In Eastern Europe, CT-P13 Provides Effective, Cost-Saving Alternative to Reference Infliximab in IBD

Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.
Kelly Davio
July 15, 2019
Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.

However, with the introduction of biosimilars, more patients may be able to gain access to effective treatment; a multicenter, observation cohort study demonstrated that, among patients with ulcerative colitis (UC) and Crohn disease (CD), biosimilar infliximab CT-P13 (Inflectra, Remsima) was safe and effective, and it provided a cost-effective alternative to the reference (Remicaid).

The study was conducted at sites in Romania, the Czech Republic, and Bulgaria, and the 85 patients enrolled were adults with moderate to severe CD (n = 38) or UC (n = 47). The patients, 80% of whom were naïve to infliximab, received treatment with CT-P13 for up to 30 weeks.

At week 30, the response rate was 65.8% (95% CI, 49.8%-78.9%) among patients with CD and 55.3% (95% CI, 41.2%-68.6%) in patients with UC. Remission rates were 47.4% (95% CI, 32.5%-62.7%) and 48.9% (95% CI, 35.3%-62.8%) in the 2 groups, respectively.

In the combined patient population, quality of life improved significantly over the observation period; the mean Short Inflammatory Bowel Disease Questionnaire score increased from 40.0 (±11.3) at baseline to 56.2 (±9.3) at the end of treatment (P < .0001).

Of 31 total adverse events (AEs) observed, 2 were considered to be related to infliximab. Both were infusion-related reactions, 1 of which led to discontinuation.

The authors note that a budget impact analysis in European nations that included Romania and the Czech Republic showed that using biosimilar infliximab in place of its reference in patients with CD could allow 700 to 1500 additional patients to be treated. Another model, conducted in the Netherlands, found that cost savings resulting from biosimilar use could reach 30%, and in 2015, biosimilar infliximab was projected to produce annual direct drug cost savings in several European countries of 10% to 30%.

“Together with other studies reporting on the effectiveness and tolerability of biosimilar infliximab in patients with chronic inflammatory conditions including IBD, the weight of evidence suggests that biosimilar infliximab is an effective and cost-effective replacement for originator infliximab,” conclude the authors.

Reference
Gheorghe C, Svoboda P, Mateescu B. Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis. J Drug Assess. 2019;8(1):129-134. doi: 10.1080/21556660.2019.1626735.

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