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.

Combe, Bernard;Allanore, Yannick;Alten, Rieke;Caporali, Roberto;Yoo, Dae Hyun;et.al.
(2021) Arthritis research & therapy — Vol. 23, n° 1, p. 119 [1-11] (2021)

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Authors
  • Combe, Bernard
    Author
  • Allanore, Yannick
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  • Alten, Rieke
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  • Caporali, Roberto
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  • Durez, PatrickUCLouvain
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  • Yoo, Dae Hyunorcid-logo
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Abstract
(en) BACKGROUND: A 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. METHODS: A 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). RESULTS: The 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. CONCLUSIONS: CT-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 REGISTRATION: EudraCT, 2016-002125-11 , registered 1 July 2016; EudraCT 2010-018646-31 , registered 23 June 2010.
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Combe, B., Allanore, Y., Alten, R., Caporali, R., Durez, P., Iannone, F., Nurmohamed, M. T., Toumi, M., Lee, S. J., Kwon, T. S., Noh, J., Park, G., & Yoo, D. H. (2021). 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, 23(1), 119 [1-11]. https://doi.org/10.1186/s13075-021-02487-x (Original work published 2021)