CT-P13 Safe, Cost Effective in Treating Pediatric IBD

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.
The Center for Biosimilars Staff
October 09, 2017
Biosimilar infliximab CT-P13 became available for use in the United Kingdom in 2015, but pediatric experience with the therapy has been limited. Use of reference infliximab (Remicade) in patients with pediatric inflammatory bowel disease (PIBD) was notably limited by the lack of a pediatric license for the therapy, as well as by the high cost of therapy. Furthermore, studies demonstrating biosimilarity of CT-P13 and its reference were conducted in rheumatologic indications that did not use standard dosing strategies for the treatment of IBD or PIBD.

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of PIBD with biosimilar infliximab, with a focus on safety and effectiveness. The study found that CT-P13 (which is marketed as both Remsima and Inflectra) was both as effective as the reference infliximab and responsible for significant cost savings in the treatment of children with PIBD.

In the study, all patients in 2 regional health systems in Scotland who had PIBD and who were initiating treatment with infliximab were given CT-P13. Forty patients initiated treatment with CT-P13 between August 2015 and June 2016. Of this group, 29 patients had Crohn’s disease, and 11 had either ulcerative colitis or unclassified IBD. The patients had a median age of 13.7 years (range, 13 to 16) at the time they began treatment.

Data were collected at initiation, and patient response was reviewed following 3 induction doses (approximately 12 weeks after treatment initiation). Prospective clinical data were collected from laboratory reports, electronic patient records, and case notes. The weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) and Pediatric Ulcerative Colitis Activity Index (PUCAI) were used to document disease activity at initiation and follow up. The cost for originator infliximab versus the cost of the biosimilar were obtained from a national framework agreement on drug procurement for Scotland.

The researchers found the following:
  • The median interquartile range (IQR) for wPCDAI improved from 27.5 at initiation to 5 at the 12-week review
  • The median IQR for PUCAI improved from 45 at initiation to 23.8 at the 12-week review
  • Among patients with Crohn’s disease, the percentage of patients who were in remission increased from 28% at initiation to 67% at the 12-week review
  • 2 patients had antidrug antibodies recorded, 1 of whom experienced an acute infusion reaction
The average cost per vial of the biosimilar during the treatment period was approximately 38% lower than that of the reference infliximab. The authors estimate that the total cost savings produced by using the biosimilar during the study period was £47,800 (approximately $62,785).

The authors conclude that using biosimilar infliximab in patients with PIBD is as safe and effective as using the originator infliximab in the short term, and that the biosimilar’s use was associated with a significant cost savings to the health system.

The authors say that “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” and that they hope that their study will encourage the wider introduction of biosimilar anti–tumor necrosis factor agents in pediatric practice.
 


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