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P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study

Bouhnik, Y.(1);Nancey, S.(2);Assing, M.(3);Mammar, N.(3);Laharie, D.(4);

(1)CHU Beaujon, Gastroenterology, Clichy, France;(2)CHU Lyon, Gastroenterology, Lyon, France;(3)Pfizer, Inflammation & Immunology, Paris, France;(4)CHU Bordeaux Haut-Lévêque Hospital, Gastroenterology, Pessac, France

Background

ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator.

Methods

This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn's disease (CD) and ulcerative colitis (UC).

Results

Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2.

Table 1. Reasons for CT-P13 withdrawing

n (%) CDN, 62 CDS, 22 UCN, 40 UCS, 4
Remission 2 (3.2) 5 (23.8) 3 (7.5) 1 (25.0)
Therapeutic failure* 32 (51.6) 5 (23.8) 22 (55.0) 2 (50.0)
Intolerance 10 (16.1) 4 (19.0) 5 (12.5) 0
Other 18 (29.0) 7 (33.4) 10 (25.0) 1 (25.0)

* Including primary non-response in IFXN pts and secondary loss of response in IFXN and IFXS pts

Table 2. Safety

n (%) CD, 508 UC, 213
Pts with ≥ 1 adverse event (AE) 213 (41.9) 82 (38.5)
Pts with ≥ 1 serious AE 53 (10.4) 25 (11.7)
Pts with ≥ 1 allergic infusion reaction 18 (3.5) 6 (2.8)
Pts with ≥ 1 infection 12 (2.4) 6 (2.8)

† Including acute and delayed hypersensitivity reactions
‡ Including severe infections, tuberculosis, opportunistic infections, B hepatitis

Conclusion

Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.

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