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Safety of SC form of infliximab biosimilar CT-P13 Posted 23/08/2019

Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

South Korean biotechnology company Celltrion presented new findings from a two-part study investigating the pharmacokinetics, efficacy and overall safety of CT-P13 SC in patients with rheumatoid arthritis (RA) over a one-year treatment period.

The study enrolled 50 patients, of whom 48 patients were randomly assigned at Week 6 into 4 cohorts (1:1:1:1 ratio). The mean Ctrough (pre-dose serum concentration of CT-P13 before next dose injection) of SC cohorts throughout the study visits were higher than those of the intravenous (IV) cohort after randomization at Week 6. Ctrough levels increased with SC dose and were sufficiently higher than the target therapeutic concentration (1 μg/mL) throughout the study period.

Overall, the efficacy results of CT-P13 SC up to Week 54 were comparable to those of CT-P13 IV. Disease improvement by Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP) and American College of Rheumatology 20% response criteria (ACR20) were comparable across all four cohorts, regardless of the route of administration or dosage of CT-P13. The safety profiles which occurred after study drug administration at Week 6 in SC cohorts were generally comparable to those of IV cohort and appeared similar to those previously reported for IV infliximab [2]. All injection site reactions were grade 1 or 2. No malignancy or death was reported.

The authors concluded that the results ‘suggest similar efficacy and safety of CT-P13 SC to CT-P13 IV in RA’. In fact, ‘the mean serum concentration in all SC cohorts consistently exceeded the threshold of target therapeutic concentration’. The authors therefore added that ‘these results show that the novel SC formulation of CT-P13 may enhance treatment options for use of infliximab biosimilar by providing high consistency in drug exposure’.

These results were presented at the European Congress of Rheumatology 2019, which took place on 12‒15 June 2019 in Madrid, Spain.

Celltrion announced positive results from a phase I study with the SC version of CT-P13 back in June 2018 [3] and the completion of a phase III study in August 2018 [4].

The South Korean biotechnology company says that it is developing Remsima SC in a bid to increase its competitiveness in the tumour necrosis factor alpha (TNF‑α) inhibitor (autoimmune disease therapeutic agent) market through a ‘twin-track’ strategy together with the existing IV formulation of Remsima.

Conflict of interest
The authors of the abstract [1] reported conflict of interest, including being employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstract [1].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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References
1. Yoo D, Jaworski J, Matyska-Piekarska E, et al. FRI0128 (2019): A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year results from a part 1 of phase I/III randomized controlled trial in patients with active rheumatoid arthritis. European Congress of Rheumatology 2019; 2019 Jun 12−15;Madrid, Spain.
2. Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82.
3. GaBI Online - Generics and Biosimilars Initiative. Positive results for infliximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-infliximab-and-trastuzumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Phase III trial for subcutaneous Remsima completed [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-for-subcutaneous-Remsima-completed

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