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Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients naïve to or switched from biologics.
- Source :
-
Modern rheumatology [Mod Rheumatol] 2022 Jul 01; Vol. 32 (4), pp. 718-727. - Publication Year :
- 2022
-
Abstract
- Objectives: The aim of this post-marketing surveillance (PMS) study is to evaluate the real-world safety and efficacy of CT-P13, the first biosimilar of infliximab (IFX).<br />Methods: Japanese patients with rheumatoid arthritis were prospectively registered from November 2014 and followed up for 1 year.<br />Results: Of 794 patients in the analysis set, 318 patients naïve to biological disease-modifying antirheumatic drugs (bDMARDs) showed an immediate decrease in Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) and increased remission rate (DAS28-CRP < 2.6). In patients who switched from IFX to CT-P13 for non-medical reasons (n = 374), the low DAS28-CRP due to previous IFX treatment decreased further with continued CT-P13 therapy. As in naïve patients, patients who switched from other bDMARDs, mainly for medical reasons (n = 102), responded similarly to CT-P13. CT-P13 in this PMS and IFX in a previous PMS had similar adverse reaction profiles, although the incidence rate in naïve patients in this current PMS was lower due to earlier initiation of CT-P13 therapy.<br />Conclusions: CT-P13 showed excellent effectiveness as first-line therapy, no clinical difficulties in switching from IFX, and clinical improvement in patients who failed other bDMARDs. CT-P13 could be a cost-effective alternative to IFX in the treatment of rheumatoid arthritis.<br /> (© Japan College of Rheumatology 2021. Published by Oxford University Press.)
- Subjects :
- C-Reactive Protein
Drug Substitution
Humans
Infliximab therapeutic use
Japan
Treatment Outcome
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal therapeutic use
Antirheumatic Agents adverse effects
Antirheumatic Agents therapeutic use
Arthritis, Rheumatoid diagnostic imaging
Arthritis, Rheumatoid drug therapy
Biosimilar Pharmaceuticals adverse effects
Biosimilar Pharmaceuticals therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1439-7609
- Volume :
- 32
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Modern rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 34918129
- Full Text :
- https://doi.org/10.1093/mr/roab068