Background/Purpose:

CT-P13 was the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Reflect trial has been set up to evaluate in real life the use of CT-P13 after the introduction of the product in French university hospitals.

Methods:

REFLECT is a multicenter, prospective, and observational study. Its objectives are to describe in real-life the patient‘(pts) characteristics treated with CT-P13 and the treatment effectiveness. Inclusion criteria were pts (≥ 6 years) with rheumatoid arthritis (RA), axial spondylo arthritis (axSpA), psoriatic arthritis (PsA), or inflammatory bowel disease treated with CT-P13. IFX naive pts (IFXn) or pts having switched from IFX originator to CT-P13 (IFXs) were enrolled. Preliminary results in pts suffering from rheumatic diseases using descriptive statistical analyses from inclusion were reported here.

Results:

On December 28^th 2017, 627 pts were included by 35 centres and 339 pts with rheumatic diseases were analyzed: 83 were suffering from RA (22.9% males; mean age: 61.7 ± 10.2; median time since diagnosis: 13.4 years), 213 axSpA (59.6%; 48.0 ± 13.3 years; 11.5 years respectively), and 43 PsA (37.2%; 53.4 ± 15.1 years; 8.6 years). The majority of pts have been already treated by CT-P13 before inclusion (64.9%, 69.9%, and 77.1% of RA, axSpA, and PsA pts, respectively); in these pts, the median treatment duration since the first administration of CT-P13 was 8.5 months for RA, 12.9 months for axSpA and 7.9 months for PsA pts. Previous treatments with other bDMARDs other than IFX were observed in 39.2% of RA, 29.9% of AS and 40.0% of PsA pts. Almost half of pts (41.9% of RA, 49.7% of axSpA, and 42.9% of PsA) switched from the originator IFX to CT-P13. At the baseline, the rate of pts in remission was 19 (26.8%), 27 (23.7%), and 14 (45.2%) of RA, axSpA, and PsA pts respectively.

At the first infusion of CT-P13, the median DAS28 score were 4.9 and 2.5 for RA pts in IFXn and INFs pts, and 3.5 and 2.2 for PsA pts respectively. In axSpA pts, the median BASDAI were 5.5 and 2.1 and the median BASFI was 5.1 and 2.8 in IFXn and IFXs pts, respectively. At 6 month follow-up, 48.5% RA pts, 37.7% axSpA pts, were in remission. The median of disease activity scores decreased from the first administration of CT-P13 to 6 month follow-up in IFXn pts and still stable in IFXs pts for RA and axSpA. The analysis of pts suffering from PsA has not been reported due to the small number of patient who had the follow-up at 6 month (6 IFXn pts and 4 IFXs pts).

The safety data are summarized in Table 1

Conclusion:

Preliminary results from this prospective cohort suggest that the treatment with CT-P13 is safe and efficient in both naïve and switched patients. The safety data did not show any new safety concerns.

Table 1: Safety data

† Including acute and delayed hypersensitivity reactions

‡ Including severe infections, tuberculosis, opportunistic infections, hepatitis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/biosimilar-infliximab-treated-patients-with-rheumatoid-arthritis-psoriatic-arthritis-and-ankylosing-spondylitis-in-france-characteristics-and-clinical-outcomes/