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 30weeks 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.

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 / B. Combe, Y. Allanore, R. Alten, R. Caporali, P. Durez, F. Iannone, M.T. Nurmohamed, M. Toumi, S.J. Lee, T.S. Kwon, J. Noh, G. Park, D.H. Yoo. - In: ARTHRITIS RESEARCH & THERAPY. - ISSN 1478-6354. - 23:1(2021), pp. 119.1-119.11. [10.1186/s13075-021-02487-x]

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

R. Caporali;
2021

Abstract

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 30weeks 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.
CT-P13; Disease activity; Indirect treatment comparison; Individual patient data; Infliximab; Intravenous; Network meta-regression; Rheumatoid arthritis; Subcutaneous; Tumour necrosis factor inhibitor; Adult; Antibodies, Monoclonal; Europe; Humans; Infliximab; Severity of Illness Index; Treatment Outcome; Antirheumatic Agents; Arthritis, Rheumatoid
Settore MED/16 - Reumatologia
Article (author)
File in questo prodotto:
File Dimensione Formato  
s13075-021-02487-x.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 901.61 kB
Formato Adobe PDF
901.61 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/943124
Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 7
  • ???jsp.display-item.citation.isi??? 8
social impact