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Effect of the extended dosing interval of anti-TNF-α NANOBODY® compound ozoralizumab in patients with low disease activity rheumatoid arthritis.
- Source :
-
Modern rheumatology [Mod Rheumatol] 2024 Jul 06; Vol. 34 (4), pp. 678-685. - Publication Year :
- 2024
-
Abstract
- Objectives: This article aims to evaluate the effect of the extended dosing interval on the efficacy and safety of ozoralizumab in patients with rheumatoid arthritis (RA).<br />Methods: In a long-term extension study (HOSHIZORA trial) for patients who had completed a phase II/III study with methotrexate or a phase III study without methotrexate, the dosing interval of ozoralizumab was allowed to extend from every 4 weeks (Q4W) to every 8 weeks (Q8W), at the physician's discretion, for patients who had maintained a 28-joint disease activity score based on erythrocyte sedimentation rate (DAS28-ESR) <3.2 at the last two time points. The continuation rate, efficacy, and safety were examined in patients who had completed 24 weeks after the change in the dosing interval by the data cut-off point.<br />Results: Of the 32 patients who maintained DAS28-ESR <3.2 and changed the interval from Q4W to Q8W, 28 (87.5%) remained on Q8W for 24 weeks. At Week 24, the percentages of patients who remained on Q8W and achieved DAS28-ESR <2.6 and <3.2 were 71.9% and 84.4%, respectively. No safety concerns were observed for 24 weeks in the Q8W group.<br />Conclusions: In patients with RA and maintained DAS28-ESR <3.2 with ozoralizumab, efficacy was sustained and well tolerated after the dosing interval was extended from Q4W to Q8W.<br /> (© Japan College of Rheumatology 2023. Published by Oxford University Press.)
- Subjects :
- Humans
Female
Male
Middle Aged
Treatment Outcome
Aged
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized therapeutic use
Drug Administration Schedule
Adult
Severity of Illness Index
Single-Domain Antibodies administration & dosage
Single-Domain Antibodies therapeutic use
Tumor Necrosis Factor-alpha antagonists & inhibitors
Methotrexate therapeutic use
Methotrexate administration & dosage
Arthritis, Rheumatoid drug therapy
Antirheumatic Agents administration & dosage
Antirheumatic Agents therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1439-7609
- Volume :
- 34
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Modern rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 37804232
- Full Text :
- https://doi.org/10.1093/mr/road097