NEW YORK (Reuters Health)—About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according to results of the first prospective study to evaluate this.
CT-P13 is the first biosimilar monoclonal antibody of reference infliximab (Remicade) approved in Europe and several other countries where it is known as Remsima. An advisory committee to the U.S. Food and Drug Administration endorsed it, and the FDA approved the treatment in April. But until now, data on the effect of CT-P13 on mucosal healing were lacking.
To investigate, Dr. Tamas Molnar of University of Szeged in Hungary and colleagues studied 63 UC patients (mean age 30, mean disease duration 5.7 years) who received CT-P13 induction therapy at three IBD clinics in Hungary and one in the Czech Republic. Reasons for starting CT-P13 included acute, severe flare up and chronic, refractory activity.
CT-P13 induction consisted of 5 mg/kg given as an intravenous infusion at Weeks 0, 2 and 6 followed by a maintenance regimen of 5 mg/kg every eight weeks, except for one Czech patient with acute severe disease who received an induction dose of 10 mg/kg.
At baseline, the mean value of total Mayo score was 9.2, with mean endoscopic subscore (eMayo) of 2.7 points at the beginning of the CT-P13 therapy.
At Week 14, the mean value of total Mayo score dropped to 3.4, with eMayo of 1.1. Both scores decreased significantly in responders at Week 14 compared with baseline (p<0.001 and p<0.001)
The cumulative clinical response rate was 82.5%. Steroids could be tapered and stopped in 60% of the patients on systemic corticosteroids at entry.
At Week 14, sigmoidoscopy showed mucosal healing in 38 patients (60.3%), the authors report. Thirty patients (47.6%) had steroid-free mucosal healing. Complete mucosal healing (eMayo of 0) was achieved in 17 (27%) patients. Trough levels of CT-P13 correlated with mucosal healing.
“Infliximab biosimilar CT-P13 represents a promising treatment option for patients with UC not only regarding clinical activity, but also in achieving mucosal healing,” the authors conclude in their paper, online on April 21 in the Journal of Crohn’s and Colitis.
In a related paper in the journal, online on April 19, Dr. Lisa Smits from Radboud University Medical Centre and colleagues report short-term clinical outcomes following a switch from brand name infliximab to CT-P13 in a “real-life” cohort of 83 patients with inflammatory bowel disease.