Quick Take: Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study

Anti-tumor necrosis factor (TNF) therapies are commonly used in the treatment of patients with moderate to severe Crohn’s disease. However, due to the high costs of anti-TNF medications, biosimilar medications are being developed. These drugs have high likeness to already licensed biological therapies and are subject to strict approval criteria by regulatory authorities. CT-P13 is a biosimilar version of infliximab, an anti-TNF monoclonal antibody, and has been approved based on randomized controlled trials in patients with ankylosing spondylitis and rheumatoid arthritis. However, CT-P13 has not yet been studied in patients with Crohn’s disease. In this randomized controlled phase III non-inferiority study, 220 patients with active Crohn’s disease with no response or intolerance to non-biological treatments were assigned in a 1:1:1:1 ratio to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. The primary outcome was the proportion of patients with a decrease of at least 70 points in the Crohn’s Disease Activity Index (CDAI) from baseline to week 6. A non-inferiority margin of -20% was used. Overall, 166 patients completed the study, with lack of response at week 14 being the most common reason for discontinuation. Researchers found that, in the intention-to-treat population, CT-P13 was noninferior to infliximab in the achievement of a CDAI-70 response at week 6 (69.4% of patients who received CT-P13 first vs. 74.3% of patients who received infliximab first, difference -4.9%, 95% CI -16.9% to 7.3%). Similarly, CT-P13 was found to be noninferior to infliximab in terms of the CDAI-70 response at weeks 14 and 30, and also in terms of the proportion of patients achieving clinical remission at weeks 6,14, and 30. The proportion of patients with at least one treatment-emergent adverse event was similar between all groups. In conclusion, results from this study show that CT-P13 has a similar efficacy and safety profile to infliximab in the treatment of patients with active Crohn’s disease

Click to read the study in Lancet

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