Cited 4 times in
Crovalimab treatment in patients with paroxysmal nocturnal haemoglobinuria: Long-term results from the phase I/II COMPOSER trial
DC Field | Value | Language |
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dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2024-01-03T00:37:09Z | - |
dc.date.available | 2024-01-03T00:37:09Z | - |
dc.date.issued | 2023-08 | - |
dc.identifier.issn | 0902-4441 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/197321 | - |
dc.description.abstract | Objectives: This study reports long-term outcomes from the open-label extension (OLE) period of the Phase I/II COMPOSER trial (NCT03157635) that evaluated crovalimab in patients with paroxysmal nocturnal haemoglobinuria, who were treatment-naive or switched from eculizumab at enrolment. Methods: COMPOSER consists of four sequential parts followed by the OLE. The primary OLE objective was to assess long-term crovalimab safety, with a secondary objective to assess crovalimab pharmacokinetics and pharmacodynamics. Exploratory efficacy endpoints included change in lactate dehydrogenase (LDH), transfusion avoidance, haemoglobin stabilisation and breakthrough haemolysis (BTH). Results: A total 43 of 44 patients entered the OLE after completing the primary treatment period. Overall, 14 of 44 (32%) experienced treatment-related adverse events. Steady state exposure levels of crovalimab and terminal complement inhibition were maintained over the OLE. During the OLE, mean normalised LDH was generally maintained at ≤1.5× upper limit of normal, transfusion avoidance was achieved in 83%-92% of patients and haemoglobin stabilisation was reached in 79%-88% of patients across each 24-week interval. Five BTH events occurred with none leading to withdrawal. Conclusions: Over a 3-year median treatment duration, crovalimab was well tolerated and sustained C5 inhibition was achieved. Intravascular haemolysis control, haemoglobin stabilisation and transfusion avoidance were maintained, signifying long-term crovalimab efficacy. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Blackwell | - |
dc.relation.isPartOf | EUROPEAN JOURNAL OF HAEMATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal / therapeutic use | - |
dc.subject.MESH | Blood Transfusion | - |
dc.subject.MESH | Duration of Therapy | - |
dc.subject.MESH | Hemoglobins | - |
dc.subject.MESH | Hemoglobinuria, Paroxysmal* / diagnosis | - |
dc.subject.MESH | Hemoglobinuria, Paroxysmal* / drug therapy | - |
dc.subject.MESH | Hemolysis | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | L-Lactate Dehydrogenase | - |
dc.title | Crovalimab treatment in patients with paroxysmal nocturnal haemoglobinuria: Long-term results from the phase I/II COMPOSER trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Alexander Röth | - |
dc.contributor.googleauthor | Satoshi Ichikawa | - |
dc.contributor.googleauthor | Yoshikazu Ito | - |
dc.contributor.googleauthor | Jin Seok Kim | - |
dc.contributor.googleauthor | Zsolt Nagy | - |
dc.contributor.googleauthor | Naoshi Obara | - |
dc.contributor.googleauthor | Jens Panse | - |
dc.contributor.googleauthor | Hubert Schrezenmeier | - |
dc.contributor.googleauthor | Simona Sica | - |
dc.contributor.googleauthor | Juliette Soret | - |
dc.contributor.googleauthor | Kensuke Usuki | - |
dc.contributor.googleauthor | Sung-Soo Yoon | - |
dc.contributor.googleauthor | Nadiesh Balachandran | - |
dc.contributor.googleauthor | Muriel Buri | - |
dc.contributor.googleauthor | Pontus Lundberg | - |
dc.contributor.googleauthor | Himika Patel | - |
dc.contributor.googleauthor | Kenji Shinomiya | - |
dc.contributor.googleauthor | Alexandre Sostelly | - |
dc.contributor.googleauthor | Jun-Ichi Nishimura | - |
dc.identifier.doi | 10.1111/ejh.14011 | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J00822 | - |
dc.identifier.eissn | 1600-0609 | - |
dc.identifier.pmid | 37321625 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/10.1111/ejh.14011 | - |
dc.subject.keyword | bone marrow failure disorders | - |
dc.subject.keyword | complement C5 | - |
dc.subject.keyword | complement inhibitor | - |
dc.subject.keyword | eculizumab | - |
dc.subject.keyword | paroxysmal nocturnal haemoglobinuria | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 111 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 300 | - |
dc.citation.endPage | 310 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF HAEMATOLOGY, Vol.111(2) : 300-310, 2023-08 | - |
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