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P295 Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients.

D. Jarzebicka*1, A. Banaszkiewicz2, A. Plocek3, J. Sieczkowska1, A. Gawronska2, E. Toporowska-Kowalska3, J. Kierkus1

1The Children’s Memorial Health Institute, Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Warsaw, Poland, 2Medical University of Warsaw, Department of Pediatric Gastroenterology and Nutrition, Warsaw, Poland, 3Medical University of Łódź, Department of Paediatric Allergology, Gastroenterology and Nutrition, Łódź, Poland

Background

A steady increase in number of paediatric patients requiring biological therapy in Crohn's disease (CD) is observed. Recently, biosimilar infliximab (INF) was authorized in European Union. With quality, efficacy and safety claimed to be equivalent to the originator, biosimilar infliximab may increase the access to biologicals due to cost reduction. The authorization covers CD, despite the lack of formal clinical studies in both adult and paediatric population. Moreover, the safety of switch between originator and biosimilar infliximab was shown only in rheumatology.

Methods

Thirty-two paediatric patients with diagnosis of CD from 3 academic hospitals who were switched from originator to biosimilar infliximab (CT-P13) were included in the study. Patient characteristics, disease history, disease severity (PCDAI), laboratory values (CRP, ESR, platelet count, haemoglobin level) were recorded. Mean, median and range values were calculated. Adverse events were recorded before and after the switch.

Results

Mean age of patients at diagnosis of CD was 11.1 years (range 2.7-15.3). Six patients had been previously treated with a biologic: infliximab (5) or adalimumab (1). Mean time from CD diagnosis to the start of current biological treatment was 1.8 years (range: 1 week - 5 years). Mean number of originator INF infusions before the switch to biosimilar was 9.9 (median 8.0; range 4-29). Disease activity (PCDAI) and laboratory values at the beginning of originator INF treatment, before switch and after first dose after switch are presented in the Table as mean (median; range). Number of patients may vary due to lack of data at given time point.

Disease activity (PCDAI) and laboratory values at the beginning of originator INF treatment, before switch and after first dose after switch are presented as mean (median; range).

At the start of originator INF treatmentAt last but one originator INF infusionAt last originator INF infusionAt switch (1st biosimilar INF infusion)At 2nd biosimilar INF infusion
Week-W -16W -8W 0W +8
No. of patients3225313225
PCDAI Mean (median; range)48 (53; 2.5–65)7 (3.8; 0–30)5.9 (2.5; 0–30)8.5 (5; 0–35)7.5 (5; 0–23)
CRP5.1 (1.1; 0–65)1.5 (0.3; 0,1-20)1.2 (0.4; 0–23)1.2 (0.35; 0–19)0.6 (0.4; 0–2.1)
ESR28 (23; 3–80)13 (7; 2–66)15 (10; 2–59)14 (9; 2–63)13 (8; 1–55)
Platelets391 (298; 169–630)306 (298; 156–543)302 (294; 171–654)304 (282; 183–804)305 (309; 175–529)
Hb12 (12.3; 10.3–14.4)13.3 (13.1; 11.6–16.7)13.2 (12.8; 10.3–15.6)13.1 (13.4; 10.4–16.4)13.3 (13.3; 11.4–15.1)

There were no infusion reaction after originator of biosimilar INF treatment. The occurrence of sporadic mild adverse events did not differ significantly when were measured before and after switching and was consistent with INF molecule safety profile. Additionally, at weeks 16, 24, 32 after switch 16, 5 and 4 patients were evaluated with no disease flare or unexpected adverse events.

Conclusion

Switching form originator to biosimilar infliximab in children with CD seems to be safe.