-Servizio di Immunoematologia, Benevento, Italy.
Simona SicaFondazione Policlinico Universitario Agostino Gemelli IRCCS-UOC Ematologia e Trapianto di cellule staminali emopoietiche, Università Cattolica Sacro Cuore, Rome, Italy.ORCID http://orcid.org/0000-0003-2426-3465
Elisabetta MetafuniFondazione Policlinico Universitario Agostino Gemelli IRCCS-UOC Ematologia e Trapianto di cellule staminali emopoietiche, Rome, Italy.
Simona RasoA.O.O.R. Villa Sofia Cervello P.O. Cervello-UOC di Ematologia per le Malattie Rare del Sangue e degli Organi Ematopoietici, Palermo, Italy.ORCID http://orcid.org/0000-0002-0967-2191
Tiziana Anna UrbanoOspedale San G. Moscati-SC Ematologia, Taranto, Italy.
Luana MaranoOspedale San G. Moscati-Ematologia, Avellino, Italy.ORCID http://orcid.org/0009-0000-1841-9887
Nicola Di RenzoOspedale V. Fazzi-UOC Ematologia, Lecce, Italy.
Pierangelo SpediniOspedale di Cremona-Ematologia, Cremona, Italy.
Alessandro RambaldiASST Papa Giovanni XXIII-UOC Ematologia, Bergamo, Italy.
Francesco LanzaUniversità di Bologna - Ospedale S. Maria delle Croci-UOC Ematologia, Ravenna, Italy.ORCID http://orcid.org/0000-0002-5189-7167
Cristina ClissaA.O.U.I. Verona Ospedale Borgo Roma-UOC Ematologia e Centro Trapianti di Midollo Osseo, Verona, Italy.
Cristina DanesinOspedale Ca' Foncello-Ematologia, Treviso, Italy.
Maria Bruna GreveGOM Bianchi Melacrino Morelli-Ematologia, Reggio Calabria, Italy.ORCID http://orcid.org/0000-0002-0292-4050
Sergio CabibboOspedale "Giovanni Paolo II"-UOSD Ematologia, Ragusa, Italy.
Alessandra OriIQVIA Solutions Italy S.r.l., Modena, Italy.ORCID http://orcid.org/0009-0004-2030-3866
Francesca CassanelliIQVIA Solutions Italy S.r.l., Modena, Italy.ORCID http://orcid.org/0000-0003-2253-7653
Federica SottanaAlexion Pharma Italy, Milan, Italy.
Benedetta CampoloAlexion Pharma, Barcelona, Spain.
Giulia GasparriAlexion Pharma Italy, Milan, Italy.
Fabio CariniAlexion Pharma Italy, Milan, Italy.
Wilma BarcelliniFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-SC Ematologia, Milan, Italy.ORCID http://orcid.org/0000-0003-1428-9944

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ravulizumab is a second-generation C5i engineered from eculizumab to achieve immediate, complete, and sustained inhibition of terminal complement activity in PNH. The REACTION observational cohort study describes the effectiveness and tolerability of ravulizumab in Italian patients who were previously treated with eculizumab. Eighty-one PNH patients were enrolled in this study. The primary endpoint was the percentage change in lactate dehydrogenase (LDH) from baseline to the end of observation (52 weeks follow-up). Among secondary endpoints, transfusion avoidance, breakthrough hemolysis (BTH) and patients' quality of life (QoL) were evaluated. The median (25-75 percentiles) percentage change in LDH at 52 weeks follow-up was -2.6 (-11.5-13.4) U/L, with 92.3% of the patients presenting LDH within or < 1.5 × upper limit of normal (ULN). Overall, 20 (25.0%) patients required transfusion during the eculizumab period and 15 (18.8%) during the ravulizumab. Seven BTH events were observed, 5 during eculizumab period and 2 (triggered by other medical conditions) during ravulizumab, suggesting the reduction of pharmacokinetic BTH during ravulizumab treatment. EORTC-QLQ-C30 and FACIT-Fatigue scores were similar to the general population, and patients' preference indicated ravulizumab as the favorite treatment. The REACTION study confirmed the effectiveness of ravulizumab in maintaining stable disease and hemolysis control in the real-world setting. Clinical trial registration. NCT05274633, 02-Mar-2022.

Indexed as

Antibodies, Monoclonal, HumanizedHemoglobinuria, ParoxysmalAdultAgedComplement Inactivating AgentsFemaleFollow-Up StudiesHemolysisHumansItalyL-Lactate DehydrogenaseMaleMiddle AgedQuality of LifeAntibodies, Monoclonal, HumanizedComplement Inactivating AgentseculizumabL-Lactate DehydrogenaseravulizumabBreakthrough hemolysisHealth-related quality of lifeLactate dehydrogenaseParoxysmal nocturnal hemoglobinuriaRavulizumab

Identifiers

PMID41566054
PMCPMC12823630

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Registered trials

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