dc.contributor.author
Burmester, Gerd
dc.contributor.author
Drescher, Edit
dc.contributor.author
Hrycaj, Pawel
dc.contributor.author
Chien, David
dc.contributor.author
Pan, Zhiying
dc.contributor.author
Cohen, Stanley
dc.date.accessioned
2022-08-04T09:12:30Z
dc.date.available
2022-08-04T09:12:30Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/35717
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-35432
dc.description.abstract
Background/objectives: ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA).
Methods: Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU.
Results: Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (− 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
Conclusions: Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.doi
10.1007/s10067-020-05305-y
dcterms.bibliographicCitation.journaltitle
Clinical Rheumatology
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.pagestart
3341
dcterms.bibliographicCitation.pageend
3352
dcterms.bibliographicCitation.volume
39
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
32876780
dcterms.isPartOf.issn
0770-3198
dcterms.isPartOf.eissn
1434-9949