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P632 Comparative analysis of the pharmacokinetics of Inflectra® biosimilar with Remicade® in the induction phase of remission in patients with Crohn's disease

Juan G.*1, Mora M.2, Alvariño A.3, Maroto N.2, Ferrer I.2, Hinojosa E.2, Hinojosa M.D.2, Ferrandis P.1, Hinojosa J.2

1Hospital de Manises, Department of Pharmacy, Manises, Spain 2Hospital de Manises, IBD Unit, Manises, Spain 3Hospital de Manises, Department of Labratory, Manises, Spain

Background

We have increasing evidence on the efficacy, pharmacokinetics, immunogenicity, safety, interchangeability and behavior of biosimilars, similar to the reference product in patients with inflammatory bowel disease (IBD). Although low, biosimilar infliximab pharmacokinetics studies on induction and maintenance show similar behavior to the original IFX.

Goal: Compare prospectively the pharmacokinetics of Infliximab biosimilar (Inflectra) with Remicade during induction of remission in Naïve anti-TNF patients with IBD.

Methods

We have performed prospective pharmacokinetic analysis in 9 patients with IBD during the induction phase of remission. Samples were taken at week 4 and week 14 to determine the baseline levels of Inflectra®. At the same time plasma albumin levels were determined in the same sample. Pharmacokinetic analysis (central distribution volume, peripheral, plasma clearance, biological half-life and AUC) was performed. All patients were on a normal level of albumin and taking conventional IMMs (AZA/MTX). The results obtained were compared with the registration of our population pharmacokinetic model with Remicade®. Serum analysis obtained pre-infusion of IFX trough levels by ELISA (Promonitor).

Results

13 patients with Crohn's disease (4 M; 5 H). Average age: 38.6 years (95% CI 30–47). Albumin levels: 4.17 g/dl (95% CI 3.99–4.25). Inflecra® trough levels: 9.72 mcg/mL (IC95% 7,19–12,26) similar of Remicade® in our cohort of patients 8.19 mcg/ml (95% CI 6.98–11.96) (p=NS). In Table 1 the individual pharmacokinetic analysis is expressed and in Table 2 the average values of Inflectra® and Remicade® series.

Limitations of the analysis: sample size.

Table 1. Pharmacokinetics of patients treated with Inflectra

Central volumePeripheral volumeClarificationBiological half-lifeAUC
(L)(L)(L/d)d–1(mg·d/L)
3.791.340.411.12937.5
3.071.20.2614.051096.15
3.81.350.3113.61217.53
3.821.340.3811.651000
2.91.70.2916.75913.79
3.923.050.3222.591328.13
3.761.460.4510.78828.36
3.991.640.3214.811133.54

Table 2. Pharmacokinetics of Inflectra and Remicade

Central volumePeripheral volumeClarificationBiological half-lifeAUC
(L)(L)(L/d)d–1(mg·d/L)
3.631.630.3414.411056.87
(3.29–3.97)(1.14–2.13)(0.28–0.39)(11.18–17.65)(916.63–1197.12)
3.521.310.3512.551062.44
(3.35–3.70)(1.25–137)(0.31–0.36)(11.5–13.4)(963.75–1161.14)

Mean values (95% CI).

Conclusion

The pharmacokinetic behavior of Inflectra® biosimilar is comparable to Remicade®.