1. Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study.
- Author
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Park EH, Lee EY, Lee YJ, Ha YJ, Yoo WH, Choi BY, Paeng JC, Suh HY, and Song YW
- Subjects
- Adult, Anti-Inflammatory Agents adverse effects, Antibodies, Monoclonal adverse effects, Biomarkers blood, Biosimilar Pharmaceuticals adverse effects, Blood Sedimentation, C-Reactive Protein metabolism, Drug Therapy, Combination, Female, Glucocorticoids adverse effects, Humans, Inflammation Mediators blood, Male, Middle Aged, Positron Emission Tomography Computed Tomography, Prednisolone adverse effects, Prospective Studies, Remission Induction, Takayasu Arteritis blood, Takayasu Arteritis diagnostic imaging, Time Factors, Treatment Outcome, Anti-Inflammatory Agents administration & dosage, Antibodies, Monoclonal administration & dosage, Biosimilar Pharmaceuticals administration & dosage, Glucocorticoids administration & dosage, Prednisolone administration & dosage, Takayasu Arteritis drug therapy
- Abstract
To evaluate the efficacy and safety of infliximab biosimilar CT-P13 in patients with active Takayasu arteritis (TAK). In this single-center open-label trial, patients with active TAK received CT-P13 at a starting dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks up to week 46. They were followed up until week 54. From week 14 to week 46, patients with inadequate response received increased dose of CT-P13 by 1.5 mg/kg. Concomitant prednisolone was allowed ≤ 10 mg/day. The primary efficacy end point was the achievement of partial or complete remission at week 30. All patients underwent positron emission tomography-computed tomography (PET-CT) at baseline and week 30. Twelve patients with TAK received CT-P13; one patient with protocol violation was excluded from analysis. Nine (81.8%) patients had taken concomitant prednisolone with median dose of 5.0 mg/day. At week 30, three (27.3%) patients achieved complete remission and six (54.5%) patients achieved partial remission. Statistically significant improvements in modified Indian Takayasu Clinical Activity Score (ITAS2010), ITAS-A, and serum levels of erythrocyte sedimentation rate and C-reactive protein were seen at week 30 from baseline. PET parameters were significantly reduced from baseline to week 30, including maximum standardized uptake value, target-to-vein ratio, target-to-liver ratio, and PET Vascular Activity Score. There were no serious adverse events. Treatment with CT-P13 may lead to improvement in clinical, radiographic, and serological activities with lower glucocorticoid requirement in TAK.Trial registration number NCT02457585.
- Published
- 2018
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