Study Suggests CPT-13 Comparable to Infliximab at Lower Cost in Patients With IBD

January 18, 2020
Deana Ferreri, PhD

The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.

An observational study found health-related quality of life and disease activity in Finnish patients on maintenance therapy for inflammatory bowel disease (IBD) were comparable before and after switching from infliximab to a biosimilar at one-third the cost.

The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.

In this observational study, health-related quality of life (HRQoL) and disease activity were assessed in adult patients on maintenance therapy for IBD at the time of switching to the biosimilar and then twice more, at 3 and 12 months. The study included 54 patients with IBD: 26 with CD, 27 with UC, and 1 with unclassified IBD.

Health-related quality of life (HRQoL) was evaluated by a survey assessing 15 dimensions of health with possible scores ranging from 0 (death) to 1 (full health). Mean scores at 3 and 12 months did not significantly differ from time of switching in patients with CD or UC. However, in patients with CD, there was a significant decrease in 2 dimensions, breathing and excretion, from time of switching to 12 months. There were no significant differences in any dimension in UC. Of the entire study group, 40% of patients experienced a clinically important improvement, and 31% experienced a clinically important deterioration at 12 months.

Disease activity was assessed by questionnaires (Inflammatory Bowel Disease Questionnaire; IBDQ), clinical evaluation (Crohn Disease Activity Index; CDAI, or Partial Mayo Score; pMayo), and an objective laboratory measurement (fecal calprotectin; FC). In the whole study group, there were no statistically significant changes in these disease activity indicators between the time of switching and 3 months or 12 months.

At 3 months there was an improvement in IBDQ scores in patients with CD compared to time of switching, but the difference was no longer statistically significant at 12 months. A change in IBDQ score indicating a clinically meaningful improvement occurred in 1/26 patients with CD and 4/27 patients with UC at 12 months. One patient with UC experienced an IBDQ score change indicating relapse.

The authors concluded infliximab and biosimilar CPT-13 performed comparably for maintenance therapy of IBD during the 12 months of follow-up. Cost of the therapy, however, did differ. When comparing 1 year on infliximab and 1 year on the biosimilar, the number of drug administration visits and doses were not significantly different, but the cost of the biosimilar was 35% that of the originator. Costs related to secondary health care were not significantly different in the year on infliximab and the year on the biosimilar.

Reference

Huoponen S, Eberl A, Räsänen P, et al. Health-related quality of life and costs of switching originator infliximab to biosimilar one in treatment of inflammatory bowel disease. Medicine (Baltimore). 2020;99(2):e18723. doi:10.1097/MD.0000000000018723.