Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study

• DOI: 10.1007/s00296-018-4159-1
• Publication Date: 2018-09-18T09:52:21Z
• Authors: Eun Hye Park; Eun Young Lee; Yun Jong Lee; You Jung Ha; Wan-Hee Yoo; Byoong Yong Choi; Jin Chul Paeng; Hoon Young Suh; Yeong Wook Song
• Keywords: Adult; Male; Time Factors; Prednisolone; Remission Induction; Anti-Inflammatory Agents; Antibodies, Monoclonal; Blood Sedimentation; Middle Aged; Takayasu Arteritis; 3. Good health; 03 medical and health sciences; C-Reactive Protein; 0302 clinical medicine; Positron Emission Tomography Computed Tomography; Humans; Clinical Trials; Drug Therapy, Combination; Female; Prospective Studies; Inflammation Mediators; Biosimilar Pharmaceuticals; Glucocorticoids; Biomarkers

AbstractTo 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.