Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials

Arthritis Research & Therapy

Taek Sang Kwon¹  Jiwon Noh¹  Gahee Park²  Sang Joon Lee²  Roberto Caporali³  Rieke Alten⁴  Mondher Toumi⁵  Michael T. Nurmohamed⁶  Bernard Combe⁷  Dae Hyun Yoo⁸  Yannick Allanore⁹  Florenzo Iannone^1,10  Patrick Durez^1,11 

[1] Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea;Celltrion Inc., Incheon, Republic of Korea;Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy;ASST PINI-CTO, Milan, Italy;Department of Internal Medicine and Rheumatology, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany;Department of Public Health, Aix-Marseille University, Marseille, France;Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands;Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands;Department of Rheumatology, CHU Montpellier, Montpellier University, Montpellier, France;Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea;Rheumatology Department, Hôpital Cochin, Paris Descartes University, Paris, France;Rheumatology Unit, Department of Emergency and Organ Transplantation, Università Degli Studi Di Bari Aldo Moro, Bari, Italy;Rheumatology, Cliniques Universitaires Saint-Luc – Universite Catholique De Louvain – Institut De Recherche Experimentale Et Clinique (IREC), Brussels, Belgium;

关键词: CT-P13;    Disease activity;    Indirect treatment comparison;    Individual patient data;    Infliximab;    Intravenous;    Network meta-regression;    Rheumatoid arthritis;    Subcutaneous;    Tumour necrosis factor inhibitor;   

DOI  :  10.1186/s13075-021-02487-x

来源: Springer

【 摘 要 】

BackgroundA subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.MethodsA network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire–Disability Index (HAQ-DI).ResultsThe two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (− 0.578; 95% confidence interval [CI] − 0.831, − 0.325; p < 0.0001), CDAI (− 3.502; 95% CI − 5.715, − 1.289; p = 0.002) and SDAI (− 4.031; 95% CI − 6.385, − 1.677; p = 0.0008) scores at 30 weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement.ConclusionsCT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV.Trial registrationEudraCT, 2016-002125-11, registered 1 July 2016; EudraCT 2010-018646-31, registered 23 June 2010.

【 授权许可】

CC BY