Subcutaneously-Administered Infliximab in the Management of Rheumatoid Arthritis: A Short Narrative Review of Current Clinical Evidence

Figures & data

Figure 1 Simulation of blood concentrations in comparison vs. IV infliximab 3 mg/kg expressed as trough concentration, or C_trough, broken down by body weight bands. Summary Forest Plots of log transformed C_trough GMRs (90% CIs) for the Simulated CT-P13 SC 120 mg Q2W Maintenance Dosing Regimen vs. CT-P13 IV 3 mg/kg Q8W Maintenance Reference Treatment by weight bands.

Notes: CT-P13 IV 3 mg/kg Q8W is the reference treatment and CT-P13 SC 120 mg Q2W is the test treatment. Grey shaded area represents the 90% prediction interval in the reference treatment, and black points with horizontal bar represent the 90% CI. Reproduced from European Medicines Agency. Assessment report on extension(s) of marketing authorisation: remsima. Available from: https://www.ema.europa.eu/en/documents/variation-report/remsima-h-c-2576-x-0062-epar-assessment-report-variation_en.pdf. ¹⁹

Abbreviations: CI, confidence interval; GMR, geometric mean ratio; Q2W, every 2 weeks; Q8W, every 8 weeks; SC, subcutaneous.

Figure 2 Simulation of blood concentrations in comparison vs. IV infliximab 5 mg/kg expressed as trough concentration, or C_trough, broken down by body weight bands. Boxplot of C_trough,ss Obtained Following 120 mg Q2W SC and 5 mg/kg Q8W IV Maintenance Dosing Regimens for NAB- subjects.

Note: Reproduced from European Medicines Agency. Assessment report on extension(s) of marketing authorisation: remsima. Available from: https://www.ema.europa.eu/en/documents/variation-report/remsima-h-c-2576-ii-0082-epar-assessment-report-variation_en.pdf. ²⁰

Abbreviations: Ctrough_ss, trough serum concentration at steady state; IV, intravenous infusion; SC, subcutaneous injection; Q2W, every two weeks; Q8W, every eight weeks; NAB, negative neutralizing antibody; Simulation B, based on population PK model with (anti-drug antibodies) ADA titer and NAB status.

Figure 3 Design of part 2 of study CT-P13 3.5, a randomized, active-controlled, double-dummy, parallel groups, non-inferiority trial. The primary endpoint was measured during the double-blind and double-dummy phase at week 22, after which all patients switched to open-label SC formulation.

Figure 4 Primary endpoint results of part 2 of study CT-P13 3.5, analysis of change from baseline of DAS28 (CRP) at Week 22 (ANCOVA).

Notes: The treatment difference at Week 22 was estimated as 0.27 with corresponding lower limit of 95% CI of 0.02, which was greater than the pre-specified NI margin (−0.6) indicating NI of CT-P13 SC compared to CT-P13 IV. The estimate of treatment difference also reached the statistical superiority criterion (difference > 0). Country, Week 2 serum CRP concentration (≤0.6 mg/dL versus >0.6 mg/dL) and Week 6 body weight (≤100 kg versus >100 kg) were considered as covariates.

Abbreviations: CI, confidence interval; LS, least squares; SE, standard error.

European Medicines Agency. Assessment report on extension(s) of marketing authorisation: remsima. Available from: https://www.ema.europa.eu/en/documents/variation-report/remsima-h-c-2576-x-0062-epar-assessment-report-variation_en.pdf. Accessed August 30, 2021.

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European Medicines Agency. Assessment report on extension(s) of marketing authorisation: remsima. Available from: https://www.ema.europa.eu/en/documents/variation-report/remsima-h-c-2576-ii-0082-epar-assessment-report-variation_en.pdf. Accessed August 30, 2021.

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