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P542 Long-term outcomes after switching from originator infliximab to biosimilar in paediatric-onset inflammatory bowel disease patients: a single centre prospective observational study

Kang B., Lee K., Choe Y.H.

Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Pediatrics, Seoul, South Korea

Background

The biosimilar of infliximab, CT-P13, has been approved worldwide for treatment in inflammatory bowel disease (IBD) patients. However, there is scarce data of its outcomes after switching from originator infliximab to CT-P13 among paediatric-onset IBD patients in real-life practice. We aimed to investigate the long-term efficacy, safety, pharmacokinetic profiles, and immunogenicity after switching from infliximab to CT-P13 for 1 year in paediatric-onset IBD patients.

Methods

This study was a prospective observational study of paediatric-onset IBD patients who had switched from infliximab to CT-P13 during September 2015 to December 2015 at the Department of Pediatrics, Samsung Medical Center. Clinical activity scores, laboratory test results, infliximab trough level (TL), and antibody to infliximab (ATI) levels were compared between the point of switch and 1 year after. Loss of response and adverse events were also investigated during the switch period.

Results

Thirty-eight paediatric-onset IBD patients [32 Crohn's disease (CD), 6 ulcerative colitis (UC) patients] were included in this study. The median age at infliximab start was 15.1 years (range: 7.6–19.9), and the median age at CT-P13 switch was 19.2 years (range: 8.7–22.5). The median duration from infliximab start to CT-P13 switch was 1.9 years (range: 0.6–7.8). Among the total subjects, 27 subjects had finished follow-up at 1 year, while 2 subjects were lost during follow-up, and 1 subject had discontinued CT-P13 after a prolonged period of clinical remission and complete mucosal healing on endoscopy. Eight subjects had not yet been followed up to 1 year. Among the 27 subjects who had finished follow-up at 1 year, 21 subjects were treated with concomitant azathioprine (77.8%). Comparison between switch point and 1 year follow-up revealed no significant differences in Harvey-Bradshaw Index (HBI) scores for CD patients, Simple Clinical Colitis Activity Index (SCCAI) scores for UC patients, white blood cell (WBC) counts, serum albumin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels, infliximab TLs, and ATI levels between the two time points. Loss of response was observed in 3 patients (11.1%), who all responded well to dose intensification. No serious adverse events or infusion related adverse events occurred.

Table 1. Comparison between CT-P13 switch point and 1 year follow-up (n=27)

At switch1 year follow-upP
HBI score (n=23)0 [IQR 0–1]0 [IQR 0–1]0.610
SCCAI score (n=4)0 [IQR 0–1.5]0 [IQR 0–1.5]1.000
WBC count, /μL6,284±1,5655,908±1,3270.345
Albumin, g/dL4.5±0.34.6±0.30.764
ESR, mm/hr11 [IQR 7.5–20.5]13 [IQR 8–18.5]0.993
CRP, mg/dL0.06 [IQR 0.03–0.2]0.04 [0.03–0.11]0.368
Infliximab TL, μg/mL5.34 [IQR 4.85–8.05]6.38 [IQR 4.3–7.58]0.500
ATI, μg/mL2.3 [IQR 1.65–3.1]2.3 [IQR 1.7–3.0]0.869

Conclusion

Switching from originator infliximab to the biosimilar infliximab, CT-P13, was feasible without serious adverse events for up to 1 year in a real-life cohort of paediatric-onset IBD patients.